U.S. GOVERNMENT PUBLISHING OFFICE

26–785 WASHINGTON : 2018

EXAMINING IMPROVEMENTS TO THE REGULATION 

OF MEDICAL TECHNOLOGIES 

HEARING 

BEFORE THE

SUBCOMMITTEE ON HEALTH 

OF THE

COMMITTEE ON ENERGY AND 

COMMERCE 

HOUSE OF REPRESENTATIVES 

ONE HUNDRED FIFTEENTH CONGRESS 

FIRST SESSION 

MAY 2, 2017 

Serial No. 115–28 

( 

Printed for the use of the Committee on Energy and Commerce 

energycommerce.house.gov 

(II) 

COMMITTEE ON ENERGY AND COMMERCE 

GREG WALDEN, Oregon 

Chairman 

JOE BARTON, Texas 

Vice Chairman 

FRED UPTON, Michigan 

JOHN SHIMKUS, Illinois 

TIM MURPHY, Pennsylvania 

MICHAEL C. BURGESS, Texas 

MARSHA BLACKBURN, Tennessee 

STEVE SCALISE, Louisiana 

ROBERT E. LATTA, Ohio 

CATHY MCMORRIS RODGERS, Washington 

GREGG HARPER, Mississippi 

LEONARD LANCE, New Jersey 

BRETT GUTHRIE, Kentucky 

PETE OLSON, Texas 

DAVID B. MCKINLEY, West Virginia 

ADAM KINZINGER, Illinois 

H. MORGAN GRIFFITH, Virginia 

GUS M. BILIRAKIS, Florida 

BILL JOHNSON, Ohio 

BILLY LONG, Missouri 

LARRY BUCSHON, Indiana 

BILL FLORES, Texas 

SUSAN W. BROOKS, Indiana 

MARKWAYNE MULLIN, Oklahoma 

RICHARD HUDSON, North Carolina 

CHRIS COLLINS, New York 

KEVIN CRAMER, North Dakota 

TIM WALBERG, Michigan 

MIMI WALTERS, California 

RYAN A. COSTELLO, Pennsylvania 

EARL L. ‘‘BUDDY’’ CARTER, Georgia 

FRANK PALLONE, JR., New Jersey 

Ranking Member 

BOBBY L. RUSH, Illinois 

ANNA G. ESHOO, California 

ELIOT L. ENGEL, New York 

GENE GREEN, Texas 

DIANA DEGETTE, Colorado 

MICHAEL F. DOYLE, Pennsylvania 

JANICE D. SCHAKOWSKY, Illinois 

G.K. BUTTERFIELD, North Carolina 

DORIS O. MATSUI, California 

KATHY CASTOR, Florida 

JOHN P. SARBANES, Maryland 

JERRY MCNERNEY, California 

PETER WELCH, Vermont 

BEN RAY LUJA ́ N, New Mexico 

PAUL TONKO, New York 

YVETTE D. CLARKE, New York 

DAVID LOEBSACK, Iowa 

KURT SCHRADER, Oregon 

JOSEPH P. KENNEDY, III, Massachusetts 

TONY CA ́ RDENAS, California 

RAUL RUIZ, California 

SCOTT H. PETERS, California 

DEBBIE DINGELL, Michigan 

(III) 

SUBCOMMITTEE ON HEALTH

MICHAEL C. BURGESS, TEXAS

Chairman 

BRETT GUTHRIE, Kentucky 

Vice Chairman 

JOE BARTON, Texas 

FRED UPTON, Michigan 

JOHN SHIMKUS, Illinois 

TIM MURPHY, Pennsylvania 

MARSHA BLACKBURN, Tennessee 

CATHY MCMORRIS RODGERS, Washington 

LEONARD LANCE, New Jersey 

H. MORGAN GRIFFITH, Virginia 

GUS M. BILIRAKIS, Florida 

BILLY LONG, Missouri 

LARRY BUCSHON, Indiana 

SUSAN W. BROOKS, Indiana 

MARKWAYNE MULLIN, Oklahoma 

RICHARD HUDSON, North Carolina 

CHRIS COLLINS, New York 

EARL L. ‘‘BUDDY’’ CARTER, Georgia 

GREG WALDEN, Oregon (ex officio) 

GENE GREEN, Texas 

Ranking Member 

ELIOT L. ENGEL, New York 

JANICE D. SCHAKOWSKY, Illinois 

G.K. BUTTERFIELD, North Carolina 

DORIS O. MATSUI, California 

KATHY CASTOR, Florida 

JOHN P. SARBANES, Maryland 

BEN RAY LUJA ́ N, New Mexico 

KURT SCHRADER, Oregon 

JOSEPH P. KENNEDY, III, Massachusetts 

TONY CA ́ RDENAS, California 

ANNA G. ESHOO, California 

DIANA DEGETTE, Colorado 

FRANK PALLONE, JR., New Jersey (ex 

officio) 

(V) 

C O N T E N T S 

Page 

Hon. Michael C. Burgess, a Representative in Congress from the State of 

Texas, opening statement .................................................................................... 1 

Prepared statement .......................................................................................... 2 

Hon. Gene Green, a Representative in Congress from the State of Texas, 

opening statement ................................................................................................ 4 

Hon. Greg Walden, a Representative in Congress from the State of Oregon, 

opening statement ................................................................................................ 5 

Prepared statement .......................................................................................... 6 

Hon. Frank Pallone, Jr., a Representative in Congress from the State of 

New Jersey, opening statement .......................................................................... 8 

Prepared statement .......................................................................................... 8 

WITNESSES

Jeffrey Shuren, M.D., J.D., Director, Center for Devices and Radiological 

Health, Food and Drug Administration ............................................................. 10 

Prepared statement .......................................................................................... 11 

Thomas Powers, Ph.D., Powers Consulting, LLC ................................................. 36 

Prepared statement .......................................................................................... 38 

Frank Lin, M.D., Ph.D., Associate Professor of Otolaryngology, Head and 

Neck Surgery, Geriatric Medicine, Mental Health, and Epidemiology, Johns 

Hopkins University .............................................................................................. 52 

Prepared statement .......................................................................................... 54 

Joe Robinson, Senior Vice President, Health Systems Solutions, Philips North 

America ................................................................................................................. 61 

Prepared statement .......................................................................................... 63 

Robert Kerwin, General Counsel, International Association of Medical Equipment Remarketers and Servicers ........................................................................ 128 

Prepared statement .......................................................................................... 130 

Patricia Shrader, Vice President, Global Regulatory Affairs, Medtronic ............ 140 

Prepared statement .......................................................................................... 142 

SUBMITTED MATERIAL

Statement of Senators Warren, Grassley, Hassan, Isakson, submitted by Mrs. 

Blackburn ............................................................................................................. 161 

Statement of Consumer Technology Association, submitted by Mrs. Blackburn ....................................................................................................................... 162

Statement of AARP, submitted by Mr. Kennedy .................................................. 164 

Statement of the Academy of Doctors of Audiology, submitted by Mr. Kennedy ....................................................................................................................... 165

Statement of the National Committee to Preserve Social Security & Medicaid, 

submitted by Mr. Kennedy .................................................................................. 167 

Statement of Consumers Union, April 17, 2017, submitted by Mr. Kennedy .... 168 

Statement of Hearing Loss Association of America, submitted by Mr. Kennedy ....................................................................................................................... 170

Statement of Bose Corporation, submitted by Mr. Kennedy ............................... 172 

Statement of TriMedx, submitted by Mr. Kennedy .............................................. 173 

Article entitled, ‘‘No more suffering in silence?,’’ Consumer Reports, March 

2017, submitted by Mr. Burgess ......................................................................... 179 

Statement of the International Hearing Society, submitted by Mr. Burgess ..... 185 

Statement of the American Speech-Language-Hearing Association, submitted 

by Mr. Burgess ..................................................................................................... 190 

Statement of the Academy of Doctors of Audiology, submitted by Mr. Burgess 192 

Page

VI 

Statement of the American Academy of Otolaryngology—Head, and Neck 

Surgery, submitted by Mr. Burgess .................................................................... 201 

Statement of the Consumer Technology Association, submitted by Mr. Burgess ........................................................................................................................ 204 

Statement of Consumers Union, May 1, 2017, submitted by Mr. Burgess ......... 206 

Statement of Repair.org, submitted by Mr. Burgess ............................................ 210 

Statement of the Association of Medical Device Service Organizations, submitted by Mr. Burgess ......................................................................................... 213 

Statement of Mobile Instrument Service & Repair, submitted by Mr. Burgess 215 

(1) 

EXAMINING IMPROVEMENTS TO THE 

REGULATION OF MEDICAL TECHNOLOGIES 

TUESDAY, MAY 2, 2017 

HOUSE OF REPRESENTATIVES, SUBCOMMITTEE ON HEALTH, COMMITTEE ON ENERGY AND COMMERCE, Washington, DC. 

The subcommittee met, pursuant to call, at 10:03 a.m., in room 

2123, Rayburn House Office Building, Hon. Michael Burgess, M.D. 

(chairman of the subcommittee) presiding. 

Present: Representatives Burgess, Guthrie, Barton, Upton, Shimkus, Blackburn, Lance, Griffith, Bilirakis, Long, Bucshon, Brooks, 

Mullin, Hudson, Collins, Carter, Walden (ex officio), Green, Engel, 

Schakowsky, Butterfield, Castor, Sarbanes, Schrader, Kennedy, 

Eshoo, and Pallone (ex officio). 

Also Present: Representatives Dingell and Costello. 

Staff Present: Ray Baum, Staff Director; Zachary Dareshori, 

Staff Assistant; Daryll Dykes, Health Fellow; Paul Edattel, Chief 

Counsel, Health; Jay Gulshen, Legislative Clerk, Health; Katie 

McKeough, Press Assistant; Carly McWilliams, Professional Staff 

Member, Health; Alex Miller, Video Production Aide and Press Assistant; Danielle Steele, Policy Coordinator, Health; John Stone, 

Senior Counsel, Health; Jeff Carroll, Minority Staff Director; 

Samantha Satchell, Minority Policy Analyst; Kimberlee Trzeciak, 

Minority Senior Health Policy Advisor; and C.J. Young, Minority 

Press Secretary. 

OPENING STATEMENT OF HON. MICHAEL C. BURGESS, A 

REPRESENTATIVE IN CONGRESS FROM THE STATE OF TEXAS 

Mr. BURGESS. The Subcommittee on Health will now come to 

order. The chair recognizes himself for 5 minutes for the purposes 

of an opening statement. 

Today’s hearing is another step in the subcommittee’s work to reauthorize the Food and Drug Administration’s user fee agreements 

with industry. This subcommittee has held three hearings on the 

user fee program, during which time members have examined proposed agreements for generic drugs, biosimilar products, branded 

drugs, and medical devices. 

Last month, bipartisan leaders of the Senate and House Committees on Health released a discussion draft to reauthorize those 

agreements. Today, we will consider several bipartisan bills intended to further improve the regulation of medical technologies. 

This is one of my top priorities, is to build upon this committee’s 

work in the 21st Century Cures Act to get safe and effective treatVerDate Nov 24 2008 15:18 Oct 24, 2018 Jkt 037690 PO 00000 Frm 00007 Fmt 6633 Sfmt 6633 I:\MY DOCS\HEARINGS 115\HEARINGS\115-28 CHRIS
2 

ments to patients and providers without unnecessary delay. H.R. 

1652, the Over-the-Counter Hearing Aid Act of 2017, would implement recommendations from the President’s Council of Advisors on 

Science and Technology and the National Academies of Sciences, 

Engineering, and Medicine. 

Specifically, H.R. 1652 would direct the Food and Drug Administration to promulgate regulations establishing a category for overthe-counter hearing aids. This category of over-the-counter hearing 

aids would be limited to use by adults with mild to moderate hearing loss. Representatives Blackburn, Kennedy, and Carter introduced this bill to safely increase access and affordability in the 

hearing aid market for millions of Americans from whom it would 

benefit. 

Representatives Costello and Peters introduced H.R. 2009, the 

Fostering Innovation and Medical Imaging Act of 2017. This bill 

seeks to improve the regulation and the oversight of medical imaging devices intended for or used in conjunction with contrast 

agents. 

H.R. 2009 takes targeted steps to reduce excessive regulatory 

burdens so that patients and physicians have access to a robust 

market of medical imaging technologies. 

H.R. 2118, the Medical Device Servicing Safety and Accountability Act, also introduced by Representatives Costello and Peters, 

would require all medical device servicers to register with the Food 

and Drug Administration and maintain a compliant handling system. 

Currently, only original equipment manufacturers are required 

to register and report. This bill seeks to increase visibility and accountability for all parties servicing medical devices in order to ensure that devices that are used for patient care continue to perform 

safely and effectively. 

Representatives Bucshon, Peters, Brooks, and Butterfield introduced the fourth bill we will consider today, H.R. 1736. This bill 

would modernize the Food and Drug Administration’s device inspections to increase its consistency and transparency. More specifically, H.R. 1736 would establish risk-based inspections, the 

schedule for device facilities, standardized inspection processes, 

and increased transparency around FDA determinations related to 

inspections. 

Each of these bills we will examine today is intended to increase 

innovation and increase access to medical devices and technology 

by making certain that the regulatory environment is consistent, 

effective, and agile, ensuring that patients and providers continue 

to benefit from safe and innovative medical technology. 

This is a shared priority in our work to reauthorize the Food and 

Drug Administration user fee programs. I will thank all of our witnesses in advance for being here. I look forward to hearing from 

each of you about how these proposals might improve our ability 

to meet this goal. 

[The prepared statement of Mr. Burgess follows:] 

PREPARED STATEMENT OF HON. MICHAEL C. BURGESS

The Subcommittee will come to order. 

The Chair will recognize himself for an opening statement. 

3 

Today’s hearing is another step in this subcommittee’s work to reauthorize the 

Food and Drug Administrations’ user fee agreements with industry. The subcommittee has held three hearings on the user fee program, during which time 

members examined proposed agreements for generic drugs, biosimilar products, 

branded drugs, and medical devices. Last month, bipartisan leaders of the Senate 

and House committees on health released a discussion draft to reauthorize those 

agreements. Today we will consider several bipartisan bills intended to further improve the regulation of medical technologies. It is my top priority to build upon this 

committee’s work in the 21st Century Cures Act to get safe and effective treatments 

to patients and providers without unnecessary delay. 

H.R. 1652, the Over-the-Counter Hearing Aid Act of 2017, would implement recommendations from the President’s Council of Advisors on Science and Technology, 

and the National Academies of Science Engineering and Medicine. Specifically, H.R. 

1652 would direct FDA to promulgate regulations establishing a category for overthe-counter hearing aids. This category of OTC hearing aids would be limited to use 

by adults with mild to moderate hearing loss. Representatives Kennedy, Blackburn, 

and Carter introduced this bill to safely increase access and affordability in the 

hearing aid market for the millions of Americans that could benefit from it. 

Representatives Costello and Peters introduced H.R. 2009, the Fostering Innovation in Medical Imaging Act of 2017. This bill seeks to improve the regulation and 

oversight of medical imaging devices intended for used in conjunction with contrast 

agents. H.R. 2009 takes targeted steps to reduce excessive regulatory burdens so 

that patients and physicians have access to a robust market of medical imaging 

technologies. 

H.R. 2118, the Medical Device Servicing and Accountability Act, also introduced 

by Representatives Costello and Peters, would require all medical device servicers 

to register with the FDA and maintain a complaint handling system-currently, only 

original equipment manufacturers are required to register and report. This bill 

seeks to increase visibility and accountability for all parties servicing medical devices in order to ensure that devices used for patient care continue to perform safely 

and effectively. 

Representatives Bucshon, Peters, Brooks, and Butterfield introduced the fourth 

bill we will consider today, H.R. 1736. This bill would modernize FDA’s device inspections process to increase its consistency and transparency. More specifically, 

H.R. 1736 would establish a risk-based inspections schedule for device facilities, 

standardize inspection processes, and increase transparency around FDA determinations related to inspections. 

Each of the bills we will examine today is intended to increase innovation and 

access to medical devices and technology by making certain that the regulatory environment is consistent, effective, and agile. 

Ensuring that patients and providers continue to benefit from safe and innovative 

medical technology is a shared priority in our work to reauthorize the FDA user fee 

programs. I thank all of our witnesses for being here, and I look forward to hearing 

from each of you about how these proposals might improve our ability to meet this 

goal. 

Mr. BURGESS. I would like to yield my remaining time to Dr. 

Bucshon from Indiana for his opening statement. 

Mr. BUCSHON. Thank you, Mr. Chairman. 

H.R. 1736 seeks to improve the inspections process for medical 

technology manufacturers. The legislation achieves this goal by applying a risk-based approach to the frequency and nature of device 

establishment inspections resulting in a reduction of the burden on 

establishments with a strong history of compliance and by allowing 

the FDA to focus its resources where they are needed most. 

H.R. 1736 also enhances the communication between the FDA 

and manufacturers to provide more certainty and stability for device establishments. I would like to thank Mrs. Brooks, Mr. 

Butterfield, Mr. Peters, for their leadership on this legislation. 

I look forward to working with you, Dr. Shuren, as we move the 

legislation forward. 

I yield back the balance of my time. 

4 

Mr. BURGESS. The chair thanks the gentleman. The gentleman 

yields back. 

The chair now recognizes the ranking member of the subcommittee, Mr. Green of Texas, 5 minutes for an opening statement, please. 

OPENING STATEMENT OF HON. GENE GREEN, A 

REPRESENTATIVE IN CONGRESS FROM THE STATE OF TEXAS 

Mr. GREEN. Thank you, Mr. Chairman. 

Thank you to our witnesses for being here today. 

Today, we are examining legislative proposals to improve the 

regulation of medical technologies. Many of these ideas follow up 

on the work we did in 21st Century Cures Act and build on negotiated agreements between the FDA and stakeholders to reauthorize the medical device user fee agreement. 

I want to thank the bill sponsors, the FDA, and the broader 

stakeholder community for their efforts to improve the innovation 

pipeline and ultimately giving patients access to technologies and 

therapies that can improve their lives. 

One of the bills we are considering, H.R. 1652, the Over-theCounter Hearing Aid Act, establishes a category for over-thecounter, or OTC, hearing aids. Approximately 30 million Americans 

have hearing loss, and that number will only get bigger as the baby 

boomer population ages. Despite being a common problem that has 

significantly hampered quality of life if left untreated, only 15 to 

30 percent of the people who benefit from assistive hearings technologies actually use them. There are several reasons for low adoption rates, but one of the main barriers is cost. The legislation 

builds on a recommendation made by the President’s Council of Advisors in Science and Technology in 2015 and the National Academies of Sciences, Engineering, and Medicine in 2016 to allow for 

safe and effective OTC hearing aids to be developed. 

The goal is to find an easier, less costly way to address hearing 

loss while providing for standards in products and FDA oversight 

to ensure safety. I look forward to hearing more about this important legislation. 

We are also considering H.R. 1736, which would improve the 

process of FDA inspections of medical device establishments and 

for granting export certificates to foreign countries. The FDA is responsible for inspecting medical devices and medical device establishment to ensure consumer safety. Under current law, registered 

establishments of moderate- or high-risk devices are to be inspected every 2 years, though real-world feasibility of this has created discrepancies in the inspection process across the sector, 

which can be disruptive and don’t necessarily advance patient safety. This bill models off of improvements we have made in inspections of drug facilities. It will help ensure the FDA is able to use 

its resources to protect patient safety while giving industry additional certainty and predictability and reduce preventable disruptions in the daily workflow. 

We are also H.R. 2009, the Fostering Innovation in Medical Imaging Act. Contrast agents complement innovations in diagnostic 

imaging. They must be improved by FDA for specific use; however, 

due to the labeling constraints, FDA is hamstrung in its ability to 

5 

improve the use of a contrast agent that has been approved for one 

part of the body to be used in another despite extremely similar parameters of use. This legislation would allow FDA to improve the 

imaging device using a contrast agent if the contrast agent has the 

same dose rate and route of admission, affecting the same region 

of the body, used in the same patient population as the same imaging modality as the initial approval without the agent having to 

submit a supplemental application. 

This challenge reminds me of what we dealt with when trying to 

improve the process in which antimicrobial susceptibility test can 

be used to update break points to test for resistance. I look forward 

to learning more about this commonsense reform. 

Finally, we are considering legislation to bring more oversight 

and patient protections to the third-party servicing process. Many 

medical devices require servicing and maintenance over their 

lifecycle. This can be done by the original manufacturer or a third 

party. While original manufactures are required to registered with 

the FDA and comply with quality systems regulations and avoid 

adverse events, third-party services are not. There is a growing 

concern that not all third-party providers are equally qualified and 

that alterations to the devices, high-risk products, like an MRI machine, are not documented and can impact safety of use. Like a mechanic working on your car, improper servicing can have safety implications. 

H.R. 2118, the Medical Device Servicing Safety and Accountability Act, will require third-party providers to register with the 

FDA, to maintain a complaint handling system, and submit severe 

adverse reports if they become aware of major malfunctions. I look 

forward to hearing more about this important legislation. 

Each of these proposals has been introduced in a bipartisan manner, and I hope to learn more about these worthy ideas. 

And I want to thank our witnesses, again, for being here this 

morning. 

Mr. Chairman, I yield back my time. 

Mr. BURGESS. The chair thanks the gentleman. The gentleman 

yields back. 

The chair recognizes the gentleman from Oregon, Mr. Walden, 

chairman of the full committee, 5 minutes for opening statement, 

please. 

OPENING STATEMENT OF HON. GREG WALDEN, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF OREGON 

Mr. WALDEN. I thank the gentleman from Texas, the chairman, 

for holding this hearing and our witnesses for your testimony 

today. It is very instructive and helpful in our work. 

We meet today to once again discuss the FDA’s vitally important 

user fee programs, as you all know. Throughout these hearings we 

have held examining them this year, I have reiterated the full committee’s support for a timely reauthorization of these user fee 

agreement programs. Good news is we are well on our way. 

To date, the Health Subcommittee has held hearings on each of 

these proposed agreements that were initially submitted to Congress back in January. Since that time, we have translated those 

agreements into legislative text, and the committee released that 

6 

with the Senate Health Committee last month, bipartisan, bicameral. As part of that announcement, I have noted we will continue discussions in the House on other member priorities that 

could strengthen this important legislation. 

So today’s hearing is a great opportunity for us to learn more 

about four bipartisan medical device bills that could potentially be 

included in this effort. 

H.R. 1652, the Over-the-Counter Hearing Aid Act, introduced by 

Representatives Kennedy, Carter, and Blackburn, would require 

the FDA to issue regulations establishing a category of OTC hearing aids for adults with perceived mild to moderate hearing loss. 

Both the President’s Council of Advisors in Science and Technology 

and the National Academies have called for this approach. I understand that some patient safety concerns have been raised, and I appreciate the testimony of the FDA and our other witnesses on this 

matter. 

H.R. 2118, the Medical Device Servicing Safety and Accountability Act, introduced by Representatives Costello and Peters, 

would require both original medical equipment manufacturers and 

third-party service providers to register with the FDA and submit 

adverse event reports. 

Now, several small businesses have raised concerns about the 

costs they would incur in registering. I am committed to ensuring 

patient safety while minimizing regulatory burden, and I look forward to learning more about this bill as it goes forward. 

Meanwhile, H.R. 2009, the Fostering Innovation in Medical Imaging Act, also introduced by Representatives Costello and Peters, 

would clarify FDA’s regulation of imaging devices and contrast 

agents. This bill includes commonsense changes that would streamline the regulatory review of these important technologies. 

Finally, Representatives Bucshon, Brooks, Peters, and 

Butterfield have introduced H.R. 1736, which would improve FDA’s 

risk-based approach for inspecting medical device manufacturing 

facilities both domestically and abroad. 

We thank all of our committee members for bringing these bills 

forward. We thank the testimony of our witnesses to help inform 

our decisions, and I look forward to discussing these bills further 

as we move this process along. 

With that, I would yield to the gentlelady from Tennessee the 

balance of my time. 

[The prepared statement of Mr. Walden follows:] 

PREPARED STATEMENT OF HON. GREG WALDEN

Thank you Chairman Burgess. 

As I have previously stated and will reaffirm today, the Energy and Commerce 

Committee is fully committed to a timely reauthorization of FDA’s vitally important 

user fee programs. The good news is that we are well on our way. 

The Health Subcommittee held hearings on each of the proposed agreements that 

were initially submitted to Congress in January. Since that time, we have translated those agreements into legislative language which the committee released with 

the Senate HELP committee several weeks ago. 

As part of that release, I noted that as the legislative process proceeds I look forward to continued discussions with my colleagues in the House on other member 

priorities that could strengthen this important legislation. 

Today’s hearing is a great opportunity for us to learn more about four bipartisan 

medical device bills that could potentially be included. 

7 

H.R. 1652, the Over-the-Counter Hearing Aid Act, introduced by Reps. Kennedy, 

Carter, and Blackburn would require FDA to issue regulations establishing a category of OTC hearing aids for adults with perceived mild to moderate hearing loss. 

Both the President’s Council of Advisors on Science and Technology and the National Academies have called for this approach. I understand that some patient safety concerns have been raised and I look forward to hearing more about that from 

FDA and our witnesses on the second panel. 

H.R. 2118, the Medical Device Servicing and Accountability Act, introduced by 

Reps. Costello and Peters, would require both original medical equipment manufacturers and third-party service providers to register with the FDA and submit adverse event reports. Several small businesses have raised concerns about the costs 

they would incur in registering. I am committed to ensuring patient safety while 

minimizing regulatory burden and look forward to learning more about this bill 

going forward. 

H.R. 2009, the Fostering Innovation in Medical Imaging Act, also introduced by 

Reps. Costello and Peters would clarify FDA’s regulation of imaging devices and 

contrast agents. This bill includes common-sense changes that would streamline the 

regulatory review of these important technologies. 

Last but not least, Reps. Buschon, Brooks, Peters, and Butterfield have introduced H.R. 1736, which would improve FDA’s risk-based approach for inspecting 

medical device manufacturing facilities both domestically and abroad. 

Thank you to all of our witnesses for their testimony and I yield back the balance 

of my time. 

Mrs. BLACKBURN. Thank you, Mr. Chairman. 

And I want to thank you, Dr. Shuren, and all of our witnesses 

who are here today. 

And, Mr. Chairman, I thank you for the hearing and being able 

to move these bills forward. It is so nice when we can say we have 

bipartisan legislation that we are moving forward. And Mr. Kennedy and I are pleased to have worked on the hearing aid bill, as 

it is called, H.R. 1652, and to see it finally moving forward. 

I do want to say for the record that the Academy of Doctors of 

Audiology, the oldest independent national audiology association 

and the leading authoritative body in private practice audiology, 

has been a proponent of this legislation. It is a win-win situation 

for consumers, for patients, and for innovation. And the ADA notes 

that creating an FDA-regulated OTC hearing device market will 

foster competition, broaden consumer choice, improve affordability, 

and accelerate innovation without increasing existing risk to the 

public. As I said, this creates a win-win environment. 

Additionally, in support of H.R. 1652, the Over-the-Counter 

Hearing Aid Act of 2017, I would like to submit a letter for the 

record authored by my Senate colleagues Senators Warren, Grassley, Hassan, Isakson; and a letter of support by the Consumer 

Technology Association. 

Mr. BURGESS. Without objection, so ordered. 

[The information appears at the conclusion of the hearing.] 

Mrs. BLACKBURN. Thank you, Mr. Chairman. 

I yield back. 

Mr. BURGESS. The chair thanks the gentlelady. The gentlelady 

yields back. 

The chair now recognizes the gentleman from New Jersey, ranking member of the full committee, Mr. Pallone, for 5 minutes of 

opening statement, please. 

8 

OPENING STATEMENT OF HON. FRANK PALLONE, JR., A REPRESENTATIVE IN CONGRESS FROM THE STATE OF NEW JERSEY 

Mr. PALLONE. Thank you, Mr. Chairman. 

Today we are examining additional legislation that would help to 

improve the way the Food and Drug Administration reviews medical device products. Medical devices have made enormous advances over the last few decades, and new and emerging technologies hold a promise to treat and cure diseases in ways previously not thought of. While not the subject of today’s hearings, 

reauthorizing the medical device user fee amendments will help to 

ensure that FDA has the resources and personnel needed to continue to improve upon the medical device review process and to 

work with industry to bring devices to market more efficiently. And 

I look forward to working with my colleagues to have all of the user 

fee agreements considered and sent to the President hopefully 

early this summer. 

I understand that members are interested in exploring the possibility of attaching additional policy to the user fee agreements. 

This hearing provides the opportunity to learn more about whether 

these bills meet the test of being noncontroversial and enjoying 

broad bipartisan support. And today we will be hearing from witnesses about the following four bills. I think that we have pretty 

much covered these bills. So I don’t want to go into the details 

about them because I think my colleagues have already done that. 

So I just wanted to say I look forward to learning more from Dr. 

Shuren as well as our stakeholders about their interest in the legislation before us, and I would yield the balance of my time or 

whatever time he wants to Mr. Kennedy. 

[The prepared statement of Mr. Pallone follows:] 

PREPARED STATEMENT OF HON. FRANK PALLONE, JR. 

Thank you, Mr. Chairman. Today we are examining additional legislation that 

will help to improve the way the Food and Drug Administration reviews medical device products. 

Medical devices have made enormous advances over the last few decades, and new 

and emerging technologies hold the promise to treat and cure diseases in ways previously not thought of. While not the subject of today’s hearing, reauthorizing the 

Medical Device User Fee Amendments will help to ensure that FDA has the resources and personnel needed to continue to improve upon the medical device review 

process and to work with industry to bring devices to market more efficiently. I look 

forward to working with my colleagues to have all of the user fee agreements considered and sent to the President early this summer. 

I understand that Members are interested in exploring the possibility of attaching 

additional policy to the user fee agreements. This hearing provides the opportunity 

to learn more about whether these bills meet the test of being non-controversial and 

enjoying broad bipartisan support. 

Today we will be hearing from our witnesses about the following four bills: 

• H.R. 1652, sponsored by Representatives Kennedy, Blackburn, and Carter, 

would direct FDA to establish by regulation a category of over-the-counter hearings 

aids for adults with perceived mild to moderate hearing loss. This bill could open 

up access to affordable hearing aid devices for the more than 37 million American 

adults who suffer from hearing loss today. 

• H.R. 2009, sponsored by Representative Peters and Costello, would clarify the 

FDA review process for new indications of contrast agents used with medical imaging devices. 

• H.R. 2118, also sponsored by Representative Peters and Costello, would require 

third party service providers of medical devices to register with the FDA, maintain 

9 

a complaint handling system, and submit adverse event reports as original equipment manufacturers do today. • And finally, H.R. 1736, sponsored by Representatives Peters, Butterfield, 

Buschon, and Brooks, would move FDA inspections of medical device facilities to a 

risk-based schedule, and would improve communication between FDA and industry 

throughout the inspection process. 

I look forward to learning more from Dr. Shuren, as well as our other stakeholders, about their interests in the legislation before us. 

Mr. KENNEDY. Thank you to Mr. Pallone. 

I want to thank Chairman Walden—both of them—for convening 

this important bipartisan hearing today. 

By beginning these conversations now, we can begin to prepare 

for innovation taking place in our districts across the country. 

To all of the witnesses, thank you for taking the time to testify 

before our committee to help guide us as we consider these four 

bills. And I would specifically be interested in hearing your 

thoughts on our Over-the-Counter Hearing Aid Act. 

Finally, to my cosponsor, Congresswoman Blackburn, it has been 

an honor to work with you on this bill. I am looking forward to 

working with you in the months ahead. I think the idea of a Blackburn-Kennedy-Warren-Grassley combination is a winning one 

going forward on a whole bunch of stuff. 

So many of us here today have experienced the pain and frustration of loved ones beginning to lose their hearing. Shared experiences at large gatherings, like sporting events, concerts, become 

less enjoyable. Balance and health begin to decline. And even personal one-on-one conversations become challenging. Nearly half of 

Americans over 60 years old experience hearing loss. But a pair of 

hearing aids can cost anywhere from $4,000 to $6,000, and Medicare will not cover them. Too many of our neighbors, friends, colleagues, relatives will simply choose to suffer without relief. 

With the innovation taking place in our districts and increased 

competition among businesses, we can improve the quality of hearing aids and protect patients while simultaneously lowering costs. 

That is why Congresswoman Blackburn and I introduced this bipartisan legislation and why it already has the support of consumers, doctors, and industry. For Americans who are beginning to 

lose their hearing and the families who love them, we should pass 

this bill quickly. 

Thank you very much to Mr. Pallone. 

I yield back. 

Mr. PALLONE. Thank you. I don’t know if any of my other Democratic colleagues wanted time. 

If not, Mr. Chairman, I will yield back. 

Mr. BURGESS. The gentleman yields back. The chair thanks the 

gentleman. 

This now concludes member opening statements. The chair 

would remind members that, pursuant to committee rules, all 

members’ opening statements will be made part of the record. 

And we do want to thank our witnesses for being here today, for 

taking time to testify before the subcommittee. Each witness will 

have the opportunity to give an opening statement followed by 

questions from members. 

We will have two panels of witnesses today and begin with Dr. 

Jeffrey Shuren, friend of the subcommittee, Director, Center for 

10 

Devices and Radiological Health at the Food and Drug Administration. We certainly appreciate you being here again today, Dr. 

Shuren. You are now recognized for 5 minutes for an opening statement. 

STATEMENT OF JEFFREY SHUREN, M.D., J.D., DIRECTOR, CENTER FOR DEVICES AND RADIOLOGICAL HEALTH, FOOD AND 

DRUG ADMINISTRATION 

Dr. SHUREN. Well, thank you. Chairman Burgess, Ranking Member Green, members of the committee. Thank you for having me 

here today. I am pleased to be back to discuss potential changes 

to the medical device program. 

I first want to say that I greatly appreciate your support for 

timely reauthorization of the medical device user fee amendments, 

or the MDUFA IV. 

As you are well aware, MDUFA has been reauthorized every 5 

years since Congress, including several members on this committee, first created the program. And as the program has evolved, 

FDA and industry have successfully negotiated agreements to improve patient access to medical devices and streamline regulatory 

processes. As we discussed just a few weeks ago, timely reauthorization of MDUFA is critical in order to maintain adequate staffing 

levels and ensure we fulfill our mission of protecting and promoting 

the public health. 

Like you, we at CDRH want patients and healthcare professionals to have timely access to high-quality, safe, and effective 

medical devices first in the world. 

Changes we have made at CDRH to our culture, policies, processes, in addition to user fee funding and direction from Congress 

through changes to Federal law, have resulted in reduced decision 

times, improved medical device pipeline, and innovative technologies being introduced in the U.S. earlier than in the past. We 

want to continue on this course, and we appreciate that additional 

changes to the law can further advance this upward trend. Therefore, I appreciate the opportunity to discuss the bills before us 

today, and I look forward to answering your questions. 

[The prepared statement of Dr. Shuren follows:] 

11 


26785.001

"Examining Improvements to the Regulation 

of Medical Technologies" 

Testimony of 

Jeffrey Shuren, M.D., J.D. 

Director, Center for Devices and Radiological Health 

Before the 

United States House of Representatives 

Committee on Energy and Commerce 

Subcommittee on Health 

May 2, 2017 

U.S. Department of Health and Human Services 

U.S. Food and Drug Administration 

www.fda.gov 

.:,)>,..,...~i~"-"::lo;•.,\. 

{ _.i1P fm:t U.S. FOOD & DRUG 1>,,~,_ • ADMINISTRATION 

RELEASE ONLY UPON DELIVERY 
12 


26785.002

Chairman Walden, Ranking Member Pallone, Chairman Burgess, Ranking Member Green, and 

members ofthe committee: 

Thank you for having me here today. I am JeffShurcn, Director of the Center for Devices and 

Radiological Health (CDRH) at the Food and Drug Administration (FDA). I am pleased to be 

back here today to discuss potential changes to the medical device program. 

I first want to say that I greatly appreciate your support for timely reauthorization of the Medical 

Device User Fee Amendments, or MDUFA IV. 

As you know, MDUFA has been reauthorized every five years since Congress first created the 

program in 2002. In fact, several current members of this committee were instrumental in the 

enactment of MDUFA I. As the program has evolved, I'D A and industry have successfully 

negotiated agreements to improve patient access to safe and effective medical devices and 

streamline regulatory processes. 

As we discussed a few weeks ago, timely reauthorization of MDUFA is critical to maintain 

adequate staffing levels and support our mission of protecting and promoting the public health, 

with the ultimate goal of getting treatments to the patients who need them. Like you, we at 

CDRH want patients and providers to continue to have timely access to safe, effective, and highquality medical devices, first in the world. Retaining the knowledge and expertise of our 

scientific staff is critical to providing predictable and timely medical device reviews. 
13 


26785.003

Changes we have made at CDRH to our culture, policies, and processes-in addition to user fee 

funding and changes to federal law-have resulted in reduced decision times, an improved 

medical device pipeline, and innovative technologies being introduced in the U.S. earlier than in 

the past. We want to continue this upward trend. 

While reauthorization ofMDUFA is the key to maintaining this trajectory, we know that there 

are additional areas of shared interest to improve patient access to safe and effective medical 

devices. Today's hearing is an important opportunity to explore some of these options. FDA is 

ready to work with Congress to make measurable improvements consistent with the approach 

outlined in the Administration's Blueprint Budget, which proposes a different way of financing 

the program. 

2 
14 

Mr. BURGESS. The chair thanks the doctor for his testimony. 

And we will move into the question-and-answer portion of the 

hearing. I recognize myself 5 minutes for questions. 

And, Dr. Shuren, let me ask you: The Food and Drug Administration recently published guidance indicating that it would no 

longer enforce the requirement that adult patients provide a physician’s medical evaluation or sign a waiver to purchase certain hearing aids. In making this announcement, the FDA noted that the 

medical evaluation requirement provided, ‘‘little to no meaningful 

benefit to patients.’’ 

Can you take us through the FDA’s decision to no longer enforce 

this requirement that had been in place since the 1970s? 

Dr. SHUREN. Yes. There had been several studies that had been 

done looking at the FDA’s requirement that there be a medical 

evaluation if not the signing of a waiver. The conclusions were that 

this was serving more as a barrier, not providing benefit to patients, and then this was further reinforced by the recent recommendations by both PCAST and the National Academies of 

Sciences, Engineering, and Medicine, who both recommended that 

we no longer enforce that requirement. 

Mr. BURGESS. So, to the extent that it was an impediment, has 

it impacted consumer access to hearing aids over the years? 

Dr. SHUREN. That is our understanding from both consumers 

who have been asked about it as well as other experts in the field. 

Mr. BURGESS. And so the FDA’s position currently aligns with 

recommendations put forth by the President’s Council of Advisors 

on Science and Technology and the National Academies of Sciences, 

Engineering, and Medicine? 

Dr. SHUREN. Yes. 

Mr. BURGESS. So Dr. Lin will testify on the second panel that 

there is absolutely no medical reason or rationale to consider limiting the intended use of over-the-counter hearing aids to only 

those individuals with a mild hearing loss. Do you agree? 

Dr. SHUREN. Yes. 

Mr. BURGESS. What, then, would be the implications of broadening that so that it included the mild and moderate designations 

in that category? 

Dr. SHUREN. Well, so, if there is an over-the-counter hearing aid 

category, it makes sense, then, it should apply to mild- and moderate-risk consumers, that the appropriate limits, let’s say in output and labeling, could be put on those technologies for appropriate 

use by consumers. Limiting it to just patients with mild hearing 

loss, may deny access for other patients who could benefit from 

hearing aids who otherwise won’t be getting it. 

You have to remember: Today, we have over 30 million Americans who may be suffering from hearing loss, but only around 20 

percent actually go and get hearing aids. So most people don’t even 

bother to get it. We have to find better ways to provide better access and better competition in the marketplace through technology. 

Mr. BURGESS. And then how could we address the concern—like 

children are a special category with hearing aids, having had a 

family member who went through this many, many years ago. 

What are the protections, then, that would exist for—what would 

15 

prevent a parent from just purchasing a hearing aid without an 

evaluation for a child? 

Dr. SHUREN. Well, we are still maintaining the requirement in 

place that there is medical evaluation, the signing at least of a 

waiver, for those individuals who are under the age of 18. 

Mr. BURGESS. Let me ask you: On the medical equipment issue, 

the FDA recently held a public hearing on whether and to what extent additional regulation of third-party service providers was necessary. I would ask you, first, what your takeaways were from that 

meeting and then, secondly, the comments that were submitted to 

the FDA? And if you need to provide those in separate testimony, 

that will be acceptable as well. 

Dr. SHUREN. Certainly. Well, we received about, I think, 176 

comments to the docket. And the comments fell into two broad 

buckets. We heard from the original equipment manufacturers concerns about, at least in some cases, the quality of servicing that 

was provided by third parties, for example, some anecdotal cases 

where the safeguards in place in imaging technology to prevent 

overdose of radiation had been bypassed or cases where lower quality parts were used in the servicing, replacement of those parts for 

endoscopes. 

We also heard concerns from those manufacturers that some of 

the third-party servicers were not providing information about 

problems that were occurring. So they didn’t have a good window 

of what was happening with their technology. 

On the flip side, third-party servicers were complaining about the 

fact that they had some manufacturers who weren’t making device 

specifications available, and they had proprietary testing methods 

that they were not making available, sometimes the need for training that was not made available, and sometimes parts, the replacement parts, not being made available and, therefore, challenges for 

them to provide good servicing. But everyone agreed there is a 

critically important role for third-party servicers in our healthcare 

system. 

Mr. BURGESS. So the underscore there was there was a critical 

need for the third-party servicers? 

Dr. SHUREN. Yes. 

Mr. BURGESS. Very good. 

I yield back the balance of my time. 

I recognize the gentleman from Texas, Mr. Green, 5 minutes for 

questions, please. 

Mr. GREEN. Thank you, Mr. Chairman. 

And, again, thank you for being here today, Doctor, and also the 

work that the FDA, last session, on the cures package. 

Making hearing aids available over the counter holds a potential 

to help reduce costs and thereby increasing access to hearing assistance that might not otherwise be available for certain adult patients. As the FDA and Congress moves forward with the creation 

of an overall category for over the counter for hearing aids, there 

has been discussion about the need to ensure that we are adequately protecting patient safety to prevent patients from suffering 

any further damage in their hearing. 

Dr. Shuren, last fall, the FDA announced that it is committed to 

considering creating a category of OTC hearing aids and noted that 

16 

OTC hearing aids could deliver new and innovative and lower cost 

products to millions of consumers. Can you discuss the benefits of 

creating such a category and how OTC hearing aids could improve 

access and affordability for patients but also to make sure these patients on their own are getting the right hearing assistance? 

Dr. SHUREN. So, on the one hand, as was mentioned, most people 

with hearing loss who would benefit from the hearing aid do not 

seek that out. So providing the opportunity for more access and affordability through competition could lead to then both a drive 

down on costs as well as better products on the market and easy 

access because they are over the counter. At the same time, we 

could see better safeguards put in place. 

In reality, there kind of is OTC products already there. So, for 

years, we have had these personal sound amplifications products 

where people with hearing loss are using them. They are not intended for patients with hearing loss, but they amplify sound, and 

so people are getting the wrong product for their needs. And there 

is a broad range of quality on them. 

The second is, since the regulations we put in effect in 1977, we 

have allowed mail order of hearing aids—you just have to provide 

the waiver—and, since then, have allowed for internet access, and 

you can provide the waiver online as long as that is acceptable to 

the state. What we don’t have, though, is the right information for 

patients out there and output limits for some of those technologies 

to appropriately tailor for the needs of consumers. 

So, if we went with a true OTC category, we now could have better product available for consumers for what they really need, truly 

hearing aids rather than these personal sound amplifications, and 

available in places like the big-box stores that can provide good 

oversight, the Walgreens of the world, better information for them 

so they know how to use it. 

And then, lastly, we are seeing a change in technology. You 

know, before you had these preprogrammed hearing aids, and you 

really needed someone to fit them. Now we are seeing increasingly 

development of self-fitting, self-programmable hearings aids, which 

now allows, then, for better tailoring by the patients themselves, 

which means that, through OTC, we could provide the right product in the right way. 

Mr. GREEN. Thank you. Thank you for your work and folks at the 

FDA last session, I want to recognize your engagement on the 

SOFTWARE Act. I think we got to a good place with that and 

deeply appreciate your input. 

One of the provisions in the part of Cures requires FDA to evaluate device accessories on their own merit as opposed to classifying 

them just based on sophistication of the parent device. As I understand it, implementing the accessories provision is challenging. The 

FDA doesn’t have any tools to do this efficiently. 

Dr. Shuren, how is implementation of that provision progressing? 

Do you feel that you have the necessary authorities to carry out the 

accessories provision in the least burdensome manner both to the 

FDA and the companies? 

Dr. SHUREN. Well, currently, we have some process challenges. If 

we are going to move an accessory that is currently in one classification and should appropriately be moved to another classificaVerDate Nov 24 2008 15:18 Oct 24, 2018 Jkt 037690 PO 00000 Frm 00022 Fmt 6633 Sfmt 6633 I:\MY DOCS\HEARINGS 115\HEARINGS\115-28 CHRIS
17 

tion, the process is so burdensome that it draws away resources 

from our other day-to-day activities. So having a streamlined process could be very helpful to the agency. It would make us use our 

resources more wisely, and it would lead to the right reduction on 

unnecessary regulatory burden on manufacturers. None of this 

changes the scientific decisionmaking that the agency goes through 

to decide the appropriate classification. 

Mr. GREEN. Thank you. I think this committee should consider 

following up on our previous work and look at ways to make the 

regulation of accessories more streamlined so that the intent of the 

SOFTWARE Act that was part of Cures can be realized. I look forward to working with the FDA. 

And I yield back the balance of my time, Mr. Chairman. 

Mr. BURGESS. The chair thanks the gentleman. The gentleman 

yields back. 

The chair now recognizes the gentleman from Kentucky, Mr. 

Guthrie, the vice chairman of the committee, 5 minutes for questions, please. 

Mr. GUTHRIE. Thank you, Mr. Chairman. 

Thanks, Dr. Shuren, for being here again. 

I want to pick up where Dr. Burgess left off dealing with the 

third-party medical equipment. I know you were talking about in 

the last hearing you are in data-gathering mode. You were talking 

about the different comments that you received. At this point, has 

FDA made any determination on what direction to go? 

Dr. SHUREN. We have not. We are still talking with people, still 

gathering information. 

Mr. GUTHRIE. Do you have any idea as you move forward what 

the registration would be like, or what would happen in them moving forward, or what fees might be associated with it? 

Dr. SHUREN. Right. Not at this time. I will say that, under current law, if you register with the FDA, then there are user fees 

that are applied, at least under current law. 

Mr. GUTHRIE. OK. A couple of years back we met in my office 

and discussed manufacturing of medical devices in the United 

States versus people relocating because of the regulatory environment. And we discussed how we can do things safely and effectively but also be less regulatory—or be more friendly in a regulatory environment while securing safety and effectiveness. 

And I have heard positive comments from different people about 

what is moving forward. Could you talk about what is happening 

now with FDA in trying to safeguard the public but also have an 

opportunity to be more friendly in terms of people remaining here 

and not moving jobs overseas? 

Dr. SHUREN. So we have made a conscience effort over the past 

few years to make changes in our culture, our policies, our processes to sort of strike the right balance. What is the smart regulation to have in place? And when I first came to CDRH in 2009, by 

the end of that year, we had approved only 24 novel devices. By 

2016, that number was 91, and it had gone up every year except 

for one. 

In 2016, that is the most number of novel device we had approved since the start of the user fee program; second highest was 

the year before. And a lot of it comes to putting in place patientVerDate Nov 24 2008 15:18 Oct 24, 2018 Jkt 037690 PO 00000 Frm 00023 Fmt 6633 Sfmt 6633 I:\MY DOCS\HEARINGS 115\HEARINGS\115-28 CHRIS
18 

centric benefit-risk frameworks, where we take into account not 

just the benefit-risk of the technologies but the benefit-risk tradeoffs of the decisions that we make. We have had a smart focus, I 

think, on the safety side, how we better use real-world evidence 

both to help technologies come to market but also to identify problems once they are on the market. 

Mr. GUTHRIE. Thank you. And I guess I have heard very positive 

comments from people trying to do their business here in the 

United States and hire American workers. What is FDA doing to 

address the discrepancies between inspections of domestic and foreign manufacturing facilities, and what about discrepancies across 

different districts in the U.S.? 

Dr. SHUREN. So our field staff, which is under our Office of Regulatory Affairs, or ORA, is about to stand up their program alignment, under which they are moving from a geographically-based 

system, their inspectors, to one that is based on commodity. So now 

there will be a medical device program with a director and where 

there are inspectors who only inspect device facilities that are 

across the country, but they report up to the same line of management. And like I said, that will get unveiled in the middle of May. 

Well, it will probably take about a little over another year to finish 

off the structure. We are also going to be looking at changes in 

their processes and their policies so that there is greater consistency in the inspections, both domestically and foreign, as well as 

people who are better focused on, I think, device inspections, which 

means getting higher quality reviews than they already do today. 

Mr. GUTHRIE. OK. Thank you. 

I appreciate the work and the effort that you are doing. 

That completes my questions. I will yield back. If you need more 

time, Mr. Chairman? 

Mr. BURGESS. The chair will be happy if the gentleman yields 

back. 

And I will recognize the gentlelady from California, Ms. Eshoo, 

for 5 minutes of questions, please. 

Ms. ESHOO. Thank you, Mr. Chairman. 

Good morning, Doctor. Nice to see you. Welcome back. 

The first comment, question I have, when I was preparing for today’s hearing last evening, I immediately went to your testimony, 

and it is the first time I have seen testimony that really isn’t testimony. You essentially say: ‘‘Good morning. It is nice to be here. We 

are reauthorizing this and looking forward to chatting with you.’’ 

That may not be the most professional description of it. 

Why—because we have I think, what, four bills before us—isn’t 

there any comment or examination of today’s hearing? 

Dr. SHUREN. So both the agency, Department of Health and 

Human Services, have been going through the legislation. We have 

been asked to provide technical assistance, and so that will be coming in time for review by the committee. But it has not finished 

going through clearance, and that is why you don’t see—— 

Ms. ESHOO. Clearance for what? 

Dr. SHUREN. For the technical assistance. Just the usual process 

as that is reviewed and provided back to Congress. 

Ms. ESHOO. I don’t quite get that. You are not supposed to comment on what is before us in this hearing? 

19 

Dr. SHUREN. Yes, I am commenting. I know people would 

like—— 

Ms. ESHOO. But I mean in written testimony. 

Dr. SHUREN. Yes, but because the technical assistance has not 

yet been finalized, that would be the substance if we were going 

into specific aspects on the testimony. 

Ms. ESHOO. Well, I don’t quite get it. But at any rate, it is the 

thinnest written testimony that, I think, I have ever seen in a 

packet. But at any rate, two questions: On the over-the-counter 

hearing aids, I think that the legislation moves in the direction 

that we need to go. What will protect people from buying the wrong 

thing? Just because it is over the counter does not make anything 

magical. And over the counter, does that connotate a savings in the 

mechanisms that are bought? So, first of all, do we know that there 

will be savings, A? And, B, what about the consumer? How do they 

know what is best for them? They know that they need help, but 

I think the question is still out there between moderate and—what 

is it?—moderate and mild? There are two categories. That is my 

first question. 

My second question is on inspections. In examining the legislation relative to both domestic and foreign inspections, does the legislation advance, I don’t know, a level of thoroughness? Do we lose 

anything? What are we gaining? I am not so sure I understand 

what the difference is between foreign and domestic inspections. 

Now, you just alluded to where you want to improve. It is going 

to take all of about a year to put things together. You are not quite 

ready for prime time to come out with that. 

Does this legislation track with what you are attempting to do? 

Does it go beyond it? So those are my two questions. 

Dr. SHUREN. Certainly. 

Ms. ESHOO. Questions within questions. 

Dr. SHUREN. Yes. So, regarding the OTC hearing aids, you first 

have to start with the practical reality that roughly about 80 percent of people with hearing loss who would benefit from a hearing 

aid never go to get one in the first place. So they never get—— 

Ms. ESHOO. So, if it is over the counter, you would calculate that, 

of the 80 percent that don’t, that maybe 60 percent of the 80 percent will? 

Dr. SHUREN. I don’t think anyone knows the percent—— 

Ms. ESHOO. We just don’t know, right. 

Dr. SHUREN. What we keep hearing, even from consumers, is—— 

Ms. ESHOO. And we want them to get help. I want them to get 

help. 

Dr. SHUREN. Exactly. So that could get them in the door. 

The second is their—putting in place, are there ways in which 

consumers can better identify maybe the extent of hearing loss 

they had and what would be a better option for them. 

Ms. ESHOO. How are they to know that, though? 

Dr. SHUREN. So there is going to be a meeting by the National 

Academies of Sciences, Engineering, and Medicine on June 9. That 

is going to be one of the topics of conversation. There is also we 

are seeing increasingly where some of the technology is building in 

the capability for us to assess the hearing capability of the individual, and that is one of the places where we see the marketplace 

20 

going. So you have technology or at least opportunities through the 

internet for some assessment of the individual that may, then, help 

in the selection of the technology. And the other is, as we see more 

and more technologies that are self-programmable—so they may 

not be locked in. They can then change the setting. But that is not 

going to happen if we don’t create the competitive marketplace for 

it. That is the challenge that we face. 

Ms. ESHOO. And inspections? 

Dr. SHUREN. And then regarding inspections, so for the thoroughness of foreign and domestic, both of them are thorough inspections. We spend the time we need to do. I think the challenge people have raised is, why is it that foreign inspections may take less 

time than domestic? And in part, that is when we send our inspectors to other countries. That is all they are there for: They do the 

inspection. They are done. They are out. 

On the domestic side, that inspector may get called away for another inspection, a for-cause inspection. They may be in the midst 

of one when they start another. Our field realizes they need to 

shrink that overall time for domestic inspections so that companies 

have better assurances it will be done more quickly. The overall 

time to do inspection, though, is pretty much the same. Most of 

those inspections are done in less than 4 or 5 days. Some of them 

are even done in one day. 

In terms of the legislation, it is not inconsistent with what our 

field is doing. In fact, it is complementary. It is one of the challenges of the law today is we are supposed to inspect everybody 

every 2 years. Well, there are over 25,000 medical device facilities 

worldwide. We do about 2,400 G&P surveillance inspections. So we 

can’t even live up to the law. 

And then we are pulled toward you got to see everybody. We 

should be focused on and we can see the value in focus where there 

are the greatest risks and then tailor or our inspections appropriately. So that would be complementary to the change that ORA 

is going to make to the program. 

Ms. ESHOO. Thank you. 

Mr. BURGESS. The gentlelady’s time has expired. 

The chair recognizes the gentleman from Texas, Mr. Barton, for 

5 minutes of questions, please. 

Mr. BARTON. Thank you, Mr. Chairman. It is good to have you 

back. It is good to see you again. 

On the hearing aid issue, what and who determines whether you 

have mild hearing loss or moderate hearing loss? 

Dr. SHUREN. So one is there are standards out there, and what 

we will likely do is start looking at, are there ways—first of all, 

what matters most is, do consumers get the technology that is 

going to best meet their needs, putting aside what the definition 

of what mild to moderate is? And so part of what we are looking 

at is, are there ways to help consumers identify what would be the 

better technology for them? And we are seeing more and more from 

the technology developers then starting to create those services for 

consumers. 

Mr. BARTON. Let’s say go to Walmart and they are allowed to sell 

over-the-counter hearing aids, would there be some sort of a protocol that there would be a sales clerk who could run some test and 

21 

have a chart and say, ‘‘OK, based on this, you have got mild,’’ or 

‘‘based on that, you have got moderate’’? Something like that? 

Dr. SHUREN. I think it is premature to sort of say what would 

be the right mechanism to put in place. That will be part of further 

dialogue. Because if we were to move forward with an OTC category, it would be through a rulemaking process. So there would 

be lots of other public engagement. That is why, as I mentioned, 

there is going to be another meeting from the National Academies 

of Sciences that is going to start addressing these issues. 

But there are a number of different options that may be in place. 

Like I said, some of the technologies themselves are starting to provide or will be providing tools for assessment. You may see there 

is also over-the-counter now audiometric testing that is available. 

And those will be part of a dialogue that we would have about, 

what is the right things to put in place? 

The other piece is we would likely also put output limits on hearing aids depending upon for which of the patient population—— 

Mr. BARTON. Well, at some point in time, if it were obvious that 

the individual seeking to purchase a hearing aid over the counter 

had more than mild loss, would the entity that was selling the 

over-the-counter hearing aid be required to refer them to a specialist so that you prevent somebody who really needs more than 

what the over-the-counter product can provide—you give them a 

way that they refer to some of the trained people who can help 

them? 

Dr. SHUREN. So I don’t want to get ahead of things, but that is 

one of the considerations about what do you do in the circumstance 

if the needs of the consumer is not being met. And that may be either through the recommendations we made back to the consumers 

or those who are providing assessment services. 

Mr. BARTON. OK. On two of the other bills, 2118, the Medical Device Servicing Safety and Accountability Act, that would require 

original equipment manufacturers and third-party providers, service providers, to register with the FDA. 

Is that something that is a necessity that we need to do? Do you 

support that, or is that an open question? 

Dr. SHUREN. Well, we are still in the midst of looking at what 

would be the appropriate, if any, steps to take regarding thirdparty servicers. What registration does do is it at least gives you 

a window on who are those entities that are providing that kind 

of service. 

Mr. BARTON. But under current law, apparently, they are not required to register and to maintain a complaint system. So I am just 

trying to figure out, is there an issue in the marketplace today that 

would require that type of legislation? Is that a problem that is not 

being addressed and this is the correct remedy? 

Dr. SHUREN. Right. And so we are not at the stage where the 

agency or the administration has made a determination one way or 

the other on whether or what action should be taken. But we do 

view, if Congress has a perspective on what we should be doing, 

that would be very helpful. 

Mr. BARTON. You mean you are going to listen to the Congress? 

That is refreshing? 

Dr. SHUREN. We always do what you tell us to. 

22 

Mr. BARTON. You always personally listen. 

And I would ask the same general question about the 1736, the 

modernization of the FDA’s risk-based approach. I strongly support 

a risk-based approach and would just be interested if the FDA has 

a position on that legislation. 

Dr. SHUREN. Yes. So we do see great value in having a risk-based 

approach to inspections. 

Mr. BARTON. I yield back, Mr. Chairman. 

Mr. BURGESS. The gentleman yields back. 

The chair thanks the gentleman. 

The chair recognizes the gentleman from Massachusetts, Mr. 

Kennedy, for 5 minutes for nonconfrontational questions, please. 

Mr. KENNEDY. Never, Mr. Chairman. Thank you. 

I wanted to start, Mr. Chairman, in a nonconfrontational way by 

submitting letters of support for the record for AARP, the ADA, the 

National Committee to Preserve Social Security & Medicaid—— 

Mr. BURGESS. Without objection, so ordered. 

Ms. KENNEDY. Consumers United—I still have a couple more to 

go. —Hearing Loss Association of America and the Consumer Technology Association. 

Mr. BURGESS. I could hear you. I just wasn’t listening. 

Without objection, so ordered. 

[The information appears at the conclusion of the hearing.] 

Mr. KENNEDY. I need more coffee this morning. And thank you, 

again, Mr. Chairman. 

Doctor, it is a pleasure to be with you. I appreciate your testimony. 

I wanted to flesh out a little bit of your testimony earlier, and 

some of the questions I know have been asked by our colleagues 

on both sides of the aisle, of the dais here this morning. 

One of the issues that has come up and that you did comment 

on briefly is around patients’ ability to self-diagnose. And there is 

a critique out there saying that patients can’t, and they are not entirely certain. They might know that they are losing some access 

to hearing, but some uncertainty as to how we might be able to 

craft a product that could meet their need given their unfamiliarity 

with it as a new product in the way that people now can go in and 

buy over-the-counter eyeglasses, but it might have been a little bit 

odd to do so when those first came on the market. I was wondering 

if the FDA might be able to—if you could talk a little bit about the 

concern there and what the FDA has done in any research to mitigate that concern. 

Dr. SHUREN. So, at this point, since we haven’t created that OTC 

category, we have not worked through all the issues about how patients might be able to appropriately self-diagnose and select other 

technology for them to use. 

So we would go through a public process in crafting that. We 

would look forward to working with, you know, the clinical community, the patient community, the industry, and others. 

That is likely to also be an evolving world, as also there is more 

competition in the marketplace. People will compete around their 

ability to provide assessments on hearing loss, not just simply the 

technologies to address hearing loss. 

23 

But all of this, keep in the context of the world today, where 

most people with hearing loss, and they are putting themselves at 

risk, greater risk, for dementia and falling and hospitalization, they 

are just not getting the technology they need. So I think whatever 

we do, there are going to be tradeoffs. We have to walk into this 

with our eyes wide open. But the public health challenges today 

are so great and the status quo today is not adequately addressing 

the needs of the majority of patients with hearing loss that an 

over-the-counter hearing aid category could be one way of trying to 

address those concerns if they are done right and ultimately provide consumers with more choice. 

Mr. KENNEDY. And we have seen some progress already around 

innovation. The FDA did approve an app, if you will, called iHear 

back in 2016, from what I understand, that does—and it provides 

consumers with some ability to discern their needs. Is that so? 

Dr. SHUREN. That is correct. We will see more of that out there, 

particularly if there is a marketplace for consumers who would 

need testing within an OTC environment. 

Mr. KENNEDY. You also touched on a little bit before and just 

now the issue that patients should see a doctor. The question goes 

to whether the loss of hearing might be a precursor to a more serious medical condition and that the ability to get something, a product, over the counter, might delay somebody from going and seeking the more advanced medical support that might be able to diagnose such an issue. Can you touch on those concerns at all? 

Dr. SHUREN. I think the real concern on the medical side is, do 

you have someone with a treatable hearing loss who otherwise 

didn’t get medical attention? And then the practical reality is that 

you have only got about 20 percent of the people with hearing loss 

who are going for a hearing aid. And then, of those, the anecdotal 

numbers are anywhere from 60 to 95 percent of those individuals 

opt to sign a waiver. So they are not even getting a medical evaluation. 

So you have a tiny segment who are getting it. Then, in terms 

of the risky conditions, things like cholesteatoma, acoustic 

neuroma, you add all those up, the really serious causes of hearing 

loss are maybe well under 1 percent. Your biggest treatable is probably ear wax, around 1 to 2 percent. So you are not likely going 

to miss many people. And most people, they are never going for the 

evaluation in the first place. 

Now, on the flip side, if you had an over-the-counter category and 

we had information out for consumers, we could start telling them, 

‘‘Look, if you have particular signs of symptoms,’’ because most of 

the serious conditions have signs and symptoms, ‘‘so if you have 

drainage from your ear, go see your doctor,’’ where right now they 

are not even getting that information to notice these. So it is possible, depending upon how this is crafted, we might get more people in, at least people who should get a medical evaluation, to get 

one. 

Mr. KENNEDY. Thank you, sir. 

And I yield back. 

Mr. BURGESS. The chair thanks the gentleman. The gentleman 

yields back. 

24 

The chair recognizes the gentleman from Illinois, Mr. Shimkus, 

5 minutes for questions, please. 

Mr. SHIMKUS. Thank you, Mr. Chairman. 

Thanks for being here, Dr. Shuren. 

I am going to just kind of focus on this Medical Device Servicing 

Safety and Accountability Act. Can you describe your understanding of how medical equipment service providers are organized? Do you know how they are organized? 

Dr. SHUREN. As an industry or—— 

Mr. SHIMKUS. As an industry, association, et cetera. 

Dr. SHUREN. So there are trade associations for third-party service providers. 

Mr. SHIMKUS. Do some of these work for the original manufacturers, or do they work for hospitals and clinics, or are they independent? Do you know? 

Dr. SHUREN. So you have a mix. Some of these are independent, 

and then they may be contracted with by a hospital. Some have a 

very close relationship with the original equipment manufacturer. 

So the industry is somewhat varied. 

Mr. SHIMKUS. Yes. So, in the second panel, we are going to have 

testimony from Joe Robinson from the Medical Imaging & Technology Alliance and then Robert Kerwin from the Association of 

Medical Equipment Remarketers and Servicers, and obviously, 

there is going to be a conflict here between the two. 

Right now, do you believe there is sufficient justification for the 

U.S. to legislate at this time? 

Dr. SHUREN. So we haven’t taken a position on what, if any, is 

the right course to take. And so part of this dialogue is helpful to 

us. 

Mr. SHIMKUS. Is there a survey being done or—again, in the second panel, in the testimony, you will see some what I think anybody would say are egregious photos of quick or maybe not even 

quick repairs to equipment. You don’t know if that is a one-time 

snapshot of one piece of equipment, or is that endemic of this sector of the healthcare delivery system? 

Dr. SHUREN. Right. So what we have at the moment is the anecdotes, which you have seen in testimony. 

Mr. SHIMKUS. Is it anecdote or anecdotes? 

Mr. SHUREN. Well, you can comfortably say anecdotes. And one 

of the challenges we face is we don’t have reporting requirements 

by third-party services in terms of problems that they may encounter or for complaints that they have, adverse events that occur, 

malfunctions, or complaints. And as a result, there isn’t a great 

window on exactly what is happening out there as opposed to the 

individual experiences that you may get from an equipment manufacturer, from a hospital dealing with the service provider. And 

that is one of the issues of the absence of evidence. It doesn’t mean 

the absence of a problem. It is just that it is hard to sort of say 

the state of it without having that ability for any kind of 

postmarket data collection. 

Mr. SHIMKUS. And I think just why I think it is important to get 

information from you all before we move to see how endemic this 

might be as a problem overall because a couple of things: In rural 

America, small facilities, remarketing of equipment is very, very 

25 

important. It is a great use for areas that don’t have the ability to 

purchase new. The second thing is, obviously, we want these areas 

to be safe, but we also worry about the folks who are servicing 

those through organizations that they don’t incur additional costs 

where, then, they don’t have the access to those medical device 

technologies in smaller rural areas. 

I would hope that, as we move forward, you could be helpful with 

an analysis to say, yes, it is a huge problem, or, no, it is not a huge 

problem and how we can address this to ensure patient safety but 

also make sure we don’t lose access to the smaller, more rural communities for the services that can be provided. 

So, with that, I think this is a great hearing. These are all pretty 

important bills. 

And I yield back the balance of my time. 

Mr. BURGESS. The gentleman yields back. The chair thanks the 

gentleman. 

The chair recognizes the gentlelady from Michigan, Representative Dingell, for 5 minutes of questions. 

The chair recognizes the gentleman from Maryland, Mr. Sarbanes, 5 minutes for questions. 

Mr. SARBANES. I shouldn’t take the full 5 minutes. 

Thank you for your testimony. I was just curious, kind of as an 

aside, is the incidence of hearing loss increasing? Is there any evidence of that in the population? Not just because of an older cohort 

demographically, but just otherwise. 

Dr. SHUREN. We are seeing an increase in hearing loss in younger individuals, and that may be due to more people using headphones and earplugs. 

Mr. SARBANES. I am just looking for ammunition for when I tell 

my kids to stop using earphones all the time. So thank you for 

that. 

Dr. SHUREN. For ammunition, I would talk to ATF. 

Mr. SARBANES. I was curious if there are some other examples 

you could give of situations where there was a technology and service bundled together in a way that made it fairly expensive for people, particularly since there wasn’t coverage by a private health insurance plan or by Medicare, where those, either the bundling has 

been pulled apart or it has led to the kind of over-the-counter solution that we are looking at in this particular case, or whether it 

might have led to a reevaluation of whether it ought to be covered 

by Medicare, for example, and then Medicare became a leader on 

how that is handled, in terms of the commercial plans, et cetera. 

Are there any analogies you can point us to that are instructive either to the process that you are undertaking or generally to our understanding of this particular issue? 

Dr. SHUREN. I am not an expert in the area on the bundling of 

payments. So I don’t have one offhand that is completely analogous. I know some people point to what has happened with reading 

glasses, but there are differences between that scenario and hearing aids. 

Mr. SARBANES. All right. Well, I will save that for another panel. 

Thank you. 

I yield back. 

26 

Mr. BURGESS. The chair thanks the gentleman. The gentleman 

yields back. 

The chair recognizes the gentleman from New Jersey, Mr. Lance, 

5 minutes for questions, please. 

Mr. LANCE. Thank you, Mr. Chairman. 

Good morning to you, Dr. Shuren. Regarding the third-party 

medical device servicing industry, do you know, Doctor, how many 

third-party companies are there? 

Dr. SHUREN. Offhand, I don’t know the exact number. 

Mr. LANCE. Thank you. We have a bill, 1736, that tries to 

streamline the communications process during a facility inspection 

between industry and the FDA. If you would, Doctor, could you 

briefly comment on how the proposed changes in the bill could improve FDA’s ability to oversee device facilities and ensure efficient 

priority resources? 

Dr. SHUREN. From the inspection side? 

Mr. LANCE. From the inspector side. And do you think that it is 

likely that this would be a significant improvement in moving forward? 

Dr. SHUREN. So moving forward, for risk-based would be very 

helpful to us. Right now, given where the law is, we try to spread 

our resources around so we have a better sort of window on what 

goes out there. But being just focused on putting our resources 

where they are most needed would just be a smarter use of our resources and I think a greater public health bang for the buck overall. 

Mr. LANCE. Thank you very much. 

And, Mr. Chairman, I yield back the balance of my time. 

Mr. BURGESS. The chair thanks the gentleman. The gentleman 

yields back. 

The chair recognizes the gentleman from Missouri, Mr. Long, 5 

minutes for questions. 

Mr. LONG. Thank you, Mr. Chairman. 

Doctor, do you believe that there are any safety issues introduced 

in using a contrast agent to image a different part of the body than 

is indicated in the contrast agent label? 

Dr. SHUREN. So there are some cases where that may be the 

case. If we are dealing with changes where we now could, like 

under the bill that has been introduced, have the ability to now approve some new indications for the use of a contrast agent with the 

medical technology through the device presubmission application, I 

think one of the important features is we are able to make that determination based on safety and effectiveness, which is what we do, 

and then the ability not to go ahead and approve it if there would 

be an adverse impact on the safety and effectiveness of that contrast agent. 

Mr. LONG. Are you aware of any examples of the use of medical 

imaging technology with a contrast agent that was approved for 

use in other countries before it was approved for use in the U.S.? 

Dr. SHUREN. Yes. I don’t have offhand, but, yes, there are things 

that occur in other countries that do not necessarily—— 

Mr. LONG. So you are aware that there—— 

Dr. SHUREN. As I understand. I don’t have the—— 

27 

Mr. LONG. Can you have your folks get with my staff and let me 

know? 

Dr. SHUREN. Yes. 

Mr. LONG. It is my understanding that the regulatory situation 

for medical imaging devices used with contrast agents has gone unresolved for nearly 20 years. What do you think it will take for the 

agency to provide a reasonable regulatory pathway for medical imaging devices and contrast agents? 

Dr. SHUREN. The challenge we faced is attorneys have interpreted that we cannot go ahead and approve a medical device with 

a drug, like a contrast agent in that case, that is inconsistent with 

the drug labeling, for that contrast agent. And that has been the 

problem we have been dealing with all these years. We certainly 

see the value, public health benefits, in providing the opportunity 

for us to now go ahead and approve or clear the use of a contrast 

agent with an imaging technology through the device submission 

and, therefore, in the device labeling and maybe inconsistent with 

the drug labeling. And, again, as long as we have the ability, which 

seems to be in the bill, that we wouldn’t approve or clear if there 

was an adverse effect on the safety and effectiveness of that drug, 

namely that the inconsistency doesn’t lead to a problem otherwise 

in the safety and effectiveness of the drug, which that, under the 

bill, we have that ability not to then approve the product in that 

circumstance. This gives us a flexibility that today we don’t have 

and gives us the ability to make those approval and clearance decisions in a least burdensome manner. 

Mr. LONG. OK. Thank you. 

And, Mr. Chairman, I yield back. 

Mr. BURGESS. The chair thanks the gentleman. The gentleman 

yields back. 

The chair recognizes the gentleman from Oklahoma 5 for minutes questions, please. 

Mr. MULLIN. I wasn’t expecting that. I was expecting Bucshon to 

go next. Your question has been answered? 

Well, thank you so much, Doctor, for being here. 

Thank you, Mr. Chairman, for recognizing me. 

At our last Medical Device User Fee Act hearing, we discussed 

my concerns about the inconsistency that we see throughout the 

agency and especially the inconsistency that we see from inspections that happen here versus overseas. Has anything changed on 

that as far as implementing some standard operating procedures? 

Dr. SHUREN. Well, not since the last hearing. 

Mr. MULLIN. Do you think that Mr. Bucshon’s bill would help 

this? 

Dr. SHUREN. So I think it may not directly address, but the opportunities for better interaction/collaboration between the inspectors and the firm that is being inspected is a step forward, and I 

think ultimately—and this was a question you also had asked the 

last time—why will it take so long to make a change? Because ultimately, the big change that has to be made is a change in culture. 

And that is something the field recognizes, but as the head of a 

center that has been going through a culture change, I can tell you 

it takes a long time. Regarding the SOPs, they do plan to change 

the SOPs for conducting inspections so that they are constraining 

28 

the amount of overall time it takes to do a domestic inspection. 

Right now, they have been focused on standing up the organizational structure on program alignment, but that will be officially 

launched as of May 15, and then they will be moving on to the 

other things they need to do, like changes in that SOP. 

Mr. MULLIN. If you are talking about the culture through the 

agency, how do you change that? I mean, legislation doesn’t fix 

that. I was hoping that there would be something that we could 

point to that we could work together. As you and I had discussed, 

we want to work with you. I think my colleague, Mr. Bucshon, that 

is the whole point of this legislation is helping to move that process 

forward to give you authority to build and go and implement. I 

mean, 3 years is what you said at the last hearing, that it would 

take roughly 3 years to implement it. As a business owner, I just 

can’t see that. I can’t see where it would take 3 years. Either people are on board or they are not on board; and if they are not on 

board, then they shouldn’t be in that position. 

Dr. SHUREN. I appreciate that. First off, changes will occur in the 

program. And, again, I am speaking on behalf of another part of 

the agency, but I think people will start seeing changes in the program a lot sooner than that. But for the full change in the program, quite frankly, to change culture, you can’t change it overnight. And, honestly, ask any company that has been through it, 

it does take a while. 

Mr. MULLIN. Sir, you don’t have to ask any company. Ask me. 

I have been through it. We have several businesses. My wife and 

I, we have several hundred employees. I get it. We have purchased 

companies. We brought them in. There has been a difference. But 

when you send out standard operating procedures, ‘‘this is our policy,’’ they are either on board or they are not on board. I understand the personnel, the training, and everything else does take 

time, but implementing a policy change shouldn’t take 3 years to 

put in place. 

And we are wanting to work with you. And I think that is the 

whole point of this legislation, is to work with you, but we are here 

to help. So I am not wanting to get in a back-and-forth with you, 

but I don’t buy the whole thing that it is going to take 3 years. Yes, 

it can take several months. It could even take 12 months to completely change because it does take time to go through and educate 

people. Three years, though, at some point, they are not interested 

in doing their job. At that point, they are interested in just getting 

a paycheck, and that has to change. 

Dr. SHUREN. I appreciate that. And I do think in terms of getting 

to less time spent for domestic inspections, the overall time, that 

is not going to take years. That will take significantly less time. 

Putting the SOP in place, making changes, getting people trained 

up on that, and implementing that, I agree with you, is more on 

the order of a shorter term undertaking. 

Mr. MULLIN. And you may answer this, and then I will yield 

back after this, but do you support this legislation that my colleague is trying to push forward? 

Dr. SHUREN. We do see the value in moving to risk-based inspections and the importance of having better interaction and collaboration between the inspectors and the firms being inspected. And 

29 

we do need, for export certificates, having that better streamlined 

and the resources we need to fully implement that and provide the 

export certificates can be helpful. 

Mr. MULLIN. So I am going to take that as a yes. 

Dr. SHUREN. [Nonverbal response.] 

Mr. MULLIN. All right. 

Mr. Chairman, I yield back. 

Mr. BURGESS. The chair thanks the gentleman. The gentleman 

yields back. 

The chair recognizes the gentleman from Georgia 5 minutes for 

questions, please. 

Mr. CARTER. Thank you, Mr. Chairman. 

Doctor, thank you for being here. 

Some real quick questions, and then we will be done. I just want 

to make sure that we do have indepth studies that we can point 

to, for instance, from the President’s Council of Advisors on Science 

and Technology and also from the National Academies of Sciences, 

Engineering, and Medicine, that they have noted through indepth 

studies that the requirement to obtain a medical evaluation before 

getting a hearing aid has really provided little usefulness and really become a barrier. True? 

Dr. SHUREN. True. 

Mr. CARTER. Secondly, that there is really no credible research 

that demonstrates that the medical evaluation requirement actually leads to the identification and treatment of conditions that you 

wouldn’t probably catch anyway. 

Dr. SHUREN. So, while there can be value in a medical evaluation 

in select individuals, on a population basis and as it is currently 

applied, we see very little value. 

Mr. CARTER. Very little. OK. And then, thirdly, there is really no 

evidence that the required medical evaluation as a condition to 

purchasing a hearing aid is going to improve the outcome for a patient seeking hearing health care? 

Dr. SHUREN. No. I agree, within the current context of today, no, 

because also most people aren’t even coming for the medical evaluation, or they are signing a waiver not to do it. 

Mr. CARTER. Right. Right. OK. Finally, you are comfortable, you 

are comfortable that making hearing aids available OTC and unregulated devices, like the personal sound amplifiers, that this is 

not going to be somehow dangerous to consumers? 

Dr. SHUREN. We think that overall for the population of patients 

with hearing loss, this is likely going to be that we will receive 

greater benefit from this approach than harm that may occur. 

Mr. CARTER. So the benefit outweighs the risk? 

Dr. SHUREN. Yes. 

Mr. CARTER. Thank you, Mr. Chairman. I yield back. 

Mr. BURGESS. The chair thanks the gentleman. The gentleman 

yields back. 

The chair recognizes the gentleman from Michigan, Mr. Upton, 

5 minutes for questions, please. 

Mr. UPTON. Thank you. I was sorry I didn’t get the door opened 

fast enough. It was stuck when I came in the door, which is why 

it slammed. So I didn’t get here in time for the gavel. But most of 

my questions have already been asked. So I just want to take this 

30 

opportunity to again thank you for your help on 21st Century 

Cures. From the beginning, we wanted to make sure that the FDA, 

both on the device side and the pharmaceutical side, had the right 

resources to be able to expedite the approval of these, particularly 

in a domestic way, knowing the jobs would stay here. And your 

participation nationwide was extremely helpful and constructive. 

I know that one of the major issues that this subcommittee is 

going to be looking to move with Dr. Burgess’ and Chairman Walden’s support is both the PDUFA and the MDUFA bill. And I 

would hope that we could move those in the next number of weeks 

because we are all concerned that, without those resources, you 

will have to RIF the people that are there in the agency to make 

these various approvals by midsummer or so. So I just want to 

thank you for your good work. We look forward to continuing to 

partner with you and make sure that you have the appropriate resources to really benefit Americans as well as folks all across the 

globe. 

So, with that, I yield back. 

Mr. BURGESS. The gentleman yields back. The chair thanks the 

gentleman. 

The chair recognizes the gentlelady from Michigan, Mrs. Dingell, 

5 minutes for questions, please. 

Mrs. DINGELL. Thank you, Mr. Chairman. Thank you for allowing me to sit on the subcommittee today. I think this is a very important hearing, and it, quite frankly, is one of my passions, and 

I am going to confine myself to the OTC hearing aid legislation introduced by Mr. Kennedy and thank him for his leadership on the 

issue. It has been one of the issues that I have been working on 

since coming to Congress. So I have my own legislation I would 

love to lobby my colleagues on to ensure that Medicare covers hearing aids. 

Many of my questions have been answered, but I think I would 

like to clarify some of the numbers because I think people don’t understand what the real impact is in society today and what is happening to people. Hearing loss is a quality of life, plain and simple. 

Nobody should feel isolated, confused, or shut out. And you and I 

both know, and so many of us in this room, that a lot of people are 

just because they can’t afford to get the treatment they need; they 

don’t have access. 

Because of the groundbreaking research done by my friend, Dr. 

Lin, who we are going to hear from later, we know that hearing 

loss is linked to increased hospitalizations, and now we are beginning to see even dementia, early-onset Alzheimer’s. So, to me, it is 

clear that we would have potential in reduced health costs and improved outcomes by increasing access to hearing aids. I think you 

would agree with me on that? 

Dr. SHUREN. Yes. 

Mrs. DINGELL. Thank you. So let me just clarify some figures because we have been dancing all around it. Dr. Shuren, is it correct 

that the National Academies of Sciences found that 30 million 

Americans today suffer from hearing loss? 

Dr. SHUREN. Yes. 

Mrs. DINGELL. And is it also correct that the prevalence of hearing loss increases with age? 

31 

Dr. SHUREN. Yes. 

Mrs. DINGELL. Forty-five percent of people age 70 to 74 have 

hearing loss, and 80 percent 85 or older is what I am told. Is that 

pretty much what you have been told too? 

Dr. SHUREN. That sounds about right. 

Mrs. DINGELL. But even though it is a common condition and 

hearing aids have been around for decades, most people don’t have 

access, and it has got a negative impact on their overall health. Is 

it correct that 67 to 86 percent of adults who may benefit from a 

hearing aid do not have access to one? 

Dr. SHUREN. Yes, that is about right. 

Mrs. DINGELL. The National Academies of Sciences I think said 

that only 15 percent of people who need the hearing aids of the 30 

million may have actual access to them. So would you agree that 

the high cost of hearing aids is a major reason and that more people who suffer from hearing loss are not using them, and we need 

to find a way to do that? 

Dr. SHUREN. Well, we do need to find a way to have better access, and our understanding is that cost is one of the drivers. 

Mrs. DINGELL. You talked about it in your earlier comments, that 

you issued the guidance not enforcing the FDA regulations that 

mandates the medical evaluation. Do you believe that creating an 

over-the-counter category for hearing aids will lower costs? You 

kind of danced it. You wouldn’t commit to it. How far are you willing to go today to tell us how you think that that might be letting 

the marketplace work might help? 

Dr. SHUREN. We do think that, certainly in other scenarios, the 

marketplace would drive down the cost of those products, particularly as they are offered over the counter. 

Mrs. DINGELL. And it is important that we continue to put patient safety first. Anna and I have been sitting here, my colleague 

and I, for this entire time, but new innovative hearing aids are now 

more safer than ever, I understand. Is it correct that FDA did not 

receive any reports of corrections or removals regarding hearing 

aids between 2011 and 2015, and what does that tell us about the 

safety of products that are already on the market? 

Dr. SHUREN. I believe that is the case. I will have to go back to 

confirm. 

Mrs. DINGELL. And from an FDA workshop. Not that I studied 

the issue or anything. So, to me, it is clear that the current market 

is broken. I thank you for your work and hope we can all work together to find a way to really address this hearing issue. 

Thank you, Mr. Chairman. 

Mr. BURGESS. The chair thanks the gentlelady. The gentlelady 

yields back. 

The chair recognizes the gentlelady from Indiana, Mrs. Brooks, 

5 minutes for questions, please. 

Mrs. BROOKS. Thank you, Mr. Chairman. 

I am very pleased that the committee is examining legislation. I 

worked with my Hoosier colleague, Congressman Bucshon, Mr. 

Peters, and Mr. Butterfield, because the goal of H.R. 1736 is to 

bring more predictability and consistency to the device inspection 

process, and I hope the committee will include this bipartisan, bicameral measure in the final user fee agreement. 

32 

But I also appreciate the committee’s attention to the oversight 

of third-party medical device service providers, because concern for 

patient safety should drive our decisions here. And when there are 

questions around how the work of some bad actors can hurt patients, it is our responsibility to examine this current system and 

see how we can improve on it. But, further, for those service providers who operate responsibly, we must be conscious of the precedent that legislation we might consider or might get set under H.R. 

2118 certainly warrants discussion. I appreciate the opportunity we 

have here today. 

Dr. Shuren, maintaining a safe and effective medical equipment 

management program is vital to any hospital or healthcare system. 

And according to industry estimates, a medium-size hospital can 

spend $5 million per year on equipment maintenance. An averagesize health system can spend up to $50 million per year on such 

costs. TriMedx, which is located in my district, is the country’s 

largest independent third-party service provider of medical equipment. They employ and manage almost 1,500 associates, who maintain more than 1.7 million pieces of equipment in over 240 hospitals across 32 states. 

Mr. Chairman, I would ask unanimous consent to support 

TriMedx’s written statement for the record. Thank you. 

[The information appears at the conclusion of the hearing.] 

Mrs. BROOKS. Dr. Shuren, independent third-party service providers—and you talked about the importance, especially after receiving comments kind of on both sides of this issue—who deliver 

this in-house medical equipment service, repair, and maintenance, 

such as TriMedx, act as agents for their hospital customers and ensure that their hospital customers comply with applicable regs. 

This includes, of course, overseeing or assisting with any internal 

investigations and reporting required. Because hospitals are already required, as I understand, to provide this information to the 

FDA, do you consider it redundant to also require third-party service providers to deliver the same information to the FDA? 

Dr. SHUREN. I think one of the issues is there is different information to be provided regarding problems that may be occurring 

with those devices in terms of servicing. For example, if there are 

complaints that are received by the third-party servicer, how are 

those being handled? Are they being followed up on? Are there 

records of them? 

And you raised an important point. From what we understand in 

the marketplace, third-party servicers, the quality of what they 

provide runs the gamut. You have some exceptional firms who provide excellent servicing, and you have some that, from what we can 

tell, do not provide the same level of quality. There is sort of a discrepancy within the marketplace. 

Mrs. BROOKS. But the third-party service providers, their customer is the hospital. And when you say there is different information, is that information that could be provided to the FDA by the 

hospital if the hospital required it of the third-party providers? 

Dr. SHUREN. So some of that information wouldn’t be information 

that a hospital otherwise would be required to report to the FDA. 

Mrs. BROOKS. But the hospital does have a number of requirements, of course, that it is required to provide. And so would that 

33 

be an expansion of hospital requirements, because I don’t think a 

patient—and certainly, this is not always based on patient issues, 

but the technicians and other issues. Anyone would go to the hospital, would they not, with issues with respect to equipment in 

their own hospitals? 

Dr. SHUREN. No. So they may have equipment that is used on 

them, and they may complain to the original manufacturer, may 

complain to their doctor, any number of places where they may 

complain. And for the hospital’s device user facilities, there is authority for sort of limited reporting to the FDA, which is different 

from the fuller spectrum of requirements that could apply—do not 

have to apply—to manufacturers, such as third-party servicers. 

Mrs. BROOKS. And all of the items when you gave your opening 

testimony that you listed as issues about third-party service providers or that the third-party service providers had about the manufacturers, is there a way, in your opinion, to remedy that nonsharing of information between the manufacturers and the independent service providers? 

Dr. SHUREN. There may be a way to do that. I mean, we certainly have in cases where there is high risk, higher risk, we have 

required that information on servicing and maintenance is made 

available with the technology. So we have done that, for example, 

with laser products. 

Mrs. BROOKS. Thank you. I am sorry. My time is up. 

I yield back. 

Mr. BURGESS. The chair thanks the gentlelady. The gentlelady 

yields back. 

Dr. Shuren, we do thank you for being here. Ranking Member 

Green and I each had one follow-up observation or question, and 

I am going to go to Mr. Green first for his question. 

Mr. GREEN. Thank you, Mr. Chairman. 

Dr. Shuren, can you discuss the rules and requirements that currently apply to third-party service providers? For example, are they 

required to register with the FDA, label products they have repaired or remanufactured, or submit adverse event reports associated with their work? 

Dr. SHUREN. So, in our regulation on quality systems, we had 

made clear that third-party servicers are manufacturers, but they 

have been subject to enforcement discretion. We have not enforced 

those requirements. 

Mr. GREEN. OK. 

Thank you, Mr. Chairman. 

Mr. BURGESS. The gentleman yields back. The chair thanks the 

gentleman. 

Dr. Shuren, we are going to hear testimony in just a few minutes 

from the Medical Imaging & Technology Alliance. And in that testimony, in the written testimony that was provided to the subcommittee, they talked about December 2009, the FDA released a 

guidance document entitled, ‘‘Guidance for Industry for New Contrast Imaging Indication Considerations.’’ 

And that guidance was apparently part of an agreement under 

the medical device user fee amendments of 2007. I was here in 

2007 on this committee. I sat way down in the front row on the 

34 

minority side. You were not at the agency in 2007, were you? Do 

I recall that correctly? 

Dr. SHUREN. I was at the agency, but in a different position. 

Mr. BURGESS. In a different role. So I guess my observation or 

where you could be helpful to this subcommittee is, obviously, we 

want to get this done. And you heard Chairman Upton talk about 

the timeliness being important, and certainly everyone on this subcommittee feels that. 

At the, same time, when I am reading this paragraph from the 

testimony from one of our next witnesses, Mr. Robinson, it occurs 

to me that language we put forward in this user fee agreement, I 

mean, here it is 10 years later, from 2007 to 2017. And I guess my 

request to you was, we so want to get this done, but we also want 

to get it done correctly, and we don’t want to leave the burden in 

10 years’ time to another Congress to deal with problems that we 

have created that turned out to be insurmountable without another 

user fee agreement. Do you understand what I am asking of you? 

Dr. SHUREN. I do. And I think the guidance that was put out in 

2009 went as far as the agency was able to go under current law. 

So it has not addressed the concerns that we are seeing from the 

imaging technology makers and also by the contrast makers too, 

who have come together, I know, with a proposal. 

So the bill, the value on the bill, we can see the potential public 

health value of now addressing situations that we could not address under the current law but may make sense to do for public 

health purposes. 

Mr. BURGESS. Very well. I thought we were through with questions, but I see the gentlelady from Tennessee is here. Let me yield 

to her 5 minutes for questions. 

Mrs. BLACKBURN. Well, thank you so much. And I am not going 

to use 5 minutes. I apologize. I had to skip to a meeting. 

I want to echo what Mr. Green said about the SOFTWARE Act 

and your work there with us. We were pleased to get that across 

the finish line in 21st Century Cures. 

And on the over-the-counter hearing aid, I honestly believe this 

is something that does answer a problem. And for my colleagues, 

I give you a great example. I have a 92-year-old mother who is a 

pistol, and she is into everything. She is a busybody. They told her 

she needed a hearing aid, and she didn’t like that. So she doesn’t 

wear the hearing aid because she needs to go back to the doctor 

to get it fixed. Now, somebody like my mother, who is a DIY aficionado, if she can’t fix it herself, it is just going to have to wait because she doesn’t have time for it. This is the kind of person who 

would buy it at the pharmacy, would go read it, and then would 

be able to use it because she has got one over here she can’t use 

because it means she has to set an appointment and interrupt her 

day and get to the doctor and get back. And I think that is where, 

you know, for someone that has a mild or moderate hearing loss 

and knows it and is aware of it, this is an item of convenience. And 

just as readers have been a boon for baby boomers because you 

need a little bit of help reading, but you don’t have any serious 

problems, or shoe inserts—look at how that has helped for people 

with orthopedic issues—or bandages or wraps or Benadryl cream, 

any of those other things that have moved to over the counter. 

35 

So I do see it as being consumer-friendly and something that, as 

you do have a generation of baby boomers coming along, will move 

people in the right direction for getting the health care they need. 

How many times have we heard people say, ‘‘Well, I have outgrown 

my readers. So I need to go and get a different’’—oh, Billy Long, 

I know that is you. You are outgrowing your readers there. 

So, anyway, I just want to thank you for that. I do know that 

from what you have said—you have already answered the question 

that I have—is that you rely on the research from the National 

Academies and the guidance from the National Academies. So I 

thank you for that. 

I yield back. 

Mr. BURGESS. The chair thanks the gentlelady. The gentlelady 

yields back. 

And, Dr. Shuren, this will conclude the question portion of this 

hearing. And we want to thank you for spending so much time with 

us this morning, and thank you for your thoughtful answers to the 

questions from the committee. 

We are not going to recess. We are just going to go directly into 

our second panel. 

So, Dr. Shuren, you are excused. 

And we will get our second panel seated and immediately transition into opening statements from the second panel. 

We do want to thank the witnesses on the second panel for taking time to be here today, taking time to testify before the subcommittee. As a reminder, each witness will have the opportunity 

to give an opening statement, and then this will be followed by 

questions from members. 

We will wait for the second panel to be seated, and I will introduce them. 

Again, we thank our second panel for being with us today. Introducing down the witness table, starting with Dr. Thomas Powers 

of Powers Consulting; Dr. Frank Lin, Associate Professor of Otolaryngology, Johns Hopkins University; Mr. Joe Robinson, Senior 

Vice President of Health Systems Solutions, Philips North America; 

Mr. Robert Kerwin, General Counsel, International Association of 

Medical Equipment Remarketers and Services; and Ms. Patricia 

Shrader, Vice President of Global Regulatory affairs at Medtronic. 

We appreciate all of you being here today. 

I will begin the panel with Dr. Powers. You are recognized for 

5 minutes for a summary of your opening statement, please. 

36 

STATEMENTS OF THOMAS POWERS, PH.D., POWERS CONSULTING, LLC; FRANK LIN, M.D., PH.D., ASSOCIATE PROFESSOR OF OTOLARYNGOLOGY, HEAD AND NECK SURGERY, 

GERIATRIC MEDICINE, MENTAL HEALTH, AND EPIDEMIOLOGY, JOHNS HOPKINS UNIVERSITY; JOE ROBINSON, SENIOR VICE PRESIDENT, HEALTH SYSTEMS SOLUTIONS, PHILIPS NORTH AMERICA; ROBERT KERWIN, GENERAL COUNSEL, 

INTERNATIONAL ASSOCIATION OF MEDICAL EQUIPMENT 

REMARKETERS AND SERVICERS; AND PATRICIA SHRADER, 

VICE PRESIDENT, GLOBAL REGULATORY AFFAIRS, 

MEDTRONIC. 

STATEMENT OF THOMAS POWERS, PH.D. 

Mr. POWERS. Chairman Burgess, Ranking Member Green, and 

members of the subcommittee, thank you for inviting me today. My 

name is Thomas Powers. I am currently a consultant to the hearing health industry. I received my doctorate in audiology from Ohio 

University and was in an audiology-based private practice and 

spent 35 years working in the hearing health field. 

I am speaking today on behalf of the Hearing Industries Association, which is the national association of hearing aid manufacturers. These companies spend over $600 million per year on research 

and development for hearing aids which are at the cutting edge of 

hearing technology. HIA is supportive of efforts to enhance hearing 

affordability and accessibility. 

We note that the market is already adapting to expand access 

and affordability. Big-box stores, such as Costco and Sam’s Club, 

now account for more than 10 percent of the market. In addition, 

CVS last week announced its major entry into the hearing aid market. All of these channels include professional testing, fitting, and 

follow-up. 

NAS has recommended the creation of an OTC category of hearing aids, and we agree that such a category should be regulated by 

FDA, to ensure such products are safe and effective. As with existing hearing aids, OTC hearing aids should be required to demonstrate effectiveness through FDA’s review process, as are other 

medical devices. Also, FDA should clearly differentiate hearing aids 

from unregulated personal sound amplifiers. 

There are no studies to demonstrate that a person with hearing 

loss can accurately self-diagnose the degree and cause of their 

hearing loss. However, we believe that an OTC option may still 

provide a gateway to the hearing health treatment for many, if 

that option were promoted carefully and with the risks minimized. 

When people finally address their hearing loss, often after many 

years of delay, if an OTC device promoted as a solution fails to 

meet the expectations, this may lead to frustration, further treatment delay, and even abandonment of efforts to address their hearing loss. Such treatment failure leaves the individual at greater 

risk of isolation, depression, falls, dementia, and other conditions 

related to untreated hearing loss. Given this risk, it is critical that 

OTC hearing aids be recommended for people with mild hearing 

loss, where the risks of failure and further delay of treatment are 

reduced. H.R. 1652, as drafted, would mandate the FDA recVerDate Nov 24 2008 15:18 Oct 24, 2018 Jkt 037690 PO 00000 Frm 00042 Fmt 6633 Sfmt 6633 I:\MY DOCS\HEARINGS 115\HEARINGS\115-28 CHRIS
37 

ommend OTC hearing aids for people with moderate hearing loss 

as well. 

Mild hearing loss is marked by having difficulty hearing soft 

speech sounds. Professionally fit hearing aids would certainly benefit this group. Mild hearing loss, as we have heard, impacts twothirds of all Americans with hearing loss, although only 12 percent 

of these individuals currently use hearing aids. And, firstly, about 

50 percent of individuals with moderate hearing loss use hearing 

aids. The degree of hearing loss is measured via an audiogram, 

using a decibel scale, and is classified by the FDA in five ranges, 

according to normal to profound. And I would like to enter this 

chart from the FDA into the record. 

Mr. BURGESS. Without objection, so ordered. 

[The information appears at the conclusion of the hearing.] 

Mr. POWERS. Mild hearing loss ranges from 20 to 40 decibels 

loss; and moderate loss ranges from 40 to 70. A moderate hearing 

loss is not an insignificant condition. From my 35 years of experience in audiology, simple amplification is not ideal for people with 

a moderate hearing loss, as they may have more complicated 

audiometric configurations, such as high-frequency loss or hearing 

loss in the middle or low frequencies. 

In addition, as the hearing loss progresses to the moderate category, the ability to understand speech may decrease significantly. 

Simply providing amplification across the range of speech frequencies may not provide the anticipated benefits and could lead 

to frustration with the process. 

We do believe that FDA should create strict labeling requirements for the OTC hearing aids. Given this reliance on labeling, we 

believe it is more important that Congress and FDA only recommend OTC hearing aids for people with mild loss. People who 

have had their hearing loss diagnosed at a moderate level should 

be discouraged from self-treatment options. Output limits proposed 

in this legislation should be configured to set the gain levels appropriate for mild loss. 

Access and affordability are important goals, but creating a new 

OTC hearing aid category should be done with care. Focusing on 

people with mild hearing loss would minimize the risks while at 

the same time providing an option for the vast majority of people 

with hearing loss who have not yet entered the hearing healthcare 

system. 

Thank you very much. 

[The prepared statement of Mr. Powers follows:] 

38 


26785.004

May 2, 2017 

Chairman Michael Burgess and Ranking Member Gene Green 

U.S. llouse of Representatives Energy and Commerce Committee 

Subcommittee on Health 

2125 Rayburn House Office Building 

Washington, DC 20515 

RE: Examining Improvements to the Regulation of Medical Technologies 

Dear Chairman Burgess and Ranking Member Green: 

The Hearing Industries Association (HIA) appreciates the opportunity to provide 

testimony on the hearing before the Subcommittee on Health entitled "Examining 

Improvements to the Regulation of Medical Technologies." HIA is the national trade 

association of manufacturers of hearing aids, assistive listening devices, component parts, 

and power sources. IliA's membership consists of 17 companies representing 

approximately 30 hearing aid brands that constitute over 90 percent of the hearing aids 

sold in the United States on an annual basis. These companies invest over $600 million 

per year on hearing aid research and development. Our members collectively employ 

more than 6,000 engineers and scientists who develop sophisticated hearing aids and 

algorithms to process sound so that it resembles natural hearing with minimal power 

consumption. 

lilA has substantial interest in the policies proposed in the Over-the-Counter 

Hearing Aid Act of 2017 (H.R. 1652), which are being considered by the Subcommittee 

today. The bill is designed to improve the accessibility and affordability of hearing aids 

by requiring FDA to establish an over-the-counter category for hearing aids. Before 

Congress proceeds in adopting the proposed legislation to create an OTC sales model for 

hearing aids, caution is wmTanted. Although promoting the goals of affordability and 

llcaring Industries Association. Suite 700. 14441 Street. NW. Washington. DC 20005, 202-449-1090 
39 


26785.005

accessibility are important, they should be secondary to assuring the safety and efficacy 

of hearing aids through the FDA's review processes and promoting the clinical interests 

of the patient There are no studies demonstrating a person can accurately self-diagnose 

and self-manage the degree or cause of hearing loss, which would be required for 

successful implementation of an OTC sales channel for hearing aids. HIA recommends 

that the current draft of H.R.1652 should be amended to allow OTC sales for mild 

hearing loss only, as the consequences of ineffective treatment in this segment are 

relatively low. 

The hearing industry is rapidly innovating, leading patients to receive more 

advanced technology at the same cost as a few years ago. Over the past decade some of 

our members have successfully miniaturized hearing devices through nanotechnology 

and !lex circuitry, developed Bluetooth and wireless features for content streaming, and 

linked hearing aids with smart phones to maximize performance in a wide variety of 

listening environments. Smatt hearing aids have won multiple awards from several 

groups as a result of these innovations. 1 Despite these impressive technological 

advances, hearing aid technology has become more affordable, with some HIA members 

manufacturing hearing aids that can be purchased for as little as $500 with the necessary 

professional services included. 2 

The hearing aid market is not the stagnant and outdated market that some recent 

reports would have one believe. 3 The new practical functions and enhanced features of 

today's hearing aids are associated with increased satisfaction rates and usagc.4 

1 IliA, !!caring Aid Industry Report (20 17) (awarded the Consumer Technology Association's CES "Best of 

Innovation Awards"; SXSW Interacting Innovation Awards & Edison Awards; B!uctooth Breakthrough Awards; 

German Design Awards; Good Design Awards; Red Dot Awards; and several others). 2 See Costco fOr a variety of hearing aids made by various manufacturers, including ReSound. Siemens (Costco's 

Kirkland brand), and others, starting at $499. including professional services, https://Vv\Vw.costco.com/hearing-aidstvles.html. 

'See President's Council of Advisors on Science and Technology, Letter to President Obama, 2 (Oct. 2015) 

(''PCAST Report"), 

https://obamawhitehouse.archives.gov/sites/default/files/microsites/ostp/PCAST/pcast hearing tech letterreport fin 

al.pdf. 

4 Harvey B. Abrams, PhD, and Jan Kihm, MS, An Introduction to Markeli·ak IX: A New Baseline for the Hearing 

,tid Market, Hearing Review (May 15, 20 15), http://www.hearingreview.com/20 15/05/introduction-marketrak-ixnew-base I i ne-hearing -aid -market!. 

2 
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26785.006

Consumer satisfaction with current hearing aids is high and growing, with a 91 percent 

satisfaction rating for those obtained since 20 14; 77 percent for hearing aids obtained 

between 2010 and 2013; and 74 percent for hearing aids obtained prior to 2010. 5 

Furthermore, overall satisfaction has increased from 74 percent in 2008 to its current 

level of 81 percent. 6 Based on more than 30 years of data from MarkeTrak- a tracking 

survey of the hearing aid market - overall satisfaction with hearing aids is at its highest 

level ever. Better products and better experiences with hearing care professionals 

contribute to the improving satisfaction rates. 

IIIA appreciates the Subcommittee's interest in pursuing legislation to promote the 

affordability and accessibility of hearing aids through the Over-the-Counter Hearing Aid 

Act of 2017 (H.R. 1652). But affordability and accessibility must not come at the cost of 

safety or effectiveness. Hearing aids arc, after ail, medical devices intended to treat a 

disease or condition. To that end, HIA believes that all hearing aids, regardless of 

method of sale, should be required to comply with the general controls established by the 

Food and Drug Administration (FDA). 

If enacted, the Over-the Counter Hearing Aid Act of 2017 would create a new 

OTC delivery channel for hearing aids. While OTC purchases may result in increased 

access and affordability, the evidence suggests the proposed OTC delivery channel may 

be effective only for a subset of hearing loss patients. Creating a new OTC distribution 

channel will not change the technology, but only a new mechanism for delivering the 

product. The relevant question is whether consumers can diagnose their own hearing loss 

and program their own hearing aids to best address their specific type and level of 

hearing loss or whether professional assistance is needed. 

With adequate FDA controls in place, HIA believes that OTC may be suitable to 

address mild hearing loss only. The consequences of ineffective treatment for mild 

hearing loss arc low, whereas the risks of failure and further delay in treatment for 

moderate hearing loss are signi1icantly greater. Such treatment failure leaves the 

5 !d. 

0 !d. 

3 
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26785.007

individual at greater risk of isolation, depression, falls, dementia and other conditions 

related to untreated hearing loss. 

I. Congress and FDA should limit any potential OTC Hearing Aid Sales to 

the Treatment of Mild Hearing Loss. H.R. 1652 Should be Amended to Allow OTC 

Sales of Hearing Aids for Patients with Mild Hearing Loss Only. 

Hearing aids are the treatment of choice for the vast majority of adults with 

hearing loss, and they play a critical role in improving communication function and 

quality of life. The scientific literature shows that untreated hearing loss is associated 

with social isolation, loss of independence, depression, dementia, and increased risk of 

falls. 7 Though hearing loss is a common corollary to aging, its impact can be serious. 

Hearing loss is a multifactorial condition, which requires a complex and skillbased approach to its treatment. There is a significant sensorineural component to 

hearing loss suffered by the vast majority of adults. Increasing audibility alone is often 

not sufficient to resolve their complex communication issues. 8 In addition to diminished 

audibility, hearing loss often involves diminished frequency resolution (difference in 

pitch), diminished temporal resolution (timing), or diminished loudness perception (range 

between softest and loudest sounds). Some hearing loss is also situational: discussions of 

hearing loss include not just idiosyncratic etiologies, but different levels of loss and 

audibility in differing settings. Hearing aids incorporate advanced signal processing 

algorithms that are designed to address the complex interactions between a damaged 

sensory organ, the desired input speech signal, and interfering environment sounds. 

Consequently, expertise in the selection, fitting and programming of these devices, as 

well as counseling patients in the likely benefits and limitations of amplification, is often 

critical for optimizing treatment outcomcs.9 

7 Seniors Research Group, The Consequences q( Untreated Hearing Loss in Older Persons, Nat'! Council on the 

Aging (May 1999); Stig Arlinger, Segalive Consequences of Uncorrected Ilearing Loss-A Review, 42 lnt'l J. of 

Audiology 2S17 (July 2003); NAS Report, supra n.l3, 273-74. 8 Julia Calderone, !fearing Loss: No More Suffering in Silence?, Consumer Reports (Feb. 2, 20 17), 

http://www .cons umerrepo11s.org/heari ng-ai ds/heari ng -loss-no-more-suffering-in-silence/. 9 Larry Humes eta!., The Effects o(Service-Delive1y .\lode/ and Purchase Price on Hearing-Aid Outcomes in Older 

A dulls: A Randomized Double-Blind Placebo-Con/rolled Clinical Trial, 26 Am. J. Audiology 53 (Mar. 20 17). 

4 
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The extent of hearing loss and its impact on different individuals varies. There is 

no technology or product that can be sold as a "one-size-fits-all" hearing solution for all 

hearing loss. The FDA defines hearing loss across five categories based on the decibel 

scale with mild hearing loss ranging from a 20 to 40 decibel hearing loss and moderate 

hearing loss ranging from 40 to 70 decibels. With two-thirds of all Americans with 

hearing loss having mild loss and only an estimated 12 percent of these people currently 

wearing hearing aids, 10 OTC hearing aids could improve adoption rates for Americans 

with mild hearing loss while presenting a favorable benefit-risk profile. Conversely, an 

estimated 50 percent of individuals with moderate hearing loss cun-ently use hearing 

aids. 11 This population, which is already utilizing hearing aids at a substantial rate, is 

much less likely to be able to self-diagnose and self-manage with OTC hearing aids, and 

the impact of an erroneous treatment would be much greater. 

Mild hearing loss, which is generally defined as difficulty hearing soft speech or 

sounds, 12 is more amenable to self-treatment through OTC hearing aids than more severe 

degrees of hearing loss. Treatment of moderate hearing loss involves a more 

comprehensive audiogram configuration. FUiiher, simple amplification across all 

fl·equency ranges is not likely to provide the anticipated clinical benefits, potentially 

resulting in patient frustration and abandonment by moderate hearing loss patients. 

Despite the abundance of hearing technology and related hearing health care services 

information available to potential patients, some of that information may be difficult for 

patients to understand without a learned intermediary. Adult-onset hearing loss is a 

c.omplex condition, and the modern hearing aid represents state-of-the-art digital 

technology with hundreds of possible style-feature combinations. Consequently, 

consumers generally benefit from conversations with a hearing health professional to 

10 HIA, final Report, MarkcTrak 9: A New Baseline, Estimating Hearing Loss And Adoption Rates and Exploring 

Key Aspects of the Patient Journey, slide 39 (Mar. 20 15) ("MarkeTrak 9). 11 There are varying classifications for degrees of hearing loss, and FDA combines "moderate" and ''moderately 

severe" hearing loss into an all-encompassing ·'moderate'' category. This would mean people with very significant 

70dll hearing loss would be advised to purchase an OTC device. This is yet another reason why HIA believes that 

referring people who will know they have a "moderate" hearing loss to purchase an OTC device is not sound policy. 10 Calderone, supra n. 8. There is, however. complexity in this definition, as a patient may have one type of hearing 

loss in one ear and another in the other car. 

5 
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26785.009

understand the complex nature of their particular hearing loss and associated hearing aid 

needs. Without this assistance, it is very difTicult for the patient to discern which hearing 

aid will be most effective or which settings or programmable features to select in that 

hearing aid. 

The nature of hearing loss is highly individualized. 13 Combining individual 

physical characteristics, such as the size, shape, and volume of the ear canal, with nonauditory factors such as cognitive function, motivation, manual dexterity, and family 

dynamics, creates a unique challenge. 14 Situational hearing loss adds further 

complexity. 15 Additionally, as described, there is a surplus of information available on 

hearing aids and health care; parsing through this information to decide which OTC 

hearing aid is appropriate would likely be challenging for many consumers. For these 

reasons, moderate or more severe hearing loss is a medical condition that is not readily 

susceptible to self-treatment. HIA therefore docs not support OTC access for moderate 

or more severe hearing loss, as the risks of abandonment or ineffective treatment are high 

given the co-morbidities related to untreated hearing loss. 

A recent placebo-controlled, double-blind, randomized clinical trial illustrated the 

advantages of consultations with a hearing health professional in the hearing aid selection 

and fltting process. The study and associated paper by Larry Humes et a!. compared 

different service-delivery models among participants with hearing loss. The results 

suggested that there were no significant differences between the two approaches on five 

of the six outcomes the exception, however, was the critical measure of satisfaction. 

Satisfaction significantly increased for those participants who initially received OTC 

devices following additional treatment under the audiology best practices (AB) model in 

which the patients received assistance from audiologists. 16 While 81 percent of the 

13 Calderone, supra n.l2 ("You can have two people with identical audiograms who have very different 

functionality. . .")(internal quotations omitted). 14 American Speech-Language-Hearing Association, Hearing Aids for Adults (last visited Mar. 24, 2017), 

http://www.asha.org/PRPSpecificTopic.aspx? folderid~85 89935381 §ion=Key Issues. 15 Donald J. Schum, PhD, Situational Pet:formance ofNoise Reduction and Directionali(v, Audiology Online (May 

16, 201 1 ), http://www .audiologvonline.comiarticles/situational-performance-noise-reduction-and-830. 16 Humes et al., supra n. 9. Of note, the study used only technologically-advanced hearing aids. 

6 
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26785.010

participants who were assigned to the AB group said they would keep their hearing aids, 

only 55 percent of the participants in the OTC group said the same. 17 At the end of the 

initial six-week trial, 44 of 53 (83%) in the AB group actually purchased their hearing 

aids compared to only 1 of 51 (2%) in the OTC group. Following the six-week trial, 49 

participants in the OTC model participated in an additional four-week trial that included 

professional adjustments to their OTC hearing aids before deciding to purchase. Notably, 

after four weeks of assistance from an audiologist, the percentage of willing purchasers in 

the OTC group jumped signiiicantly. 18 

It should be stressed that the research participants in both the AB and OTC groups 

received baseline audio logic evaluations and the same high-end, commercially-available 

digital hearing aids- conditions that will not occur in the real world of OTCs. The 

authors wrote, ''the observation that the CD participants self-select hearing aids that are 

somewhat under-powered may explain some of the inferior outcomes observed in this 

group compared to the AB participants.'.J 9 And while HIA agrees that affordable and 

accessible hearing aids are clearly in the best interests of the consumer. HIA also 

believes that the best hearing aid for a consumer is the one that is worn. HIA therefore 

believes that the risks of under-treatment or failed treatment leading to the potential 

abandonment of more effective hearing loss treatment arc far greater for people with 

moderate hearing loss than those with mild hearing loss. 

Even for patients with mild hearing loss, self-treatment will not be a panacea. 

Some speculate that increased self-treatment will act as a gateway for consumers who 

will struggle with hearing in certain situations by reducing cost barriers to hearing aid 

purchases and related medical visits. 20 But this is an untested hypothesis, at least in the 

United States. 21 With the same evidence, one could conclude that ineffective self17 This group was not fully representative of an OTC group, e.g., the patients were evaluated by a hearing 

professional against study inclusion/exclusion criteria. 

18 Jd. 

"Jdat75. 

Comments of Cl';\, Docket No. FDA-20 I 3-D-I 295, 5 (May 6, 20 I 6). 

In South Korea and Japan the results were the opposite. Both countries allow OTC hearing aids, and both 

countries have low adoption and satisfaction rates. 

7 
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26785.011

treatment may lead some to frustration and further delay in getting effective therapy 

based on a belief that if an OTC hearing aid docs not work, no hearing aid will work. 

And this possibility is of particular concern because of the variable nature of hearing loss 

it is much more complicated than simply amplifying sounds- and the complexity and 

critical importance of proper and customized programming and fitting of the device 

(collectively known as "fit" in the industry). It is expected that many patients will not be 

successful with self-fit OTCs. 22 

Limiting OTC sales to mild hearing loss will not have a significant impact on 

patient access for hearing aids for individuals with moderate hearing loss. In recent 

years, the hearing aid distribution model has evolved, making hearing aids available to 

consumers through new channels at affordable costs. 

Most notable is the addition of "big box" stores to the hearing aid market. 

Warehouse stores, like Costco and Sam's Club, have implemented ''Hearing Aid 

Centers" to offer the full array of hearing health services at value pricing. Big box stores 

now account for at least I 0 percent of the private United States hearing aid market, and 

their market share continues to grow. 23 All of these stores provide safe and effective 

FDA-compliant hearing aids while providing increased economical access. These stores 

have been able to bring down costs for consumers while providing professional services, 

waJTanties, and advanced technology. Other types of distributors, such as pharmacy 

chains, have announced they are considering entering the market to provide 

professionally-fit hearing aids as well?4 

Additionally, the internet has opened up other avenues of sales that increase access 

to services and lower prices of both goods and services. For example, the internet has 

22 National Academics of Sciences, Engineering, Medicine, llearing Jlea!th Care for Adults: Priorities for 

Improving Access and A{fordability 35 (June 2, 2016) ("NAS Report"); see also Humes et al., supra n.9 ("CD 

service-delivery model [self-selected pre-programmed high-quality hearing aids via an OTC model] was efficacious, 

with similar effect sizes. However, CD group had a signiJicantly (p < .05) lower satisfaction and percentage (CD: 

55%; AB: 81%; P: 36%) likely to purchase hearing aids after the trial). 03 US Hearing Aid Unit Sales Increased by 8. 7% in 20/6, Hearing Review (updated Feb. 9, 2017), 

http://www.hearingreview.com/20 17/0 I /us-hearing-aid-unit-sales-increased-8-7 -20 16/. 

'·'See, e.g., Laura Northrup, CIS Will Experiment With Selling Glasses and llearing Aids in Some Stores, 

Consumerist (Oct. 5, 20 15), !illps:/iconsumerist.com/20 1511 0/05/cvs-will-o!l'er-glasses-and-hearing-aids-in-storesas-pilot-project/. 

8 
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made it easier to locate and identify service providers, and patients in underserved areas 

can consult with hearing health professionals on the phone or through webcasts to 

address issues with hearing aids. And some companies have adopted a direct-toconsumer model of sales through the intemet. 25 This model requires the submission of an 

audiogram conducted by a hearing health professional or a programming kit at an 

additional cost, but proper fit remains an issue. Other companies, like Hearing Planet, are 

researching ways to make online consultations work as technology continues to evolve. 

These new sales and distribution models are indeed having a positive impact on the 

accessibility of hearing aids. 

These caveats notwithstanding, HIA supports the endeavor to reduce the banicrs 

to access hearing loss treatment. Regardless of the method of sale, HIA members will 

continue to design and innovate to improve the quality of life of individuals with hearing 

loss. HIA urges the Committee to amend H.R. 1652 to protect patients from the potential 

shortfalls of self-treatment by amending the bill to permit OTC sales of hearing aids for 

mild hearing loss only. 

II. HIA Strongly Supports the Continued Regulation of Hearing Aids as 

Medical Devices by the FDA. 

Any product "intended for use in the diagnosis of disease or other conditions, or in 

the cure, mitigation, treatment, or prevention of disease" or "to affect the structure or any 

function of the body of man or other animals, and which does not achieve [any ofj its 

primary intended purposes through chemical action" is a medical device under the 

Federal Food, Drug, and Cosmetic Act (FDCA).Z6 FDA classifies devices based on their 

level of risk. 27 Currently, air conduction hearing aids are classified as a Class I device, 

the lowest risk classification.28 Those that incorporate wireless or bone conduction 

25 See, e.g, iHear Hearing Solutions, http://ihearmedical.com/hearing-solutions#comparisonChart. 

FDCA § 201(h). 21 U.S.C. § 321(h). 

see also FDCA § 513, 21 U.S.C § 360c. 

21 C.F.R. § 874.3300(b); FDA, What does it mean for FDA to "classify" a medical device? (last updated Dec. 28, 

20 15 ), https:/iwww. fda.gov/ A boutFDA/Transparency/Basicsiucm 19443 8.htm. 

9 
47 


26785.013

features are considered Class II, or moderate risk devices. 29 Class II devices require 

greater regulatory controls to provide reasonable assurance of safety and effectiveness. 

Approximately 88 percent ofhearing aids sold in the United States in 2016 contained 

wireless features and were therefore categorized as Class II devices. Regardless of 

classit1cation, all hearing aids are subject to the Quality System Regulations (QSRs),30 as 

well as other general controls, such as establishment registration, device listing, labeling 

requirements, repm1ing, and correction and removal notification requirements. FDA 

regulations also require all medical device labeling or promotional claims to be supported 

by valid evidence. 

HIA strongly supports FDA regulation of hearing aids as medical devices and 

believes all FDA labeling requirements, electromagnetic capability (EMC) standards, and 

any standards implicating safety should be retained for OTC hearing aids. 

Additionally, HIA strongly believes that FDA review of a marketing application 

for a manufacturer's initial hearing aid device would help ensure device safety and 

etTectiveness. FDA can establish guidance documents that would clearly state the data 

needed to support this 51 O(k), facilitating entry into the market. Subsequent hearing aids 

by the manufacturer would be 51 O(k) exempt and could be marketed without FDA 

review, absent changes that under FDA's regulation would require a 51 O(k). 

Furthermore, the FDA should incorporate consumer comprehension into its 

analysis of OTC hearing aids. It is imperative to ensure that consumers can understand 

the directions and conditions for OTC hearing aids. FDA studies have shown that 

consumer comprehension is a major batTier to the effective use of all medical devices. If 

a complex medical device is to be available to consumers without a learned intermediary, 

it is essential to the safe and effective usc of the device that consumers can adequately 

understand and follow the directions on the labeling. FDA routinely requires consumer 

29 FDA, What does it mean for FDA to "classify'' a medical device? (last updated Dec. 28, 20 15); 21 C.F.R. 

§ 874.3305(b). 

'

0 See 21 C.F.R. Part 820. 

10 
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26785.014

comprehension studies of OTC drug products and home-use medical devices. 31 FDA can 

set clear expectations for how these studies should be done. FDA can also provide 

guidance on the data needed for effective home testing that is the sine qua non for OTC 

hearing aids. 

III. Any OTC Distribution Model Must Protect Patients by Assuring that 

Personal Sound Amplifiers Are Not Marketed as Products for the Treatment of 

Hearing Loss. 

Only devices intended to treat hearing loss are considered hearing aids, which 

excludes Personal Sound Amplifiers (PSAPs). !'SAPs are intended only for non-hearing 

impaired consumers. They are designed to accentuate sounds in specific listening 

environments, such as bird watching or hunting, but they arc not intended for everyday 

use or to correct hearing loss. 32 As recognized by the National Academy of Sciences 

(NAS), "PSAP manufacturers and distributors are not supposed to be offering their 

products for the purpose of compensating for hearing loss. This legal and regulatory 

distinction between hearing aids and PSAPs might not be readily apparent to users, and it 

might not be fully respected by PSAP sellers who explicitly or implicitly offer their 

products to compensate for hearing loss."33 But because !'SAPs arc not intended to 

diagnose, treat, cure or mitigate disease and do not alter the structure or function of the 

body, they are not devices as defined in the FDCA. As such, FDA has very limited 

regulatory authority over PSAPs, and PSAPs are not subject to regulatory controls or 

premarket notification. 

The distinction between a hearing aid and a !'SAP is an important one for 

protecting patients. The products arc not interchangeable and cannot be considered as 

ll FDA, FDA CDRH Public Workshop: Guidance on Medical Device Patient Labeling (Sept. 29, 2015), 

https:ilwww.fda.gov/downloadsiMedicaiDevices/NewsEvents/WorkshopsConferences/UCM465733.pdf; FDA, 

Device Labeling Guidance #G91·1 (Mar. 8, 1991), 

https :I iwww. fda. gov /Med ieal Devices!Dev ice Regu lationandGuidanee/Gu idance Documents/u em 0 81368. htm; FDA, 

Guidance for Industry: Label Comprehension Studies for Nonprescription Drug Products (Aug. 201 0), 

https:/iwww. fda.gov I down loads!Drugs/G uidanceCom pI ianceRegulatory Information/Gu idances/U CM 14 3 83 4 .pdf. 

n FDA. Guidance for Industry and FDA Staff: Regulatory Requirements for Hearing Aid Devices and Personal 

Sound Amplification Product (Feb. 25, 2009), https:l/www.fda.gov/Medica1Devices/ucm l27086.htm. 33 NAS Report, supra n.22, at 189. 

II 
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26785.015

such. The embedded chip technology in a hearing aid is much more sophisticated than 

that of the standard PSAP currently marketed; directional measurements, compression 

ratios, frequency manipulations, and feedback management all require sophisticated 

intervention. PSAPs are designed to amplify only and therefore cannot be used to treat 

sensorineural hearing loss. Because PSAPs are not intended to treat hearing loss, they 

cannot be fitted or tailored to an individual's specific communication requirements. 

Furthermore, because PSAPs are not medical devices, they are not subject to 

safety and efficacy oversight or regulatory controls. 34 FDA has no authority to require 

that a PSAP be recalled should patient safety issues arise or PSAPs be ineffective. Nor 

does a PSAP manufacturer need to inform FDA of a recall. PSAP manufacturers arc not 

even required to submit a report should their product injure a consumer.35 The Federal 

Trade Commission (FTC) has said "fi]fyour hearing is impaired don't use a PSAP as a 

substitute for a hearing aid. That may delay the diagnosis of a potentially treatable 

condition, and cause more damage to your hearing." 36 The NAS Report recommended 

maintaining the distinction between PSAPs and hearing aids "to ensure that consumers 

with hearing loss receive the benefits relating to quality, perfonnance, compatibility, and 

labeling envisioned under the OTC wearable hearing device category."37 

Consumer electronic products (like PSAPs) and other non-medical devices should 

remain prohibited from advertising that their products arc designed to treat hearing loss. 

Permitting consumer electronic products to advertise for hearing loss would be akin to 

complete deregulation of the industry. IliA believes the FTC can play an important role 

in ensuring consumers receive accurate information about the differences between PSAPs 

and hearing aids. Since PSAPs are not devices, they are not subject to FDA regulation 

14 Unless the PSAP is an electronic product that emits sonic vibrations and is subject to the electronic product 

provisions of the FDCA that also apply to non-device products. See FDCA §§ 531-542 (21 U.S.C. §§ 360hh-36ss); 

NAS Report, supra n.22, at 180. 35 And this is indeed a risk. According to a recent Consumer Reports article, "these devices have the potential to 

cause additional hearing damage by overamplifying sharp noises, such as the wail of a fire engine'' and "[PSAP 

machines that cost less than $50] don't seem to help much-if at all-and could actually further diminish your 

ability to hear.'' Julia Calderone, Can PSA Ps Jle/p Your Jlearing?, Consumer Reports (Feb. 2, 20 17), 

http://www .cons um erreports.org/hea ring -ear~care/ can ~psaps-help-your-hearing/. 

10 FTC, Sound Advice on Hearing Aids, 2 (Sept. 2010), http://www.devicewatch.org/reports/ftc hearing aids.pdf. 17 NAS Report, supra n.22, at 192. 

12 
50 


26785.016

(although FDA can intervene if PSAP manufacturers do promote their products in a 

manner that renders them devices). FTC regulation of false or misleading claims, 

regardless of whether they make medical device claims or general amplification claims, 

would help protect consumers. 

The consumer electronics market operates very differently from the medical 

device market. As such, there arc serious risks associated with the development of 

PSAPs to treat hearing loss. New consumer electronic technologies are often 

disseminated at an early stage through beta tests to accelerate, commercialize, and gain 

feedback, but this model is not appropriate for a medical product. Medical devices are 

carefully tested for safety and etTicacy before being commercialized; consumer product 

testing is primarily directed toward performance, not safety. And FDA regulates the 

investigational studies of new dcvices. 38 Thus, PSAPs need to be treated only as 

amplification devices, not as substitutes for hearing aids, and this requirement must be 

enforced. Failure to recognize and enforce these differences would lead to complete 

deregulation of the hearing industry. FDA should review and finalize its 2013 Draft 

PSAP Guidance to accomplish these goals. 

Complete deregulation of the hearing aid industry should not be considered a 

viable option. Past experiments with deregulation have shown that the unregulated 

hearing aid market does not work. Prior to hearing aid regulation, an FDA Task Force in 

1976 investigated hearing aids and discovered that many of the hearing devices sold 

"basically didn't work."39 In 1985, Colorado experimented with deregulation of hearing 

aid sales and determined that complaints tiled for hearing aids jumped from an average of 

14 per year to 100.40 The most common complaints included refusal to provide legally 

mandated refunds, problems with fittings and repairs, and contract and fraud issues. 

Colorado eventually decided to reinstate licensing requirements for hearing aid 

38 21 C.F.R. Parts 50, 56, and 812. 39 FDA, Transcript from Streamlining Good Manufacturing Practices for Hearing Aids Workshop, 12 (Apr. 21, 

20 16) (Statement of Commissioner Robert Califf), 

https://www.fda.gov/downloads/MedicaiDevices/NewsEvents/WorkshopsConferences/UCM502750.pdf. 

40 ld at 183-84. 

13 
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26785.017

distribution. 41 Complete deregulation of OTC hearing aids would likely result in a 

recurrence of the same behaviors and problems. And with the internet, it would be easier 

to commit fraud and confuse people than before. 

Conclusion 

HI!\ appreciates the opportunity to provide testimony at today's hearing. HIA 

supports the effort to promote innovation in the field of hearing technology and increase 

access for consumers. IliA believes that new distribution models and new informational 

resources are already helping to advance these goals. HIA applauds the efforts of the 

Congress, the FDA and the FTC to work together to ensure more accessible and 

affordable hearing loss treatment for all. 

Once again, HIA emphasizes the importance of safety and efficacy in the hearing 

aid industry. The health of the patient must be foremost; only after assuring safety and 

efficacy can the discussion about cost proceed. For this reason, HIA believes that OTC 

hearing aids subject to the appropriate FDA regulatory controls may be an effective costreducing option for those with mild hearing loss, but strongly encourages limiting the 

category to only those with mild hearing loss. HIA urges the Subcommittee to amend 

II.R. 1652 to permit OTC hearing aid sales to patients with mild hearing loss only. 

41 !d. at 185. 

14 
52 

Mr. BURGESS. The chair thanks the gentleman. 

Dr. Lin, you are recognized for 5 minutes for an opening statement, please. 

STATEMENT OF FRANK LIN, M.D., PH.D. 

Dr. LIN. Chairman Burgess, Ranking Member Green, and members of the subcommittee, thank you for inviting me here today. My 

name is Frank Lin, and I am an associate professor in the Johns 

Hopkins School of Medicine and the Johns Hopkins Bloomberg 

School of Public Health. From a clinical perspective, I am a boardcertified otolaryngologist with fellowship training in otology and an 

expert in the medical and surgical management of hearing loss and 

other conditions affecting the ear. From a research perspective, I 

am a public health expert on the impact that hearing loss has on 

older adults and society. My interest in and testimony on the Overthe-Counter Hearing Aid Act stems directly from this background. 

The OTC hearing aid bill, which we have been discussing, introduced by Representatives Kennedy, Carter, and Blackburn, directly 

reflects the early recommendations made by two expert committees: the President’s Council of Advisors on Science and Technology, or PCAST, in 2015; and a National Academies of Sciences, 

Engineering, and Medicine consensus study in 2016. I advised 

PCAST on their report and was also a member of the National 

Academies’ expert committee. 

Both of these expert bodies concluded that the creation of an 

FDA regulatory classification for OTC hearing aids for mild to moderate hearing loss would immediately benefit public health and 

Americans. The importance of the present bill instructing the FDA 

to carry out this recommendation is immense for public health. 

Over the past several years, research from Johns Hopkins as well 

as other academic institutions has clearly demonstrated that hearing loss, while being a usual process of aging for all Americans, is 

not without consequence. These studies have demonstrated that individuals with hearing loss are at a greater risk of developing dementia, having falls, and having greater healthcare costs. These research studies also clearly suggest that hearing loss treatments, 

such as using hearing aids, potentially decrease these risks and 

lead to real and tangible benefits for society. 

And yet, currently, less than 20 percent of nearly 38 million 

Americans with hearing loss currently have access to hearing aids. 

The reason for this low rate of use stems largely in part from the 

current regulatory framework that only allows for a one-size-fits-all 

model of obtaining hearing care; that is, for an average American 

nowadays to obtain hearing aids, he or she has to make repeated 

trips back and forth to a licensed hearing professional, who basically serve as the gatekeepers now to consumers being able to obtain hearing aids. While this model is clearly appropriate for people 

with more severe hearing losses and more complex hearing losses, 

this model is extremely expensive, and it is clearly not needed by 

every one of the 38 million Americans with hearing loss. At 

present, the average cost of obtaining two hearing aids is about 

$4,700, which, when put into perspective, means that, for the average American, a pair of hearing aids could be their third largest 

material purchase in life after a house and a car. 

53 

The passage of the OTC hearing aid bill would allow for hearing 

aids meeting explicit performance standards that would ensure 

safety and effectiveness for mild-to-moderate hearing loss to be directly available to consumers. Based on the scientific literature, the 

best studies we have to date, such devices could safely provide levels of amplification that would be effective for individuals with mild 

to moderate hearing loss. Both established hearing aid manufacturers as well as consumer technology companies that have economies 

of scale in manufacturing would then be able to enter the marketplace to sell devices directly to consumers that will come at a lower 

cost as many more are sold. 

Importantly, the availability of OTC hearing aids for mild to 

moderate hearing loss does not in any way preclude the invaluable 

services in counseling, education, device programming that a hearing professional could provide. One would expect—and we already 

see this, actually—that many adults would, in fact, still want to 

seek out a hearing professional to learn how to use the devices and 

customize the device to their hearing needs, while others may learn 

to use these devices on their own, much like any other consumer 

electronic. 

The important point is that the availability of OTC hearing aids 

for mild-to-moderate hearing loss would bring hearing technology 

out from under the explicit control of hearing professionals, such as 

me, and allow consumers to choose what level of hearing care best 

meets their own needs and priorities. 

I should note that some critics of OTC hearing aids commonly 

raise concerns about the safety of these devices to consumers, the 

risk of children using these devices, and whether these devices 

should only be for mild hearing losses. While, as a medical and surgical expert on hearing loss, I can appreciate where these concerns 

are coming from; these concerns are misguided and more often 

than not are being raised by parties who are more interested in 

preserving the status quo rather than truly improving the lives of 

Americans with hearing loss and advancing public health. These 

latter priorities are what mainly concern me as an academic as 

well as a physician, but also concern PCAST and the National 

Academies in their recommendations that serve as the direct basis 

of the wording of the over-the-counter hearing aid bill. 

I provide a more extensive discussion of these concerns in my 

written testimony, and I am also more than happy to address further in questions from any of the subcommittee members. Thank 

you for allowing me to share my views with you. 

[The prepared statement of Dr. Lin follows:] 

54 


26785.018

"Examining Improvements to the Regulation of Medical Technologies" 

Testimony of 

Frank R. Lin, M.D. Ph.D. 

Associate Professor 

Departments of Otolaryngology-Head & Neck Surgery, 

Geriatric Medicine, Mental Health, and Epidemiology 

Johns Hopkins University 

Before the 

United States House of Representatives 

Committee on Energy and Commerce 

Subcommittee on Health 

May 2, 2017 
55 


26785.019

Chairman Burgess, Ranking Member Green, and Members of the Subcommittee: 

Thank you for inviting me here today. My name is Frank Lin, and I'm an 

Associate Professor in the Departments of Otolaryngology-Head & Neck Surgery and 

Geriatric Medicine at the Johns Hopkins School of Medicine and in the Departments of 

Epidemiology and Mental Health at the Johns Hopkins Bloomberg School of Public 

Health. From a clinical perspective, I'm a board-certified otolaryngologist with fellowship 

training in otology, and I am an expert in the medical and surgical management of 

hearing loss and other conditions affecting the ear. From a research perspective, I am a 

public health expert on the impact that hearing loss has on older adults and society. My 

interest in and testimony on the Over-the-Counter Hearing Aid Act (H.R.1652) stems 

directly from this background. 

The OTC hearing aid act introduced by Representatives Blackburn and Kennedy 

directly reflects the earlier recommendations made by 2 expert committees-the 

President's Council of Advisors on Science and Technology issued a report in October 

20151, and this was then followed by a National Academies consensus study report2 on 

Affordable and Accessible Hearing Care for Adults in June 2016. I advised PCAST on 

their report and was a member of the National Academies expert committee. Both of 

these expert bodies concluded that the creation of an FDA regulatory classification for 

OTC hearing aids would immediately benefit public health and Americans. 

The importance of the present bill instructing that the FDA carry out this 

recommendation is immense for public health. Over the past several years, research 

from Johns Hopkins as well as from other academic institutions has demonstrated that 

hearing loss, while being a usual process of aging for nearly all Americans, is not 

without consequence. These studies have demonstrated that individuals with hearing 

loss are at a greater risk of developing dementia3·

5 , having falls6·

7, becoming 

hospitalized8·

9, and having greater health care costs 10 These research studies also 

clearly suggest that hearing loss treatments such as using hearing aids and other forms 

of amplification could potentially decrease these risks and lead to real and tangible 

benefits for individuals, families, and society. And yet, presently, <20% 11 of the nearly 

38M Americans 12 with a significant hearing loss currently has access to hearing aids. 
56 


26785.020

The reason for this low rate of use stems largely in part from a current regulatory 

framework that only allows for a one-size-fits-all model of obtaining hearing care-that 

is, for an American to obtain hearing aids, he or she has to make repeated trips back 

and forth to a licensed hearing professional who serve as the gatekeepers to 

consumers being able to obtain hearing aids. While this model is appropriate for those 

with more complex hearing losses, this model is extremely expensive and is clearly not 

needed by every one of the 38M Americans with hearing loss. At present, the average 

cost of obtaining 2 hearing aids in the U.S. under this model is approximately $47002 

which means that for the average American a pair of hearing aids could be their third 

largest material purchase in life after a house and a car. 

The passage of the OTC hearing aid bill would allow for hearing aids meeting 

explicit performance standards that would ensure safety and effectiveness to be directly 

available to consumers. Based on the scientific literature13, such devices could safely 

provide levels of amplification that would be effective for those individuals with mild-tomoderate hearing losses. Both established hearing aid manufacturers as well as 

innovative new startup companies and consumer technology companies that have 

economies of scale in manufacturing would then be able to enter the marketplace to sell 

devices directly to consumers that will come at a lower cost as many more are sold. At 

present, with current regulations prohibiting direct access to consumers and 98% of the 

world's hearing aid marketplace being controlled by 6 companies, there is little incentive 

or ability for innovation and for new companies to enter the market 

Importantly, the availability of OTC hearing aids does not in any way preclude the 

invaluable services in counseling, education, and programming that a hearing 

professional could provide. One would expect that many adults would in fact still want to 

seek out a hearing professional to learn how to use these devices and customize the 

device to their hearing needs, while others may learn to use these devices on their own 

much like any other consumer electronic. The important point is that the availability of 

OTC hearing aids would bring hearing technologies out from under the explicit control of 

a group of individuals (such as me) and allow consumers to choose what level of 

hearing care best meets their needs and priorities. 
57 


26785.021

I should note that some critics of OTC hearing aids raise concerns about the 

safety of these devices for consumers without having a professional exam, the risk of 

children using these devices, and the suitability of these devices for mild-to-moderate 

hearing loss. While as a medical and surgical expert on hearing loss, I can appreciate 

where these concerns are coming from, these concerns are misguided and more often 

than not are being raised by parties who are more interested in preserving the status 

quo rather than in improving the lives of Americans with hearing loss and advancing 

public health. These latter priorities are what mainly concern me and what also 

concerned PCAST and the National Academies in their recommendations that serve as 

the basis of the present OTC hearing aid act. 

Possible concerns raised about OTC hearing aids 

Device safety One of the most important aspects of the current legislation is that 

the FDA would establish evidence-based performance standards for OTC hearing aids 

to ensure that they are both safe (e.g., maximum sound output levels) and effective. At 

present and without this regulatory classification, the market is awash with unregulated 

hearing devices (i.e., personal sound amplification devices) commonly found in 

drugstores and advertised in magazines that make wild and unsubstantiated claims 

about performance and many of which have unsafe sound output levels. Consumers 

seeking out more affordable hearing technologies often turn to these devices, but 

without proper FDA regulation, they have no way of knowing which devices could in fact 

benefit them. FDA re-regulation would bring clarity to the marketplace ensuring that 

consumers could have access to safe and effective devices. 

Consumer safety Some clinicians make the argument that obtaining a hearing 

aid without first having a medical exam is unsafe. While this argument is sound for 

children, it doesn't make sense for adults where 2 of every 3 adults over 70 years have 

a hearing loss14 In the absence of signs such as a draining ear, sudden hearing loss, 

etc. (all of which would be listed as warning signs to see a doctor for in the labelling of 

an OTC device), the chances of missing important clinical diseases are minute 2 (e.g., 

an acoustic neuroma [a benign hearing nerve tumor] is diagnosed in -0.001% of people 

per year) and far outweighed by the benefits of ensuring access to hearing technology 
58 


26785.022

for the millions of people who currently do not seek help for their hearing loss. By the 

same extension, we as a society have long accepted the risk and benefits of OTC 

reading glasses (despite the fact that poor vision could be from glaucoma which is 

prevalent in 5% of older adults) or OTC aspirin for headaches (despite the fact that 

headaches may be masking neurologic conditions or that aspirin can and does 

occasionally lead to fatal internal bleeding). In both of these latter cases and as with 

OTC hearing aids, the benefit of access to these OTC products for society far exceeds 

any theoretical risks. 

More importantly, there is an even greater likelihood that the availability of OTC 

hearing aids will intensify awareness of hearing loss in society and lead even more 

(rather than fewer) Americans to seek a hearing professional's evaluation of hearing 

once affordable OTC hearing aids are known to be available. At present, many 

consumers avoid seeking out professional hearing evaluations because of the 

perceived lack of affordable treatment options for hearing loss. 

Device effectiveness for mild-to-moderate hearing loss and consumer ability to 

self-diagnose and self-fit hearing aids: The strongest scientific study to date consisting 

of a definitive NIH-funded randomized controlled triaJ13 demonstrated that consumers 

can self-fit OTC hearing aids and that these devices benefit consumers with a mild-tomoderate hearing loss. There is absolutely no medical reason or rationale to consider 

limiting the intended use of OTC hearing aids (and hence the FDA performance 

standards of these devices) to only those individuals with a mild hearing loss. 

Risk to children Some individuals have raised the concern that children with 

hearing loss may be given OTC hearing aids by their parents rather than being taken for 

medical and audiological evaluation. As a medical and surgical expert in hearing loss, I 

agree that this would not be in the child's best medical interest, but any concern that I 

have is tempered by the actual circumstances concerning how pediatric hearing loss is 

already managed in the U.S. Presently, universal newborn hearing screening and 

school-age hearing screening programs have long been active in all states, and children 

are thereafter referred appropriately for follow-up. For low-income families with children 

qualifying for Medicaid, the Early and Periodic Screening, Diagnosis, and Treatment 
59 


26785.023

Program under Medicaid already mandates coverage of all medically-necessary hearing 

aid services and hearing aids for children. As such, it is highly unlikely that a significant 

hearing loss in a child would go unrecognized in the current environment such that a 

parent would take it upon themselves to feel compelled to self-diagnose and treat their 

child without consulting with a medical and/or audiological professional. 

As a society, we have also long ago accepted that many OTC products could 

theoretically be inappropriately used by children and cause harm, but that the overall 

benefits to society far outweigh these theoretical risks. For example, using the case of 

aspirin discussed above, when given to children recovering from viral illnesses aspirin 

can increase the risk of Reye's syndrome, a potentially fatal condition involving brain 

swelling. However, with proper labelling instructing parents to avoid giving aspirin to 

children with viral-like illnesses, this condition remains very rare, and we continue to 

recognize the benefits to society of having OTC aspirin widely available despite the 

theoretical risks. 

Conclusion 

The OTC hearing aid bill under consideration by Congress would enable the FDA 

to sensibly re-regulate hearing aids to ensure that 38M Americans with hearing loss 

have access to safe and effective OTC hearing technologies that can enable them to 

communicate and fully engage in society. The benefits of OTC hearing aids for 

improving public health, promoting innovation in the hearing technology marketplace, 

and lowering costs are substantial and profound. Passage of this bill represents a 'winwin' for the 38M Americans 12 with hearing loss (in particular American seniors of whom 

nearly 2 of 3 have a significant hearing loss 14), hearing health professionals who will 

have a wider range of hearing technologies to choose from with which to help their 

patients, and both established hearing aid and other technology companies who will 

now be able to develop innovative new hearing technologies that can be offered directly 

to American consumers. 

Thank you for the opportunity to present my views to you today. I am happy to 

happy to answer any questions that you may have. 
60 


26785.024

1 Aging America & Hearing Loss: Imperative of Improved Hearing Technologies. President's 

Council of Advisors on Science and Technology, October 2015. 

2 Hearing health care: Priorities for improving access and affordability. National Academies of 

Science, Engineering, and Medicine. Washington, D.C., 2016. 

3 Lin, F. R. eta/. Hearing loss and incident dementia. Arch Neuro/68, 214-220, 2011. 

4 Gallacher, J. eta/. Auditory threshold, phonologic demand, and incident dementia. Neurology 

79,1583-1590,2012. 

5 Lin, F. R. & Albert, M. Hearing loss and dementia who is listening? Aging Ment Health 18, 671-

673, 2014. 

6 Viljanen, A. et of. Hearing as a predictor of falls and postural balance in older female twins. J 

Gerontal A Bioi Sci Med Sci64, 312-317, 2009. 

7 Kamil, R. J. et of. Association of Hearing Impairment With Incident Frailty and Falls in Older 

Adults. J Aging Health 28, 644-660, 2016. 

8 Genther, D. J. eta/. Association Between Hearing Impairment and Risk of Hospitalization in 

Older Adults. Journal of the American Geriatrics Society 63, 1146-1152, 2015. 

9 Genther, D. J., Frick, K. D., Chen, D., Betz, J. & Lin, F. R. Association of hearing loss with 

hospitalization and burden of disease in older adults. JAMA 309, 2322-2324, 2013. 

10 Foley, D. M., Frick, K. D. & Lin, F. R. Association between hearing loss and health care 

expenditures in older adults. Journal of the American Geriatrics Society 62, 1188-1189, 2014. 

11 Chien, W. & Lin, F. R. Prevalence of hearing aid use among older adults in the United States. 

Arch Intern Med 172, 292-293, 2012. 

12 Go man, A. M. & Lin, F. R. Prevalence of Hearing Loss by Severity in the United States. American 

journal of public health 106, 1820-1822, 2016. 

13 Humes, L. E. eta/. The Effects of Service-Delivery Model and Purchase Price on Hearing-Aid 

Outcomes in Older Adults: A Randomized Double-Blind Placebo-Controlled Clinical Trial. American 

journal of audiology 26, 53-79, 2017. 

14 Lin, F. R., Thorpe, R., Gordon-Salant, S. & Ferrucci, L. Hearing loss prevalence and risk factors 

among older adults in the United States. J Gerontal A Bioi Sci Med Sci 66, 582-590, 2011. 
61 

Mr. BURGESS. The chair thanks the gentleman. 

The chair recognizes Mr. Robinson 5 minutes for questions, 

please. 

STATEMENT OF JOE ROBINSON 

Mr. ROBINSON. Thank you, Chairman Burgess, Ranking Member 

Green, and distinguished members of the subcommittee. Thank you 

for the opportunity to appear before you today to discuss improvements to the regulation of medical technologies. 

I am Joe Robinson, senior vice president of Health Systems Solutions at Philips North America and the chair of the MITA board 

of directors. I am here today to testify on behalf of the Medical Imaging & Technology Alliance in support of H.R. 2009, the Fostering 

Innovation in Medical Imaging Act, and H.R. 2118, the Medical Device Servicing and Accountability Act. 

Before I get started, I want to also indicate MITA’s support for 

H.R. 1736, also the subject of the hearing, to make improvements 

to the FDA’s inspection process. And I will tell you that, after listening to my colleagues here on the panel, I very much support 

your hearing aid bill as well. 

Let me start with contrast, H.R. 2009. Contrast agents may be 

prescribed by physicians for use with diagnostic imaging equipment 

to enhance imaging, allowing for improved visualization and characterization of organs and tissue. The use of contrast agents has 

become an essential part of the clinical practice for a variety of imaging modalities. The FDA has not been willing to approve or clear 

imaging devices or enhancements for use with current approved 

contrast agents if they are not also labeled for that use, as Dr. 

Shuren had mentioned earlier. FDA believes that their regulations 

prevent them from doing so. 

The purpose of H.R. 2009 is to provide clarification to the agency 

on an appropriate clearance approval pathway for imaging devices 

with contrast agents. Neither physicians nor patients benefit from 

the current situation, as new innovations are being held up at the 

agency, I believe you referenced earlier, since 2007, which was part 

of our submission. This legislation would allow patients to move in 

the U.S. to have more rapid access to new imaging technologies 

that involve the use of contrast agents. 

MITA and CORAR have been working collaboratively with the 

FDA for decades to find a reasonable solution to the issue. In fact, 

the topic was addressed, as, again, I referenced just a moment ago, 

in MDUFA II, the agreement of 2007. 

Mr. Chairman, you brought that up yourself. 

Ten years later, the problem has yet to be resolved and continues 

to hinder the agency’s goals of fostering innovation, improving patient safety, and promoting public health. This legislation builds on 

the 2017 user fee agreements, reduces unnecessary regulatory hurdles, and allows patients in all communities to access cutting-edge 

innovation and diagnostic imaging that helps physicians detect disease earlier when it is more treatable. 

To address service, H.R. 2118. As medical imaging device manufacturers, we are not only responsible for making the devices, but 

we also often provide servicing activities for devices, both our own 

devices and manufactured by other companies. There are also a 

62 

number of non-manufacturer independent service organizations 

who repair and maintain medical devices. In what is probably a 

surprise to many, currently only service activities performed by a 

manufacturer are regulated by the FDA. Service activities performed by a third-party independent service organization do not 

have the same oversight or quality, safety, and regulatory requirements. Third parties are not even required to register with the 

FDA—I believe that came up earlier in some of the questions—creating an enormous blind spot. Unfortunately, unregulated third 

parties have caused a number of patient safety issues in their attempts to repair medical devices. We have raised these concerns 

with the FDA and included examples in my written testimony, 

which I believe all of you received. In raising these issues, some 

have questioned our motives, accusing us of wanting to overburden 

third-party service providers. I want to emphatically state that our 

only goal is to ensure that all service and maintenance always results in safe and effective operation of medical devices. This is a 

patient safety issue, pure and simple. 

H.R. 2118 takes an important first step toward the accomplishment of this goal by requiring that all independent service organizations step out of the dark and register with the FDA, file adverse 

event reports, and maintain a complaint handling system. That is 

it; that is what we are asking for here today. These are reasonable, 

basic requirements which device manufacturers already meet, by 

the way, 80 percent of which are small businesses with fewer than 

20 employees. These are minimum requirements that will give the 

agency information about how many businesses are engaging in 

servicing medical equipment and we hope will help get a better 

handle on adverse events to ensure that they never happen again. 

From a patient safety and adverse event avoidance perspective, 

this is the very least we can do for patients. 

Patients and doctors have enough to worry about. H.R. 2118 

seeks to protect patients and ensure effective device performance, 

to increase visibility and accountability for the medical device 

servicers. MITA urges Congress to include both H.R. 2009 and H.R. 

2118 in the MDUFA IV reauthorization. Passage of both of these 

bills will protect the patient safety and ensure timely access to the 

most innovative technologies. 

I want to thank you for the opportunity to testify and present my 

views in front of you today. I am happy to answer questions. 

[The prepared statement of Mr. Robinson follows:] 

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MIT~ MED!Clll IMAGING 

& TECHNOLOGY AlLIANCE 

A DIVISION OF Nal4' 

STATEMENT 

OF 

JOE ROBINSON 

1300 North 171h Street • Suite 900 

Arlington, Virginia 22209 

Tel 703.841.3200 

Fax: 703.841.3392 

www.medicalimaging.org 

SENIOR VICE PRESIDENT OF HEALTH SYSTEMS SOLUTIONS FOR 

PHILIPS NORTH AMERICA 

ON BEHALF OF 

THE MEDICAL IMAGING & TECHNOLOGY ALLIANCE (MITA) 

REGARDING A HEARING ON 

"Examining Improvements to the Regulation of Medical Technologies" 

BEFORE THE 

U.S. HOUSE OF REPRESENTATIVES 

COMMITTEE ON ENERGY AND COMMERCE 

SUBCOMMITTEE ON HEALTH 

Tuesday, May 2, 2017 
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SUMMARY OF TESTIMONY 

MIT A fully supports II.R. 2009, the Fostering Innovation ·in Medical Imaging Act of2017 

and H.R. 2118, the Medical Device Servicing and Accountability Act and urges their 

inclusion in the MDUFA IV legislation. 

H.R. 2009 will help manufacturers of medical imaging devices clear unnecessary regulatory 

hurdles and improve access to advancements in medical imaging that help physicians detect 

disease earlier when it's more treatable. It will also permit, but not require, medical imaging 

contrast agent manufacturers to conform the indications to the new device indication by 

adding the new device indication through a NDA supplement. Removing impediments to 

technological advancements in medical imaging will encourage innovation and allow 

physicians to better diagnose and treat patients in the United States in a manner that is 

consistent with medical practice internationally. 

• H.R. 2118 will help to ensure patient safety and medical device performance by requiring 

that medical device servicing organizations register with the FDA, maintain an internal 

complaint handling system, and file adverse event reports. This legislation seeks to protect 

patients and ensure efTective device performance through increased visibility and 

accountability for medical device servicers. 

2 
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26785.027

Chairman Burgess, Ranking Member Green, and distinguished members of the 

Subcommittee. Thank you for the opportunity to appear before you today to discuss 

improvements to the regulation of medical technologies. I am Joe Robinson, Senior Vice 

President of Health Systems Solutions for Philips North America and chair of the M!TA Board of 

Directors. I'm here today to testify on behalf of the Medical Imaging and Technology Alliance 

(MITA). 

MIT A is pleased to submit the following testimony on H.R. 2009, the Fostering 

Innovation in Mcd ical Imaging Act of 2017 and H.R. 21 I 8, the Medical Device Servicing and 

Accountability Act. These very important pieces oflegislation will help patients get the care they 

need safely and effectively. 

MIT A also supports H.R. 1736, also the subject of this hearing, to make improvements to 

the FDA ·s inspections process. 

* * * 

H.R. 2009- THE FOSTERING INNOVATION IN MEDICAL IMAGING ACT OF 2017 

MITA is the collective voice of medical imaging equipment and radiopharmaceutical 

manufacturers, innovators and product developers. It represents companies whose sales comprise 

more than 90 percent of the global market for medical imaging technology. These technologies 

include: magnetic resonance imaging (MRI), medical X-Ray equipment, computed tomography 

(CT) scanners, ultrasound, nuclear imaging, radiopharmaceuticals, and imaging information 

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systems. Advancements in medical imaging are transforming health care through earlier disease 

detection, less invasive procedures and more effective treatments. The industry is extremely 

important to American healthcare and noted for its continual drive for innovation, fast-aspossible product introduction cycles, complex technologies, and multifaceted supply chains. 

Individually and collectively, these attributes result in unique concerns as the industry strives 

toward the goal of providing patients with the safest, most advanced medical imaging currently 

available. 

The Council on Radionuclides and Radiopharmaccuticals (CORAR) is an association 

comprised of companies who manufacture and distribute radiopharmaceuticals, radionuclides, 

and contrast agents primarily used in medicine and life science research. CORAR advocates for 

regulations and legislation that facilitate innovation in diagnosis and therapy to advance health 

care for patients and providers. Specifically, CORAR focuses on manufacturing, transportation, 

safety, security, government reimbursement, and regulatory issues that can impact the 

radiopharmaceutical, radionuclide, sealed source, and contrast agent industries. CORAR pursues 

a proactive agenda which includes education of the Congress and regulatory bodies on the 

benefits of radiopharmaceuticals, radionuclidcs, and contrast agents to medical and life sciences. 

FDA CLEARANCE OF IMAGING DEVICES AND THE USE OF CONTRAST IMAGING AGENTS 

Contrast agents and radiopharmaceuticals may be prescribed by physicians for use with 

diagnostic imaging equipment for a number of clinical applications to enhance images allowing 

for improved visualization and characterization of organs and tissues for diagnostic purposes. 

For contrast agents, these uses include pediatric diagnosis, MRI for adults, MRA of the brain, CT 

and many other imaging uses as stipulated in the contrast agents' indications for usc. The usc of 

contrast agents has become a central part of modern clinical practice including ultrasound scans, 

4 
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x-ray exams, computed tomography scans and magnetic resonance imaging. Although some 

imaging procedures may be performed without contrast agents, the administration of contrast 

agents improves the clarity of the images obtained. Radiopharmaceuticals are integral to nuclear 

medicine and positron emission tomography (PET) procedures, as there is no image generated 

without the usc of the radiopharmaceutical. 

Contrast agents and radiopharmaceuticals are administered in ditTerent ways. Some are 

administered orally; others arc injected or delivered through an intravenous line. After the 

imaging procedure, most are naturally excreted by the body. 

The United States Food and Drug Administration (FDA) is currently not willing to 

approve or clear imaging devices, or imaging device enhancements, for use with currently 

approved contrast agents if the contrast agents are not also labeled for that usc. Since a contrast 

agent manufacturer often has no need or incentive to revise the labeling, updates to contrast 

agent labeling are not keeping pace with the technological advancements of medical imaging 

devices, and such advancements are not being approved or cleared by FDA. FDA believes that 

their regulations prevent them from approving or clearing a device for use with an approved 

contrast agent where the use is not also specified in the contrast agent labeling. The purpose of 

this bill is to authorize FDA, under narrowly specified conditions, to approve or clear an imaging 

device or an imaging device enhancement (called an "applicable medical imaging device" in the 

bill) for usc with a contrast agent in a new indication that is not among the approved indications 

of the contrast agent. 

MIT A, CORAR, and their respective members have been working collaboratively with 

the FDA for nearly 20 years to lind a reasonable solution to this issue. In fact, the topic was 

addressed as part of the MDUFA II agreement in 2007. Ten years later, the problem has yet to be 

5 
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resolved by the Agency. Therefore, we are asking Congress to pass H.R. 2009, the Fostering 

Innovation in Medical Imaging Act of2017 to provide clarification to the Agency on an 

appropriate clearance and approval pathway for imaging devices used with contrast agents. 

WHY THIS MATTERS TO PATIENTS AND PHYSICIANS 

Diagnostic imaging that utilizes contrast agents to enhance the image is a safe and 

invaluable tool for clinicians and the standard of care in many cases. Neither physicians nor 

patients benefit t!·om the current situation as new imaging innovations are being held up at the 

Agency or are being omitted from equipment in order to obtain approval or clearance, while 

being widely available in other pmis of the world. Without the benefit of new imaging 

innovations, physicians know less about a patient's condition and must make a less informed 

decision about the required course of treatment. 

This legislation would allow patients to have more rapid access to new imaging 

technologies that involve the use of contrast agents. We believe this would allow for a broader 

and more equitable adoption of the latest innovation in the use of medical imaging. Currently, 

there can be a disparity between research centers of excellence and the community hospitals that 

serve most patients across the country. Research centers have the capability and resources to 

conduct the research necessary to use imaging technology in an expanded way. Through this 

research, they develop advanced imaging techniques. Generally, device manufacturers are then 

able to usc the research and seek clearance or approval for expanded indications. For indications 

that include the usc of contrast agents, the regulatory pathway for expanded indications is 

confusing and cumbersome, and manufacturers have been unable to obtain clearance or approval. 

Therefore, information about the new indications is not reaching outside of the research centers, 

meaning many American patients do not have access to the latest innovation. In some cases, new 

6 
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indications for contrast agents and medical imaging devices are widely available in other 

countries years before they are available to American patients. 

MITA urges Congress to pass H.R. 2009, the Fostering Innovation in Medical Imaging Act of 

2017 to ensure that patients and physicians. regardless of the type of institution, have access to 

innovative diagnostic imaging capabilities. 

FDA TREATMENT OF NEW CONTRAST INDICATIONS FOR DEVICES 

In December 2009, FDA released a guidance document entitled: "Guidance for Industry: 

New Contrast Imaging Indication Considerations for Devices and Approved Drug and Biological 

Products." This Guidance was part of an agreement under the Medical Device User Fcc 

Amendments of2007 (MDUFA). Specifically, FDA agreed to develop a guidance document for 

medical imaging devices used with ''contrast agents or radiopharmaceuticals" to help both FDA 

reviewers and industry to understand the appropriate pathway for approval or clearance of these 

products. 

Imaging device manufacturers requested this guidance from FDA because for years they 

had struggled to find a consistent pathway through the FDA regulatory process and anticipated 

the guidance providing stability and transparency. Unfortunately, the 2009 guidance did not 

provide the clarity manufacturers' were seeking. In many ways it is so restrictive that it has 

made the process more confusing and cumbersome than before, essentially restricting the 

regulatory process for innovative imaging devices that may be used with contrast agents, where 

the device indication is not described in the labeling of the contrast. 

Over the course of2010, as the guidance was implemented, the Center for Drug 

Evaluation and Research (COER) and the Center for Devices and Radiological Health (CDRH) 

struggled to interpret the guidance with regard to the circumstances in which the use of contrast 

7 
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agent may be acceptable. As a result, imaging devices that had been cleared by FDA even a year 

or two bcl(Jre guidance was issued, that included features involving the use of approved contrast 

agents were no longer being cleared or approved by the Agency. This left manufacturers with 

few options for FDA clearance short of stripping new devices of contrast imaging functionalities 

-in effect .. defcaturing" devices- turning back the clock on technology and running counter 

to the practice of medicine. Further. these basic features arc not new or novel. 

In 20 ll, the FDA met with key stakeholders, including Mll'A and the American College 

of Radiology (ACR) to discuss the potential public health consequences of continued 

implementation of the guidance. The FDA agreed to a non-enforcement policy for a period of 

two years while they considered a more efficient method for approving medical imaging 

equipment that may be used with contrast agents with non-conforming labels. The two-year 

period has long since expired, and the guidance is still in place on the FDA website, which could 

lead to further confusion in the marketplace and the Agency. MlTA and CORAR have met with 

FDA throughout the intervening years to discuss the issue, but no resolution has been 

forthcoming. 

H.R. 2009, FOSTERING INNOVATION IN MEDICAL IMAGING ACT OF 2017 

The current situation for contrast agent and medical imaging device approval and 

clearance hinders the Agency's goals of fostering medical device innovation, enhancing 

regulatory predictability, improving patient safety and promoting public health. The Fostering 

Innovation in Medical Imaging Act of201 7 makes clear that CDRH has the authority to consider 

and approve or clear, under certain specified conditions, a prcmarket application or notification 

for a medical imaging device for use with a contrast agent even if the labeled indications do not 

match. The bill also specifics that contrast agent manufacturers arc permitted, but not required, to 

8 
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update their labels to add the new device contrast indication through an NDA supplement. MIT A 

and CORAR support the passage of this legislation. 

Specifically, CDRII may clear or approve a medical imaging device for a new indication 

involving the usc of an approved contrast agent where the contrast agent is not approved for that 

indication, as long as the contrast agent is not used: 

• in a concentration, rate of administration, or route of administration that is different from 

those described in the approved labeling of the contrast agent; 

in a region, organ, or system of the body that is different from those described in the 

approved labeling of the contrast agent, unless the Secretary determines, based on 

information contained in the device application or 51 O(k) notification, that the difference 

does not affect the safety of the contrast agent when used with the device; 

• in a patient population different from the patient population described in the approved 

labeling for such contrast agent, unless the Secretary determines that there is no increased 

risk; or 

in an imaging modality, such as ultrasonic, ionizing radiation, or magnetic resonance, that 

is different from those described in the approved labeling ofthe contrast agent. 

By clarifying the process for imaging equipment manufacturers to gain approval or 

clearance for new technologies that utilize formerly approved contrast agents, this bill will spur 

even more innovation. This is an opportunity to ensure patient access to new imaging 

technology and give their physicians even more specific information when considering treatment 

options. This bipartisan bill provides medical imaging device and contrast agent manufacturers a 

clear regulatory pathway to ensure all patients have timely access to innovative advanced 

9 
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26785.034

medical imaging technologies. Many of these new medical imaging technologies arc indicated 

with previously approved contrast agents. In many instances, medical imaging technology 

advancements have outpaced the approved contrast agent labels. 

H.R. 2009, the Fostering Innovation in Medical Imaging Act of 2017 will help 

manufacturers of medical imaging devices clear unnecessary regulatory hurdles and improve 

access to advancements in medical imaging that help physicians detect disease earlier when it's 

more treatable. It will also permit, but not require, contrast agent manufacturers to conform the 

indications to the new device indication by adding the new device indication through a NDA 

supplement. Removing impediments to technological advancements in imaging will encourage 

innovation and allow physicians to better diagnose and treat patients in the United States in a 

manner that is consistent with medical practice internationally. This bill builds on the 2017 user 

fee agreements and will ultimately allow patients in all communities to access the cutting edge 

innovation in diagnostic imaging by labeling products with new indications for use. 

* * * 

H.R. 2118- THE MEDICAL DEVICE SERVICING AND ACCOUNTABILITY ACT 

Currently, only servicing activities performed by medical device manufacturers are held 

to any quality, safety, or regulatory requirements by the FDA. Non-manufacturer entities have no 

FDA oversight and do not have to follow FDA regulations. This is an important problem because 

performance of servicing activities within a quality system by properly trained personnel using 

10 
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qualified properly sourced parts reduces the risk of harm to the patient, healthcare provider, or 

device operator and reduces risk of poor performance of the device. 

The medical device servicing industry has changed significantly since the issue of device 

servicing was last seriously considered by the FDA in 1997-98. The number of unregulated and 

unregistered organizations and persons servicing medical devices has increased over the last 

twenty years without any comparable adjustment in the regulatory framework governing these 

activities. Unregulated and unregistered service providers are a growing and significant portion 

of the industry about which the FDA, health care providers, patients, and manufacturers know 

very little due to the lack of regulatory oversight, registration, or reporting. 

Our goal is to ensure that performance of these activities always results in the safe and 

effective operation of medical devices. H.R. 2118, the Medical Device Servicing and 

Accountability Act takes an important first step toward this goal by requiring that all medical 

device servicers register with the Food and Drug Administration (FDA), maintain an internal 

complaint handling system, and report adverse events to the FDA. 

MITA member companies are responsible for the innovation, original design, 

manufacture, packaging, labeling, assembling and upgrading of medical devices. Original 

equipment manufacturers also often provide servicing activities for installed devices both their 

own and those originally manufactured by other companies. 

Whether or not the manufacturer is also the entity which services a device, it has a stake in 

all service activities. Improper servicing presents significant concerns to the manufacturer, 

including creating challenges such as: 

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Difficulties in future manufacturer-provided servicing operations and the potential for 

signilicant periods of downtime if poorly performed previous repairs must be remedied; 

Difficulties in providing future field upgrades or field corrections to the device if 

improper parts have been used or if the device has otherwise been altered; 

• Lack of required regulatory reporting and incomplete device history does not allow for 

tracking of significant events, root cause investigation, or prevention of adverse events; 

Voided existing device certifications (e.g. UL certifications); 

Diminished brand value due to unsafe and ineffective operation of the device; and 

• Liability concerns for the manufacturer if the device injures directly or indirectly a 

patient or operator. 

Due to the fact that our member companies and their service departments regularly 

encounter these and other challenges, we have raised this issue with the FDA several times over 

the past few years. In raising this issue, our goal is to ensure the performance of servicing 

activities always results in the safe and effective operation of medical devices. 

More specifically, our interest in this issue is driven by patient safety. It is because of 

patient need that medical imaging devices exist. Medical imaging is essential for the screening, 

diagnosis, staging, therapy guidance, therapy monitoring, risk stratification, and surveillance of a 

multitude of medical conditions. For this reason, the patient is the most important stakeholder in 

medical device servicing. Patients and their healthcarc providers count on the safe, effective, and 

reliable operation of medical devices. If medical devices do not perform properly or do not 

perform at all due to improper servicing, patients may not be able to receive the care they need 

and healthcare professionals are unable to do their job effectively. 

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The nature of the risk to the patient is discussed in greater detail below, but, in general, 

there are two main categories of patient harm: 

I) Direct bodily harm resulting from improper functioning of the device due to 

mechanical, maintenance, or calibration issues 1 or healthcare-associated infections2 

2) Indirect harm resulting from delayed diagnosis or misdiagnosis due to poor 

image qualiti 

Generally there is a risk of delivering non-conforming devices if servicing activities are 

not properly performed as defined by the original equipment manufacturer. A non-conforming 

device means that the device docs not fulfill its specifications and poses a risk in regards to the 

safety and effectiveness of the device, and thus potentially also to the health and safety of 

patients and users. 

Although this is not a comprehensive list, there arc a number of specific risks depending 

on the kind of device in question: 

Electrical shock-All medical imaging devices require electricity to function. If the 

device has not been properly wired, has incorrect parts, etc ... , then there is the risk that a 

living being interacting with the device could receive an electrical shock. 

Over exposure to radiation-Some imaging devices, including X-Ray and CT scanners, 

emit radiation, resulting in potential over-exposure if not properly calibrated or 

maintained, leading to bodily harm. 

: 1: g, CX~CSSlVC radmt10n i~om 

" 1: g mfccuons resu!ong !rom 

'E g blun~y tmages due to m<S•cahlorat,on 

equipment or physical injul)' from mechanical l~1ilurc 

ultrasound transducers 

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• Poor image quality-If improper servicing leads to a device being improperly 

calibrated, the images the device produces could be of poor diagnostic quality due to 

artifacts or other issues, This could lead to misdiagnosis including both false positives 

and false negatives. It could also require re-imaging due to poor image quality. 

• Mechanical failure--If the device in question experiences mechanical failure due to 

improper servicing, bodily harm to the patient ranging from pinching to crushing could 

result. 

Air embolism-In the case of injection devices, if the device has not been properly 

serviced, the patient could experience an air embolism and die. 

• Infection-In tbe case of ultrasound and other devices, if the device has not been 

properly scaled as part of servicing activities, patient infection could result. 

Explosion-If the magnet in an MRI machine is not properly vented, pressure can build 

up inside the magnet resulting in eventual explosion. 

• Burns- Incorrect replacement materials or parts in an MRI machine may disrupt the 

path of radio frequency energy, causing excessive heating and resulting in patient burns. 

Interference with other equipment-If a device's electromagnetic shielding has been 

improperly serviced, operation of the device could be potentially detrimental to other 

equipment in surrounding area. 

• Asphyxiation-If the magnet in an MRl is improperly vented, then helium gas could 

displace air in the room, resulting in asphyxiation. 

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The patient has the most at stake if the device fails to perform in a safe and effective 

manner due to improper servicing. Patients should be able to assume an equivalent level of safety 

and efficacy regardless of the service provider. Performance of these activities within a quality 

system by properly trained personnel using qualified, properly sourced parts greatly reduces the 

risk of harm to the patient. 

Unfortunately, it is not currently possible to know the full scope of problems that have 

occuned when there has been no prior scrutiny or any regulatory oversight of non-manufacturer 

service providers and other third parties which would require reporting of problems. The only 

way to determine the magnitude of the problems associated with improper perfmmance of these 

activities would be through regulation of all entities which perform these activities, including 

registration and reporting. 

Although further steps will be necessary to ensure consistent safety and quality, the 

Medical Device Servicing and Accountability Act will take a crucial first step in addressing this 

issue by requiring that non-manufacturer 3'd party servicing organizations step out of the dark 

and make themselves known to the FDA and the American public, maintain an internal 

complaint handling system, and report adverse events to the FDA. 

Often, a manufacturer does not learn of an issue with its device unless the owner or 

operator of the device or a third party service entity reports an issue to the manufacturer. This 

does not happen in all cases. Further, the manufacturer often is not notified of an issue with the 

device until the device has failed or encountered some other problem which the servicer has been 

unable to resolve. Although the manufacturer may be made aware of the issue at this juncture, 

the manufacturer is not necessarily informed of the issues which led to this event. In many cases, 

there will have been a series of problems with the device for which assistance from a non15 
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manufacturer entity was sought. These activities performed by the non-manufacturer entity arc 

not required to be reported to the FDA or to any other organization which would be compiling 

and trending a comprehensive database of problems. 

Further complicating the situation is the fact that it is often difficult for manufacturers to 

determine the source of observed problems because third parties generally do not place any 

labeling on the device to indicate it has passed through their hands. Awareness of device 

problems will decrease as equipment becomes less traceable due to turnovers in service 

providers and equipment ownership. 

Manufacturers regularly encounter examples of improper servicing. Although they are in 

no way comprehensive or inclusive, the examples below serve as a sample of the issues that are 

regularly encountered. In some cases, we have photographic documentation of the issue. 

However, not all situations easily lend themselves to visual representation. 

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IMPROPER SERVICING OF AN MRI SYSTEM 

The following photos were obtained in January 2017 from an MRI system being used to 

scanning patients. The manufacturer was contacted to service the system due to poor image 

quality that the third party was unable to correct. The system was found to be in significant 

disrepair with several components damaged, poorly repaired or missing. After a detailed 

evaluation the manufacturer recommended a significant amount of repair that was similar to 

dcinstalling and reinstalling the system to replace the necessary components and recalibrate the 

system. 

Receive Channels Disconnected 

This MRI system includes four receive channels from the coils used to scan different 

portions of the anatomy. As shown in this photo, three of the four channels were disconnected 

because they were nonfunctional. Troubleshooting showed all three other were open and the 

fourth connected line was also compromised with readings that were outside of specification. 

(Continued on next page) 

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Incorrect Cable Replacement 

At the foot of the patient table one of the 4 receive cables (the only remaining functional) was 

replaced with the incorrect cable. The incorrect cable is the larger diameter cable the center of 

the photo. 

(Continued on next page) 

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Shoulder Coil Serviced With Tape 

The shoulder coil was found damaged with several attempted repairs using a white tape. The use 

of tape would prevent proper cleaning of the coil. The coil failed to meet specification when 

tested. 

(Continued on next page) 

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Head Coil Latch Damaged and Non Functional 

The screw holes on both sides of the coil latch were stripped out. Repairs were attempted with 

incorrectly sized screws and tape. The top portion of the coil could not be properly secured to 

assure a good connection of the receive lines in the top portion of the coil. 

(Continued on next page) 

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Missing Signal Amplifiers 

The patient table is equipped with 4 pre-amps. The manufacturer found two of the pre-amps 

were missing from the system and had not been replaced. 

Incorrect Computer Replacement 

The manufacturer found the commercial grade SUN workstation normally used to operate the 

system replaced with a consumer grade system. The possible impact on system performance is 

not clear and would require extensive testing to validate and verify proper operation when 

combined with the entire MRI system. No photo available. Additionally the system indicated it 

was upgraded but the proper software upgrade was not loaded. This would indicate an incorrect 

software reload was performed. 

(Continued on next page) 

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Aluminum Foil Used for Shielding 

The manufacturer found aluminum foil used to shield some of the cables in the scan room. It is 

believed this was an effort to shield the receive cables to correct poor signal and artifacts in the 

images. This can present safety and electrical issues when used within the MRI filter panel that 

contains high voltage. 

(Continued on next page) 

22 
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Patient Table Pads Damaged 

The patient table pads were damaged and should be replaced to allow for proper cleaning. 

23 
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IMPROPER SERVICING OF AN MRI SYSTEM 

A third party service sub-contractor hired by an onsite contractor was working at a 

customer site troubleshooting an MRI system. The servicer was working in the service panel 

with the power on when an arc flash occurred resulting in burns to the contractor. The blast 

knocked him back and onto the floor. Other people working in the area said the event sounded 

like an explosion. The event also resulted in approximately half of the hospital losing power. 

It is not known with total certainty what the servicer was doing at the time of the event or 

what caused the event to occur. He was going to be hooking up a power monitor to the system, 

but at what stage of that process he was at is unknown. He could have been checking the 

voltages prior to connecting the monitor or performing some other troubleshooting activity. 

It is known, however, that he did not have on his Arc Flash Personal Protection 

Equipment (PPE) at the time of the event. The PPE itself would not have prevented the incident 

from occurring, but it would have prevented or lessened the severity of the injuries that occurred. 

This is potentially an example of inadequate training and non-compliance which resulted in 

bodily harm, equipment damage, and loss of power to the hospital. 

(Continued on next page) 

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Panel where arc flash occurred 

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26785.050

IMPROPER PART 1:\1 AN ANGIOGRAPIIIC POWER IN.JECTOR SYSTEM 

During a recent service call for an angiographic power injector, it was observed that a 

third-party service vendor inappropriately substituted an original equipment manufacturer's steel 

pin with a simple sheet metal screw to hold a syringe turret in place. 

Angiographic power injectors of this class can inject fluid at pressures of up to 1200 psi. 

If this substituted sheet metal screw were to break or otherwise fail during a procedure, the turret 

could break free, potentially causing the turret and connected syringe to act as dangerous 

projectiles. Additionally, this improper pmt could cause vibrations during the injection, thereby 

leading to ancillary issues such as delay of procedure and eventual diagnosis due to unexpected 

equipment behavior. 

Common sheet metal screw substituted for steel pin 

26 
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26785.051

h!PROPER SERVICING OF AN MRI SYSTEM 

In this example a customer called the manufacturer and requested service on a 0.3T 

permanent magnet MRI due to ghosting on multiple images. The customer had been 

experiencing machine downtime due to the inability to properly scan patients. It is unknown for 

how long this problem existed. The manufacturer determined that the device had been 

improperly serviced, noting that additional wiring had been added to the electronics cabinet with 

no markings and terminations using hand-secured wire nuts. Further, the primary power supply 

cables lacked strain relief and protection from abrasions. 

(Continued on next page) 

27 

Speaker wire 

connecting power 

supply to 

unknown points 

and terminated 

with wire nuts 
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(Continued on next page) 

28 

Example of 

ghosting on 

medical images 

The primary 

power supply 

cables lacked 

strain relief 

and protection 

from abrasion 
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26785.053

This posed a risk of patient harm for a number of reasons: 

Ghosting which may require additional patient scans, delaying care or causing a 

misdiagnosis; 

• Noise bands which may require additional patient scans, delaying care or causing a 

misdiagnosis; 

Additional wiring which may void any NRTL listing of the system (i.e. UL or ETL 

certification) and may not meet electrical codes; 

The primary power supply cables entering the electronics cabinet did not have the proper 

strain relief and were not properly protected from abrasion where they entered the 

cabinet, potentially causing an electrical short, fire, or electrocution; and 

• These issues may have resulted in the device no longer meeting electrical codes. 

This improper servicing caused decreased equipment performance due to the resulting poor 

image quality as well as the electrical issues which may have caused an electrical short, fire, or 

electrocution. 

The customer was advised to discontinue use of the system and was provided with a 

proposal to perform a full system installation review for repair and calibration. 

29 
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26785.054

IMPROPER SERVICING OF A CT SCANNER 

In aCT scanner it was discovered that the computer cooling ducts, image control system, and 

image reconstruction cabinet had clogged filters and ducts. Further, it was noted that: 

The image evaluation system software back-up was out of date; 

The image evaluation system CD drive did not work; 

The image reconstruction system computer CD drive did not work, requiring computer 

replacement; 

The gantry water temperature was showing as ··out ofTolcrance"; 

The gantry water pressure was too low and out of specification; 

The gantry left front cover safety switch required replacement; 

The CT control box buttons were worn out; 

The table vertical drive was emanating scraping noises; and 

• The network node (creation/deletion) problem had existed for approximately one year. 

This resulted in the reliability of the image control system being compromised. The database 

could not be rebuilt, causing slow system performance. Further, the image reconstruction system 

was compromised, causing slow image reconstruction. The CT scanner was offline for several 

days while the issue was remedied. 

(Continued on next page) 

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(Continued on next page) 

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26785.057

IMPROPER SERVICING OF A NUCLEAR MEDICINE CAMERA 

A manufacturer was contacted by a dealer who was dealing with a customer complaint 

about their nuclear medicine camera. The customer had been using a third party servicer which 

improperly serviced their device and was now refusing to return and correct the issue. 

The device had numerous masked adjacent pixels in the detector image which could also 

mask any heart defects in the image. Further, the cooling unit was improperly connected to 

external power, bypassing the system's isolated power and grounding system potentially 

compromising patient safety and device performance. 

When adjacent pixels arc removed, a portion of the imaging detector is lost, so portions 

of the heart would not be imaged, meaning a heart defect could go undetected by the reviewing 

physician. When one pixel fails, the system uses data from adjacent pixels surrounding the failed 

pixel to extrapolate. If two adjacent pixels are bad, then the system does not have a complete 

sampling of data surrounding the pixels to get a good image. The resulting image would have a 

blurred spot, resulting in lower diagnostic quality. 

With respect to the improper power connection of the cooling system, the way in which 

the system was connected violates the manufacturer's power and grounding isolation scheme, 

potentially compromising patient safety and device performance. Further, this issue could have 

led to the detector overheating and pixels failing. These modifications violate the Nationally 

Recognized Test Lab (NRTL) (e.g. UL!EL) listing of the device. 

This resulted in such great degradation to the detector head that the customer could not 

use the device. 

(Continued on next page) 

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26785.058

(Continued on next page) 

34 

Remote chiller installed 

outside the unit on the 

floor with the cover of 

the unit off, exposing 

the camera internals 

Remote chiller 

installed outside 

the unit on the 

floor with the 

cover of the unit 

off, exposing the 

camera internals 
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Masked pixels 

Masked pixels 

35 
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IMI'ROI'ER REI' AIR OF AN MRI COIL 

In a 0.3T permanent magnet MRI RF coil the signal cable had been pulled out of a 

connector housing and was repaired with zip tics and plastic tubing. It is unknown for how long 

the hazard was present. 

Coil with plastic tubing and zip 

ties used to cover damaged 

cable 

36 

Example of failed coil that was 

hidden using zip ties and plastic 

tubing 
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26785.061

This posed a risk of patient harm for a number of reasons: 

• Cable failure may result in: 

o Lost signal or image artifacts causing misdiagnosis or requiring additional scans 

o Electrical arcing causing electrocution or burns 

• Zip tic edges are not smooth and may catch on patient skin or clothing; 

Zip tics and plastic tubing did not appear to be material tested and approved for patient 

contact; 

• Zip tics and tubing did not provide proper strain relief for the cable and may have 

allowed fmiher cable failure; and 

Plastic tubing may have further hidden additional cable failure 

This improperly repaired coil did not meet manufacturer quality specifications and was 

removed from service and repaired. 

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26785.062

IMPROPER SERVICING OF ACT SCANNER 

A facility reported to the manufacturer that it had been having issues with aCT table, 

workstation, and tube for approximately six months. The manufacturer's service engineer 

identified table cabling connections that were modified to be non-standard, exposed wiring, nonmanufacturer fuses installed, improperly exposed and non-manufacturer soldering connections, 

cable connections routed and repaired using electrical tape, bent table bolt, and defective 

transmit cable. 

I. The bank of black fuses is not connected to cables, per original equipment manufacturer 

design and manufacturing specifications 

2. Cables have been field repaired with fuses taped to the cable 

3. Grease identified in cabling area 

(Continued on next page) 

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4. Non-qualified fuse, with field repair to reform connector to fit around non-qualified fuse 

39 
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5. Transmit wire connection repaired previously and taped and visible and exposed at 

joint of green wire 

(Continued on next page) 

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6. Bent screw found, preventing table from full range of horizontal motion 

(Continued on next page) 

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7. Manufacturer's service engineer identified horizontal travel distance 

blocked by bent screw 

(Continued on next page) 

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8. Excessive oil identified 

(Continued on next page) 

43 
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I 

9. Oil and debris identified in back corners of gantry 

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26785.069

Improper Repair of an Ultrasound System 

An ultrasound endocavitary probe was received for testing from a US hospital. The dome 

had been replaced as part of a repair done by a third party. The dome material and thickness were 

different than that of the original device. The result was significantly more attenuation of the 

acoustic signal as shown below. The clinical user was complaining of lack of depth of 

penetration in the A-Mode image of the ''repaired'' probe. 

Improper ultrasound probe dome 

This improper repair could have resulted in delayed diagnosis or misdiagnosis as well as health 

conditions associated with a non-biocompatible material. 

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26785.070

Improper Parts in an MRI System 

In a 0.3T permanent magnet MRI the system CPU and monitor were replaced with 

unknown aftermarket units that were not tested and validated to operate with the manufacturer's 

software. It is unknown for how long the hazard was present. 

Aftermarket monitor installed on 

the MRI system 

46 

Aftermarket CPU installed on 

the MRI system 
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This posed a risk of patient harm for a number of reasons: 

• Potential for improper operation or failure of the MRI software due to unknown or 

untested drivers for the computer components and monitor, and 

Since the monitor was not properly sourced, there is the potential for incorrect calibration 

or inadequate function for displaying patient images. 

These improper paiis were removed and replaced with qualified parts. 

47 
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26785.072

Improper Servicing of a Fluoroscopy/RadiographY System 

In this example, the detector on a fluoroscopy/radiography system had been replaced with 

a third party detector system which included the third party's user-console and radiation release 

button. Further, the third party had installed a jumper cable on circuitry to allow grid movement 

and sensing to be bypassed. This also allowed for multiple exposures to be taking on a single 

cassette without resealing/resetting the bucky. This, in effect, removed the manufacturer's 

double-exposure safety feature. 

Third party installed a jumper cable on 

manufacturer circuitry to allow grid 

movement and sensing to be bypassed 

48 

Manufacturer detector replaced 

with non-qualified detector system 

which included their user-console 

and radiation release button 

(manufacturer exposure button 

covered over w/Plexiglas plate to 
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26785.073

Improper Materials Used to Seal an Endoscope 

In this example, a porous unidentified material has been used by a non-manufacturer to 

seal the shaft from the handle of an endoscope. Being porous, there is a chance for bioburdcn to 

infiltrate the device and potentially cause cross contamination. Further, it is unclear whether this 

material will hold up to sterilization parameters. The scope could fail during use if the shaft were 

to disconnect from the handle. 

Unidentified porous material used 

to seal the shaft of an endoscope. 

49 
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26785.074

Improper Materials Used to Seal a Laparoscope 

In this example, the light post of a laparoscope has been improperly sealed using nonmanufacturer epoxy. The epoxy is failing and bubbling. This improper material will not hold up 

to sterilization parameters. Further, epoxy can harbor bioburden. Charring is also visible in this 

picture due to pyrogenic reaction. This could cause the light post to overheat and potentially 

ignite. 

50 
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Improper Sealing on an Optical Forcep 

In this example, non-manufacturer epoxy has been used on the flushing end of an optical 

forcep, This material would not hold up to reprocessing and sterilization, The material is pitting 

and the pitted areas can harbor bioburden, Further, a hole has formed in the materiaL The 

integrity of this material could fail and the port could break off during a surgical procedure. 

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26785.076

Improperly Serviced Hemostasis Management System 

In this example, the field service technician was asked to service a Hemostasis 

Management System due to motor stalls. The unit was previously serviced by a 3rd- Party 

provider on June 17th, 2016. Upon inspection of the unit, the field service technician found the x 

-motor slide assembly completely inoperable, due to dried grease on the gear. While repairing 

the unit, the field service technician found multiple other errors, such as a bad ADU board, xy 

interface board, spring sensor, stripped out hardware, resulting in a $13,000 repair of the unit. 

This is a time-sensitive multi-functional testing system that is used to help preserve 

patient's clotting factors, assist in the prevention of thrombus formation, and monitor multiple 

aspects of clot formation. The benefits of the system include fewer complications associated with 

excess blood loss, preservation of the coagulation system, resulting in fewer transfusions, and 

fewer surgical reoperations. 

(Continued on next page) 

52 
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26785.078

Improperly Serviced Hemostasis Management Svstem 

In this example, the field service technician was asked to service a hemostasis 

management system due to motor stalls. Upon arrive the field service technician noted that the 

unit has a PM sticker from a 3rd party service provider indicating a preventive maintenance 

(PM) was completed a few weeks prior on the unit. 

Per procedures, the unit is required to be disassembled, cleaned, lubricated, and 

verification of calibrations. The attached images indicate that the unit was never opened to 

complete the requirements of a PM. 

Improper lubrication of the unit, as in this case, could cause inaccurate dispensing 

volumes and inaccurate test results. 

Improper cleaning may cause the EQC to give false error codes or actual test cartridges 

not to function properly, enhance possible false or erroneous results to the patient. 

(Continued on next page) 

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Improperly Serviced Blood Transfusion System 

In this example, the field service technician was contacted by the hospital to service their 

autologous blood transfusion system due to noise coming from the centrifuge bowl. The unit was 

serviced by a 3rd party provider. Based on the field service technician's assessment he 

dete1mined that: 

The roller assembly was never removed for cleaning 

The roller assembly significant issues of rust and corrosion 

The centrifuge holder was not in proper position and was pushing the centrifuge 

assembly to one side of the unit. 

This would cause improper function of the roller head for processing blood, additional 

wear and tear to the disposable tubing, improper volume calculations, and potential motor stalls 

to the point of not being usable during a case. 

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26785.081

Improperly Serviced Cardiopulmonary Bypass Unit 

In this example, the field service technician was at the facility to complete service on a 

cardiopulmonary bypass unit, The technician noted autologous blood transfusion system unit 

with a calibration tag dating back to January of20 !5. The technician informed the hospital 

biomedical engineer that the unit was overdue for service. The hospital biomedical engineer 

informed the field service technician that the unit was recently serviced by a third-party provider. 

The field service technician showed the attached image to the hospital biomedical 

engineer and informed her that the autologous transfusion system contains internal filters, and if 

these filers become obstructed, such as in this case can lead to equipment malfunctions of 

improper operation inadequate vacuum and overheating. 

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Improperly Serviced Cardiopulmonary Bypass Unit 

In this example, the field service technician noticed an issue with a cardiopulmonary 

bypass procedures. As a good faith gesture, the field service technician powered on the 

equipment to confirm the unit was functioning. The field service technician noticed a third-party 

service card that indicated the unit was just serviced. 

The unit failed to power-on due to depleted batteries which are a critical safety feature of 

the device. Concemed for the increased risk to the patient and operator, had the operator tried 

using this unit in the battery mode, the operator would have to change to the hand crank 

operation to maintain proper flow for the patient until AC power was available, the field service 

technician, notified the customer of the issue. The hospital submitted a P.O. to service the 

equipment resulting in additional charges to the hospital over what the hospital paid the thirdparty service provider. 

The image is the manufacturer's 'tamper' sticker that remained intact after the unit was 

serviced by the third-party. Verifying that the unit's cover was not removed by the third-party 

service provider to conduct proper servicing, which is also necessary to test or replace the unit's 

batteries. 

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Improperly Serviced Speed Controller System 

In this example, the field service technician was called to service a Speed Controller 

System. The unit was just serviced by a 3rd- party provider, however, when they turned the unit 

to battery (back- up for power failure or unavailability of power), the unit stopped functioning. If 

the battery fails during patient support, the perfusionist must operate in manual mode and hand 

crank the blood through the system until and alternate power source can be identified. 

Based on the state of the equipment, the field service technician determined that the unit 

was not removed from the base of the heart lung machine. The unit contains two external filters. 

One filter was obstructed (over-heating, improper performance) and the other was completely 

missing, allowing dirt and contaminate to get into the electro-mechanical parts. 

Along with debris getting inside the unit with the potential to over-heat the equipment, if 

the operator needed to use this unit in the battery mode, it would increase patient and operator 

risk. The operator would have to change to the hand crank operations to maintain proper flow 

for the patient until AC power was available. 

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An informal survey of the manufacturer community also revealed several other frequently 

encountered issues with improper servicing: 

Conversion of analog X-ray systems to digital, which include interfacing and 

modification of circuits. Modifications of this nature have been performed by multiple 

third party entities. These modifications resulted in rewiring, the blockage of safety 

features, and changing, at least in part, the intended use of the device. These 

modifications are being done without coordinating with the manufacturer to ensure that 

safety, efficacy, and other product requirements arc maintained. 

Angiographic X-ray systems: 

o Breaking the video circuit for various purposes (video capture for storage and 

manipulation). In many cases, the exposure circuit was also broken to trigger the 

video. In these events, rarely is the equipment isolated or properly grounded. This 

leads to noise injected into the video and can create a safety issue in which 

equipment could be touched by the patient while a wire is in him or her. 

o Installation of various wire guidance devices or ultrasound systems physically 

attached to system. Power and data are typically run on the outside of the system 

and usually arc taped or Vclcroed to the imaging system. The improper parts may 

actually be physically attached to the device, creating grounding loops. 

Mobile Conversions to MR and CT Systems: In general the manufacturer has learned of 

instances in which third parties have been installing fixed site equipment into uncertified 

mobile trailers. These installations do not meet planning guide requirements that certified 

trailer manufacturer's must adhere to. The manufacturer's mobile conversion kits were 

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not installed and the manufacturer's mobile planning guide not followed. It is important 

to note that the device was not ordered from the factory as a mobile device and the 

manufacturer's 51 O(k)s are not filed for certain MR and CT systems to be used as mobile 

equipment. 

• Converting a fixed site MRI system into an uncertified trailer without using mobile 

specific components creates an unsafe, unserviceable system. The system did not have 

proper magnet venting and magnetic shielding. The system's cabling had been modified, 

compromising access to electronics. The magnetic shielding did not contain magnetic 

rield, posing significant risks. The quench vent had not been validated. The magnet 

venting had not been rated for high altitude. The serial number was not recognized as a 

mobile system by factory. Safety updates specific to mobile equipment will not be issued. 

• Host computer swap on a mobile MR system: 

o In general this creates an issue as any software updates issued will not be 

compatible with the host installed as updates are serial number-specific. This also 

results in software licenses that were purchased for a particular serial number 

being used on a completely different piece of equipment. 

• In a case involving maintenance by a third-party company, an overhead counterpoise 

support system arm (accessory to a powered contrast injector system) separated and fell, 

striking a radiology technologist due to a support arm separation. That company, which 

had the maintenance contract for this equipment, also did not maintain adequate service 

history records for the system. When the manufacturer was called to address the 

incident, it was unclear if the equipment had been regularly inspected and maintained 

appropriately. Regular preventive maintenance is important in ensuring that the device 

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continues to meet its performance specifications. Thus, the cause of this failure may have 

been identified and prevented from occurring if routine preventive maintenance had been 

conducted. 

i\ case was recently logged detailing a third-party service vendor that had improperly 

removed a printed circuit board from a powered contrast injector during servicing. 

During the manufacturer's investigation. it was determined that the service vendor had 

applied excessive force to the connector, pulling it away from the Servo/CPU board. This 

instance resulted in several damaged components that had to be replaced in order to 

restore the equipment to normal operation. 

Improper third party parts installed as depicted in pictures below: 

62 

Wires soldered 

to exposure 

switch circuit 

board by third 

party vendor (it 

is unknown what 

these wires do) 
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26785.087

63 

Third party 

vendor power 

supply and other 

cables inside 

control box 
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A third party component and cable were inserted on 

the cable that was connecting Device 1 to Device 2 

as seen in the diagram and picture 

The above examples in no way are a fully comprehensive or inclusive list of the problems 

or kinds of problems which have been caused by improper servicing. A true statistical analysis 

and a complete understanding of the extent of the problems caused by improper servicing cannot 

be achieved unless all service providers arc held to the same regulatory. registration, and 

reporting requirements. 

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CONCLUSION 

All entities engaged in servicing of medical devices should be required to have an 

appropriately scaled quality system adequate to the activity being performed, meet minimum 

quality, safety, and regulatory requirements. Although further steps will be required to address 

all of these concerns, the Medical Device Servicing and Accountability Act takes an important 

first step in requiring that all servicers register with the FDA and maintain a complaint handling 

system to address device safety and performance issues caused by poor servicing. 

* * 

MITA urges Congress to include both H.R. 2009 and H.R. 2118 in the MDUFA IV 

reauthorization. We believe that passage of both of these bills will protect the safety of patients 

and ensure patients have timely access to the most innovative devices and diagnostics necessary. 

Thank you for the opportunity to present our views. 

65 
128 

Mr. BURGESS. The chair thanks the gentleman. 

Mr. Kerwin, you are recognized for 5 minutes for an opening 

statement. 

STATEMENT OF ROBERT KERWIN 

Mr. KERWIN. Thank you, Mr. Chairman, Ranking Member Green, 

and members of the subcommittee, for this opportunity. 

On behalf of the International Association of Medical Equipment 

Remarketers—we call ourselves IAMERS—we wish to express our 

thanks to the committee in permitting IAMERS to testify on behalf 

of the independent service organizations and small-business owners 

in our diagnostic imaging association. IAMERS members sell and 

service diagnostic imaging. We are not in the dark. We sell MRIs, 

CT, ultrasound, nuclear medicine, and general radiography. They 

are often alumni of OEM training programs who have gone on 

their own and service equipment at a much lower price in regional 

and rural hospitals. And we also assist the manufacturers, who 

may find a need for their assistance on multivendor programs. 

Without further ado, we wanted to offer the top five reasons why 

this legislation should not be supported. 

Reason No. 5: This is a solution for which there has been no evidence of a problem. As with the auto industry, not every repair 

needed go to a dealer or manufacturer. We are speaking of manufacturers as the largest companies in the world. Our small- and 

medium-size businesses have been safely serving and servicing 

without registration with the FDA for many years. While some can 

present anecdotal stories of bad workmanship—and we, in turn, 

can present some on behalf of the manufacturer should that have 

any merit, and we think not—there has been no evidence to support a systemic problem. I am sure the hospitals would be contacting this body if such were happening, but don’t take our word. 

The respected scientific research institute, ECRI, after reviewing 

FDA MAUDE reports, has concluded there is no evidence to date 

that a patient safety problem exists. 

The American College of Clinical Engineering also weighed in 

and commented that there is no real-world evidence needed to support further regulation. 

The Joint Commission commented, ‘‘No knowledge of any statistically significant level of safety problems resulting from activities 

of any kind of maintenance/service providers.’’ 

Penn State Health commented: very little evidence of systemic 

problems existing. 

Reason No. 4: Independent service organizations offer their services at a significantly lower cost than manufacturers—$150 to $200 

per hour versus $500 to $600 per hour, with a 4-hour minimum in 

some cases. Although, once competition is in the marketplace, we 

sometimes hear that, in fact, the manufacturers do lower their 

price. Our people are important for manufacturing competition. 

Registration, however, with the FDA, as this legislation would 

require, is, respectfully, a changed equilibrium and much more 

than filing a piece of paper. The act is burdensome and a costly 

process and would seek to impose many of the requirements currently imposed on a manufacturer for quality system service. 

129 

Reason No. 3: With the extra paperwork comes significant additional cost to be shouldered by the small- and medium-size business owners or passed on to the owners or possibly not continue. 

As detailed specifically or more specifically in my written statement, the complaint management system, the staffing, the training, the assessment costs, the outside auditors, there are significant additional costs that this legislation would require compliance 

with 21 CFR 820.198. This section basically requires every repair 

that is done to be cataloged, documented, and processed. In an area 

of smart regulation, this seems to be at odds. 

Reason No. 2: This legislation will hurt rural and regional health 

care. The National Rural Health Care Association reports on its 

Web site that more than 75 rural hospitals have closed and 673 are 

vulnerable. Some of our members, indeed, service rural America. 

These are the small hospitals with dedicated staff but not all the 

resources of the larger facilities, and they depend on independent 

service organizations. Imposing these extra costs will require dealing with it somehow, some way, and perhaps passing those costs 

on. We are not seeing the corresponding benefit in either adding 

the cost or potentially having independent servicing less accessible. 

If this was such a significant problem, we again say, why have we 

not heard the hospitals clamoring for this? 

Reason No. 1: Put aside all the reasons for the moment. There 

is a body of information—the chairman referred to it—which may 

be tapped from the 177 comments to the FDA public record and the 

2 days of an FDA workshop on this issue last year, in October of 

this last year. This information in its totality will not support passage of this act. And I ask respectfully—and I believe Dr. Shuren 

may have referenced it—if the transcript of the 2 days of proceedings, October 27 and 28, before the FDA may be entered into 

this record as perhaps the comments provided to the FDA on its 

electronic docket. 

Mr. BURGESS. Without objection, so ordered. 

Mr. KERWIN. The conclusion is that we think if this was a significant problem, we would have heard the hospitals clamoring. At a 

time of rising healthcare costs and the demand for smart regulation, adding to the regulatory burden, which only serves to burden 

the small business, this is troubling and shouldn’t be supported. 

This is an opportunity for industry collaboration, especially as independents do not always receive the passwords, the equipment 

manuals, and training from the original equipment manufacturer 

at reasonable cost. It is truly a time together to work for patient 

safety. Thank you. 

[The prepared statement of Mr. Kerwin follows:] 

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lAMERS 

STATEMENT OF 

ROBERT J. KERWIN, GENERAL COUNSEL, 

INTERNATIONAL ASSOCIATION OF MEDICAL 

EQUIPMENT REMARKETERS AND SERVICERS, INC. 

BEFORE THE SUBCOMMITIEE ON HEALTH ON 

"EXAMINING IMPROVEMENTS TO THE REGULATION 

OF MEDICAL TECHNOLOGIES" 

MAY2, 2017 

Mr. Chairman, Ranking Member Green, and Members of the Subcommittee, thank you for the 

opportunity to offer testimony on behalf of the independent service organizations and small business 

members of our diagnostic imaging trade association, the International Association of Medical 

Equipment Remarketers and Servicers, Inc. ("lAMERS") with regard to the "Medical Device Servicing 

Safety and Accountability Act". 

1. This Legislation is a solution for which there has been no evidence to support there is a Problem. 

The respected scientific research institute, ECRIInstitute, after reviewing the FDA MAUDE 

reports, submitted to the FDA in March 2016 a report (110 pages) which concluded that there 
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26785.091

is no evidence to date that a patient safety problem exists. The American College of Clinical 

Engineering also stated that there is no real-world evidence to support further regulation. 

2. This Legislation will require Independent Servicers to absorb the cost of complying with the 

Quality System Regulations as if the Servicers were Manufacturers or pass these costs along. 

3. This Legislation Will hurt Rural and Regional Healthcare. Rural and regional Hospitals rely heavily 

on independent servicers for competition and lower prices and if the independent servicer is not 

available, this greatly impacts the rural hospitals. Some servicers will not be able to compete. 

BACKGROUND: lAMERS 

For almost 24 years, lAMERS has been the leading voice of the secondary market sellers and 

servicers of diagnostic imaging equipment. The imaging modalities of lAMERS members are MRI, CT, 

ultrasound, nuclear medicine and general radiography. lAMERS members safely service regional and 

rural hospitals throughout the United States. lAMERS members offer quality services at a lower cost 

than the original equipment manufacturers ("OEMs"). lAMERS members offer competition in a 

healthcare marketplace dominated by the largest companies in the world. lAMERS' Independent Service 

Organizations {ISOs) are much valued and nowhere more so than in rural America. To the rural hospitals 

of West Virginia, Kentucky, Alabama, and many other rural areas of the country, ISOs are an essential 

component in the health care ecosystem. 

The majority of our members are made up of small independents including sellers and servicers 

who are alumni of OEMs. lAMERS members work closely with OEMs and are hired to support OEM 

multi-vendor programs (hospital programs in which the OEM is responsible for handling another OEM's 

equipment which may be located at a particular hospital). This subcontracting is significant as the OEMs 

trade organization, the Medical Imaging Technology Alliance ("MIT A"), a division of the National 
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Association of Electrical Manufacturers Association) has claimed for some time on behalf of the GEMs a 

'lack of uniform performance' and yet.... its members continue to hire lAMERS !50s to perform multivendor service contracts or to service their customers in remote locations. !50s are also hired by GEMs 

to service, install and move the GEM's systems that are now considered legacy and no longer within the 

expertise of the OEM. GEMs hire I 50s because the ISOs perform their work with skill and dedication to 

patient safety. Skill and patient safety are at the core of lAMERS values. So, if the ISOs are so bad, why 

are the GEMs hiring them to fulfill their contractual obligations? 

lAMERS ETHICS, EDUCATION AND BEST PRACTICES 

Among the things which separate lAMERS from other medical device organizations is that we 

require our members to adhere to a Code of Ethics. This isn't just lip service. If a complaint is raised by a 

hospital, group medical practice or other lAMERS member, the complaint is considered by the Ethics 

Committee. Adverse determinations have resulted in public reprimands or expulsions. No member is 

excluded from this requirement. 

Last year both our American and European members unanimously passed a program for Best 

Practices. This program now includes specific templates to be customized by a member to supplement 

the member's business practices. These templates include recommended practices as to inventory 

management, traceability, complaint management, data management and other key components. It is 

an extensive voluntary program but it does not require the retention of a compliance officer to address 

the quality system requirements which the proposed legislation may well de facto require. 

We have long maintained a robust educational agenda for our members which occurs at every 

meeting. For much of the last twenty years we have had participation in our meetings and educational 

programs from the FDA, Compliance Consultants, and others. Past programs have been conducted on 

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FDA inspections, UDI requirements, reporting of adverse events and many other areas which impact 

patient safety, 

lAMERS WORKS WITH ALL STAKEHOLDERS 

lAMERS also has longstanding and much valued OEM members including GE, Siemens, Toshiba 

and Philips. Several OEMs will join us, as usual, for our annual meeting this week. We welcome their 

presence, We are fortunate also to have at our meeting this week FDA Chief Scientist Dr. Maisel as well 

as Mark Bruley, Vice President for Accident and Forensic Investigation at ECRIInstitute, We have been 

fortunate to have past faculty from the Center for Medicare and Medicaid Services, the Medical Device 

Manufacturer's Association and of course other OEMs. lAMERS has a proud tradition of education, 

training and outreach and we wish to do more. Our members value quality and understand education 

and training are important components. 

2016 FDA PUBLIC DOCKET ON SERVICING 

And FDA OCTOBER WORKSHOP DO NOT SUPPORT 

THIS LEGISLATION 

This Legislation is, however, a solution for a problem which has not been shown to exist In 

March 2016, the FDA opened a public docket to solicit comment on (among other things) whether to 

regulate servicers. The FDA received comments from 177 interested parties, See 

https://www.regulations.gov/docket?D~FDA-2016-N-0436, It is interesting to note that there was 

almost a complete absence of negative comments from hospitals and group medical practices with 

respect to independent service organizations, It is perhaps worth repeating then .... .if this legislation is 

truly addressing a serious health care issue, why is there no clamor from the hospitals to impose a 

change? Respectfully we urge the Committee not simply to accept the statement of lAMERS but look at 

the comments submitted on the FDA Public Docket by independent industry observers, The nationally 

recognized leader in performance measurement, the Joint Commission, in its comment filed in the FDA 

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docket, stated that the Joint Commission "has no knowledge of any statistically significant level of safety 

problems resulting from the activities of any kind of maintenance/service provider." In its comment, 

Penn State Health stated "[v]ery little evidence of systemic problems exists." Citing four statistical 

analyses which reviewed the root cause of events, Penn State further stated the "analyses above clearly 

show that inappropriate servicing and maintenance is not a statistically significant root cause for safety 

events" 

In October 2016, the FDA held a two-day workshop on October 27-28, 2016 entitled the "Public 

Workshop-Refurbishing, Remarketing, Remanufacturing and Servicing of Medical Devices Performed by 

Third Party Entities and Original Equipment Manufacturers. Over 500 people attended in person and 

many more attended via web access. Over 40 speakers presented and 20 additional attendees voiced 

their opinions. MIT A showed pictures of equipment issues, attributed to nameless independents and 

advocated for further regulation. The American College of Clinical Engineering offered that there was a 

lack of real world evidence to support MIT A's advocacy for additional regulation. lAMERS advocated that 

the FDA should not regulate by anecdote. The FDA has advised that it is preparing a summary of the 

information gathered at the workshop. In the last few months, the FDA has contacted stakeholders to 

clarify and confirm stakeholder information and identify takeaways from the workshop. The FDA report 

has not, yet, issued. 

IF THERE IS A HEALTH SAFETY ISSUE: WHY HAVE NOT THE MAJORITY OF THE HOSPITALS 

ADVOCATING FOR ISO REGULATION? 

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If independent servicing is such a significant healthcare problem, we respectfully inquire again: 

why has the Committee not heard from hospitals clamoring for further regulation of ISOs? Perhaps the 

more relevant question is: why is it that the OEM trade organization, MIT A, advocating so strongly for 

passage? We believe that the motivation is because ISOs represent a competitive and viable alternative 

to OEM domination of the hospital servicing marketplace. Such domination may well result in an ever 

upward spiral in the cost of providing diagnostic imaging services. 

INDEPENDENT SERVICERS ARE A COST-EFFECTIVE ALTERNATIVE 

To offer a brief cost contrast: the cost of a service call by an independent service organization 

("ISO") is typically in the range of $150-$250 per hour. The cost of a service call by an OEM is reportedly 

in the range of $500-$600 per hour with a 4- hour minimum requirement. Plainly !50s offer competitive 

choices for hospitals who are keenly aware that capital equipment costs are often 45% of their budget. 

Time after time I 50s provide appropriate high quality maintenance services and do so at lower cost to 

the healthcare provider, thus easing their budgetary restrictions. How good are the ISOs in servicing 

medical devices? As noted, the OEMs routinely hire ISOs to perform their multi-vendor work or to 

service medical facilities in remote areas and in facilities in which they have a system wide contract (and 

may lack the knowledge required to service imaging devices of other OEMs and older versions of their 

own devices). OEMs have advocated for the further regulation of ISOs with the possible intent of 

making it even more challenging for the ISO segment of the market to exist and be able to offer 

competitive services as a cost-effective alternative to the OEM. 

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RIGHT TO REPAIR: NOT EVERY REPAIR HAS TO BE 

UNDERTAKEN BY THE MANUFACTURER 

To borrow from the auto industry: every time you need an oil change, tune-up, or any other 

auto repair, the manufacturer is not the only option. Perhaps that is why some states have pending for 

consideration 'right to repair' legislation. 

Consideration of the implications of the "Medical Device Servicing Safety and Accountability 

Act" raises a significant question: Will the U.S. health care ecosystem become like the European model, 

where there are very few ISOs or will we support our hospitals having choices? Perhaps the system 

works in Europe where most hospitals are reportedly single payer government supported institutions. 

As this Committee is aware, the private hospital system is different in the U.S. 

The hospitals and the regulatory bodies including CMS, the Joint Commission, and other 

accrediting agencies require third parties to use manufacturer's recommendations for servicing 

equipment. Hospitals have the ability to detect and as appropriate, weed out inadequate players. Stated 

otherwise, these hospitals and group medical practices can (and do) vote with their feet by imposing 

contractual consequences which all parties need to observe if services are inadequate. 

The Proposed legislation Will Impose Significant Additional Costs On ISOs 

Under Sec. 2 of the proposed legislation, entitled 11Registration of Servicers of Devices" section 

510 of the Federal Food, Drug and Cosmetic Act (21 U.S.C. 360) would be amended by requiring all 

servicers to be registered: 

" ... not later than 18 months after the date of the enactment, the FDA is to issue final 

regulations requiring any person who owns or operates any establishment in any State engaged 

in the servicing of a device ..... to register ... " 

Registration would impose the reporting requirements of a manufacturer or remanufacturer. Among the 

requirements to be mandated is that the FDA require the ISO to implement a complaint handling system 

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equivalent to the manufacturer's requirements under 820.198 of title 21. This complaint system 

requires virtually every repair to be recorded even where no adverse event or MDR is involved. 

According to existing FDA regulations as they apply to manufacturers, a complaint means: 

"~written, electronic or oral communication that alleges deficiencies related to 

the identity, quality, durability, reliability, safety, effectiveness or performance of 

a device after it is released for distribution (emphasis supplied)" 

ISOs would need then to consider any repair service work as a complaint and keep a complaint 

record in accordance with 820.198. This imposes substantial extra work and may well require a quality 

control or compliance officer to be employed. It is not altogether clear that this extra cost and extra 

work on the part of the ISO, would substantially advance information on device failures. We are 

informed that most of the service calls relate to scheduled maintenance or repair of the device. 

However, the ISO would be required (if the provisions of 820.198 were to be followed) to undertake the 

burden of record keeping for the extremely rare instance when an adverse event occurs. A web based 

request system would have to be implemented to capture more data. ISOs would likely need to 

purchase new systems. 

Manufacturer lobbyists have long been pushing for this requirement so that ISOs would fall 

under the same FDA quality system regulations as the manufacturers. The measure at its core benefits 

the original equipment manufacturer by burdening the independent servicer with substantial additional 

costs without a concomitant safety benefit. ISOs will have to charge more to absorb the costs. 

Additional staff such as quality managers would be needed for the documentation requirements. At a 

minimum, an ISO would need to have training provided to at least one employee or perhaps multiple 

employees for a quality management system and to address the FDA requirements. The average cost of 

quality system management training has been reported to lAMERS to be no less than $3,000 per 

employee. If the ISO elects at one location to become either 9001 or 13485 certified by a registered 

body the minimum cost might be $10,000 for the first year. An external auditor, if retained to audit the 

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quality management system, might well charge $5,000. On average, the ISO might well be required to 

pay in addition to the retention of an employee, possibly $20,000 exclusive of the costs of training other 

employees on processes and on additional regulatory or state requirements as they are imposed. 

If FDA applies the same registration process that currently exists for manufacturers and 

importers, it could be rather costly for small service companies. The registration fee for a small 

manufacturer was reported as approximately $4000 in 2016. We understand that an increase has been 

proposed. These costs, when considered as a whole, will have a significant effect on the ability of the 

ISO to offer the !SO's services at competitive rates. 

If Patient Safety Is The Goal- Why Does The Legislation NOT Require OEMs To Cooperate in 

Providing AIAT and Service Key Information At A Reasonable Cost 

If the genesis of this legislation was truly to address patient safety, provisions could have be 

included which require the delivery by the OEMs at reasonable cost of equipment manuals, passwords 

and training. Each year including this year, lAMERS receives reports of !50s who encounter resistance 

by the OEMs to providing this information. 

Conclusion 

As one respected Stephen Grimes has noted, many hospitals are spending 8 to 10 times over 

what they spent annually 10 years ago on medical capital equipment. These hospitals welcome 

competition and service from independent service organizations. Imposing manufacturer quality system 

and reporting requirements upon independent servicers only serves to burden the ISO with additional 

costs-which are either passed on or absorbed-if the !SO's cost structure permits. This legislation, if 

implemented, may well jeopardize the independent servicer business model without real world 

evidence as to the need. The additional compliance burdens of the new legislation will make them 

challenging for small business owners to comply. In the absence of real world evidence establishing the 

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need for further regulation of ISOs, the "Medical Device Servicing, Safety and Accountability Act" should 

not be supported. 

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Mr. BURGESS. The chair thanks the gentleman. 

The chair recognizes Ms. Shrader 5 minutes for your opening 

statement, please. 

STATEMENT OF PATRICIA SHRADER 

Ms. SHRADER. Thank you, Chairman Burgess, Ranking Member 

Green, and members of the committee, for the opportunity to testify today. 

My name is Pat Shrader. I am the Vice President for global regulatory affairs at Medtronic. 

Today, I am pleased to testify on behalf of AdvaMed, the Advanced Medical Technology Association. We believe we are on the 

right track with FDA’s device center and that recent progress, combined with the provisions of the new user fee agreement, promise 

to keep things heading in the right direction to strengthen the med 

tech innovation ecosystem. We appreciate this committee’s commitment to reauthorizing this important program, and we urge Congress to act as a whole to promptly reauthorize the Medical Device 

User Fee Program. 

We also appreciate the committee’s work in holding this hearing 

to consider additional measures that would improve the regulation 

of medical devices by advancing commonsense policies that will 

continue to improve the agency’s operation. 

We are speaking today in strong support of H.R. 1736, introduced by Representatives Bucshon, Peters, Brooks, and Butterfield, 

to improve the medical device inspections process. The current inspection process is plagued by challenges that lead to significant inefficiencies for both manufacturers and the FDA. There are great 

discrepancies in inspections between facilities in the U.S. as well 

as between facilities of the same company within the U.S. and outside. These discrepancies result in facilities being held to different 

standards. 

I do want to be clear about the next point. H.R. 1736 does not 

in any way limit or restrict FDA’s authority to inspect medical device facilities at any time. 

Medtronic, like other companies in our industry, understands the 

robust FDA inspections serve an important oversight function to 

ensure the public that we are succeeding in producing safe and 

high-quality medical devices. 

What H.R. 1736 will do is improve the device inspection process 

to increase consistency, predictability, and transparency and to ensure that both FDA and industry resources are best targeted to 

public health needs. 

H.R. 1736 has three main provisions: First, it establishes a riskbased inspection schedule for device facilities based on the risk profile of the facility. This commonsense shift to the risk-based approach to device inspections would ensure that FDA is inspecting 

where the risk to patients is greatest and is not utilizing important 

resources to repeatedly inspect facilities with good compliance profiles. 

Second, the bill proposes standardized and enhanced processes 

including communications between FDA and the facility prior to, 

during, and after inspections. It is important to note that standardizing processes and enhancing communications have played a key 

141 

role in the improvements in the premarket review process leading 

to reduced review times. These will have a similar impact on FDA 

inspections. Timely communication can also help speed corrective 

action by companies being inspected where a correction is needed. 

The last provision of the bill involves the lack of transparency 

that currently exists in the export certification process. In order to 

market medical devices in many countries, there is a requirement 

for documentation that devices are legally marketed in the U.S. 

and are in compliance with U.S. law. This documentation is called 

a certificate to foreign governments, or CFG. Due to an unclear 

interaction between FDA’s inspection process and the CFG process, 

device companies can be caught in bureaucratic red tape that results in devices being lawfully marketed in the U.S. being denied 

certification for marketing in other countries. Clarifying this process would enable device manufacturers to continue to market our 

products to other parts of the world, thus strengthening our economy. 

Again, we strongly support 1736 and urge the committee to pass 

this important legislation. I would like to note that we support a 

number of the other proposals that we believe would help improve 

the medical device regulatory process: H.R. 2144, which builds on 

21st Century Cures to provide a streamlined procedural mechanism for reclassification of device accessories. We support 2118, an 

important step to assure that FDA has visibility into third-party 

servicing companies to ensure that devices in service remain safe 

and effective in use. And, finally, I would note that several 

AdvaMed member companies also support H.R. 2009. 

In conclusion, I appreciate the committee’s work in considering 

these measures that enhance and complement the underlying user 

fee agreement to improve the regulation of medical devices. We 

look forward to continuing to work with you on these important 

issues and on timely reauthorization of the user fee program. 

Thank you. 

[The prepared statement of Ms. Shrader follows:] 

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Testimony of Patricia Shrader, Medtronic 

House Energy & Commerce Health Subcommittee Hearing 

"Examining Improvements to the Regulation of Medical Technologies" 

May 2, 2017 

Thank you Chairman Burgess and Ranking Member Green and members of the Committee for 

the opportunity to testify today. 

My name is Pat Shrader, and I am the Vice President for Global Regulatory Affairs for 

Mcdtronic. Medtronic is among the world's largest medical technology, services and solutions 

companies-alleviating pain. restoring health and extending life for millions of people around the 

world. Medtronic therapies improve the lives of two people every second. 

I'm pleased to testify today on behalf of AdvaMed, the Advanced Medical Technology 

Association, and speak specifically to improving the FDA regulation of medical technologies. 

have been part of this industry for 40 years and have seen the enormous advances in healthcare 

due to medical devices over this period of time. Assuring that new safe and effective 

technologies can be made available to the American public via robust and sensible regulation is 

personally very important to me and my family as users of medical devices, including implants 

and as a person who has seen up close the amazing impact devices can have on life and health. 

The U.S. Medical Technology Industry 

AdvaMcd's member companies produce the medical devices, diagnostic products, and digital 

health technologies that are transforming health care through earlier disease detection, less 

invasive procedures, and more effective treatments. Our members range from the largest to the 

smallest medical technology innovators and companies. Collectively, we are committed to 

ensuring patient access to life-saving and life-enhancing devices and other advanced medical 

technologies. 

I am very optimistic about what this industry can do for patients if the right policies arc in place. 

Fundamental advances in knowledge of human biology down to the molecular level and 

continued progress in a range of disciplines computing, communications, materials science, 

physics and engineering- are fueling innovation, and the potential to save and improve patients' 

lives is almost limitless. 

Patient access to advanced medical technology improves outcomes, enhances care quality, and 

generates efficiencies and cost savings for the health care system. For example, between 1980 

and 20 I 0, advanced medical technology helped cut the number of days people spent in hospitals 

by more than half and added five years to U.S. life expectancy while reducing fatalities from 

heart disease and stroke by more than hal f. 

FDA Regulation of Medical Devices- MDUFA IV 

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We believe we are on the right track at FDA's device center, and that recent progress--

combined with the provisions of this new user fee agreement-- promise to keep things heading 

in the right direction to strengthen the medtech innovation ecosystem. 

The ground-breaking process improvements that were built into the MDUFA III agreement, and 

the oversight done by this Committee, have led to improvements in FDA's regulation of medical 

devices. FDA has brought down the total time it takes to receive a decision from FDA on a 

product submission, while still maintaining the strongest standards for evaluating safety and 

effectiveness. Opportunities for engagement between applicants and FDA throughout the device 

review process have increased greatly, leading to fewer misunderstandings, fewer false starts, 

and a better understanding of FDA data needs. As a result, the consistency and predictability of 

the FDA review process has improved. 

0 f course, there arc many areas where FDA could further enhance the predictability and 

efficiency of its review process, and the new MDUFA IV agreement lays the groundwork for 

further FDA performance improvements through more ambitious goals, important process 

changes, and increased accountability, supported by additional resources. MDUF A IV also 

recognizes the importance of the global market and of global regulatory efficiencies to patients, 

regulators, and companies and supports harmonization via new funding for international 

standards and enhancement of the third party review process. 

The MDUF A IV agreement is good for industry. It is good for FDA. Most importantly, it is good 

for patients and, in fact, specifically addresses and provides funding for an enhanced role for 

patient engagement in the FDA decision-making process. We appreciate this Committee's 

commitment to reauthorizing this important program and we urge Congress as a whole to act 

promptly to reauthorize the medical device user fee program and enact this agreement into law. 

Failure to act would not only jeopardize the critical improvements made by the new agreement 

but would have a devastating impact on our industry's ability to bring innovative diagnostics, 

treatments and cures to patients. 

H.R. 1736 

We appreciate the Committee's work in holding this hearing to consider measures that would 

enhance the MDUFA agreement, and improve the regulation of medical devices. When the 

committee last took up a Medical Device User Fee reauthorization, the relationship between the 

FDA and industry was strained, and performance at the agency was at an all-time low. As I 

noted, there have been significant improvements since that time. But more work remains, and I 

am encouraged that the committee is open to advancing common-sense policies that will 

continue to improve the agency's operations. We should continue to look for ways that we can 

make the process more rational and predictable for innovators and the patients that we serve. 

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We strongly support l-LR. 1736, introduced by Representatives Bucshon, Peters, Brooks and 

Butterfield, and we appreciate your leadership on the issue of improving the medical device 

inspections process. 

Regulatory compliance is essential to the production of safe and high quality medical devices. 

This is a shared goal between industry and the FDA. Unfortunately, the current inspection 

process is plagued by challenges that lead to significant inefficiencies, both for manufacturers 

and the FDA. The problems of inconsistency and a lack of transparency and predictability work 

against attempts to ensure an ongoing and mutual understanding of what is required to comply 

with regulations. These also hinder the ability of companies to assure they are taking appropriate 

corrective actions, when they are required. 

The medical device industry is concerned with the vast discrepancies in inspections, between 

facilities across U.S. districts, as well as between facilities of the same company within the U.S. 

and outside the U.S. These discrepancies result in facilities being held to different standards, 

solely based on location. 

l want to be clear about this next point: H.R. 1736 does not limit or restrict FDA's authority to 

inspect medical device facilities in any way. Medtronic, just like all other companies in our 

industry, understands that robust FDA inspections serve an important oversight function to 

ensure the public that we arc succeeding in producing safe and high quality medical devices. 

This is an important partnership. What H.R. 1736 will do is improve the device inspections 

process to increase predictability and transparency of FDA routine inspections, and to ensure that 

both FDA and industry resources are best targeted to public health needs. 

1-l.R. 1736 has three main provisions, and I'd like to go into further detail about each of them. 

First, the bill establishes a risk-based inspections schedule for device facilities based on the risk 

profile of facility. The frequency and nature o finspections of device facilities is not consistent 

within the United States or around the world. Also, the U.S. FDA is not the only regulatory 

agency performing facility inspections; numerous regulators inspect to standards that are very 

similar to FDA's Quality Systems requirements for devices. Some facilities arc inspected 

multiple times each year: some facilities may go much longer periods of time between 

inspections (and this is only for routine inspections-I'm not referring to for cause inspections). 

For example, we have facilities that manufacture class Ill devices. While the facilities have 

positive compliance profiles, they routinely experience as many as a half dozen regulatory 

inspections a year; including multiple inspections by FDA (this includes pre-approval and postapproval inspections, as well as routine surveillance audits). Establishing a risk-based schedule 

for device facility inspections would focus FDA inspection resources on the more significant 

risks to public health. Factors for FDA to consider when deciding on the extent and frequency of 

device inspections include compliance history; record, history and nature of recalls; inherent risk 

of the device(s) manufactured at the facility; inspection frequency and history of the 

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establishment; and inspection by foreign governments. This common-sense shift to a risk-based 

approach to device inspections would ensure that FDA is inspecting where the risk to patients is 

greatest. 

Second, the bill proposes standardized and enhanced processes including communications 

between FDA and the facility-prior to, during, and after inspections. To understand the 

importance of these process improvements, I think it's first critical to set the scene of an FDA 

inspection. When an FDA investigator comes to a facility to conduct an inspection, it is an "all 

hands on deck" situation. The manufacturer might have as many as l 00 employees involved in 

responding to and interacting with the FDA investigator. The employees supporting the 

inspection are typically highly skilled team members--engineers, clinical personnel, regulatory 

and/or legal experts-who arc taken away from their current projects. Device facilities in the 

U.S. are often given very short advance notice of an inspection. This short notice, plus the often 

erratic schedules of investigators, leads to challenges in assembling the appropriate team 

members to provide the required documents and materials requested by the FDA. While we 

recognize that FDA investigators sometimes have to deal with urgent matters elsewhere, it is an 

incredible challenge to manage workflow when an investigator initiates an inspection and then 

calls each morning to let the facility know whether or not she will be on site that day. Technical 

experts and other resources arc required to be on stand-by at the location which disrupts 

productivity as they are unable to plan more than I day in advance. It is also difficult to maintain 

continuity in an inspection conducted over a long period of time, with an investigator who may 

be on site for a day or two, then elsewhere for a period of time (sometimes several days) before 

returning to the facility. Medtronic has experienced both of these types of challenges. 

H.R. 1736 would address these issues by standardizing procedures for inspections, including 

communications between FDA and industry, before, during and after an inspection. The 

communication prior to an inspection enables the investigator to gather background information 

and give the company an opportunity to assemble the records and personnel that will be needed 

for the inspection. The communications during an inspection provide an opportunity to clarify 

any information or misunderstandings so that the most accurate outcome can be assured. It may 

also enable the company to make corrections during the inspection, which the investigator can 

then verify prior to concluding the inspection. The post-inspection communication is 

particularly important for ensuring that any remaining issues that arc noted during the inspection 

arc promptly addressed. 

If an inspection leads to a company having to make a correction, companies have 15 days to 

submit a remediation plan to FDA. Unfortunately, there is no such timelinc for FDA to respond 

to the proposed plan of correction. Thus, companies are left in an awkward situation of wanting 

to make the correction as soon as possible, but being unsure if they have fully understood the 

scope and intent of the finding and that their correction will address the issue to FDA's 

satisfaction. There also is the concern that if the correction and timetable arc not sufficiently 

detailed, further enforcement action, such as a Warning Letter, may be taken by FDA. 

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Depending on the type of correction that is needed, some remediation activities are extremely 

costly and time-consuming and may not be appropriate. H.R. 1736 would require FDA to 

provide non-binding feedback to proposed remediation plans. This feedback would allow 

companies to confidently move forward with their correction plans in a timely manner, or make 

impottant course corrections before investing in process improvements. 

The last provision of the bill involves the lack of transparency that currently exists in the export 

certification process. In order to market medical devices in certain countries, those countries 

require documentation that the device is legally marketed in the U.S. and that it is in compliance 

with U.S. law. This documentation is called a CFG-certificatc to foreign governments. Due to 

an unclear interaction between FDA's inspections process and the CFG process, device 

companies are frequently caught in bureaucratic red tape which can result in devices that are 

lawfully marketed in the U.S. being denied certification for marketing in other counties because 

the appropriate correction of deficiencies noted in inspections has not been confirmed by FDA. 

In some instances, the company may have made the corrective actions months or even years ago. 

To alleviate this situation, the draft legislation requires that, if FDA refuses to issue a CFG, it 

will provide a written justification for the denial and summarize the specific deficiencies 

preventing issuance of the certificate. The legislation also requires that FDA provide a process 

for resolution of a refused certification to allow for establishments to present new information 

related to addressing identified deficiencies. Clarifying this process would enable device 

manufacturers to continue to market our products to other parts of the world, thus strengthening 

our country's economy. 

Again, we strongly support H.R. 1736, and urge the Committee to pass this important legislation. 

Other Proposals 

There are a number of other proposals that would improve the medical device regulatory process 

by bringing more predictability and consistency to the review process. I'd like to note a few of 

these: 

l. We support H.R. 2144, a bill recently introduced by Congresswomen Walters and Kuster. 

This bill builds upon the good work done by this Committee in the 21st Century Cures law by 

providing FDA with a streamlined mechanism for considering medical device accessories. 

Accessories are devices that arc intended to support, supplement, and/or augment the 

performance of one or more parent devices. For example, a plastic tray that holds a LASIK 

instrument is an accessory. Prior to passage of Cures, FDA evaluated accessories based on their 

parent device's risk classification. Thus, the tray, a very low risk device, was regulated as a class 

Ill high risk device, because the LASIK instrument is high risk. This makes no sense. Cures 

included a provision that directed FDA to classify a device accessory independent of the parent 

device. While this provision was very much needed, FDA lacks a procedural mechanism to 

carry that out. H.R. 2144 provides for streamlined processes for FDA to carry out its regulation 

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of accessories, both those that are on the market but inappropriately classified, and those that 

would come before FDA in future submissions. 

2. We support establishing an alternative pathway to market for certain moderate risk medical 

devices that are well-understood. Currently, for these particular devices, the statute requires 

companies making these devices to both demonstrate to FDA that their product complies with 

special controls established by FDA for that particular type of device, and companies must 

demonstrate that the product is substantially equivalent to a legally marketed device. This 

duplication of information and effort is simply redundant and does not provide FDA with 

additional, meaningful information. In addition, the revised pathway is more consistent with 

requirements for lower risk devices in other countries, further supporting global hannonization 

of regulatory requirements. 

3. We support streamlining the process to make simple, low-risk modifications to already 

approved medical devices. The House-passed 21st Century Cures bill included a provision that 

reduced the review burden on FDA and on companies by allowing companies to make certain 

changes to devices without a prcmarket submission if their quality systems are certified as 

capable of evaluating such changes. Quality systems arc the organizational structure, 

responsibilities, procedures, processes and resources for implementing quality management, 

which includes a system for assessment and control of device changes. Manufacturers whose 

quality system was certified by an FDA-authorized third party would not be required to submit 

and await approval by FDA for certain low-risk changes to already approved medical devices. 

Taking these items off of FDA's plate, while still ensuring that companies are accountable, 

would be a significant reduction in FDA's workload, allowing it to focus on higher-priority 

activities, and would represent a significant cost and time saving for companies. 

Lastly, I would also like to add my voice of support for H.R. 2118. This bill is an important step 

in ensuring that FDA has visibility into third-party servicing companies. These third-party 

scrviccrs are sometimes hired to perform maintenance on medical devices. Requiring third-party 

scrvicers to register with the FDA is an important common sense, first step in assuring that 

patient safety is not put at risk by well-intentioned but poorly-carried out repairs or substandard 

or inappropriate parts. Also, I'd note that several AdvaMcd member companies support H.R. 

2009, and we appreciate its inclusion in this hearing. 

Conclusion 

In conclusion, I appreciate the Committee's work in considering these measures that enhance and 

compliment the underlying MDUFA user fee agreement, and that seck to improve regulation of 

medical devices. Your focus on improvements to the medical device regulatory landscape 

enables our companies to continue to innovate, and ensures that these innovations get to patients 

in a predictable and timely manner. We look forward to continuing to work with you on these 

important issues, and on timely reauthorization of the MDUFA program. 

6 
148 

Mr. BURGESS. The chair thanks the gentlelady and all of our witnesses for their testimony today. 

We will go to the question portion of the hearing. And I will recognize the gentleman from Illinois 5 minutes for questions, please. 

Mr. SHIMKUS. Thank you, Mr. Chairman. 

Just two questions. This one goes to Mr. Robinson, Mr. Kerwin. 

Obviously, there is a dispute here and which might likely cause 

this bill not to be included unless you all get together and work 

something out that seems to be helpful. 

These people who repair the equipment are trained how, Mr. 

Robinson? 

Mr. ROBINSON. As an OEM, we have—and I can speak for Philips 

in my case—we have Philips supply training, you know, based on 

factory protocols and engineers and—— 

Mr. SHIMKUS. So, if there is an independent person, they still 

have to be trained by you on your equipment. Is that correct? 

Mr. ROBINSON. We offer training—and, again, I am speaking for 

Philips—— 

Mr. SHIMKUS. That is fine. I am assuming most people are probably going to be similar. 

Mr. ROBINSON. There are certain types of training that we offer 

to third parties as well. 

I would also add that Philips and all the member companies, as 

Mr. Kerwin had mentioned as well, we leverage and utilize thirdparty service a lot ourselves and, in many cases, are third-party 

servicers—— 

Mr. SHIMKUS. Right. 

Mr. ROBINSON [continuing]. Of other folk’s equipment. So we actually have to send people for training on other equipment as well 

and organizations that do that. 

Mr. SHIMKUS. Right. 

Mr. Kerwin. 

Mr. KERWIN. Congressman, many times, however, the equipment 

manufacturer, if you don’t have a contractual relationship with 

them, will withhold the training. And we are always concerned 

about this because, from time to time, they will cite uneven levels 

of performance, and, yet, when we ask to have members trained, 

unless you have a contractual relationship, more often than not it 

is declined. I look at it by the football analogy of knocking someone 

down on the field with a hard hit and then claiming later there 

might be a delay of game. 

Mr. SHIMKUS. Well, this is a very similar debate that we have 

had in this committee to the automobile manufacturers and the 

independent repair folks who always there is a debate about getting the data, being able to hook up to the computer module or also 

what type of equipment to replace. So it seems like the similar type 

of dispute that we have had. 

And I guess I would just say there are—also, part of the discussion was cost incurred to—and I said is this in my opening—in the 

opening round of questions, the projected costs incurred to small, 

rural, or regional hospitals. So, Mr. Robinson, do you accept that 

as part of the concern? 

149 

Mr. ROBINSON. First of all, I want to be clear. What we are requesting here is the registration and a complaint system. That is 

it. That is the request—— 

Mr. SHIMKUS. But Mr. Kerwin said there would be—every repair, 

visit, would require additional—a filing of what occurred. Is that 

correct? 

Mr. ROBINSON. I don’t think that is the case for a complaint filing. You file a complaint when there is a problem or an adverse 

event. That is when that occurs. 

Now, what they would incur, as I think Dr. Shuren implied, 

under the current regulation, there is a registration fee to register 

with the FDA. I am not sure of the exact amount of fee. I think 

it is a few thousand dollars. It would be required by everybody who 

registers, but I think it would also be in the discretion of the FDA 

if they wanted to waive that fee as a point if that were burdensome 

to the small business. But that is not our request. 

Mr. SHIMKUS. I am going to stop on this. I am going to just for 

the hearing aid debate, and I think it is just helpful because a lot 

of us aren’t practitioners in the field. So hearing loss is classified 

in mild, moderate, moderately severe, severe, profound, and deaf. 

Is that correct? 

So the only dispute that you all have is between mild and moderate while we still have moderately severe, severe, profound, and 

deaf. Is that correct? 

Mr. POWERS. Yes. I would agree. I think that there is also a 

small difference in defining mild, moderate, and then moderately 

severe, how many categories you really have, and where does it extend? I think the concern comes from the current definition used 

within FDA, up to 720 dB hearing loss, which is a significant hearing loss, and those folks in many cases may require the services of 

a professional. So our view is that the mild hearing loss is certainly 

one that should be promoted through the OTC category for the vast 

majority of people have mild hearing loss and would benefit the 

most from. 

Mr. SHIMKUS. And Dr. Lin, in your testimony, you think that 

OTC could also comply with the moderate hearing loss? 

Dr. LIN. Yes, absolutely. From the clinical perspective, mild to 

moderate is on a natural continuum. There are no sharp barriers. 

We see right now moderate hearing loss affects about 30 percent 

of everyone with a hearing loss. So you are talking about cutting 

out 30 percent of the marketplace, and consumers could benefit 

from the mild to moderate. But from a clinical perspective, there 

is no such thing right now as a hearing aid only for mild hearing 

loss or hearing only for moderate hearing loss. Right now, it is the 

same thing, basically. So, by trying to limit to mild hearing loss, 

we are essentially limiting the functionality of that hearing at 

eventually to 30 percent of the people with hearing loss out there, 

saying, ‘‘I am sorry, but you will have to go through the standard 

channels and pay $4,500.’’ 

More from a research perspective, the best clinical trial to date 

funded by the NIH, completely independent academic medical center, demonstrably showed that treatment of mild to moderate hearing loss with over-the-counter hearing aids is effective. So that is 

a scientific perspective. 

150 

Now, more important, I think from a larger perspective, I think 

it is easy to frame this as an either/or. You have to either get an 

over-the-counter hearing aid, or you have to go see a clinician. 

There is nothing in between. It is just not true. It is a very much 

an ‘‘and’’ phenomenon. 

And already what we are seeing right now with availability of 

and more attention paid to over-the-counter devices is that more 

patients are coming to my clinic now and seeing my colleagues saying, ‘‘I have heard of this an over-the-counter device. Would this be 

relevant for me? Could I use this?’’ So, in many cases, you may 

have someone with a moderate hearing loss. They try a device. 

They think it works. It may not be great. It drives them to see the 

clinician. The clinician can help them. It is not an either/or phenomenon. 

By limiting it to mild hearing loss, that means when a patient 

goes to see, let’s say, an audiologist, then the audiologist can’t even 

help them anymore with the over-the-counter device because there 

is a cap placed on how much benefit could be obtained from it. It 

comes under safety, and it comes under efficacy. I think both have 

already been well established both clinically. I think it is a testament to the American Doctors of Audiology, the leading audiology 

group for private practice audiologists, already coming on full support of this as well as multiple medical organizations. 

Mr. SHIMKUS. Excellent. Thank you. 

I yield back. 

Mr. BURGESS. The chair thanks the gentleman. The gentleman 

yields back. 

The chair recognizes the gentleman from Texas, Mr. Green, 5 

minutes of questions, please. 

Mr. GREEN. Thank you, Mr. Chairman. 

And, Dr. Lin, I know you have been involved in research that led 

to recommendations by two expert committees, both of which concluded that the creation of an FDA regulatory classification for 

OTC hearing aids would benefit the public. Can you elaborate on 

this work? I think you did that in your testimony and some other— 

it would help, obviously, for the cost, but it also may drive people 

to a professional because they find out that the over-the-counter 

may not work. It is like my colleague’s reading glasses that he 

bought at the drugstore. 

Dr. LIN. Yes. So very much I think that is the case, Representative Green. I think what we are seeing right now is already, with 

increased attention paid to hearing loss over-the-counter devices, it 

is driving people to ask about their hearing, to come in to get evaluated, and then they may still go and get an over-the-counter device, but a lot of times under the guidance or advice. 

I think the tendency is to think, well, if you have an over-thecounter device, all of the sudden, people are going to want to avoid 

doctors; they are going to want to avoid audiologists. It is exactly 

the opposite. As we have a regular over-the-counter category, which 

is broadly applicable to the vast majority of Americans with hearing loss, it drives someone to ask more questions about hearing 

loss. It drives more people to go to their physicians and say, ‘‘I have 

heard these devices are available. Would you help me decide?’’ It 

151 

is a very much the opposite, I think, in terms of what would actually be projected to happen by some people in the industry. 

Mr. GREEN. Thank you. 

Mr. Robinson, we know certain types of medical devices and 

types of technology often require servicing and maintenance and 

repair. Hospitals and health systems have a right to rely on any 

of the original or a third-party service entity to fulfill that maintenance decision. The bill that we are considering today, H.R. 2118, 

would require third-party service entities to register and report certain adverse events and malfunctions to the FDA. 

In your understanding, is that all this bill does? 

Mr. ROBINSON. Yes. That is all this bill does. And the other thing 

I would point out: it excludes hospital-owned in-house service—— 

Mr. GREEN. So if you are an employee of the hospital, you know 

where the responsibility is? 

Mr. ROBINSON. Right. Exactly. 

Mr. GREEN. Can you discuss briefly why you feel legislation in 

this area is needed and the types of issues associated with thirdparty servicing that your company is aware of? 

Mr. ROBINSON. Can you repeat the question, sir? 

Mr. GREEN. Since you support the legislation, what types of 

issues associated with third-party servicing that your company has 

become aware of? 

Mr. ROBINSON. Oh. Well, as MITA, we submitted a big document 

of a number of adverse events that have been documented by member companies when they have been encountered and not being 

serviced by them. There are over 30 examples that are in there. 

In terms of complaints in general or adverse effects in general, 

I know the ECRI study claims that there is nothing wrong here; 

so why should we do anything? There is nobody reporting. So what 

I would suggest is maybe a good place to look is the FDA’s own 

database around adverse complaints that are reported by the manufacturers who are required to do that. 

Mr. GREEN. Under current law, the FDA rules and regulations 

are on manufacturers that perform servicing are required to comply with it. And what FDA rules and regulations are third-party 

service entities required to comply with? 

Mr. ROBINSON. None that I am aware of. 

Mr. GREEN. OK. In your opinion, does H.R. 2118 help to address 

the service issues witnessed by your company? 

Mr. ROBINSON. Yes. I think it would help. I think it would help 

the industry in general and the FDA as you work and track complaints. 

You know, as an example, if we have a piece of equipment, 

whether it is Philips or General Electric, any member company, 

and it is not being serviced by us and there have been a number 

of issues that occur that become redundant and common that we 

are not seeing, we don’t know to address them. You know, so a 

common complaint handling system would escalate and elevate 

that. 

Mr. GREEN. Under current law, what FDA regulations are the 

manufacturers that perform servicing required to comply with? 

Mr. ROBINSON. I can’t cite the exact law, but there is one, and 

we are all required to have quality management systems. And they 

152 

are inspected and audited on—I think it is a biannual basis. And 

we report proactively, complaint handling system that rolls up. 

Mr. GREEN. Thank you, Mr. Chairman. I have run out of time 

unless you want to give me 5 minutes more. 

Mr. BURGESS. No. That would be a no. The chair thanks the gentleman. The gentleman does yield back. 

The chair recognizes the gentlelady from Tennessee 5 minutes 

for questions, please. 

Mrs. BLACKBURN. Thank you, Mr. Chairman. 

And thank you to each of you for being here today. I am happy 

to see so much love and support for over-the-counter hearing aids. 

We appreciate that. 

Mr. Robinson, I thank you that you have come in line saying you 

even support, even though—— 

Mr. ROBINSON. I have aged in-laws that suffer with this. 

Mrs. BLACKBURN. You can relate to the story of—— 

Mr. ROBINSON. I can relate to the story. 

Mrs. BLACKBURN. Yes, absolutely. 

Ms. Shrader, we thank you for your presence in Tennessee. We 

appreciate that Medtronic is one of our companies there and your 

presence in Memphis, and that one out of every four jobs in Memphis, Tennessee, is a medical-device-related job. So we appreciate 

that presence. 

Dr. Lin, I think that you have pretty much stated why this is important having the over-the-counter hearing aids, and I appreciate 

that. 

Let’s look for just a minute, though. One more thing I want to 

touch on very quickly, state laws and why we may need to preempt 

those state laws as we look at the availability, especially in underserved areas. So just a couple of seconds on that, and then, after 

he finishes, Mr. Chairman, I will yield back. 

Dr. LIN. Thank you, Representative Blackburn. Right now as the 

act you help coauthor clearly states, there is a very narrow preemption of state law specifically for this over-the-counter class of 

hearing aids. And this follows in line with what the National Academies and PCAST recommended, is we want to make these devices 

broadly available to 38 million Americans with hearing loss. We 

don’t want some states saying, ‘‘Well, this can’t be given over the 

counter.’’ So it does call for a very, very narrow preemption only 

for this one specific class of hearing aids. 

Right now, all States have on their books that hearing aids cannot be sold over the counter, and those regulations evolved 40 

years ago when the hearing aids back then could not be safely 

given over the counter. But clearly now, with the purpose of this 

act, it would create a narrow regulatory classification for a safe and 

effective hearing aid that could be given over the counter and, 

hence, the need for a very narrow limited set of state preemption 

for this. 

Mrs. BLACKBURN. I appreciate it. 

I yield back. 

Mr. BURGESS. The chair thanks the gentlelady. The gentlelady 

yields back. 

The chair now recognizes the gentleman from North Carolina, 

Mr. Butterfield, for 5 minutes of questions, please. 

153 

Mr. BUTTERFIELD. Thank you very much, Chairman Burgess. 

Thank you for holding this hearing today and including H.R. 1736 

in the list of bills that we are considering today. I am proud of bipartisan legislation that I introduced with my friends and colleagues, Dr. Bucshon, Mrs. Brooks, and Mr. Peters. This bipartisan 

legislation will improve patient safety by ensuring that the FDA is 

making the best use of its inspection resources. And so this may 

be the beginning of more bipartisanship in this Congress, and that 

is a good thing. 

This legislation, Mr. Chairman, will provide much-needed consistency and transparency in the routine inspections process by establishing rules of the road—rules of road for FDA inspectors, including inspecting device facilities and regular communications between FDA inspectors and the facility both before and during and 

after the inspection. 

Importantly, nothing in this bill takes away or limits the FDA’s 

ability to inspect. It directs the FDA to focus its inspection resources on the more significant risk to public health. 

My clock is not running, Mr. Chairman. Thank you. You must 

have known I had a birthday last week. 

Mr. BURGESS. The gentleman’s time has expired. 

Mr. BUTTERFIELD. No. I am just going to have one or two questions momentarily. I won’t take up the full time. I am proud to 

work with my colleagues and thank the witnesses for their testimony. 

Ms. Shrader, I will just do one or two questions with you and call 

it a day. I have heard from other companies based in North Carolina that, when FDA comes to inspect a facility, it is an all-handson-deck situation and that, with FDA inspectors coming and going 

with no regular schedule, not communicating to the facility when 

they will be back, it creates a problem. 

Can you speak to that, please? 

Ms. SHRADER. Certainly. And thanks for the question. You described very well what happens in some of the less pleasant FDA 

inspections where we can’t be sure from day to day whether the investigator or investigators will be on the premises or not, and 

where they are not willing to share their concerns with us. 

As you mentioned, we can have 100 people on call for an FDA 

inspection in order to answer all the questions that might be asked 

with the appropriate level of expertise, pull documents, make copies, et cetera, to ensure that the inspection goes very smoothly. 

Obviously, when the investigators are willing to share concerns 

with us, we can have a discussion about those concerns and, in 

many cases, we can take immediate corrective action. 

Mr. BUTTERFIELD. That leads me into my next question—— 

Ms. SHRADER. OK. 

Mr. BUTTERFIELD [continuing]. About the timeframe. What happens when an FDA inspector does find a shortcoming during the 

inspection that a company needs to address? Is there a timeframe 

that companies are required to get their correction back to the 

FDA? 

Ms. SHRADER. By FDA policy, we typically have 15 days from the 

end of the inspection until a written response to any inspection or 

observations is required. 

154 

If we don’t respond within that period of time, we are at risk of 

receiving a warning letter from FDA. At the same time, I would 

note that there is no specified period of time for FDA to review our 

response and give us feedback if they feel that the response hasn’t 

been adequate. 

Mr. BUTTERFIELD. I know this is time-consuming for the companies, but are there costs associated with waiting for FDA to get 

back with their decision, financial costs? 

Ms. SHRADER. Yes, there certainly are. Of course, the cost of 

delay translates into, perhaps, manufacturing delays while we wait 

to hear whether—— 

Mr. BUTTERFIELD. It is the uncertainty. It is the uncertainty. Am 

I right about it? 

Ms. SHRADER. Right. Exactly. 

Mr. BUTTERFIELD. Thank you, Mr. Chairman. As promised, I 

yield back. 

Mr. BURGESS. The chair thanks the gentleman. 

The chair recognizes the gentleman from Indiana, Mr. Bucshon, 

for questions, please. 

Mr. BUCSHON. Thank you, Mr. Chairman. 

Mr. Robinson, I have a question for you. Wouldn’t you agree that 

it would be imperative that whoever is servicing or maintaining 

medical equipment must have access to the materials, tools, and 

support necessary to properly service and maintain the equipment 

in accordance with state and federal law? That would seem like 

that—— 

Mr. ROBINSON. Yes. And we do that today. 

Mr. BUCSHON. So if you have equipment that is serviced by a 

third party and they need information, you provide that? 

Mr. ROBINSON. We supply information to the owner of the equipment. So it can be a hospital, a doctor’s office, whoever. 

Mr. BUCSHON. OK. So then they would be able to through 

that—— 

Mr. ROBINSON. And they would access it. 

Mr. BUCSHON. Do you think that is an industrywide approach? 

Do you know? 

Mr. ROBINSON. I think so. I think that that is the common practice. 

Actually, Bob, you might know better than me if that is a common practice. 

Mr. BUCSHON. Mr. Kerwin, you can comment on that. 

Mr. KERWIN. We have approached the FDA many times over the 

years because, sadly, it is not a common practice. Though we believe, since 1973, there have been regulations in place, which require delivery of the AIAT and other information, sir. 

Mr. ROBINSON. So we are required by law, and as Philips, we fulfill the requirement. 

Mr. BUCSHON. Yes. Because it would seem to me, if a hospital 

or third-party provider under a contractual relationship agreed to 

protect their proprietary information, for example, which there is 

proprietary information on these products and/or pay for it, there 

shouldn’t be any reason why they shouldn’t be able to get that information? 

Mr. ROBINSON. Yes. 

155 

Mr. BUCSHON. Great. Thank you. 

Ms. Shrader, first of all, thank you for your support of the legislation, and I think you pretty much answered the question with 

some of your comments, 1736. But just to further clarify, it sounds 

like that you feel and your company feels that it would provide 

meaningful improvement to the FDA inspections with less delay to 

do it that way? 

Ms. SHRADER. That is correct, yes. 

Mr. BUCSHON. Yes. And Dr. Shuren pretty much talked about 

how the vast numbers of inspections—I think 25,000 a year or 

something in that area—and, hence, the reason we put together 

this bipartisan legislation, because we want them to be able to 

focus on areas where it is most needed and people that have been 

in long-term compliance not to be as much of the focus. So I appreciate your support. 

And, Mr. Chairman, I yield back. 

Mr. BURGESS. The gentleman yields back. The chair thanks the 

gentleman. 

The chair recognizes the gentleman from Massachusetts, Mr. 

Kennedy, for 5 minutes of questions. 

Mr. KENNEDY. Thank you, Mr. Chairman. 

Dr. Lin, thank you for your testimony and your advocacy on behalf of hearing health. Thank you for some of the questions that 

you answered earlier with regards to H.R. 1652. 

I want to flesh out a little bit, in your testimony you talked to 

this, and I know there is some questions about it too about the 

value of crafting that legislation from mild and moderate hearing 

loss versus just mild hearing loss. I was hoping that you could just 

flesh out for me the medical difference between mild and moderate 

in terms of the causes and in terms of treatment to start. 

Dr. LIN. So, from a clinical medical perspective, there is no difference. It is on a natural continuum. People progress from mild to 

moderate. That currently encompasses, again, about 95 percent of 

people with hearing loss have a range from mild to moderate. From 

a clinical perspective now, when you see an audiologist, they don’t 

necessarily distinguish a different device for mild versus moderate. 

It is the same device; you just program it a little differently. That 

was very much the basis for the National Academies’ recommendations that I served on as well as PCAST, recognizing there is a 

broad base of hearing loss that is very much treated the same way, 

and, hence, if we can have devices that are over the counter that 

are safe and effective for that broad range, why are we purposely 

handicapping it? So we say 30 percent of the people with hearing 

loss, they have to go through the traditional model. I think it is a 

little paternalistic from a medical point of view to say that. 

Now, I think importantly too, as I mentioned before, it is not an 

either/or phenomenon. Already what we are seeing is people who 

have access or learn about over-the-counter devices are coming to 

the physician a lot of times asking, you know, ‘‘What I should I do? 

What should I get?’’ So, in many cases, you can imagine—and I 

think this is where the American Doctors of Audiology sees this 

going—is it is just another avenue of a way to help patients that 

come to see you, is that I can recommend to you my services. I can 

recommend to you a custom-fitted, super customized hearing aid, 

156 

or I can help you use an over-the-counter hearing aid. So to purposely limit it to a mild hearing loss only handicaps the clinicians 

who are out there to help the patients, basically, and, hence, a 

broad need to address mild-to-moderate in this classification. 

Mr. KENNEDY. And why would not requiring for a professional 

visit be safe for those with mild loss but unsafe for those with moderate loss? 

Dr. LIN. I can think of none. From a medical and surgical standpoint, there is no distinction between the two. If it is safe for mild, 

it would be safe for moderate too as well as effective. I think as 

you go to more severe forms of moderate hearing loss, it is not that 

it becomes not effective. It gradually diminishes. You might need 

more assistance. But, again, this is why it is not an either/or phenomenon. That is when you would go see a clinician, and they 

could help you use that over-the-counter device, help you program 

it to adapt it to your lifestyle. 

Mr. KENNEDY. Great. 

Mr. Chairman, I also ask unanimous consent to submit two studies for the record: one from the National Academies of Sciences, 

Engineering, and Medicine, and the other, as referenced by the witness, the President’s Council of Advisors in Science and Technology, both studies. 

Mr. BURGESS. Without objection, so ordered. 

Mr. KENNEDY. Thank you. And I yield back. 

Mr. BURGESS. The gentleman yields back. The chair thanks the 

gentleman. 

The chair recognizes the gentleman from New York, Mr. Engel, 

5 minutes for questions. 

Mr. ENGEL. Thank you very much, Mr. Chairman. 

And thanks to our witnesses for being here and sharing your expertise. 

At some point or another, every one of us is going to use a medical device without even realizing it. I keep getting asked when I 

go through to take an airplane trip, if I have any medical devices 

on me. I guess it is with age that comes along. 

But some need devices to go about their daily activities more 

comfortably, and some may depend on one for their very survival; 

therefore, we all have a stake in the issue. And it is important, of 

course, that we assure medical devices are effective, safe, and readily accessible to those who need them. And I think that is a principle that we can agree on. 

Let me ask you, Dr. Lin. I have a few questions for you. During 

your testimony, you mentioned some of the concerns that have 

been raised with respect to over-the-counter hearing aids. You also 

noted that less than one-fifth of the nearly 38 million Americans 

with substantial hearing loss presently have access to hearing aids. 

Could you elaborate, please, on how the potential risks of over-thecounter hearing aids stack up in comparison to the risks of 

unaddressed hearing loss? 

Dr. LIN. So I think that is exactly the question. I think anything 

we ever do policywise is a balance of benefits versus risks. And I 

think the benefits here now, now that we know from research that 

hearing loss is linked with things like dementia, higher healthcare 

costs, falls, is that anything we can do to address hearing loss to 

157 

increase usage could only benefit public health. So those are clear, 

tangible, real benefits for our parents, for our seniors, for society 

right now. 

The risks, on the other hand, I would say are minute. When you 

talk about hearing loss in older adults, two out of every three 

adults over 70 have a hearing loss. As FDA described before, again, 

not every person needs to be medically evaluated. The vast majority of hearing loss that is of a ‘‘dangerous nature’’ from a surgical 

perspective, things like cholesteatoma, tumors, things like that, invariably in almost all cases have warning signs—either it is only 

a unilateral hearing loss, not in both ears, it is one hearing in the 

ear, you have pain, you have drainage, you have dizziness, you 

have vertigo—all of which would be clearly labeled at the outset in 

the labeling of these devices. 

So I think the minute chances of an undetected condition that do 

have not presenting symptoms are very, very, very small and clearly outweighed by several orders of magnitude of the benefits of allowing the 80 percent of people who do not have hearing treatment 

now to get some form of help. 

Mr. ENGEL. Dr. Lin, late last year, FDA actually signaled that 

it might create a category of over-the-counter hearing aids. And, 

similarly, I understand that FDA released guidance in December 

outlying its decision not to enforce a requirement that adults undergo a doctor’s exam or sign a waiver for purchasing hearing aids. 

As an expert in hearing loss and as a medical professional, do you 

feel these are sound decisions on the part of FDA? 

Dr. LIN. I am sorry. The last one? Do I agree with these decisions? 

Mr. ENGEL. Yes. 

Dr. LIN. Yes. No, I fully agree, and that is coming from my perspective as having served on the National Academies, advising 

PCAST, as well as my own role of, again, otolaryngologist and 

otologist at an academic medical center. 

Mr. ENGEL. Thank you. And, finally, how does this bill affect consumer protections regarding the safety and effectiveness of hearing 

aids? And by that, in your professional opinion, is there any reason 

to believe that consumers would be less safe as a result of legislation before us today? 

Dr. LIN. No. And I think, as I mentioned before, I think they are 

actually far safer in fact. I think the reason why that is, is because, 

as you have an over-the-counter regulated class that is broadly applicable to the 95 percent of people with hearing loss out there, it 

drives interest and it drives questions. It causes consumers and patients to ask more about hearing loss, to ask their physicians about 

hearing loss, to go see an audiologist to get their advice. It doesn’t 

drive people away from hearing care; it drives people toward hearing care by offering them an avenue that they can now approach 

on their own terms. 

Mr. ENGEL. Thank you very much. 

I yield back. 

Mr. BURGESS. The chair thanks the gentleman. 

The chair recognizes himself for 5 minutes for questions. 

Dr. Lin, I really do appreciate your testimony and your forthright 

answers to all the questions. Just so I am clear on this, are there 

158 

any illnesses that would present with mild hearing loss that would 

be different from illnesses that would present with moderate hearing loss? 

Dr. LIN. No, absolutely not. From the clinical and medical perspective, it is on a natural continuum from one to another. There 

is no difference between the two in terms of how necessarily manage it with existing devices. 

Mr. BURGESS. And I thank you for your written testimony. You 

actually addressed some of the concerns I had about children and 

the screening tests done at birth and the school testing done. In 

your opinion, is that going to be an adequate catchment for those 

individuals? 

Dr. LIN. Absolutely. Fortunately, the way we manage pediatric 

care in most of this country is actually very well done. We have 

universal newborn screening. Every state has some degree of 

school-based screening. If you are low income, Medicaid in all 50 

states covers hearing aids and services for children. So the medical 

system for hearing loss and kids is completely different in many 

ways, fortunately. So I do not see virtually any risk of these being 

inadvertently or improperly used in children. There is no reason to. 

Mr. BURGESS. Very well. 

Mr. Kerwin, Mr. Robinson, I want to talk about the devices. Mr. 

Robinson, someone mentioned about anecdotes. I think we have established in this committee that the plural of anecdote is not data. 

But, nevertheless, you had the plural of anecdote in your testimony. 

When I first started looking through that, I thought, the world 

isn’t like that. And then I looked at some of the examples and saw 

tape on the equipment, and I thought, oh, that totally happens. 

You see that, unfortunately, all the time. 

So I guess, Mr. Kerwin, you said there is no evidence to support 

a problem with the servicing of medical equipment. Mr. Robinson 

has provided some compelling visual data that suggests otherwise. 

Shouldn’t each entity that is hired to fix or refurbish equipment 

be equally responsible for documenting and submitting adverse-related problems that may be connected to their work? 

Mr. Kerwin, that is to you. 

Mr. KERWIN. Mr. Chairman, I believe that we are responsible. 

Our members, we have contractual obligations to the hospital. The 

hospitals have the ability to vote with their feet if we do not satisfy 

those obligations, notwithstanding we have long-term relationships. 

We voluntarily report adverse events. And in the ECRI study that 

Mr. Robinson referred to, they had analyzed 137,000 MAUDE reports, and there was only a total of 0.1 percent of total events: 241 

incidents in the ECRI study. And I recognize that was a little while 

ago. 

But we say, Mr. Chairman, that the enormous amount of resources that would be dedicated toward reporting for, perhaps, 0.1 

percent of total events, when it will create a sea change in the 

manner in which the rural and regional hospitals deal with the 

independents, and we feel, on balance, we do report, and we do 

have energetic internal trade association programs on medical devices, on adverse events, on UDI, on best practices for all of the 

events. And we recognize patient safety is our paramount interest. 

159 

Mr. BURGESS. Just so I am clear, Mr. Robinson, for the original 

equipment manufacturer, are you required to report adverse events 

to the Food and Drug Administration? 

Mr. ROBINSON. We are required. And if volunteer were good 

enough, maybe we should request the FDA to make it all voluntary, but I don’t think there would be an interest in doing that. 

Mr. BURGESS. And I was going to say that there are probably not 

many constituents clamoring for that. So I guess that is a question 

that I have at the end of this lengthy hearing. And, again, I do appreciate all of you putting so much time in with us today. If you 

are each doing the same servicing work, why the different treatment by the Food and Drug Administration? 

Mr. ROBINSON. I couldn’t answer that for you. And I think, actually, Dr. Shuren had made a reference to there were some guidelines in place that there was, I think his words were, ‘‘lacks enforcement of.’’ So there seems to be something in place, but there 

is not a requirement to implement it. That is my take from his 

comment, but I am not 100 percent sure. 

Mr. BURGESS. Mr. Kerwin, you look like you wanted to say something. 

Mr. KERWIN. Mr. Chairman, this was examined 20 years ago. 

And, again, it is being examined today. And during this entire time 

of 20 years, we have not heard of the reporting of adverse events 

or the underreporting of adverse events. I understood that Dr. 

Shuren was referring to laparoscopic issues, and I had seen some 

publications relative to this. I have not heard, with respect to diagnostic imaging, anything of this nature. And it would seem that if 

we had followed the report from ECR, that if we are looking at a 

total of 0.1 percent of total events, is it really, in our era of having 

smart regulation, appropriate to now create a change in the manner in which all of these hospitals, particularly these rural hospitals, do business? 

Mr. ROBINSON. The good news is there is no new regulation. We 

are simply asking for the distribution of the existing regulation to 

the independent services. 

Mr. BURGESS. And I appreciate that it is infrequent, but we 

know, as you look at some of these pictures that were provided to 

us, would I want a family member to be utilizing that equipment—— 

Mr. ROBINSON. I would not. 

Mr. BURGESS [continuing]. Would I be perfectly comfortable with, 

honestly, some of it is quite sophisticated, like the cooling mechanism for the magnet in an MRI, but some of it is fairly mundane, 

like cracks in the plastic—or the rubberized guard on a patient mat 

on a gurney. 

Mr. KERWIN. Mr. Chairman, if I may speak to that? 

Mr. BURGESS. Turn your mike on. 

Mr. KERWIN. Mr. Chairman—— 

Mr. BURGESS. Is your microphone on? 

Mr. KERWIN. My apologies. 

Mr. BURGESS. Thank you. 

Mr. KERWIN. In preparation for our hearing today, we contemplated, would we bring our pictures? Would we show areas 

where we have taken over for the manufacturer? And I have been 

160 

assured by several companies that, if necessary, we, too, can 

produce. But we thought the attribution to nameless independents 

paints an entire industry and perhaps unfairly. And we would like 

to focus on the collegiality. 

At one point in 1997, FDA assisted in the collaboration with 

AME and with all the stakeholders working toward an industry solution relative to this. Let’s turn over the passwords, equipment 

manuals, and training; let’s cooperate relative to the reporting. 

And, unfortunately, the person at AME who was coordinating much 

of that departed, and we did not reach closure. We called for a collaborative effort during the October 27, 28 meeting before FDA. We 

think this belongs with industry, particularly where there is no 

real-world evidence to back this up. And I still await attribution of 

these nameless independents for whom we have pictures. And if 

the committee wishes, we can bring pictures, but we don’t think 

that is the ultimate solution. 

Mr. BURGESS. Mr. Robinson, what about that? What about the 

sharing of data and passwords? 

Mr. ROBINSON. Yes, we comply with all the laws. And every one 

of the member companies, to the best of my ability, complies with 

those laws and regulations. We supply the servicing and preventive 

maintenance manuals to the owners of the equipment, as required. 

What I would tell you is, in general, no industry is perfect. The 

people who repair machines are people. The people who build machines are people. And that is why they break. And that is why 

companies like ours do service. And the OEMs, in terms of pictures 

or adverse events, are an open book. We have to report it to the 

FDA. All we are asking for is the same open book. Let’s not have 

it in nameless pictures. Let’s have everyone report the same way, 

and that is all we are requesting in this. 

Mr. BURGESS. Well, obviously, that does not conclude this discussion, but it concludes our hearing. 

Mr. ROBINSON. But thank you for your time and attention. 

Mr. KERWIN. Thank you for your time. 

Mr. BURGESS. Well, seeing that there are no further members 

wishing to ask questions, I do want to thank our witnesses for 

being here today. 

We have received outside feedback from a number of organizations on these bills. So there are statements to submit for the 

record from AARP, from the International Hearing Society, from 

the American Speech-Language-Hearing Association, from the 

Academy of Doctors of Audiology, from the American Academy of 

Otolaryngology-Head, and Neck Surgery, Consumer Technology Association, Aramark, Consumers Union, Repair.org. 

Without objection, so ordered. Those will be entered into the 

record. 

[The information appears at the conclusion of the hearing.] 

Mr. BURGESS. Pursuant to committee rules, I remind members 

they have 10 business days to submit additional questions for the 

record. 

And I ask the witnesses to submit their responses within 10 

business days upon receipt of those questions. 

And, without objection, the subcommittee is adjourned. 

[Whereupon, at 12:39 p.m., the subcommittee was adjourned.] 

161 

[Material submitted for inclusion in the record follows:] 


26785.106

Statement in Support of the Over-the-Counter Hearing Aid Act of 2017 

We are pleased to join a bipartisan group of our House colleagues to support the Over-theCounter Hearing Aid Act of 2017, which would increase access to affordable hearing aids by 

giving consumers new options, increasing competition, and removing unnecessary barriers to 

innovative technology. 

The time to increase access to affordable hearing technology is now. Hearing loss in older adults 

is widespread. More than two-thirds of people in their seventies have hearing loss, and that 

figure jumps to nearly ninety percent of people over the age of 80. Indeed, the risk of hearing 

loss in older adults is about 10 to 20 times higher than the risk of heart disease and 100 times 

higher than the risk of cancer. Untreated hearing loss can be socially isolating. and is associated 

with serious health conditions such as cognitive decline, falls, and depression. 

And recent research from the CDC finds that about I in 4 American adults who report excellent 

to good hearing already have some form of irreversible hearing loss without knowing it, meaning 

the need for hearing aids will only grow over time as these individuals age and as seniors make 

up an increasingly large share of our population. 

Unfortunately, only 14 percent of the roughly 48 million Americans with hearing loss use a 

hearing aid -and cost is a major reasons for this treatment gap. The average cost of one hearing 

aid is more than $2,000, and most people need two devices. 

The Over-/he-Counter Hearing Aid Act implements recommendations made by the National 

Academies of Sciences, Engineering, and Medicine and creates an FDA-regulated category of 

hearing aids that would be available directly to consumers. The legislation has been endorsed by 

consumer and senior groups, hearing health practitioners, and hearing loss advocates. 

Hearing aids shouldn't be a luxury only available to those who can afford steep out-of-pocket 

costs. This bill is a commonsense, bipartisan approach to bringing down costs, loosening up 

outdated regulations, and improving hearing healthcare, and we urge continued support for it in 

both chambers of Congress. 

Senator Elizabeth Warren 

Senator Chuck Grassley 

Senator Margaret Wood Hassan 

Senator Johnny Isakson 
162 


26785.107

May 1, 2017 

The Honorable Michael C. Burgess 

Chairman, Subcommittee on Health 

House Energy and Commerce Committee 

U.S. House of Representatives 

Washington, DC 20515 

The Honorable Gene Green 

Ranking Member, Subcommittee on Health 

House Energy and Commerce Committee 

U.S. House of Representatives 

Washington, DC 20515 

RE: Support for the Over-the-Counter Hearing Aid Act of 2017 

Dear Chairman Burgess and Ranking Member Green, 

The Consumer Technology Association (CTA)'" applauds the Subcommittee on Health for convening its May 

2, 2017 hearing on "Examining Improvements to the Regulation of Medical Technologies." Specifically, CTA 

strongly supports the Over-the-Counter Hearing Aid Act of 2017 (H.R. 1652), as introduced by Chairman 

Blackburn and Representative Kennedy. As the trade association representing 2,200 world-class technology 

innovators, CTA has deep experience promoting technologies to change people's lives for the better. In 

fact, CTA's affiliated public, national CTA Foundation was launched in 2012 with the mission to link seniors 

and people with disabilities with technologies to enhance their lives, and providing affordable hearing 

solutions is an important piece of that mission. 

The Over-the-Counter Hearing Aid Act of 2017 will change lives for the better by directing the Food and 

Drug Administration (FDA) to create a new regulatory class of hearing aids that could be sold over the 

counter. This new regulatory class will addresses the needs of adults with mild to moderate hearing loss, a 

population that desperately warrants attention. According to a June 2016 report published by the National 

Academies of Sciences, Engineering, and Medicine, age-related hearing loss is an increasing public health 

concern as the population of older adults grows. Indeed, the NAS report, Health Care for Adults: Priorities 

for Improving Access and Affordability, notes that, 

"Hearing is a vital human sense that is important to communication and health and can affect 

quality of life. Yet for a variety of reasons, many people with hearing loss do not seek out or receive 

hearing health care. Estimates of hearing aid use are that 67 to 86 percent of people who may 

benefit from hearing aids do not use them, and many hearing assistive technologies as well as 

auditory rehabilitation services are not fully utilized." 
163 


26785.108

Today, hearing aids range in price from $1,000 to $6,000, while devices such as a class of over-the-counter 

hearing devices are a fraction of that cost- $100 to $600. CTA's own research study, Personal Sound 

Amplification Products: A Study in Consumer Attitudes and Behavior, found that most adults with hearing 

problems do not get the hearing assistance they need. Key barriers to addressing hearing problems include: 

the high cost of hearing aids, inconvenience, and the cost of doctor appointments. 

The Over-the-Counter Hearing Aid Act of 2017 would dramatically change the environment for adults 

suffering from mild to moderate hearing loss by allowing them easier and more affordable access to 

hearing assistance devices. 

CTA is accredited by the American National Standards Institute (ANSI) to write standards for the consumer 

technology industry. Closed captioning is one well-known example of CTA's important accessibility-related 

standards. In January 2017, CTA released ANSI/CTA-2051, Persona/Sound Amplification Performance 

Criteria, which sets out minimum performance requirements to be considered a high quality OTC hearing 

aid. The goal is to assure the FDA and consumers that manufacturers who build to this standard have built a 

quality, reliable OTC hearing aid. In short, industry-led standards can help to pre-package the set of rules 

that the government and consumers can rely on. CTA will work with the FDA to incorporate this standard 

into any FDA-promulgated regulations on over-the-counter hearing aids. 

The Over-the-Counter Hearing Aid Act of 2017 will ensure that Americans with mild to moderate hearing 

loss get the hearing assistance they need and deserve at a reasonable and affordable price. We pledge our 

support and urge immediate passage. 

Sincerely, 

President & CEO 

CC: The Honorable Greg Walden, Chairman, House Energy and Commerce Committee 

The Honorable Frank Pallone, Ranking Member, House Energy and Commerce Committee 

Members, Subcommittee on Health, House Energy and Commerce Committee 
164 


26785.109

Real Possibilities 

March 28, 2017 

The Honorable Joseph P. Kennedy Ill 

434 Cannon House Office Building 

Washington, DC 20515 

The Honorable Buddy Carter 

432 Cannon House Office Building 

Washington, DC 20515 

60; E Street, NW ! Wash1ngto'1, DC 201)19 

20?.·434"2.2!7 l 1-888-0UR·AARP 1·888-687-227/ , ITY 1-877-t\34-7598 

,;,ww.aarp.org tw1~tcr ©aarp i faceoook com/aarp i youtubo com/aarp 

The Honorable Marsha Blackburn 

2266 Rayburn House Office Building 

Washington, DC 20515 

Dear Representative Kennedy, Representative Blackburn, and Representative Carter: 

AARP is pleased to endorse the Over-the-Counter Hearing Aid Act of 2017, which would implement 

recommendations from the President's Council of Advisors on Science and Technology's (PCAST) and 

the National Academies to help the millions of Americans affected by hearing impairment. 

Your bill, by making certain types of hearing aids available over the counter, requiring the FDA to issue 

regulations on this new category of over-the-counter hearing aids, and requiring the FDA to update its 

guidance on Personal Sound Amplification Products (PSAPs), among other reforms, would help create 

a more consumer-friendly market for hearing devices. 

At AARP, part of our mission is ensuring older Americans continue to lead active and engaging lives. A 

person's ability to hear greatly affects how they interact with other people, loved ones, and the 

environment around them. Difficulty hearing creates a barrier to social interaction, and can have a 

negative health impact. Roughly 40 percent of the over-60 population experiences hearing loss. 

Unfortunately, hearing aid usage by those experiencing hearing loss is very low, with only about 20 

percent of those affected using a hearing aid. A significant factor in the lack of utilization is the cost of 

hearing aids- which average over $2,000 per ear. Cost and other factors, such as access and social 

stigma, prevent people from using these life-altering technologies. 

AARP believes your bill will improve consumers' access to affordable hearing technologies that can 

improve their daily living. Thank you for your leadership on this important issue. If you have any 

questions, please feel free to contact Andrew Scholnick of our Government Affairs staff at 

ascholnick@aarp.org or 202-434-3770. 

Sincerely, 

9[[A·¥ 

Joyce A. Rogers 

Senior Vice President 

Government Affairs 
165 


26785.110

ADA Supports Bipartisan, Bicameral Over-the-Counter Hearing Aid Act of 2017 

March 22,2017 

The Academy of Doctors of Audiology (ADA) supports S. 670/H.R. 1652, the Over-the-Counter 

Hearing Aid Act of 2017, and commends Senators Warren and Grassley, and Representatives 

Blackburn and Kennedy for their foresight in introducing this legislation, which if enacted, will remove 

unnecessary and burdensome barriers to hearing care for millions of Americans. 

The Over-the-Counter Hearing Aid Act of 2017 would allow hearing aids, intended to be used by adults to 

compensate for mild to moderate hearing impairment, to be sold over the counter (OTC), and would 

eliminate the requirement that adult consumers obtain a medical evaluation or sign a waiver in order to 

acquire these hearing aids. This landmark legislation also directs the FDA to issue regulations containing 

safety and labeling requirements for this new category of OTC hearing aids and to update FDA draft 

guidance on Personal Sound Amplification Products (PSAPs). 

The Over-the-Counter Hearing Aid Act is consistent with ADA's longstanding position to implement 

recommendations from the President's Council of Advisors on Science and Technology (PCAST) and the 

National Academies of Sciences, Engineering, and Medicine (NASEM), which have both recommended 

making some types of hearing aids available over the counter and removing the requirement of a medical 

evaluation in order to allow millions more Americans to access hearing aids. 

The availability of FDA-registered OTC hearing devices will allow consumers to make better informed 

decisions about their treatment options, and will also facilitate increased competition, enhance quality 

and improve transparency with regard to the purchase of direct-to-consumer hearing amplification 

products. 

"The ADA is unaware of any credible research demonstrating that the medical evaluation requirement 

actually leads to the identification and treatment of medical conditions that would not otherwise be 

identified appropriately by the patient," said ADA President, Angela Morris, Au.D. "There is no evidence 

that the required medical evaluation, as a condition of purchasing a hearing aid, improves the outcome 

for patients seeking hearing health care. Further, anecdotal evidence suggests that the medical evaluation 

waiver is widely used." 

Academy of Doctors of Audiology I 446 E. High St., Suite 10 I Lexington, KY 40S07 

866-493-SS44 I www.audiologist.org 
166 


26785.111

The ADA stipulates that there are risks with self-treatment, including overlooking conditions that warrant 

medical intervention. However, we contend that in the current regulatory environment, those risks are 

already being taken by consumers with either limited information--or worse yet, misinformation. 

There is a preponderance of data available today that demonstrates that, when it comes to hearing loss, 

the risk of non-treatment may be greater than the risk of self-treatment. The tremendous co-morbidities 

and maladies associated with untreated hearing loss are well documented, as are the benefits of 

amplification in improving quality of life and mitigating serious health conditions. Therefore, the public 

will be best served if basic hearing devices are available to consumers over the counter, just as they are 

already available over the internet. 

The regulatory environment has struggled to keep pace with rapid advances in hearing amplification 

technology. Creating an OTC hearing device market will foster competition, broaden consumer choice, 

improve affordability, and accelerate future innovation. As consumers already have direct-to-consumer 

internet access to hearing aids and similar unregulated technologies, the creation of a regulated OTC class 

will not increase existing risks to the public. 

The ADA and its members seek expanded access for consumers to audiology services. We strive to 

accomplish this goal through the advancement of practitioner excellence and high ethical standards in the 

provision of quality audiologic care. The Over-the Counter Hearing Aid Act will help to facilitate these 

objectives and is consistent with the ADA's mission and philosophy. 

In summary, the removal of the medical clearance requirement and the availability of a regulated OTC 

hearing device, which calls for FDA to include appropriate labeling and safety measures, will expand access 

to quality hearing health products and services, reduce duplicative costs, and remove unnecessary, nonbeneficial barriers to care. For this reason, the ADA is pleased to support the Over the Counter Hearing 

Aid Act. 

Contact: 

Stephanie Czuhajewski, CAE 

Executive Director 

446 E. High St. 

Lexington, KY 40507 

sczuhajewski@audiologist.org 

859-977-7444 

Academy of Doctors of Audiology 446 E. High St., Suite 10 I Lexington, KY 40507 

866-493-5544 I www.audiologist.org 
167 


26785.112

@iii~@) ~lllllllil~ttoolll rr-w I :.mcia1 Security&Medicarff Ill Trusted • tndependent • Effective 

April 18, 2017 

The Honorable Elizabeth Warren 

United States Senate 

Washington, DC 20510 

The Honorable Maggie I lassan 

United States Senate 

Washington, DC 20510 

Dear Senators Warren, Grass ley, Hassan and Isakson: 

The Honorable Charles Grassley 

United States Senate 

Washington, DC 20510 

The Honorable Johnny Isakson 

United States Senate 

Washington, DC 20510 

On behalf of the millions of members and supporters of the National Committee to Preserve 

Social Security and Medicare, I am writing to endorse S. 670, the "Over-the-Counter I !caring 

Aid Act of 2017 ,"which you introduced. 

Hearing loss is the third most prevalent chronic health condition facing older adults. Yet 70 

percent of Americans between age 65 and 84 with hearing loss arc not using hearing aids 

because Medicare docs not cover them, and paying for the devices out-of-pocket is expensive. 

In a recent study, Consumer Reports found that where the wholesale price of the aids could be 

verified, the average retail markup was 117 percent. The cost is high because a small group of 

companies control the hearing aid market, and many health care professionals who sell the 

devices bundle their costs in the final price paid by consumers. Better access to more affordable 

over-the-counter (OTC) devices could be helpful to individuals with mild to moderate hearing 

loss. Your bill, the ·'Over-the-Counter Hearing Aid Act of2017," would encourage the 

development of these devices by requiring that the Food and Drug Administration provide for the 

regulation ofOTC hearing aids within three years of enactment of the bilL 

Medicare should cover hearing aids. Until that happens, seniors will need more affordable 

options to treat hearing loss. Your bill fills this gap. For that reason, the National Committee 

supports the ''Over-the-Counter Hearing Aid Act of 20 17,'' and we look forward to working with 

you towards enactment of this needed legislation. 

Sincerely, 

Max Richtman 

President and CEO 

10 G Street. NE, Suite 600 • Washington, DC 20002-4215 • 202-216-0420 • www.ncpssm.org 
168 


26785.113

ConsumersUnion· 

POLICY & ACTION FROM CONSUMER REPORTS 

The Honorable Elizabeth Warren 

The Honorable Chuck Grassley 

The Honorable Maggie Hassan 

The Honorable Johnny Isakson 

United States Senate 

Washington, DC 20510 

Aprill7,2017 

Dear Senators Warren, Grassley, Hassan, and Isakson: 

Consumers Union, the policy and mobilization arm of Consumer Reports, is pleased to 

supportS. 670, the '·Over-the-Counter Hearing Aid Act of2017," your legislation to help make 

hearing aids available to consumers more conveniently and affordably. 

As noted in our recent article in the March 20 l 7 issue of Consumer Reports, 1 price 

considerations keep many Americans from getting bearing assistance instruments that could 

make a big difference in their quality of life. 

S. 670 would broaden the range of hearing aids available over the counter to adults with 

mild to moderate hearing loss. These devices would then be available for purchase separately 

from medical evaluations and services, giving consumers more affordable and accessible 

options. 

We believe the bill would preserve and reinforce important consumer safety protections, 

including state laws holding manufacturers responsible for harm caused by unsafe and defective 

products, while overriding state laws designed to block or impede consumer access to over-thecounter hearing aids. This would include overriding state laws that require medical exams as a 

prerequisite for purchasing these over-the-counter products. We continue to encourage 

consumers with hearing loss problems to seek medical evaluation, to rule out other possible 

medical issues. But consumers can benefit from a system in which the medical evaluation is 

separated from the purchase of the device, so consumers are able to make their own choices, to 

shop around for medical services and hearing aids that best suit their needs and their budget. 

1 Insights: No More Suffering in Silence", http://consumersunion.org/research/consumer-reports-insights-no-moresu ffcring-in-silcnce/. 
169 


26785.114

We look forward to working with you to enact this beneficial consumer legislation into 

law. Thank you for your leadership on this important issue. 

Lisa McGiffert 

Director, Safe Patient Project 

Consumers Union 

Sincerely, 

2 

George P. Slover 

Senior Policy Counsel 

Consumers Union 
170 


26785.115

The Nation's Voice for People with Hearing Loss 

May 1, 2017 

The Honorable Michael Burgess, Chairman 

The Honorable Brett Guthrie, Vice Chairman 

The Honorable Gene Green, Ranking Member 

House Committee on Energy and Commerce 

Subcommittee on Health 

United States House of Representatives 

Washington, DC 20515 

Dear Representatives Burgess, Guthrie and Green: 

On behalf of the nation's foremost organization representing people with hearing loss, I am 

pleased to offer our enthusiastic endorsement of legislation to expand access to over-thecounter hearing aids. The "Over-the-Counter Hearing Aid Act of 2017" HR 1652 will 

dramatically improve the lives of millions of Americans living with hearing loss. 

Of the estimated 30 million Americans who have age-related hearing loss, only about 14 

percent of them are currently using hearing aids. The primary reason for this disparity is the 

high cost of hearing aids. The average cost of one hearing aid is $2,000 and most people need 

two. Medicare and most insurance do not cover hearing aids. Each and every day, our office 

receives letters, phone calls and emails from people with hearing loss inquiring about financial 

assistance to purchase hearing aids, up to 10 requests a day. The financial help page on 

hearingloss.org is the number one visited page on HLAA's website. Sadly, there are few financial 

aid resources. Creating a category of over-the-counter hearing aids will go a long way toward 

making these essential devices affordable for the millions of Americans who need them. 

The approval of over-the-counter hearing aids will also cut through the red tape and confusing 

federal, state and local regulations that currently make purchasing a hearing aid intimidating even 

for those who can afford them. As hearing aids become more affordable and easier to purchase, 

HLAA believes that far more Americans will take advantage of them. 

The current regulatory framework regarding hearing aids was developed at a time when overthe-counter devices provided little real benefit and too often added to the frustration of those 

experiencing hearing loss. Technological advances in recent years have made over-the-counter 

hearing aids a viable option for many people with mild and moderate hearing loss. 

7910 Woodmont Avenue, Suite 1200, Bethesda, MD 20814 I www.hearingloss.org I 301.657.2248 I Fax 301.913.9413 
171 


26785.116

The benefit of making hearing aids more affordable and accessible extends far beyond the wellbeing of the individual with hearing loss and his or her family. As more consumers with hearing 

loss make use of hearing aids, workers become more productive creating a potential economic 

benefit to the nation at large. 

Thank you for your leadership on this important issue. The Hearing Loss Association of America 

and our thousands of members across the nation stand ready to work with you to see this vital 

legislation become law. 

Sincerely, 

Barbara Kelley 

Executive Director 

7910 Woodman\ Avenue, Suite 1200, Bethesda, MD 20814 I www.hearingloss.org 301.657.2248 I Fax 301.913.9413 
172 


26785.117

Bose Corporation 

100 The Mountain Road 

Framingham, MA 01701 

The Honorable Joseph Kennedy Ill 

United States House of Representatives 

434 Cannon House Office Building 

Washington, DC 20515 

Dear Representative Kennedy, 

March 20, 2017 

As a leading Massachusetts-based consumer electronics company with a long history of 

expertise in hearing science and audio engineering, we are writing to commend you and 

Representative Blackburn for your work to address the major problem of lack of access 

to innovative, high quality hearing health products for many Americans. 

We applaud your leadership in introducing the Over-the-Counter Hearing Aid Act of 2017 

to address the barriers to innovative hearing health solutions. Your legislation would 

invigorate competition, spur innovation, and facilitate access to affordable solutions to 

help millions of Americans hear better. We support this legislation, and the goal of 

addressing unmet hearing needs. 

Sincerely, 

BOSE CORPORATION 

Fontaine 

Executive Vice President 
173 


26785.118

WRITTEN TESTIMONY OF TIMOTHY A. MCGEATH, 

SENIOR VICE PRESIDENT AND GENERAL COUNSEL, 

TRIMEDX HOLDINGS, LLC 

UNITED STATES HOUSE OF REPRESENTATIVES 

ENERGY AND COMMERCE COMMITTEE, SUBCOMMITTEE ON HEALTH 

HEARING ON "EXAMINING IMPROVEMENTS TO THE 

REGULATION OF MEDICAL TECHNOLOGIES" 

MAY2,2017 

MR. CHAIRMAN, RANKING MEMBER GREEN A:-10 MEMBERS OF THE SUBCOMMITTEE: 

As a national provider of "in-house" medical equipment service and maintenance management, 

TriMedx has developed a safe, efficient and effective model to work directly with hospitals and 

other healthcare facilities to manage their medical equipment and technology. Founded in 1998, 

TriMedx began as the hospital clinical engineering department for St. Vincent Hospital in 

Indianapolis, Indiana. Effectively created by healthcare to serve healthcare, TriMedx's focus was 

and is to enhance the patient experience through innovative on-site equipment management 

programs designed to optimize equipment service and reduce costs. Ascension Health, the largest 

non-profit healthcare system in the country, has provided TriMcdx the sole responsibility for 

managing the service, maintenance and repair of equipment for all hospitals within its system. 

The value proposition contained in the original vision for TriMedx creating an independent, 

provider-oriented technology management company driven by core values has been validated 

by TriMcdx's rapid growth outside of Ascension Health. Over the past decade, TriMcdx has 

become a meaningful and important strategic partner to some of the nation's most prominent 

healthcarc providers, including a broad range of nonprofit health systems, academic medical 

centers and for-profit health systems. Today, TriMedx: 

serves more than 240 hospitals and 1.800 healthcare provider locations across 32 

states; 

maintains data for more than 1.7 million pieces of equipment (including more 

than 60,000 unique models); 

employs and manages approximately 1,500 associates nationwide; and 

has saved hundreds of millions of dollars in capital expenditures and operating 

costs for its client partners through its comprehensive program. 

EQUIPMENT SERVICE MODELS- ISOs AND OEMS. 

The National Healthcare Expenditure Accounts estimate the cost of healthcare in the United 

States accounted for 17.5% of the nation's Gross Domestic Product in 20 14. 1 Reports have 

shown that a medium size facility can spend $5 million per year on equipment maintenance and 

an average system can spend $50 million per year on such costs. It is clear that an effective 

equipment management program is a key component in reducing costs, optimizing services and 

ultimately freeing up financial resources. 

Centers for Medicare & Medicaid Services, https://www.cms.gov/Research~Statistics-Data-and-Systems/StatisticsTrends-and-Reoorts/Nationa!HealthExpendData/NationaiHealthAccountsHistorica!.html. 
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In an effort to support such healthcare providers, the clinical engineering industry developed 

managerial programs focused on asset and strategic management of equipment inventory. These 

programs are typically offered through independent third-party service organizations, or "ISOs" 

and may include: (i) outsourcing of a traditional in-house clinical engineering department; (ii) 

medical equipment management services, including consulting services for the acquisition, 

maintenance and disposal of medical equipment; and/or (iii) the provision of specialty 

maintenance and repair services. 

Independent third-party service providers play a key role in ensuring that hcalthcarc is delivered 

in a cost-effective manner. By providing alternative and additional service options to original 

equipment manufacturer ("OEM") services, third-party service providers not only increase 

market competition but also drive other OEMs to maintain quality and cost-effective programs 

for healthcarc providers. 

EXISTING STATUTES AND REGULATORY FRAMEWORK. 

Under the Federal Food, Drug, and Cosmetic Act (the "Act"), except for very limited and 

specific circumstances, the Food and Drug Administration ("FDA") has appropriately exercised 

little authority related to the manner in which healthcare providers and hospitals service and 

maintain their own equipment. Likewise, the FDA's regulations do not currently apply to 

independent third-party scrvicers of equipment when the independent third-party service 

provider contracts directly with the hospital or healthcare provider. Therefore, TriMedx 

interprets the FDA's current position to mean that independent third-party service providers are 

governed by the same regulatory framework as its hospital customers. 

This interpretation is futiher supported by the fact that a hospital's service, repair and 

maintenance of equipment is subject to various existing statutory/regulatory schemes and 

accreditation conditions, including the Clinical Laboratory Improvement Act, the Safe Medical 

Devices Act of 1990, the CMS Conditions of Participation and conditions of The Joint 

Commission, depending upon the specific type of equipment at issue. As a hospital service 

provider, TriMedx is obligated to abide by the rules and regulations applicable to its customers, 

in addition to several others. Since TriMedx and other ISOs provide services as an agent or ann 

of the hospital, we arc bound by the same laws. 

In fact, as we shared in our comments to the FDA, healthcare providers and hospitals arc already 

subject to a substantial amount of regulation and reporting through the existing federal, state and 

accreditation framework. Given that TriMedx offers a comprehensive medical device 

management program to its hospital customers, it assists them every step of the way in 

complying with the existing rules and regulations. Adding an additional reporting and audit 

burden would, we fear, simply add more cost and confusion to this highly regulated space. 

FDA'S REQlJEST FOR COMMENTS REGARDING SERVICING OF MEDICAL DEVICES. 

TriMedx would like to take this opportunity to commend the FDA for its continued diligence 

around the refurbishing, rebuilding, remarketing, remanufacturing and servicing of medical 

devices. On March 4, 2016, the FDA issued a request for public comments, asking that 

stakeholders provide information regarding the refurbishing, reconditioning, rebuilding, 

remarketing, remanufacturing and servicing of medical devices perfonned by third-party service 

2 
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providers and OEMs ("Request for Comments"). The FDA received an overwhelming response 

to this request that included over 175 comments from hospitals, OEMs, independent third party 

service providers, clinical engineers and other interested stakeholders. 

On October 27th and 281

h, the FDA held a public workshop, which afforded stakeholders an 

additional opportunity to share their thoughts and viewpoints. The FDA indicated it would 

review the findings and recommendations before taking further action. We found the workshop 

to be an invaluable opportunity to exchange concerns and recommendations. It also helped to 

ensure that FDA understands the interplay between hospitals, health systems, ISOs and OEMs 

and the impact that additional regulation may have on each. We left with an even greater 

appreciation for the complexities that come to bear when one of the pieces of the existing 

regulatory framework shifts. 

In response to a question posed by a member of this Committee during its recent hearing on the 

Medical Device User Fee Program, Dr. Jeffrey Shuren, Director of the Center for Devices and 

Radiological Health, testified that FDA continues to review the feedback it received and "is still 

in the data gathering mode." We appreciate the time and resources that Dr. Shuren and his very 

knowledgeable, experienced team at the FDA have dedicated to this and look forward to 

reviewing their recommendations regarding the current regulatory framework. 

MEDICAL DEVICE SERVICING SAFETY AND ACCOUNTABILITY ACT (1-I.R. 2118). 

The Medical Device Servicing Safety and Accountability Act (H.R. 2118) would require ISOs to 

register with the FDA, establish a complaint handling system equivalent to that applicable to 

OEMs, and comply with the same reporting requirements. The bill also creates an exemption for 

in-house service departments. Put differently, if a device user facility, such as a physician office, 

ambulatory surgery center, or hospital, were to elect to maintain, service and repair its own 

equipment, without contracting through an OEM or an ISO, these same registration and reporting 

requirements would not apply. 

At TriMedx, as with many other service providers around the country, our number one priority is 

patient safety. We believe TriMedx can positively impact that priority by ensuring the medical 

devices arc safely and effectively maintained, repaired and available for safe patient use by 

healthcare providers. As a result, we support any initiatives that clearly advance the common 

goal of ensuring patient safety. TriMedx appreciates the Committee's interest in furthering the 

safe and effective use of medical devices. However, we arc concerned that H. R. 2 I 18 is only the 

first step to more comprehensive and burdensome regulatory requirements without a clear and 

corresponding benefit to patient safety. Therefore, we urge the Committee to approach this issue 

with caution and offer the following concerns and recommendations regarding the measure as 

currently drafted. 

TilE FDA Is WORKI.VG TO ADDRESS TlllS ISSUE. 

As noted above, the FDA received substantial input through its request for comment and its 

public workshop. In fact, it is still in the process of gathering information before recommending 

next steps. Consequently, we are concerned that this legislation is premature and believe, given 

the extensive work the FDA has already done around this very issue, the agency should be 

allowed to complete its work before Congress intervenes with legislation. 

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TilE REGISTIIAT!Oh LLVGUAGE IS VAGUE. 

In addition to requiring scrvicers of medical devices to register with the FDA, H.R. 2118 permits 

the FDA to "specify the timing, format, and information" that must be submitted. While we 

appreciate the need to provide the FDA with flexibility to determine what information must be 

submitted, it should not be information that will be burdensome and costly to produce. By itself, 

the notion of registering with the FDA does not appear to be overly burdensome and we would 

be happy to comply, but we believe the application and maintenance of the registration should 

not be unduly burdensome and provide a commensurate benefit. 

TilE COMPLA!ST HAXDUNG AX!l REPORTING REQU!R!iMloN7S ARE DUPLICAT!VE AND CREAIE A.\' 

AWKW.IRD COc\ST!WC'T: 

Federal regulations (21 C.F.R. 820.198) require manufacturers to maintain a complaint reporting 

process and procedure. This is designed to ensure that any potential concerns with a particular 

device are relayed to one party, the manufacturer, for further investigation and analysis. If the 

same reporting requirements are extended to serviccrs, it is unlikely that the manufacturer will 

know the number of complaints received and may not be able to understand the scope of a 

problem, which will hinder its ability to provide a remedy as soon as possible. Additionally, 

while a scrvicer may investigate an issue and report its findings to the manufacturer, it is likely 

that the manufacturer will still conduct its own analysis. These duplicative efforts are unlikely to 

bring any benefit to our healthcare system and, instead, represent a further diversion from the 

shared goal of delivering care in a safe and cost-effective manner. 

Section 519(a) of the Act (21 U.S.C. 360i) contains two primary reporting categories: subsection 

(a), which applies to manufacturers and importers; and subsection (b), which applies to device 

user facilities. The legislation amends Section 519(a) to apply the manufacturer and impmier 

complaint processing requirements to ISOs. Unfortunately, this would be duplicative because, as 

the manager of a device user facility's medical equipment, 1S0s like TriMedx are responsible for 

helping their hospital customers comply with subsection (b). 1n fact, these ISOs assist with the 

internal investigation, gather information and help produce the report that is submitted to the 

FDA. Thus, they are already indirectly responsible for complying with subsection (b) under this 

existing regulatory framework. 

We appreciate the need for these current regulations and believe the reporting requirements in 

subsection (b) are designed to provide the FDA with the information that is necessary to identify 

and manage equipment that is not safe or effective. Likewise, subsection (a) is tailored to require 

manufacturers and importers to provide information to which they are privy and which allows 

the FDA to ensure that devices are safe and effective for their intended use. While manufacturers 

and importers arc governed by the same regulation, the reporting requirements applicable to each 

vary under part 803 of title 21 of the Code of Federal Regulations. Part 803 provides more 

specific guidance regarding the amount of information to be reported, the reports that must be 

maintained and the follow-up work that may need to occur in the event of a report. The 

guidelines under Part 803 arc different for manufacturers, importers and device user facilities. 

Put differently, there are already carefully crafted reporting requirements in place which strike 

the balance of ensuring that the right information is delivered at the right time. As mentioned 

above, many ISOs are already working with their clients, the device user facilities, to deliver this 

4 
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information to the FDA. We believe the current reporting framework is sufficiently 

comprehensive and appropriately tailored to require delivery of information that is most readily 

available to the reporting party. However, if it is determined that changes arc needed, we 

recommend that the legislation take into account existing reporting requirements in order to 

avoid redundancy. 

Finally, by adding "serviccrs" to the manufacturer and importer reporting requirements 

additional regulatory action will need to be taken to craft reporting requirements that identify the 

information JSOs must produce. Simply adding the term "servicers" into obligations intended for 

manufacturers creates an awkward and unintended construct and has the potential of creating 

more confusion when it becomes unclear as to where the JSOs' obligations end and the OEMs' 

responsibilities begin. Moreover, we strongly believe the result would be reporting requirements 

identical to those of the device user facilities, which would result in a surplus of duplicative 

infom1ation being provided to the FDA that only adds to the cost of the device user facilities and 

to our already overburdened health care system. 

TilE LEGISLATION COULD REDUCE COM!'ETI770N. 

TriMedx firmly believes a marketplace that encourages equipment owners, operators, their 

chosen service providers and OEMs to work openly and collaboratively to further advance 

quality outcomes and decrease costs is one that will present the best opportunity for 

optimization, innovation and continued advancements in the delivery of safe patient care. As 

noted herein, hospitals and the JSOs who act as their agents are subject to certain regulations 

designed to ensure that equipment is maintained in a manner that best facilitates the provision of 

high quality patient care and ensures patient safety. The registration and reporting requirements 

add another layer of administrative tasks and, consequently, costs that smaller ISOs may not be 

able to bear. Therefore, we arc concerned that 1-l.R. 2118 may have an adverse impact on a 

competitive marketplace. 

l'ROi'ISIOVS T!L1T REQUIRE A.\'[) PROMOTE COUABOR,1TION SHOULD BE ADDED. 

TriMedx believes a regulatory framework that promotes collaboration and information sharing 

between OEMs and ISOs would benefit healthcare providers, hospitals and patients. Since the 

Quality System Regulation rule was proposed in 1993, many OEMs have been unwilling to share 

servicing and maintenance procedures and methodologies with their customers. In fact, a 2013 

CMS memorandum on servicing and maintenance acknowledges that, "Hospitals may find that 

manufacturer's recommendations for some equipment are not available to them or their 

contractors ." At a meeting on November 6, 2012, relative to revising its position, CMS 

inquired, "It seems that manufacturers keep their manuals proprietary and do not share the 

information needed to maintain equipment. Whar happens in cases where no service manual is 

available for the equipment?" 

CMS's current position recognizes that OEMs generally do not provide this information to their 

customers, that it lacks the authority to compel the OEMs to provide such information and that, 

without such infonnation, a hcalthcare provider, hospital and their respective agents may not be 

able to comply with GEM-recommended maintenance schedules, procedures and specifications. 

TriMedx has also encountered OEMs that have precluded it or the hospital customer from 

purchasing supplies or parts needed for repairs unless the hospital entered into an OEM service 

5 
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agreement. These practices frustrate those customers' preferences, as they are ultimately 

prevented from implementing a comprehensive in-house program or purchasing the same 

services from independent third-party service providers. 

The end result is an increase in the overall cost of healthcare and a diversion of the healthcarc 

dollar that could otherwise be allocated to enhancing the patient experience, improving 

population health or serving the disadvantaged. The needs of our current hcalthcarc landscape 

demand that OEMs be required to work collaboratively with lSOs and their hospital customers. 

Indeed, if this legislation is truly intended to place the same requirements on lSOs as OEMs, then 

it is only fair that those OEMs who do not cooperate with qualified lSOs be required to provide 

the materials, tools and support necessary to ensure not only patient safety, but a [eve[ and 

competitive playing Jield. 

CONCLUSION. 

TriMedx is guided by the principle that patient care should be delivered in the safest, most 

effective and ctftcient way possible. While we will always support initiatives that are intended to 

improve the quality of patient care, we believe this legislation, as drafted, may be trying to solve 

a problem that has not properly been defined and would create additional and duplicative 

regulatory requirements without a clear and corresponding benefit to patient safety. Thus, we 

hope the concerns and recommendations set forth herein will receive your careful consideration. 

Thank you for the opportunity to provide this written testimony and we look forward to working 

with the Committee on these important issues. 

4852-2589-3447. v. 6 

6 
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Insights 

Notable rtews and smart solutions 

No More Suffering 

in Silence? 

loss is a widespread health 

with and even 

on solutlohs and what's 

to g1ve eyeryone access to treatment. 

by Julia Calde~one 

H£Ail!NB LOSS lNCHJ£NCE lN ONE 01:1 

<!OTH EARS !NCili;'.ASF.S AS WE AGE 
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Insights 

AGf}RELA1'ED HEARING Joss 

has long been thought of as an 

inevitable part of getting older 

and more a nuisance than a lite. 

alteTing medical condition -at 

least by those not experiencing 

it But that's all changing. In the 

past two years, the President's 

Council of Advisors on Science 

and Technology (PCAST) and the 

~ational Academy of Sciences 

{NAS) have published reports 

calling untreatC'd hearing loss 

a significant national health 

concern, one that's <~ssociated 

with other serious health 

problems, including depression 

and a decline in memory and 

concentration. Sever<~! studies 

suggest a link between hearing 

loss <lnd dementia. 

The estim<lted 48 million 

Americans affected by hearing 

impairment didn't need that 

memo. More than 100 years 

ago, Helen Keller, who was 

deaf and blind, described the 

isolation caused by hearing loss 

aptly when she said: "Blindness 

separates people from things. 

Now Hear This 

Deafness separates people 

from people." 

Lise Hamlin, director of 

public policy for the nonprofit 

Hearing Loss Associ<~tion 

of America (HLAA) echoes 

that sentiment: "We're social 

creatures. When you shut down 

the ability to talk and interact 

with people, that isolation 

affects your health and your 

ability to participate in society." 

Most sufferers, not so 

surprisingly, are older adults, 

Recent research shows that the 

number of people with hearing 

loss has declined slightly among 

Americans of working age, 

but continues to be a problem 

for seniors, affecting about 

28.6 mi!Jion Americans ages 60 

and above. 

Despite of the prevalence of 

hearing loss and the negative 

impact it can have on health 

and quality of life, relatively 

few people seek treatment. 

Almost half of the 131,669 

Consumer Reports subscribers 

surveyed for our 2015 Annual 

Where do you fa!! on the hearmg-!oss spectrum? 

There are two main types of 

hearing Joss. Sensorineural, 

the most common, is usually 

caused by the destruction of 

hair cells in the inner ear due 

to aging, heredity, certain 

drugs, loud noises, and nerve 

damage from illnesses like 

mumps. It's the type that most 

affects people over 60 and Is 

treated with hearing aids or 

cochlear implants, devices that 

send sound signals directly to 

the auditory nerve. Conductive 

hearing loss occurs when a 

physical block such as earwax 

Some 

advocacy 

groups 

say that 

hearing aids 

are more 

expensive 

than they 

should be 

and that 

cost is an 

obstacle to 

treatment. 

or a malformation stops sound 

from traveling through the ear 

canal. Removing the blockage 

usually restores hearing. 

Hearing loss is measured by 

degrees ranging from mild to 

profound. Although the only way 

to know for certain whether 

Mild Moderate Moderate/Severe Severe 

Difficulties hearing Trouble hearing Trouble understanding Inability to hear speech 

soft speech or quiet conversations amid group conversations atnormalor!oud 

conversations, background noise; or hearing sounds such volumes and sounds 

or sounds such as a inability to hear the hum as a running shower or such as a toilet flushing 

babbling brook. of a refrigerator motor. air conditioner. or a garbage disposal. 

16 

Fall Questionnaire reported 

having trouble hearing in 

noisy environments, yet only 

25 percent had their hearing 

checked in the previous year. 

And according to research 

published in the Archives 

of Internal Medicine,just 

14 percent of those who could 

benefit from hearing aids 

actually buy them. 

People don't seek help for 

several reasons, but one of 

the most common is that they 

can't afford it. Hearing aids, 

according to NAS, cost an 

average of$4,700 per pair in 

2013 and can dimb to almost 

twice that price. And they're 

usually not covered by health 

insurance or Medicare. 

No wonder the market for 

less expensive over-the·counter 

hearing helpers known as PSAPs 

(personal sound amplification 

products) is growing. 

We've dug deep to find out 

why the treatments for hearing 

loss are so costly and what's 

being done to bring solutions 

you have hearing impairmentand to what degree-is to 

see on audiologist or other 

hearing professional, the 

chart below can give you an 

idea of where you may fall on 

the scale. 

Prafound 

Difficulty hearing or tot a! 

inability to hear even 

the loudest of noises, 

such as a revving 

motorcycle engine. 
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26785.126

within reach. We also tested 

several PSAPs to determine 

whether they're an affordable 

alternative to hearing aids for 

llere'swhatwe 

Great Strides in Treating 

Hearing__hoss 

Though most of us take our 

hearing for granted until we 

begin to lose it, the ab!lit.Y to 

perceive and make sense of 

sound is a marveL In simple 

terms, sound waves travel 

through the air to the inner ear. 

There, microscopic hair cells 

convert them into electrical 

signals that are shuttled to 

the brain, which interprets 

them into meaningful sounds, 

language, music, and more. 

But a constellation of 

abnormalities in various 

parts oft he auditory system 

can cause this process to 

malfunction. For those who 

have mild to severe hearing 

problems (see "Now Hear 

This," on the facing page) such 

as difficulty understanding 

conversation in noisy 

restaurants or hearing a TV 

program at normal levels, 

hearing aids have traditionally 

been the solution. 

These prescription devices 

contain a microphone, which 

picks up and converts sound 

waves into electrical signaLs, and 

an amplifier, which makes the 

signals louder. The amplified 

sounds ar€ directed to the inner 

ear, where hair cells detect them 

and direct them to the brain. 

Worn in or behind the ear, 

hearing aids have come a long 

way since the handheld ear 

trumpets of the 19th century, 

particularly in the past 20 to 30 

years. Today's aids are smaller 

and, thanks to digitization, 

better at amplifying sound 

~1Jedfically in the frequencies 

where it's needed. Most aids can 

now be adjusted by wearers for 

a variety of environments, from 

quiet rooms to loud parties. 

Modern hearing aids are also 

better at reducing unpleasant 

feedback and background 

noise, and often have teleC"oi!s, 

small copper wires that improve 

sound clarity by picking it 

up directly from phones and 

public-address systems. At the 

higher end, hearing aids have 

features such as Bluetooth 

connectivity, allowing users to 

stream music and take phone 

calls through them. 

The result of this progress is 

that 4G percent of our survey 

n'spondents reported they 

were very or completely 

satisfied with their aids; only 

3 percent tried aids and found 

they didn't work. 

Despite the advances, 

compensating for hearing loss 

continues to he a challenge. For 

instance, experts say that even 

the most sophisticated devices 

can't fullv normalize impaired 

hearing. As Marvin M. Lipman, 

M.D., Consumer Reports' chief 

medical adviser, notes: "No 

hearing aid can match the 

efficiency and function oft he 

human ear. There's nothing like 

the real thing." 

Some people benefit more 

from hearing aids than others. 

"You can have two people with 

identical audiograms who have 

very difihent functionality," 

says Debara Tucci, M.D., a 

professor of otolaryngology at 

Duke Uniwrsity Medical Center, 

referring to a commonly used 

hearing test. 

Other impediments to 

treatment include people 

hearing negative experiences 

from friends or family 

members or being unaware 

they need help. 

Then there's the matter of 

image: Hearing aids are still 

sometimes viewed as a sign of 

faltering health. "There's much 

more of a stigma for wearing 

a hearing aid than there is for 

wearing glasses," says james 

C. Denneny !Il, M.D., who is 

CEO of the American Academy 

of Otolaryngology- Head and 

Neck Surgery. 

Priced Out of 

fl!.atment Opti~! 

But by far the biggest barrier to 

treatment is price. You can buy 

the newestsmartphone~a far 

Continued on poge 18 ) 

5 Ways to Save Money 

on Prescription Hearing Aids 

1.1nvestigate your 

coverage, Veterans, some 

children and federal 

workers, and residents of 

Arkansas, Connecticut, 

New Hampshire, and 

Rhode Island can 

get them covered by 

insurance. A few plans, 

Including some from 

Medicare Advantage, 

offer partial coverage or 

discounts. If you have a 

high-deductible insurance 

plan, you can put up 

to $3.400 in a health 

savings account to pay for 

aids with pretax dollars. 

With a flexible spending 

account, you can use 

up to $2,600 in pretax 

dollnrs for aids, batteries, 

and maintenance. 

2. Don't buy more hearing 

aid than you need. 

Skipping extras you won't 

use-such as Bluetooth 

copability-can slash your 

bill by hundreds of dollars. 

3. Ask fora price break. 

Almost half of the survey 

respondents who tried 

to negotiate received a 

lower price. 

4. Shop around. Costco, 

which was highly rated for 

customer satisfaction in 

our survey {see "Ratings of 

Hearing Aid Retailers", 

at right), offers no-cost 

screenings and hearing aids 

for about $500 to $1,500 

each, Only some stores have 

on-site audiologists or hearing 

specialists, so cal! ahead. 

Buying aids online can save 

you upward of $2,000 a pair, 

but you may need to mail 

them back for adjustments or 

pay a local specialist to do so. 

5. Check out groups that can 

help. Some government, 

state, and independent 

organizations such as the 

Uons Club may he!p you 

pay for hearing aids or offer 

discounts. {Go to asha.org.) 

READERS WEIGH IN ON HEARING AID RETAILERS 

Criteria include hearing evaluations, product options, 

staff courtesy, and follow-up adjustments. 

••n•- ConnectHear!ng ~ 

Cos teo 

Sam'10Ciub 

HearUSA 

Hearing Planet 

Audibel 

Mirada-Ear 

Bottone 

Zounds Store 

Starkey Store 

17 
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26785.127

Insights 

more complex device than any 

hearing aid, for less than $1,000 

dollars, But hearing aids cost 

$3,300 to $8,000 per pair~and 

prices continue to rise. 

Groups such as l\'AS and 

PCAST say that hearing aids 

are more expensive than th('y 

should be. The PCAST report 

cites a 2010 study that found 

that the cost of hearing aid 

components could be purchased 

for Jess than $100. 

But many of the professionals 

who sell hearing- aids, most of 

whom are audiologists with 

doctoral degrees, note that 

the price also covers many 

services. These include hearing 

tests, assessments to determine 

\"lhich device is best and which 

features are needed most, 

fittings, and follow-up. As Todd 

Ricketts, Ph.D., director of 

graduate studies in hearing and 

speech sciences at Vanderbilt 

University Medical Center, 

explains, evaluating people 

and then making adjustments 

to ensure that their hearing 

aids works as well as possible is 

exacting and time-consuming. 

But "bundling" the price of 

the product with services this 

way makes it more difficult for 

people to know exactly what 

they're paying for. According to 

a recent l'iAS report, the lack 

of transparency with bundling 

also forces consumers to pay 

for services they don•t actually 

need. (See "5 Ways to Save 

Money on Prescription Hearing 

Aids," on page 17, for tips on 

unbundling.) 

What's more, neither 

:-,..tedkare nor a majority of 

commercial insurance plans,-

which often follow Medicare's 

lead~generally cover the cost. 

Nor do they offer coverage for 

an additional fee, as many plans 

do with dental and vision care. 

Given the established link 

between hearing loss and other 

serious health problems, why 

don't insurers or Medicare pay 

for hearing aids? 

"l don't know why we don't 

cover the cost of hearing aids," 

said a spokesman for Aetna, 

Matthew Clyburn, when we 

asked. "Medicare doesn't 

1B 

cover them either, so it doesn·t 

seem to be highly out of the 

ordinary," he added. 

When we requested an 

interview with a representative 

from Medicare, a spokeswoman 

sent an email explaining that 

she couldn't address why 

hearing aids are excluded from 

Medicare coverage. And she 

suggested that we refer to the 

Congressional Record of 1965· 

the year that Medicare was 

signed into \aw··for an answer. 

Likely reasons for the 

exclusion of hearing aids 

when Medicare was created 

are that they were far more 

affordable at that time, the 

industry was poorly regulated. 

and hearing loss was not yet 

viewed as a significant health 

concern. As Kim Cavitt, Au. D., 

an audiologist and adjunct 

lecturer at Northwestern 

l:"niversity, says, "You don't die 

from hearing loss." 

But the continued lack of 

Medicare and health insurance 

coverage has not gone 

unnoticed by certain members 

of Congress, who are pushing 

to make hearing aids more 

affordable and easily available. 

"We know now that 

70 percent of all SE'niors 

between the ages of65 and 

84 who need a hearing aid 

simply do not get one because 

they can't afford it," says Rep. 

Debbie Dingell, D-Mkh., who 

introduced a bill in 2015 that 

would require Medicare to pay 

for hearing aids. "People with 

untreated hearing loss arc cut 

off from their communities," 

she said. "Thlcy feel isolated 

and depressed. We must get 

agreement in Congress that 

people need to hear." 

Dingell's blll failed to find 

traction in 2015, but she says 

she plans to reintroduce 

it this year. !n December, 

Senators Elizabeth Warren, 

0-:'vtass., and Chuck Grassley, 

R-Iowa, introduced legislation 

that would make ~imple, 

more affordable hearing 

aids easier for consumers to 

obtain by allowing them to 

Continued on page 20 ) 

Are OTC Hearing 

Helpers Any Good? 

PERSONALS SOUND 

amplification products, or 

PSAPs, cost a fraction of the 

price of the average hearing 

aid. The most expensive 

ones are about $500 each. 

Prescription aids generally 

start at about $1,660 each, 

including fees for the 

services of an audiologist 

or hearing-aid specialist. 

(Some less expensive 

prescription aids are 

available online and through 

retailers such as Costco,) 

The Food and Drug 

Administration currently 

doesn't allow PSAPs to 

be marketed as devices 

to improve impaired 

hearing. But the National 

Academy of Sciences and 

the President's Council 

of Advisors on Science 

and Technology have 

recently said that PSAPs 

can help some people with 

mild to moderate hearing 

impairment. Both groups are 

calling for the FDA to allow 

PSAPs to be marketed as a 

way to address hearing loss. 

To find out whether 

these hearing-aid looko!ikes can help people 

with hearing loss, we had 

three CR employees who 

were diagnosed with 

mild to moderate hearing 

impairment try four PSAPs 

(from $20 to $350) for three 

to seven days at the office, 

at home, in restaurants, and 

in our audio labs, where we 

tested how well they could 

he!p pick out words in a 

noisy environment. For an 

expert opinion, we had a 

hearing·aid researcher test 

each PSAP in areas such as 

amplification, battery and 

microphone function, and 

sound distortion. 

We found that some 

PSAPs, if properly fit and 

adjusted. can help people 

with mild to moderate 

hearing loss (see "Degrees 

of Hearing Loss," on page 

16). As with prescription 

hearing aids, PSAPs aren't 

one·size-fits-aH, so it's 

best to have a professional 

hearing test first and 

to consider asking an 

audiologist or hearing-aid 

specialist for guidance in 

determining which device 

might be best for you. 

When Pinching Pennies 

Can Hurt You 

Our PSAP evaluations 

included two very 

inexpensive models-the 

Bell & Howell Sliver Sonic XL 

and the MSA 30X- priced 

at $20 to $30 each. These 

devices showed very little 

benefit in any of our tests, 

and sometimes actually 

blocked incoming sounds 

the way earplugs do. 

Even more concerning: 

Our hearing expert says 

these devices have the 

potential to cause additional 

hearing damage by 

overamplifying sharp noises, 

such as the wail of a fire 

engine. 

Our expert recommends 

avoiding very inexpensive 

models, which are generally 

in the $10 to $30 range, 

They don't seem to help 

much, if at all, and could 

actually further diminish 

your ability to hear. 
183 


26785.128

Conversation Piece 

SoundWorld Solutions CS50+ 

$350 

This rechargeable device 

offers some background 

noise reduction; settings for 

entertainment, everyday, and 

restaurant environments; and 

Bluetooth capability. It can be 

customized with a smartphone 

app to amplify the frequencies 

a user needs most. 

Tuned Into TV 

Etymotic Bean (no T~Coil) 

$299 ($550 if purchased 

osopo1r) 

An in-ear device that runs 

on disposable batteries that 

last about one to two weeks, 

the Etymotic Bean has an 

omnidirectional microphone 

that picks up sounds around the 

wearer. A toggle switch controls 

volume levels. 

WHATWELIKED WHATWEDIDN'TLIKE OUROEVICEADVICE 

Panelists found it comfortable The CSSO+ didn't help wearers The CSSO+ could be of use to 

and easy to use; two out of 

three felt it improved their 

ability to hear a TV and 

conversations. Our expert 

noted that it's the only PSAP 

we tested that allowed them 

to tweak settings to amplify 

sounds in the frequencies 

where they have the most 

trouble hearing, a feature 

similar to what you'd find 

in a basic hearing aid. The 

directional microphone can 

pick up sounds in front of the 

user, making it easier to hear 

conversations in noisy places 

like a crowded restaurant. 

Panelists also found it useful to 

be able to palr this PSAP with 

smart devices via Bluetooth, 

which allowed them to take 

phone calls and stream music 

while wearing it. 

WHATWE'LI.KE'D 

Panelists found the Etymotic 

Bean easy to use and 

inconspicuous; they reported 

that it improved their ability 

to hear a television. Our expert 

liked that it requires no initial 

adjustments, is ready to use 

right out of the box, and 

that-unlike less expensive 

devices-it protects against 

overamplification of sharp 

sounds, which could damage 

hearing. 

decipher conversations in 

the noisy environment we 

created in our lab, One panelist 

felt it minimally improved 

hearing but found it useful for 

streaming music, Our expert 

noted that none of the threEJ 

panelists was able to adjust 

the customizab!e settings to 

optimally compensate for their 

hearing loss. 

WHAT WE DIDN'T LIKE 

The Etymotic Bean didn't 

help wearers decipher 

conversations in the noisy 

environment we created in our 

lab. Panelists reported that the 

device squeals unpleasantly 

until it's placed firmly in the 

ear, and that it can turn on 

when stored in the case, 

draining the battery. Our 

expert says that the shallow 

tip could lead to a blocked 

or stuffy feeling in the ear. 

He also noted that the small 

parts may be challenging to 

manipulate and that the device 

doesn't amplify sounds in the 

lower pitches, such as vowel 

sounds like the letter "o~ in the 

word "pot. 

people with early or mild to 

moderate hearing loss. The 

customizable settings and 

smartphone connectivity mean 

the device can potentially work 

as well as a simple hearing 

aid for some people, though 

only if fit and settings are 

adjusted correctly_ The device 

protects your ears by limiting 

overamplification of sharp, 

hearing-damtlging sounds, 

suchasawailingfireengine, 

though not as much as the Bean 

(below). 

OUR DEVICE ADVICE' 

The Etymotlc Bean can be 

helpful for those with early 

or mild to moderate hearing 

loss in the higher frequencies. 

But it probably won't amplify 

sound enough if your hearing 

loss is in the !ow frequencies 

(think bass drum) or extremely 

high frequencies (the whine 

of a mosquito). Although it 

doesn't reduce background 

noise, placing the device in 

the ear properly may block out 

some unwanted sounds. 

19 
184 


26785.129

Insights 

"We be sold oveN he-counter and 

eliminating the requirement 

that people have a medical 

exam or sign a waiver before 

purchasing them. And the 

Food and Drug Administration 

recently announced that 

it would no longer enforce 

the medical exam or waiver 

requirement. 

Affordable Over-theCQ~c;ns--

Given the high cost of hearing 

aids, it's no surprise that we're 

seeing a growing array ofless 

expensive OTC products, such 

as wireless headphones for 

TV watching and phone apps 

that amplify sound. But PSAPs, 

which range from about $10 

outdoor spaces or movie 

theaters-or none at all. Ami 

unlike a majority of hearing 

aids, PSAPs are generally 

analog, not digital, so they're 

usually less able to rE"duce 

annoying feedback and they 

consistently target only the 

frequencies in which users really 

need amplification. "That's a 

big difference," says Cavitt, 

who co-authored a 2016 study 

comparing PSAPs with hearing 

aids. "When tht> sound comes 

in, does it merely amplify it, or 

can it also suppress fE"edback or 

extraneous noise?" . 

That may be challenging 

for consumers to figure out. 

PSAPs aren't regulated by 

must get 

agreement 

in Congress 

that people 

need to 

hear," says 

Rep. Debbie 

Dingell, 

D-Mich. 

staff officer for audiology at the 

American Speech·Languageliearing Association (ASHA). 

Experts agree that people 

who already have moderate 

to severe hearing Joss won't 

benefit from PSAPs. To see 

how well they work for those 

wlth mild to moderate hearing 

loss, Consumer Reports had 

three volunteers who fit that 

definition test four devices 

(see "Are OTC Hearing Helpers 

Any Good?, on page 18). We 

found that the higher·end 

PSAPs helped our volunteers 

hear better, especially while 

watching TV. 

Ricketts urges consumers 

to see a hearing professional to 

determine their level of hearing 

loss and which ranges need 

amplification most. (A hearing 

specialist can also diagnose 

more easily remedied issues 

such as earwax buildup or 

to $500 each, arc the most 

common OTC option. 

They sit in or behind the ear 

and contain some of the same 

components as hearing aids: 

a receiver, a microphone, and 

an amplifier. In theory, they 

should boost the volume of 

the sounds you have trouble 

hearing. And depending on 

the device, thev should reduce 

background n~ise, just as many 

prescription hearing aids can. 

Most PSAPs are fairly basic, 

offering few adjustments for 

varied environments ··say, 

the FDA as hearing aids are, 

and manufacturers aren't 

permitted to call them 

hearing aids or claim that they 

improve impaired hearing. 

(In fact, according to the FDA, 

the devices art>n't meant 

for those with hearing loss 

but are "intended for nonhearing impaired consumers 

to amplify sounds in certain 

environments.") 

And because PSAPS are so 

loosely regulated, consumers 

have no way of knowing whether 

one is better than another, 

says Neil DiSarno, Ph.D., chief 

more serious prohlems such as 

ear-canal tumors.) Audiologists 

usually don't sell PSAPs or 

adjust those that consumers 

huy on their own, although 

this might soon be changing. 

"Even if PSAPs are not perfect," 

Denneny says, "they may gi\'e 

people a relatively simple entry 

point into the healthcare system 

at a markedly reduced cost. 

- - - - -

~i._J1i~~7 -_ ~ - _- - -

20 

Jijl ~~:~;~~~~::~~:blade-used W for cutting, chopping, and dicing-

,' , on about 8 mlllion Cuisinart food 

.....,.. processors has been recalled because 

it can crack and break over time. There have 

been 69 reports from consumers who found 

small metal pieces from a cracked blade in their 

food; in 30 cases, they suffered cuts to the 

mouth or tooth injuries. The processors wem 

sold online and at stores from July 1996 through 

December 2015. 

What to do Stop using the blnde immediately 

and contact Cuisinart at 877-339·2534 or go to 

cu1sinart.com to get a free replacement blade. 

You can still use the processor with its other 

attachments. 

SMOKE/CO ALARMS 

Ill Kidde is recalling about 3.6 rni!llon 

NightHawk combination smoke/CO 

alarms. Once the backup batteries 

are replaced, the units can fail to chirp when 

they reach their seven-year end of Hfe, which 

may lead users to think they're still working. 

That means that consumers may have no alert 

during a fire or CO incident The alarms were 

sold online and at electrical distributors and 

home centers nationwide from June 2004 

through December 2010. 

What to do Rep!sce the alnrm, Contact Kidde 

at 855·239·0490 or go to kidde.com for 

a free replacement alarm or a discount on a 

new alarm. 

DEHUMIDIFIERS 

The manufacturers Gree and Midea 

are reca\!lng about 5.9 mH!ion 

dehumidifiers because they can 

overheat, smoke, and catch fire, posing 

serious fire and burn hazards. Mldea is 

recalling 51 brands sold at stores nationwide 

from January 2003 through December 

2013. Gree is recalling 13 brands sold online 

and at stores from January 2005 through 

August2013. 

What to do Stop using the appliance. Go to 

midea.comjus/ or greedehumldifierrecal!.com 

for details on affected brands and mode! 

names. Call Gree at 866·853·2802 fat a 

full refund or Midea. at 800·600·3055 for a 

replacement or partial refund. 
185 


26785.130

Written Testimony of the 

International Hearing Society 

To the House Energy and Commerce Subcommittee on Health 

In Opposition to 

H.R. 1652, the Over-the-Counter Hearing Aid Act of 2017 

May 2, 2017 

Dear Chairman Burgess, Ranking Member Green, and Members: 

Thank you for the opportunity to provide comments on II.R. 1652. the Over-the-Counter Hearing Aid 

Act. The International Hearing Society (IHS) commends the Subcommittee and sponsors of the 

legislation for their interest in hearing health care issues, including exploring options for expanding 

access to those individuals who could benefit from the use of hearing aids but arc not yet using them. 

As an association that represents hearing aid dispensing professionals, our members see the positive 

impact that hearing aid use and aural rehabilitation has on their patients, including their overall health 

and improved function in their daily lives and relationships. IHS supports the ultimate goal at stake here 

of increasing competition and reducing cost. 

Respectfully, our society must stand in opposition to H.R. 1652, the Over-the-Counter Hearing Aid Act 

of 2017. We take this position due to concerns that individuals arc not able to accurately self-diagnose 

and self-treat their hearing impairment and there being a lack of associated evidence to the contrary; that 

federal preemption of stale licensing laws will lead to an unregulated distribution market that will in turn 

lead to poor satisfaction, poor adoption, and patient harm; and the absence of professional involvement 

at any point during the process of over the counter (OTC) hearing aid acquisition, as proposed, 

compromise consumer safety and efficacy. 

There is also ample evidence that recent innovations in the delivery of care, technology, and access arc 

already moving the needle in the direction of greater acceptance of hearing aids while adhering to the 

reasonable and limited regulatory standards that exist today. Panelists at the Federal Trade Commission 

workshop held April IS'h discussed these advancements at length. Just two weeks ago, CVS announced 

an expansion into the hearing healthcare delivery system through the establishment of hearing aid 

centers into 50 of its clinics and future clinic model. 

The FDA Safety & Effectiveness Standards for OTC Products dictate that OTC products must meet the 

"same standards as prescription drugs, and consumers must be able to I) self-diagnose, 2) self-treat, and 

3) self-manage [the condition], which can be assessed through label comprehension studies and actual 

usc studies."' As you may know, the recommendation for OTC hearing aids originated from the 

President's Council of Advisors on Science and Technology (PCAST) and the National Academies of 

Science, Engineering, and Medicine (NASEM). However, in public forums, representatives of these 

groups have stated that their recommendations were made on the presumption that individuals are able 

to self-diagnose, self-treat, and self-manage their loss. OTC hearing aids do not pass the litmus test, and 
186 


26785.131

consistent with FDA standards, it is IHS's position that any movement to create such a category must be 

predicated on the production of validated evidence that a consumer can reliably self-diagnose, self-treat, 

and self-manage his/her hearing loss. To date, the evidence contradicts this goal. A recent study- the 

first of its kind- conducted by AZ Marketing Research for Amplifon found that of individuals who had 

self-perceived mild or moderate hearing loss: only I in 4 individuals correctly assessed their hearing 

loss, 13% had an FDA Red flag (condition requiring medical referral), 10% had no hearing loss, 3 7% 

had a more severe loss than what they self-reported, and 20% sclf-sclcctcd a hearing device (online 

hearing aid or personal sound amplifier) with an output above safe levels (l20db+)." further, a selfdiagnosis goes beyond just assessing the degree and type of hearing loss. Hearing loss is a symptom of 

an underlying medical or functional disorder. for example, someone with the symptom of hearing loss 

may have the diagnosis of a cholesteatoma, bilateral age-related hearing loss, impacted cerumen, an ear 

infection, otosclerosis, or a variety of other conditions. A self-administered pure-tone hearing test alone 

cannot provide a proper diagnosis, nor are individuals capable of reliably self-diagnosing the reason why 

they may be experiencing a hearing loss. 

As proposed by H.R. 1652, a reliance on individuals' self-diagnosing and self-treating their "perceived" 

hearing loss is likely to result in their purchasing hearing aids unnecessarily or when they may have an 

underlying medical condition (thereby delaying care), or purchasing the wrong hearing aid for their loss. 

The physiology (and psychology) of hearing loss is unique to each individual. The proper evaluation of 

hearing loss involves several important tests to include a patient history and audiometry, as well as the 

identification of possible related medical conditions, speech testing, and an otoscopic evaluation each 

of which require, by necessity, the involvement of a licensed professional. If hearing aids are 

appropriate, optimal outcomes depend upon the proper fit of the hearing aid, aural rehabilitation 

(counseling), and ongoing follow-up care. Consider this- according to a survey conducted by !HS in 

2015 of hearing aid dispensing professionals, the average new hearing aid patient has at least five 

appointments with their provider within the first year. This demonstrates the level of professional 

attention necessary to achieve a satisfactory result. 

The alternative- creating an over the counter hearing aid classification- would most certainly lead to 

patient harm and poor outcomes for the thousands, or perhaps millions, of individuals seeking hearing 

aids. And perhaps equally as concerning, these poor outcomes will lead to the widespread lowering of 

hearing aid adoption rates and use. We have seen this happen in Asian markets like in Japan where 

professional intervention is minimal and hearing aids are widely available over the counter. Japan has a 

39% satisfaction rate (compared to 81% in the US) and a 14.1% adoption rate (compared to 30.2% in the 

US). Interestingly, at the same time the U.S. is considering lowering its standards, the International 

Organization for Standardization is looking to establish a Hearing Aid Fitting Management standard 

based on the U.S. model, which is considered the gold standard for safe and effective care. This work 

comes as the result of a request from South Korea, which lacks professional standards and consequently 

has low adoption and satisfaction rates. 

In our increasingly socially-connected world, we know more about the experiences and opinions of our 

personal network (friends and family) than ever. According to the American Express Global Customer 

Service Barometer survey conducted in 2014, "When it comes to poor customer service experiences, 

nearly all (95%) consumers talk about them, with 60% reporting that they talk about these experiences 

all of the time. On average, consumers tell 8 people about their good experiences, and over twice as 

2 
187 


26785.132

many people (21) about their bad experiences." These statistics don't bode well for the concept of an 

OTC hearing aid market since we know that satisfaction and hearing aid use is tied to the involvement of 

the licensed provider and use of best practices."' 

Il-lS understands the intention of the legislation is to not bind a consumer to a licensed practitioner in the 

purchase of a device. However, we see the potential for many unintended harmful patient outcomes 

under the proposed model beyond just the implications described above. Specifically, the federal 

preemption of slate licensing laws will lead to the natural development of an incompetent and 

unlicensed group of individuals opening up shop to sell, customize, and service individuals who have 

purchased OTC hearing aids from another source. It is presently a common occurrence that a consumer 

will take an internet hearing aid or personal sound amplifier to a hearing aid specialist or audiologist for 

assistance. The public will have no understanding of the difference between a licensed and non-licensed 

provider, and will undoubtedly be harmed by the lack of competency and standards, as well as sales 

tactics that come along with unregulated providers. At a meeting of the Hearing Industries Association 

in March 2017, Dr. Dan Blazer, co-chair of the NASEM Committee on Hearing Health Care for Adults 

expressed to an IHS representative that the intention of the committee's recommendation was not to 

create an unlicensed class of providers, yet H.R. 1652 would do just that. As a result, not only is the 

consumer at risk of receiving inappropriate, unsafe, and/or unethical care through an unscrupulous, 

incompetent, and unlicensed provider, but poor outcomes will erode consumer trust and create negative 

perceptions of hearing aid providers and hearing aids. 

In 1986, the State of Colorado determined that the regulation of audiologists and hearing aid specialists 

was no longer needed because of a lack of complaints by consumers and subsequently eliminated 

professional licensure and all standards that went along with licensure. This action essentially created 

an OTC hearing aid marketplace in the state. The result of unregulated hearing aid sales spoke for itself. 

Within months unscrupulous, untrained, unlicensed, and incapable would-be sales people flocked to the 

state. These were people who could not get licensed previously or had their licenses revoked either in 

Colorado or in other states, or who were merely trying to make a quick dollar. They would open 

storefronts or operate out of their vehicles, but when a client needed services, they would often 

disappear. Many would hold seminars for the public promising phenomenal results, taking money from 

those in need, and not deliver on their promises. People with hearing loss, including the elderly, were 

hurt in these transactions both financially and psychologically, and the recovery, once licensure was 

reinstated, took several years. In its 1999 Sunset Review, the Colorado Department of Regulatory 

Agencies Office of Policy and Research stated, ''This sunset review found that there is significant actual 

public harm by the unregulated practice of hearing aid sales," and as a result the department 

recommended continued regulation of hearing aid dealers."·' This is in spite of the fact that during the 

deregulation period- from 1986 through 1995 -the regulation of hearing aid sales had been governed by 

the state's Consumer Protection Act. Even with state oversight, licensure of those dispensing hearing 

aids was still deemed necessary. 

The concept of reestablishing this model across the country, and with our most vulnerable population as 

the target, is of significant concern. Federal and state regulations governing who can dispense hearing 

aids and requirements associated with the sale are a necessary safeguard and must be maintained in 

order to prevent the widespread abuse and mistrust that would inevitably arise out of the establishment 

of an OTC hearing aid classification. Not to mention the lack of state-based consumer protections that 

3 
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would no longer be afforded the patient who purchases an over the counter hearing aid. The mistakes 

corrected after Colorado's failed experiment should not be repeated on a nationwide scale. 

Over time, the hearing aid dispensing community has worked diligently to improve patient satisfaction 

and acceptance of hearing aids as a solution, and most importantly build trust within their communities 

and with prospective and existing patients. Their efforts are reflected in the current satisfaction rates for 

hearing care providers (hearing aid specialists and audiologists). J\ recent study shows that 95% of 

owners and 87% of non-owners are satisfied with the health care providers they have seen in the last five 

years. The same study shows that satisfaction with hearing aids is high as well, with satisfaction at 

''91% for hearing aids obtained in the last year; 77% for hearing aids obtained 2-5 years ago; and 74% 

for hearing aids obtained 6 or more years ago." The overall satisfaction rate is at 81%.''' Comparatively, 

cellular telephone companies' (oftentimes affiliated with consumer electronics) satisfaction rates are on 

average 79%, with a maximum satisfaction rate of 81% in 2016."' The aforementioned efforts by the 

hearing care provider community to build trust and a respected reputation is critical because of an 

overall wariness by individuals with hearing loss to obtain hearing aids due to stigma, vanity, and denial. 

Stigma being the number one reason that people choose not to seck out hearing aids is a difficult 

challenge, but !l-IS believes that other recommendations made by the NASEM to include increasing 

consumer education and awareness and engage primary care physicians can help move the needle in a 

positive way. 

While the eyeglass analogy tends to be used in comparison to hearing aids- truly an apples and oranges 

comparison in terms of the complexity in identification, physiological and medical implications, and 

treatment of hearing loss- the regulation and delivery of eyeglasses and contacts can serve as a useful 

model for drawing the line between expanded competition and the overall lowering of cost, and patient 

safety. The current model allows for individuals to purchase eyeglasses and contacts from online and 

other retailers if they have a prescription from a licensed ophthalmologist or optometrist within the 

previous six months. This model ensures that the eyeglasses or contacts are appropriate for the 

patient/consumer, yet still allows for them to investigate the delivery model that will best meet their 

needs and shop around. If hearing aids were to be sold direct to the consumer, building in a requirement 

that the consumer obtain an order from a licensed professional within the previous six months that 

affirms the individual has had an audiometric evaluation and visual inspection of the ear, has mild to 

moderate hearing loss, and could benetit from the use of a hearing aid, coupled with FDA regulations 

governing the safety of the devices, would minimize patient safety and efficacy concerns. This model 

would create an informed consumer who could then explore all the options available to him/her, which 

would be a better alternative than the complete elimination of the hearing care provider in the process. 

further, most hearing aid providers offer free hearing screenings, so this requirement would not add a 

cost barrier. 

It is for the aforementioned reasons that the International Hearing Society opposes H.R. I652 in its 

current form. HIS believes the creation of an FDA-approved classification of OTC hearing aids should 

only be considered following a comprehensive actual use study to validate whether individuals can 

reliably self-diagnose, selt~trcat and self-manage their hearing loss. lfthey cannot, such study should 

determine which mechanisms must be put into place to ensure safe and effective care, such as having an 

in-person hearing evaluation from a licensed provider (a hearing aid specialist, audiologist, or physician, 

preferably an otolaryngologist) within six months of' purchasing a device over the counter. This model 

4 
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26785.134

will enable consumers to be informed consumers and make a decision on which treatment model they 

prefer once they fully understand their hearing loss and options. Finally, we would ask for a resolution 

to our concerns with full federal preemption of state licensing laws related to OTC hearing aids so that 

consumers can be assured that individuals who dispense, fit and modify OTC hearing aids are 

competent, held to an accepted standard, and that protections exist if they arc harmed. Therefore, IHS 

respectfully asks that you delay further consideration of 1-l.R. 1652 until the studies arc completed and 

the appropriate model based on evidence be determined. Alternatively, IHS would be pleased to offer 

amendment language for the subcommittee's consideration. 

IHS respectfully also suggests time be given to sec through new initiatives that arc being undertaken 

within the hearing healthcarc field and marketplace, each of which can have a profound impact on 

hearing aid adoption rates before seeking to take the extreme step of legislating an over the counter 

hearing aid category. These initiatives, for which agreement was made at the December 2016 NASEM 

meeting to move forward, include a public awareness campaign, outreach to the medical community to 

promote hearing loss as an important health care issue, the establishment of standards for hearing aid 

outcomes and metrics for patients to use to assess their hearing ability, and creating consensus standards 

for community-based service providers. These are in addition to the other NASEM recommendations 

that are being implemented by individual organizations just as we are doing at IHS. Fortunately, hearing 

aid use, outcomes, and accessibility are presently on a positive trajectory. It would be a detriment to 

overall healthcare outcomes to place this positive momentum at risk at this time. 

Thank you for your consideration. With questions or to discuss further, please contact IHS Government 

Affairs Director Alissa Parady at 734.522.7200 or aparady@ihsinfo.org. 

Founded in 1951, the International Hearing Society represents hearing aid dispensing professionals 

worldwide, including dispensing audiologists, dispensing physicians, and the approximately 9,000 

hearing aid specialists licensed in the U.S. presently. Hearing aid specialists dispense and provide 

professional services to approximately half of the non-VA hearing aid market, operate in both urban and 

rural areas, and often perform nursing home and home visits delivering care to those in need, including 

those in remote locations. II IS promotes and maintains the highest possible standards for its members in 

the best interests ofthc hearing-impaired population they serve by conducting programs in competency 

accreditation, testing, education and training, and encourages continued growth and education for its 

members through advanced certification programs. 

1 https :/ /www .fda. gov I down loads/aboutfdafcentersoffices/cder/ucm 14805 5 .pdf 11 http://www .hearingrev iew .com/20 16/ 12/imolications-counter -approach-hcaring-healthcare-consumer-study/ 

~'' ''tvtarkeTrak VIII: The Impact of the Hearing Healthcare Professional on Hearing Aid User Success: Correlations between 

dispensing protocols and successful patient outcomes." Hearing Review, April2010. 1

" http://hermes.cde.state.co.us/drupal/islandoralobject/co%3A4646 

\'Also known as hearing aid specialists, hearing instrument specialists. hearing aid dispensers. and hearing aid fitters. 

"' http://www .heari ngreview .com/20 15/05/introduction~ marketrak ~ix ~new~baseli ne-hearing-ai d-market/ 

http://www. theacsi.org/i ndex. php?option=com contcnt&view=artic le& id-"" 14 7 &catid=&Itemid'-"'212&i=Cellu Jar+ Telephones 
190 


26785.135

American Speech-Language-Hearing A~sociation 

Statement for the Record for the Health Subcommittee of the 

Energy and Commerce Committee 

Regarding Over-the-Counter Hearing Aids (H.R. 1652) 

While the American Speech-Language-Hearing Association (ASHA) continues to maintain that the 

best model of hearing health care features audiologists and consumers collaborating on treatment 

options, it recognizes instances where that model can be modified. There may he advantages to 

making hearing aids directly available to some consumers with mild hearing loss. Less costly overthe-counter (OTC) hearing aids could serve as an early gateway for users with mild hearing loss to 

explore whether they could eventually adapt to hearing technology without significant financial 

outlay. It is already the case that consumers with perceived mild hearing loss can seek amplification 

on their own, without professional involvement, by purchasing unregulated personal sound 

amplification products or other products and devices that arc indirectly marketed for hearing loss. 

ASHA recommends the following changes H.R. 1652: 

restrict OTC hearing aids to mild hearing loss; 

establish safe levels of gain and output (power) for these hearing aids; 

ensure that OTC hearing aids arc only available for adults; 

establish a means for collecting information on consumer safety and other potential complaints; 

require labeling that strongly recommends seeking audio logic diagnostic and rehabilitative 

services; and 

require labels that provide consumers with warning signs for conditions that require medical 

treatment. 

Furthermore, ASHA strongly encourages the Subcommittee to take a more holistic approach to 

access to and affordability of hearing aids. A parallel effort must be undetiaken to ensure the 

establishment of both public and private insurance coverage for patients with hearing loss who do not 

benefit from OTC hearing aids. These additional categories of services would include coverage of the 

professional auditory rehabilitation services of an audiologist that would allow a person with hearing 

loss to maximize their communication abilities with ampliiication. Without meaningful coverage of 

all hearing health care services for all individuals with hearing loss, there is a high probability that 

these individuals \viii inappropriately self-prescribe OTC hearing aids and fail to receive appropriate 

care; thereby, not achieving the sufficient benefit from OTC hearing aids. 

ASHA suppm1s effot1s by Congressman Gus Bilirakis related to Medicare coverage of professional 

services provided by an audiologist, and is working with him and his staff for reintroduction of this 

legislation in this Congress. We urge the Subcommittee to consider and pass this legislation, which 

would allow Medicare beneficiaries to receive coverage of these important hearing health care 

services. 

We respectfully request that the Subcommittee move cautiously forward. !!caring loss is permanent, 

and over-amplification can cause further damage to the ear and greater degrees of hearing loss. 

Conversely, under-amplification may cause the consumer to become frustrated and leave their 

hearing problems untreated. Therefore, inappropriately chosen OTC hearing aids present a significant 

health risk to individuals. By limiting the legislation to mild hearing loss and requiring data 

collection on consumer safety and complaints, the U.S. Food and Drug Administration (FDA) can 

2.200 RJ-:ShARL'fl BOULEVARD • ROCKVILLE. MARYJ.J\ND 20850-3289 • 301-296-5700 VOICE OR TTY • www asha.org 
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26785.136

ASHA Statement 

Page 2 

better assess both the positive and negative implications of a "do-it-yourself' model for hearing 

health care. 

Background 

Hearing loss is a medical condition that can be categorized by which part of the auditory system is 

damaged. There are three types of hearing loss: conductive, sensorineural and mixed. Some 

conductive loss can be corrected by medical or surgical intervention and include such conditions as a 

build-up of wax in the ear, ear infections, or a perforated eardrum. Sensorineural hearing loss 

involves damage to the inner car or a nerve pathway from the inner ear to the brain. This type of 

hearing loss cannot be medically or surgically corrected, and is the most common type of pennanent 

hearing loss. Sensorineural loss can occur through aging, illness, head trauma, or exposure to loud 

nose. An individual can experience both conductive and sensorineural hearing loss at the same time, 

which is referred to as mixed hearing loss. 

Individuals cannot self-diagnose the cause or the magnitude of their hearing loss nor can they selftreat the hearing disability that results from hearing loss. Access to devices used to treat moderate to 

profound hearing loss should remain under FDA regulation, and access to necessary professional 

services should not be eliminated for these individuals through a "do-it-yourself" OTC option. 

Individualized treatment and counseling arc necessary to most effectively address the multi-faceted 

and disabling effects of this chronic health condition. Given that hearing loss is a medical condition 

with the potential for other health implications, it stands to reason that medical devices that are 

intended to treat moderate to profound hearing loss should be made available only after an evaluation 

and consultation with an audiologist. 

Hearing aids are not analogous to OTC reading glasses. They are more analogous to contact lenses. 

Much like an individual would not place contacts in their eyes without the appropriate prescription, 

one should not usc hearing aids without first understanding the magnitude of their hearing loss and, 

patiicularly, the difficulties related to understanding speech in background noise, which can only be 

addressed through a professional audio logic evaluation. Those in favor ofOTC hearing aids believe 

that a device alone can ameliorate hearing loss. This is far from the truth. A device alone cannot and 

docs not address the hearing health care needs of a consumer. Without professional involvement, 

consumers run the risk of either exacerbating their condition with over-amplification or becoming 

frustrated with the device due to under-amplification, which may result in a decision to not seek 

further professional care for their hearing loss. Both pose serious health and safety risks to the 

consumer. 

While the legislation being considered is intended for adults, there are no safeguards in the 

legislation to ensure that children do not have access to OTC hearing aids. It is imperative that 

OTC hearing aids should not be permitted for children. Children treated with these devices are at 

risk for severe complications due to untreated ear disease; inadequate amplification leading to 

severe, permanent, and disabling language impairment; as well as additional hearing loss due to 

inappropriate levels of amplification. The effects of hearing loss on children are far greater than those 

of adults. 

The American Speech-Language-Hearing Association (ASHA) is the national professional, 

scientific, and credentialing association for 191,500 members and affiliates who are audiologists; 

speech-language pathologists; speech, language, and hearing scientists; audiology and speechlanguage pathology support personnel; and students. For more information, contact lngrida Lusis, 

ASHA's director offederal and political advocacy, at ilusis@asha.org. 
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Honorable Michael Burgess, M.D. 

Chairman 

Subcommittee on Health 

Committee on Energy and Commerce 

2125 Rayburn House Office Building 

Washington, D.C. 20515 

Honorable Gene Green 

Ranking Member 

Subcommittee on Health 

Committee on Energy and Commerce 

2125 Rayburn House Office Building 

Washington, D.C. 20515 

Statement of the Academy of Doctors of Audiology Supporting the Over-the-Counter 

Hearing Aid Act of 2017 

Introduction 

The Academy of Doctors of Audiology (ADA) supports H.R. 1652/5.670, the Over-the-Counter Hearing Aid Act 

of 2017, and commends Representatives Blackburn and Kennedy, and Senators Grassley and Warren for their 

foresight in introducing this legislation, which if enacted, will remove unnecessary and burdensome barriers 

to hearing care for millions of Americans. 

Congress should enact this legislation to allow adult consumers with mild-to-moderate hearing loss to 

purchase some types of hearing aids over the counter (OTC), and eliminate the requirement that adult 

consumers obtain a medical evaluation or sign a waiver in order to acquire these hearing aids. This landmark 

legislation will also direct the U.S. Food and Drug Administration (FDA) to issue regulations containing safety 

and labeling requirements for this new category of OTC hearing aids, and to update FDA draft guidance on 

Personal Sound Amplification Products (PSAPs). 

The Over-the-Counter Hearing Aid Act is consistent with ADA's longstanding position that the FDA should 

implement recommendations from the President's Council of Advisors on Science and Technology (PCAST) and 

the National Academies of Sciences, Engineering, and Medicine (NASEM), which have both independently 

suggested establishing a regulatory framework that permits OTC hearing aid sales and abolishes medical 

clearance requirements for adults, in order to improve access to life-changing hearing technologies for 

consumers nationwide. 

Hearing Health Care Challenges in the United States 

According to a recent report from the Centers for Disease Control (CDC), hearing loss is the third-most 

common chronic physical condition among adults in the United States after hypertension and arthritis, and is 

twice as likely as diabetes or cancer. 1 Hearing loss is associated with low employment rates, lower worker 

productivity, and high health care costs. In addition, adults with hearing loss are more likely to have low 

income and be unemployed or underemployed than adults with normal hearing. 

1 https flwww cdc gov/mmwrfvolurnes/66/wr/mm660Se3 htm 
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Unclear pathways to care, inconsistent and incongruent state and federal laws and regulations, and 

ambiguous classifications regarding emerging amplification and assistive technologies, create confusion and 

impede access to care for many Americans. Therefore, Congress' commitment to work with the FDA to 

streamline and modernize hearing aid regulations is both warranted and welcomed. 

Hearing technology has advanced significantly over the past several years, and today's hearing aids are more 

sophisticated, user-friendly, and powerful than ever before. Unfortunately, hearing aid usage rates have not 

improved over the same time period; far too many Americans live with hearing loss and treatment is too 

expensive. Only about 14 percent of the 37 million Americans with hearing loss actually use a hearing aid 

and one major reason for this treatment gap is cost. Prices for different types and models of hearing aids can 

vary, but the average cost of a device, with services, is about $2,400. Most people need two hearing aids, one 

for each ear, and devices typically need to be replaced every five years. Several prominent national 

organizations and federal governmental bodies, including Congress, 2 have sought to address the high cost of 

hearing care over the past few years through administrative and legislative efforts, designed to make hearing 

aids and/or associated hearing health care services more affordable and accessible.' 

According to the Better Hearing Institute, the consumer-facing arm of the Hearing Industries Association, 33% 

of individuals with hearing loss have incomes of less than $30,000 per year and 68% of those with hearing loss 

cite financial constraints as a core reason they do not use hearing aids.' 

Access to care is another key barrier to treatment for hard of hearing adults. The 10.8 million U.S. adults who 

currently use hearing aids only account for 26% of those who could benefit from hearing amplification. 5 There 

are fewer than 25,000 providers who dispense hearing aids (including audiologists, physicians and hearing aid 

specialists). Practically speaking, there are an average of 1,700 hearing impaired consumers for every single 

licensed dispenser today-and there will be 10,000 consumers turning 65 years old each and every day from 

now until20306 The number of providers is not growing-but the number of consumers who will need hearing 

aids is growing dramatically. The current provider-driven model will not be able to keep up with the demand 

for hearing healthcare services in the years to come. Introducing OTC hearing aid options for consumers with 

mild-to-moderate hearing loss will ease pressure on provider-reliant networks, allowing audiologists to focus 

on providing specialized treatment for complex cases. 

In ADA's estimation, the single greatest barrier to hearing aid adoption is awareness. Hearing health is not 

prioritized to the same degree as vision and dental health are, even among other health care providers, despite 

the high risks associated with untreated hearing loss. Most physicians do not include hearing screening or 

hearing testing in their annual, preventive care visits. 

What's more, Medicare, the largest payer of health care in the elderly, does not include a hearing screening 

or evaluation in the "Welcome to Medicare" evaluation that every new Medicare beneficiary has available to 

'l14th Con~ress Heanng A!d A»lstonce lax Credit Act {H.R. 1882/S. 31S), MedKare Heanng Coverage Act {H.R.1653), Help rxtend Auditory Rehef Act (H.R 2748), Audwlogy Patient Cho1ce 

Act {H.R 2519), Med1c~re Audmlogy Serv1ces Enhanc.ement Act {H R 1116) htto•ffwww nap i'du'cataiog/23<146/heanng-h~alth-cM~-for-adu!t>·RfFO!>\te> for-,mprov<ng-acceS>-ancl, 

https f!www comum<>r ftc.gov/art>cies/0158·b<IY"lg·hearmg·atd 114th Congre.s H~.o~nng Ald A>S<stance Tax Cred•t Act {H R 1882/$ 31~). Med~eare Heanng Coverage Mt (ll.R 1653), Help 

Extend Audttary Rel1d Act {11 R 2748), Aud1a!agy Pat1ent ChoEce Act (H R 2519), Medicare Audwlogy Serv~tes Enhancement Act IH R 1116] 
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them when they enter the payment system-' This lack of attention to prevention and early detection of hearing 

loss, by the broader health care community is a major barrier to the ultimate adoption of amplification and 

other treatments. 

The OTC Hearing Aid Act Offers a Responsible Solution for Millions of Americans 

The ADA believes that a widespread commitment to prevention and early diagnosis could have a significant 

impact on the social stigma associated with hearing loss. Enactment of the Over the Counter Hearing Aid Act, 

and the widespread availability of OTC hearing aids for use by those with mild-to-moderate hearing loss will 

help integrate the importance of evaluation and treatment into the health care landscape, and individuals will 

begin to see hearing health as a greater health care concern. 

Safety and Efficacy 

The ADA is pleased that the Over the Counter Hearing Aid Act mandates the Health and Human Services 

Secretary, in conjunction with the FDA to complete the following: 

(A) include requirements that provide reasonable assurances of the safety and efficacy of over-thecounter hearing aids; 

(B) include requirements that establish or adopt output limits appropriate for over-the-counter 

hearing aids; 

(C) include requirements for appropriate labeling of the over-the-counter hearing aids, including how 

consumers may report adverse events, any conditions or contraindications, and any advisements to 

consult promptly with a licensed physician; and 

(D) describe the requirements under which the sale of over-the-counter hearing aids is permitted, 

without the supervision, prescription, or other order, involvement, or intervention of a licensed 

person, to consumers through in-person transactions, by mail, or online. 

The OTC Hearing Aid Act will not de-regulate hearing aids. Rather, it will re-regulate them in a way that 

standardizes safety, efficacy, consumer protection and access for all Americans. The availability of FDAregistered OTC hearing devices will allow consumers to make better informed decisions about their treatment 

options, and will also facilitate increased competition, enhance quality and improve transparency in the 

purchase of direct-to-consumer hearing amplification products. Opening the market to FDA-regulated OTC 

hearing aids is a responsible means of providing consumers, with mild-to-moderate hearing loss, with more 

affordable, more efficient access to care than exists now. 

The ADA recommends that over-the-counter (OTC) hearing aids be very specifically labeled and include a 

strong recommendation that a patient seek a comprehensive audiologic evaluation from an audiologist or 

physician prior to purchasing any device for the treatment of hearing loss, especially if the patient exhibits any 

of the warning signs of ear disease (tinnitus, dizziness, drainage from the ear, sudden hearing loss, asymmetric 

hearing, foreign body in the ear, cerumen impaction, pain, congenital or traumatic deformity of the ear). 

Manual f\etneved October 29, 201S, from www ems gov 3 Your Medicare Coverage (n d) 
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With regard to amplification gain and output, appropriate safety measures should be undertaken for all 

amplification devices including hearing aids, smart phones, headphones, hearables, assistive listening devices 

(ALDs), and PSAPs. The ADA is pleased that the legislation includes requirements that establish or adopt 

appropriate output limits for OTC hearing aids. 

ADA suggests that one potential mechanism for ensuring that OTC hearing aid products are confined to use 

by the intended consumers (those with mild-to-moderate hearing loss), is to implement amplification gain 

and output threshold specifications that stay within the ranges that will only provide a meaningful benefit to 

those with mild-to-moderate hearing loss. 

While a comprehensive evaluation and treatment by an audiologist remains the recommended standard of 

care, it is not the chosen pathway to care for every consumer. There is a preponderance of data available 

today that demonstrates that, when it comes to hearing loss, the risk of non-treatment may be greater than 

the risk of self-treatment.' Untreated hearing loss is associated with serious health risks, such as depression, 

dementia, and social isolation. Seniors with untreated hearing loss are also at a higher risk of falls -the 

leading cause of fatal injury among older adults. The tremendous co-morbidities and maladies associated 

with hearing loss are well documented,' as are the benefits of amplification in improving quality of life and 

mitigating serious health conditions.10 Therefore, the public will be best served if the FDA allows hearing 

devices to be available to consumers over the counter, just as they are already available over the Internet. 

There are promising new tools being developed that offer promise for consumers self-identify "red flag" and 

other serious medical conditions of the ear. For example, the Consumer Ear Disease Risk Assessment (CEDRA), 

developed by Dr. David Zapala, is designed to effectively assist consumers in making informed decisions about 

the need for further medical evaluation." Additionally, home hearing tests such as the FDA-approved iHEAR, 

as well as screening tools such as Jacoti Hearing Suite and the National Hearing Test, can be used by consumers 

to help determine if an OTC product may be suitable for their type and degree of hearing loss. 

State consumer protection laws offer specific recourse and information to consumers regarding the 

requirements for the sale and return of hearing aids. Existing product liability laws and regulations for the 

manufacture of hearing aids offer sufficient protections for consumers, in terms of product safety. 

Exclusion of Children 

The Over the Counter Hearing Aid Act specifically and appropriately excludes children. OTC hearing aids are 

not designed for or indicated for use in children. Children inappropriately treated with these devices are at 

risk for severe complications due to untreated ear disease. In addition, children inappropriately treated may 

be at risk for speech or language delays, poor school performance and/or cognitive delay. 

Regulatory precautions should be taken to ensure that OTC hearing aids do not fall into the hands of children; 

however, there is no evidence that indicates any demand for adult hearing aids for use in children, and there 

is no reason to believe that adult hearing aids would be purchased OTC by or for children. 

Low income families have far more options available to address hearing loss in children than adults. The Early 

and Periodic Screening, Diagnosis and Treatment (EPSDT) Program provides a national mandate for hearing 
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aid coverage for children under 2111 . EPSDT is the child health component under Medicaid (42 U.S.C. 

1396a(a)(10)(A); 1396d(a)(4)(B); 1396d(r)). EPSDT services are mandated for children from birth through age 

21. A state must provide to Medicaid beneficiaries under age 21 hearing services, including appropriate 

screening, diagnostic, and treatment, including hearing aids. Specifically, EPSDT covers the following 

medically necessary audiological services for children who are at risk for hearing impairment: Audiological 

assessments; Hearing aid evaluation; and Medically necessary hearing aid services, including hearing aids and 

hearing aid accessories and services. These hearing services must be provided periodically at intervals that 

meet reasonable standards of medical practice. Medicaid coverage requirements will go a long way to ensure 

that families would not seek OTC hearing aid options to try to treat children. 

Just as with OTC medications and other FDA-regulated OTC products, OTC hearing device warning labels 

should include information detailing contra-indications for use in children. FDA warning labels are shown to 

be largely effective in deterring the use of OTC products in children when they pose dangers. The ADA 

acknowledges that there have been instances where OTC products were used by, and caused harm to, 

children. For example, Reye's Syndrome, a rare but serious condition in children, has been linked to aspirin 

use. Even so, the benefits of selling aspirin over the counter far outweigh the potential risks to children. 

Similarly, the low potential for contra-indicated OTC hearing aid use by children presents a low risk, which 

does not outweigh the potential benefits of OTC hearing aids for the millions of American adults with hearing 

loss who would achieve clinical and functional benefits from their use. 

Consistency, Clarity and Continuity in Rulemoking 

The ADA stipulates that there are risks with self-treatment by adults who suspect that they have hearing loss, 

including overlooking conditions that warrant medical intervention. However, the ADA contends that in the 

current regulatory environment, those risks are already being taken by consumers with either limited 

information--or worse yet, misinformation. The Over the Counter Hearing Aid Act will bring about much 

needed consistency, clarity and continuity for the sale of hearing aids to adults across the United States. 

Hearing aids have been widely purchased over the internet and through the mail for decades without 

government interference. The courts upheld online hearing aid sales without professional intervention, in 

2006, with the case: Missouri Boord of Examiners for Hearing Instrument Specialists v. Hearing Help Express, Inc. 

The gth District Court of Appeals overturned the Missouri (state) ban on online hearing aid sales without prior 

fitting or testing, noting that the existing FDA regulations (allowing for widespread use of the waiver for the 

required medical evaluation) preempted the state ban. The Court's opinion was as follows: 

"We conclude that the requirements of Mo. Stat. § 346.110{1) are in addition to the federal requirements 

applicable to the sale of hearing aids and that they directly relate to the safety of consumers and the 

effectiveness of the devices. The Missouri statute therefore "interfere[s] with the execution and 

accomplishment of the objectives of the FDA's hearing aid regulation," 45 Fed. Reg. at 67327, and must be 

deemed preempted by the MDA {Medical DevicesAmendment)."13 

As consumers already have direct-to-consumer Internet access to hearing aids and similar unregulated 

technologies, the creation of a regulated OTC class will not increase existing risks to the public. Audiologists 

will continue to play a critical role in a system that includes OTC hearing aids. 
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Many audiologists will elect to offer these products through their practices, just as they currently offer 

traditional hearing aids. Many consumers will seek audiology services after purchasing OTC devices, regardless 

of whether they purchase them online, over-the-counter, or at the audiologist's office. 

In addition to creating a consistent regulatory framework for the direct-to-consumer purchase of hearing aids, 

the Over the Counter Hearing Aid Act will also permanently remove archaic medical evaluation requirements, 

which channel consumers towards a narrow set of providers, and pose undue interference in clinical practice. 

Existing FDA regulations for the requirement for a medical evaluation prior to the purchase of a hearing aid, or 

the use of a waiver for adults to opt-out of the evaluation", was first promulgated in 1977 and can be found 

in Section 21 CFR 801.421. 

The regulations state: 

(l)Except as provided in paragraph (a) {2) of this section, a hearing aid dispenser shall not sell a hearing aid 

unless the prospective user has presented to the hearing aid dispenser a written statement signed by a licensed 

physician that states that the patient's hearing loss has been medically evaluated and the patient may be 

considered a candidate for a hearing aid. The medical evaluation must have taken place within the preceding 

6 months. 15 

{2} Waiver to the medical evaluation requirements. if the prospective hearing aid user is 18 years of age or 

older, the hearing aid dispenser may afford the prospective user an opportunity to waive the medical 

evaluation requirement." 

As early as 1993, it became clear that the medical clearance requirement was simply not functioning as the 

FDA intended. In his 1993 testimony to the U.S. Senate, Dr. David Kessler, then Director of the FDA, reported 

that the medical waiver provision was used far more extensively than expected and did not fulfill its original 

mission. He further noted that an audiological evaluation would suffice and testified that state licensure 

ensures competency and that consistent training should replace medical clearance." 

Anecdotal evidence also indicates that use of the waiver is widely utilized. The ADA is unaware of any credible 

research demonstrating that the medical evaluation requirement actually leads to the identification and 

treatment of medical conditions that would not otherwise be identified appropriately by the consumer. 

On June 2, 2016, the NASEM released a landmark report, Hearing Health Care for Adults: Priorities for 

Improving Access and Ajfordability, which affirms this recommendation. The NASEM Committee stated, "In 

examining the Food and Drug Administration's (FDA's) requirements far physician evaluation prior to obtaining 

hearing aids, the committee finds no evidence that the required medical evaluation or waiver of that evaluation 

provides any clinically meaningful benefit. In weighing the rareness of the medical conditions, the incidence of 

hearing loss in adults, the widespread need for hearing health care, and the wide use of the medical waiver, 

the committee recommends removing this regulation to serve consumers' best interests. "

18 

Evidence suggests that more than 90 percent of adults with hearing loss have sensorineural hearing loss that 

is not due to a medically and surgically treatable condition." It should also be noted that hearing loss is 

'''Code of >ederal Regulat1om Iitle 21. Chapter L Subchapter H, S~ct1on 501 http'{/www accessdata fda ~ov/scripts/cdrh/cfdocs/dcfr/cfrsearch. dm?cfrpart~ 

801&showfr~1&>ubpartnode,2180 1127 

" https_f/www accessdataJda gov/scdpt3/cdrh/cfdocs/ddr/CfRSI>.orch cfm?fr=801.421 
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identified through diagnostic audiologic testing, not through a medical evaluation. 

The FDA agrees that the medical evaluation requirement should be removed. As of December 7, 2016, the 

FDA has voluntarily ceased enforcement of the medical evaluation requirement, for adults over 18 years of 

age, because "it offers little or no meaningful clinical benefit." 20 U nfortu nat ely there are still many state laws 

that contain medical clearance requirements, which mirror the FDA regulation. Congress should, therefore, 

take immediate action to eliminate the medical evaluation requirements (including the use of a waiver) for 

adults pursuing amplification devices across the 50 states and U.S. territories by enacting the Over the 

Counter Hearing Aid Act. 

PSAP Guidance 

The Over the Counter Hearing Aid Act will direct the Secretary to update and finalize the draft guidance of 

the Department of Health and Human Services entitled, "Regulatory Requirements for Hearing Aid Devices 

and Personal Sound Amplification Products (PSAPs)." This is important since it is no longer possible to 

distinguish unregulated and regulated hearing devices by intended use. Nor is it always possible to use 

technological features or performance to differentiate hearing aids from non-regulated products such as 

PSAPs. 

The FDA states, "A hearing aid is a wearable sound-amplifying device that is intended to compensate for 

impaired hearing. Hearing aids are usually programmed to address an individual's degree of hearing loss 

across sound frequencies to improve speech intelligibility. Additionally, hearing aids may be coupled 

acoustically or wirelessly to external electronic products such as televisions, MP3 players, and telephones. A 

hearing health professional (such as on audiologist or a hearing aid dispenser) is usually required to program 

and optimize the performance of hearing aids with these more complex features. 

In contrast, a Personal Sound Amplification Product or PSAP is o wearable electronic product that is not 

intended to compensate for impaired hearing, but rather is intended for non-hearing impaired consumers to 

amplify sounds in certain environments, such as for hunting or other recreational activities. PSAPs typically 

are simpler sound amplification devices with fewer features and less functionality than hearing aids, although 

some of the technology and functionality of hearing aids and PSAPs may be similar. "21 

Contrary to the FDA's statement, many of today's PSAPs are technologically equivalent to hearing aids-" 

Further, technologies will undoubtedly continue to emerge and advance for both classifications of devices. 

Attempts to categorize or differentiate these products merely by technological features are 

cou nterp rodu ctive. 

The purposeful allowance of an OTC category of hearing devices, for adults, will streamline regulations in a 

manner that encourages all hearing device manufacturers to register and market their products transparently 

and responsibly, therefore increasing consumer choice and aligning the products' intended and actual uses. 

The availability of OTC hearing devices will allow the public to make better informed decisions about their 

treatment options, and will also likely lower the cost of hearing aids for the hearing impaired. 

'" http; jjwww.fda gov/ncwsevcnts/ncwsroom/pressJnnouncemi'!llts/ucmS3200S htm 
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Additional Considerations for Congress to Ensure Access to Audiology Services Under 

Medicare 

Treatment for hearing loss can be complex and include anatomical, physiological, emotional, psychological, 

social, and vocational issues that need to be addressed for any given patient. Moreover, clinical treatment 

for hearing loss is most often focused on improving patients' communicative ability. That utreatment11 goes 

well beyond the utilization of any device, be it a hearing aid, an assistive listening device (ALD), a PSAP, or a 

smart phone application. Functional improvement in communication is the primary goal for patients with 

hearing loss. 

Providing consumers with mild-to-moderate hearing loss with streamlined access to OTC hearing aids is a 

step forward, but it alone does not complete the journey to better outcomes for patients. Efforts in Congress 

to improve access to audiology services for Medicare patients are underway - and will be integral to 

widespread patient success with OTC hearing aids. Many older adults, in particular, will require audiologic 

care for successful treatment. We are pleased to report that the Audiology Patient Choice Act will be 

reintroduced in the 115'' Congress by Representative Tom Rice (R-5C). 

The Audiology Patient Choice Act will modernize existing Medicare regulations that undermine access and 

affordability for many older Americans. For example, Medicare Part B patients are currently required to 

obtain medical order before Medicare will cover an audiologic evaluation from 

licensed audiologist. There is absolutely no sound rationale for this approach now that the medical 

evaluation requirement has been voluntarily removed by the FDA, because it offers no benefit to the patient. 

Medicare Part B patients are also shuffled back and forth between providers in an inefficient process, 

because audiologists are only recognized under Medicare Part B as diagnosticians, despite the fact that they 

are licensed to provide Medicare-covered rehabilitative services. The Audiology Patient Choice Act, if 

enacted, will alleviate many of these barriers within the Medicare system, and allow Medicare Part B 

beneficiaries to have the same access to audiology care as Medicare Advantage beneficiaries and most 

Americans do. 

Technological advances have made it possible for audiologists to utilize telehealth for hearing screening, 

hearing aid counseling and aural rehabilitation and some hearing aid fitting, orientation and follow-up 

services. Unfortunately, licensure and reimbursement models have not kept pace with this technology. The 

success of the Over the Counter Hearing Aid Act will be greatly fortified if Congress also takes action to enact 

the Audiology Patient Choice Act to ensure that consumers have access to comprehensive diagnostic and 

rehabilitative audiology services. 

Conclusion 

According to statistics compiled by the National Institute on Deafness and Other Communication Disorders 

(NIDCD), 37.5 million American adults, aged 18 and older, report some form of hearing loss. However, only 

30% of adults aged 70 and older and 16% of adults aged 20 to 69 who could benefit from wearing hearing aids 

have ever used them-" 

Lack of awareness, among consumers and the medical community, regarding the importance of protecting and 

optimizing hearing aver a lifetime, is well documented, as are associated co-morbidities and the substantial 

risks of non-treatment of hearing disorders. 

"https ffwww nidcd nih goll/health/statzstlcsjquid statist:n-he3ring 
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Most consumers wait 7-10 years to seek treatment after they discover that they have a hearing loss. For 

many it is cost, for others access-and still more don't recognize the importance of optimizing their hearing 

over their lifetimes. 

The regulatory environment has struggled to keep pace with rapid advances in hearing amplification 

technology. Creating an OTC hearing device market will foster competition, broaden consumer choice, 

improve affordability, and accelerate future innovation. OTC products will also provide an additional entry 

point that may guide consumers into the hearing healthcare system sooner, so that they can get the help 

that they need. 

The ADA and its members seek expanded access for consumers to audiology services. We strive to accomplish 

this goal through the advancement of practitioner excellence and high ethical standards in the provision of 

quality audiologic care. The Over-the Counter Hearing Aid Act will help to facilitate these objectives and is 

consistent with the ADA's mission and philosophy. ADA further encourages Congress to consider a holistic 

approach to hearing healthcare that will also ensure streamlined access to audiology services. 

In summary, the removal of the medical clearance requirement and the availability of a regulated OTC hearing 

devices, which include appropriate labeling and safety measures, will expand access to quality hearing health 

products and services, reduce duplicative costs, and remove unnecessary, non-beneficial barriers to care. For 

this reason, the ADA is pleased to support the Over the Counter Hearing Aid Act. 

Contact: 

Stephanie Czuhajewski, CAE 

Executive Director 

446 E. High St. 

Lexington, KY 40507 

sczu hajewski@ audiologist.org 

859-977-7444 
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AMERICAN ACADEMY OF 

OTOLARYNGOLOGYHEAD AND NECK SURGERY 

Statement for the Record rc: H.R. 1652 

To the U.S. House of Representatives Committee on Energy and Commerce 

Health Subcommittee Hearing Regarding 

''Examining Improvements to the Regulation of Medical Technologies" 

Tuesday, May 2, 2017 

The American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNS) thanks 

the Subcommittee on Health for the oppottunity to submit a statement for the record 

regarding H.R. 1652, the "Over-the-Counter Hearing Aid Act of2017." 

I iearing loss is one of the most common issues faced by individuals as they age, and 

unfortunately, many adults fail to seek appropriate intervention when symptoms of hearing loss 

first appear. If enacted, H.R. 1652 would help provide a new pathway for consumers to access 

assistive hearing devices by establishing a new category of~'basic" or ·'over-the-counter" 

(OTC) hearing aids for adults with mild-to-moderate hearing loss. The AAO-IINS supports 

the concept ofOTC hearing aids for adults with mild-to-moderate hearing loss, but 

respectively urges members of the Committee to consider the f()llowing 

comments/recommendations prior to advancing H.R. 1652 as a standalone bill and/or including 

it in any comprehensive piece of legislation. 

As background, the AAO-IINS is the world's largest medical organization representing 

specialists who treat the ear, nose, and throat, and related structures of the head and neck. The 

Academy represents approximately II ,000 otolaryngologist-head and neck surgeons in the 

United States who diagnose and treat disorders of those areas. The medical disorders treated by 

our physicians arc among the most common that afflict all Americans, young and old. They 

include chronic car infection, sinusitis, snoring and sleep apnea, hearing loss, allergies and hay 

fever, swallowing disorders, nosebleeds, hoarseness, dizziness, and head and neck cancer. 

And, in the context of the hearing healthcare "debate,'' otolaryngologist-head and neck 

surgeons arc the 2.!Jly healthcare providers with the breadth of training and medical expertise to 

treat all aspects of hearing loss. 

The AAO-IINS recognizes the continued momentum in the United States and 

worldwide to increase the utilization of hearing health care services, particularly the 

adoption of technology designed to improve the hearing of those with mild-to-moderate 

hearing loss. We also acknowledge that to achieve this goal, structural changes regarding 

access to, and the delivery of. hearing healthcarc services will be necessary. 

There arc many reasons why those with hearing loss are not participants in the current system, 

including, but not limited to: failure to realize the problem, denial of the problem, perceptions 

regarding a potentially complex system, and cost The AAO-HNS supports continued efforts 

to mitigate these barriers. However, a preoccupation with increased utilization and 

broader access (by casing entry and reducing costs) must not overshadow the equally 

important need to ensure the quality and safety of hearing hcalthcarc services and/or 

devices. 

As such, the AAO-HNS continues to supp011 the concept of denoting a ''hasie" category of 

hearing aids. which would be more easily available for purchase OTC by adults/seniors. 

Empowering oto!;uyngologist-head and ne(k surgeons to deliver the Jw.s.t path:mt care 
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Although the AAO-HNS believes providing access to a lower-cost or '·basic" hearing aid 

could/would likely benefit a large p01iion of the adult (especially senior) population, we 

caution that specific action should first be taken to ensure a particular 

individual/patient's condition actually falls into the category where non~surgical, air~ 

conduction hearing aids intended to address bilateral, gradual onset, mild-to-moderate 

age-related hearing loss would be of value. Although we find ourselves in a period of 

disruptive technology that has made it possible for many patients to patticipatc in selfscreening, early detection, and monitoring of many diseases, we assert it is an overstatement 

to conclude that all patients/consumers could or would be able to self-diagnose, self-treat, 

and self-monitor tbcir hearing loss. 

Although the Food and Drug Administration (FDA) announced in December 2016 that it 

would no longer enforce the requirement for a medica! evaluation/waiver prior to purchasing a 

hearing aid (for adults), the AAO-HNS stands by its recommendation regarding the 

benefits of a medical evaluation by a physician, followed by a standardized hearing test 

(via a hearing health professional or appropriate online/technological source), BEFORE 

an individual purchases any type of basic hearing aid or other FDA~regulated assistive 

hearing device. Even if the resulting end-product is purchased OTC, a patient will still benefit, 

and will certainly not be harmed, by receiving an appropriate evaluation of their actual hearing 

loss. 

Therefore, the AAO-HNS urges lawmakers to consider amending II.R. 1652 to include the 

follo\ving provisions, before it is advanced on its own, or via a broader legislative package: 

Requirement for medical evaluation/hearing screening. This initial step will ensure 

an individual's hearing loss falls into the category where non-surgical, air-conduction 

hearing aids intended to address bilateral, gradual onset. mild-to-moderate age-related 

hearing loss would be of value. 

ii. Requirements relating to the standardization of OTC hearing aid packaging and 

inserts. Ensuring consumers receive consistent information and adequate protections 

regarding any OTC hearing device is criticaL Per its December 2016 guidance, the 

FDA agrees that the inclusion of the following notice should remain a requirement for 

all prospective hearing aid device packaging: 

''Good health practice requires that a person with a hearing loss have a medical 

evaluation hy a licensed physician (preferably a physician trho specializes in diseases qf 

the ear) before purchasing a hearing aid. Licensed physicians who specialize in diseases 

of the ear are qften referred to as otolaryngologists, otologists, or otorhinolwyngo!ogists. 

The purpose qlthe medical evaluation is to assure thai all medicalrv treatahle conditions 

that may affect hearing are identffied and treated before the hearing aid is purchased." 

The AAO-HNS also recommends that lawmakers instruct the FDA to revise the abovestated notice to also include "medically treatable conditions" associated with hearing loss. 

Specifically, conditions that need medical management to prevent further hearing loss and 

possibly eliminate the need for a hearing aid. Such conditions include: cerumen (wax) 

impaction; infection; perforation of the ear drum; Meniere's disease; tumors of the ear; 

otosclerosis; and sudden sensorineural hearing loss. 
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26785.148

AMERICAN ACADEMY OF 

OTOLARYNGOLOGYHEAD AND NECK SURGERY 

In addition, all package inserts should also notify consumers of the FDA "Red Flag'' 

warnings for car disease. These warning conditions include: 

(i) Visible congenital or traumatic deformUy of the ear; 

(10 History of active drainage from the ear within the previous 90 days; 

(iii) History afsudden or rapidly progressive hearing loss within the previous 90 days: 

(iv) Acute or chronic dizziness: 

tv) Unilateral hearing loss of, .. ;udden or recent onset within the previous 90 days; 

(1'i) Audiometric air-bone gap equal to or greater than 15 decibels at 500 hertz (Hz). 

1, 000 Hz, and 2, 000 Hz; 

(vii) Visible evidence of_.,·fgnificant cerumen accumulation or a foreign bo,(v in the ear 

canal; and 

(viii) Pain or discomfort in the ear. 

iii. Structured mechanism for at least five years of data collection. The potential 

availability ofOTC hearing aid devices represents a substantial shift in the paradigm 

for hearing healthcare, As such, the AAO-HNS supports a simultaneous effort to 

collect data to assist in the analysis of consumer/patient and provider satisfaction and 

usage. Such data will help mitigate issues r~garding any future or ''"next generation'' 

hearing-related devices. 

Finally, we emphasize that the above comments/recommendations are framed in the context of 

a specific type of hearing loss (bilateral, gradual onset, mild-to-moderate, age-related) and for 

specific patient populations (adults/seniors). We strongly believe any/all potential OTC 

hearing devices arc inappropriate for individuals under the age of 18. 

Again, we thank the Subcommittee for its interest in creating a new pathway fOr adults with 

mild-to-moderate hearing loss to access assistive devices, and appreciate the consideration of 

the above-stated recommendations. The AAO-HNS looks forward to working the Committee, 

the bill's authors, as well as others in the hearing health community, to ensure safe, timely, 

and affordable access to hearing healthcare services. If you have any questions or would like 

additional information, please contact the J\J\0-HNS Legislative Advocacy team at 

~deralW!entnet.org. 

Empowering otolnryttgclo_gist-head Md ne(k '>Urget~ns to dellv~r the best patient care 
204 


26785.149

May 1, 2017 

The Honorable Michael C. Burgess 

Chairman, Subcommittee on Health 

House Energy and Commerce Committee 

U.S. House of Representatives 

Washington, DC 20515 

The Honorable Gene Green 

Ranking Member, Subcommittee on Health 

House Energy and Commerce Committee 

U.S. House of Representatives 

Washington, DC 20515 

RE: Support for the Over-the-Counter Hearing Aid Act of 2017 

Dear Chairman Burgess and Ranking Member Green, 

The Consumer Technology Association (CTA)'" applauds the Subcommittee on Health for convening its May 

2, 2017 hearing on "Examining Improvements to the Regulation of Medical Technologies." Specifically, CTA 

strongly supports the Over-the-Counter Hearing Aid Act of 2017 (H.R. 1652), as introduced by Chairman 

Blackburn and Representative Kennedy. As the trade association representing 2,200 world-class technology 

innovators, CTA has deep experience promoting technologies to change people's lives for the better. In 

fact, CTA's affiliated public, national CTA Foundation was launched in 2012 with the mission to link seniors 

and people with disabilities with technologies to enhance their lives, and providing affordable hearing 

solutions is an important piece of that mission. 

The Over-the-Counter Hearing Aid Act of 2017 will change lives for the better by directing the Food and 

Drug Administration (FDA) to create a new regulatory class of hearing aids that could be sold over the 

counter. This new regulatory class will addresses the needs of adults with mild to moderate hearing loss, a 

population that desperately warrants attention. According to a June 2016 report published by the National 

Academies of Sciences, Engineering, and Medicine, age-related hearing loss is an increasing public health 

concern as the population of older adults grows. Indeed, the NAS report, Health Care for Adults: Priorities 

for Improving Access and Affordabi/ity, notes that, 

"Hearing is a vital human sense that is important to communication and health and can affect 

quality of life. Yet for a variety of reasons, many people with hearing loss do not seek out or receive 

hearing health care. Estimates of hearing aid use are that 67 to 86 percent of people who may 

benefit from hearing aids do not use them, and many hearing assistive technologies as well as 

auditory rehabilitation services are not fully utilized." 
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26785.150

Today, hearing aids range in price from $1,000 to $6,000, while devices such as a class of over-the-counter 

hearing devices are a fraction of that cost- $100 to $600. CTA's own research study, Personal Sound 

Amplification Products: A Study in Consumer Attitudes and Behavior, found that most adults with hearing 

problems do not get the hearing assistance they need. Key barriers to addressing hearing problems include: 

the high cost of hearing aids, inconvenience, and the cost of doctor appointments. 

The Over-the-Counter Hearing Aid Act of 2017 would dramatically change the environment for adults 

suffering from mild to moderate hearing loss by allowing them easier and more affordable access to 

hearing assistance devices. 

CTA is accredited by the American National Standards Institute (ANSI) to write standards for the consumer 

technology industry. Closed captioning is one well-known example of CTA's important accessibility-related 

standards. In January 2017, CTA released ANSI/CTA-2051, Personal Sound Amplification Performance 

Criteria, which sets out minimum performance requirements to be considered a high quality OTC hearing 

aid. The goal is to assure the FDA and consumers that manufacturers who build to this standard have built a 

quality, reliable OTC hearing aid. In short, industry-led standards can help to pre-package the set of rules 

that the government and consumers can rely on. CTA will work with the FDA to incorporate this standard 

into any FDA-promulgated regulations on over-the-counter hearing aids. 

The Over-the-Counter Hearing Aid Act of 2017 will ensure that Americans with mild to moderate hearing 

loss get the hearing assistance they need and deserve at a reasonable and affordable price. We pledge our 

support and urge immediate passage. 

Sincerely, 

President & CEO 

CC: The Honorable Greg Walden, Chairman, House Energy and Commerce Committee 

The Honorable Frank Pallone, Ranking Member, House Energy and Commerce Committee 

Members, Subcommittee on Health, House Energy and Commerce Committee 
206 


26785.151

The Honorable Michael Burgess, M.D. 

Chairman, Subcommittee on Health 

House Energy and Commerce Committee 

U.S. House of Representatives 

Washington, D.C. 20515 

The Honorable Gene Green 

Ranking Member, Subcommittee on Health 

House Energy and Commerce Committee 

U.S. House of Representatives 

Washington, D.C. 20515 

Krlsti McDermott 

President, Aramark Heallhcare Technologies 

Re: H.R. 2118 - Medical Device Servicing Safety and Accountability Act 

Dear Chairman Burgess and Ranking Member Green: 

Aramark appreciates the opportunity to submit this written testimony to the House Energy and 

Commerce Subcommittee on Health, regarding its consideration ofH.R. 2118, the Medical 

Device Servicing Safety and Accountability Act. As described below, as one of the largest 

independent providers of medical device maintenance services to hospitals and healthcare 

facilities across the United States, and a stakeholder in the Food and Drug Administration's 

("FDA") comprehensive review of medical device servicing issues, we respectfully request that 

the Subcommittee defer further consideration of H.R. 2118 until the FDA completes its review of 

these issues. 

Aramark, through its various sectors and affiliates, is a leading global provider of a broad range 

of services to businesses; educational, healthcare and governmental institutions; and sports, 

entertainment and recreational facilities. Within Aramark's Healthcare Sector, the Company's 

Healthcare Technologies business unit is among the largest independent providers ofhealthcare 

technology management services in the United States, and has been providing multi-vendor 

medical device services for more than 40 years through approximately 1,600 trained technicians, 

engineers, and staff. We are proud to provide high quality repair, service, and technology 

management for medical devices every day at over 550 healthcare facilities in 45 states across 

the United States. Collectively, Aramark's clients have entrusted to our care more than 

1,300,000 active medical devices covering 87 classes of medical devices and more than 43,000 

distinct model numbers. These devices include both biomedical devices Cl<.&, dialysis 

equipment, infusion pumps, critical care monitors, ventilators, and defibrillators), as well as 

high-end, diagnostic imaging devices such as CT, MRI, vascular/cardiac catheterization 

laboratory, ultrasound, nuclear medicine, and mammography devices. 

Aramark conducts medical device repair, service, and reconditioning activities on-site at a 

client's facilities, including at hospitals, surgery centers, imaging centers, and physicians' 
207 


26785.152

offices. Aramark provides these services either by comprehensive, on-site management of the 

operation of the facility's clinical engineering department or through field-based support for a 

facility's medical devices. Clients look to Ararnark because our deep technical expertise and 

scale allow us to tailor customized service solutions to their needs. When providing 

comprehensive management services, Aramark brings expertise to our clients throughout all 

phases of the lifecycle of medical devices, including: planning capital spending, assisting with a 

healthcare facility's evaluation of medical device acquisition options, project management 

around the installation of medical devices, everyday maintenance and support for medical 

devices, and consulting regarding medical device disposition and replacement. 

Ararnark also provides aftermarket part repair, sales, and equipment refurbishment activities. 

Through ReMedPar, Ararnark's wholly-owned aftermarket parts and equipment refurbishing 

organization, Ararnark sources, repairs, and distributes medical device parts and components and 

reconditions and refurbishes diagnostic imaging devices for its field personnel, hospital and other 

health care clients, and other customers. ReMedPar' s quality system and processes are compliant 

with international industry standards (ISO 9001:2008). 

Aramark's focus is on quality and patient safety. Through its Technology & Innovation Center, 

a I 05,000 square foot facility located in Charlotte, North Carolina, the Company has made a 

significant investment in enhancing the technical capabilities and training of our personnel as 

well as expanding the services we provide to our healthcare clients. In the field, the Company's 

personnel utilize their expertise and resources to help their healthcare partner facilities meet 

existing federal and state regulatory and accreditation requirements. Aided by resources and 

scale, Aramark meets our commitment to quality and patient safety while also achieving savings 

for our clients in today's challenging, cost-sensitive healthcare environment. 

As the Subcommittee is aware, the FDA is currently reviewing many of the issues addressed by 

H.R. 2118. The Agency requested comments in March 20 16 on medical device servicing and 

maintenance activities and held a public workshop on these matters on October 27-28, 2016. 

Over 170 comments were submitted to the docket, representing a wide range of views from 

various sectors. The comments reveal that the issues are complex, and affect multiple aspects of 

delivery ofhealth care, including efforts to reduce hospital and other facility costs without 

sacrificing patient health and safety. 

Aramark supports and appreciates FDA's efforts to gather information and to study the 

stakeholders and maintenance activities for medical devices, and we believe that all stakeholders 

and the healthcare system deserve the benefit of the FDA's and its new Commissioner's careful, 

informed evaluation of these issues. We also believe that any action seeking to change the laws 

or regulations in this area should be thoughtfully considered and with the input of all 

stakeholders. Aramark believes that the existing requirements and standards of other regulatory 

agencies and accrediting bodies appropriately address the quality and safety of medical device 

maintenance activities. Additionally, Ararnark ensures the quality and safety of our medical 

device maintenance activities by focusing on the education and training of our employees, and 

establishing standardized, rigorous operational practices that meet existing regulatory 

requirements and accreditation standards. Additional federal mandates will merely duplicate 

existing requimnents, thus adding costs to our health care system at a time when we should be 
208 


26785.153

looking for ways to reduce those costs. We, therefore, respectfully request that consideration of 

this legislation be deferred until the FDA completes its review. 

We appreciate the opportunity to present our views and look forward to working with the 

Subcommittee as it considers legislation to improve the regulation of medical technologies. 

Sincerely, 

~::,. President 

Ararnark Healthcare Technologies 

10510 Twin Lakes Pkwy I Charlotte, NC 28269 I 704·948·7906 
209 


26785.154

ConsumersUnion· 

POLICY & ACTION FROM CONSUMER REPORTS 

United States House of Representatives 

Washington, DC 20515 

May I, 2017 

Dear Representative: 

On hehalf of Consumers Union, the public policy arm of nonprofit Consumer Reports, we write 

to express our support ofH.R. 1652, the ''Over-the-Counter Hearing Aid Act of2017." As we 

noted in our recent article in the March 2017 issue of Consumer Reports, 1

price considerations 

keep many Americans from getting hearing assistance instruments that they need. This 

legislation will help make hearing aids available to consumers more conveniently and affordably 

and help improve their quality of life. 

H.R. 1652 would broaden the range of hearing aids available over the counter to adults with mild 

to moderate hearing loss. These devices would then be available for purchase separately from 

medical evaluations and services, giving consumers more options, including more affordable 

options. According to a 2015 survey of Consumer Reports subscribers, half of the respondents 

reported having trouble hearing in noisy environments, yet only 25% had their hearing checked 

the previous year. The Archives of Internal Medicine published research that finds that just 14% 

of consumers who could benefit from hearing aids actually use them. 

Cost is a major concern as the price of hearing aids can range between $3,000 and $8,000 and is 

not covered by Medicare or most commercial insurance plans. Many seniors and others with 

hearing loss who could benefit from these devices simply cannot afford them. We believe H.R. 

1652 would preserve and reinforce important consumer safety protections, including state laws 

holding manufacturers responsible for harm caused by unsafe and defective products, while 

overriding state laws designed to block or impede consumer access to over-the-counter hearing 

aids. The legislation requires the FDA to establish standards for these over the counter products 

that would address safety and efficacy and appropriate labeling. 

We continue to encourage consumers to seek medical evaluation before purchasing a hearing aid, 

to rule out other possible medical issues, yet we think consumers can benefit from a system in 

which the medical evaluation is separated from the purchase of the device. This gives consumers 

the ability to make their own choices, to shop around for medical services and hearing aids that 

best suit their needs and their budget. 

W c look forward to working with you and your cosponsors to enact this beneficial, common 

sense consumer legislation into law. Thank you for your attention on this important issue. 

Sincerely, 

George Slover Lisa McGiffert Victoria Burack 

Cc: House Energy and Commerce Committee 

1

Insights: No More Suffering in Silence?, Consumer Reports, March 2017. 
210 


26785.155

0) repair.org 

House Energy and Commerce Subcommittee on Health 

2125 Rayburn House Office Building 

Washington, D.C. 20515 

Dear Chairman Burgess and Committee Members: 

Re HR 2118 Medical Device Servicing and Accountability Act 

About Repair.Org 

Repair.Org is a 501(c) 6 non-profit trade association representing the industry repair industry for 

technology-enabled assets such as computers, communications, consumer electronics, and technology 

enabled medical equipment. Our members include companies in the business of independent medical 

equipment repair, hospitals, and Biomedical Engineering Technicians (BMET). 

HR 2118 will increase, rather than decrease OEM Repair Monopolies 

Our primary concern with HR 2118 is the impact this bill will have on independent repair businesses and 

the health care facilities that hire them. Currently, competition for repair services is being destroyed for 

high-tech medical equipment by manufacturers that refuse to provide access to the basic information 

and materials necessary for repair, including directly to their customers. These are true repair 

monopolies and have been determined as such as recently as April 27, 2017 where GE was found in 

violation of anti-trust law for monopolizing repair of anesthesia equipment. 1 

Repair businesses only operate under the supervision of regulated hospitals, physicians, and BMETs. 

These are the parties responsible for patient care, not the repair business. These users are not 

demanding more regulation of repair and are seeking our help driving legislation to improve competition 

for repair services. 

It appears to us that the primary impetus behind HR 2118 is to help OEMs reduce their exposure to 

competition for repair as a business. We know these OEMS are in opposition to state legislative efforts 

to expand access to modern repair, and it does not surprise us to see attempts to use the FDA and 

Congress to achieve their aims. 

1 See Red Lion Medical v GE https:/ jwww.law360.com/cases/54f64405a09caa5024000001 
211 


26785.156

Registration Requirement will Kill Jobs and Damage Patient Care 

Repair businesses are nearly all small business- and the financial burdens of registration alone will 

cause many to go out of business. Thousands of repair technicians that support older equipment will 

lose their jobs, and hospitals will lose the option of keeping older equipment in use. Patients will have 

less access to technology enabled medical services as fewer and fewer facilities will be able to afford 

equipment. 

Driving competition out of business is a benefit to the OEMs that can sell new equipment to replace 

unsupported models and command arbitrary labor rates and parts prices. 

Purpose of Registration: 

We have heard the theory that independent repair businesses are not subject to the same rules as 

OEMs. This is framed as a matter of fairness- which would be reasonable if the two businesses were 

the same. They are not. Repair and Manufacturing are two totally separate industries. It happens that 

some OEMS engage in both manufacturing and repair, but repair businesses are not manufacturers. 

Independent repair providers do not, and cannot, fix problems that originate with the manufacturersuch as poor design or buggy software. The FDA requires registration from OEMS because they are 

responsible for oversight of patient safety and can demand corrections from OEMS. We agree that if 

repair providers engage in manufacturing they should be required to register- but without a 

manufacturing function there is nothing for the FDA gain through registration. 

Reporting Requirement is Duplicative: 

The requirement to require independent repair providers to report on patient outcomes will not 

improve information flow to the FDA. Repair technicians, both OEM and ISP, are called on to repair a 

specific product and following completion return the equipment to the user for return to service. 

Service technicians are not privy to patient records and would not have any knowledge of patient 

outcomes. Only the user (hospital, supervising physician, or BMET) would be able to report on patient 

outcomes to the FDA. 

Common Misconceptions about Repair: 

Repair is restoration of equipment to full function using the documentation, tools, and parts designed by 

the OEM for the purpose of repair. Repair is not tinkering, customization, or modification. If repair 

information is hidden or blocked- the business of repair is monopolized to the OEM. 

OEMs write service documentation and diagnostics so that technicians can quickly identify the hardware 

failure, remove the failed part, insert a spare, and re-run diagnostics to confirm the repair is complete. 

This process is identical regardless of if the technician is employed by the OEM, ISP, or a hospital 

(BMETS). The only difference between OEM and ISP repair is availability ofthe information intended to 

be used for repair. 
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26785.157

Incomplete Repair: 

Technically, it is difficult to consider any device repaired if it does not "fully execute" its original 

diagnostics. This has been the standard for digital electronics repair for decades and eliminates any 

guesswork based on the relative skills of the technician. It may take a poorly trained tech longer to 

complete a repair, but the repair itself is just as complete once the unit successfully executes its 

diagnostics. 

Projections of patient harm due to incomplete repair are therefore suspect. 

Post-Repair Problems: 

Following repair, some devices may undergo further processing, such as sterilization, before patient use. 

These services may be provided by independent providers, but these services are not repair. Issues of 

improper handling for invasive surgical procedures should not become an excuse to further monopolize 

repair. 

We welcome the opportunity to work with all stakeholders to make sure that all care facilities have 

access to the highest quality repair services. 

Thank you for your consideration. 

Sincerely 

Gay Gordon-Byrne 

Executive Director, Repair.Org 

5 Cranberry Court 

North Haledon, NJ 07508 

ggbyrne@ repair.org 

973-949-5164 (office) 

201-747-4022 (cell) 
213 


26785.158

AIIII2SII 

May 1, 2017 

Mr. John Stone 

Ms, early McWilliams 

Energy and Commerce Subcommittee on Health 

Rayburn Office Building 

Washington, DC 

Mr. Stone and Ms. McWilliams, 

I am writing to oppose H.R 2118 and request an audience for Independent Service 

Organizations (I SO's) to provide perspective on the value that is delivered daily to 

healthcare providers. 

To summarize, the Association of Medical Device Service Organizations (AMDSO) believes 

that patient safety should be the focal point of activities from various perspectives such as 

diagnosis, treatment, device development, device service as well as legislation. H.R 2118 

seeks to create legislation for which there is no evidence to support there is a problem. 

Secondly, this legislation would require Independent Servicers to absorb unneeded costs of 

complying with regulations designed for manufacturers. Thirdly, this legislation will limit 

health care systems right to choose service and drive up costs. 

There is no evidence supporting that a problem exists when an Independent Service 

Organization repairs a device. The 2016 FDA public docket soliciting comment on 

regulation of servicers, ECRIInstitute report submitted in March 2016 and the Joint 

Commission comment filed in the FDA docket, all indicate and support there is little, if any, 

evidence of problems. At the FDA hosted workshop on October 27-28, 2016, the American 

College of Clinical Engineering offered a lack of real world evidence to support additional 

regulations. AMDSO members participated in the workshop and continue to work with the 

FDA to provide insight into technician training as well as demonstrate Quality Systems they 

have in place. 

Independent Service Organizations provide health care systems the right to choose service 

and keep costs down. As I SO's work with healthcare systems to reduce repairs through 

education and training, they help improve provider efficiency. Additionally, they often extend 

the useful life of devices, which helps avoid premature and costly replacement. There is no 

data identifying a difference in quality between an OEM and ISO repair. Requiring a service 

organization to comply with regulations written for device manufacturers will burden the ISO 

with unneeded costs and endanger their ability to continue to provide the financial benefit 

many healthcare systems desire and choose daily to receive education, training, service and 

repair. 

8412 Fern Lake Court! Fort Worth, TX 76137 

214-725-8714! gary.fans!er~cVAMDSO.org I AMDSO.org 
214 


26785.159

Page2 

AMDSO believes the evident benefits that !SO's offer healthcare systems daily, along with the lack 

of evidence there is a problem with quality, indicate there is no need to lose these benefits by further 

consideration of the "Medical Device Servicing Safety and Accountability Act". The Subcommittee 

on Health is urged to not support H.R. 2118. 

Crary Fansler II 

Executive Director 
215 


26785.160

Ms. Carly McWilliams 

Mr. John Stone 

House Subcommittee on Health 

Rayburn Office Building 

Washington. DC 

Ms. McWilliams and Mr. Stone, 

May 1, 2017 

l am writing to you to express opposition to ll.R. 2118, Medical Device Servicing and Accountability Act 

which is scheduled to be discussed on May 2, 2017 at a subcommittee hearing on various proposals to 

improve regulation of medical technologies. 

There is no evidence to suggest that H.R. 2118 will improve public health as intended, According to the 

only definitive, independent analysis of the FDA's data on adverse events resulting from malfunctioning 

reusable medical devices, a mere 0.005% of the reportable events were related to servicing regardless of 

who (manufacturer or independent service organization) performed the service'. No objective evidence 

that has been presented to date through the FDA's multi-year and exhaustive analysis of this subject 

supports the need for regulation of independent service organizations. 

Provider organizations make the choice to usc independent servicers every day as thousands of devices 

are successful and cost-effectively repaired. One reason there arc few incidents and providers embrace 

independent service organizations is that reusable device repair and maintenance is subject to regulatory 

scrutiny through existing CMS rules on hospital's maintenance programs. This existing framework 

ensures that devices are maintained according to manufacturer recommendations and is enforced through 

The Joint Commission and state health departments. 

The proposed legislation would do irreparable harm to the independent service industry by imposing rules 

that were designed for medical device design and manufacture on companies who repair existing devices 

to their original operating condition. The regulatory burden of the legislation will drive independent 

servicers fi·om the market resulting in greater market control by manufacturers. The impact will be felt in 

at least three key areas. 

l. Patient Safety. By making repair and maintenance services convenient and accessible, health 

care providers arc more likely to properly maintain their equipment than if they must send it to a 

manufacturer for service. Independent scrviccrs also provide vital education and advice to 

clinicians on caring for devices to help improve patient safety. 

1 Refer to the ECRI Institute comments submitted June 1 to FDA located at https://www.rcgulations.gov/document?D""FDA2016-N-0436-0 126 

333 W\Her Avenue + Bellefontaine, Ohio 43311 • 800-722-3675 

~~Y .. !IJohileinst..-unt<~nt.conl 
216 

Æ 


26785.161

Letter to Subcommittee on I lealth 

May l, 2017 

Page 2 

2. Device Efficacy. When devices are maintained properly, the critical diagnostic and treatment 

functions performed with the devices arc assured and outcomes for patients improve. 

3. Cost Control. By providing an alternative to manufacturer service, independent service 

organizations eliminate the virtual service monopolies that manufacturers operate and reduce the 

cost of repairs by as much as 50% compared to manufacturer service. Further, when devices are 

maintained properly, they last longer and reduce the need to buy a replacement. 

It is not coincidental that the proposed legislation has been put forward by a consortium of for-profit, 

medical device imaging system manufacturers. The consortium has much to gain by reducing 

competition for service and I believe that their motives have more to do with profits than protection of 

patients. Faced with increased scrutiny of new regulations from the White House, the consortium has 

turned to Congress to advance its agenda. 

Rejecting FDA action and turning to a legislative solution is at best premature .. As recently as the 

Subcommittee hearing on MDUF A IV in March, Dr. Shuren of the FDA stated that agency staff is still 

collecting information, meeting stakeholders, and analyzing options regarding oversight for independent 

scrvicers. In addition, it is not coincidental that the proposed legislation includes an "exemption" for 

hospital staff who perform services on millions of devices each year. These individuals repair each year 

would not be subject to oversight even when the work performed is the same as an independent servicer. 

It seems clear the ·•exemption" is present so manufacturers can avoid alienating the buyers of their 

equipment while reducing competition from independent scrviccrs. 

Lacking evidence of a problem to be solved, realizing that 0.005% of reportable events involved service 

activities, and the high likelihood that safety, efficacy, and costs would be adversely impacted, this 

legislation is neither necessary nor justified. This is an example of manufacturers turning to legislative 

action to enhance their commercial opportunities. The Subcommittee should reject this legislation and let 

the FDA perform their statutory responsibilities without external influence. 

[would welcome an opportunity to meet with you or members of the Subcommittee to more fully explain 

our positions and ensure that you have the perspective of independent service organizations as you 

consider this legislation. l can be reached at 404-518-1486 or danbari@mobilinstrument-ga.com. 

Sincerely, 

David Anbari 

Vice President and General Manager 

333 Water Avenue t BcUcfontainc, Ohio 43311 t 800-722-3675 

w"vw.~.Q.hiltjntl!'_ll!!lent.com