Document ID: FDA-2021-N-0555-1132
Agency: fda
Document Type: Rule
Title: Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the Counter Hearing Aids
Posted Date: 2022-08-17T04:00Z

[Federal Register Volume 87, Number 158 (Wednesday, August 17, 2022)]
[Rules and Regulations]
[Pages 50698-50762]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-17230]

[[Page 50697]]

Vol. 87

Wednesday,

No. 158

August 17, 2022

Part II

Department of Health and Human Services

-----------------------------------------------------------------------

Food and Drug Administration

-----------------------------------------------------------------------

21 CFR Parts 800, 801, et al.

Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the-
Counter Hearing Aids; Final Rule

  Federal Register / Vol. 87 , No. 158 / Wednesday, August 17, 2022 / 
Rules and Regulations  

[[Page 50698]]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 800, 801, 808, and 874

[Docket No. FDA-2021-N-0555]
RIN 0910-AI21

Medical Devices; Ear, Nose, and Throat Devices; Establishing 
Over-the-Counter Hearing Aids

AGENCY: Food and Drug Administration, Department of Health and Human 
Services (HHS).

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA, we, or the Agency) is 
establishing a regulatory category for over-the-counter (OTC) hearing 
aids and making related amendments to update the regulatory framework 
for hearing aids. Specifically, we define OTC hearing aids and 
establish applicable requirements; amend existing rules for consistency 
with the new OTC category; repeal the conditions for sale applicable to 
hearing aids; amend the existing labeling requirements for hearing 
aids; and update regulations relating to decisions on applications for 
exemption from Federal preemption that will become obsolete as a result 
of changes to the hearing aid requirements. In creating a regulatory 
category for OTC hearing aids and amending existing rules, we intend to 
provide reasonable assurance of safety and effectiveness for these 
devices as well as foster access to, and innovation in, hearing aid 
technology, thereby protecting and promoting the public health.

DATES: 
    Effective date: This rule is effective October 17, 2022.
    Compliance dates: For hearing aids that have been legally offered 
for sale prior to October 17, 2022, including hearing aids that already 
have a 510(k) clearance, compliance with the new or revised 
requirements must be achieved by April 14, 2023. For hearing aids that 
have not been offered for sale prior to October 17, 2022, or have been 
offered for sale but are required to submit a new 510(k) due to changes 
unrelated to this rule, compliance with the new or revised requirements 
applicable to the hearing aid, and obtaining 510(k) clearance if 
applicable, must be achieved before marketing the device on or after 
October 17, 2022.
    Incorporation by reference: The incorporation by reference of 
certain material listed in this rule is approved by the Director of the 
Federal Register as of October 17, 2022.

ADDRESSES: For access to the docket to read background documents or 
comments received, go to https://www.regulations.gov and insert the 
docket number, found in brackets in the heading of this final rule, 
into the ``Search'' box and follow the prompts and/or go to the Dockets 
Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 
240-402-7500.

FOR FURTHER INFORMATION CONTACT: 
    With regard to the final rule: Srinivas Nandkumar, Center for 
Devices and Radiological Health, Food and Drug Administration, 10903 
New Hampshire Ave., Silver Spring, MD 20993, 301-796-6480, 
[email protected].
    With regard to the information collection: Amber Sanford, Office of 
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-8867, 
[email protected].

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Executive Summary
    Purpose of the Final Rule
    Summary of the Major Provisions of the Final Rule
    Legal Authority
    Costs and Benefits
II. Table of Abbreviations and Acronyms Commonly Used in this 
Document
III. Background
    A. Need for the Regulation
    B. History of this Rulemaking and Public Participation
    C. Summary of Changes Between Proposed and Final Rules
    D. Incorporation by Reference
IV. Legal Authority
V. Comments on the Proposed Rule and FDA's Responses
    A. Device Classification and Marketing
    B. Scope (Sec.  800.30(a))
    C. Definitions (Sec. Sec.  800.30(b) and 801.422(b))
    D. Labeling (Sec.  800.30(c))
    E. Output Limits (Sec.  800.30(d))
    F. Other Device Requirements (Sec.  800.30(e) and (f))
    G. Conditions for OTC Sale (Sec.  800.30(g))
    H. Preemption Provisions (Sec.  800.30(h))
    I. Repeal of Restrictions and Modifications for Prescription 
Labeling (Sec. Sec.  801.420, 801.421, 801.422)
    J. Other Amendments
VI. Effective and Compliance Dates
    A. Effective Date
    B. Compliance Dates for Hearing Aids Not Legally Offered for 
Sale Prior to the Effective Date
    C. Compliance Dates for Hearing Aids Legally Offered for Sale 
Prior to the Effective Date
VII. Economic Analysis of Impacts
VIII. Analysis of Environment Impact
IX. Paperwork Reduction Act of 1995
X. Federalism
XI. Consultation and Coordination with Indian Tribal Governments
XII. References

I. Executive Summary

A. Purpose of the Final Rule

    Hearing loss affects an estimated 30 million people in the United 
States and can have a significant impact on communication, social 
participation, and overall health and quality of life. Despite the high 
prevalence and public health impact of hearing loss, only about one-
fifth of people who could benefit from a hearing aid seek intervention. 
Several barriers likely impede the use of hearing aids in hearing-
impaired individuals such as high cost, stigma of being perceived as 
old or debilitated, and value (perceived hearing benefit relative to 
price). FDA is finalizing rules to address some of these concerns.
    Moreover, the FDA Reauthorization Act of 2017 (FDARA) (Pub. L. 115-
52) directs FDA to establish a category of OTC hearing aids through 
rulemaking, and FDARA sets forth various requirements for OTC hearing 
aids, including for reasonable assurance of safety and effectiveness, 
as well as Federal preemption provisions. In addition to protecting and 
promoting the public health, these rules establish the OTC category and 
implement the requirements of FDARA.

B. Summary of the Major Provisions of the Final Rule

    FDA is establishing a regulatory category for OTC hearing aids to 
improve access to hearing aid technology for Americans. OTC hearing 
aids are intended to address perceived mild to moderate hearing loss in 
people aged 18 or older. Along with the OTC category, we are finalizing 
multiple related changes to the overall regulatory framework for 
hearing aids to harmonize existing rules with the new OTC category. We 
have determined that the requirements set forth in this rulemaking will 
protect the public health by providing reasonable assurance of safety 
and effectiveness for hearing aids, as well as promote the hearing 
health of Americans by lowering barriers to access and fostering 
innovation in hearing aid technology.
    Among other things, FDARA amended the Federal Food, Drug, and 
Cosmetic Act (FD&C Act) by defining OTC hearing aids and providing the 
authorities to establish the OTC category of hearing aids among 
provisions that are, by definition, general controls. We are finalizing 
general controls for OTC hearing aids consistent with FDARA.

[[Page 50699]]

We are finalizing lower output limits than we proposed but have not 
substantially changed the other electroacoustic performance 
requirements for OTC hearing aids. We have simplified the phrasing 
throughout the required labeling and have restated the maximum 
insertion depth for OTC hearing aids in terms of a fixed measurement. 
However, we are not realigning the air-conduction hearing aid 
classification regulations as proposed.
    This rulemaking also affects other regulations that applied to 
hearing aids. FDA had established device restrictions for hearing aids 
that included labeling requirements as well as conditions for sale. We 
are removing these device restrictions for hearing aids and 
establishing a new regulation for prescription hearing aid labeling. 
Further, FDA had by regulation granted or denied exemptions from 
Federal preemption for State requirements pertaining to hearing aids. 
The removal of the device restrictions on hearing aids, as well as 
certain provisions of FDARA, impact most of these previous exemption 
decisions, for example, by altering their scope. We are removing the 
regulations codifying these decisions and establishing other 
regulations clarifying some of the effects of statutory preemption 
under FDARA.

C. Legal Authority

    The FD&C Act establishes a comprehensive system for the regulation 
of devices intended for human use. Hearing aids are devices intended 
for human use and so are subject to, among other requirements, the 
device provisions of the FD&C Act. FDA has authority to establish 
regulatory controls needed to provide reasonable assurance of safety 
and effectiveness for these devices. As such, FDA is establishing 
regulatory controls for OTC hearing aids and amending regulatory 
controls for prescription hearing aids. Moreover, the FD&C Act directs 
the establishment of an electronic radiation control program, and 
hearing aids and personal sound amplification products (PSAPs) are 
electronic products, subject to the electronic radiation control 
requirements.
    Specific to OTC hearing aids, the FD&C Act and FDARA authorize 
multiple controls, including authority for FDA to establish 
requirements for device labeling, output limits, conditions for sale 
and distribution, and other requirements that provide reasonable 
assurance of safety and effectiveness of OTC hearing aids. FDARA 
specifically directs FDA to establish a category of OTC hearing aids by 
regulation that must include the aforementioned requirements.
    More generally, the FD&C Act further provides for labeling 
requirements as general controls such that devices (and other medical 
products) will not be misbranded. The FD&C Act also authorizes FDA to 
issue regulations for the efficient enforcement of the FD&C Act. We are 
establishing the following regulations pursuant to these authorities 
and to fulfill the directive under FDARA.
    Additionally, both the FD&C Act and FDARA include preemption 
provisions applicable to hearing aids.

D. Costs and Benefits

    This rule to establish OTC hearing aids and align other regulations 
generates potential cost savings for consumers with perceived mild to 
moderate hearing impairment who wish to buy lower cost hearing aids not 
bundled with professional services and not requiring professional 
advice, fitting, adjustment, or maintenance but who are currently 
unable to buy such products online because of State regulations or 
because they do not shop online. This rule also generates costs for 
hearing aid manufacturers for changing labeling of existing hearing 
aids as well as for reading the rule and revising internal standard 
operating procedures in response to the rule. We estimate benefits of 
between $6 million and $147 million per year based on 5th and 95th 
percentile Monte Carlo results with a mean of $63 million per year. We 
estimate annualized costs of between $1 million and $2 million per year 
based on 5th and 95th percentile Monte Carlo results with a mean of $1 
million per year. Combining benefits and costs, we used Monte Carlo 
analysis to estimate annualized net benefits of between $5 million and 
$145 million per year based on the 5th and 95th Monte Carlo percentile 
results with a mean of $62 million per year at both 3 percent and 7 
percent discount rates.

II. Table of Abbreviations and Acronyms Commonly Used in This Document

 
------------------------------------------------------------------------
     Abbreviation/acronym                    What it means
------------------------------------------------------------------------
510(k).......................  A premarket notification for certain
                                devices.
ANSI.........................  American National Standards Institute.
APA..........................  Administrative Procedure Act.
ASA..........................  Acoustical Society of America.
ASHA.........................  American Speech-Language-Hearing
                                Association.
CDRH.........................  Center for Devices and Radiological
                                Health.
CFR..........................  Code of Federal Regulations.
cm\3\........................  Centimeter cubed (cubic centimeter).
CTA..........................  Consumer Technology Association.
dB...........................  Decibel.
dBA..........................  A-weighted decibel.
EA...........................  Environmental assessment.
ENT..........................  Ear-Nose-Throat.
FDA..........................  Food and Drug Administration.
FD&C Act.....................  Federal Food, Drug, and Cosmetic Act.
FDARA........................  FDA Reauthorization Act of 2017.
FONSI........................  Finding of no significant impact.
FR...........................  Federal Register.
FRIA.........................  Final Regulatory Impact Analysis.
IQA..........................  Information Quality Act.
ISO..........................  International Organization for
                                Standardization.
ITU..........................  International Telecommunication Union.
mm...........................  Millimeter.
ms...........................  Millisecond.

[[Page 50700]]

 
MSW..........................  Municipal solid waste.
NASEM........................  National Academies of Sciences,
                                Engineering, and Medicine.
NIOSH........................  National Institute for Occupational
                                Safety and Health.
OMB..........................  Office of Management and Budget.
OSPL90.......................  Output sound pressure level with 90-dB
                                input.
OTC..........................  Over-the-counter.
PRA..........................  Paperwork Reduction Act of 1995.
PSAP.........................  Personal sound amplification product.
Pub. L.......................  Public Law.
RMS..........................  Root mean square.
SPL..........................  Sound pressure level.
U.S.C........................  United States Code.
WHO..........................  World Health Organization.
------------------------------------------------------------------------

III. Background

    FDA is defining and establishing general controls for an OTC 
category of hearing aids. We intend these controls to provide for 
reasonable assurance of safety and effectiveness for these devices, 
thereby protecting the public health. We also intend these controls to 
help improve access to and foster innovation in hearing aid technology 
for Americans, thereby promoting the public health. We are making 
various other revisions, as described in this document, to align 
existing regulations with statutory requirements and the new OTC 
category.
    For brevity, we will use the following terms as shorthand in this 
document: ``Over-the-Counter Hearing Aid Controls'' for the general 
controls for OTC hearing aids that we are finalizing under Sec.  800.30 
(21 CFR 800.30).
    ``Commercial activity involving OTC hearing aids'' to refer to any 
or all of the following activities: servicing, marketing, sale, 
dispensing, use, customer support, or distribution of OTC hearing aids 
through in-person transactions, by mail, or online.
    ``Customizable'' or ``customization,'' unless otherwise noted, to 
refer to the elements of the statutory definition for OTC hearing aids 
described in section 520(q)(1)(A)(iii) and (iv) of the FD&C Act (21 
U.S.C. 360j(q)(1)(A)(iii) and (iv)). That is, for the purposes of this 
document, a customizable hearing aid is one that, through tools, tests, 
or software, allows the user to control the hearing aid and customize 
it to the user's hearing needs. To do so, the hearing aid may use 
wireless technology or include tests for self-assessment of hearing 
loss. (See also the response to Comment 1 explaining customization in 
more technical terms.)
    ``Involvement of a licensed person'' to refer to the supervision, 
prescription, or other order, involvement, or intervention of a 
licensed person.
    ``State or local requirement'' to refer to any State or local law, 
regulation, order, or other requirement.

A. Need for the Regulation

    Hearing loss affects an estimated 30 million people in the United 
States and can have a significant impact on communication, social 
participation, and overall health and quality of life (Refs. 1 and 2). 
Despite the high prevalence and public health impact of hearing loss, 
only about one-fifth of people who could benefit from a hearing aid 
seek intervention (Ref. 3). The use of hearing aids has been linked to, 
among other health benefits, reductions in the incidence or severity of 
cognitive decline, depression, and other health problems in older 
adults (Refs. 2, 4, and 5). Additionally, benefits of hearing aid use 
can include improved social participation and a better quality of life.
    Besides health benefits for individuals, more-widespread adoption 
of hearing aids could have broader effects. By increasing social 
participation, hearing aids could help to improve inclusion of 
individuals in family, economic, civic, and religious life. Thus, 
reducing barriers to hearing aid access might contribute to such 
improvements. This could be particularly true for people of color, 
rural Americans, low-income individuals, and others for whom barriers 
to hearing aid access may be especially burdensome.
    Several barriers likely impede the use of hearing aids in hearing-
impaired individuals such as high cost, stigma of being perceived as 
old or debilitated, and value (perceived hearing benefit relative to 
price) (Ref. 6). FDA is finalizing rules to address some of these 
concerns.
    Moreover, section 709 of FDARA directs FDA to establish a category 
of OTC hearing aids through rulemaking, and sets forth various 
requirements for OTC hearing aids, including for reasonable assurance 
of safety and effectiveness, as well as Federal preemption provisions. 
In addition to protecting and promoting the public health, these rules 
establish the OTC category and implement the requirements of FDARA.

B. History of This Rulemaking and Public Participation

    On October 20, 2021, in the Federal Register, FDA proposed multiple 
regulatory changes, including proposing requirements for OTC hearing 
aids, that would serve to provide reasonable assurance of safety and 
effectiveness of hearing aids, address barriers to access to hearing 
aids, and effectuate the requirements of section 709 of FDARA (86 FR 
58150). Although the October 2021 proposal was the first step in this 
rulemaking, the proposal followed other steps FDA had already taken to 
initiate an update of the regulatory framework for hearing aids. Please 
refer to the aforementioned issue of the Federal Register for further 
details on the proposal and other steps taken by FDA.
    We received more than 1,000 comments on the proposed rule by the 
close of the comment period, which was January 18, 2022. Commenters 
included consumers, professionals, professional associations, hearing 
aid manufacturers, public health organizations, public advocacy groups, 
members of Congress, and State agencies. We describe and respond to the 
comments in section V of this document. We have grouped similar 
comments together under the same number, and in some cases, we have 
separated different issues discussed in the same comment and designated 
them as distinct comments for purposes of our responses. The number 
assigned to each comment or comment topic is purely for organizational 
purposes and does not signify the comment's value or importance or the 
order in which we received comments.

[[Page 50701]]

C. Summary of Changes Between Proposed and Final Rules

    In response to comments, we have made (and declined) a number of 
changes for the final rule. The following summarizes the outcomes that 
may be of greatest interest to readers:
    Output limits. We are finalizing lower output limits than we 
proposed. The general limit will be 111 decibels of sound pressure 
level (dB SPL), with 117 dB SPL allowable for devices while input-
controlled compression is activated.
    Gain limit. We did not propose, and are not finalizing, a separate 
gain limit.
    Design requirements. We have revised the allowable insertion depth. 
The most medial (innermost) component of an OTC hearing aid must be 
reasonably expected to remain at least 10 millimeters (mm) from the 
tympanic membrane (eardrum). We are also requiring that all OTC hearing 
aids have a user-adjustable volume control.
    Labeling. We have improved phrasing throughout the labeling to make 
it more understandable for hearing aid users (non-experts).
    Conditions for sale. We are not requiring age verification for the 
sale of OTC hearing aids. Prescription hearing aid sales will be 
subject to the requirements in Sec.  801.109 (21 CFR 801.109), 
including that they be sold only to or on the prescription or other 
order of a practitioner licensed by law to use or order the use of 
(prescribe) the devices (which is as proposed).
    Scope and definitions. Perceived mild to moderate hearing 
impairment remains the scope of the intended use of OTC hearing aids, 
and we are declining to require measurements of hearing loss to 
establish prospective users' qualification to purchase OTC hearing 
aids.
    OTC category and self-fitting air-conduction hearing aid 
classification. We are not requiring that OTC hearing aids be self-
fitting devices, and we have provided clarification on the difference 
between customization and fitting.
    Quality System requirements. OTC hearing aids will be subject to 
the requirements under part 820 (21 CFR part 820), which describes a 
quality management system appropriate for medical devices.
    We explain those decisions and others, as well as provide our 
thinking on other topics in the sections that follow.

D. Incorporation by Reference

    FDA is incorporating by reference ANSI/CTA-2051, ``Personal Sound 
Amplification Performance Criteria,'' dated January 2017, which was 
approved by the Office of the Federal Register. You may obtain a copy 
from the Consumer Technology Association (CTA), 1919 S. Eads St., 
Arlington, VA 22202; https://www.cta.tech, 703-907-7600. Among other 
things, it describes how to measure frequency response and includes 
technical data for adaptations for different circumstances and provides 
a standardized way to quantify frequency response for OTC hearing aids 
and to meet the related electroacoustic performance requirements.
    FDA is also incorporating by reference ANSI/ASA S3.22-2014 (R2020), 
``Specification of Hearing Aid Characteristics,'' dated June 5, 2020, 
which was approved by the Office of the Federal Register. You may 
obtain a copy from the Acoustical Society of America (ASA), 1305 Walt 
Whitman Road, Suite 300, Melville, NY 11747 Telephone: 1 (631) 390-
0215, Fax: 1 (631) 923-2875, Email: [email protected] or 
the American National Standards Institute (ANSI), 1889 L Street NW, 
11th Floor, Washington, DC 20036; https://www.ansi.org, 202-293-8020. 
ANSI/ASA S3.22-2014 (R2020) describes tolerances and test methods used 
for certain measurements of hearing aid performance. The application of 
ANSI/ASA S3.22-2014 (R2020) provides professional hearing instrument 
specialists with standardized technical information to help them select 
the correct hearing aid and ensure optimal fit and performance for 
hearing aid users.

IV. Legal Authority

    The FD&C Act establishes a comprehensive system for the regulation 
of devices, as defined in section 201(h) of the FD&C Act (21 U.S.C. 
321(h)), intended for human use. Section 513 of the FD&C Act (21 U.S.C. 
360c) defines three classes of devices, reflecting the regulatory 
controls needed to provide reasonable assurance of their safety and 
effectiveness. The three classes of devices are class I (general 
controls), class II (special controls), and class III (premarket 
approval) (see 21 U.S.C. 360c). Hearing aids are devices intended for 
human use and are subject to the FD&C Act. Currently, air-conduction 
hearing aids are generally either class I or class II devices.
    The FD&C Act also directs the establishment of an electronic 
product radiation control program under section 532(a) to protect the 
public health and safety (see 21 U.S.C. 360ii(a)), and requires, among 
other things, that manufacturers of electronic products provide 
notification of certain defects (see 21 U.S.C. 360ll). Section 
531(1)(B) of the FD&C Act defines electronic product radiation as, 
among other phenomena, any sonic, infrasonic, or ultrasonic wave 
emitted from an electronic product as the result of the operation of an 
electronic circuit (see 21 U.S.C. 360hh(1)(B)). In turn, any 
manufactured or assembled product which, when in operation, contains or 
acts as part of an electronic circuit and emits (or in the absence of 
effective shielding or other controls would emit) electronic product 
radiation would be an electronic product (see 21 U.S.C. 360hh(2)(A)). 
As such, hearing aids and PSAPs emit electronic product radiation and 
are electronic products, meaning they are subject to the electronic 
product radiation control requirements.
    FDARA amended the FD&C Act to apply requirements specific to 
certain hearing aids and defined the term ``over-the-counter hearing 
aid'' (see 21 U.S.C. 360j(q)). We are issuing these requirements for 
OTC hearing aids pursuant to section 709(b) of FDARA, which authorizes 
FDA to establish requirements for labeling, output limits, conditions 
for sale and distribution of OTC hearing aids, and other requirements 
that provide for reasonable assurance of safety and effectiveness of 
these devices.
    In addition, the FD&C Act provides that a device is misbranded 
unless, among other requirements, its labeling bears adequate 
directions for use (see section 502(f)(1) of the FD&C Act (21 U.S.C. 
352(f)(1)). Consistent with section 502 of the FD&C Act, FDA has issued 
regulations that exempt certain kinds of devices from the requirement 
for adequate directions for use. Section 502(f)(2) further requires 
adequate warnings against use of a device in those pathological 
conditions, or by children, where use of the device may be dangerous to 
health. The labeling must also bear adequate warnings against unsafe 
dosage or methods or duration of administration or application (see 
section 502(f)(2) of the FD&C Act). Such warnings must be in such 
manner and form as are necessary for the protection of the users (see 
section 502(f)(2) of the FD&C Act).
    A device is also misbranded if its labeling is false or misleading 
in any particular (see section 502(a) of the FD&C Act). Section 201(n) 
of the FD&C Act states that in determining whether labeling or 
advertising is misleading, there shall be taken into account not only 
representations made or suggested but also the extent to which labeling 
or advertising fails to reveal material facts.
    Other misbranding provisions under the FD&C Act would apply as 
well,

[[Page 50702]]

including section 502(c), which deems a device to be misbranded if any 
word, statement, or other information required by or under authority of 
the FD&C Act to appear on the label or labeling is not prominently 
placed thereon with such conspicuousness and in such terms as to render 
it likely to be read and understood by the ordinary individual under 
customary conditions of purchase and use.
    Additionally, section 701(a) of the FD&C Act authorizes FDA to 
issue regulations for the efficient enforcement of the FD&C Act (21 
U.S.C. 371(a)). The regulations established in this rulemaking are for 
the efficient enforcement of the FD&C Act because they will provide 
standards for the legal marketing of safe and effective hearing aids.
    Violations of any final rules from this rulemaking, once in effect, 
would render the hearing aids adulterated and/or misbranded under 
sections 501 and/or 502 of the FD&C Act, and subject to enforcement 
action, for example, seizure (see section 304 of the FD&C Act (21 
U.S.C. 334)), injunction (see section 302 of the FD&C Act (21 U.S.C. 
332)), and criminal prosecution (see section 303 of the FD&C Act (21 
U.S.C. 333)). Prohibited acts include, among others, introducing an 
adulterated or misbranded device into interstate commerce (see section 
301 of the FD&C Act (21 U.S.C. 331)). Sections 538 and 539 of the FD&C 
Act additionally set forth prohibited acts and provisions for 
enforcement for electronic product radiation control (see 21 U.S.C. 
360oo and 360pp, respectively).
    Under section 521 of the FD&C Act, no State or political 
subdivision of a State may establish or continue in effect with respect 
to a device intended for human use any requirement that is different 
from, or in addition to, any requirement applicable under the FD&C Act 
to the device and that relates to the safety or effectiveness of the 
device or to any other matter included in a requirement applicable to 
the device under the FD&C Act (21 U.S.C. 360k). Section 521 of the FD&C 
Act also provides that FDA may grant an exemption from preemption under 
certain circumstances. Section 709(b) of FDARA also includes a 
preemption provision with respect to requirements for OTC hearing aids.

V. Comments on the Proposed Rule and FDA's Responses

    In the proposed rule, FDA welcomed comments on all aspects of the 
proposal, and we specifically requested comments on certain topics to 
encourage more-targeted feedback. Such topics included:

    the clarity of the definitions and ways to improve them;
    labeling requirements;
    equitable access to hearing aids and information about them;
    whether State or local requirements for returns would promote or 
restrict or interfere with commercial activities involving OTC 
hearing aids;
    design requirements to limit insertion depth;
    proposals for modification of, or alternatives to, the current 
applicable Quality System requirements for OTC hearing aids;
    conditions for sale of OTC hearing aids to prevent sale to or 
for people younger than 18;
    the removal of regulations in 21 CFR part 808 (part 808) 
regarding exemptions from Federal preemption for State and local 
requirements respecting hearing aids;
    possible effects of the rule on small manufacturers;
    data concerning the environmental assessment and our proposal 
for a finding of no significant impact (FONSI);
    topics related to the Paperwork Reduction Act of 1995 (PRA) and 
associated estimates for recordkeeping burdens; and
    potential impacts on Indian Tribes from this rulemaking.

    As appropriate, we summarize such comments that we received, along 
with other pertinent comments, and respond to them in the corresponding 
subsections that follow. As we indicated in the proposal, we considered 
only comments submitted to the docket for this rulemaking that were 
timely and pertinent (see 86 FR 58150-58161).
    The vast majority of comments that we received supported rulemaking 
to encourage wider adoption of safe and effective hearing aids for 
people who could benefit from them. FDA agrees that rulemaking can 
encourage wider adoption of such devices, and we expect this final rule 
to do so. Many commenters conveyed enthusiasm for affordable hearing 
aids and/or wider availability without the involvement of a licensed 
person, telling us that they expect the difference to make hearing aids 
accessible to them--in some cases, for the first time. Some comments 
observed that hearing impairment often correlates with lower income, 
suggesting that lower prices may be particularly helpful for people who 
may want to use hearing aids and that OTC hearing aids could serve an 
important role in achieving equitable health outcomes.
    Still, many commenters voiced both support and concern for the role 
of licensed persons and the value of professional services for hearing 
health. In finalizing this rule, FDA is not suggesting that licensed 
persons or their professional services are unimportant or not valuable. 
Indeed, we recommend consulting licensed persons in several 
circumstances, including for the diagnosis of hearing impairment and in 
the fitting and continued use of OTC hearing aids when consumers choose 
to seek such services. Many commenters asserted that the professional 
services are worth the cost. In that vein, one comment suggested that, 
like providing alternative distribution channels, increasing the number 
of audiologists and other hearing health care providers would also 
improve accessibility. This final rule, however, focuses on subjects 
within FDA's purview, establishing device requirements that provide 
reasonable assurance of safety and effectiveness for OTC hearing aids 
without the involvement of a licensed person, as directed by FDARA.
    As for specific provisions, the comments generally supported 
establishing requirements for labeling, output (volume) limits, 
electroacoustic performance requirements, and other design requirements 
for OTC hearing aids. However, individual comments varied on the extent 
to which they supported specific proposals or proffered alternatives. 
Comments that provided a rationale and/or evidence generally lent more 
insight for FDA's consideration.
    We acknowledge that some comments did not support this rulemaking, 
many of them stating that hearing aids are medical devices and should 
not be regulated as consumer electronics. We interpret such comments to 
mean that OTC hearing aids should not have a relaxed standard for 
safety or effectiveness, nor should OTC hearing aids be subject to less 
stringent requirements for product quality than other medical devices. 
We agree that OTC hearing aids must meet the same standard as other 
devices for having reasonable assurance of safety and effectiveness, 
consistent with the FD&C Act and section 709 of FDARA, and that OTC 
hearing aids be subject to the quality system requirements applicable 
to other devices. However, we note that different device types and 
categories will raise different issues related to safety and 
effectiveness. Thus, while devices must meet the same standard of 
having reasonable assurance of safety and effectiveness, different 
device types and categories can engender different regulatory 
requirements to achieve the same standard. This final rule establishes 
requirements specific to hearing aids and although the requirements for 
OTC and prescription hearing aids are not the same, these requirements, 
along with other applicable requirements under the FD&C Act, provide 
for reasonable assurance of safety and effectiveness for

[[Page 50703]]

both categories of hearing aids (we note that in this document when we 
describe the requirements in Sec.  800.30 (21 CFR 800.30) or Sec.  
801.422 (21 CFR 801.422) as providing reasonable assurance of safety 
and effectiveness, we mean in conjunction with other applicable 
requirements under the FD&C Act).

A. Device Classification and Marketing

    We received several comments about the interplay among device 
classification regulations, the OTC Hearing Aid Controls, and premarket 
notification requirements. Generally, we agree that clarification on 
such issues will help ensure that manufacturers identify and follow the 
appropriate regulatory requirements for their devices.
    (Comment 1) Multiple comments requested clarification on the 
difference between self-fitting hearing aids classified under Sec.  
874.3325 (21 CFR 874.3325) and hearing aids that, through tools, tests, 
or software allow users to control the hearing aids and customize them 
to the users' hearing needs. Many such comments pointed out that the 
clarification will help manufacturers determine the applicability of 
premarket notification requirements and special controls.
    (Response) Under section 520(q)(1)(A) of the FD&C Act, an OTC 
hearing aid must be controllable by the user and customizable to the 
user's hearing needs. We interpret the requirement for customization to 
hearing needs to mean that the device must allow the user to cause 
frequency-dependent changes based on the user's preference. This is 
because a single profile for gain versus frequency is unlikely to 
accommodate the majority of hearing needs for perceived mild to 
moderate impairment. For example, a flat gain profile across frequency 
is unlikely to meet the hearing needs of users with sloping hearing 
loss, the kind of impairment often associated with aging, as well as a 
non-flat gain profile across frequency would. However, a flat gain 
profile across frequency may be preferable for some people with a 
different kind of hearing loss. In short, to have reasonable assurance 
of safety and effectiveness of OTC hearing aids, the devices must offer 
capabilities for a variety of perceived mild to moderate hearing 
impairments, and customization is the method or process that allows the 
user to match the device output to individual preference.
    We interpret the requirement for user control to mean that the user 
can access or select the output characteristics most significant to the 
user's hearing perception. For an OTC hearing aid, we consider these 
characteristics to include the frequency-dependent output profile and 
the output volume. The controls must allow the user to select the 
output volume and profile according to preference. The user may control 
the output profile, for example, with a physical toggle switch, a 
selection through a software interface, or providing preferences for 
software to select the optimal profile dynamically.
    FDA views customization as a more-general concept than self-
fitting. Fitting is a customization process that instills in the device 
frequency-dependent settings for the specific user. A self-fitting 
process instills frequency-dependent settings through the user 
interacting with the device or an accessory to the device. Self-fitting 
hearing aids incorporate technology, including software, that 
integrates user input with a self-fitting strategy and enables users to 
independently derive and customize their hearing aid fitting and 
settings (see Sec.  874.3325(a)). A self-fitting strategy is a fitting 
process, with the selected output profile intended to correspond to the 
user's audiogram more closely than a hearing aid that is not fitted. 
Many hearing aids that are customizable but not fitted have a limited 
set of standardized output profiles, often called ``presets.''
    In considering whether a hearing aid is self-fitting, FDA takes 
into account, among other things, the device's design and labeling. For 
purposes of distinguishing fitting a hearing aid from selecting among 
standardized output profiles, we focus on the determination and 
configuration of device settings that would be appropriate for the 
specific user, especially the frequency-dependent settings. (However, 
this focus does not exclude other factors that would still be relevant 
to determining intended use.) For example, a hearing aid outputting a 
preset likely would not be self-fitting, but a hearing aid that allowed 
the user to make frequency-dependent modifications to a preset to suit 
the user's preferences likely would be self-fitting.
    FDA recognizes that, because a preset may approach a user's ideal 
fitting, a device with several presets may be difficult to distinguish 
from a self-fitting device. However, we note that devices with a small 
number of presets, for example, three, are not ordinarily considered 
self-fitting when the user chooses the profile. However, a hearing aid 
with a greater number of profiles would more closely resemble a fitting 
process, with the selected output profile intended to correspond to the 
user's audiogram more closely, in which case the hearing aid likely 
would be considered self-fitting. Similarly, toggling between a small 
number of programs, for example, for noise reduction or scene 
selection, would generally not indicate self-fitting, but setting or 
adjusting compression knee points in frequency sub-bands, would tend to 
indicate self-fitting. Moreover, FDA would likely consider a device 
that includes self-fitting functionality to be self-fitting, regardless 
of whether the individual user takes advantage of the functionality.
    In sum, customization need not entail self-fitting, though self-
fitting is a kind of customization. Whether a hearing aid is self-
fitting depends on its intended use, which may be shown by, among other 
things, the device's design and labeling (see Sec.  801.4 (21 CFR 
801.4)). Some limited feature sets would not ordinarily cause a device 
to be a self-fitting hearing aid, while more advanced adjustment 
capability, especially for frequency-dependent settings, would tend to 
indicate that the device is a self-fitting hearing aid. FDA has made a 
minor revision to the requirement to provide specific instructions for 
use of tools, tests, or software to clarify that such instructions need 
not always refer to self-fitting; such instructions must include 
instructions for self-fitting only when the OTC hearing aid is a self-
fitting device (see final Sec.  800.30(c)(2)(vii)(B)).
    (Comment 2) Many comments urged FDA: to clarify that the definition 
of OTC hearing aids under section 520(q)(1)(A) of the FD&C Act is 
synonymous with the identification for self-fitting air-conduction 
hearing aids under Sec.  874.3325(a); to declare that self-fitting 
hearing aids are OTC devices; to declare that OTC hearing aids must be 
self-fitting; and/or to require that OTC hearing aid labeling bear the 
description ``self-fitting'' or a similar description.
    (Response) Although FDA expects that many OTC hearing aids will be 
self-fitting, we do not agree with these comments. As explained in the 
response to Comment 1, a hearing aid may be customizable in the manner 
required under section 520(q)(1)(A)(iii) of the FD&C Act yet not be 
intended to entail fitting. Thus, we are not requiring that OTC hearing 
aids be self-fitting devices.
    By extension, we are not requiring in this final rule that OTC 
hearing aids bear labeling that describes the devices as ``self-
fitting'' or a similar description. However, Sec.  801.61 (21 CFR 
801.61) still applies, and this provision requires, among other things, 
a statement of identity on the principal display panel of an OTC 
device. (See also the responses to Comment 21, regarding other 
considerations for self-fitting

[[Page 50704]]

capabilities of OTC hearing aids, and Comment 18, regarding identifying 
and selling OTC hearing aids.)
    Moreover, FDA intends that any hearing aid that uses the same 
fundamental scientific technology as those defined under Sec. Sec.  
874.3300(a) (21 CFR 874.3300(a)), 874.3305 (21 CFR 874.3305), and 
874.3325 (21 CFR 874.3325) qualify as an OTC hearing aid (provided it 
satisfies all other applicable requirements). Some future hearing aid 
device types may also meet the statutory definition (and satisfy all 
other applicable requirements) to be available over the counter. 
Requiring that OTC hearing aids be a currently classified air-
conduction hearing aid could have the effect of limiting the OTC 
category to current technologies rather than allowing the category to 
extend to new types of hearing aids.
    (Comment 3) Some comments requested clarification on what would 
qualify as ``tools, tests, or software'' for the purposes of 
controlling an OTC hearing aid and customizing it to the user's hearing 
needs. Similar comments requested that FDA clarify which legacy and 
wireless air-conduction hearing aids would satisfy the customization 
requirement but not be a self-fitting hearing aid.
    (Response) FDA interprets the requirement for tools, tests, or 
software broadly. We would, for example, consider a device that allows 
the user to cycle through output profiles with a push-button selector 
switch and to set the volume with a knob to meet the requirement. 
Should such a hearing aid be sufficiently customizable, and should it 
not incorporate wireless or self-fitting technology, then it would 
presumably be an air-conduction (``legacy'') hearing aid classified 
under Sec.  874.3300 and could be made available OTC. (See the response 
to Comment 1 for more about distinguishing customization and fitting.)
    (Comment 4) Comments expressed concerns about the potential to 
bypass premarket notification requirements and special controls if non-
self-fitting hearing aids could be later configured or modified, for 
example, if the manufacturer ``unlocks'' self-fitting software or 
provides the user with options for ``advanced settings'' or the like. 
They urged FDA to finalize rules to prevent such an outcome.
    (Response) Existing requirements already address modifications to 
devices, including hearing aids. Under Sec.  807.81(a)(3) (21 CFR 
807.81(a)(3)), a 510(k) is required if the device is about to be 
significantly changed or modified, namely, a major change or 
modification in the intended use or other kind of change or 
modification that could significantly affect the safety or 
effectiveness of the device. For example, a change or modification that 
causes a device to fall within a different classification regulation 
would be considered significant. Additionally, as explained in the 
response to Comment 1, aspects of the device's design and labeling can 
demonstrate the device's intended use (see Sec.  801.4). If a wireless 
air-conduction hearing aid later incorporates self-fitting technology 
(for example, by downloading software) or such technology is later made 
accessible to the user (for example, by ``unlocking'' after an 
additional purchase), such a change would almost certainly demonstrate 
that the modified device was a self-fitting air-conduction hearing aid 
classified under Sec.  874.3325 (assuming it was not a new device 
type). As such, it would be subject to the premarket notification 
requirements and special controls that apply to self-fitting air-
conduction hearing aids.
    In sum, a change in intended use or other aspect can cause a change 
in applicable requirements, and a device must comply with applicable 
regulatory requirements. As such, if a manufacturer intends to unlock 
or similarly upgrade its hearing aid with self-fitting technology such 
that it would fall within the self-fitting air-conduction hearing aid 
classification regulation, then prior to initial introduction into 
interstate commerce of the device, the manufacturer must comply with 
applicable requirements, including 510(k) requirements and compliance 
with the special controls. (See also the response to Comment 6 about 
the information a 510(k) should include.)
    (Comment 5) Several comments requested clarification on when 
manufacturers of OTC hearing aids would need to submit a premarket 
notification, also called a 510(k). Many of these comments urged FDA to 
require 510(k)s for all OTC hearing aids.
    (Response) FDA's existing requirements and related policies for 
submitting 510(k)s apply to hearing aids intended for OTC availability 
and use. We are not imposing additional general requirements for 
510(k)s.
    For manufacturers that have already legally introduced self-fitting 
air-conduction hearing aids into interstate commerce, changes to their 
devices to satisfy the OTC Hearing Aid Controls may require submission 
of a 510(k). However, in certain situations FDA intends not to enforce 
the requirement for a 510(k), as discussed in section VI on effective 
and compliance dates.
    This policy also applies to non-self-fitting devices (wireless air-
conduction and legacy air-conduction hearing aids). However, 
manufacturers of non-self-fitting devices may wish to consider the 
implications of using a test for somebody besides the user to fit the 
device. For devices intended for fitting based off of a user-supplied 
audiogram, a requirement for the involvement of a licensed person to 
produce the audiogram may cause the device not to be an OTC hearing aid 
as defined in section 520(q)(1)(A) of the FD&C Act.
    Further, if a manufacturer or other non-licensed person obtains 
hearing ability data to customize (or even fit) a hearing aid, the 
manufacturer should consider whether the instrument used to obtain the 
data is a diagnostic (or other) device. Using a hearing aid with a 
diagnostic device may implicate changes to a hearing aid concerning the 
compatibility or interoperability with other devices, including other 
components or accessories, that could significantly affect the hearing 
aid's risk profile, necessitating a 510(k).
    Notwithstanding these general principles, in each case, 
manufacturers should evaluate any changes in light of FDA's guidance, 
``Deciding When to Submit a 510(k) for a Change to an Existing 
Device,'' issued October 25, 2017, which describes specific changes 
that generally do or do not require premarket notification.\1\
---------------------------------------------------------------------------

    \1\ The document is available online at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/deciding-when-submit-510k-change-existing-device.
---------------------------------------------------------------------------

    To illustrate: If a manufacturer of a wireless air-conduction 
hearing aid updates device labeling and adds a user self-assessment 
test intending the test to enable the user to independently customize 
and derive the fitting and settings (the device is intended to entail 
fitting), then FDA would anticipate the manufacturer would need to 
submit a 510(k). FDA's guidance document lists several considerations 
that would likely apply. In this example, the changes included:
    the directions for use, including the use and application of the 
self-test to the device settings (see A4 of the aforementioned guidance 
on deciding when to submit a 510(k), ``Could the change affect the 
directions for use of the device?'');
    the control mechanism and/or operating principle (see B2 of the 
same guidance, ``Is it a control mechanism, operating principle, or 
energy type change?'');
    the device's design, specifically changes to its performance, 
components

[[Page 50705]]

or accessories, and human factors of the interface (see B5 of the same 
guidance, ``Is it any other change in design (e.g., dimensions, 
performance specifications, wireless communication, components or 
accessories, or the patient/user interface)?''); and
    those that significantly affect its use, potentially necessitating 
clinical validation data (see B5.1 and B5.3 of the same guidance, 
``Does the change significantly affect the use of the device?'' and 
``Are clinical data necessary to evaluate safety or effectiveness for 
purposes of design validation?'').
    Each of those changes in this example could require a 510(k), 
depending on the specifics of the changes. In deciding whether to 
submit a 510(k), manufacturers may want to review the guidance in its 
entirety since the considerations for the example are not exhaustive 
and may or may not be applicable, depending on the specific device. 
Manufacturers may also want to review FDA's guidance, ``Deciding When 
to Submit a 510(k) for a Software Change to an Existing Device,'' 
issued October 25, 2017.\2\
---------------------------------------------------------------------------

    \2\ The document is available online at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/deciding-when-submit-510k-software-change-existing-device.
---------------------------------------------------------------------------

    Note that, although a wireless air-conduction hearing aid 
classified under Sec.  874.3305, or a legacy air-conduction hearing aid 
classified under Sec.  874.3300, is exempt from requirements for 
premarket notification, some changes could exceed the limitations of 
exemption under Sec.  874.9 (21 CFR 874.9), depending on the specifics.
    (Comment 6) Commenters requested clear guidance on the specific 
information manufacturers would need to submit in a 510(k) to bring 
devices to market quickly, avoiding unnecessary delays or unnecessarily 
hindering innovation.
    (Response) In addition to the required information specified in the 
510(k) procedures under 21 CFR part 807, subpart E, the specific 
information that a manufacturer should submit will vary based on the 
new device or specific changes made to an existing device. Therefore, 
providing specific guidance for all manufacturers in this final rule is 
not feasible. However, FDA's usual policies on the content and format 
of 510(k)s apply to submissions for hearing aids, including for 
modifications made to satisfy applicable special controls and the OTC 
Hearing Aid Controls. Manufacturers may wish to review publicly 
available information regarding the De Novo classification of self-
fitting air-conduction hearing aids. (See the response to Comment 5 
regarding when to submit a 510(k).)
    In the case of OTC hearing aids, we anticipate that many 
manufacturers that submit a 510(k) could avail themselves of the 
Abbreviated 510(k) Program, as described in FDA's guidance of that 
name, issued on September 13, 2019.\3\ Should a manufacturer 
incorporate self-fitting (or other) technology into one of its existing 
legacy or wireless devices and need to submit a 510(k), we would expect 
that the manufacturer could leverage the similarity with exempt devices 
as a least-burdensome way to obtain marketing authorization for the 
device that is not exempt from premarket notification requirements. 
Manufacturers of existing devices may not need to re-address questions, 
for example, related to electromagnetic compatibility (EMC), provided 
the manufacturer has not made changes that would affect EMC and require 
a 510(k) under our usual policies. Further, summary reports describing 
how the hearing aid complies with applicable special controls may be 
especially useful in addressing clinical data that support the 
effectiveness of the self-fitting strategy, usability testing, and 
software verification, validation, and hazard analysis.
---------------------------------------------------------------------------

    \3\ The document is available online at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/abbreviated-510k-program.
---------------------------------------------------------------------------

    Moreover, manufacturers that have decided to submit a 510(k), 
whether traditional or abbreviated, may wish to review FDA's guidance, 
``Format for Traditional and Abbreviated 510(k)s,'' issued on September 
13, 2019.\4\ The guidance provides a general framework for the format 
and content of a 510(k).
---------------------------------------------------------------------------

    \4\ The document is available online at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/format-traditional-and-abbreviated-510ks.
---------------------------------------------------------------------------

    (Comment 7) Commenters requested that FDA exempt certain kinds of 
hearing aids, including self-fitting devices, from premarket 
notification requirements. Some posited that FDA would accrue 
sufficient experience with self-fitting air-conduction hearing aids to 
evaluate the potential for 510(k) exemption 2 years after the effective 
date of this final rule. Others requested that FDA explain how OTC 
hearing aids will become 510(k)-exempt.
    (Response) FDA's usual policies for exempting devices from 
premarket notification requirements apply to self-fitting air-
conduction hearing aids. Stakeholders may wish to review FDA's 
guidance, ``Procedures for Class II Device Exemptions from Premarket 
Notification,'' issued February 19, 1998.\5\ The guidance lists several 
factors that FDA may consider for exemption, including:
---------------------------------------------------------------------------

    \5\ The document is available online at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/procedures-class-ii-device-exemptions-premarket-notification-guidance-industry-and-cdrh-staff.

    The history (if any) of false or misleading claims or of risks 
associated with inherent characteristics of the device, such as 
device design or materials (FDA considers the risks associated with 
false or misleading claims, and the frequency, persistence, cause, 
or seriousness of the inherent risks of the device);
    How characteristics of the device necessary for its safe and 
effectiveness performance are well established;
    How changes in the device that could affect safety or 
effectiveness will either be readily detectable or not materially 
increase the risk of injury, incorrect diagnosis, or ineffective 
treatment;
    How any changes to the device would not be likely to result in a 
change in the device's classification; and
    The role of the limitations of exemption.

    Although the amount of time that has passed since the 
classification of the device in question may affect how FDA views the 
factors, for example, the history of false or misleading claims, the 
amount of time since classification is not generally directly relevant. 
That is, 2 years after the effective date of this final rule may or may 
not afford sufficient experience and information to exempt all self-
fitting air-conduction hearing aids from premarket notification 
requirements. We did not propose to exempt self-fitting air-conduction 
hearing aids and are not doing so now (see 86 FR 58150 at 58171).

B. Scope (Sec.  800.30(a))

    We received several comments on which devices should be subject to 
the OTC Hearing Aid Controls and, conversely, which devices should be 
prescription. Sometimes these comments referred to definitions rather 
than scope. In this section, we respond to comments on scope, including 
comments where the suggested changes to the definitions affect the 
scope. The next section of this document, specifically for definitions, 
responds to comments that relate more directly to the clarity of terms 
or the usefulness of different terms.
    (Comment 8) Comments requested clarification on the applicability 
of the OTC Hearing Aid Controls in circumstances in which software 
intended for compensation for hearing loss operates or adapts the 
output of other hearing products such as earbuds or headphones.

[[Page 50706]]

    (Response) To date, FDA has not classified a device that adapts the 
output of other hearing products, such as earbuds, to compensate for 
perceived mild to moderate hearing impairment, including a device that 
accomplishes this through software. Overall, FDA encourages innovation 
of hearing products that are safe and effective and, to that end, 
intends to consider developing guidance to provide clarification on the 
applicability of laws and regulations implemented by FDA in 
circumstances where software would operate or adapt the output of 
hearing products to compensate for perceived mild to moderate hearing 
impairment. However, considering that in such circumstances, the 
software might be distributed separately from the hearing product, FDA 
has added requirements in the OTC Hearing Aid Controls for software 
device labeling. Similar requirements for software device labeling were 
also added to Sec.  801.422. (See Additional Revision 3 in section 
III.D.6 describing the labeling requirements for hearing aid 
software.\6\) The software device labeling requirements take into 
consideration certain aspects associated with software not distributed 
with the hearing product, including that such software may not be 
provided in a package.
---------------------------------------------------------------------------

    \6\ We refer to ``additional revisions'' to indicate changes 
that FDA has made in further consideration of comments and the 
issues involved in this rulemaking, but that are additional to the 
suggestions made explicitly in comments. We have numbered the 
Additional Revisions in the order that they appear in this document, 
which depends upon the subject of the revision--definitions, outside 
package labeling, etc.--not the order in which the Additional 
Revisions are cross-referenced in our responses to comments.
---------------------------------------------------------------------------

    (Comment 9) A comment questioned whether a software interface for 
professionals such as audiologists or hearing instrument specialists 
would cause a hearing aid to be a prescription device if the 
professional could adjust the output in excess of the applicable limit.
    (Response) If a manufacturer markets an OTC hearing aid that meets 
the OTC hearing aid definition and complies with all applicable 
requirements of the OTC Hearing Aid Controls--but also offers an 
additional separate feature, a software interface for professionals 
that allows only licensed persons to adjust the device output--FDA 
likely would not consider the hearing aid to be a prescription device, 
but the software interface for professionals would be a prescription 
device and therefore must comply with Sec. Sec.  801.422 and 801.109. 
(Note that a software interface for an air-conduction hearing aid, 
which is the subject of this response, would be distinct from the 
hypothetical hearing-aid software device, described in the response to 
Comment 8, that operates or adapts the output of other hearing products 
such as earbuds or headphones.)
    However, the intended use of a device can change after initial 
introduction into interstate commerce (see Sec.  801.4). If a 
manufacturer intends prescription uses of a device, the manufacturer 
should consider how to ensure the device will satisfy all applicable 
requirements, for example, prescription labeling requirements. Should a 
manufacturer provide or allow users, and not just licensed persons, 
ready access to an interface that allows the user to configure the 
device to provide output in excess of that allowed for OTC hearing 
aids, this would indicate the device is intended for users (not limited 
to licensed persons) to set an excessively high output. FDA would be 
more likely to determine that the intended use was not for perceived 
mild to moderate hearing impairment. Additionally, such a device would 
not meet the required output limits in the OTC Hearing Aid Controls. 
Therefore, such a device would be considered a prescription hearing aid 
and must meet applicable requirements, including those under Sec. Sec.  
801.422 and 801.109; otherwise, it would be in violation of the FD&C 
Act.
    (Comment 10) Some comments suggested that FDA limit the scope of 
the OTC Hearing Aid Controls to devices intended only for people with 
perceived mild, but not moderate, hearing impairment. Some of these 
comments suggested that perceived moderate hearing impairment requires 
the involvement of a licensed person for successful treatment, and as 
such, hearing aids intended for perceived moderate hearing impairment 
should not be available over the counter.
    (Response) FDA disagrees that the involvement of a licensed person 
is necessary for hearing aids intended for perceived moderate hearing 
impairment. We are retaining perceived moderate hearing impairment 
within the scope of the OTC Hearing Aid Controls. The question of 
whether the involvement of a licensed person would benefit an 
individual's hearing healthcare is separate from whether the individual 
would benefit from the use of an OTC hearing aid. In other 
circumstances, the availability and use of OTC medical products to 
treat an illness or impairment does not imply the illness or impairment 
is not serious. Similarly, the availability and use of OTC medical 
products does not negate the benefit of a licensed person's 
involvement. FDA considers the use of OTC hearing aids, even when 
intended for perceived moderate hearing impairment, to be such a set of 
circumstances.
    Further, by statute, OTC hearing aids include devices that are 
intended to compensate for perceived moderate hearing impairment, and 
such devices are to be available to consumers over the counter without 
the involvement of a licensed person (see 21 U.S.C. 360j(q)(1)(A)(ii) 
and (v)). Section 709(b) of FDARA requires FDA to issue regulations 
that include, among other requirements, provisions for reasonable 
assurance of safety and effectiveness. This rule will provide 
reasonable assurance of safety and effectiveness, without the 
involvement of a licensed person, for OTC hearing aids, including for 
hearing aids intended for perceived moderate hearing impairment.
    Thus, while the involvement of a licensed person may benefit people 
with perceived hearing impairment, whether of a mild or moderate 
degree, FDA does not agree that consumers must attempt to obtain such a 
benefit prior to purchasing hearing aids over the counter. FDA is 
maintaining perceived moderate hearing impairment within the scope of 
the OTC Hearing Aid Controls.
    (Comment 11) Some comments objected to the inclusion of 
``perceived'' when referring to the kind of hearing impairment for 
which OTC hearing aids are intended. The commenters express concern 
that a person's perception of hearing loss may be too subjective, and 
that the use of OTC hearing aids should be based on more objective 
measures. Some of the comments suggested that FDA require prospective 
users to obtain audiograms, which are graphs or test results showing 
the person's ability to hear different frequencies, from a licensed 
person prior to purchasing an OTC hearing aid.
    Besides obtaining an audiogram, other comments suggested a more 
general testing or examination requirement by a licensed person for 
prospective users, prior to purchase. In this way, these commenters 
suggested, OTC hearing aid users would have more certainty that OTC 
hearing aids would appropriately compensate for their hearing 
impairment, and/or the prospective user does not have an underlying, 
medically treatable cause of hearing impairment, for example, one of 
the ``red flag'' conditions. (A ``red flag'' condition is a sign or 
symptom that should prompt a consultation with a doctor, preferably an 
ear-nose-throat doctor.)
    (Response) FDA disagrees. We are retaining ``perceived'' in 
reference to a

[[Page 50707]]

person's degree of hearing impairment and the intended use of OTC 
hearing aids for legal and policy reasons. The term ``perceived'' is 
used in section 520(q)(1)(A)(ii) of the FD&C Act to describe the 
intended use for OTC hearing aids. Moreover, objective measurements of 
hearing impairment are not necessary for reasonable assurance of safety 
and effectiveness of OTC hearing aids.
    Relying on perceptions of hearing impairment is also appropriate 
because the type and degree of impairment exist on a continuum, as does 
a person's perception and experience of the impairment. A given degree 
(quantification) of hearing impairment will not necessarily reflect 
whether an OTC hearing aid is likely to benefit a specific individual. 
We have therefore focused on communication and other perceptual 
experiences (such as listening to music) in which an intended user is 
likely to suspect or notice--that is, to perceive--hearing impairment. 
FDA expects this approach based on perception to assist users and 
prospective users better than an approach that does not.
    Additionally, while FDA agrees that an audiogram would provide a 
prospective user with an objective measure of hearing impairment, we do 
not agree that the scope of the OTC Hearing Aid Controls should include 
only hearing aids for objectively measured impairments. Such a 
limitation is counter to the objectives of section 709 of FDARA, 
including making available hearing aids OTC, without the involvement of 
a licensed person, to consumers through in-person transactions, by 
mail, or online.
    We acknowledge that this places some onus on users and prospective 
users. However, this is the case with respect to OTC availability of 
many medical products, and we are establishing requirements that will 
provide reasonable assurance of safety and effectiveness for such 
availability of hearing aids. We also observe that, while an audiogram 
might help a user or a licensed person tailor the hearing aid, or 
initially select it, even a hearing health care provider would still 
ask the user how the device sounds to the user. The user's perception 
would help the hearing health care provider make further adjustments. A 
person's desire to seek and use hearing aids depends more directly upon 
that person's perception of their hearing impairment than the 
definitive degree of impairment, and even a licensed person fitting and 
adjusting the device would also account for the user's perception. (See 
also the response to Comment 24 about defining hearing loss 
numerically.)
    Further, FDA has included information in the labeling requirements 
for OTC hearing aids intended to help users understand whether the 
devices are suitable based on their perceptions, realistic expectations 
for hearing aid use, and suggestions on when to obtain professional 
assistance before and after purchase. Should prospective OTC hearing 
aid users still feel uncertain about their perceptions of impairment, 
notwithstanding the availability of the aforementioned information, 
they may choose to obtain or undergo professional testing prior to 
purchase.
    (Comment 12) Some commenters suggested that FDA require a 
prescription for OTC hearing aids.
    (Response) FDA disagrees. Requiring a prescription to purchase an 
OTC hearing aid would be contrary to the purposes of this rulemaking, 
the definition of OTC hearing aids in the FD&C Act, and FDARA which 
includes the mandate to establish requirements for hearing aids to be 
available over the counter (see section 520(q)(1)(A)(v) of the FD&C Act 
and section 709(b)(1) and (b)(2)(D) of FDARA). It also would negate the 
probable health benefits created by wider availability of hearing aids, 
as we described in the proposal (see 86 FR 58150 at 58152).
    (Comment 13) Multiple comments suggested FDA remove dispensing from 
the list of commercial activities that FDA included in the definition 
of ``licensed person.'' The definition listed commercial activities 
involving OTC hearing aids for which a State or locality could not 
require the involvement of a licensed person. For example, a State 
could not require a person representing as a dispenser of OTC hearing 
aids to undertake special licensing or equivalent activities solely for 
that reason.
    Such comments cited various reasons, for example, that State 
regulatory regimes impose obligations on people representing as 
dispensers, so referring to the term in the OTC Hearing Aid Controls 
would create an inconsistency with State regulatory requirements. Other 
comments pointed out that people expect dispensers to have licenses, 
and FDA's regulations would be inconsistent with such expectations. 
Still others cited the need for dispensers to acquire and/or 
demonstrate qualifications prior to dispensing OTC hearing aids.
    Similar comments suggested that FDA instead refer to dispensers as 
``sellers,'' ``vendors,'' ``merchants,'' or other such terms. These 
terms, the comments assert, would distinguish salespeople from hearing 
health care providers.
    (Response) FDA is not modifying the scope of the OTC Hearing Aid 
Controls or the definition of ``licensed person'' to exclude dispensing 
of OTC Hearing Aids. As we explained in the proposed rule, FDARA lists 
certain activities that may be undertaken with respect to OTC hearing 
aids for which a State or locality cannot require the involvement of a 
licensed person (see 86 FR 58150 at 58158). One such activity that 
FDARA explicitly lists is the dispensing of OTC hearing aids. This 
means that, under Federal law, a State or locality cannot require a 
dispenser of OTC hearing aids to undertake special licensing or 
equivalent activities because that would in essence require the 
involvement of a licensed person, contrary to section 709(b)(2)(D) of 
FDARA and section 520(q)(1)(A)(v) of the FD&C Act.
    Additionally, in establishing the OTC category for hearing aids, we 
have developed requirements to provide reasonable assurance of safety 
and effectiveness for OTC hearing aids without the involvement of a 
licensed person (see section 709(b)(2) of FDARA). Imposing special 
licensing requirements or equivalent activities, therefore, is not 
necessary to provide reasonable assurance of safety and effectiveness 
of OTC hearing aids. Although not required, a purchaser of OTC hearing 
aids can still seek the assistance of a licensed person when selecting 
a hearing aid.
    Since a person may dispense OTC hearing aids without a specialized 
license or the need to involve a licensed person, referring to 
dispensers by another term such as ``vendor'' or ``seller'' is not 
necessary to distinguish dispensing from activities requiring 
specialized licensure or the involvement of a licensed person. 
Moreover, we have previously defined dispensers as persons engaged in 
the sale, lease, or rental of hearing aids (see prior Sec.  
801.420(a)(3)). The regulations we are finalizing in this rulemaking 
use essentially the same definition. In sum, using alternative titles 
for dispensers may serve to confuse consumers by unnecessarily 
establishing another term for a legally permissible activity as well as 
incorrectly implying that FDA's interpretation of the term has changed.
    FDA recognizes that State and local requirements sometimes 
incorporate the term ``dispenser,'' and multiple States impose 
requirements on account of dispensing hearing aids. However, FDARA 
section 709(b)(4), to summarize, provides that no State or local 
government shall continue in effect certain State or local requirements 
that are different from, in addition to, or otherwise not identical to 
the

[[Page 50708]]

regulations issued under FDARA section 709(b). Thus, regardless of 
whether a State or locality amends or otherwise updates its 
requirements, it may not continue in effect the inconsistent 
requirements prior to their amendment or repeal.
    As we explained in the proposal, despite the fact that licensure is 
not required for dispensing OTC hearing aids, some persons may 
voluntarily identify as a ``licensed dispenser,'' (see 86 FR 58150 at 
58168). Although a State or locality could not require dispensers (or 
other persons) to undertake special licensing solely on account of 
commercial activity involving OTC hearing aids, a State or locality 
could still establish licensure criteria that would apply to those 
voluntarily identifying as licensed persons. In such a case, the 
dispenser's identification as a licensed person would imply that the 
dispenser complies with applicable State or local licensing 
requirements, albeit voluntarily. (See also the responses to Comment 
15, discussing other licensing considerations, and Comment 127, 
discussing the involvement of a licensed person for prescription 
hearing aids.)
    In sum, in light of Federal statutory and other requirements, 
including those that provide reasonable assurance of safety and 
effectiveness of OTC hearing aids, FDA is not narrowing the scope of 
the OTC Hearing Aid Controls to exclude dispensing. This does not, 
however, prevent dispensers of OTC hearing aids from voluntarily 
subjecting themselves to State or local licensing requirements to 
obtain a license (or its equivalent).
    (Comment 14) Comments suggested that OTC hearing aids be available 
for all degrees of hearing impairment, including degrees greater than 
moderate. Some of these comments further noted that Medicare does not 
currently pay for or reimburse the cost of hearing aids. As such, the 
comments asserted that OTC hearing aids should be usable as lower-cost 
alternatives to prescription hearing aids for individuals with more-
profound impairments.
    (Response) For the reasons explained in the response to Comment 10, 
FDA is establishing requirements for perceived mild to moderate hearing 
impairment. Thus, the appropriate device output limit that we are 
establishing would not extend to hearing impairment that would require 
a greater output than that which is appropriate for perceived moderate 
hearing impairment.
    However, devices of the same type may generally be intended either 
for prescription or OTC use. For example, a manufacturer marketing an 
OTC wireless hearing aid could also market another wireless hearing aid 
with a higher output than that permitted for OTC hearing aids. This 
higher output would render it a prescription device. As with other 
products that have differing uses but share manufacturing similarities, 
a hearing aid manufacturer may be able to realize economies of scale by 
selling an OTC version and a prescription version of hearing aids that 
fall within the same type, which in turn could lower the prices for 
prescription hearing aids. (See also the response to Comment 17 about 
limitations on FDA's authority to require reimbursement for devices.)
    (Comment 15) Some comments suggested FDA define which activities 
involving hearing aids would require licensure.
    (Response) FDA does not generally determine which activities 
involving medical products require licensure. However, section 
709(b)(4) of FDARA lists several activities for which States or 
localities may not require specialized licensure for, or the 
involvement of a licensed person in, commercial activity involving OTC 
hearing aids. These listed activities are the servicing, marketing, 
sale, dispensing, use, customer support, or distribution of OTC hearing 
aids through in-person transactions, by mail, or online. As we 
explained in the proposal, we interpret the listed activities broadly, 
so for example, the term ``sale'' would include leases or rentals (see 
86 FR 58150 at 58165).
    States usually determine the requirements for licensure or the 
involvement of licensed persons. States may still do so with respect to 
hearing aids when not prohibited by section 709(b)(4) of FDARA (and 
other applicable laws). Where section 709(b)(4) of FDARA does not list 
an activity, when construing the terms broadly, a State may require 
licensure for that activity as it relates to OTC hearing aids. We note 
that the proposal provided a discussion and some examples (see 86 FR 
58150 at 58167-58168). Thus, for example, a State may require a license 
for a hearing aid fitter, because ``fitting'' is not listed among the 
activities in section 709(b)(4) of FDARA, and we do not interpret any 
of the listed activities to include fitting. A person could not be a 
fitter in that State, even for OTC hearing aids, without a license. 
However, the State could not require a hearing aid fitting prior to a 
user purchasing an OTC hearing aid because that would restrict or 
interfere with commercial activity involving OTC hearing aids. See the 
response to Comment 13 for further explanation.
    Thus, a State may still establish criteria for licensing dispensers 
should a person voluntarily decide to become a licensed dispenser of 
OTC hearing aids. In other words, although a State cannot require a 
license for dispensing OTC hearing aids, a State can establish what a 
person must do to obtain, and claim to have, a license for dispensing 
hearing aids. FDA expects that States may wish to continue in effect 
licensing requirements to dispense prescription hearing aids, and we 
expect that some hearing aid dispensers may wish to obtain a license in 
the event they desire to advertise as ``licensed'' and/or to sell 
prescription hearing aids in addition to OTC hearing aids.
    (Comment 16) Some comments urged FDA to limit the scope of OTC 
availability as much as possible, at least in the beginning. These 
comments conveyed concerns for the absence of a licensed person in 
various roles, including education and counseling. One such comment 
suggested that a more-limited scope would be easier to broaden later 
than the reverse, limiting a broader scope.
    (Response) In the proposed rule, we explained that several barriers 
likely impede people's access to hearing aids, including among others, 
Federal and State regulatory requirements (see 86 FR 58150 at 58152, 
58154). We are undertaking this rulemaking in part to remove or reduce 
such barriers to access by establishing requirements that will provide 
reasonable assurance of safety and effectiveness while encouraging 
broad availability (see 86 FR 58150 at 58158). Moreover, we received a 
wealth of thoughtful and nuanced comments about the scope of the OTC 
Hearing Aid Controls, including this Comment, and we have determined 
that a more-restrictive approach is not necessary for reasonable 
assurance of safety and effectiveness of OTC hearing aids. Considering 
our purpose to broaden access and our determinations regarding 
reasonable assurance of safety and effectiveness, we do not agree that 
narrowing the scope of the OTC Hearing Aid Controls, with the intention 
of considering a broader scope later, is currently an appropriate 
strategy.
    (Comment 17) Some comments noted the role of health insurers, 
including Medicare, in a person's ability to obtain hearing aids. 
Comments suggested that FDA focus on payments or reimbursements for 
hearing aids, potentially including financial incentives.
    (Response) FDA does not have authority to require payors to pay for 
or reimburse the cost of hearing aids or to offer financial incentives 
to obtain the

[[Page 50709]]

devices. However, we intend this rule, among other ends, to broaden 
access to hearing aids by eliminating certain kinds of requirements 
that likely add to the cost of accessing the devices. For example, we 
are establishing rules to make OTC hearing aids available without the 
involvement of a licensed person.

C. Definitions (Sec. Sec.  800.30(b) and 801.422(b))

    This section focuses on explaining the final definitions. 
Generally, commenters sought clarity, and we have generally accepted or 
declined suggestions with the goal of improving clarity of the 
definitions.
    (Comment 18) Multiple comments proposed that FDA use another name 
to identify OTC hearing aids. For example, some comments proposed 
``over-the-counter hearing device,'' ``self-fit over-the-counter 
hearing device,'' ``hearing amplifiers,'' and ``hearing devices.'' 
Generally, these commenters sought to avoid confusion with existing 
devices for both consumers and State regulators. Otherwise, commenters 
believed, consumers may be misled into believing that OTC hearing aids 
are equivalent to prescription hearing aids with respect to 
performance, safety, and effectiveness, and there may be regulatory 
issues for State licensing boards. Other comments argued that the 
availability of OTC devices through retailers such as grocery or 
department stores would suggest that these devices are not hearing 
aids, so referring to them as such would be inappropriate.
    By identifying OTC hearing aids in a different way, consumers, 
regulators, and other stakeholders would, the comments argued, have a 
clearer indication of devices subject to the new regulatory category. 
Many such comments noted that the use of a term other than ``hearing 
aid'' was recommended by the National Academies of Sciences, 
Engineering, and Medicine (NASEM) in their report, ``Hearing Health 
Care for Adults: Priorities for Improving Access and Affordability,'' 
and by the Hearing Care Associations in their Consensus Paper, 
``Regulatory Recommendations for OTC Hearing Aids: Safety & 
Effectiveness'' (Ref. 7).
    (Response) FDA will continue to use the term ``hearing aids'' to 
refer to the OTC and prescription devices subject to this rulemaking 
because the use of this term is appropriate. Hearing aids, whether OTC 
or prescription, are wearable sound-amplifying devices intended to 
compensate for impaired hearing. The term ``hearing aid'' describes 
several device types reflected in various classification regulations. 
Although OTC hearing aids use air-conduction technology, prescription 
hearing aids may do so as well (for example, an air-conduction hearing 
aid that provides a higher output than that specified in the OTC 
Hearing Aid Controls would be prescription). Therefore, the use of the 
term ``hearing aid'' is appropriate to reflect both OTC and 
prescription devices that fall within the same device type (for 
example, wireless air-conduction hearing aids under Sec.  874.3305). 
Moreover, section 520(q)(1)(A) of the FD&C Act explicitly uses and 
defines the term ``over-the-counter hearing aid[s],'' and section 
709(b)(1) of FDARA requires the establishment of ``a category of over-
the-counter hearing aids.'' Thus, referring to the devices by a 
different name would not only be inconsistent with the applicable 
classification regulations and statutes, but also FDA expects that 
doing so would cause confusion and uncertainty for consumers 
considering purchasing an OTC hearing aid.
    Further, we expect this rulemaking to broaden the kinds of 
retailers that sell OTC hearing aids, helping to increase the 
availability of the devices. By extension, the availability of OTC 
hearing aids (by that name) in grocery and department stores would help 
fulfill one of the purposes of this final rule. Moreover, many 
technologically similar products are available and go by several names, 
including ``personal amplifier.'' Based on their intended use(s), some 
of these may not be devices and/or meet applicable requirements for 
devices, yet they may appear to some prospective purchasers to be 
suitable alternatives to safe and effective devices.\7\ We expect that 
consumers are familiar with the name ``hearing aid,'' and using that 
name will better support broadened use of the devices. At the same 
time, we expect that introducing yet another name for a similar 
technology, albeit regulated as a device, would only serve to increase 
confusion in the marketplace because prospective purchasers may think 
that a hearing aid could be marketed under other names, including those 
used for products that do not meet applicable device requirements. 
Thus, we have determined that the best way to indicate whether the 
device is subject to this rulemaking is to use the name ``hearing aid'' 
as used for the device types in the applicable classification 
regulations, and the name that is established in the FD&C Act and 
FDARA, OTC hearing aids.
---------------------------------------------------------------------------

    \7\ FDA is finalizing a guidance alongside this rulemaking to 
help stakeholders distinguish hearing aids from PSAPs. To summarize, 
a PSAP is an electronic product intended for non-hearing-impaired 
people to amplify sounds in certain environments. A PSAP is not 
intended to aid with or compensate for impaired hearing.
---------------------------------------------------------------------------

    To assist consumers further, as well as ease determining the 
applicability of the OTC Hearing Aid Controls, we are modifying the 
labeling and conditions for sale for OTC hearing aids. See Additional 
Revisions 2 (section III.D.3) and 4 (section III.G), respectively, for 
further explanation.
    Although the technical specifications are different for OTC hearing 
aids and prescription hearing aids, as explained elsewhere in this 
document, FDA believes the technical specifications for each category 
are appropriate. Additionally, information on the technical 
specifications is required to be provided in the device labeling. FDA 
believes that OTC hearing aids that comply with Sec.  800.30 and other 
applicable requirements (for example, Quality System requirements) will 
have reasonable assurance of safety and effectiveness for people aged 
18 and older with perceived mild to moderate hearing impairment.
    (Comment 19) A comment suggested that the definition of ``hearing 
aid'' should include an explicit statement that PSAPs are not hearing 
aids. The comment mentioned the draft guidance we are finalizing 
concurrently with this final rule, ``Regulatory Requirements for 
Hearing Aid Devices and Personal Sound Amplification Products,'' which 
is published elsewhere in this issue of the Federal Register and is 
also available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/regulatory-requirements-hearing-aid-devices-and-personal-sound-amplification-products, and characterized the draft of 
the guidance as ``provid[ing] essential distinctions between [hearing 
aids] and PSAPs.''
    (Response) FDA agrees that distinguishing between hearing aids 
(devices) and PSAPs (non-devices) can be an important interest for 
purchasers, manufacturers, and other stakeholders. We are finalizing 
requirements for the principal display panel on the package of an OTC 
hearing aid to bear the marks ``OTC'' and ``hearing aid'' (see 
Additional Revision 2 in section III.D.3). We are also finalizing a 
corresponding condition for sale that sellers may only make a hearing 
aid available OTC when its package bears the requisite marks (see 
Additional Revision 4 in section III.G). Moreover, we are finalizing 
the aforementioned draft guidance document, intended to describe 
hearing aids, PSAPs, their respective intended uses, and the regulatory 
requirements that apply to both types of products.

[[Page 50710]]

    We are not, however, modifying the definition of ``hearing aid'' to 
state that PSAPs are not hearing aids. As we explained in the proposed 
rule, the name of a product on its own would not ordinarily demonstrate 
intended use (86 FR 58150 at 58154). Thus, merely excluding PSAPs from 
the definition of hearing aid does not remove a product from device 
regulation under the FD&C Act if, for example, its labeling 
demonstrated that the product was intended to compensate for hearing 
loss. We think the actions we are taking will better assist 
stakeholders to distinguish between products than modifying the 
definition of ``hearing aid'' in the OTC Hearing Aid Controls.
    (Comment 20) Some comments suggested adding definitions to the 
classification regulation for self-fitting hearing aids (Sec.  
874.3325). For example, comments suggested FDA define ``programming the 
hearing aid'' and ``self-fitting strategy.''
    (Response) FDA is not adding definitions for purposes of the self-
fitting air-conduction hearing aid classification at this time. In 
considering possible definitions to add, including those suggested in 
the comments, we sought to balance clarity with flexibility. The 
phrasing of Sec.  874.3325(a) is intended to cover a range of 
technologies, both present and future, without unduly constraining 
innovation. For example, the regulation refers to a ``self-fitting 
strategy,'' rather than a more prescriptive description. Under this 
regulation, manufacturers could choose different strategies to achieve 
self-fitting by the user while still being substantially equivalent to 
other devices of the same type. After considering the comments, we have 
decided not to constrain the classification further.
    However, we recognize that these commenters desired to clarify the 
classification of different types of air-conduction hearing aids, 
including the applicability of special controls and premarket 
notification requirements. We have provided our thinking and 
expectations in section V.A. of this document to address such concerns. 
Further, FDA may issue guidance on this subject in the future following 
our Good Guidance Practices and inviting additional comments (see 21 
CFR 10.115).
    (Comment 21) Several comments requested that FDA define self-
fitting hearing aids in such a way as to clarify that the devices must 
be manipulable by the general public. Many of these comments showed 
concern about predatory business practices, through which manufacturers 
might prevent users from customizing device output, because they did 
not view self-fitting capability as clearly required for OTC hearing 
aids.
    (Response) FDA agrees that OTC hearing aids must be somehow 
manipulable by lay users; however, we are not adopting these 
suggestions.
    As explained in the response to Comment 1, not all OTC hearing aids 
are self-fitting devices classified under Sec.  874.3325. Thus, FDA 
declines to define self-fitting hearing aids in the way suggested by 
comments.
    Further, modifying the self-fitting hearing aid classification 
regulation in the suggested way is not necessary. By definition, self-
fitting air-conduction hearing aids allow users to program their 
hearing aids, and the devices integrate user input with a self-fitting 
strategy and enable users to independently derive and customize their 
hearing aid fitting and settings. Should users themselves be unable to 
derive or customize the fitting and settings independently, or program 
their hearing aids, FDA likely would not consider it a self-fitting 
air-conduction hearing aid.
    More generally, section 520(q)(1)(A)(iii) the FD&C Act defines an 
OTC hearing aid, in part, as a device that allows the user to control 
the hearing aid and customize it to the user's hearing needs. Should 
users of a hearing aid be unable to control and customize the device in 
the manner required, the hearing aid would not be an OTC hearing aid as 
defined in the FD&C Act or final Sec.  800.30, and thus, would be a 
prescription device.
    FDA also notes that the FD&C Act, the OTC Hearing Aid Controls, and 
the classification regulation for self-fitting air-conduction hearing 
aids all refer to the ``user'' of the hearing aid. Referring to 
manipulation by the general public may not accurately or adequately 
represent the intended user(s) of a hearing aid because the intended 
user(s) may differ in significant ways from the general population. 
However, FDA agrees that manufacturers should generally assume that 
users are laypeople (not experts) regarding OTC hearing aids, and we 
are finalizing the definition of ``tools, tests, or software'' as 
proposed. The definition specifically requires that a lay user be able 
to control and customize an OTC hearing aid. Further, because OTC 
hearing aids are not prescription devices (and are not otherwise exempt 
from certain labeling requirements), the labeling must include adequate 
directions for use, which are directions under which a layperson can 
use the device safely and for its intended use(s) (see Sec.  801.5 (21 
CFR 801.5)).
    (Comment 22) A comment suggested that FDA explicitly require that 
users have control of the device output to customize the device to 
their hearing needs. This comment argued the phrasing of the definition 
for ``tools, tests, or software'' that FDA proposed is ambiguous, 
potentially allowing manufacturers to restrict control of the device to 
physical fit but not the sound output.
    (Response) As explained in the response to Comment 21, section 
520(q)(1)(A)(iii) of the FD&C Act defines an OTC hearing aid as a 
device that, through tools, tests, or software, allows the user to 
control the hearing aid and customize it to the user's hearing needs. 
In final Sec.  800.30(b), we define ``tools, tests, or software'' as 
components that allow lay users to control the device and customize the 
device sufficiently. As explained in the response to Comment 1, we 
interpret the requirement for customization to hearing needs to mean 
that the device must allow the user to cause frequency-dependent 
changes based on the user's preference, and the requirement for user 
control to mean that the user can access or select the output 
characteristics most significant to the user's hearing perception. 
These elements sufficiently describe the requisite controllability and 
customization without unnecessarily constraining future technologies 
that could be available OTC. We are not modifying the OTC Hearing Aid 
Controls as suggested. However, as explained elsewhere in this 
document, we added a user-adjustable volume control to the design 
requirements for OTC hearing aids so users will be able to control this 
aspect of the sound output.
    (Comment 23) Comments suggested that FDA include in the definition 
of ``used hearing aid'' a stipulation that a bona fide hearing aid 
evaluation extend through a trial period that might last as long as 90 
days. That is, a device would not be considered a ``used hearing aid'' 
solely because a prospective purchaser wore it for an extended trial 
period, without the presence of the dispenser or a hearing health 
professional selected by the dispenser.
    (Response) FDA is not adopting this suggestion because purchasers 
should be aware of use of the device outside of observation to ensure 
appropriate operating conditions. This is because a device will be in 
contact with the ultimate user's skin for extended periods, and the 
device contains sensitive electronics. Without observation, a device 
that a prospective

[[Page 50711]]

user is evaluating may be used in a way that would make the device 
unsanitary for the ultimate user, or the device could have been 
subjected to damaging conditions.
    However, we are revising the definitions and labeling requirements 
to clarify labeling terms to convey information better. If a 
manufacturer inspects and tests a used hearing aid, makes any necessary 
modifications to the hearing aid to ensure it satisfies applicable 
requirements to be available OTC, including for labeling, 
electroacoustic performance, and design, and the manufacturer has 
adequately reprocessed the hearing aid for the next user, then the 
manufacturer may describe the device as ``rebuilt'' in the required 
labeling rather than ``used.''
    (Comment 24) Multiple comments proposed that FDA define mild to 
moderate hearing impairment in terms of objective criteria. For 
example, these comments suggested that FDA adopt thresholds used by the 
American Speech-Language-Hearing Association (ASHA) or the World Health 
Organization (WHO) to categorize hearing impairment. Others suggested 
more generally that labeling describe hearing impairment in detail so 
that prospective OTC hearing aid users would ``understand exactly'' 
their degree of hearing impairment.
    (Response) FDA is declining to define hearing impairment for 
purposes of the OTC Hearing Aid Controls in terms of objective 
measurements because defining hearing impairment in such a way is 
neither necessary for, nor consistent with, establishing an OTC 
category of hearing aids.
    Inconsistency would arise because the requirements to establish the 
OTC category focus on the hearing aid user's perception as well as 
making devices available without the involvement of a licensed person. 
Specifically, section 520(q)(1)(A)(ii) of the FD&C Act refers to 
``perceived'' impairment in defining the intended use of OTC hearing 
aids. As explained in the response to Comment 11, the subjective nature 
of hearing impairment is integral to the regulatory category we must 
establish for OTC hearing aids.
    Further, an objective definition based on measurement of hearing 
impairment would imply the need to involve a licensed person, such as 
an audiologist or hearing instrument specialist, to administer a test 
or otherwise provide an exact understanding. However, OTC hearing aids 
must be available without the involvement of a licensed person (see 21 
U.S.C. 360j(q)(1)(A)(v)), and FDA has determined that an objective 
measurement of hearing impairment is not necessary for reasonable 
assurance of safety and effectiveness of OTC hearing aids. Thus, 
defining the degrees of impairment in objective terms, using one of 
several available schemes for categorization, would be contrary to the 
purposes of this final rule as well as unnecessary.
    We acknowledge that many licensed persons use audiometric 
threshold-based hearing loss categories to describe hearing loss 
severity, and this information may be useful to OTC hearing aid users 
should they choose to seek it out. However, the perception of hearing 
difficulties is on a continuum that is not confined to specific 
audiometric threshold categories. For example, two people with the same 
audiometric thresholds may have different subjective perceptions of, 
and different personal preferences for addressing, the impairment. The 
intended user population will have a broad range of perceptual 
difficulties and communicative function because of the wide variability 
and overlap in perception of hearing impairment within and across 
hearing loss severity.
    The ASHA and WHO hearing loss categories each reflect a continuum 
while providing high-level clinical guidance. These categories do not 
represent discrete perceptual boundaries for the patient or for the 
treating professional. Furthermore, these hearing loss categories were 
not formulated to determine regulatory questions such as whether an 
individual should have access to OTC hearing aids. We are declining to 
adapt and apply such a scheme in that way.
    Nonetheless, we are establishing labeling requirements to help 
consumers recognize perceived mild to moderate hearing impairment. See 
the response to Comment 35 for more on this topic. Further, the 
labeling encourages users and prospective users to seek professional 
services in several circumstances, and people who wish to measure their 
degree of hearing impairment objectively or definitively may still 
obtain such measurements voluntarily.
    (Comment 25) One comment suggested that the definition of 
``prescription hearing aid'' be revised to further state that these 
devices are dispensed by a State-licensed professional.
    (Response) FDA declines to revise the definition of ``prescription 
hearing aid'' as suggested because it is unnecessary. Prescription 
hearing aids are prescription devices and as such, they are subject to 
Sec.  801.109. Under Sec.  801.109(a), a prescription device is a 
device that is: (1) either in the possession of a person, or his agents 
or employees, regularly and lawfully engaged in the manufacture, 
transportation, storage, or wholesale or retail distribution of such 
device or in the possession of a practitioner, such as physicians, 
dentists, and veterinarians, licensed by law to use or order the use of 
such device and (2) is to be sold only to or on the prescription or 
other order of such practitioner for use in the course of his 
professional practice. Because prescription hearing aids are required 
to be in the possession of persons lawfully engaged in the retail 
distribution (or certain other activities) of such devices, and must be 
sold only to or on the prescription or other order of a licensed 
practitioner, the revision suggested in the comment is unnecessary.
    (Additional Revision 1) After further consideration, FDA is 
modifying the definition of ``dispenser'' for the purposes of 
prescription hearing aids under final Sec.  801.422(b). FDA proposed 
that the term refer to any person engaged in the sale of prescription 
hearing aids. However, we observed a potential for confusion based on 
comments we received, because a person engaged in the sale of OTC 
hearing aids would also be a dispenser. Thus, while the definition of 
the term in Sec.  801.422(b) is for the purposes of prescription 
hearing aid labeling, the definition as proposed may have appeared to 
create an inconsistency with the use of the term outside of Sec.  
801.422. To avoid the potential inconsistency and confusion, we are 
removing ``prescription'' from the final definition of ``dispenser.''

D. Labeling (Sec.  800.30(c))

    FDA received many comments related to labeling for OTC hearing 
aids. Most of these comments focused on ensuring the information would 
be easy to understand for most people, that is, people who are not 
professionals in a field related to hearing impairment. Commenters 
suggested various means to improve the labeling, including different 
phrasing, formatting, or positioning. Others provided general feedback 
and emphasized Plain Language principles, and a need to avoid jargon or 
overly technical phrasing, to help readers understand information in 
the labeling. FDA agrees that Plain Language principles apply in the 
case of labeling for hearing aid users, and that Plain Language will 
help users to understand the information in the device labeling.

[[Page 50712]]

1. User-Friendly Labeling
    (Comment 26) Some comments expressed concern that FDA did not 
validate the labeling of the OTC hearing aids. Many of these comments 
are concerned that without labeling validation, a consumer's ability to 
self-diagnose their hearing loss will be hindered. These comments 
suggested that a requirement for manufacturers to validate labeling 
will help to ensure that users can properly self-diagnose their hearing 
loss.
    (Response) FDA is declining to adopt labeling validation 
requirements for OTC hearing aids at this time. The labeling 
requirements we are finalizing benefitted from extensive input from 
many sources, including docket comments and public workshops, such as 
the one convened by NASEM. Additionally, self-fitting air-conduction 
hearings aids under Sec.  874.3325 are subject to a special control 
requiring usability testing, which inherently includes testing the 
directions for use by the user. Further, any device must have labeling 
bearing adequate directions for use unless subject to an exemption (see 
section 502(f)(1) of the FD&C Act and Sec.  801.5). This means that the 
directions for use for an OTC hearing aid must allow a lay user to use 
the device safely and for its intended purposes (see Sec.  801.5). 
Given these requirements, and the extensive input we have received for 
labeling, a requirement for additional validation is not needed for 
reasonable assurance of safety and effectiveness.
    (Comment 27) Multiple comments proposed that labeling refer to an 
``Ear-Nose-Throat Doctor,'' ``ENT,'' or similar terms instead of 
referring to an ``ear specialist.'' These comments suggested that ``ear 
specialist'' is not specific enough because it might imply somebody 
besides a physician. For example, it could refer to an audiologist or a 
hearing aid dispenser, neither of whom need be a physician. As such, 
``ear specialist'' may confuse or inadvertently mislead hearing aid 
users.
    (Response) FDA agrees that ``ear-nose-throat doctor'' and ``ENT'' 
are more descriptive and likely more common than ``ear specialist.'' We 
have revised labeling throughout to adopt this suggestion when 
referring to physicians.
    (Comment 28) A comment suggested that labeling refer to 
``physicians'' rather than ``doctors'' because people who are not 
physicians may be doctors, for example, people who hold Ph.D.s 
(philosophical doctors) or chiropractors (some of whom are doctors of 
chiropractic).
    (Response) We are not adopting this suggestion. We are adopting 
suggestions to refer to ``ear-nose-throat doctors'' instead of ``ear 
specialists'' to provide better guidance to people who may be 
unfamiliar with hearing healthcare delivery (see the response to 
Comment 27). However, we do not expect that people will seek the 
assistance of philosophical doctors or chiropractors for their hearing 
needs just because the labeling for OTC hearing aids refers to a 
``doctor'' rather than a ``physician.'' Instead, we expect people who 
seek the assistance of a doctor for their hearing needs will exercise 
reasonable judgment in discerning which kind of doctor might help them 
with their hearing needs, in the same way they might exercise 
reasonable judgment to find appropriate providers when suggested by OTC 
labeling for other health concerns.
    (Comment 29) A comment requested that ``doctor'' and ``physician'' 
in the labeling be revised to ``licensed healthcare practitioner.'' The 
comment argued that use of ``licensed healthcare practitioner'' is 
consistent with FDARA and would ensure that patients see qualified 
individuals, yet not confuse and limit consumers about whom they can 
consult.
    (Response) FDA is declining to replace all references to ``doctor'' 
or ``physician'' with ``licensed healthcare practitioner'' because 
there are certain aspects of hearing care where it is warranted that a 
patient consult a ``doctor.'' As discussed in the response to Comment 
27, FDA is updating the term ``ear specialist'' to ``ear-nose-throat 
doctor (ENT)'' to avoid confusion as to whom a consumer should consult. 
Where FDA now uses the term ``ENT'' it is to clarify who is best 
positioned for a patient to consult on a particular matter. For 
example, an ENT would generally be the kind of provider who has the 
necessary qualifications and expertise to conduct an examination for 
the diagnosis of Red Flag conditions. We acknowledge, however, that not 
all hearing healthcare providers need to be physicians and there are 
many situations, such as consumers continuing to have difficulty 
hearing even after beginning use of OTC hearing aids, where consulting 
licensed healthcare providers would be necessary or appropriate.
    (Comment 30) A few comments recommended rewording the ``red flag'' 
condition warnings to present the issue first and then the solution. 
Comments suggested the warning should be updated to read, ``[p]rior to 
purchasing this device, if you have any of the following you should 
promptly consult with a licensed physician, preferably, an Ear-Nose-
Throat (ENT) doctor.''
    (Response) FDA agrees that a different presentation would more 
effectively communicate the warning. In response to comments proposing 
rewording to increase readability, we have retitled the warning and 
reordered the introduction in the manner suggested and adopted slightly 
different phrasing that we think will be more user-friendly.
    (Comment 31) A comment expressed concern about the caution that 
hearing aids are not hearing protection. Some comments argued that it 
is impracticable for hearing aid users to take out their hearing aids 
in situations where a loud sound is passing by. Comments recommended 
the caution be updated to advise individuals to mute or turn off their 
hearing aids when experiencing a loud sound and only recommend removal 
of hearing aids if the hearing aid does not provide any hearing 
protection.
    (Response) FDA is declining to implement this revision. FDA has 
included information in the labeling requirements to help users have 
realistic expectations when using hearing aids. This particular caution 
is intended to assist users in the day-to-day use of their hearing aid 
and to notify them that they should not rely on their hearing aid for 
hearing protection. Additionally, the labeling includes a caution that 
individuals should turn down the volume or remove the device if the 
sound is uncomfortably loud or painful. These two cautions provide 
appropriate guidance to help ensure safety when experiencing a loud 
sound.
    (Comment 32) A few comments requested revisions to the note 
regarding expectations about what a hearing aid can do to use more 
positive framing. Comments argued that the note was more a notice of 
what hearing aids cannot do, and a more positive framing would increase 
readability and product desirability.
    (Response) FDA agrees that it is important for users to read and 
understand the labeling easily, and we have updated the note to include 
language about the benefits as well as limitations of OTC hearing aids. 
The language was further updated to provide notice that users may need 
to wait a few weeks to get used to their hearing aids.
    (Comment 33) A few comments requested that FDA require a minimum 
font size so that consumers can read and understand the particulars of 
each OTC hearing aid. Comments recommended requiring font sizes from 
12-14 points.
    (Response) FDA is declining to implement this suggestion. This rule 
applies to a large number of manufacturers and their various hearing 
aids so FDA believes some flexibility is

[[Page 50713]]

warranted. Additionally, we do not believe a minimum font size is 
necessary to ensure users can read and understand the labeling for OTC 
hearing aids because there are requirements that address this. For 
example, under section 502(c) of the FD&C Act, a device is misbranded 
if any word, statement, or other information required by or under 
authority of the FD&C Act to appear on the label or labeling is not 
prominently placed thereon with such conspicuousness and in such terms 
as to render it likely to be read and understood by the ordinary 
individual under customary conditions of purchase and use (see 21 
U.S.C. 352(c)). Given this and other requirements, and the need for 
some flexibility as the rule applies to a variety of devices, FDA does 
not believe a minimum font size is warranted.
    (Comment 34) A few comments recommended that the descriptions of 
functions of the hearing aids include figures and videos alongside text 
to provide additional clarity on how to use hearing aids.
    (Response) To help users after purchase, the inside labeling must 
include, among other information, a description of accessories; 
illustration(s) of the OTC hearing aid that indicates operating 
controls, user adjustments, and battery compartment; adequate 
directions for use; technical specifications; and a description of 
commonly occurring, avoidable events that could adversely affect or 
damage the OTC hearing aid. The labeling requirements will allow a lay 
user to use the device safely and for its intended purposes (see Sec.  
801.5). The additions suggested by comments are not necessary for 
reasonable assurance of safety and effectiveness.
2. User Education
    (Comment 35) A comment suggested that device package labeling 
describe hearing impairment in terms of common perceptual difficulties. 
In specific, it proposed that labeling describe mild impairment as 
having difficulty hearing soft-spoken people and young children. 
According to the comment, people with mild impairment are often able to 
hear loud or more-intense vowel sounds but may miss some of the softer 
consonant sounds. Thus, they may have to ask people to speak up or 
repeat themselves on occasion. The comment further stated that for 
someone with typical hearing, this is comparable to placing a finger in 
one's ears.
    The comment proposed that labeling describe moderate impairment as 
having additional difficulty hearing vowel sounds in addition to 
missing consonant sounds. According to the comment, this means that 
when someone is speaking at a normal volume, a person with moderate 
hearing impairment is unable to hear most of the speech sounds. 
Accordingly, people with moderate hearing impairment often comment that 
they hear sounds but cannot always understand speech.
    (Response) To help users determine whether they have perceived mild 
to moderate hearing impairment, FDA has revised the package labeling 
requirements by simplifying the language and making it less formal. 
(See the response to Comment 41 for more about these revisions.) 
However, while we agree that the suggested descriptions may also be 
useful for prospective users, other factors impact determining the 
labeling requirements. These factors include, for example, the limited 
space available for the outside package labeling, as many comments 
emphasized, and whether the information is necessary to provide 
reasonable assurance of safety and effectiveness. The descriptions 
suggested in the comment would add to the length of the material on the 
outside packaging for OTC hearing aids. Additionally, the required 
information under final Sec.  800.30(c)(1)(B) sufficiently helps to 
provide reasonable assurance of safety and effectiveness, without the 
addition of the suggested text, because it contains enough information 
for someone to identify whether an OTC hearing aid may be intended for 
their particular hearing impairment. Therefore, we are not revising 
this final rule in the way suggested by the comment.
    However, as stated above, the additional information described in 
the comment may still be useful so we intend to add similar information 
to FDA's website, which has pages focused on hearing aids and hearing 
loss. You can access the main web page at: https://www.fda.gov/medical-devices/consumer-products/hearing-aids. You may also wish to review 
information from the National Institute on Deafness and Other 
Communication Disorders. You can access their web pages at: https://www.nidcd.nih.gov/health/hearing-ear-infections-deafness. These 
websites provide more information for people interested in learning 
about hearing aids and hearing loss.
    (Comment 36) A few comments expressed concern that, without proper 
warnings on the label, purchasers would not be informed on the 
limitations of OTC hearing aids with regard to their degree of hearing 
impairment.
    (Response) FDA agrees and is finalizing the clear statement that we 
proposed, with an updated, more user-friendly list of common symptoms 
of mild to moderate hearing impairment. We are also finalizing the 
requirement, with similarly improved language, that the labeling 
describe signs of more severe impairment.
    (Comment 37) A few comments expressed concern about the statement 
that hearing aids will not restore normal hearing and that training and 
counseling from a hearing healthcare professional may increase 
satisfaction. Comments argued that these ideas are based upon current 
limitations of hearing aids and recommended the statement be removed 
because, they argued, future hearing aids may have the capability to 
restore hearing to a normal level.
    (Response) FDA is declining to remove this statement. The note 
informs consumers of the limitations and benefits they should expect 
from an OTC hearing aid. Since many purchasers will be selecting and 
using OTC hearing aids without the involvement of a licensed person, 
FDA has included statements, including the one discussed above, to help 
consumers have realistic expectations about OTC hearing aids. This 
helps provide reasonable assurance of safety and effectiveness.
    (Comment 38) A few comments requested that labeling include a 
warning of when to stop use of OTC hearings aids. The comments 
expressed concerns that some hearing aid users may be unaware that they 
should stop use of OTC hearing aids due to the onset of certain 
conditions, for example, ear drainage, pain, and balance issues.
    (Response) FDA agrees that certain conditions should suggest that 
users consult with a hearing healthcare provider, but we do not agree 
that the onset of such conditions necessarily indicates the user should 
stop using OTC hearing aids. FDA has revised the labeling to make it 
more general so that it warns users to see a doctor, preferably an ear-
nose-throat doctor, if the user experiences any of the listed problems 
before or after purchase.
    (Comment 39) A few comments recommended an additional warning on 
the inside package labeling to alert individuals that there is 
potential harm when wearing hearing aids for longer than recommended. 
Comments proposed a warning to users to exercise special care in the 
use of the device. It would warn against use of the hearing aid for 
more than 12 hours a day, for example, and against use if the device 
becomes uncomfortable, either due to the loudness of sound or the 
physical fit of the device. Such proposed warnings sought to mitigate 
the risk of further

[[Page 50714]]

impairment if the device was set to the maximum output level and worn 
for periods of time exceeding these recommendations.
    (Response) FDA is declining to implement such suggestions. OTC 
hearing aids are designed to be worn all waking hours in a variety of 
listening environments and situations. The labeling required in this 
rule provides reasonable assurance of safety and effectiveness, 
including through notices that the hearing aid sound output should be 
neither uncomfortable nor painful, and that the hearing aid should not 
cause pain or discomfort when inserting or placing it.
    (Comment 40) A few comments expressed concern that the labeling 
lacked reference to how a hearing healthcare professional can assist 
and benefit a person purchasing an OTC hearing aid. Comments 
recommended FDA develop labeling that includes guidance that, due to 
their specialized knowledge, hearing healthcare professionals are 
better at assisting in hearing tests and maximizing the benefits of a 
hearing aid.
    (Response) FDA declines to make this addition to the labeling. This 
rule includes requiring specific language to assist consumers in 
determining whether an OTC hearing aid best meets their needs and when 
to consult a licensed professional. As mandated by FDARA, this rule 
establishes requirements to provide reasonable assurance of safety and 
effectiveness of OTC hearing aids without the involvement of a licensed 
person; therefore, while FDA agrees that licensed professionals provide 
valuable services, FDA will not be incorporating further requirements 
to include additional information about the benefit of licensed 
professionals in the labeling.
    (Comment 41) FDA proposed that the outside package labeling include 
a statement that the device may not be useful for more significant 
hearing loss or complicated hearing needs. Some comments expressed 
concern that the warning used ``significant hearing loss'' without 
providing a definition of how to distinguish mild to moderate from 
significant hearing loss. These comments suggested that FDA further 
delineate mild to moderate from significant hearing loss, some of them 
suggesting we use objective criteria rather than more-subjective 
perceptual terms.
    (Response) The final labeling requirements include the signs 
suggestive of both perceived mild to moderate hearing impairment and 
more significant hearing impairment. FDA included this information to 
assist consumers in determining whether OTC hearing aids can meet their 
needs. We have improved the phrasing of this information to be more 
understandable to inexperienced hearing aid users, including by 
removing the phrases the comments characterized as not defined well 
enough. However, as discussed in the response to Comment 24, FDA is 
declining to define hearing impairment in terms of objective criteria 
for the reasons explained in that response. We are continuing to 
delineate the different degrees of severity with perceptual terms as we 
believe this will be most useful to the intended users.
    (Comment 42) Comments expressed concern that the symptoms 
suggesting perceived mild to moderate hearing impairment can also be 
indications of more significant hearing loss.
    (Response) FDA infers these comments are concerned that consumers 
may mistake their degree of hearing loss due to the commonality of 
symptoms. FDA disagrees. FDA has specified some listening scenarios 
that represent some of the most common perceptual difficulties a user 
with perceived mild to moderate hearing impairment may experience. 
Although these symptoms may apply to multiple types and degrees of 
impairments, they are most common to perceived mild to moderate hearing 
impairment and therefore helpful to prospective users of OTC hearing 
aids. Further, FDA is also requiring that the symptoms commonly 
experienced by individuals with more significant impairment, with a 
recommendation to consult with a hearing healthcare professional, be 
included on the outside package labeling. Although FDA is finalizing 
more user-friendly language, we are declining to modify the symptoms 
for perceived mild to moderate hearing impairment. We believe that this 
information, along with the information required in the labeling to 
assist people with more severe impairment, will help prospective users 
determine whether an OTC hearing aid is a good choice for them.
    (Comment 43) A few comments suggested labeling requirements include 
notice to individuals younger than 18 years old who are experiencing 
hearing issues that they should visit a hearing healthcare provider 
prior to using hearing aids due to complications that can cause 
auditory impairment and developmental issues.
    (Response) FDA agrees with the concerns expressed by these comments 
and believes the labeling requirements address these concerns. For 
example, the labeling requirements in the proposed rule, which are 
being finalized here, include language that individuals under the age 
of 18 should consult with a doctor and refrain from using OTC hearing 
aids. It emphasizes the possible need for medical testing and the 
potential for hearing impairment in younger people to affect speech and 
learning.
    (Comment 44) A few comments recommended that labeling include an 
explanation on the differences between prescription hearing aids, OTC 
hearing aids, and PSAPs to help consumers to select the appropriate 
device.
    (Response) FDA is declining to require in the labeling an 
explanation of the differences between OTC hearing aids, prescription 
hearing aids, and PSAPs. Although this information may be helpful to 
know, it is not necessary for reasonable assurance of safety and 
effectiveness of OTC or prescription hearing aids. The labeling 
requirements for OTC hearing aids include common symptoms of those with 
mild to moderate hearing impairment and symptoms of more significant 
hearing loss to help consumers decide whether an OTC hearing aid is a 
good choice for them. Further, as discussed elsewhere in this document, 
prescription hearing aids must be sold only to or on the prescription 
or other order of a licensed practitioner (see Sec.  801.109). 
Therefore, a licensed practitioner will be involved in determining 
whether a prescription hearing aid is appropriate for an individual 
with hearing impairment. Additionally, FDA is issuing a guidance with 
this final rule that will provide additional clarification of the 
differences between hearing aids and PSAPs. The notification of 
availability for the guidance appears elsewhere in this issue of the 
Federal Register.
    (Comment 45) A few comments requested that OTC hearing aid labeling 
include a warning that people should not use OTC hearing aids if they 
have tinnitus. Comments expressed concern that tinnitus can be an 
indicator of serious medical conditions requiring proper management 
from a hearing healthcare professional, and failure to seek immediate 
treatment could cause further harm.
    (Response) In the labeling requirements, FDA has included tinnitus 
in one ear as a condition for which users should seek medical 
evaluation. FDA is declining to expand upon this labeling requirement 
to include tinnitus in both ears since bilateral tinnitus often occurs 
in the presence of any degree of hearing loss. As such, the warning 
would be overly broad if it were to include bilateral tinnitus.

[[Page 50715]]

    (Comment 46) A few comments suggested modifying the proposed 
language recommending users consult a hearing healthcare professional 
if they remain concerned about their hearing or struggle to use the 
device. The comments suggested that the labeling recommend users first 
contact the manufacturer to allow them an opportunity to resolve any 
issues.
    (Response) FDA is declining to implement this suggestion. The 
statement notifies users that dissatisfaction with the compensation for 
impaired hearing may call for the attention of a hearing healthcare 
professional. Although FDA sees the potential benefit in users 
consulting with manufacturers to resolve certain technical or use 
questions, the purpose of the note is not to assist with device 
troubleshooting. Manufacturers may, however, include a troubleshooting 
section (or similar section) in the user instructions and provide 
suggestions for when users should consult them for technical or use 
issues that would not necessarily call for the involvement of a hearing 
healthcare professional.
    (Comment 47) Some comments requested FDA require the labeling on 
and/or inside the package of OTC hearing aids include information about 
telecoils. Comments expressed concern that first-time hearing aid 
purchasers will not be able to make informed decisions about telecoils 
without an explanation of telecoil capabilities. Specific labeling 
suggestions varied, but they included statements of whether the device 
includes telecoils, explanations of what telecoils are, and the 
benefits telecoils may provide.
    (Response) FDA is declining this suggestion because not all OTC 
hearing aids will have telecoils, and existing requirements would 
apply, for example for adequate directions for use (see section 
502(f)(1) of the FD&C Act and Sec.  801.5). (See also the response to 
Comment 94 about requiring telecoils.) Including the information about 
the feature could be confusing to consumers when the device does not 
include telecoils. Conversely, if a hearing aid includes telecoils, 
information about them would be necessary to provide adequate 
directions for use, so the information would have to appear in the 
labeling (see section 502(f)(1) of the FD&C Act and Sec.  801.5).
    (Comment 48) Some comments requested that labeling for OTC hearing 
aids include a questionnaire to assist consumers in deciding if OTC 
hearing aids are appropriate for them. Comments recommended the 
questionnaire to assist consumers in determining if they have a medical 
condition that requires a visit to a hearing health care provider prior 
to using OTC hearing aids.
    (Response) FDA will not be implementing this suggestion. The 
labeling requirements we are finalizing, including information on Red 
Flag conditions and symptoms of more significant hearing loss, are 
sufficiently informative to provide reasonable assurance of safety and 
effectiveness without the additional time and effort necessary to 
complete a questionnaire and assess the results for purposes of 
deciding whether an OTC hearing aid is appropriate.
    (Comment 49) A few comments expressed concern about the note 
regarding what a hearing aid can do, which includes a statement that, 
if a user has hearing loss in both ears, use of hearing aids for both 
ears (bilateral hearing aids) may provide more benefit than just one 
hearing aid. Comments suggested that this may discourage individuals 
who wish to begin with only one hearing aid. Comments recommended 
removing this paragraph from the note.
    (Response) FDA disagrees that this statement would deter 
individuals from using one hearing aid. This statement does not suggest 
that individuals must use two hearing aids in all cases. This statement 
in the note simply conveys that two OTC hearing aids may provide more 
benefit in the case of hearing loss in both ears. Moreover, should 
individuals with hearing loss in both ears start with one OTC hearing 
aid and desire more benefit, this information would be useful to help 
them understand how to achieve greater benefit.
    (Comment 50) A few comments requested that the labeling include 
guidance as to what to do when an eartip gets stuck in the ear canal.
    (Response) FDA infers that the information requested by comments is 
meant to assist users in determining when to consult a healthcare 
professional. FDA agrees that providing guidance to users on this issue 
is important. We have updated the labeling to help users decide when to 
seek medical help (see new Sec.  800.30(c)(2)(iii)(C)).
3. Outside Package Labeling and Purchasing Decisions
    (Comment 51) A few comments recommended a statement for individuals 
with ability limitations, such as a developmental disability, similar 
to statements directing people under the age of 18 to seek examination 
and evaluation by hearing healthcare professionals. Commenters implied 
that, just as with individuals under 18, individuals with ability 
limitations may not have the same ability to determine their hearing 
loss or the presence of more serious medical issues; therefore, 
evaluation by a licensed professional would be necessary.
    (Response) FDA is declining to implement this suggestion. The 
statements addressed to those under age 18 concern hearing healthcare 
needs that are specific to younger people, such as speech and learning 
difficulties. Additionally, as explained in the proposal, the use of 
OTC hearing aids in people younger than 18 presents risks to health 
beyond those typically associated with use in older people. Whereas 
hearing loss in older adults is most commonly related to noise exposure 
and aging, the etiology (causes) of hearing loss in younger people is 
varied and may result from conditions that warrant prompt diagnosis to 
avoid serious risks to health (see 86 FR 58150 at 58158). The comments 
provided no information to support that adults with ability limitations 
face similar risks to those younger than 18.
    Further, we have revised the labeling with more user-friendly terms 
throughout. We believe the information required in the labeling, 
including statements identifying Red Flag conditions and advising users 
to consult with a hearing healthcare professional if they continue to 
struggle with or remain concerned about their hearing, are appropriate 
for adults with perceived mild-to-moderate hearing impairment. We do 
not agree that revising the labeling or limiting purchases for certain 
adults in the manner suggested by the comments is necessary to provide 
reasonable assurance of safety and effectiveness of OTC hearing aids.
    (Comment 52) A comment requested that FDA standardize the names of 
hearing aid features so that interested people could compare products 
more easily. In that vein, multiple comments suggested that FDA develop 
a rating system to compare features. The commenter expressed that 
information should be accessible to lay users and that relying on a 
regulatory guidance document, should FDA issue one in the future, to 
convey such information is unlikely to assist most consumers, who are 
not experts in hearing aid technology. Similar comments desired a 
rating system for device performance in certain conditions, for 
example, live concerts.
    (Response) FDA agrees that interested people should have sufficient 
information to compare products as easily as possible, and we have made 
various revisions in this final rule to

[[Page 50716]]

improve the usefulness of the required labeling for laypeople. We are 
also finalizing a requirement for a conspicuous mark identifying the 
hearing aid as OTC that we expect will help purchasers and others 
distinguish product categories (see Additional Revision 2 in section 
III.D.3). Further, FDA's website describes common hearing aid 
technologies and features to help orient consumers with the technology 
and terminology, available at: https://www.fda.gov/medical-devices/hearing-aids/types-hearing-aids. However, we are not making additional 
revisions in the final rule to standardize the names of device 
features.
    We note that a number of regulatory requirements will nevertheless 
assist consumers to compare devices and features. For example, the 
applicable classification regulation for a device specifies the name of 
the device type (so is standardized in that way), and the principal 
display panel on the package of an OTC device must display a statement 
of identity that includes the common name of the device, in bold 
typeface (see Sec.  801.61). Further, the labeling must include 
adequate directions for use that allow a layperson to use the device 
safely and for its intended purpose(s) (see Sec.  801.5). And for OTC 
hearing aids, we proposed and are finalizing a requirement under new 
Sec.  800.30(c)(4) that the labeling include certain technical 
specifications. Purchasers interested in the electroacoustic 
performance could use this information to compare across devices.
    We acknowledge that manufacturers may use proprietary names for 
device features, even when other manufacturers offer a similar feature 
under a different name (perhaps also proprietary). However, FDA expects 
that hearing aid technology will continue to evolve and that device 
features will similarly evolve, including the specific capabilities. 
Precisely identifying, describing, and naming those features and ways 
to compare them by regulation, even for the present, is neither 
practical nor necessary. Further, individuals may have different 
preferences as to which features are more valuable in a hearing aid. 
For similar reasons, a rating system is neither practical nor 
necessary. Even with additional standardization of terminology, the 
import of each feature may still not be apparent to purchasers, and 
similarly, rating systems may not reflect (rate highly) the features of 
a device that a given purchaser would value. Thus, finalizing 
regulatory requirements for such a system of comparison is not likely 
to communicate useful information to purchasers and may hinder 
innovation by codifying current characteristics of device features.
    To communicate useful information, we expect that manufacturers 
will describe their devices' features in ways that best appeal to the 
intended users, and the labeling of a hearing aid will have to be 
available to prospective users prior to purchase (see new Sec. Sec.  
800.30(c)(2) and 801.422(c)(2)). Moreover, the labeling of a device 
must not be false or misleading in any particular (see 21 U.S.C. 
352(a)(1)). These requirements will help ensure that purchasers have 
accurate information about a hearing aid and its features in a way that 
allows them to compare these devices.
    As for ratings for device performance in certain conditions, given 
the subjective nature of user preferences, developing a useful rating 
system is impracticable. We expect that purchasers will have access to 
a wealth of opinions from other purchasers, product testers or 
reviewers, and consumer information organizations. This will allow 
purchasers to find ratings that reflect their interests more than any 
possible criteria standardized by regulation. For example, a purchaser 
may prefer OTC hearing aids that users rate highly for use in a 
restaurant. Additionally, user preferences may change in the future, so 
any rating system may become quickly outdated.
    Regarding device performance more generally, as we explained in the 
proposal, we are establishing electroacoustic performance requirements 
for high-fidelity amplification (see 86 FR 58150 at 58163). A hearing 
aid must meet these requirements to be available OTC, but the device 
need not outperform them. By extension, a device need not perform 
better than a high-fidelity level of amplification. Establishing a 
rating system for compliant devices, that is, for those that would 
already have high fidelity, would incorrectly imply some devices are 
substandard. We are not finalizing requirements for describing how well 
a device performs beyond the electroacoustic performance specifications 
in the labeling, the performance itself being required to meet a 
standard for high fidelity.
    (Comment 53) A few comments recommended that information about 
whether a battery was included, and what type of battery is required, 
be included on the labeling. Comments recommended the inclusion of this 
information so that consumers can purchase the necessary batteries at 
the same time as the OTC hearing aid and adequately compare OTC hearing 
aids.
    (Response) We agree that it is important for manufacturers to 
include information about the type, as well as the number, of 
batteries, and whether batteries are included because this is 
information consumers will need to use the hearing aid. Therefore, FDA 
is revising the final rule to require this information on the labeling 
outside the package of the hearing aid so that consumers are aware of 
the battery requirements prior to, or at the time of, purchase.
    (Comment 54) A few comments recommended including a description of 
any smartphone compatibility requirements to operate the hearing aid on 
the outside package labeling. Comments argued this would allow 
consumers to determine if they have the necessary device and 
programming to operate the hearing aid prior to purchase.
    (Response) FDA agrees with the comments that this information is 
important for consumers to know when comparing OTC hearing aids at the 
retailer. Similar to the battery information discussed above, 
information on the control platform is necessary for use of the hearing 
aid. Therefore, FDA is revising the final rule to require that the 
outside package labeling indicate whether a mobile device or other non-
included control platform is required, such as a smartphone, a remote 
sold separately, or a personal computer. The labeling also will have to 
indicate the type of control platform and how the hearing aid connects 
to the control platform, for example, via Bluetooth and/or USB-C.
    (Comment 55) A few comments suggested that the rule require a list 
of other basic features of each OTC hearing aid (for example, mobile 
operating system, volume controls, feedback, telecoil, or accessories) 
on the outside package. Comments expressed concern that, without a list 
of features, consumers may have difficulty comparing different OTC 
hearing aids and make an informed decision.
    (Response) FDA is declining to implement this suggestion in its 
entirety. The packaging provides limited space for required labeling, 
and while we have adopted some such suggestions--see the responses to 
Comment 53, about batteries, and Comment 54, about smartphone 
compatibility--we have not determined that the other information is 
necessary on the outside package labeling to provide reasonable 
assurance of safety and effectiveness. Additionally, we are finalizing 
the requirements as proposed

[[Page 50717]]

that the inside package labeling, among other requirements, provide 
illustration(s) of the OTC hearing aid that indicates operating 
controls, user adjustments, and the battery compartment (see Sec.  
800.30(c)(2)(iv)), provide information on the function of all controls 
intended for user adjustment (see Sec.  800.30(c)(2)(v)), and describe 
any accessory that accompanies the OTC hearing aid (see Sec.  
800.30(c)(2)(vi)). As the inside package labeling must be made 
available prior to purchase (see Sec.  800.30(c)(2)), consumers will be 
able to access this information prior to purchase. Further, as 
discussed in the response to Comment 26, any OTC hearing aid must have 
labeling that bears adequate directions for use that allow a lay user 
to use the device safely and for its intended purposes (see Sec.  
801.5). In cases where necessary for adequate directions for use, 
information on other features not specified in Sec.  800.30(c) will 
have to appear in the labeling, and prospective users will have access 
to the labeling prior to purchase.
    (Comment 56) Some comments expressed concerns for device labeling 
that states an OTC hearing aid is ``FDA approved,'' ``FDA cleared,'' or 
otherwise endorsed by the FDA. The comments asserted that such labeling 
indicates that: FDA has inspected an OTC device for quality and/or 
compliance with applicable legal requirements, that FDA has approved 
the device for use by the individual purchaser, and/or that FDA favors 
the device over others without such labeling. The comments argued that 
such indications are misleading for purchasers.
    (Response) FDA does not endorse particular devices and 
representations of such in labeling can be false or misleading. The 
determination of whether ``FDA cleared,'' ``FDA approved,'' or similar 
language on a device's labeling suggests FDA endorsement of the device 
or is otherwise false or misleading is made on a case-by-case basis.
    Clearance of a device indicates that FDA has determined the device 
to be substantially equivalent to a class I or II device. It does not 
in any way denote official approval of a device or in any way imply 
that the device is in compliance with any other pertinent sections of 
the FD&C Act (see 41 FR 37458 at 37462, September 3, 1976). Likewise, a 
grant of a De Novo classification request under 21 CFR 860.260(a)(1) or 
compliance with registration and listing requirements under part 807 
does not denote official approval or imply compliance with other 
pertinent device requirements. Any representation that creates an 
impression of official approval of a device due to complying with 
requirements for premarket notification or registration is misleading 
and constitutes misbranding (see Sec. Sec.  807.97 and 807.39, 
respectively).
    The labeling of a device may be false or misleading for other 
reasons too. For example, if a statement in the labeling creates an 
impression that FDA officially favors one classified device over 
another, it would likely be false or misleading. Or, if the labeling 
uses FDA's logo, creating an impression that FDA has endorsed the 
product, it would likely be false or misleading.\8\ A device would be 
deemed to be misbranded under section 502(a)(1) of the FD&C Act if its 
labeling included such false or misleading statements. The FD&C Act 
prohibits doing or causing certain acts with respect to a misbranded 
device (see, e.g., 21 U.S.C. 331(a)-(c), (k)).
---------------------------------------------------------------------------

    \8\ FDA's logo is not for use on private sector materials, 
including device packaging. For more information, you may wish to 
review FDA's logo policy, available at: https://www.fda.gov/about-fda/website-policies/fda-logo-policy.
---------------------------------------------------------------------------

    (Comment 57) A comment requested clarification on the applicability 
of prescription labeling requirements under new Sec.  801.422 to the 
implantable components of a bone-conduction hearing aid. The comment 
argued that applying the labeling requirements to the implantable 
components is unnecessary because a surgeon has already decided to 
implant specific components, and the labeling under new Sec.  801.422 
is neither necessary nor helpful for the surgeon or the hearing aid 
user. In contrast, the non-implantable components of a bone-conduction 
hearing aid, such as the sound processor, are often marketed separately 
and not necessarily through a physician.
    (Response) FDA agrees that the labeling requirements under Sec.  
801.422 are not necessary for reasonable assurance of safety and 
effectiveness with respect to the implantable components of a bone-
conduction hearing aid. We have modified the classification regulation 
to clarify that the labeling requirements for prescription hearing aids 
apply only to the non-implantable components of a bone-conduction 
hearing aid. In cases where the implantable components are not sold or 
distributed with the non-implantable components, the implantable 
components need not bear the labeling under new Sec.  801.422.
    (Comment 58) One comment requested that FDA strike Sec.  
801.422(c)(1)(ii)(A). The comment stated that the decision to offer 
trial rentals or purchase options is a trade issue and does not relate 
to the safety or effectiveness of the device.
    (Response) FDA has decided to retain Sec.  801.422(c)(1)(ii)(A) (in 
the final rule, this information is in Sec.  801.422(c)(1)(i)(C)). FDA 
notes that Sec.  801.422(c)(1)(ii)(A) does not require offering a 
trial-rental or purchase-option program. Instead, this provision just 
requires that the outside package labeling for a prescription hearing 
aid include information advising prospective users to inquire about the 
availability of a trial-rental or purchase-option program.
    FDA also notes that Sec.  801.422(c)(1)(ii)(A) is substantially 
identical to what was already required to be included in the user 
instructional brochure for a hearing aid under former Sec.  
801.420(c)(3). In other words, the information required under Sec.  
801.422(c)(1)(ii)(A) is not new and has been required to be in hearing 
aid labeling for many years. The only differences between Sec. Sec.  
801.420(c)(3) and 801.422(c)(1)(ii)(A) are: Sec.  801.422(c)(1)(ii)(A) 
applies only to prescription hearing aids, Sec.  801.422(c)(1)(ii)(A) 
requires that the information be provided on the outside package 
labeling for a prescription hearing aid, and the required statement 
under Sec.  801.422(c)(1)(ii)(A) uses language that is easier to 
understand.
    FDA continues to believe that this labeling requirement is 
necessary to provide reasonable assurance of safety and effectiveness 
of prescription hearing aids. When FDA included the requirement in 
former Sec.  801.420(c)(3) to provide information in the user 
instructional brochure advising prospective users to inquire about the 
availability of a trial-rental or purchase-option program, FDA 
acknowledged the difficulty of determining in advance whether an 
individual will benefit from a hearing aid, and we noted that voluntary 
trial-rental or purchase-option programs for prospective hearing aid 
users were available (42 FR 9286 at 9289).
    FDA believed that trial-rental or purchase-option programs, which 
provide prospective hearing aid users the opportunity to wear the 
selected hearing aid so that the user can make an informed judgment on 
whether a benefit is obtained from the use of the hearing aid, were 
important to the welfare of the hearing impaired and therefore, 
required that the user instructional brochure contain information 
advising prospective users to inquire about the availability of such 
program (42 FR 9286 at 9289). FDA explained that this information would 
help assure that the

[[Page 50718]]

selected hearing aid would be beneficial and would encourage hearing 
aid use among those prospective users who lack the motivation to try a 
hearing aid because of the fear that they will spend a great deal of 
money with no guarantee of benefit (42 FR 9286 at 9289). FDA believes 
that the reasons for requiring this information in labeling continue to 
apply for prescription hearing aids, which are typically sold through 
licensed hearing aid dispensers, many of whom offer such programs.
    (Additional Revision 2) In response to various concerns evident in 
the comments, we are including in this final rule a requirement that 
the principal display panel of the outside package labeling of an OTC 
hearing aid bear the conspicuous marks, ``OTC'' and ``hearing aid.'' 
FDA intends these marks to clarify for purchasers and others, including 
retailers and State agencies, whether a product is a hearing aid 
(regulated as a device), and whether it is available OTC. (See also the 
response to Comment 18 discussing hearing aid terminology.) However, 
these marks do not in any way denote official approval of the device, 
and any representation that creates an impression of official approval 
because of complying with these marking requirements or with the OTC 
Hearing Aid Controls would be considered false or misleading and 
constitute misbranding. (See also the response to Comment 56 regarding 
other false or misleading statements.) The marking is necessary for 
reasonable assurance of safety and effectiveness of OTC hearing aids 
because it provides assurances that non-OTC hearing aids or non-devices 
will not be confused for OTC hearing aids.
    The marks must have the same prominence as required under Sec.  
801.61(c) for the device's statement of identity, and a manufacturer 
may satisfy this new marking requirement if the statement of the 
device's common name includes both ``OTC'' and ``hearing aid.'' For 
example, a manufacturer may label its product as a ``Self-Fitting OTC 
Hearing Aid'' (assuming the device's common name is ``self-fitting 
hearing aid''). Such a device would meet this new marking requirement 
as well as the requirement for the common name in the statement of 
identity. Alternatively, the manufacturer may, for example, label its 
product without including the marks in the common name of the device, 
perhaps by placing ``OTC'' in a corner of the principal display panel 
with the required prominence (assuming the device's common name 
includes ``hearing aid''). Formatting the marks, for example, by 
outlining them with a box, would be permissible provided the formatting 
does not cause the marks to lack the required prominence (see 21 CFR 
801.15(a)(6)).
4. Labeling Inside the Package and Technical Matters
    (Comment 59) A few comments requested that the frequency response 
and ANSI S3.22 specifications of OTC hearing aids be included in the 
user manual.
    (Response) FDA infers this request is to assist in selecting an OTC 
hearing aid with optimal performance. We are not requiring the 
requested information in OTC hearing aid labeling because, as we 
explained in the proposal, this information is highly technical and 
generally not useful to the lay user (see 86 FR 58150 at 58163). 
However, we are finalizing the proposed requirement that OTC hearing 
aid labeling include key electroacoustic performance specifications 
that are more likely to assist prospective lay users in comparing and 
selecting the devices, including the values for maximum output, full-on 
gain, total harmonic distortion, self-generated noise, latency, and 
upper and lower cutoff frequencies for the acoustic bandwidth.
    (Comment 60) A few comments expressed concern that requiring 
summaries of clinical studies conducted by or for the manufacturer on 
the inside labeling is not practical. Comments suggested that providing 
a link to an online library of the clinical studies and a summary of 
each study on the manufacturer's website would suffice.
    (Response) FDA disagrees that providing summaries of clinical 
studies in the labeling inside the package is impractical. While we 
understand that fully appreciating the outcomes of a study can entail a 
lengthy technical document, presenting the most important findings 
regarding the performance of the OTC hearing aid, in a user-friendly 
format, need not take significant space in the labeling. We are 
finalizing the requirement as proposed.
    (Comment 61) A few comments requested that the labeling include 
information on how the OTC hearing aid can be fixed or repaired. 
Comments requested that the information include whether a local hearing 
healthcare professional can repair the device or if it needs to be sent 
to the manufacturer. Comments argued this would allow prospective users 
to make an informed decision when purchasing their devices.
    (Response) FDA agrees that manufacturers should provide users with 
information on how to have their hearing aid repaired because this 
information may be difficult for users to obtain on their own. The 
inside package labeling requirements now include information on how and 
where to obtain repair service or replacements, with at least one 
specific address where the user can go or send the OTC hearing aid to 
obtain such repair service or replacements.
    (Comment 62) A few comments expressed concern that estimating the 
expected battery life will be difficult for manufacturers due to 
inconsistencies between batteries and use conditions. Comments proposed 
removing this requirement from the labeling inside the package.
    (Response) FDA recognizes that battery performance can vary but 
will retain this requirement in the final rule because this information 
will help prospective purchasers determine whether a hearing aid will 
be suitable for their circumstances. Recognizing that performance can 
vary from device to device, we did not propose, and are not requiring, 
a specific method of estimating the battery life. However, 
manufacturers may want to review Clause 4.7 (Battery Life) of ANSI/CTA-
2051:2017, which currently provides an acceptable method to estimate 
the battery life (Ref. 8).
    (Comment 63) A comment proposed a requirement for OTC hearing aid 
labeling to include information about the transport methods for 
configuration information and other data to and from the OTC hearing 
aid with all points along the supply chain.
    (Response) FDA is not adopting this proposal because such 
information is focused on the electronic transfer of non-diagnostic 
data and is not generally necessary for reasonable assurance of safety 
and effectiveness of all OTC hearing aids. We note, however, that 
should States establish or continue in effect requirements to disclose 
such information, and the requirements are not specifically applicable 
to hearing products, section 709(b)(4) of FDARA likely would not 
preempt them. However, FDA is not opining on whether such disclosure 
requirements likely would or would not be preempted under section 
521(a) of the FD&C Act. (See also the response to Comment 115 
concerning the collection of personal information as part of a sale of 
an OTC hearing aid.)
    (Comment 64) A comment requested that FDA require labeling that 
specifies the latency of any wireless streaming technologies the OTC 
hearing aid uses.
    (Response) In certain circumstances, latency information in the 
labeling may be necessary under existing requirements. For example, if 
the information is necessary to provide adequate directions for use or 
necessary

[[Page 50719]]

for practitioners licensed by law to use the device safely and for its 
intended purpose(s), then the latency information would have to appear 
in the device labeling (see Sec. Sec.  801.5 and 801.109(c), 
respectively).
    However, as a general matter for hearing aids that incorporate 
wireless streaming technology, FDA has determined that stating the 
streaming latency is not necessary to provide reasonable assurance of 
safety and effectiveness. Additionally, a variety of factors can affect 
wireless streaming latency, including nearby radio interference, 
distance between the transmitter and receiver, and the presence of 
materials that absorb certain radiofrequencies. As such, a standardized 
wireless streaming latency value may not reflect a particular device's 
design or the environment in which the user wears the hearing aid; and 
thus, FDA is not adding a requirement to include wireless streaming 
latency information for all OTC hearing aids in this rule. We note that 
FDA is finalizing requirements for OTC hearing aid labeling to include 
manufacturer contact information. If users or prospective users are 
interested in the streaming latency specifically, they will be able to 
contact the manufacturer.
    (Comment 65) A few comments requested a labeling requirement 
describing the fitting range across different frequencies (500, 1000, 
2000, and 4000 Hertz) to help consumers determine the suitability of 
different OTC hearing aids to meet their needs.
    (Response) FDA understands that traditionally, hearing aids are 
designed and marketed with a specific fitting range in mind, and 
manufacturers may maintain this practice. However, OTC hearing aids are 
intended to be available without the involvement of a licensed person 
(see 21 U.S.C. 360j(q)(1)(A)(v)). As such, FDA is not using audiometry-
defined thresholds or ranges of hearing loss in the final rule. 
Instead, FDA is using descriptions of common symptoms of mild to 
moderate hearing impairment in the labeling. As such, describing the 
fitting ranges across different frequency bands is not necessary for 
reasonable assurance of safety and effectiveness of OTC hearing aids. 
However, manufacturers may choose to include this information in device 
labeling, and prospective users will have access to the manufacturer's 
contact information prior to purchase should they desire to inquire 
about the fitting ranges.
5. Adverse Event Reporting
    (Comment 66) The proposed labeling included instructions on 
reporting adverse events through the MedWatch portal, https://www.fda.gov/Safety/Medwatch, or by phone, 1-800-FDA-1088. A few 
comments requested that email and mailing options also be provided for 
adverse event reporting. Comments further recommended that FDA provide 
a receipt of the complaint to individuals.
    (Response) We are declining to include a mailing address in the 
labeling because submissions by mail should be on a MedWatch form, for 
example, the Consumer Voluntary Reporting Form (FDA 3500B), which 
contains the address along with additional instructions. Reference to 
just the address in hearing aid labeling may result in reports 
submitted in an unexpected manner and format, potentially causing 
confusion, incomplete reports, and significant delays in processing 
them. However, in addition to reporting events through the MedWatch 
portal and 1-800-FDA-1088, consumers can submit their adverse event 
reporting form to FDA by fax or the mailing address according to the 
instructions on the form. Submitters will receive a reply from FDA 
after we receive their report. Email is not currently an alternative to 
the MedWatch online submission system.
    (Comment 67) A few comments recommended that in addition to 
labeling information on reporting adverse events to FDA, contact 
information for manufacturers should be required so that manufacturers 
are provided the opportunity to review adverse events. Comments implied 
that providing manufacturers with awareness about adverse events and 
opportunity to address them would be beneficial to consumers.
    (Response) To help facilitate communications between users and 
manufacturers, FDA has added the manufacturer's email and mailing 
address to the labeling requirements (see final Sec.  
800.30(c)(1)(i)(E)). Should users wish to report adverse events to the 
manufacturer, they may use this information to do so. Manufacturers may 
also include instructions in the labeling, that do not conflict with 
the labeling requirements, on how to directly report adverse events to 
them.
    (Comment 68) FDA included in the proposed labeling examples of 
adverse events to be reported to FDA: irritation of the ear canal or 
outer ear skin, injury from the device (like cuts or scratches, or 
burns from an overheated battery), pieces of the device getting lodged 
in the ear canal, and sudden increased severity in hearing loss with 
the device. Some commenters suggested limiting the list to more-serious 
conditions to avoid the adverse reporting system being overwhelmed by 
reports of minor adverse events. Commenters expressed concern that if 
the labeling were finalized as proposed, more serious adverse events 
may get lost in the volume of what the commenters see as minor. 
Commenters recommended adverse event reporting be limited to 
significant injury and/or death.
    (Response) FDA is declining to limit the examples of adverse 
events, or the reporting of adverse events, to significant injury and/
or death. FDA is interested in receiving information on all adverse 
events to have a better understanding of OTC hearing aid product safety 
and performance. Additionally, under section 709(d) of FDARA, FDA is 
required to submit a report to Congress ``analyzing any adverse events 
related to over-the-counter hearing aids.'' FDA is prepared to review 
adverse event reports and has experience in sorting through adverse 
event reporting data to identify safety signals and trends.
    (Comment 69) Comments requested that users of prescription hearing 
aids be able to report adverse events to FDA similar to how OTC hearing 
aid users can report through the MedWatch portal at https://www.fda.gov/Safety/Medwatch, or by phone, 1-800-FDA-1088.
    (Response) We agree that prescription hearing aid users should also 
report adverse events to FDA. We proposed and are finalizing the same 
note for prescription hearing aids to notify users of how to report 
adverse events to FDA.
6. Miscellaneous Labeling Considerations
    (Comment 70) Some comments recommended that restrictions on the use 
of OTC hearing aids by individuals under the age of 18 be removed. 
Comments expressed the need for cost effective hearing aids for 
individuals under 18. Additionally, comments asserted that individuals 
under 18 are increasingly suffering from hearing loss as a result of 
exposure to loud sounds, which they argued is hearing loss that can be 
addressed by OTC hearing aids.
    (Response) FDA is declining to allow the sale of OTC hearing aids 
to individuals under the age of 18. This condition for sale is 
consistent with section 709(b)(2)(C) of FDARA and section 
520(q)(1)(A)(ii) of the FD&C Act, which establish that OTC hearing aids 
are only intended for people aged 18 and older. The use of OTC hearing 
aids

[[Page 50720]]

in people younger than 18 presents risks to health beyond those 
typically associated with use in older people. While FDA appreciates 
the need for cost effective hearing aids for individuals under the age 
of 18, the sale of OTC hearing aids will be limited to individuals who 
are age 18 and older.
    (Comment 71) A few comments expressed concern that the manufacturer 
contact information that FDA proposed to include in the labeling of OTC 
hearing aids is limiting because the only alternative to a website 
address was a telephone number. Comments argued that many individuals 
with hearing loss do not prefer to communicate using the telephone and 
recommended the inclusion of the manufacturer's email and mailing 
address on labeling to provide greater access to users.
    (Response) FDA agrees that providing additional ways for users to 
communicate with manufacturers will allow for users to resolve issues 
with their hearing aids more easily. The labeling requirements have 
been updated to include the manufacturer's mailing address and email 
address.
    (Comment 72) A few comments noted that hearing aids are physically 
small and do not have room for a serial number on them. Comments 
recommended that the serial number be located on an accompanying item, 
such as on the storage case or registration card.
    (Response) FDA is declining to implement this suggestion. 
Manufacturers have been complying with this long-standing requirement 
for labeling under Sec.  801.420, which we are revising and renumbering 
as Sec.  801.422, and marking the serial number on the device itself 
(since 1977). Additionally, because accompanying items can be 
misplaced, marking the device itself is essential to the utility of the 
serial number.
    (Additional Revision 3) As noted in the response to Comment 8, we 
are finalizing labeling requirements for hearing aid software. We 
expect much of the labeling to be electronic in nature, for example, 
the graphic and printed matter that appear on a download web page or in 
electronic display ``cards'' or dialogs in the software's user 
interface. As such, electronic labeling may have a transitory nature, 
and we are specifying the occasion and persistence of presentation. For 
example, we are requiring that the labeling present a warning against 
use in people younger than 18. In this example, the electronic 
labeling, perhaps appearing in a modal dialog, need not appear at all 
times. Rather, we are requiring that the labeling present the warning 
to the user prior to first use of the software and persist until the 
user acknowledges it. We are further requiring that the software 
provide access to all of its labeling for later review, for example, 
through a Help menu selection.
    We intend the software device labeling requirements to correspond 
with the labeling requirements we proposed for packaged hearing aids to 
the greatest extent possible. As such, we are requiring that the 
software device labeling present certain information prior to first use 
or obtaining payment information for the software (not necessarily the 
hearing aid or amplification platform), reflective of the nature of the 
information we are requiring on the packaging, that is, information the 
prospective user should know prior to purchase, if a purchase is 
involved. Some labeling is required prior to first use, but it could 
appear after purchase of the software, if a purchase is involved. Other 
labeling is required to be accessible in the software, but it need not 
be presented at any particular time.
    We recognize that some of the information required in the labeling 
under final Sec.  800.30(c)(1) through (4) may not apply to software. 
For example, specific instructions for cleaning and disinfection likely 
would not apply to stand-alone software (see final Sec.  
800.30(c)(2)(vii)(D)). As another example, an illustration of the 
battery compartment likely would not apply (see final Sec.  
800.30(c)(2)(iv)). To address this, we made it clear that certain 
information is required to the extent applicable. Thus, in the first 
example, the software device labeling need not include instructions for 
cleaning and disinfection if that information is not applicable. In the 
second example, the software device labeling must include an 
illustration(s), but not necessarily of the battery compartment if not 
applicable. Further, in that example, a video would be an adaptation of 
and suffice for an illustration(s). Although software may not have a 
principal display panel like a packaged hearing aid, a software-loading 
or Home screen could serve a similar function to provide the 
information required under Sec.  800.30(c)(1)(iii).
    We have also included requirements for the software device labeling 
to disclose compatibility requirements as well as any fees or payments. 
Disclosure of compatibility requirements is necessary for reasonable 
assurance of safety and effectiveness because this information 
describes some of the necessary conditions under which the software 
device will be usable and thus safe and effective. The disclosures of 
any fees or payments are similarly necessary because they describe 
necessary conditions under which the software or additional features 
will start, continue, and/or cease to operate safely and effectively.
    The software labeling requirements we are finalizing under new 
Sec.  800.30(c)(5) are in addition to any other applicable requirement, 
including special controls. For example, 21 CFR 801.50, regarding 
labeling requirements for stand-alone software, would still apply to 
the software when appropriate under that regulation. As another 
example, the general requirements for adequate directions for use (see 
section 502(f)(1) of the FD&C Act and Sec.  801.5) would also apply, 
unless the software device is exempt under Sec.  801.109.
    We are adding similar software device labeling requirements in 
Sec.  801.422.

E. Output Limits (Sec.  800.30(d))

    Generally, comments on the output limits for OTC hearing aids 
either agreed that FDA's proposed limits were appropriate or comments 
proposed lower limits. Several comments recommended output limits that 
depend on device design, for example volume control, compression, or a 
limit on gain. FDA received many comments on this subject, some of 
which included references to published scientific literature, consensus 
standards, stakeholder position papers, and public health guidelines. 
For the following reasons, we are finalizing lower output limits than 
we proposed--111 and 117 dB SPL, which are multiples of 3-dB reductions 
from the proposal--but we are not including a separate gain limit.
1. Finalizing Lower Output Limits
    After further considering the potential risk of worsening users' 
hearing impairments as discussed below, as well as the literature 
submitted to us in the comments (e.g., Refs. 10 and 11), we have 
decided to finalize lower output limits than we proposed. We are 
retaining the conditional structure of the output limits, with the 
higher output permitted for devices with activated input-controlled 
compression. (See the response to Comment 87 about requiring a user-
adjustable volume control for all OTC hearing aids.) We are also 
retaining the limits expressed as Output Sound Pressure Level 90 
(OSPL90) values rather than A-weighted values as suggested by some 
comments. OSPL90 values are more common expressions of hearing aid 
outputs, and they are consistent with the consensus standards we are 
adopting, which refer to OSPL90 values.

[[Page 50721]]

    Comments suggested a variety of lower limits, but we are adopting a 
general limit of 111 dB SPL, which is sufficient to mitigate the 
greater risk potential from both acute high-output-levels and 
cumulative exposure that we identified after further consideration. We 
are correspondingly finalizing the higher conditional limit of 117 dB 
SPL for devices with activated input-controlled compression.
    Many commenters suggested an output limit of 110 dB SPL and 
considered this output limit sufficient to address even moderate 
impairment, as each commenter defined the term ``moderate.'' However, 
as discussed further below, we have applied an equal-energy principle 
and used a 3-dB exchange rate in revising the general output limit to 
111 dB SPL. We do not believe that an output limit of 110 dB SPL would 
provide any meaningful difference with regard to safety.
    The output limits that we are finalizing balance safety and 
effectiveness without unduly sacrificing either. We are not adopting 
the even lower limits suggested in some comments because these lower 
limits would reduce device effectiveness for people with perceived mild 
to moderate hearing impairment to such a degree that the limits would 
exclude some intended users from obtaining sufficient benefit of OTC 
hearing aids. At the same time, progressively lower output limits yield 
diminishing returns in terms of safety. Thus, lowering the output limit 
even further as suggested in some comments would begin excluding 
intended users without achieving meaningful improvements in safety for 
them. As a result, lowering the output limits even further as suggested 
in some comments would not provide reasonable assurance of 
effectiveness for people with perceived mild to moderate hearing 
impairment, and thus would not be ``appropriate'' for OTC hearing aids 
per section 709(b)(2)(B) of FDARA.
    The reduction in effectiveness and benefit would result primarily 
because, with even lower output limits, the hearing aid would no longer 
have a sufficient dynamic range (``headroom'') for high-fidelity 
amplification. The hearing aid could then apply compression and/or 
other output limiting measures more often or to a greater degree, 
resulting in perceptibly lower-fidelity (less effective) amplification. 
In such circumstances, OTC hearing aids would have significantly 
reduced effectiveness for the intended users, sometimes even in 
normally non-hazardous environments. This reduction in effectiveness 
would be increasingly noticeable for intended users as the device 
output is reduced.
    By way of comparison, a comment urging FDA to adopt an output limit 
of 102 dB SPL also urged FDA to limit the intended users of OTC hearing 
aids to people with mild impairment rather than mild to moderate 
impairment. As we explain in the response to Comment 10, we are not so 
limiting the OTC category, and an output limit that low would not 
provide reasonable assurance of safety and effectiveness in addressing 
perceived mild to moderate hearing impairment. As provided in section 
520(q)(1)(A)(ii) of the FD&C Act, OTC hearing aids are ``intended to be 
used by adults age 18 and older to compensate for perceived mild to 
moderate hearing impairment.''
    Moreover, many comments urging FDA to adopt lower limits than the 
ones we are finalizing referred to material that stated output levels 
in root mean square (RMS) terms. The limits we are finalizing are 
expressed differently--expressed in terms of maximum peak values 
(implicit in the measurement of OSPL90 values). To derive a peak value 
based on an RMS level, one would increase the RMS level by an amount 
that represents the ``crest factor'' of the output. Thus, except in one 
circumstance that is not applicable to the materials submitted to us, 
RMS values are lower than peak values for the purposes of considering 
the sound output of hearing aids, and comparisons between RMS and peak 
values need to take this difference into account.\9\
---------------------------------------------------------------------------

    \9\ For square wave signals, the peak and RMS values would be 
the same (a 0-dB difference). However, for the purposes of 
describing hearing aid performance, a crest factor would be an 
important element for considering limits as RMS values, for example, 
to ensure a limit expressed as an RMS value allowed for effective 
amplification of speech. Crest factors for speech are often 12-17 
dB, with 15 dB being a value frequently cited in comments.
---------------------------------------------------------------------------

    As noted, we are also finalizing a lower limit for OTC hearing aids 
with input-controlled compression activated. This value, 117 dB SPL, is 
intended to maximize the available headroom for OTC hearing aids while 
still providing reasonable assurance of safety and effectiveness. As we 
explained in the proposal, input-controlled compression is an automatic 
function that dynamically reduces the device's output and helps prevent 
the device from continuously performing at its output limit (see 86 FR 
58150 at 58161-58162). In these ways, the use of input-controlled 
compression adequately addresses the safety concerns that the increased 
output can raise. We explain our reasons for finalizing lower output 
limits in more detail below.
    We wish to emphasize that, in finalizing lower output limits, we do 
not intend to reduce the number of intended users for whom the use of 
OTC hearing aids is safe and effective (in comparison to the proposed 
limits). Rather, we are lowering final limits to allow sufficient 
headroom for the same intended users, albeit less headroom than we 
proposed. As stated above, the output limits that we are finalizing are 
intended to balance safety and effectiveness without unduly sacrificing 
either.
    In response to comments, we are also revising the final regulation 
to permit the use of alternative acoustic couplers when a 2-cubic 
centimeter (cm\3\) coupler is not compatible with the device design. 
See the response to Comment 81 for more on this topic.
    Additionally, we are slightly modifying the phrasing of the 
regulation to clarify that the device may reach the higher limit only 
while the input-controlled compression is activated. For example, if a 
user were to deactivate the feature, the device must not exceed the 
general output limit of 111 dB SPL while the feature is deactivated.
2. Considerations for Appropriateness of Output Limits
    In deciding to finalize lower output limits, FDA is primarily 
considering output limits that will provide reasonable assurance of 
safety and effectiveness and are ``appropriate'' for OTC hearing aids 
as section 709(b)(2)(B) of FDARA uses the term. To determine such 
limits, we are balancing considerations of safety and effectiveness for 
all intended users of these devices to both protect and promote the 
public health. As we explained in the proposed rule, too high of an 
output can be unsafe (see 86 FR 58150 at 58161). However, too low of an 
output reduces device effectiveness and can lead to poor device 
performance, and ultimately, can reduce satisfaction and use (see 86 FR 
58150 at 58161).
    Many comments described the communication needs of hearing aid 
users and how those interests relate to the output limits and the 
purposes of establishing the OTC category of hearing aids. FDA agrees 
that those interests are relevant to safety and effectiveness as well 
as what would be appropriate. However, balancing the various 
considerations related to safety and effectiveness is complex and 
involves the application of scientific judgment. Thus, while FDA agrees 
with the many thoughtful comments that several factors, discussed 
further in this section, affect the determination of appropriate output 
limits, we do not always agree

[[Page 50722]]

with the determination reached by commenters.
    One of the purposes of this rulemaking is to address a widespread 
public health need stemming from relatively low adoption and use of 
hearing aids by people who could benefit from them. More specifically, 
an underlying goal of this rulemaking is broadening access to these 
devices, without the involvement of a licensed person, to compensate 
for perceived mild to moderate hearing impairment in adults. (See the 
responses to Comments 10-12 for more about the scope of this 
rulemaking.) FDA is mindful of the need to establish or adopt output 
limits that would provide sufficient amplification to meet the user's 
listening needs and thereby bolster user satisfaction, adoption, and 
use. Moreover, OTC hearing aids need a sufficient output, maximizing 
the available dynamic range (the headroom), to meet the hearing needs 
of the breadth of the intended population of adults with perceived mild 
to moderate hearing impairment. Therefore, the output limits must not 
be too low.
    The appropriateness of output limits for OTC hearing aids should 
also account for circumstances in which users must determine for 
themselves when amplification may be excessive and then potentially 
take action to mitigate or avoid the situation, without the involvement 
of a licensed person for training or intervention. We are aware that 
some users of hearing aids who have perceived mild to moderate 
impairment may have difficulties with such tasks. For example, they may 
have reduced dexterity or may have difficulty judging their listening 
environments. Thus, we are also mindful of the need to establish or 
adopt output limits that provide for reasonable assurance of safety and 
effectiveness for such users and others. Therefore, the output limits 
must not be too high. (See also the response to Comment 100 regarding 
the use of consensus standards.)
    FDA has considered quantitative information to inform our 
consideration of safety and effectiveness. In the proposed rule, we 
referred to a national workplace safety guideline, ``Occupational Noise 
Exposure,'' developed by the National Institute for Occupational Safety 
and Health (NIOSH) (see 86 FR 58150 at 58161-62) (Ref. 9). That 
guideline, which we will refer to as NIOSH-98, defines, among other 
subjects, hazardous levels of sound exposure in relation to the 
duration of exposure. It uses as its basis 85 dBA (A-weighted decibels) 
over 8 hours (as in, a generic workday) as the maximum non-hazardous 
exposure level (see paragraph 1.1 of NIOSH-98). Roughly speaking, the 
difference between A-weighted decibels and decibels of sound pressure 
level, for present purposes, is about 5 dB. As such, 120 dB SPL, or 
about 115 dBA, of exposure over 28 seconds would be equivalent to a 
full workday's allowable exposure for purposes of occupational safety 
(see table 1-1 of NIOSH-98). To address different levels of exposure 
besides 85 dBA, NIOSH-98 uses a 3-dB exchange rate (or equal-energy 
rule), meaning that the allowable time before the exposure is 
considered hazardous halves for every 3-dB increase (see paragraph 
1.1.2 of NIOSH-98). In other words, for louder exposures, NIOSH-98 
indicates less allowable time than 8 hours and vice versa for lower 
exposures.
    We have applied an equal-energy principle and used a 3-dB exchange 
rate as a basis for revising the output limits. This interval, rather 
than another amount, more clearly reflects our consideration of non-
hazardous outputs and the differing output levels. Thus, 117 dB SPL, 
which is 3 dB less than proposed, represents half the output power of 
the proposal or twice the time to achieve the same cumulative exposure 
(when the hearing aid is outputting at the limit). This translates to a 
lower risk of impairment from using OTC hearing aids. However, half the 
allowable power does not mean the output will sound ``half as loud.'' 
As such, not only does 117 dB SPL translate to a lower risk, it also 
does not unduly sacrifice effectiveness.
    For the purpose of illustration, you might think of a person as 
having a ``budget'' of allowable sound exposure from a hearing aid to 
avoid further hearing impairment. The rate at which the person goes 
through the budget depends on the output level, and higher outputs 
(which have higher power) will use up the budget faster than lower 
outputs. In other words, because outputs at 117 dB SPL are half the 
power of those at 120 dB SPL, 117 dB SPL will use up the sound budget 
more slowly. If a hearing aid user encounters a sound at 117 dB SPL 
while using hearing aids, the user will thus have more of the budget 
left over to continue wearing the hearing aid for the rest of the day 
(without over-exposure) than if the loud sound were at 120 dB SPL. 
Note, however, that this analogy is merely an illustration of some 
concepts of cumulative exposure. Hearing healthcare professionals use 
more technical and precise concepts to describe the effects of sound 
exposure on hearing abilities.
    FDA notes that nothing in this rulemaking is intended to interpret 
the application of NIOSH-98 for purposes of occupational exposure. 
Rather, we are considering the effects of cumulative and ongoing 
exposure in relation to equivalent peak output levels for the purposes 
of this rulemaking. Conversely, we wish to clarify that referring to 
NIOSH-98 does not mean that hearing aids should offer an output 
comparable to occupational noise exposure. (The sound output of a 
hearing aid is unlikely to reach its output limit regularly.) 
Nonetheless, NIOSH-98 provides a well-reasoned quantitative approach to 
the effects of sound exposure on people's hearing.
    While many comments agreed that FDA's proposed output limits 
provided an adequate safety margin, other comments disagreed and called 
our attention to scenarios in which sound exposure at a relatively high 
level might be followed by continuing exposure at a relatively modest 
level. In certain circumstances, the equal-energy principle would imply 
that the relatively modest exposure could nevertheless be hazardous. In 
the proposed rule, we used the 3-dB exchange rate to compare the 
presumable reaction times between 120 dB SPL and 115 dB SPL, explaining 
that the latter offers about triple the time, an additional 61 seconds 
(approximately), given the 5-dB difference (see 86 FR 58150 at 58161). 
This does not imply that a continuous sound output of 115 dB SPL is 
safe for an extended period of use of an OTC hearing aid. This also 
does not imply that the user has approximately 89 seconds to intervene 
(for example, to remove the OTC hearing aid). Experiencing these output 
levels for long-enough periods of time could place the user at greater 
risk for further hearing impairment even though the user might judge 
the follow-on exposures to be modest or normal.
    We acknowledge that the statement in ANSI/CTA-2051:2017 that 115 
dBA (about 120 dB SPL) is an acceptable listening level for up to 30 
seconds might imply that repeated exposures to 115 dBA (about 120 dB 
SPL) over the course of a day's use of a hearing aid are necessarily 
acceptable as long as the exposures are shorter than 30 seconds. (Note 
that a day's use of a hearing aid may be longer or shorter than the 
generic 8-hour workday that NIOSH-98 uses.) Further, we recognize that 
referring to the full time as a safety margin did not adequately 
account for exposure to other sounds throughout the day because using 
the entire 28-second interval would equate to a day's worth of 
allowable cumulative exposure. The

[[Page 50723]]

28-second interval assumes no other sound exposure during that 8-hour 
timeframe rather than continuing use (and exposure) at a low-enough 
level. In consideration of the comments, especially those calling our 
attention to possible scenarios leading to excess cumulative exposure, 
we have determined we should reduce the risks of cumulative exposure 
and do so by finalizing lower output limits than proposed.
    Nevertheless, FDA does not expect OTC hearing aids to perform at or 
near their maximum output capabilities for extended periods of time 
during the day, if at all. As such, neither our reference to NIOSH-98 
nor to ANSI/CTA-2051:2017 should be read to imply that constant outputs 
at or near 115 dB SPL (about 110 dBA) are necessarily safe. Instead, 
the limits we are finalizing are meant to be high enough to allow 
sufficient headroom for high-fidelity amplification for people with 
perceived mild to moderate hearing impairment, including amplification 
of occasional peaks necessary to reproduce certain kinds of higher 
intensity, but infrequent, sounds (see 86 FR 58150 at 58161-62).\10\ 
However, a device's design or software may have sufficient headroom 
without reaching the maximum allowable output. We intend these output 
limits to facilitate wide adoption of hearing aids and design 
flexibility without being unnecessarily prescriptive.
---------------------------------------------------------------------------

    \10\ The maximum output for a person with greater hearing 
impairment is likely to be higher than for a person with less 
impairment; however, this general rule is subject to considerable 
individual variability.
---------------------------------------------------------------------------

    Some comments recommended that FDA adopt a requirement for 
dosimetry, in essence applying similar principles as those described in 
NIOSH-98. That is, they suggested that FDA require that OTC hearing 
aids be able to measure the weekly sound exposure from the use of the 
device. Instead of limiting peak output, the devices could then limit 
exposure to a safe cumulative dose. While this approach may be one way 
to limit exposure, insufficient scientific data exist regarding 
cumulative exposure with the use of hearing aids by people with 
perceived mild to moderate hearing impairment. Moreover, as we noted 
above, this rulemaking and NIOSH-98 contemplate very different 
contexts, so the quantitative information cannot be directly applied to 
determining cumulative output limits appropriate for OTC hearing aids. 
In sum, FDA believes that establishing a dosimetry-based limit for 
regulatory purposes would be scientifically premature at this time.
    Indeed, quantitative analyses of safe maximum output limits are 
generally difficult to apply because the data do not necessarily 
reflect regulatory considerations. For example, they do not fully 
reflect the intended users, specifically users with perceived mild to 
moderate hearing impairment, or other considerations for reasonable 
assurance of safety and effectiveness of OTC hearing aids. Some sources 
use audiometric threshold-based analyses to quantitatively predict safe 
maximum output limits (e.g., Ref. 10). However, such analyses use 
criteria that FDA is not adopting as they have the effect of excluding 
some people for whom OTC hearing aids would be appropriate. Other 
references use threshold-based analyses for the maximum output for a 
hearing aid that is programmed using existing professional fitting 
formulas, applied to a database of audiograms (e.g., Ref. 11). These 
results, however, do not fully reflect the intended users of OTC 
hearing aids, and interpreting the results often involves the 
application of criteria that FDA is not adopting, for example, the 
choice and application of threshold-based hearing loss categories.
    In either case, these findings are limited for identifying 
appropriate output limits for OTC hearing aids because this rulemaking 
is intended to address perceived, not audiometrically quantified, 
impairment. (See also the response to Comment 24 regarding measurements 
of hearing loss and incorporating numerical thresholds into this 
rulemaking.) Moreover, different commenters interpreted the same 
references differently, demonstrating that even quantitative analyses 
leave much to interpretation. Well-reasoned, scientific views still 
exhibited significant diversity. The analyses are instructive, and we 
have updated our risk assessment based in part on them, but they cannot 
definitively settle the regulatory questions of this rulemaking. Hence, 
although we are finalizing lower output limits based on the available 
information, we are establishing the limits at 111 and 117 dB SPL 
(peak, not RMS, values) rather than the even lower levels found or 
suggested in some of the references submitted to us.
    Other comments recommended FDA adopt international standards 
developed jointly by the WHO and the International Telecommunication 
Union (ITU). These comments identified ITU-T H.870 (2018), ``Guidelines 
for safe listening devices/systems,'' and ITU-T H.871 (2019), ``Safe 
listening guidelines for personal sound amplifiers.'' However, the 
guidelines refer to a WHO-derived standard value for the cumulative 
sound exposure for non-hearing-impaired adults. In other words, they 
use a dosimetry-based method, which we do not believe is a suitable 
basis to establish an appropriate limit, as explained above.
    The guidelines do equate this to an output value of 80 dBA for 40 
hours per week. However, the rationale underlying the guidelines relies 
on WHO thresholds and citations to literature that, as explained, FDA 
is not adopting and does not consider definitive (see the response to 
Comment 24 about the WHO hearing loss thresholds). Further, as even 
ITU-T H.871 (2019) explains, Ref. 10 can be read to suggest 90 dB SPL 
RMS as the maximum sound output for persons with normal hearing (see 
Appendix II of ITU-T H.871 (2019)). Such maximum sound output 
recommendations for normal-hearing listeners cannot be used to derive 
maximum output limits for a hearing aid to compensate for perceived 
mild to moderate hearing impairment. Thus, FDA is declining to adopt 
this cumulative exposure limit or the equivalent peak output value.
    The lack of sufficient data to establish regulatory limits based on 
dosimetry does not, however, mean that dosimetry is not a useful 
feature. Manufacturers that wish to include dosimetry-based features in 
OTC hearing aids may do so.
    Ultimately, as stated previously the output limits that we are 
finalizing reflect a balancing of safety and effectiveness. By lowering 
the output limit 3 dB SPL from the proposed rule, these output limits 
result in a meaningfully lower risk to the intended users, without 
unduly sacrificing effectiveness.
3. Applying Analyses to Real-World Use of Hearing Aids
    As we explain in the responses to Comments 11 and 24, the 
perception of hearing impairment is conceptually integral to 
establishing the OTC category of hearing aids, and the application of 
audiometric thresholds to make regulatory decisions is inconsistent 
with how the hearing loss categories themselves were formulated. 
Moreover, audiometric threshold ranges or databases of audiograms do 
not necessarily reflect the needs and wants of the intended users of 
OTC hearing aids in a precise way. As such, while quantitative analyses 
provide useful information, including data on exposure versus stability 
of hearing impairment, the conclusions have inherent limitations that 
militate against adopting them wholesale for the regulatory purposes of 
this rulemaking.
    FDA also considered how hearing health care providers fit hearing 
aids in

[[Page 50724]]

a clinical environment. Ordinarily, a fitting algorithm determines the 
necessary amplification, including the effective output limit of the 
device for a given user. The provider would then make further, 
iterative adjustments in consultation with the hearing aid user. These 
processes effectively guarantee that the device's output will rarely 
reach the device's maximum capability, if ever.
    However, OTC hearing aids may not have features that prevent the 
user from continuous access to the device's maximum output. Some 
comments conveyed concerns that users, without the aid of professional 
judgment, would want to use unnecessarily high amplification on a 
continual basis; they would tend to prefer higher outputs than a 
hearing healthcare professional would set. In a worst-case example, the 
volume control and other features could cause maximum device 
amplification in a loud environment, and the user does not take action 
to mitigate the effects. In such a worst-case scenario, the user could 
suffer further impairment. Although these comments used anecdotes or 
more general concerns based on professional experience to support their 
views, we recognize that hearing healthcare providers sometimes 
recommend lower outputs than hearing aid users might initially prefer. 
Thus, while we would expect that a device would seldom perform at its 
maximum, much less continuously, even when set at the applicable output 
limit, that possibility is greater than for professionally fit devices, 
for which the audiologist or hearing instrument specialist has, in 
effect, limited the output. In further consideration of the differences 
between professionally fit and user-customizable devices, we find 
additional indications that the safety margin of the proposed output 
limits is lower than we initially believed regarding the risks of 
cumulative exposure.
    Several comments suggested that FDA also reconsider users' ability 
to react to loud situations in which continued use of an OTC hearing 
aid could present significantly increased risks of injury should the 
user not remove the hearing aids or reduce the output. Some comments 
observed that users of OTC hearing aids are likely to have 
characteristics not shared by the general population. For example, OTC 
hearing aid users may be more likely to have reduced dexterity or 
experience cognitive difficulties. Such characteristics can hinder 
adjusting a device in sufficient time, especially if the controls are 
physically small or require navigation (as in opening a software 
application on a smartphone to navigate to the correct control 
interface).
    Other comments noted that, while obviously-loud sounds pose risks 
of further hearing impairment, continuous exposure to lower intensities 
can pose such risks over a sufficiently long period of device use. 
Under the proposed limits, overexposure is possible in scenarios where 
the device is set to its maximum (providing the maximum gain), yet the 
amplified output does not discomfit the user enough to mitigate the 
exposure. Such a scenario would entail an increased risk of impairment 
to residual hearing from use of an OTC hearing aid.
    The ability for users to act to protect themselves was an important 
factor in our proposed output limits (see 86 FR 58150 at 58162), and it 
remains so for this final rule. FDA recognizes that some OTC hearing 
aid users may need more time or assistance to react to noticeable 
overexposure than an average member of the general population. The 
required design and electroacoustic performance features for OTC 
hearing aids will significantly reduce such risks for the intended 
users. For example, a user-adjustable volume control will allow a user 
to set and maintain the device's output below the maximum. However, 
after considering the diversity of scientific comments, we are 
persuaded that our proposal did not adequately account for cumulative 
exposure to lower-intensity sounds during daily use over an extended 
period of time--on account of users' ability or desire to intervene as 
well as the other factors, explained above, that might increase 
cumulative exposure and the resulting risks. Since a dosimetry-based 
limit is impractical as discussed above, we are lowering the allowable 
maximum output to address considerations of cumulative exposure.
4. Declining To Include Gain Limit
    Multiple comments, many of which urged FDA to establish or adopt a 
lower output limit, recommended that FDA also adopt a gain limit. These 
comments contended that a gain limit would improve device safety by 
further reducing the risks of over-amplification, primarily due to the 
device reaching its gain limit and providing no further amplification 
before it reached its output limit (see 86 FR 58150 at 58162). In 
effect, a gain limit would lower the output limit.
    FDA acknowledges that a gain limit may play a role in the 
management of risks from overamplification. However, a gain limit 
reduces the ability to adequately amplify soft sound inputs in some 
cases, which can lead to decreased device effectiveness and user 
satisfaction. Moreover, the appropriate gain for a given device will 
depend on device design and features. Imposing a gain limit may 
constrain device design and innovation, which could have an undesirable 
effect on device benefit for intended users.
    In addition to preserving flexibility in device design, FDA is not 
requiring a gain limit in order to maximize access to these devices for 
the full range of intended users with perceived mild to moderate 
hearing impairment. Intended users of these devices are a heterogenous 
population with a range of hearing and communication difficulties and 
needs. By not requiring a gain limit, the broadest range of intended 
users will have access to effective devices. This flexibility empowers 
users to customize their hearing aids to their needs, listening 
preferences, and communication goals, and it allows for a wider range 
of options should users' needs, preferences, and goals change over 
time.
    FDA is establishing requirements to provide reasonable assurance of 
safety and effectiveness of OTC hearing aids for the intended user 
population, and further reducing the device's output by establishing a 
gain limit is not necessary for such reasonable assurance. Indeed, a 
gain limit in this case may detract from such reasonable assurance by 
broadly reducing the available amplification for the user and limiting 
the range of intended users of the device. Because the appropriate 
output limits we are finalizing will sufficiently limit device output, 
we are not finalizing a gain limit that would further reduce the 
output. (See also the response to Comment 78, describing how frequency 
response smoothness helps prevent under- and overamplification of 
frequency bands, in effect, a more-focused reduction than a gain 
limit.) This also allows manufacturers the flexibility to design their 
devices to balance the required output limits with the amplification 
needs of the intended user population.

F. Other Device Requirements (Sec.  800.30(e) and (f))

    Several comments shared a concern for an influx of unsafe or 
ineffective devices to the marketplace, for example, devices that do 
not satisfy the requirements of the OTC Hearing Aid Controls because of 
lax enforcement and/or manufacturers or sellers evading regulatory 
controls necessary for reasonable assurance of safety and effectiveness 
of OTC hearing aids. Such comments tended to focus on the risks to 
health of violative or non-conforming products, for example, impairment 
of

[[Page 50725]]

remaining hearing from excessive device output, injury stemming from 
inferior manufacturing practices, or ineffective treatment resulting 
from the possible difficulty of distinguishing an OTC hearing aid from 
consumer electronics not intended to compensate for hearing loss.
    To provide reasonable assurance of safety and effectiveness of OTC 
hearing aids, and thereby avoid an influx of unsafe or ineffective 
devices, we are establishing requirements for, among other things, the 
design and performance of OTC hearing aids. At the same time, the 
requirements will not unnecessarily constrain device design or burden 
manufacturing, which could hinder innovation or impede adoption and use 
of the devices. Further, compliance with regulatory controls is a 
concern for all devices, and FDA monitors the marketplace and conducts 
regular inspections and other postmarket surveillance as part of 
maintaining reasonable assurance of safety and effectiveness.
1. Electroacoustic Performance
    (Comment 73) Some comments urged FDA to adopt the same 
electroacoustic performance requirements for prescription hearing aids 
as those for OTC hearing aids.
    (Response) While FDA agrees that prescription hearing aids should 
provide high-fidelity amplification for users, we do not agree that 
prescription hearing aids should be subject to the same electroacoustic 
performance requirements as OTC hearing aids. The requirements for OTC 
hearing aids will provide reasonable assurance of safety and 
effectiveness without the involvement of a licensed person, such as an 
audiologist or hearing instrument specialist, to adjust the device 
output and ensure it performs adequately. However, the requirements we 
are finalizing for prescription hearing aids presume the involvement of 
a licensed person: As prescription devices, they may only be sold to or 
on the prescription or other order of a practitioner licensed by law to 
use or order the use of the devices (see Sec.  801.109(a)(2)).
    The labeling requirements we are finalizing for prescription 
hearing aids include technical specifications that an audiologist or 
hearing instrument specialist can use to select and adjust the hearing 
aid (see 86 FR 58150 at 58164). These requirements are virtually 
identical to the long-standing labeling requirements for hearing aids 
in former Sec.  801.420(c)(4) upon which professionals rely. 
Additionally, we are finalizing a new requirement to state the latency 
of the prescription hearing aid, measured with a method that is 
accurate and repeatable to within 1.5 ms. This information will be 
particularly useful for fitters given evolving hearing aid designs and 
sound processing capabilities. However, we are not also establishing a 
latency performance limit for prescription hearing aids. The 
aforementioned information and the involvement of a licensed person 
will provide reasonable assurance of safety and effectiveness of 
prescription hearing aids without the additional performance 
requirements necessary for OTC hearing aids.
    (Comment 74) A comment recommended that the requirements for an OTC 
hearing aid sold by a licensed person be no different than those for 
sale by a non-licensed person, and that the final rule should clearly 
state that preemption would apply to this situation.
    (Response) To the extent that this comment recommends that the 
requirements for the OTC hearing aid itself be no different when sold 
by a licensed person, versus a non-licensed person, FDA agrees with the 
comment. The requirements for OTC hearing aids themselves (output 
limits, electroacoustic performance, labeling, etc.) that we are 
finalizing apply equally to those sold by licensed and non-licensed 
persons. To the extent that this comment recommends that State 
regulation of the activities associated with the sale of OTC hearing 
aids, for example, via licensing requirements, be preempted, we have 
addressed that request along with similar comments in the Preemption 
sections III.H and VIII.
    (Comment 75) A comment suggested that prescription hearing aids 
have the same output limit as OTC hearing aids.
    (Response) FDA does not agree that prescription hearing aids should 
have the same output limit as OTC hearing aids because people with a 
more severe degree of hearing loss than perceived moderate impairment 
may need additional gain, and therefore would need a higher output, 
potentially above limits appropriate for OTC hearing aids. We recognize 
that people with more severe hearing impairment can still suffer 
further impairment of their remaining hearing, so the device output 
must not be too high for them. We are finalizing a requirement, as 
proposed, that labeling warn dispensers to exercise special care when 
selecting and fitting a hearing aid with an output that exceeds 132 dB 
SPL. This warning is nearly the same as the required warning statement 
in former Sec.  801.420(c)(2). Nevertheless, the output necessary to 
compensate for more severe hearing impairment safely and effectively, 
though subject to individual variability, will generally be higher than 
would be permissible for OTC hearing aids.
    (Comment 76) Comments suggested that FDA require input-controlled 
compression for all OTC hearing aids to help significantly reduce the 
risk that users could worsen their hearing impairment by using an OTC 
hearing aid.
    (Response) FDA agrees that input-controlled compression can provide 
multiple benefits for OTC hearing aid users. For example, this feature 
allows the device to adapt the output dynamically, based on the 
listening environment. This can reduce the user interaction necessary 
to adjust the device for different situations. Some users find the 
feature improves the hearing aid's comfort, contributing to their 
satisfaction and encouraging continued use. This in turn can help 
accomplish this rule's purposes of promoting wider adoption and use. 
However, some users find the feature annoying or distracting, reducing 
their satisfaction and discouraging them from using their hearing aids. 
Moreover, the feature is not necessary for reasonable assurance of 
safety or effectiveness (when the device does not exceed an output of 
111 dB SPL). For these reasons, FDA is not requiring input-controlled 
compression for all OTC hearing aids. (See also the response to Comment 
77 about including noise-cancelling technology.)
    (Comment 77) A comment suggested requiring that OTC hearing aids 
include noise-cancelling technology to prevent a loss of benefit from 
using the devices in noisy environments.
    (Response) FDA agrees that noise-cancelling technology can help 
hearing aid users in certain situations. For example, the feature can 
help improve the clarity of voices by reducing the volume of only 
background noise. This can reduce the user interaction necessary to 
adjust the device for different situations. However, the feature is not 
generally necessary for reasonable assurance of safety or effectiveness 
because air-conduction hearing aids can still provide adequate 
amplification to achieve effectiveness without the feature, so FDA is 
not requiring noise-cancelling technology for all OTC hearing aids. 
(See also the response to Comment 76 about including input-controlled 
compression.)
    (Comment 78) Comments requested that FDA remove the frequency 
response smoothness requirements so, these comments asserted, OTC 
hearing aids would accommodate all kinds of

[[Page 50726]]

perceived mild to moderate hearing impairment, not just individuals 
with typical age-related, sloping hearing impairment.
    (Response) Although FDA agrees that OTC hearing aids should be safe 
and effective for the breadth of the intended user population with 
perceived mild to moderate hearing impairments, we are not removing the 
frequency response smoothness requirements for OTC hearing aids. As we 
explained in the proposed rule, a smooth frequency response will ensure 
that an OTC hearing aid does not under- or overamplify certain sounds 
(see 86 FR 58150 at 58164). A device that does not have a smooth 
frequency response can, for example, perceptibly distort speech quality 
(see 86 FR 58150 at 58164).
    Moreover, the proposed frequency response smoothness requirements 
do not limit device output to compensating only for typical age-
related, gradually sloping hearing impairment. More specifically, the 
frequency response smoothness describes the flatness of the output when 
the device is set to provide constant gain as a function of frequency, 
that is, when the device is not set to provide frequency shaping. The 
idea is that the flatter the response when the device is not set to 
provide frequency shaping, the more consistently the device will 
achieve any intended frequency shaping to accommodate the user's 
customization, for example, to compensate for a sloping hearing loss.
    This is similar to how a loudspeaker's frequency response is later 
adjusted by an equalizer, which shapes the input signal. In short, 
frequency response smoothness does not prevent the device from 
appropriately amplifying lower frequencies. Instead, it helps prevent 
under- and overamplification at any frequency band that could result 
from a device that does not appropriately shape the output. We are 
finalizing the smoothness requirements as proposed.
    (Comment 79) Some comments proposed that OTC hearing aids have 
cutoff limits: if the output were to exceed certain thresholds for a 
long-enough time, the device would reduce or stop amplification, even 
if the device never exceeded the allowable output limit.
    (Response) FDA agrees that an OTC hearing aid user could experience 
over-amplification even if the device does not exceed the allowable 
output limit. As we explain in section V.E of this document, we have 
considered this possibility further and are correspondingly finalizing 
output limits lower than we proposed. We also explain in that section 
that insufficient data exist to establish regulatory limits for 
exposure over time based on dosimetry. As with implementing dosimetry-
based features, manufacturers may establish cutoff limits for their 
devices, but FDA is not requiring such features for OTC hearing aids.
    (Comment 80) A comment requested that FDA allow greater latency for 
OTC hearing aids, suggesting 25 milliseconds (ms). The comment argued 
that this delay would still not be perceptible to the user. Other 
comments requested that FDA address latency for wireless streaming 
technologies, such as Bluetooth, and other hearing aid designs.
    (Response) FDA does not agree that allowing greater latency will be 
imperceptible. One comment cited for support material that showed four 
out of nine people perceived a delay of 25 ms. (Two out of nine 
perceived it at 15 ms.) This does not suggest that allowing greater 
latency will be equally imperceptible, though such a small sample may 
not have yielded generalizable results. Regardless, human hearing 
perception can be sensitive to differences longer than 15 ms, depending 
on frequencies and conditions, and signal processors for hearing aids 
can reliably achieve latencies shorter than 15 ms. Given these 
considerations, we do not agree that greater latency will be 
imperceptible or that a limit of 15 ms unduly constrains device design. 
FDA is not revising the latency limit for OTC hearing aids.
    Regarding wireless streaming technologies, the latency limit we are 
finalizing is an electroacoustic performance metric that describes how 
quickly an OTC hearing aid must produce the output sound relative to 
the input sound, that is, the acoustic input (see 86 FR 58150 at 
58164). It does not describe the time necessary for an OTC hearing aid 
to receive and process a wireless signal after transmission, which can 
often exceed 15 ms, even under ideal conditions. In contrast to 
electroacoustic performance, FDA has not determined that a wireless 
transmission latency limit is generally necessary for reasonable 
assurance of safety and effectiveness of OTC hearing aids because air-
conduction hearing aids compensate for impaired hearing primarily by 
detecting sounds with on-board microphones. As such, wireless streaming 
latency does not generally raise the same perceptual concerns as 
electroacoustic latency. Therefore, we are not establishing a wireless 
transmission latency limit. (See also the response to Comment 64 
regarding labeling for wireless streaming latency.) However, there may 
be circumstances where, based on the device's design, wireless 
streaming latency does raise the same perceptual concerns as 
electroacoustic latency. In such circumstances, manufacturers will 
likely need to consider wireless transmission latency for devices that 
incorporate such technology.
    As for different device designs regarding acoustic transmission, 
the latency limit applies. For example, ``open-fit'' devices that allow 
some incoming sound to bypass the hearing aid would also need to 
respect the latency limit. Moreover, the latency limit is a performance 
baseline. Manufacturers may design devices with lower latency should 
they want to improve electroacoustic performance.
    (Comment 81) Some comments suggested that FDA permit different 
acoustic couplers than proposed for the electroacoustic performance 
testing requirements. These comments argued that standard 2-cm\3\ 
couplers would not be the most appropriate for some device designs, and 
performance measurements would more accurately reflect device 
capabilities if more suitable couplers were permitted.
    (Response) FDA agrees that 2-cm\3\ couplers may not be compatible 
with some device designs. We are revising the final regulations to 
permit use of alternative acoustic couplers that are compatible with 
the device. The manufacturer would have to document how use of the 
alternative approach is scientifically valid and technically 
equivalent.
    (Comment 82) A comment requested that FDA prescribe the method to 
test latency beyond requiring that measurements be accurate and 
repeatable to within 1.5 ms.
    (Response) Although FDA is finalizing standardized test methods to 
ensure other electroacoustic specifications are comparable across 
devices, the comparability of latency is less sensitive to the specific 
method. Latency is a measurement of time, so essentially any 
scientifically suitable and accurate timing method will produce a 
result that is comparable to other suitable and accurate methods, even 
though the methods may differ in the specifics. As such, we are 
specifying how accurate the timing must be but allowing flexibility for 
the specific method. Nevertheless, clause 4.8 of ANSI/CTA-2051:2017 
suggests two different methods, either of which is acceptable provided 
the testing equipment is sufficiently accurate and precise.
    (Comment 83) A comment observed that FDA considered the 
electroacoustic performance requirements in ANSI/

[[Page 50727]]

CTA-2051:2017, including the self-generated noise limit. However, FDA 
did not specify A-weighted measurements for the self-generated noise 
limit in the proposed regulation as the standard does. The comment 
suggested FDA specify A weighting consistent with the standard.
    (Response) FDA agrees that A weighting is more consistent with the 
standard. We are revising the self-generated noise limit in the final 
regulation to refer to A-weighted decibels.
2. Design Requirements To Ensure Proper Physical Fit and Prevent User 
Injury
    (Comment 84) Several comments urged FDA to hold OTC hearing aids to 
the same hardware standards as prescription hearing aids. Some of these 
comments focused on Quality System requirements (see Comment 95 and our 
response). Others focused on equivalent electroacoustic performance.
    (Response) FDA agrees that OTC and prescription hearing aids should 
both be held to standards appropriate for medical devices. However, we 
are not applying all of the same specific rules to both because OTC and 
prescription hearing aids differ in important respects, for example, 
the intended uses.
    Some of the same rules will apply to both. As we explain in the 
response to Comment 95, OTC hearing aids will be subject to quality 
management system requirements that are appropriate for medical 
devices. The same will be true for prescription hearing aids. Thus, 
both OTC and prescription hearing aid manufacturers will need to comply 
with the same Quality System requirements under part 820, even if their 
individual implementations differ in the details. (See also the 
response to Comment 96 about a risk-based approach to quality 
management systems.)
    However, some of the requirements will differ, such as those for 
device performance. We explain in the responses to Comments 73 and 75 
that OTC and prescription hearing aids have different intended uses, 
and therefore, they must satisfy different performance needs. Thus, 
having reasonable assurance of safety and effectiveness of both 
categories of hearing aids entails different specific requirements for 
each category.
    (Comment 85) Some comments proposed requiring that eartips for OTC 
hearing aids be made of ``medical grade'' materials to prevent 
irritation or damage from the components of the device in contact with 
the ear canal.
    (Response) FDA agrees that contact with substances can cause 
adverse tissue reactions like skin irritation; however, the design 
requirements that we are finalizing for OTC hearing aids, along with 
existing requirements and policies, are sufficient to address the kinds 
of materials used.
    The design requirements that we are finalizing for OTC hearing aids 
include a requirement that the material for the eartip be atraumatic, 
which is the same as proposed. As explained in the proposal, atraumatic 
materials are those that prevent injuries to the skin and bone, and the 
use of atraumatic materials reduces the chance that daily use or 
accidental contacts will cause damage to the delicate skin or bone of 
the ear (86 FR 58150 at 58165). In evaluating the material for the 
eartip to determine whether it meets this requirement, manufacturers 
may wish to review FDA's guidance, ``Use of International Standard ISO 
10993-1, `Biological evaluation of medical devices--Part 1: Evaluation 
and testing within a risk management process,' '' issued September 4, 
2020, which describes FDA's approach to biocompatibility evaluation of 
medical devices, including considerations and recommendations for 
manufacturers.\11\
---------------------------------------------------------------------------

    \11\ The document is available online at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/use-international-standard-iso-10993-1-biological-evaluation-medical-devices-part-1-evaluation-and.
---------------------------------------------------------------------------

    As described in the aforementioned guidance, OTC hearing aids 
(depending on the specific device) would likely be a surface device in 
contact with intact skin. As such, manufacturers should consider the 
specific biological effects of cytotoxicity (toxic effects on cells), 
sensitization (becoming more sensitive to materials over time), and 
irritation or intracutaneous reactivity (a reaction within the layers 
of the skin). The use of certain common materials in surface devices 
contacting intact skin may help manufacturers to pursue least-
burdensome methods for evaluating biocompatibility.
    Additionally, as we explain in the responses to Comments 95, 96, 
and 97, OTC hearing aids will be subject to the Quality System 
requirements, which will also help provide for reasonable assurance of 
safety and effectiveness.
    (Comment 86) Several comments suggested requiring that OTC hearing 
aids use non-proprietary designs and/or open-platform technology 
because, in the commenters' views, proprietary designs or closed 
platforms would limit the compatibility of accessories, availability of 
replacement parts, or possibility of modifications to the devices.
    Other, similar comments proposed that OTC hearing aids have a 
standard user interface or support a standard application programming 
interface (API) to allow users to access and modify device settings, 
perhaps through third-party software, when the manufacturer has not 
exposed the desired settings to user control. Some comments identified 
a standard API (or some other standard protocol) as a way to enable 
device interaction with other electronics of the user's choosing, for 
example, a smartphone from a different manufacturer.
    (Response) While some OTC hearing aid users may desire such 
features, we do not currently consider them necessary for reasonable 
assurance of safety and effectiveness of OTC hearing aids generally. 
Hearing aids that incorporate proprietary designs and interfaces can be 
safe and effective, without interaction with third-party products. 
Manufacturers may implement open features, but we are not requiring 
them.
    (Comment 87) Several comments suggested that all OTC hearing aids 
have a user-adjustable volume control because the feature would be 
integral to device safety regardless of its output limit. A comment 
suggested that all hearing aids should have a volume control built into 
the device itself, separate from a software controller (as in, a 
``slider'' in a smartphone application, for example).
    (Response) FDA agrees that a user-adjustable volume control should 
be a design feature of all OTC hearing aids, and we are finalizing such 
a requirement under new Sec.  800.30(f)(5). However, although FDA 
understands that a physical (that is, built into the device itself) 
volume control could provide ready access for some users to adjust the 
volume, we are declining to adopt this suggestion.
    While some users may find a physical volume control useful, several 
comments that FDA received observed that many users of OTC hearing aids 
may have limited dexterity, which would in turn limit the usefulness of 
a hardware controller, for example, a small dial or push buttons on the 
device. Similarly, we received comments emphasizing hearing aid users' 
desire for a discreet device, including both its form and its 
operation. A user interface, perhaps implemented on a remote control or 
a mobile device, will allow design flexibility for manufacturers to 
develop and market smaller hearing aids, and adjusting the volume 
through such an interface may feel more discreet for many users than 
reaching up to the

[[Page 50728]]

device to adjust it, perhaps needing additional effort to manipulate 
physically small controls.
    This is consistent with the many comments we received urging that 
we require the devices to have wireless controls. (See the response to 
Comment 94 for further discussion on this topic.) For people who are 
less inclined to use software, they may still purchase a device with a 
physical volume control or, alternatively, they may still manually 
limit the sound exposure by, for example, removing the device, covering 
the microphone, or seeking a quieter environment.
    (Comment 88) A comment suggested that all OTC hearing aids have an 
option for volume limitation and a parental volume control.
    (Response) FDA is not adopting these suggestions because the output 
limits we are finalizing will provide reasonable assurance of safety 
and effectiveness without requiring an additional feature that would 
limit the output further. (See also section V.E.4 of this document 
explaining why FDA is not establishing a separate gain limit.) However, 
we are finalizing a requirement that all OTC hearing aids have a user-
adjustable volume control (see the response to Comment 87).
    A parental volume control is likewise not necessary for reasonable 
assurance of safety and effectiveness, including cases in which the 
caregiver is not the user's parent. Moreover, establishing a 
requirement for ``parental control'' may imply that the devices are 
intended for people younger than 18, which is not the case for OTC 
hearing aids (see 21 U.S.C. 360j(q)(1)(A)(ii)).
    (Comment 89) A comment proposed that the user-adjustable volume 
control must allow for at least 6 dB of potential adjustment to the 
device output to ``ensure perceptual functionality.'' This amount, the 
comment asserted, would help significantly reduce the risk that users 
could worsen their hearing impairment by using an OTC hearing aid. 
Other similar comments suggested that FDA specify the performance 
requirements for the volume control in terms of the range.
    (Response) FDA is not requiring that a user-adjustable volume 
control adjust the volume in 6-dB increments at a minimum, and FDA is 
not specifying the range for the volume control.
    The comment proposing 6-dB increments asserted that a 3-dB change 
in signal intensity is the average needed for users to perceive a 
volume difference, thus a 6-dB increment would ensure that users 
perceive it. However, FDA expects that users will manipulate the 
control until they perceive not only a difference but a satisfactory 
output volume, regardless of the size of the increment. Further, a 6-dB 
minimum increment may force users to increase the volume more than 
desired, providing unnecessarily high amplification while constraining 
device design and performance. FDA does not agree that a minimum volume 
adjustment increment of 6 dB will appreciably reduce risks or increase 
effectiveness.
    As for the range over which the volume control must operate, a 
specification is not necessary for reasonable assurance of safety or 
effectiveness, and it may constrain device design unnecessarily. The 
output of an OTC hearing aid may not exceed the applicable limit under 
final Sec.  800.30(d) regardless of the performance of the volume 
control, so establishing an upper limit would be redundant. As for a 
lower limit, a specific minimum setting would generally depend on the 
device design. Thus, for similar reasons to not requiring a minimum 
increment, we are not requiring a minimum volume setting.
    (Comment 90) Comments suggested establishing an absolute limit on 
the maximum insertion depth for OTC hearing aids. There was variability 
in the range of recommended insertion depth limit ranging from 7.5 mm 
to 21 mm, though the most frequent recommendation was 15 mm to 17 mm.
    (Response) FDA agrees that a fixed limit on the insertion depth of 
an OTC hearing aid is a better measurement than the anatomical landmark 
that we proposed (the bony cartilaginous junction). We are finalizing a 
fixed insertion depth limit relative to the expected distance from the 
eardrum (tympanic membrane). Note that a ``fixed insertion depth 
limit'' means a limit that is a specific distance measurement rather 
than a more relative description. This meaning is different from 
describing a hearing aid as ``fixed length'' (or similar) in reference 
to a hearing aid that does not change length. FDA did not propose and 
is not finalizing a design requirement that hearing aids have a fixed 
length.
    As we explained in the proposal, the length of the ear canal can 
vary greatly among adults (see 86 FR 58150 at 58165). A fixed insertion 
depth limit may be too deep for some individuals, potentially resulting 
in injury. Comments noted that a hearing aid inserted too deeply in the 
ear canal can cause increased sound pressure levels to be delivered to 
the eardrum as well as push earwax deeper into the ear canal. However, 
the same fixed depth limit may be too short for others, potentially 
reducing device effectiveness. As comments recognized, the hearing aid 
must be inserted deeply enough for it to stay in place despite jaw 
movement, and deeper insertion also helps with reducing acoustic 
feedback and improving gain (amplification). Moreover, deeper insertion 
can help reduce the cosmetic impact of the hearing aid, that is, help 
it to be less visible, which may reduce self-consciousness or 
perceptions of stigma from wearing the device.
    Furthermore, we are not aware of any widely accepted method to 
describe the measurement of the insertion depth of hearing aids. Ear 
canal anatomy varies across individuals, and methods may not agree on 
exactly where to start the measurement for various OTC hearing aid 
designs. These factors may lead to significantly different measurements 
of insertion depth for the same device.
    We proposed a limit based on an anatomical landmark, and several 
comments characterized the proposal as insufficiently defined and 
subject to significant variability across individuals. While 
measurements relative to the individual's anatomy would be ideal, we 
recognize it is not currently practical, considering the uncertainties 
stemming from anatomical variability and insertion depth measurement.
    As such, following review of all relevant comments, we have 
determined a limit defined by the distance of the innermost (that is, 
most medial) component of the hearing aid relative to the eardrum. This 
should be a generally understandable and consistently measurable way to 
ensure safe design of the device with respect to placement in the ear 
canal. Thus, we are limiting the insertion depth to a specific expected 
distance (``setback'') from the eardrum (tympanic membrane): 10 mm from 
the innermost component of the device to the eardrum. In establishing 
this limit, we considered that its primary purpose is to minimize the 
risk of injury to the tympanic membrane and the skin of the bony 
portion of the ear canal. We believe that an OTC hearing aid designed 
to have a 10-mm setback will minimize the risk of injury from inserting 
the device too deeply while allowing for individual anatomic 
variability, but without unduly limiting effectiveness.
    For adults, the average length of the ear canal has been estimated 
to be 23-28 mm (Refs. 12 and 13). Using an average length of 25 mm, 
manufacturers may generally assume that the maximum insertion depth of 
a hearing aid designed with a setback of 10 mm

[[Page 50729]]

from the tympanic membrane would be approximately 15 mm. We acknowledge 
that an OTC hearing aid design based on this setback limit may result 
in an actual setback of somewhat less than 10 mm in users with shorter 
than average ear canals. However, we believe that the limit is 
conservative enough to ensure safety even in these cases. Some comments 
pointed out that receiver-in-the-canal hearing aids can have insertion 
depths of 20-21 mm. However, an audiologist or hearing instrument 
specialist typically fits such a device. We do not currently consider 
such insertion depths to be appropriate for OTC hearing aids.
    (Comment 91) Some comments proposed either encouraging or requiring 
that OTC hearing aids use only instant-fit eartips or customized 
eartips, fabricated based on non-invasive ear scans, to couple the 
device to the ear canal. A few of these comments further suggested that 
FDA require a licensed person to fabricate custom earmolds or ear 
shells.
    (Response) FDA is not requiring the use of instant-fit eartips or 
eartips fabricated based on non-invasive ear scans because currently 
classified devices to create earmolds and ear shells are not intended 
for the user of the OTC hearing aid. Instead, earmolds and ear shells 
are intended for use by a hearing health professional because they 
often require an impression-making procedure. As some comments noted, 
improperly taking the impression can leave behind impression material 
or injure the ear. Separately requiring instant-fit (or non-invasively 
created) eartips is unnecessary for reasonable assurance of safety and 
effectiveness of OTC hearing aids.
    However, a manufacturer may design an OTC hearing aid intended to 
be compatible with custom earmolds or ear shells, that is, the use of 
such is optional but not necessary. (A device intended to rely on 
taking impressions would imply the need for a licensed person, hence 
the device would not be ``available'' over the counter.) We do not wish 
to preclude this possibility, nor do we wish to limit the kinds of 
eartips in the future that may be safe and effective for users of OTC 
hearing aids. Considering the current regulatory framework and a desire 
to avoid unduly constraining design, we are not adopting this 
suggestion.
    (Comment 92) A comment suggested that OTC hearing aids with 
removable eartips must have a specific minimum amount of force to 
remove the eartips from the device. The comment asserted this would 
help prevent an eartip from falling off the device and lodging in the 
ear canal.
    (Response) FDA is not requiring that eartips have a minimum force 
to detach them from the device because determining a generally 
applicable threshold would be impractical and unnecessary. The force 
exerted on an eartip during normal removal or wear may vary depending 
on the device design, materials, and the user's anatomy, among other 
factors. Furthermore, any minimum force requirement would need to 
ensure that the force was not so great as to hinder the ability of 
users to change eartips, particularly for users who have limited 
dexterity. However, we note that manufacturers of devices with 
removable eartips should consider the risks of accidental separation of 
an eartip within the canal and ensure their specific designs prevent 
such adverse events. Although we are not establishing a threshold for 
force that would apply to all OTC hearing aids, manufacturers should 
incorporate robust device designs that help provide for safe and 
effective hearing aids.
    (Comment 93) Comments suggested that FDA require a self-
administered hearing test to accompany OTC hearing aids because users 
are not always able to determine whether their hearing loss is mild or 
moderate.
    (Response) While a self-administered hearing test may be one way 
for users to control OTC hearing aids and customize the devices to 
their hearing needs, we are not requiring that self-administered 
hearing tests accompany OTC hearing aids. In some cases, a test is not 
necessary to achieve safe and effective amplification to compensate for 
perceived mild to moderate hearing impairment. For example, a self-
fitting strategy could do so by guiding the user through a setup 
process that is not a diagnostic hearing test. Further, users may wish 
to obtain a hearing test by some other means, for example, by 
voluntarily visiting an audiologist. The inclusion of a hearing test 
with the device, in either case, would be unnecessary. Manufacturers 
may decide to incorporate a validated diagnostic function as 
appropriate for their device designs, but we do not agree that it 
should be a requirement for all OTC hearing aids.
    (Comment 94) A comment suggested requiring that OTC hearing aids 
integrate Bluetooth or telecoil technology so users can configure the 
devices with their smartphones.
    (Response) While Bluetooth or other wireless technologies may be 
desirable for some users of OTC hearing aids, we are not requiring such 
functionality. We acknowledge that, by definition, a wireless hearing 
aid will incorporate wireless technology in its programming or use, and 
we would expect that, with current technologies, most OTC hearing aids 
will incorporate wireless.
    However, we also expect that wireless technology will continue to 
evolve, and specifying protocols or capabilities may unnecessarily 
constrain design and hinder innovation. For example, telecoil 
technology may currently be practical for relatively larger form factor 
devices, but users may not desire the functionality or the size 
necessary to incorporate a telecoil, for example, if preferring a 
smaller device. Other methods of connectivity may also develop, and 
such devices may be appropriate for OTC availability despite lacking 
wireless technology. In sum, requiring such features could potentially 
increase cost while hindering innovation and reducing adoption and use 
of OTC hearing aids. (See also the response to Comment 87 about 
requiring a physical control for volume adjustment.)
3. Quality System Requirements
    In the proposal, we sought input on the Quality System requirements 
that would apply to OTC hearing aids but also explained that any 
changes to the Quality System requirements would be proposed in a 
separate rulemaking proceeding (86 FR 58150 at 58165). Below we 
summarize the input that we received and respond to it.
    (Comment 95) Many comments supported FDA's proposal that all 
applicable Quality System requirements under part 820 remain in force 
for the manufacture of OTC hearing aids. Most of these comments 
emphasized that hearing aids are medical devices and, as such, should 
be subject to commensurate manufacturing requirements. Most such 
comments also opined that the current requirements are not unduly 
burdensome or unreasonably costly, and in fact, can aid device 
development. For example, as one such comment stated, the application 
of Quality System requirements helps manufacturers to identify risks 
and problems early, helping to focus resources on the most promising 
new ideas. Such requirements allow manufacturers to identify what works 
well and effectively investigate what does not. The requirements 
collectively help reduce costs and time to market.
    (Response) We have further considered the applicability of Quality 
System requirements under part 820, and we are not modifying the 
applicability of the requirements for

[[Page 50730]]

OTC hearing aids. The device quality system requirements are part of 
the general controls for all devices that help provide for reasonable 
assurance of safety and effectiveness. In the proposal, we explained 
that we had previously received conflicting feedback on the 
possibilities but that we believed a quality management system specific 
to medical devices was appropriate (see 86 FR 58150 at 58165). 
Moreover, we consider the Quality System requirements to be 
interdependent yet inherently flexible (see 86 FR 58150 at 58165). We 
continue to hold these views, and although we again received 
conflicting comments, we agree that the requirements are not unduly 
burdensome. (See also the response to Comment 96, explaining the risk-
based nature of the Quality System requirements and the revisions FDA 
is proposing in a separate rulemaking.)
    (Comment 96) A comment proposed that the extent of Quality System 
controls be based on the risks of device use and the complexity of the 
device. It suggested that manufacturers be allowed to maintain a 
Declaration of Conformity, along with supporting documentation, that 
the manufacturer could provide to FDA upon request.
    (Response) As we explained in the proposed rule, the Quality System 
requirements under part 820 are inherently flexible (see 86 FR 58150 at 
58165). We have elsewhere explained that one of the purposes of the 
flexibility is to allow manufacturers to develop and follow procedures 
and processes that are appropriate to a given device and according to 
the state of the art for designing and manufacturing that device (see 
87 FR 10119 at 10121, February 23, 2022). Moreover, FDA is proposing to 
harmonize part 820 with an international consensus standard, 
International Organization for Standardization (ISO) 13485:2016, 
``Medical devices--Quality management systems--Requirements for 
regulatory purposes,'' that has an even more flexible approach to 
quality based on risk management (see 87 FR 10119 at 10122). Thus, 
although FDA agrees that Quality System controls should be based in 
part on the risks of device use, we are not modifying this final rule 
because the requirements are already flexible and risk-based, and we 
are elsewhere proposing to harmonize the risk-based approach with a yet 
more flexible international consensus standard.
    Regarding the use of Declarations of Conformity, section 
514(c)(1)(A) of the FD&C Act provides that a person may submit a 
Declaration of Conformity to an FDA-recognized consensus standard to 
meet a requirement under the FD&C Act (see 21 U.S.C. 360d(c)(1)(A)). If 
a person elects to use a Declaration of Conformity in such a way, the 
person must provide a Declaration of Conformity certifying that the 
device in question is in conformity with an FDA-recognized consensus 
standard (see 21 U.S.C. 360d(c)(1)(B)). That is, Declarations of 
Conformity appertain to devices themselves; to declare that a device is 
in conformity to a standard for a quality management system is not 
equivalent to declaring that the quality management system itself 
conforms to the standard. For more information on using Declarations of 
Conformity, you may wish to refer to FDA's guidance, ``Appropriate Use 
of Voluntary Consensus Standards in Premarket Submissions for Medical 
Devices,'' issued September 14, 2018.\12\
---------------------------------------------------------------------------

    \12\ The document is available online at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/appropriate-use-voluntary-consensus-standards-premarket-submissions-medical-devices.
---------------------------------------------------------------------------

    For systems, a certificate (or certification process) is an 
analogous mechanism to document and declare conformity. However, in our 
separate proposal regarding harmonization of Quality System 
requirements with an international consensus standard, we stated that 
FDA does not intend to exempt from FDA inspections manufacturers that 
are certified as conforming to the standard (see 87 FR 10119 at 10128). 
Further, FDA does not intend to develop a certification program or 
issue such certificates (see 87 FR 10119 at 10128). As explained 
elsewhere in this document, FDA does not view OTC hearing aids as a 
unique case for purposes of Quality System requirements. As such, we 
are declining to modify how manufacturers may use Declarations of 
Conformity or to accept certifications in lieu of demonstrating 
compliance under FDA's usual policies for the manufacture of OTC 
hearing aids. Should FDA determine to follow a different general 
approach to certifications for purposes of quality management, we will 
announce such a determination in the final rule based on our proposal 
to harmonize part 820 with ISO 13485:2016.
    (Comment 97) Multiple comments proposed that OTC hearing aids be 
exempt from the Quality System requirements of part 820. Some of these 
comments stated that the requirements of the Hearing Aid Restrictions, 
Sec. Sec.  801.420 and 801.421, addressed safety concerns with 
specialized labeling but that modern devices no longer raise these 
concerns. As such, these commenters viewed the requirements under part 
820 as unnecessary.
    (Response) FDA does not agree that specialized labeling for, or the 
diminution of past risks of, hearing aids suggests that the OTC 
category of hearing aids be exempt from Quality System requirements. 
Rather, FDA expects that the establishment and continued application of 
an appropriate Quality System would help reduce device risks and 
support effectiveness, and are an important control to help provide for 
reasonable assurance of safety and effectiveness. Further, an 
appropriate Quality System serves different purposes than labeling, and 
the two are not substitutes for each other. For example, a Quality 
System includes production and process controls to ensure that a device 
conforms to its specifications (see Sec.  820.70(a)). Labeling does not 
serve this purpose and cannot substitute for production and process 
controls. We note that the implementation of a Quality System entails 
risk-based decision-making and that the system's appropriateness is 
related to the device. The Quality System requirements are inherently 
flexible, and comments we received agree that a Quality System that 
complies with part 820 is not unduly burdensome.
4. Choice and Specification of Standards
    (Comment 98) Some comments suggested that FDA not specify the exact 
editions of the standards we are incorporating by reference. In this 
way, the commenters sought to simplify the process for keeping 
regulations up to date with new editions of the standards, as the 
respective organizations develop and publish them.
    (Response) While FDA appreciates the value in keeping regulations 
in sync with consensus standards, we are not adopting this suggestion 
as doing so would impermissibly allow the standards organizations to 
change regulatory requirements without FDA going through notice-and-
comment rulemaking. In addition, we note that, under the incorporation 
by reference regulations issued by the Office of the Federal Register, 
incorporation by reference of a publication is limited to a specific 
edition and ``future amendments or revisions of the publication are not 
included'' (1 CFR 51.1(f)). Thus, under Federal regulations, we cannot 
incorporate by reference a specific standard and all future editions of 
that standard. By incorporating all or parts of a standard by 
reference, we are referring to those parts exactly as they are in that 
specific edition, at the time we finalize the rule.

[[Page 50731]]

    (Comment 99) Some comments observed that FDA proposed different 
consensus standards for regulatory purposes for OTC and prescription 
hearing aids, specifically ANSI/CTA-2051:2017 and ANSI/ASA S3.22-2014, 
respectively. These comments raised concerns that the different 
standards treat the same hearing aid performance aspects differently, 
which could be confusing or create inconsistencies. They proposed that 
FDA use only one standard for both OTC and prescription hearing aids.
    (Response) FDA does not agree that these standards treat the same 
performance aspects differently. These standards are not incompatible 
or divergent for purposes of regulating OTC and prescription hearing 
aids. Rather, the standards serve different purposes, which is 
appropriate for regulating different categories of hearing aids.
    As we explained in the proposal, ANSI/ASA S3.22-2014 specifies test 
methods and measurement tolerances, not device performance (see 86 FR 
58150 at 58163). For example, ANSI/ASA S3.22-2014 does not specify an 
output limit. Instead, it describes to manufacturers one way to 
determine the maximum output, using an OSPL90 curve over a specific 
bandwidth, and the measurement tolerance for it, that the maximum 
``shall not exceed that specified by the manufacturer plus 3 dB,'' (see 
clause 6.2). ANSI/ASA S3.22-2014 does not help provide for safety and 
effectiveness by establishing a baseline for performance but rather, in 
effect, by defining common terms to describe device performance.
    ANSI/CTA-2051:2017 itself integrates use of those common terms. For 
example, ANSI/CTA-2051:2017 relies on ANSI/ASA S3.22-2014 to describe 
test methods by using OSPL90 curves. (However, we note that in one 
place, the standard refers to ANSI/ASA S3.22-2009, rather than 2014, as 
a normative reference.) In other words, one standard builds on the 
other: ANSI/CTA-2051:2017 specifies how well an amplifier should 
perform instead of leaving it solely to the manufacturer (as ANSI/ASA 
S3.22-2014 does for hearing aids), but in either case, the 
specifications are measured and tested based on ANSI/ASA S3.22-2014.
    (Comment 100) Some comments objected to the use of ANSI/CTA-
2051:2017 for purposes of regulating hearing aids on the basis that an 
industry group developed the standard rather than a disinterested 
organization. Other similar comments alternatively or additionally 
objected that the standard was developed for consumer electronics but 
not medical devices. In either case or both, these comments argued, the 
use of the standard is not appropriate for the regulation of OTC 
hearing aids.
    (Response) FDA acknowledges that, in some cases, standards 
developed specifically for medical devices may be more appropriate for 
regulatory purposes. For example, we are continuing to apply Quality 
System requirements specific to manufacturing medical devices, as 
opposed to a quality management system intended for other kinds of 
manufacturers. We note that the comments questioning the use of ANSI/
CTA-2051:2017, as opposed to a standard specifically for medical 
devices, generally did not question the test methods or performance 
specifications specifically--the major exception being the device 
output limit in clause 4.3, as discussed in the previous section. (Some 
comments did question the performance specifications on grounds besides 
being adopted from a consumer-technology standard. See, for example, 
Comment 78 and the response.)
    Some of these comments suggested that FDA use ANSI/ASA S3.22-2014 
instead because that standard applies specifically to hearing aids. 
However, as explained in the response to Comment 99, the standards do 
not serve the same purposes, so they are not substitutes for each 
other. Additionally, as explained in response to Comment 99, although 
ANSI/CTA-2051:2017 specifies how well an amplifier should perform 
instead of leaving it solely to the manufacturer (as ANSI/ASA S3.22-
2014 does for hearing aids), in either case, the specifications are 
measured and tested based on ANSI/ASA S3.22-2014. Although ANSI/CTA-
2051:2017 was intended for personal sound amplification more generally 
than hearing aids, as discussed elsewhere in this document (see also 
the discussion in 86 FR 58150 at 58163-64), the performance 
specifications we are adopting based on that standard will provide 
reasonable assurance of safety and effectiveness of OTC hearing aids. 
We are therefore not replacing it with a different standard.
    (Comment 101) A comment stated that FDA violated the Information 
Quality Act by not subjecting the ``CTA Standard'' to pre-dissemination 
review requirements. This comment argued that FDA cannot therefore use 
the ``CTA Standard'' in support of the output limits.
    (Response) Neither the Information Quality Act (IQA) nor any 
information quality guidelines require FDA to engage in the pre-
dissemination review this comment said is required.
    The IQA, or Data Quality Act,\13\ required the Director of the 
Office of Management and Budget (OMB) to issue ``guidelines . . . that 
provide policy and procedural guidance to Federal agencies for ensuring 
and maximizing the quality, objectivity, utility, and integrity of 
information (including statistical information) disseminated by Federal 
agencies.'' Under the IQA, the guidelines OMB issues must require each 
covered Federal agency to issue guidelines concerning information 
``disseminated by the agency,'' and to ``establish administrative 
mechanisms allowing affected persons to seek and obtain correction of 
information maintained and disseminated by the agency that does not 
comply'' with OMB's guidelines. OMB's initial guidelines, as corrected, 
were published in February 2002. ``Guidelines for Ensuring and 
Maximizing the Quality, Objectivity, Utility, and Integrity of 
Information Disseminated by Federal Agencies; Republication'' (67 FR 
8452, February 22, 2002) (``OMB Guidelines''). HHS's guidelines, which 
include the FDA guidelines, were published in September 2002 and have 
been periodically updated (``HHS/FDA Guidelines'').\14\
---------------------------------------------------------------------------

    \13\ Section 515 of the Treasury and General Government 
Appropriations Act, 2001, Public Law 106-554 (2000) (codified at 44 
U.S.C. 3516 note).
    \14\ These are available at https://aspe.hhs.gov/reports/hhs-guidelines-ensuring-maximizing-quality-objectivity-utility-integrity-information-disseminated.
---------------------------------------------------------------------------

    In 2005, OMB published its Final Information Quality Bulletin for 
Peer Review, which addressed ``peer review of scientific information 
disseminations that contain findings or conclusions that represent the 
official position of one or more agencies of the Federal government'' 
(70 FR 2664 at 2666, January 14, 2005). In 2019, OMB issued a 
Memorandum entitled ``Improving Implementation of the Information 
Quality Act'' (``Improving Implementation Memorandum''),\15\ the 
purpose of which was to ``reinforce, clarify, and interpret agency 
responsibilities with regard to responsibilities under the Information 
Quality Act (IQA).''
---------------------------------------------------------------------------

    \15\ M-19-15 (April 24, 2019).
---------------------------------------------------------------------------

    As an initial matter, the IQA ``orders the Office of Management and 
Budget to draft guidelines concerning information quality and specifies 
what those guidelines should contain.'' Salt Inst. v. Leavitt, 440 F.3d 
156, 159 (4th Cir. 2006). The IQA does not require pre-dissemination 
review. Nevertheless, to the extent pre-dissemination review may be 
required under the OMB Guidelines, it would not apply here, as

[[Page 50732]]

FDA did not disseminate the referenced information.
    The specific source this comment asserted required pre-
dissemination review is ANSI/CTA-2051, a voluntary consensus standard 
established by the ANSI and the CTA. In the proposal, FDA explained 
that the Agency is basing its proposed output limits on physiological 
data and stakeholder input. ANSI/CTA-2051:2017 is one of the scientific 
sources FDA has considered. Other data and scientific sources 
considered are described in the proposal and include a national 
workplace safety guideline from the National Institute for Occupational 
Safety and Health, comments from speakers at a 2017 public workshop 
meeting held by NASEM, and public comments stemming from a 2016 FDA 
public workshop (Refs. 14 and 15).
    The IQA and associated information quality guidelines concern only 
information ``disseminated'' by a Federal agency. ANSI/CTA-2051:2017 is 
not within the scope of the IQA and OMB guidelines because it is 
disseminated by ANSI and CTA, not a Federal agency. See, e.g., HHS 
Guidelines section I.D.2.h. (`` `Dissemination' means agency initiated 
or sponsored distribution of information to the public.''). Because a 
Federal agency did not develop or disseminate ANSI/CTA-2051:2017, ANSI/
CTA-2051:2017 is not within the scope of the IQA or any information 
quality guidelines, and is not subject to any pre-dissemination review 
requirements arising under them.
    FDA is committed to using and developing high quality information 
and follows the applicable requirements and guidelines. See, e.g., 67 
FR 8452 at 8459 (``Agencies shall treat information quality as integral 
to every step of an agency's development of information, including 
creation, collection, maintenance, and dissemination.''). Additionally, 
as discussed elsewhere in this document and as discussed in the 
proposal (see 86 FR 58150 at 58163-64), FDA believes the performance 
specifications for OTC hearing aids, having taken into account ANSI/
CTA-2051:2017, will provide reasonable assurance of safety and 
effectiveness of these devices.
    (Comment 102) A comment stated that FDA has denied the right of a 
work group, composed of several third-party trade groups and/or 
professional associations, to seek or secure adoption of a purported 
voluntary consensus standard it has put forth (``work group's 
standard''). This comment stated that the National Technology Transfer 
and Advancement Act, OMB Circular No. A-119, the Administrative 
Procedure Act, the Information Quality Act, and Executive Order 12866 
give this work group that right. The comment further stated that, to 
remedy the alleged violation(s), FDA must incorporate the work group's 
standard into an amended notice of proposed rulemaking or the final 
rule.
    (Response) None of the authorities this comment cited require FDA 
to adopt the work group's standard.
    Section 12(d) of the National Technology Transfer and Advancement 
Act of 1995 (NTTAA) states that ``all Federal agencies and departments 
shall use technical standards that are developed or adopted by 
voluntary consensus standards bodies'' unless their use is 
``inconsistent with applicable law or otherwise impractical.'' Public 
Law 104-113, section 12(d)(1), (3) (1996). Office of Management and 
Budget Circular No. A-119, as revised (Circular A-119), implements 
NTTAA section 12(d) by establishing policies on Federal use of 
voluntary consensus standards, among other things. Contrary to this 
comment's assertion, the work group's standard does not fit within 
Circular A-119's definition of a ``voluntary consensus standard.'' 
According to this comment, the work group's standard was created by 
several trade groups and/or professional associations. So the work 
group's standard is not a voluntary consensus standard within the 
meaning of Circular A-119, because it was not ``developed or adopted'' 
by an organization that ``plan[s], develop[s], establish[es], or 
coordinate[s] voluntary consensus standards using agreed-upon 
procedures.'' Circular A-119 section 4.A., 4.A.1. But even if the work 
group's standard were a voluntary consensus standard, nothing in NTTAA 
or Circular A-119 would require FDA to choose it over ANSI/CTA-
2051:2017, the voluntary consensus standard FDA included in the 
proposal. As explained in the proposal, ANSI/CTA-2051:2017 is, to FDA's 
knowledge, the first voluntary consensus standard to describe 
performance characteristics for hearing amplifiers. In the proposal, 
FDA proposed to establish as requirements a subset of specifications 
from ANSI/CTA-2051:2017, in conjunction with other proposals. FDA's 
actions are consistent with NTTAA and Circular A-119. Indeed, Circular 
A-119 states that it ``does not establish a preference among standards 
developed in the private sector.'' Id. section 6.g.
    This comment did not identify any language in the Administrative 
Procedure Act (APA) or IQA it claimed would require FDA to adopt the 
work group's standard. And these statutes do not require FDA to adopt 
any particular standard. These are procedural statutes that do not 
demand specific substantive outcomes, let alone use by FDA of any 
commenter's preferred standard.
    Finally, this comment asserted that the ``compelling need 
requirement'' set forth in Executive Order 12866 prohibits FDA's 
consideration of ANSI/CTA-2051. Under Executive Order 12866, Federal 
agencies should issue only such regulations as are required by law, are 
necessary to interpret the law, or are made necessary by compelling 
public need, such as material failures of private markets to protect or 
improve the health and safety of the public, the environment, or the 
well-being of the American people. Regulatory Planning and Review, 
section 1, 58 FR 51735 (September 30, 1993). FDA has complied with this 
provision of Executive Order 12866 because the regulation it is issuing 
is ``required by law.'' See FDARA, section 709(b) (2017). In any event, 
Executive Order 12866 ``reaffirm[s] the primacy of Federal agencies in 
the regulatory decision-making process,'' gives ``due regard to the 
discretion that has been entrusted to the Federal agencies,'' 
recognizes that ``Federal agencies are the repositories of significant 
substantive expertise and experience,'' and does not ``displac[e] the 
agencies' authority or responsibilities, as authorized by law.'' 
Executive Order 12866 pmbl., sections 2(a), 9; see In re United Mine 
Workers of Am. Int'l Union, 190 F.3d 545, 551 (D.C. Cir. 1999) (stating 
that Executive Order 12866 ``does not purport'' to ``set aside 
congressional legislation''). Executive Order 12866 certainly does not 
prohibit or require adoption of any particular standard. See Helicopter 
Ass'n Int'l, Inc. v. FAA, 722 F.3d 430, 439 (D.C. Cir. 2013) 
(explaining that Executive Order 12866 does not ``create[] private 
rights'').
    (Comment 103) A comment stated that a third party provided a 
standard to FDA in advance of the proposal, and that FDA's alleged 
failure to consider that standard before issuing the proposal is 
arbitrary and capricious and therefore a violation of the 
Administrative Procedure Act.
    (Response) The APA's notice-and-comment procedures provide the 
requirements that govern this rulemaking, and do not require the kind 
of pre-proposal special consideration this comment discussed.
    Consistent with the APA, FDA published in the Federal Register, a 
``[g]eneral notice of proposed rulemaking'' that included, among other 
things, ``the terms or substance of the

[[Page 50733]]

proposed rule or a description of the subjects and issues involved.'' 5 
U.S.C. 553(b)(3). The APA states that, ``[a]fter notice required'' 
thereby, the agency ``shall give interested persons an opportunity to 
participate in the rule making through submission of written data, 
views, or arguments.'' Id. section 553(c). FDA has complied with this 
provision by, in the proposal, soliciting public comment.
    FDA has considered the comments received in response to the 
proposal, and is in this preamble responding as appropriate. But the 
APA's notice-and-comment procedures, which require that the public be 
given an opportunity to participate in the rule making only ``[a]fter'' 
publication of the notice of proposed rulemaking (NPRM), id., do not 
require that FDA consider or respond to any comments received in 
advance of the NPRM.

G. Conditions for OTC Sale (Sec.  800.30(g))

    Many comments on the conditions for sale of OTC hearing aids sought 
more stringent conditions or enforcement to prevent possible misuses of 
OTC hearing aids. Although FDA is attentive to these concerns, we are 
also mindful of unduly impeding access by creating barriers rather than 
removing them if appropriate (see also 86 FR 58150 at 58166).
    (Comment 104) Some comments suggested that FDA require any seller 
of OTC hearing aids to staff customer support in the United States with 
licensed persons, for customers to meet with them via telemedicine 
technology.
    (Response) FDA is not adopting these suggestions because this would 
require the involvement of a licensed person in the sale of an OTC 
hearing aid, contrary to section 520(q)(1)(A)(v) of the FD&C Act and 
section 709(b)(2)(D) of FDARA. Further, the requirements in this 
rulemaking will provide reasonable assurance of safety and 
effectiveness of OTC hearing aids without the involvement of a licensed 
person. In any case, FDA would expect such a requirement to entail 
substantial, perhaps prohibitive, costs for sellers in addition to a 
significant amount of time to develop or contract for such services. 
Neither would be compatible with the purposes of this rulemaking, 
including the purpose of broadening the kinds of sellers that can offer 
OTC hearing aids.
    (Comment 105) Multiple comments proposed a requirement for age 
verification prior to the sale or delivery of an OTC hearing aid. 
Similarly, comments proposed a requirement for purchasers to affirm 
that they are at least 18 years old at the time of purchase. Some of 
these additionally proposed that purchasers acknowledge or agree that 
the OTC hearing aid is not for use by anyone younger than 18 years old.
    (Response) FDA is not adopting these suggestions. While people 
younger than 18 should not use hearing aids without the involvement of 
a licensed person, such as an ear-nose-throat doctor, we do not agree 
that the risk warrants age verification at this time.
    We considered other purchases that require age verification and 
found that, in such cases, the risks to individuals and the public 
health were significantly greater than the risks posed by the use of 
OTC hearing aids by people younger than 18. Furthermore, we do not 
expect that OTC hearing aids will be as attractive for purchase by 
people younger than 18 as other age-restricted products that do require 
verification. Thus, the benefit of mandatory age verification would 
likely be small relative to the risks posed to the individual by OTC 
hearing aids compared to the benefit of restricting and risks posed by 
other age-restricted products.
    At the same time, we would expect mandatory age verification, or 
similar processes like certifications or acknowledgments, to increase 
the difficulty or complexity of purchases by people who are the 
intended users, and can benefit from the use, of OTC hearing aids. 
Since one of the purposes of this rulemaking is to promote the public 
health by reducing or eliminating barriers to access for such people, 
we considered which approach is likely to benefit the public health 
more. In this case, lower-income people or people who live in 
relatively isolated conditions (for example, in rural areas) are more 
likely to benefit from broadened access while at the same time being 
less able to present official documentation of their age (for example, 
because they lack a driver's license or are buying hearing aids by 
mail). We have determined that the public health is better served at 
this time by not imposing requirements for age verification, 
certification, or acknowledgment.
    The above considerations also took into account that we are 
finalizing requirements to improve the warnings against use of OTC 
hearing aids by people younger than 18. We are also finalizing the 
condition for sale that will prohibit sale of OTC hearing aids to or 
for people younger than 18 under new Sec.  800.30(g)(1). These 
requirements, along with the others in this rule, will help provide 
reasonable assurance of safety and effectiveness of OTC hearing aids 
for the intended users without the need for age verification. We expect 
that sellers will likely adopt their own practices, tailored to their 
business models, to prevent violating this condition for sale and/or 
engaging in a prohibited act. Such practices may, but are not required 
to, entail age verification by checking a government-issued 
photographic identification. However, in some cases, the seller may not 
need to check a government-issued photographic identification, for 
example, when the seller has personal knowledge of the purchaser's age 
or may otherwise be certain that the purchaser is 18 or older.
    (Comment 106) Several comments proposed that FDA enhance 
enforcement of legal requirements for labeling, sales, or other 
provisions for legally marketing hearing aids. Similar comments 
suggested that FDA enhance enforcement for selling non-compliant 
products as hearing aids, for example, by making false or misleading 
statements or improperly avoiding premarket requirements for devices. 
Other such comments urge in any case that FDA monitor the sales of OTC 
hearing aids and/or non-compliant consumer electronics marketed as 
hearing aids.
    (Response) FDA intends to apply existing practices for monitoring 
the market and will take action, including enforcement as necessary and 
appropriate. Should stakeholders wish to call FDA's attention to 
potential concerns that we may not otherwise learn, including potential 
regulatory misconduct, they may file a report sometimes known as a 
trade complaint. Anyone may file such a report (a complaint), and we 
encourage people to include supporting and contact information for 
possible followup questions. However, the reports can be anonymous. 
More information about the process is available on FDA's website: 
https://www.fda.gov/medical-devices/medical-device-safety/reporting-allegations-regulatory-misconduct. See also the response to Comment 122 
regarding the role of State authorities in enforcing requirements 
applicable to OTC hearing aids.
    Moreover, we are finalizing labeling requirements that describe the 
process of reporting adverse events to FDA (see final Sec. Sec.  
800.30(c)(2)(iii)(F) and 801.422(c)(2)(ii)(E)). Section 709(d) of FDARA 
directs FDA to report on an analysis of adverse events relating to OTC 
hearing aids not later than 2 years after the date we issue this final 
rule. FDA expects this information to be helpful in identifying and 
analyzing device risk trends, and it will likely inform enforcement 
prioritization.

[[Page 50734]]

    (Comment 107) Comments suggested that FDA impose a penalty on 
persons who sell an OTC hearing aid that is used by a child.
    (Response) The FD&C Act sets forth penalties for prohibited acts 
respecting devices and electronic products as described in section IV 
of this document (see 21 U.S.C. 331, 333, 360oo and 360pp(b)). 
Prohibited acts include, among other things, doing or causing a variety 
of acts involving adulterated and/or misbranded devices (see, e.g., 21 
U.S.C. 331(a)-(c), 331(k)). In turn, a device is deemed adulterated 
and/or misbranded for a variety of reasons (see 21 U.S.C. 351 and 352). 
For example, an OTC hearing aid sold to or for a person younger than 18 
would not, among other deficiencies, bear adequate directions for use 
for such users. The hearing aid would be deemed misbranded (see 21 
U.S.C. 352(f)), and certain activities with respect to the misbranded 
device (for example, the introduction of the misbranded device into 
interstate commerce) would be a prohibited act in that example and 
subject to the penalties under the FD&C Act.
    (Comment 108) Several comments suggested that FDA establish a 
variety of post-sale requirements on manufacturers or sellers of OTC 
hearing aids. Such proposals included requirements that manufacturers 
or sellers: accept returns for a certain minimum period (either for 
money back or credit), warrant certain features or components for a 
given period, guaranty products or services in some way, and/or provide 
a minimum rescission period (a period in which a buyer could cancel the 
purchase).
    Many of these comments mentioned user satisfaction and that, if 
users buy an unsatisfactory device and are unable to return or exchange 
it, such users could incur unnecessary expenses to obtain a 
satisfactory OTC hearing aid or forego hearing aid use entirely. Other 
such comments described a benefit or need to establish a national 
standard, as opposed to one that varies by State, to encourage broader 
availability of the devices. The proposed time periods for the 
application of such requirements varied but were generally 30, 45, 60, 
or 90 days after purchase.
    (Response) FDA is not establishing the suggested post-sale 
requirements on manufacturers or sellers of OTC hearing aids. We are 
finalizing a requirement for OTC hearing aid labeling to provide notice 
of the manufacturer's return policy. We believe this adequately 
addresses the concern mentioned in the comments that the risk of 
obtaining an unsatisfactory OTC hearing aid may result in people 
foregoing hearing aid use entirely, and that additional requirements in 
this regard are not necessary to provide a reasonable assurance of 
safety and effectiveness for OTC hearing aids. To the extent the post-
sale requirements proposed in the comments are aimed at consumer 
protection rather than providing a reasonable assurance of safety and 
effectiveness for OTC hearing aids, we note that there may be other 
Federal laws, administered by other agencies that provide this type of 
consumer protection. Likewise, many States have existing requirements 
that also address these types of consumer protection concerns. See the 
response to Comment 122 regarding the applicability of State consumer 
protection requirements.
    (Comment 109) A comment proposed that FDA prohibit the resale of 
OTC hearing aids by consumers. The comment expressed a need for 
appropriate disinfection of used hearing aids and the need to apply 
labeling required for used hearing aids. The comment asserted that used 
OTC hearing aids should be returned by the vendor to the manufacturer 
for it to take the necessary steps to market a used OTC hearing aid.
    (Response) Although FDA agrees that all used hearing aids should be 
labeled as required and adequately reprocessed regardless of the type 
of reseller, we are declining to revise the proposed rule to 
incorporate this suggestion. We are finalizing the requirement that if 
the OTC hearing aid is used or rebuilt, the outside package must 
declare that fact, and we have modified the design requirements for OTC 
hearing aids to specify that if the OTC hearing aid is used or rebuilt, 
it must be adequately reprocessed for the next user prior to sale. OTC 
hearing aids must meet these requirements regardless of the type of 
reseller. We believe that the requirements that we are finalizing for 
OTC hearing aids provide for reasonable assurance of safety and 
effectiveness, and prohibiting resale of an OTC hearing aid by a 
consumer will not add anything and will likely be impractical to 
enforce.
    (Comment 110) Comments proposed that FDA require referrals to 
physicians for prescription hearing aids when a user or prospective 
user manifests any of the ``red flag'' conditions. However, one such 
comment proposed an option for waivers since, it asserted, most people 
with a ``red flag'' condition have already been advised to seek or 
previously sought an examination by a physician.
    (Response) FDA is declining this suggestion because it would 
require the involvement of a licensed person in the use of OTC hearing 
aids in some cases, and it is not necessary for reasonable assurance of 
safety and effectiveness of OTC hearing aids. We believe that the 
required prominent warnings and other statements in the labeling of OTC 
hearing aids are sufficient to advise users and prospective users to 
consult hearing health care providers, including ENT doctors, in 
certain circumstances, such as when experiencing certain pathological 
(``red flag'') conditions. For these reasons, we are not including an 
examination or waiver requirement for the OTC category of hearing aids.
    (Comment 111) Some comments urged FDA to establish generally more-
stringent requirements for the sale of OTC hearing aids. These comments 
reasoned that because hearing aids are medical devices, are 
technologically complex, and/or intended to compensate for a complex 
condition, they should not be as easily available as other devices such 
as bandages (see, e.g., 21 CFR 880.5075, classifying elastic bandages).
    (Response) Except as explained elsewhere in this document, FDA is 
declining this suggestion. We are establishing requirements that are 
sufficiently stringent to provide reasonable assurance of safety and 
effectiveness of OTC hearing aids. We have taken into account, among 
other considerations, the seriousness of hearing impairment as well as 
the complexity of both the impairment and the technology intended to 
compensate for it. More stringent requirements are not necessary to 
provide reasonable assurance of safety and effectiveness, and the 
requirements we are establishing generally do not depend on the sales 
environment, provided the environment does not cause the device to be 
adulterated, misbranded, or otherwise out of compliance with applicable 
requirements (see, e.g., 21 U.S.C. 351(a)(2)(A) regarding adulteration 
if held under insanitary conditions).
    Moreover, the extent to which the availability of OTC hearing aids 
is comparable to that of elastic bandages does not suggest the devices 
themselves are otherwise similar. Similarly, the broad availability of 
elastic bandages does not cause the devices to be less safe and 
effective for their intended use(s), and the same would be true for OTC 
hearing aids. The purposes of this rule include promoting broader 
availability of OTC hearing aids while establishing requirements that 
will provide reasonable assurance of safety and effectiveness, which is

[[Page 50735]]

incompatible with establishing unnecessarily stringent regulations.
    (Comment 112) Comments suggested that sellers of OTC hearing aids 
be required to keep the devices behind the counter or in a locked 
cabinet to prevent people younger than 18 from purchasing the devices.
    (Response) FDA is declining this suggestion because we are allowing 
flexibility for sellers to determine how to comply with the condition 
for sale that prohibits the sale of OTC hearing aids to or for people 
younger than 18. FDA intends this flexibility to minimize regulatory 
burdens while promoting access to safe and effective devices. If a 
seller determines that it can comply with the condition for sale 
without special storage provisions, then it need not make such storage 
provisions. Mandating special storage provisions for such sellers of 
OTC hearing aids would add unnecessary burdens. However, a seller may 
decide keeping the devices in a locked display case and verifying the 
purchaser's age with a form of photographic identification will be the 
most practical approach for its circumstances. (See also the response 
to Comment 105 regarding age verification.) Although we are not 
mandating a specific approach to ensure that OTC hearing aids are not 
sold to people younger than 18, FDA expects that sellers will implement 
an approach appropriate for their circumstances.
    (Comment 113) A comment suggested pairing the purchase of an OTC 
hearing aid with membership in an organization that could serve first-
time hearing aid users, for example, by assisting with or explaining 
the initial selection and purchase of an OTC hearing aid.
    (Response) FDA is not adopting this suggestion as condition for 
sale of OTC hearing aids. Although such organizations can provide 
useful and valuable services for users and prospective users of hearing 
aids, FDA proposed and is finalizing requirements for OTC hearing aids 
that would provide reasonable assurance of safety and effectiveness 
without the involvement of a licensed person. Requiring the involvement 
of such an organization is neither necessary for reasonable assurance 
of safety and effectiveness nor consistent with the approach we are 
taking to establish the OTC category for hearing aids to promote 
broader availability of OTC hearing aids.
    Further, as we explained in the proposal, we expect this final rule 
to lower costs of hearing aids by unbundling the purchase of hearing 
aids from professional services, including professional advice, 
fitting, adjustment, or maintenance to make the devices available over 
the counter (see 86 FR 58150 at 58172). Requiring membership in an 
organization with the purchase of OTC hearing aids would be contrary to 
our intent of unbundling services and device purchases. In that vein, 
we would expect that membership with such an organization would present 
costs to users, either directly, as in a membership fee, or indirectly, 
as in increasing the purchase price of a device. Thus, although users 
and prospective users may choose to seek membership with organizations 
to obtain related benefits, we do not agree that such membership should 
be required with the purchase of an OTC hearing aid.
    (Comment 114) A comment proposed that FDA require sellers of OTC 
hearing aids to obtain certifications for relevant standards developed 
by the ISO as well as comply with appropriate Quality System 
requirements. For example, dispensers might conform to ISO 21388:2020, 
``Acoustics--Hearing aid fitting management.''
    (Response) FDA is not requiring sellers of OTC hearing aids that 
are not manufacturers to comply with part 820 requirements for a 
Quality System or conform to consensus standards. An OTC hearing aid, 
by definition, is a device that, among other qualities, allows the user 
to control and customize it to the user's hearing needs, without the 
involvement of a licensed person (see 21 U.S.C. 360j(q)(1)(A)(iii) and 
(v)). Further, multiple provisions of this rule are intended to ensure 
that persons do not incur special licensing obligations or the 
equivalent (certifications, for example) on account of commercial 
activity involving OTC hearing aids (see, e.g., final Sec.  
800.30(h)(2)(i)). As such, requiring a seller of OTC hearing aids to be 
specially licensed or certified is both unnecessary for reasonable 
assurance of safety and effectiveness of OTC hearing aids and 
inconsistent with the approach we are taking to establish the OTC 
category for hearing aids.
    Additionally, the scope of part 820 extends to manufacturers of 
finished devices, as Sec.  820.3(o) defines the term, but generally not 
other persons (see Sec.  820.1(a)(1)), and the requirements of part 820 
are not intended to extend to sellers who are not manufacturers. 
Instead, part 820 specifies that, among other controls, manufacturers 
must ensure that device labeling, packaging and shipping containers 
maintain label and device integrity during customary conditions of 
processing, storage, handling, and distribution (see Sec. Sec.  
820.120(a) and 820.130).
    We likewise observe that the consensus standard ISO 21388:2020 
applies to hearing aid fitting management (see clause 1), but not non-
licensed persons (i.e., non-hearing aid professionals). As such, this 
standard is not likely to apply to sellers of OTC hearing aids who are 
not licensed persons. As we explained above, sellers of OTC hearing 
aids are not required to have a specialized license or the equivalent.
    Nevertheless, FDA acknowledges that quality management may also be 
useful to many persons who are not manufacturers or hearing aid 
professionals (as ISO 21388:2020 defines the term). Some concepts in 
part 820, ISO 21388:2020, or ISO 13485:2016, for example, may help 
inform such other person's determination of best practices. A number of 
standards exist for other persons to implement quality management 
systems, for example, ISO 9001:2015, ``Quality management systems--
Requirements,'' and those persons may wish to obtain related 
certifications and advertise as such. However, FDA has determined that 
special licensing (or its equivalent) is not necessary, as explained, 
and we are not requiring sellers of OTC hearing aids that are not 
manufacturers to comply with part 820 or conform to ISO 21388:2020, ISO 
13485:2016, or any other consensus standard.
    (Comment 115) A comment proposed that FDA protect consumers from 
predatory practices throughout the supply chain for OTC hearing aids. 
It specifically referred to unnecessarily collecting or sharing private 
information by or with several kinds of persons: manufactures, 
retailers, medical practitioners, payment processors, service 
providers, device monitoring and configuration providers, data 
aggregators, computer hosting services, and platforms.
    (Response) FDA is declining this proposal because it is not 
necessary for reasonable assurance of safety and effectiveness of OTC 
hearing aids. Moreover, although certain deceptive practices would be 
prohibited under the FD&C Act, other Federal and State agencies 
establish and enforce such requirements as those concerning protection 
of private information. For example, if a seller were to modify the 
labeling of an OTC hearing aid to mislead prospective purchasers, that 
would constitute misbranding of a device while held for sale in 
interstate commerce, which is prohibited under the FD&C Act (see, e.g., 
21 U.S.C. 331(k)). Deceiving prospective purchasers in such a way may 
additionally violate Federal and/or State requirements that FDA is not

[[Page 50736]]

responsible for administering or enforcing. For more information about 
the kinds of health fraud issues FDA addresses, which includes unlawful 
sales of medical products, you may visit our website: https://www.fda.gov/consumers/health-fraud-scams.
    However, FDA does not generally administer or enforce requirements 
respecting predatory commercial practices that do not involve the 
safety or effectiveness of FDA-regulated products. Should stakeholders 
wish to raise concerns for deceptive practices not related to 
requirements that FDA administers or enforces, they should approach the 
appropriate Federal or State agencies. For example, stakeholders may 
wish to report fraud to the Federal Trade Commission's Bureau of 
Consumer Protection. More information is available online: https://www.ftc.gov/about-ftc/bureaus-offices/bureau-consumer-protection.
    (Additional Revision 4) FDA is finalizing a condition for sale for 
OTC hearing aids that sellers may not sell the devices over the counter 
unless the principal display panel of the outside package labeling bear 
prominent marks identifying the device as ``OTC'' and a ``hearing 
aid.'' As explained in Additional Revision 2 (section III.D.3), FDA is 
finalizing a requirement for the outside package labeling to bear the 
marks to assist purchasers and others, including retailers and State 
agencies. However, in some cases, purchasers may not view the principal 
display panel of the package prior to purchase. For example, a person 
shopping online may filter a list of the devices offered by the seller 
with ``OTC'' and view only pictures of the device itself. This 
condition for sale will help ensure that only OTC hearing aids are sold 
as such, particularly for purchasers who shop online or by mail. This 
is necessary for reasonable assurance of safety and effectiveness of 
OTC hearing aids because it provides assurances that non-OTC hearing 
aids or non-hearing aids will not be sold as or confused for OTC 
hearing aids.

H. Preemption Provisions (Sec.  800.30(h))

    Most comments on preemption sought clarification on the effects of 
this rule on State and local requirements, including consumer 
protections and professional licensing requirements. Many strongly 
supported preserving States' roles in protecting prospective and 
current hearing aid users.
    (Comment 116) Several comments suggested that FDA define ``restrict 
or interfere'' in the FDARA preemption provision because these terms 
are ambiguous. Specifically, one suggestion was that FDA define 
``restrict or interfere'' to pertain only to State and local laws that 
prevent or create an obstacle to a commercial activity involving OTC 
hearing aids so that State consumer protection laws that pertain to 
commercial activity involving OTC hearing aids, such as a warranty 
requirement and mandatory returns for OTC hearing aids, would not be 
preempted. Another suggestion was that FDA define ``restrict or 
interfere'' to mean ``present actual legal or procedural impediment to 
the exclusion of business disincentives.'' One comment expressed 
concerns that return requirements could be viewed as interfering with 
distribution of OTC hearing aids because such requirements make 
distribution chains more complicated and potentially more expensive; 
warranty requirements would, by mandating servicing of OTC hearing 
aids, interfere with the servicing of the devices; and both kinds of 
requirements could be viewed as discouraging the sale of OTC hearing 
aids by increasing prices for patients.
    (Response) FDA declines to include the definitions suggested by 
comments because the Agency is concerned that the suggested definitions 
may not be consistent with ``restrict or interfere with'' in section 
709(b)(4) of FDARA. For example, the dictionary defines ``restrict'' to 
mean ``to confine within bounds,'' Merriam-Webster at https://www.merriam-webster.com/dictionary/restrict, and this definition seems 
somewhat different from ``prevent or create an obstacle'' or ``present 
actual legal or procedural impediments.''
    Instead of adopting the definitions proposed by the comments or 
some other definition, in assessing whether a State or local 
requirement would ``restrict or interfere with'' commercial activity 
involving OTC hearing aids, FDA intends to consider, among other 
things, the ordinary meaning of these terms in the context of section 
709 of FDARA, including the objectives of section 709, and the specific 
facts, such as the specific language of the State or local requirement 
and the effects of the requirement on commercial activity involving OTC 
hearing aids.
    One of the reasons for the proposed definitions of ``restrict or 
interfere'' in the comments appears to be the concern that State 
consumer protection laws, such as those that provide for a return 
period or warranty for hearing aids, would be preempted under section 
709(b)(4) of FDARA. For a discussion of this topic, see the response to 
Comment 122.
    FDA notes that ``restrict or interfere with'' is just one element 
of the FDARA preemption provision in section 709(b)(4). In other words, 
there are other elements to consider in assessing whether a State or 
local requirement is preempted under section 709(b)(4) of FDARA, such 
as whether the State or local requirement is ``specifically related to 
hearing products.'' As discussed in the proposal, we do not interpret 
FDARA to preempt generally applicable requirements, i.e., requirements 
that relate to other products in addition to hearing products, to 
services not specific to hearing products, or to unfair trade practices 
in which the requirements are not limited to hearing products. See 86 
FR 58150 at 58167 for further discussion.
    (Comment 117) A comment suggested that FDA consider requests from 
States for exemption from Federal preemption as OTC devices enter the 
market. Another comment suggested that FDA state in the final rule that 
the existing processes in Sec.  808.20 (21 CFR 808.20) (which relate to 
requests for exemption from Federal preemption under section 521 of the 
FD&C Act) will continue to apply, and that FDA will find against 
preemption when consistent with the statutory language and ``in the 
public interest.''
    (Response) As discussed in the proposal, section 709(b)(4) of FDARA 
established preemption specific to OTC hearing aids that is different 
from the general rule for preemption under section 521 of the FD&C Act. 
See 86 FR 58150 at 58166. Unlike section 521 of the FD&C Act, section 
709(b)(4) of FDARA does not provide for any exemptions for State or 
local requirements that fall within this provision. Therefore, FDA is 
unable to provide exemptions from preemption for State or local 
requirements that fall within the scope of section 709(b)(4).
    Section 521 of the FD&C Act does provide for exemption from 
preemption for State or local requirements that fall within this 
provision, and the procedures for requesting and granting or denying an 
exemption are provided in part 808, subpart B (21 CFR part 808, subpart 
B). Section 808.20 will continue to apply to State or local 
requirements that fall within section 521 of the FD&C Act, such as 
requirements for prescription hearing aids. FDA did not propose any 
changes to Sec.  808.20.
    FDA intends to assess preemption consistent with the statutory 
language of section 709(b)(4) of FDARA for State or local requirements 
that fall within this provision. We believe this approach to assessing 
preemption is consistent with the Supreme Court's approach to Federal 
preemption. See, e.g., Puerto

[[Page 50737]]

Rico v. Franklin Cal. Tax-Free Trust, 579 U.S. 115, 125 (2016) 
(explaining that ``because the statute contains an express preemption 
clause, we do not invoke any presumption against preemption but instead 
focus on the plain wording of the clause, which necessarily contains 
the best evidence of Congress' pre-emptive intent.'' (citations and 
internal quotations omitted)). Additionally, FDA believes that this 
approach will achieve the objectives of section 709 of FDARA, which 
include promoting access to safe and effective OTC hearing aids for 
adults with perceived mild to moderate hearing impairment, and in so 
doing, will be in the public interest. FDA also intends to assess 
preemption consistent with section 521 of the FD&C Act for State or 
local requirements that fall within this provision, and consider 
exemption from preemption when requested in accordance with Sec.  
808.20. As indicated in Sec.  808.20, FDA considers, among other 
things, information on how the public health may be benefitted if an 
exemption is granted.
    (Comment 118) A comment suggested that FDA set up an informal 
process by which States could request feedback from the Agency about 
whether specific requirements are preempted under section 709(b)(4) of 
FDARA. Another comment requested that FDA specify in the final rule 
that the process in Sec.  808.5(a) (21 CFR 808.5(a)) apply to State and 
local requirements concerning hearing products because this process 
would increase transparency.
    (Response) At this time, FDA does not believe it is necessary to 
set up a separate informal process for States or localities to request 
feedback from the Agency about whether specific requirements are 
preempted under section 709(b)(4) of FDARA because there are existing 
informal processes that States or localities can use to make such 
requests. For example, State or localities that have questions about 
preemption may contact the Center for Devices and Radiological Health 
(CDRH)'s Ombudsman at [email protected] or FDA's 
Intergovernmental Affairs Staff at [email protected]. (CDRH's Division of 
Industry and Consumer Education can also answer general questions 
regarding device regulation.) Additionally, we note that Sec.  808.5(a) 
does not set forth a separate process but rather relies on the advisory 
opinion process in Sec.  10.85 (21 CFR 10.85). States or localities may 
request an advisory opinion under Sec.  10.85 with respect to whether 
FDA regards a particular State or local requirement as preempted under 
section 709(b)(4) of FDARA.
    (Comment 119) Two comments noted that part 808 includes a list of 
the types of State or local requirements that are not preempted, and 
requested that FDA expand this list with additional examples pertaining 
to hearing aids, such as requirements that relate to warranties, 
returns, and the sale of hearing aids for users under 18 years of age.
    (Response) The list in part 808 of the types of State or local 
requirements that are not preempted pertains to preemption under 
section 521 of the FD&C Act. Specifically, Sec.  808.1(d) provides 
examples of the types of State or local requirements that are not 
preempted by section 521 of the FD&C Act, including examples of State 
or local requirements that are not considered ``requirements applicable 
to a device'' under section 521 of the FD&C Act.
    However, providing general categories of State or local requirement 
on hearing aids that are not preempted under section 709(b)(4) of FDARA 
would be challenging because preemption under this section depends in 
part on whether the requirement would ``restrict or interfere with'' 
commercial activity involving OTC hearing aids. Whether a State or 
local requirement would ``restrict or interfere with'' commercial 
activity involving OTC hearing aids will depend on the specific facts, 
including the specific language of the State or local requirement and 
the effects of the requirement.
    We note that in the proposal, we did provide specific examples of 
State or local requirements that we believe would or would not be 
preempted under section 709(b)(4) of FDARA. See 86 FR 58150 at 58167-
68. Additionally, as discussed in the proposal, we do not interpret 
section 709(b)(4) of FDARA to preempt generally applicable 
requirements, i.e., requirements that relate to other products in 
addition to hearing products, to services not specific to hearing 
products, or to unfair trade practices in which the requirements are 
not limited to hearing products. See 86 FR 58150 at 58167 for further 
discussion. However, we noted that if a State or local requirement 
appears on its face to be generally applicable, but in practice it was 
specifically related to hearing products and would restrict or 
interfere with commercial activity involving OTC hearing aids, the 
requirement would be preempted. See 86 FR 58150 at 58167.
    Further, State or local requirements specifically related to 
hearing products would not be preempted under section 709(b)(4) of 
FDARA if they would not restrict or interfere with commercial activity 
involving OTC hearing aids. For example, we believe that reasonable 
return or warranty requirements for OTC hearing aids would likely 
promote, rather than restrict or interfere with, commercial activity 
involving OTC hearing aids by reducing the financial risk to 
purchasers. For further discussion of this topic, see the response to 
Comment 122.
    We also note that section 709(b)(5) of FDARA specifies, ``[n]othing 
in this section shall be construed to modify or otherwise affect the 
ability of any person to exercise a private right of action under any 
State or Federal product liability, tort, warranty, contract, or 
consumer protection law.'' Therefore, laws that fall within the scope 
of this savings clause would not be preempted under section 709(b)(4) 
of FDARA provided that they do not conflict with the OTC Hearing Aid 
Controls or frustrate the purposes and objectives of section 709 of 
FDARA. See, e.g., Am. Tel. and Tel. Co. v. Central Office Tel., Inc., 
524 U.S. 214, 226 (1998) (holding that a remedies savings clause in the 
Communications Act of 1934 did not save State laws that were 
inconsistent with Federal law); Automobile Importers of America, Inc. 
v. Minnesota, 871 F.2d 717, 722 (8th Cir. 1989) (although the relevant 
Federal statute had a broad savings clause, the court stated ``State 
legislation is preempted if compliance with the state law frustrates 
the purposes and objectives of federal law'').
    States or localities that have questions about preemption may 
contact CDRH's Ombudsman at [email protected] or FDA's 
Intergovernmental Affairs Staff at [email protected], or they may request 
an advisory opinion under Sec.  10.85 with respect to whether FDA 
regards a particular State or local requirement as preempted under 
section 709(b)(4) of FDARA.
    The OTC Hearing Aid Controls in Sec.  800.30 do not apply to 
hearing aids intended for users under 18 years of age. Hearing aids 
intended for users under 18 years of age would be considered 
prescription hearing aids as defined in Sec. Sec.  800.30(b) and 
801.422(b). State or local requirements governing the sale of hearing 
aids for users under 18 years of age would fall within the scope of 
section 521 of the FD&C Act, and therefore, that section and part 808 
would continue to apply. To the extent that a State or local 
requirement is preempted under section 521 of the FD&C Act, the State 
or political subdivision may apply for exemption from preemption in 
accordance with part 808, subpart B.
    (Comment 120) A comment from an association of State Attorneys 
General

[[Page 50738]]

stated that ``the proposed rule includes broad language that could be 
interpreted to repeal virtually all the state-requested exemptions from 
preemption issued by the FDA since 1980--even those related exclusively 
to non-OTC hearing aids'' and that this could create confusion and 
unnecessary litigation.
    (Response) While we are removing most of the regulations codifying 
the exemption decisions, we are doing so because we are repealing or 
revising the specific counterpart Federal regulations that preempted 
State and local requirements respecting devices. In addition, 
preemption specific to OTC hearing aids would generally nullify the 
exemptions to the extent the State or local requirements would apply to 
OTC hearing aids except in certain specific circumstances.
    With respect to OTC hearing aids, as discussed in the proposal, 
section 709(b)(4) of FDARA established preemption specific to OTC 
hearing aids that is different from the general rule for preemption 
under section 521 of the FD&C Act. See 86 FR 58150 at 58166. The FDARA 
preemption provision preempts State and local requirements specifically 
related to hearing products that would restrict or interfere with 
commercial activity involving OTC hearing aids, and that are different 
from, in addition to, or otherwise not identical to regulations issued 
under FDARA section 709(b). Unlike section 521 of the FD&C Act, section 
709(b)(4) of FDARA does not provide for any exemptions for State or 
local requirements that fall within this provision. Therefore, FDA is 
unable to continue in effect any previously granted exemptions from 
preemption for State or local requirements that fall within the scope 
of section 709(b)(4) of FDARA.
    With respect to prescription hearing aids and other State and local 
requirements for hearing aids not otherwise preempted by FDARA section 
709(b)(4), FDA is removing all of the regulations in part 808 related 
to hearing aids; that is, almost all regulations codifying the previous 
decisions in Sec. Sec.  808.53 through 808.101, except for the portions 
of Sec.  808.55 (California) that do not relate solely to hearing aids. 
As discussed in the proposal, those exemptions are no longer applicable 
because this final rule repeals or revises the underlying Federal 
requirements from which those exemptions were granted. See 86 FR 58150 
at 58170. In addition, FDA is aware that several States have modified 
their requirements that were the subject of the exemption decisions 
since they applied for exemptions, in which case the exemption decision 
may no longer be applicable.
    We note that removal of these exemptions does not itself mean that 
those State or local laws are now preempted given that we are repealing 
or revising the specific counterpart regulations. For example, the 
repeal of the conditions for sale in Sec.  801.421 means that State or 
local requirements that differed from, or were in addition to, the 
repealed counterpart Federal requirements will no longer be preempted 
under section 521(a) of the FD&C Act (see Sec.  808.1(d)). However, 
some of the new requirements we are establishing in this rule would 
implicate preemption under section 521(a) of the FD&C Act. For example, 
the prescription hearing aid labeling requirements set forth in Sec.  
801.422 will preempt certain State or local requirements that are 
different from, or in addition to, those Federal requirements. These 
new requirements are similar but not identical to those in Sec.  
801.420 and include substantive changes. To the extent that any 
previously granted petitions for exemptions related to labeling 
requirements, any such exemptions would be rendered inapplicable due to 
changes in the underlying Federal requirements from which the 
exemptions were granted.
    States or localities that have questions about preemption may 
contact CDRH's Ombudsman at [email protected] or FDA's 
Intergovernmental Affairs Staff at [email protected], or they may request 
an advisory opinion under Sec.  10.85 with respect to whether FDA 
regards a particular State or local requirement as preempted.
    (Comment 121) A comment from the Rhode Island Department of Health 
noted that Rhode Island General Laws sections 5-49-2.1 and 2.2 contain 
provisions that would require consumers or purchasers to obtain a 
certificate of need from a physician who attests that the individual is 
in need of a hearing aid, and therefore requested that FDA retain Sec.  
808.89, which denied Rhode Island's request for exemption from 
preemption. Doing so, the comment said, would align with FDA's approach 
of authorizing non-physician licensed hearing professionals to make 
determinations of need and would also benefit consumers by reducing 
unnecessary costs and added time to the process of obtaining a hearing 
aid.
    (Response) FDA has decided not to retain Sec.  808.89, because the 
repeal of the conditions for sale in Sec.  801.421 substantively 
changes the underlying Federal requirements against which the previous 
denial of exemption from preemption was made. The repeal of Sec.  
801.421 means Rhode Island General Laws sections 5-49-2.1 and 2.2 are 
no longer preempted under section 521(a) of the FD&C Act, because no 
counterpart Federal requirement exists (see Sec.  808.1(d)). Without 
that preemption, the previous denial would have no effect even were we 
to retain the regulation.
    However, section 709(b)(4) of FDARA would separately preempt the 
Rhode Island provisions to a certain extent, regardless of our previous 
exemption decisions and whether or not Sec.  808.89 were retained. For 
example, to the extent the Rhode Island laws require a certificate of 
need from a physician for the sale of OTC hearing aids, they are now 
preempted by FDARA section 709(b)(4), because they are specifically 
related to hearing products, would restrict or interfere with 
commercial activity involving OTC hearing aids, and are different from, 
in addition to, or otherwise not identical to, FDA's regulations issued 
under FDARA section 709(b).
    (Comment 122) Some comments expressed concern that State consumer 
protections would be preempted. For example, one comment stated that 
many States tie consumer protections, such as return requirements, for 
purchasers of hearing aids to licensing requirements, and stated that 
these protections would be preempted under the proposed rule. To 
address the concern, comments recommended that Federal consumer 
protections, such as requiring that hearing aid sales be accompanied by 
a receipt, information relating to warranty, and mandatory return or 
trial period, be established, for example as conditions for sale under 
Sec.  800.30(g).
    (Response) FDA declines to include the requirements suggested by 
comments because at this time, the Agency believes requiring that OTC 
hearing aid sales be accompanied by a receipt, information relating to 
warranty, and mandatory return or trial period is not necessary to 
provide reasonable assurance of the safety and effectiveness of OTC 
hearing aids.
    FDA notes that the preemption provision in Sec.  800.30(h)(1) is 
intended to incorporate the preemption provision in section 709(b)(4) 
of FDARA. In other words, the preemption provision in Sec.  
800.30(h)(1) simply reflects the statute, which expresses clear 
Congressional intent to preempt certain State and local requirements. 
As explained in the proposal, FDA decided to codify the FDARA 
preemption provision in the regulations to assist stakeholders in 
understanding the legal framework for OTC hearing aids given that the 
FDARA

[[Page 50739]]

preemption provision was not incorporated into the FD&C Act (a process 
known as U.S. Code classification). 86 FR 58150 at 58166. In this 
response, FDA focuses on the express preemption provision in section 
709(b)(4) of FDARA but notes that there are other types of preemption 
that may apply such as conflict preemption. See, e.g., Nat'l Fedn. of 
the Blind v. United Airlines, Inc., 813 F.3d 718, 724 (9th Cir. 2016) 
(describing conflict preemption in addition to express preemption).
    Whether a State or local requirement is preempted under section 
709(b)(4) of FDARA would depend on the specific facts, including the 
language of the requirement and the effects of the requirement on 
commercial activity involving OTC hearing aids. However, FDA believes 
that many State or local consumer protection requirements would not be 
preempted under section 709(b)(4) of FDARA because they are not 
``specifically related to hearing products'' or would not ``restrict or 
interfere with'' commercial activity involving OTC hearing aids. As 
discussed in the proposal, we do not interpret FDARA to preempt 
generally applicable requirements, i.e., requirements that relate to 
other products in addition to hearing products, to services not 
specific to hearing products, or to unfair trade practices in which the 
requirements are not limited to hearing products. See 86 FR 58150 at 
58167. For example, generally, we would not consider a State or local 
warranty requirement for assistive devices to be ``specifically related 
to hearing products'' under section 709(b)(4) of FDARA because the 
requirement relates to other products (e.g., wheelchairs) in addition 
to hearing products.
    Whether a State or local consumer protection requirement that 
specifically related to hearing products would ``restrict or interfere 
with'' commercial activity involving OTC hearing aids would depend on 
the specific facts. However, generally, FDA believes that State or 
local requirements that provide for a reasonable warranty or return 
period for hearing aids (e.g., 60-day period) would likely promote, 
rather than restrict or interfere with, commercial activity involving 
OTC hearing aids. Such requirements may help to encourage people who 
could benefit from an OTC hearing aid to purchase the device by 
reducing their financial risk. As discussed in the proposal, despite 
the high prevalence and public health impact of hearing loss, only 
about one-fifth of people who could benefit from a hearing aid seek 
intervention, likely due to barriers such as high cost. 86 FR 58150 at 
58151. An important objective of section 709 is to lower some of the 
barriers and improve access to these devices for people who could 
benefit from them. See id.; see also ``FDA User Fee Agreements: 
Improving Medical Product Regulation and Innovation for Patients, Part 
I,'' Hearing before the Comm. on Health, Education, Labor, and 
Pensions, 115th Cong. 115-255 (2017), at 74 (Remarks by Sen. Elizabeth 
Warren regarding S. 670, the Over-the-Counter Hearing Aid Act of 2017, 
which was largely incorporated into section 709 of FDARA, indicating 
that this legislation was intended to improve access and affordability 
to safe and effective OTC hearing aids for millions of consumers who 
could benefit from these devices); ``Examining Improvements to the 
Regulation of Medical Technologies,'' Hearing before the Subcomm. on 
Health of the H. Comm. on Energy and Commerce, 115th Cong. 115-28 
(2017), at 3 (Statement of Rep. Michael C. Burgess regarding H.R. 1652, 
the Over-the-Counter Hearing Aid Act of 2017, which was largely 
incorporated into section 709 of FDARA, stating that this bill was 
introduced ``to safely increase access and affordability in the hearing 
aid market for millions of Americans from whom it would benefit.'').
    Additionally, State or local requirements that provide for 
reasonable disclosure of the terms of sale in a receipt or similar 
document would likely promote, rather than restrict or interfere with, 
commercial activity involving OTC hearing aids by providing important 
information in writing, such as return or warranty information, to help 
people with mild to moderate hearing impairment make fully informed 
purchasing decisions.
    Congress also recognized the importance of maintaining certain 
State consumer protection laws as reflected in section 709(b)(5) of 
FDARA. Specifically, section 709(b)(5) states, ``Nothing in this 
section shall be construed to modify or otherwise affect the ability of 
any person to exercise a private right of action under any State or 
Federal product liability, tort, warranty, contract, or consumer 
protection law.'' Therefore, laws that fall within this savings clause 
would not be preempted unless they conflict with the OTC Hearing Aid 
Controls or frustrate the purposes and objectives of section 709 of 
FDARA. See, e.g., Am. Tel. and Tel. Co. v. Central Office Tel., Inc., 
524 U.S. 214, 226 (1998) (holding that a remedies savings clause in the 
Communications Act of 1934 did not save state laws that were 
inconsistent with federal law); Automobile Importers of America, Inc. 
v. Minnesota, 871 F.2d 717, 722 (8th Cir. 1989) (although the relevant 
Federal statute had a broad savings clause, the court stated ``State 
legislation is preempted if compliance with the state law frustrates 
the purposes and objectives of federal law'').
    With regard to State or local requirements that tie consumer 
protections to licensing requirements, the consumer protections are not 
necessarily preempted. As we explained in the proposal, under section 
709(b)(4) of FDARA, a State or local government cannot require persons 
engaged in commercial activity involving OTC hearing aids to undertake 
special licensing or equivalent activities solely on that basis (see 86 
FR 58150 at 58158). However, such persons who voluntarily identify as a 
licensed person would be subject to corresponding State or local 
requirements for such licensed persons, including consumer protection 
requirements, to the extent that the State or local requirements do not 
restrict or interfere with commercial activity involving OTC hearing 
aids (see section 709(b)(4) of FDARA; see also the discussion in 86 FR 
58150 at 58158).
    Therefore, the issue is not necessarily that the consumer 
protections are preempted, but rather the issue is that the consumer 
protections are tied to the licensing requirements. Thus, to the extent 
that consumers purchase OTC hearing aids from non-licensed persons, 
they may not get the additional consumer protections they would get if 
they purchased the OTC hearing aid from a licensed person. However, 
Congress made clear that any State or local requirement for the 
involvement or intervention of a licensed person for consumers to 
access OTC hearing aids is preempted under section 709(b)(4) of FDARA. 
Even if certain consumer protections are not required as part of the 
sale of OTC hearing aids by non-licensed persons, we do not believe 
that consumers who purchase OTC hearing aids from non-licensed persons 
will be left without consumer protections. In addition to consumer 
protection laws administered by the Federal Trade Commission, many 
States have generally applicable consumer protection requirements that 
would not be preempted under section 709(b)(4) of FDARA, such as those 
that address unfair and deceptive business practices, false or 
misleading advertising, warranties, etc.
    (Comment 123) A comment suggested that FDA preempt State 
requirements for hearing aids as they apply to OTC hearing aids but 
that such requirements

[[Page 50740]]

should continue to apply to prescription hearing aids. Another comment 
expressed concern that State hearing aid laws that are not severable 
could be preempted as applied to all hearing aids.
    (Response) If a State requirement does not fall within section 
709(b)(5) of FDARA and is preempted under section 709(b)(4) of FDARA, 
FDA would consider it to be preempted to the extent that it applies to 
OTC hearing aids. Such State requirement may continue to apply to 
prescription hearing aids unless the requirement is preempted under 
section 521 of the FD&C Act.
    (Comment 124) A comment noted that there are State statutes and 
rules that refer to Sec. Sec.  801.420 and 801.421 or incorporate the 
same or similar language contained in those provisions, and requested 
input on whether such State laws would continue to apply or whether 
they would be preempted by the new Federal rules. The comment also 
encouraged FDA to consider using the existing sections to capture the 
new labeling requirements or special controls because using the 
existing sections may be beneficial for State laws that refer to those 
sections.
    (Response) State laws or rules that incorporate language that is 
the same as, or substantially identical to, the language contained in 
former Sec.  801.421 may continue in effect as applied to prescription 
hearing aids. However, one exception is the statement that was required 
under Sec.  801.421(a)(2)(iii). Specifically, Sec.  801.421(a)(2)(iii) 
required that the hearing aid dispenser affords the prospective user 
the opportunity to sign the following statement: ``I have been advised 
by (Hearing aid dispenser's name) that the Food and Drug Administration 
has determined that my best health interest would be served if I had a 
medical evaluation by a licensed physician (preferably a physician who 
specializes in diseases of the ear) before purchasing a hearing aid. I 
do not wish a medical evaluation before purchasing a hearing aid.'' 
State or local laws or rules that require this statement would no 
longer be in effect because this statement was based on the waiver of 
the medical evaluation that was required under Sec.  801.421, which FDA 
is repealing.
    Because Sec.  801.420 was issued under section 520(e) of the FD&C 
Act (among other authorities), and FDA is not relying on this authority 
for the revised labeling requirements for prescription hearing aids, 
FDA has decided to establish the revised labeling requirements in new 
Sec.  801.422. In the labeling requirements for prescription hearing 
aids in Sec.  801.422, FDA has retained in substance most of the 
labeling requirements that were in Sec.  801.420 but also made some 
revisions. Whether State hearing aid labeling requirements that 
incorporate language from Sec.  801.420 are preempted as applied to 
prescription hearing aids due to the new labeling requirements in Sec.  
801.422 depends on whether they are different from, or are in addition 
to, the new requirements. If they are equal to, or substantially 
identical to, the requirements in Sec.  801.422, they would not be 
preempted as applied to prescription hearing aids. See Sec.  
808.1(d)(2). State hearing aid labeling requirements incorporating 
language from Sec.  801.420 would be preempted as applied to OTC 
hearing aids if they are different from, in addition to, or otherwise 
not identical to, the OTC hearing aid labeling requirements in Sec.  
800.30. See section 709(b)(4) of FDARA.
    We note that the requirements in Sec. Sec.  801.420 and 801.421 
were considered general controls that applied to all hearing aids 
regardless of the device's classification. In other words, these 
requirements were not special controls under section 513(a)(1)(B) of 
the FD&C Act. Similarly, the labeling requirements for prescription 
hearing aids in Sec.  801.422 are considered general controls that 
apply to all prescription hearing aids regardless of the device's 
classification. Special controls apply to class II devices and the 
special controls for a class II hearing aid are specified in the 
particular classification for the hearing aid (e.g., Sec.  874.3305).
    (Comment 125) Comments requested that FDA clarify the types of 
State or local requirements for an audiological or medical evaluation, 
prior to purchasing a prescription hearing aid, that this rule would 
not preempt. Many of these comments conveyed uncertainty about the 
effects on existing State and local requirements with the withdrawal of 
previous exemption decisions that allowed States and localities to 
establish and continue in effect requirements respecting hearing aids.
    (Response) State or local requirements that were preempted solely 
because they differed from or were in addition to the conditions for 
sale requirements in Sec.  801.421 and for which FDA previously granted 
exemptions from Federal preemption may continue in effect with respect 
to prescription hearing aids after the withdrawal of the previous 
exemption decisions. This is because State or local requirements are 
preempted under section 521(a) of the FD&C Act only when FDA has 
established specific counterpart regulations or there are other 
specific requirements applicable to a particular device that make State 
or local requirements applicable to the device different from, or in 
addition to, the specific Federal requirements (see Sec.  808.1(d)). 
The repeal of Sec.  801.421 will remove this specific counterpart 
regulation that currently makes State or local requirements different 
from, or in addition to, the specific Federal requirements therein. As 
such, the State requirements that were preempted solely because they 
differed from or were in addition to the requirements in Sec.  801.421 
and for which FDA previously granted exemptions will no longer be 
preempted under section 521(a) of the FD&C Act. They may therefore 
continue in effect for prescription hearing aids, without an exemption, 
so FDA is removing the exemption decisions that will become 
unnecessary.
    As a result, if a State establishes or continues in effect a 
requirement that, for example, people younger than 18 must have a 
medical evaluation by an ear-nose-throat doctor to obtain a 
prescription hearing aid, then that requirement would, as a general 
matter, no longer be ``different from, or in addition to,'' the 
examination and waiver requirements in Sec.  801.421 that we are 
repealing. Similarly, a State could establish or continue in effect a 
requirement, for example, that a licensed hearing instrument specialist 
refer an adult prescription hearing aid candidate for a medical 
examination if the specialist observes a Red Flag condition. However, a 
State could not establish or continue in effect such a referral 
requirement for OTC hearing aids, as explained elsewhere in this 
document.
    Additionally, as explained elsewhere in this document, FDA is 
revising the labeling requirements in Sec.  801.420 by, among other 
things, moving them to new Sec.  801.422 and applying them to 
prescription hearing aids. State or local requirements with respect to 
prescription hearing aids that differ from, or are in addition to, the 
requirements in Sec.  801.422 would be preempted under section 521(a) 
of the FD&C Act.

I. Repeal of Restrictions and Modifications for Prescription Labeling 
(Sec. Sec.  801.420, 801.421, 801.422)

    Many comments related to repealing the conditions for sale for 
hearing aids expressed concerns for maintaining the involvement of a 
licensed person in the adoption and use of hearing aids. One result of 
this rulemaking is that non-OTC air-conduction hearing aids will be 
prescription hearing aids, which will require the order (prescription) 
of a

[[Page 50741]]

practitioner licensed by State law, as we explain elsewhere in this 
document. Thus, the repeal of Sec.  801.421 does not imply the removal 
of a licensed person from hearing health care with respect to 
prescription hearing aids.
    Other comments communicated a desire for regulatory consistency 
and/or continuity. While FDA would agree these are legitimate 
interests, we generally declined to maintain the restrictions on those 
bases. However, we note that final Sec.  801.422 retains many of the 
labeling requirements under Sec.  801.420, and we have made the 
labeling requirements for prescription hearing aids consistent with 
that for OTC hearing aids to the extent appropriate.
    (Comment 126) One comment expressed concern that with the repeal of 
the hearing aid restrictions, the previous preemption decisions would 
no longer apply. The comment stated that while many State laws that had 
been denied an exemption have since been repealed, some unrepealed laws 
that have been unenforceable would now be enforceable, including those 
that would restrict and/or impede the sale of hearing aids.
    (Response) FDA is repealing Sec.  801.421 which sets forth the 
conditions for sale of hearing aids, and revising the labeling 
requirements under Sec.  801.420 by, among other things, applying them 
to prescription hearing aids only and moving them to new Sec.  801.422. 
We assume that the comment is referring to the repeal of Sec.  801.421 
given that the labeling requirements, although revised and moved to new 
Sec.  801.422, would continue to exist and apply to prescription 
hearing aids. FDA is repealing Sec.  801.421 because the Agency 
believes these requirements are no longer necessary to provide 
reasonable assurance of safety and effectiveness of prescription 
hearing aids. FDA had been exercising enforcement discretion by 
generally not enforcing most of the requirements in Sec.  801.421 since 
late 2016. Additionally, we note that prescription hearing aids will 
require a written or oral authorization from a practitioner licensed by 
law to administer the device (see Sec.  801.109). This requirement, 
along with the revised labeling requirements for prescription hearing 
aids, will help provide reasonable assurance of safety and 
effectiveness of these devices. State or local requirements that were 
previously preempted under section 521 of the FD&C Act solely on the 
basis that they were different from, or were in addition to, the 
requirements in Sec.  801.421 would no longer be preempted as applied 
to prescription hearing aids.
    We note that State or local requirements would be preempted under 
section 709(b)(4) of FDARA if they: specifically related to hearing 
products; would restrict or interfere with the sale of, or other 
commercial activity involving, OTC hearing aids; are different from, in 
addition to, or otherwise not identical to, the OTC Hearing Aid 
Controls; and do not fall within section 709(b)(5) of FDARA.
    (Comment 127) Several comments proposed that prescription hearing 
aids remain restricted devices. Many of these comments expressed 
concerns about the role of licensed persons in fitting and dispensing 
hearing aids, and a desire to ensure that prescription hearing aids 
would only be sold pursuant to the written authorization of a qualified 
hearing aid professional or, in some cases, a physician specifically. 
Such comments, sometimes referring to ``special controls,'' also sought 
to retain oversight of licensed persons.
    (Response) Although FDA agrees that the selection and use of 
prescription hearing aids should involve a licensed person, we are not 
maintaining the device restrictions because the restrictions are 
unnecessary to ensure the involvement of a licensed person in the use 
of prescription hearing aids.
    Under final Sec.  800.30(b), a prescription hearing aid is one that 
does not meet the definition of ``over-the-counter hearing aid'' or 
does not meet the requirements of the OTC Hearing Aid Controls. Any 
hearing aid that is not OTC is a prescription device. A prescription 
hearing aid is subject to Sec.  801.109 regarding prescription devices 
(explained in the proposal, 86 FR 58150 at 58168). Among other 
requirements, Sec.  801.109 specifies that prescription devices are 
those to be sold only to or on the prescription or other order of a 
practitioner licensed by law to use or order the use of the devices in 
the course of professional practice (see Sec.  801.109(a)(2)). Further, 
Sec.  801.109 requires labeling indicating that the device is only for 
prescription use (see Sec.  801.109(b)(1)). A prescription hearing aid 
that lacks this labeling would be misbranded (see final Sec.  
801.422(c)(6)). Marketing a misbranded device, for example, by 
introducing it into interstate commerce, and other activities with 
respect to misbranded devices are prohibited acts (see, e.g., 21 U.S.C. 
331(a)-(c), 331(k)).
    FDA notes that, in some circumstances, requirements on prescription 
hearing aids once this rule is in effect may be more stringent than 
under former Sec.  801.421 which allowed a prospective hearing aid user 
18 or older to waive the requirement for a medical evaluation (former 
Sec.  801.421(a)(2)). Further, as we explained in the proposal, FDA had 
expressed that we do not intend to enforce the medical evaluation, 
waiver, or recordkeeping requirements with respect to prospective 
purchasers who are 18 or older (see 86 FR 58150 at 58154). However, 
once this rule repeals those restrictions, any hearing aid that meets 
the definition of a prescription hearing aid will be subject to 
requirements for prescription devices, such as those in Sec.  
801.109(a)(2). That is, such devices may be sold only to or on the 
prescription or other order of a licensed practitioner. We also note 
that States, not FDA, generally determine the licensing requirements 
for practitioners to use or order the use of a prescription device. 
Thus, States may, for example, require that prescription hearing aids 
be ordered by physicians (medical doctors) or audiologists, which may 
involve a medical or audiological evaluation of the prospective user, 
including someone who is 18 or older. (See also the response to Comment 
128.)
    (Comment 128) A few comments suggested that FDA apply device 
restrictions to OTC hearing aids. A comment suggested that FDA make 
both OTC and prescription hearing aids restricted devices. The comment 
argued this would ensure regulatory consistency between categories as 
well as supporting complementary State and local consumer protections.
    (Response) FDA is declining to take these suggestions. We are not 
making OTC hearing aids restricted devices under section 520(e) of the 
FD&C Act, and we are repealing the existing restrictions on hearing 
aids. For OTC and prescription hearing aids, at this time we believe 
the authorities that we are relying on, including those described in 
section IV of this document, are adequate. Because we are not relying 
on our restricted device authority at this time, neither OTC hearing 
aids nor prescription hearing aids would be restricted devices under 
section 520(e) of the FD&C Act. Therefore, there would be regulatory 
consistency between these categories in this respect.
    Further, to the extent the comment is requesting that FDA maintain 
the restrictions in Sec.  801.421, the restrictions that we are 
repealing do not in themselves enable or support complementary State 
and local consumer protections. Indeed, many of the State requirements 
for hearing aids for which FDA had granted exemptions from Federal 
preemption were

[[Page 50742]]

preempted because of the restrictions (they were different from, or 
were in addition to, the restrictions), and the State requirements 
continued in effect because the States applied for, and FDA granted, 
exemptions. Absent the restrictions, those State requirements, many of 
which related to patient or consumer protection, likely would not have 
been preempted (all else being equal) and could have continued in 
effect without FDA acting to exempt them.
    Moreover, section 709(b)(4) of FDARA would continue to apply to OTC 
hearing aids and, as described elsewhere, would still preempt certain 
State and local requirements pertaining to a wide range of commercial 
activity involving OTC hearing aids, regardless of whether or not OTC 
hearing aids are restricted devices. Additionally, FDA would not expect 
that making OTC hearing aids restricted devices would augment State and 
local consumer protections that would continue in effect. (See also the 
response to Comment 127.)
    (Comment 129) Some comments proposed that prescription hearing aids 
remain restricted devices to ensure that FDA retain the added 
regulatory authority over advertising material for restricted devices. 
These comments asserted that advertising has falsely or misleadingly 
suggested that products were hearing aids, inducing people to use 
products that were not safe or effective options to address or 
compensate for hearing loss. The use of unsafe or ineffective products, 
instead of hearing aids, has an increased risk of impairing the user's 
remaining hearing or convincing users not to seek safer, more effective 
options.
    (Response) FDA is not accepting this proposal because as explained 
in the response above, at this time we believe the authorities that we 
are relying on, including those described in section IV of this 
document, are adequate.
    Additionally, restricted device authority is not necessary for FDA 
regulation of products that are marketed as hearing aids but do not 
comply with applicable requirements. The intended use of an article 
(not just restricted devices) may be shown by, among other indicia, the 
circumstances surrounding distribution as well as advertising matter 
(see Sec.  801.4). Should such circumstances or advertising show that 
the article is intended to compensate for hearing loss, then it would 
be subject to labeling and other requirements for hearing aids. Failure 
to meet these requirements would render the article adulterated and/or 
misbranded (see 21 U.S.C. 351 and 352). Marketing (for example, by 
introducing such articles into interstate commerce) and other 
activities with respect to such articles would constitute prohibited 
acts even though prescription hearing aids would not be restricted 
devices (see, e.g., 21 U.S.C. 331(a)-(c), 331(k)).
    (Additional Revision 5) FDA has identified additional revisions 
that would provide for clarity and consistency upon the removal of 
Sec.  801.420 and the repeal of Sec.  801.421. We proposed to amend 
Sec.  874.3950 (21 CFR 874.3950), the classification regulation for 
transcutaneous air-conduction hearing aid systems, by specifying that 
the devices would be subject to new Sec.  801.422. This would clarify 
that the devices are prescription hearing aids and subject to 
corresponding labeling requirements.
    However, the regulation currently specifies that transcutaneous 
air-conduction hearing aid systems are subject to special controls 
described by the document, ``Class II Special Controls Guidance 
Document: Transcutaneous Air Conduction Hearing Aid System (TACHAS); 
Guidance for Industry and FDA,'' issued on November 7, 2002 (see Sec.  
874.3950(b)).\16\ That document in turn currently refers to Sec. Sec.  
801.420 and 801.421. Further, in reviewing the document for consistency 
with this rulemaking, we observed that its Scope section refers 
incorrectly to Sec.  874.3340, which is not the correct citation for 
the classification regulation for transcutaneous air-conduction hearing 
aid systems.
---------------------------------------------------------------------------

    \16\ The document is available online at: https://www.fda.gov/medical-devices/guidance-documents-medical-devices-and-radiation-emitting-products/transcutaneous-air-conduction-hearing-aid-system-tachas-class-ii-special-controls-guidance-document.
---------------------------------------------------------------------------

    For clarity and consistency, in addition to the amendment that we 
proposed to Sec.  874.3950(a), we are revising the special controls 
document by replacing references to Sec. Sec.  801.420 and 801.421 with 
Sec.  801.422 for both. We also are correcting the reference to the 
incorrect classification regulation to the correct one, which is Sec.  
874.3950. To indicate these revisions, we are adding a statement to the 
special controls document that we revised the document. We will publish 
the special controls document with the revisions on or around the 
effective date of this final rule. However, we are not revising the 
substance of the special controls document, and as such, we are not 
updating the date on which the document was issued. The revisions to 
the special controls document will appear on FDA's website.

J. Other Amendments

    (Comment 130) One comment suggested that FDA include a misbranding 
provision for OTC hearing aids with respect to labeling, similar to the 
provision included for prescription hearing aids (final Sec.  
801.422(c)(6)).
    (Response) FDA declines to include a similar misbranding provision 
for OTC hearing aids under Sec.  800.30. As provided in Sec. Sec.  
800.30(a) and (b) and 801.422(a) and (b), any hearing aid that does not 
satisfy the requirements of Sec.  800.30, including the labeling 
requirements of that section, is a prescription hearing aid, and as 
such, must meet the requirements of Sec. Sec.  801.422 and 801.109. In 
other words, a hearing aid that fails to meet the labeling requirements 
of Sec.  800.30 would be subject to Sec. Sec.  801.422 and 801.109. In 
turn, failure to meet the labeling requirements of Sec. Sec.  
801.422(c) and 801.109 would render the product misbranded, as stated 
in final Sec.  801.422(c)(6). In other words, hearing aids that fail to 
comply with the requirements in Sec.  800.30 would be prescription 
hearing aids and would be misbranded if they fail to comply with 
Sec. Sec.  801.422 and 801.109. For example, such a hearing aid would 
be misbranded under section 502(f)(1) of the FD&C Act in that its 
labeling would fail to bear adequate directions for use and it would 
not be exempt from this requirement.
    (Comment 131) A comment proposed that FDA develop a national 
standard to sell prescription hearing aids via telemedicine visits with 
licensed persons to people who are 18 years of age or older. The 
comment suggested that the standard could include calibrated in-home 
tests for both air-conduction and bone-conduction devices.
    (Response) Although FDA establishes performance standards for 
devices, among other general and special controls, in appropriate 
circumstances, FDA does not generally establish standards for medical 
practice, including telemedicine. However, we note that in-home hearing 
tests may meet the definition of ``device'' and be subject to the 
provisions of, and regulatory controls under, the FD&C Act, including 
those described in section IV of this document. Classification of a 
hearing test would establish the controls necessary to provide 
reasonable assurance of safety and effectiveness of the device for its 
intended use(s), and these would apply to the devices nationally. (See 
also section X describing the implications of federalism.)

[[Page 50743]]

    (Additional Revision 6) FDA has decided not to realign the 
classification regulations by sound conduction mode as proposed. 
Combining the existing regulations may have suggested to stakeholders 
that only a single device type was appropriate for OTC availability or 
vice versa. However, as explained elsewhere, for example, in the 
response to Comment 2, that is not the case. To reduce the potential 
for this kind of confusion, we are keeping the various air-conduction 
generic types in their existing regulations. However, we are proceeding 
to separate bone-conduction hearing aids into their own classification 
regulation, new Sec.  874.3302, including the reassignment of product 
codes. We are also proceeding with the other proposed minor revisions 
to the air-conduction classification regulations, including the 
revisions to the special controls as provided in proposed Sec.  
874.3305(b) and clarifying the applicability of requirements under 
either final Sec.  800.30 or Sec.  801.422 for the various generic 
types.

VI. Effective and Compliance Dates

    (Comment 132) FDA received several comments proposing that the 
compliance date be the same for hearing aids that have and have not 
been offered for sale prior to the effective date of this final rule. 
These comments provided various reasons, including that: new entrants 
into the hearing aid market need time to make pre-launch adjustments to 
their marketing and devices they plan to introduce and need more than 
the 60 days proposed; that FDA takes longer than 60 days to review 
510(k)s; and that different compliance dates for different 
manufacturers would be unfair. Most such comments proposed a compliance 
date of 240 days after the publication of this final rule.
    (Response) FDA is not establishing the same compliance dates 
because hearing aids that are not offered for sale, that is, not on the 
market, are not similarly situated as hearing aids offered for sale, 
that is, on the market, prior to the effective date. The compliance 
date is not the date by which new entrants must start marketing, and if 
new entrants find they need additional time prior to marketing their 
devices, they may take it. Moreover, should a new entrant need to 
obtain 510(k) clearance, it could not market the device until it 
obtains clearance, regardless of the compliance date.
    We acknowledge that hearing aids on the market will have a 
different timeframe for compliance. However, the consequences of 
noncompliance with the new requirements are different for hearing aids 
that are on the market from those not on the market when this rule 
takes effect. For hearing aids that are on the market, they are subject 
to enforcement actions if they do not comply with the new requirements 
as well as other applicable requirements. Given this, they need 
sufficient time to come into compliance. Hearing aids that are not on 
the market do not face these consequences--as discussed above, if such 
hearing aids do not comply with the new requirements and other 
applicable requirements, manufacturers may take whatever time they need 
to bring the devices into compliance. As such, the same compliance 
timeframe is not appropriate in this case. See the response to Comment 
133 about considerations for 510(k)s for marketed devices.
    (Comment 133) Some comments regarding marketed devices also raised 
concerns that FDA may take too long to review 510(k)s, and devices 
could be out of compliance even if a manufacturer submitted a 510(k) 
soon after the publication of this final rule. They sought 
clarification and/or a change in the compliance date.
    (Response) In consideration of the comments, for hearing aids 
legally offered for sale prior to the effective date, FDA intends not 
to enforce the requirement for a 510(k) in certain situations, as 
discussed in the compliance date section below.
    (Comment 134) Some comments questioned how soon hearing aids could 
be made available OTC, including whether manufacturers would need to 
wait 60 days (until the effective date).
    (Response) Generally, hearing aids could not be available OTC 
within the meaning of section 520(q)(1)(A)(v) of the FD&C Act until the 
effective date of this final rule.

A. Effective Date

    This final rule will be effective 60 days after the publication in 
the Federal Register. We are finalizing the following compliance dates:

B. Compliance Date for Hearing Aids Not Legally Offered for Sale Prior 
to the Effective Date

    For hearing aids that have not been offered for sale prior to the 
effective date of the final rule, or have been offered for sale but are 
required to submit a new 510(k) under Sec.  807.81(a)(3) due to changes 
unrelated to this rule (an example of such is the addition of self-
fitting technology to a wireless air-conduction hearing aid), 
compliance with the new or revised requirements applicable to the 
hearing aid, and obtaining 510(k) clearance if applicable, must be 
achieved before marketing the device on or after the effective date of 
this final rule. If a person (e.g., manufacturer) markets such a device 
without complying with the new or revised requirements or if 
applicable, obtaining 510(k) clearance, then FDA would consider taking 
action against such person under our usual enforcement policies.

C. Compliance Date for Hearing Aids Legally Offered for Sale Prior to 
the Effective Date

    For hearing aids that have been legally offered for sale prior to 
the effective date of the final rule, including those that already have 
a 510(k) clearance, compliance with the new or revised requirements 
that apply to the hearing aid must be achieved 180 days after the 
effective date of the final rule (i.e., 240 days after the publication 
of the final rule). After that date, if a person (e.g., manufacturer) 
continues to market such a device but does not comply with the new or 
revised requirements that apply to the device, then FDA would consider 
taking action against such person under our usual enforcement policies.
    However, FDA does not intend to enforce the requirement to submit a 
510(k) and obtain 510(k) clearance where a hearing aid is legally 
offered for sale prior to the effective date; the changes that require 
a new 510(k) are made on or before the compliance date and are made 
solely to satisfy the OTC Hearing Aid Controls; the changes do not 
adversely affect device safety or effectiveness; the device is 
otherwise in compliance with applicable requirements; and on or before 
the compliance date, the manufacturer documents the changes and its 
determination that the changes do not adversely affect device safety or 
effectiveness.
    At present, legacy and wireless air-conduction hearing aids are 
exempt from section 510(k) (21 U.S.C. 360(k)) of the FD&C Act, subject 
to the limitations of exemption described in Sec.  874.9. (Legacy 
hearing aids are class I devices and are 510(k) exempt under section 
510(l)(1) of the FD&C Act.) See the response to Comment 5 for more 
about considerations for when to submit a 510(k).

VII. Economic Analysis of Impacts

    We have examined the impacts of this final rule under Executive 
Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5 
U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 
104-4). Executive Orders 12866 and 13563 direct us to assess all

[[Page 50744]]

costs and benefits of available regulatory alternatives and, when 
regulation is necessary, to select regulatory approaches that maximize 
net benefits (including potential economic, environmental, public 
health and safety, and other advantages; distributive impacts; and 
equity). This rule is an economically significant regulatory action as 
defined by Executive Order 12866.
    The Regulatory Flexibility Act requires us to analyze regulatory 
options that would minimize any significant impact of a rule on small 
entities. Because the estimated annualized cost over 10 years is $0.009 
million per firm, which is unlikely to represent more than three 
percent to five percent of the revenue of an affected manufacturer, we 
certify that this final rule will not have a significant economic 
impact on a substantial number of small entities.
    The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires 
us to prepare a written statement, which includes an assessment of 
anticipated costs and benefits, before proposing ``any rule that 
includes any Federal mandate that may result in the expenditure by 
State, local, and tribal governments, in the aggregate, or by the 
private sector, of $100,000,000 or more (adjusted annually for 
inflation) in any one year.'' The current threshold after adjustment 
for inflation is $165 million, using the most current (2021) Implicit 
Price Deflator for the Gross Domestic Product. This final rule will 
result in an expenditure in at least one year that meets or exceeds 
this amount.
    This rule defines a new regulatory category for OTC hearing aids 
and makes corresponding changes to the existing regulatory framework, 
including defining hearing aids not meeting the OTC requirements as 
prescription medical devices, as well as providing new labeling 
requirements for both OTC and prescription hearing aids. This rule 
would generate potential cost savings for consumers with perceived mild 
to moderate hearing impairment who wish to buy lower cost hearing aids 
not bundled with professional services and not requiring professional 
advice, fitting, adjustment, or maintenance but who are currently 
unable to buy such products online because of State regulations or 
because they do not shop online. This rules also generates costs for 
hearing aid manufacturers for changing labeling of existing hearing 
aids as well as for reading the rule and revising internal standard 
operating procedures in response to the rule. Table 1 summarizes our 
estimate of the annualized costs and the annualized benefits of this 
final rule.

                                      Table 1--Summary of Benefits, Costs and Distributional Effects of Final Rule
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                   Units
                                                                                   ------------------------------------
                   Category                       Primary       Low        High                               Period                  Notes
                                                 estimate    estimate    estimate      Year      Discount     covered
                                                                                      dollars    rate  (%)    (years)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Benefits:
    Annualized Monetized $millions/year.......         $63          $6        $147        2020           7          10  ................................
                                                        63           6         147        2020           3          10
    Annualized Quantified.....................  ..........  ..........  ..........  ..........           7  ..........  ................................
                                                                                                         3
                                               ---------------------------------------------------------------------------------------------------------
    Qualitative...............................  Potential increase in hearing aid   ..........  ..........  ..........  ................................
                                                and hearing technology use,
                                                leading to associated health
                                                benefits, potential fostering of
                                                innovation in hearing aid
                                                technology. Potential increase in
                                                consumer utility, derived from
                                                reduced health risks, from
                                                inability to buy some existing
                                                hearing aids under existing
                                                conditions.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Costs:
    Annualized Monetized $millions/year.......           1           1           2        2020           7          10  ................................
                                                         1           1           2        2020           3          10
    Annualized Quantified.....................  ..........  ..........  ..........  ..........           7  ..........  ................................
                                                                                                         3
                                               ---------------------------------------------------------------------------------------------------------
    Qualitative...............................  Potential loss of consumer utility  ..........  ..........  ..........  ................................
                                                from inability to buy existing
                                                hearing aids under existing
                                                conditions, including consumers of
                                                online hearing aids that do not
                                                meet OTC requirements. Costs to
                                                manufacturers of hearing aids sold
                                                online that do not meet OTC
                                                requirements to render their
                                                products and sales methods
                                                consistent with the requirements
                                                of either OTC or prescription
                                                hearing aids.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Transfers:
    Federal Annualized Monetized $millions/     ..........  ..........  ..........  ..........           7  ..........  ................................
     year.                                                                                               3
                                               ---------------------------------------------------------------------------------------------------------
    From/To...................................  From:
                                                To:                                 ..........
--------------------------------------------------------------------------------------------------------------------------------------------------------
    Other Annualized Monetized $millions/year.  ..........  ..........  ..........  ..........           7  ..........  ................................
                                                                                                         3
                                               ---------------------------------------------------------------------------------------------------------
    From/To...................................  From:
                                                To:                                 ..........
--------------------------------------------------------------------------------------------------------------------------------------------------------
Effects:
    State, Local or Tribal Government:..................................................................................................................
    Small Business:.....................................................................................................................................

[[Page 50745]]

 
    Wages:..............................................................................................................................................
    Growth:.............................................................................................................................................
    Distributional effects are also possible that would favor general retailers and new manufacturers entering into the hearing aid market who do not
     have relations with current specialty retail suppliers and disfavor specialty retail suppliers and associated workers including hearing healthcare
     professionals, and established manufacturers with relations with those suppliers..
--------------------------------------------------------------------------------------------------------------------------------------------------------

    We have developed a comprehensive Economic Analysis of Impacts that 
assesses the impacts of this rule. The full analysis of economic 
impacts is available in the docket for this rule (Ref. 16) and at 
https://www.fda.gov/about-fda/reports/economic-impact-analyses-fda-regulations.

VIII. Analysis of Environmental Impact

    FDA has carefully considered the potential environmental impact of 
this final rule and of possible alternative actions. In doing so, the 
Agency focused on the environmental impacts of its action as a result 
of increased use and eventual disposal of OTC hearing aids that will 
need to be handled after the effective date of this final rule.
    The environmental assessment (EA) considers environmental impacts 
related to additional waste to landfills at municipal solid waste (MSW) 
facilities. The selected action will likely increase the availability 
and use of hearing aid devices, which would result in additional waste 
from increased disposal of these devices and their associated 
batteries, as well as an increase in industrial waste associated with 
any domestic production to meet market demand for the new devices. 
Overall, given the current limited use of these devices, projected slow 
growth with increase in availability, and the small mass of waste 
material to be disposed or recycled, the selected action is not 
expected to have a significant impact on MSW, landfill facilities, and 
the environment.
    The Agency has concluded that the final rule will not have a 
significant impact on the human environment, and that an environmental 
impact statement is not required. FDA's FONSI and the evidence 
supporting that finding, contained in an EA prepared under 21 CFR 
25.40, are on display with the Dockets Management Staff (see ADDRESSES) 
and are available for viewing by interested persons between 9 a.m. and 
4 p.m., Monday through Friday; they are also available electronically 
at https://www.regulations.gov.

IX. Paperwork Reduction Act of 1995

    This final rule contains information collection provisions that are 
subject to review by OMB under the PRA (44 U.S.C. 3501-3521). The 
title, description, and respondent description of the information 
collection provisions are shown in the following paragraphs with an 
estimate of the annual reporting, recordkeeping, and third-party 
disclosure burden. Included in the estimate is the time for reviewing 
instructions, searching existing data sources, gathering and 
maintaining the data needed, and completing and reviewing each 
collection of information.
    Title: Medical Device Labeling Regulations; OMB Control Number 
0910-0485--Revision.
    Description: FDA is establishing a regulatory category for OTC 
hearing aids and making related amendments to update the regulatory 
framework for hearing aids. Among other amendments described in this 
rulemaking, we amend the existing labeling requirements for hearing 
aids. In creating a regulatory category for OTC hearing aids and 
amending existing rules, we intend to provide reasonable assurance of 
safety and effectiveness for hearing aids as well as foster access to, 
and innovation in, hearing aid technology, thereby protecting and 
promoting the public health.
    Description of Respondents: Respondents to the information 
collection are manufacturers of hearing aids.
    We estimate the burden of the collection of information as follows:

                                                       Table 2--Estimated One-Time Burden \1\ \2\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                             Number of                        Average
                        Activity                             Number of      records per    Total annual     burden per      Total hours    Total capital
                                                           recordkeepers   recordkeeper       records      recordkeeping                       costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
Understanding and implementing new regulatory                        105               1             105             290          30,450      $4,100,000
 requirements from hearing aids rule....................
Hearing aids relabeling.................................             105               8             840              68          57,120       6,000,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no operating and maintenance costs associated with this collection of information.
\2\ Numbers have been rounded to the nearest whole number.

                             Table 3--Estimated Annual Recordkeeping Burden \1\ \2\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average
    Activity; 21 CFR section         Number of      records per    Total annual     burden per      Total hours
                                   recordkeepers   recordkeeper       records      recordkeeping
----------------------------------------------------------------------------------------------------------------
Labeling disclosures under                   105               8             840               1             840
 800.30(c)(2) and 801.422(c)(2);
 Hearing aids; electronic
 version of user instructional
 brochure.......................
----------------------------------------------------------------------------------------------------------------
\1\ There are no operating and maintenance costs associated with this collection of information.
\2\ Numbers have been rounded to the nearest whole number.

[[Page 50746]]

                         Table 4--Estimated Annual Third-Party Disclosure Burden \1\ \2\
----------------------------------------------------------------------------------------------------------------
                                                     Number of
                                     Number of      disclosures    Total annual       Average
    Activity; 21 CFR section        respondents         per         disclosures     burden per      Total hours
                                                    respondent                      disclosure
----------------------------------------------------------------------------------------------------------------
OTC Hearing Aid Controls--800.30             105               7             735              19          13,965
Prescription Hearing Aid                     105               1             105              19           1,995
 Labeling--801.422..............
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............          15,960
----------------------------------------------------------------------------------------------------------------
\1\ There are no operating and maintenance costs associated with this collection of information.
\2\ Numbers have been rounded to the nearest whole number.

    Our burden estimate is based on FDA Uniform Registration and 
Listing System data; FDA's Operational and Administrative System for 
Import Support data; informal communications with industry; and our 
knowledge of and experience with information collection pertaining to 
medical device labeling. We intend the burden estimates to be 
consistent with our Final Regulatory Impact Analysis (FRIA) for this 
rulemaking (Ref. 16).
    Estimated One-Time Burden: Understanding and implementing new 
regulatory requirements from hearing aids rule--one-time burden 
(Recordkeeping): As noted in the FRIA for this rulemaking, we estimate 
it will take 5 hours each for an executive, a lawyer, and a marketing 
manager to read and understand the rule. Also included in our estimate 
is time for revising guidelines or standard operating procedures. We 
assume this may take up to 25 hours for one executive, up to 100 hours 
for one marketing manager, and up to 150 hours for one technical 
writer. Therefore, we estimate a one-time recordkeeping burden of 290 
hours for each manufacturer.
    Hearing aids relabeling--one-time burden (Third-Party Disclosure): 
The rulemaking necessitates the relabeling of all current hearing aids 
(approximately 840). The labeling cost model used in the FRIA suggests, 
based on a compliance date 240 days after publication of the final 
rule, a one-time estimated third-party disclosure burden for relabeling 
of about 68 hours per product.
    Estimated Annual Burden: Over-the-Counter Hearing Aid Controls--
Sec.  800.30 (Recordkeeping and Third-Party Disclosure): Section 800.30 
sets forth labeling requirements for OTC hearing aids. Section 
800.30(c)(1) describes the warnings and other important information 
that the outside package must bear. Manufacturers must include on the 
outside package label: certain specified warnings and statements; a 
weblink to all labeling and any additional resources; contact 
information to request a paper copy of the labeling; their return 
policy or absence thereof; if the OTC hearing aid is used or rebuilt, 
they must declare that fact; the principal display panel must bear the 
marks ``OTC'' and ``hearing aid''; battery information; and control 
platform information if applicable.
    Section 800.30(c)(2) describes device-specific requirements for 
labeling, inside the package. Among the labeling requirements listed 
are a user instructional brochure, an electronic version of which is to 
be made available for download; additional warnings; caution and 
notices for users; other specified information; and any other 
information necessary for adequate directions for use as defined in 
Sec.  801.5. Also required under proposed Sec.  800.30(c)(2) is the 
identification of any known physiological side effects associated with 
the use of the OTC hearing aid that may warrant consultation with a 
physician; the technical specifications required by Sec.  800.30(c)(4); 
a description of commonly occurring, avoidable events that could 
adversely affect or damage the OTC hearing aid; if applicable, 
information relating to electromagnetic compatibility and wireless 
technology and human exposure to non-ionizing radiation; information 
regarding repair service or replacements; and, if applicable, a summary 
of all clinical or non-clinical studies conducted to support the 
performance of the OTC hearing aid.
    Section 800.30(c)(3) provides requirements for the labeling on an 
OTC hearing aid itself, specifically, serial number, information 
regarding the battery and, if the OTC hearing aid is used or rebuilt, 
the manufacturer must physically attach a removable tag to the hearing 
aid declaring that fact.
    Section 800.30(c)(5) provides requirements related to software 
device labeling.
    We include no estimate for provisions under proposed Sec.  
800.30(c)(1)(i)(A) through (D), (c)(2)(i)(A) through (C), and 
(c)(2)(iii)(A) through (F) because we consider the labeling to be 
``public disclosure of information originally supplied by the Federal 
government to the recipient for the purpose of disclosure to the 
public,'' consistent with 5 CFR 1320.3(c)(2). Thus, those labeling 
provisions are not within the definition of collection of information.
    The FRIA for this rulemaking estimates that 105 firms manufacture 
air-conduction hearing aids sold in the United States, based on FDA 
Medical Device Registration data. We estimate that each manufacturer 
has an average of eight products that would need relabeling.
    For each hearing aid product, we assume a 1-hour annual 
recordkeeping burden for maintaining the electronic version of the user 
instructional brochure (under Sec. Sec.  800.30(c)(2) and 
801.422(c)(2)).
    The rulemaking would necessitate the relabeling of all current 
hearing aids (approximately 840) according to either the OTC or 
prescription hearing aid labeling requirements. While we lack specific 
data regarding what portion of hearing aids will be relabeled as 
prescription devices and what portion will be relabeled as OTC hearing 
aids, for this analysis, we assume that 10 percent will be relabeled as 
prescription medical devices (about 1 product per manufacturer) and 90 
percent as OTC hearing aids (about 7 products per manufacturer). The 
labeling cost model used in the FRIA suggests an annual estimated 
third-party disclosure burden of about 19 hours per product.
    Prescription Hearing Aid Labeling--Sec.  801.422 (Third-Party 
Disclosure): Section 801.422(c) sets forth labeling requirements for 
prescription hearing aids. However, as with some of the provisions 
under proposed Sec.  800.30(c), we include no estimate for provisions 
under Sec.  801.422(c)(1)(i)(A) through (C), (c)(2)(i)(A) through (C), 
and (c)(2)(ii)(A) through (F) because we consider the labeling to be 
``public disclosure of information originally supplied by the Federal 
government to the recipient for the purpose of disclosure to the 
public,'' consistent with 5 CFR 1320.3(c)(2).
    Section 801.422(c)(1) provides the warnings and notice that must be 
on the

[[Page 50747]]

outside package labeling; if applicable, that the prescription hearing 
aid is used or rebuilt; battery information; and if applicable, control 
platform information.
    Section 801.422(c)(2) describes requirements for prescription 
hearing aid labeling, inside the package. Among the labeling 
requirements listed are a user instructional brochure, an electronic 
version of which is to be made available for download; warnings; 
caution and notices for users; and additional information that must be 
included in the user instructional brochure.
    Section 801.422(c)(3) provides the requirements for the labeling on 
a prescription hearing aid itself, specifically, serial number; 
information regarding the battery if applicable; and if the 
prescription hearing aid is used or rebuilt, the manufacturer must 
physically attach a removable tag to the hearing aid declaring that 
fact.
    Section 801.422(c)(4) provides the technical specification elements 
that must appear in the user instructional brochure or in separate 
labeling that accompanies the device.
    Section 801.422(c)(5) provides requirements related to software 
device labeling.
    The FRIA estimates that 105 firms manufacture air-conduction 
hearing aids sold in the United States, based on FDA Medical Device 
Registration data. We estimate that each manufacturer has an average of 
eight products that would need relabeling.
    For each hearing aid product, we assume a 1-hour annual 
recordkeeping burden for maintaining the electronic version of the user 
instructional brochure (under Sec. Sec.  800.30(c)(2) and 
801.422(c)(2)).
    The rulemaking would necessitate the relabeling of all current 
hearing aids (approximately 840) according to either the OTC or 
prescription hearing aid labeling requirements. While we lack specific 
data regarding what portion of hearing aids will be relabeled as 
prescription devices and what portion will be relabeled as OTC hearing 
aids, for this analysis, we assume that 10 percent will be relabeled as 
prescription medical devices (about 1 product per manufacturer) and 90 
percent as OTC hearing aids (about 7 products per manufacturer). The 
labeling cost model used in the FRIA suggests an annual estimated 
third-party disclosure burden of about 19 hours per product.
    As required by section 3506(c)(2)(B) of the PRA, FDA provided an 
opportunity for public comment on the information collection 
requirements of the proposed rule.
    We received more than 1,000 comments on the proposed rule. We 
describe and respond to the comments in section V of this document, 
``Comments on the Proposed Rule and FDA's Responses.'' Comments and 
responses related to the provisions that underlie the information 
collection are described in the following sections: III.B, regarding 
scope; III.D, regarding labeling; and III.F, regarding other device 
requirements. We have not made changes to the estimated burden as a 
result of those comments.
    We also received a comment relating to the information collection 
burden estimate. The comment expressed concern that, for a small 
business, the ``cost for building a system from scratch'' and for 
reading and understanding the rule, without a lawyer or a marketing 
manager, is overly burdensome.
    Included in our estimate of 290 hours for ``Understanding and 
implementing new regulatory requirements from hearing aids rule,'' is 
an average of 5 hours each for an executive, a lawyer, and a marketing 
manager to read and understand the rule. Therefore, we estimate 15 
hours for reading and understanding the rule. We assume that a 
manufacturer who does not employ a lawyer or marketing manager, would 
take approximately the same amount of time to read and understand the 
rule. This is consistent with the comment's statement that it took ``at 
least 8 hours to read through and understand this rule.''
    While it is not clear what is meant by ``building a system from 
scratch'' in this context, included in our estimate is time for 
revising guidelines or standard operating procedures. We assume this 
may take up to 25 hours for one executive, up to 100 hours for one 
marketing manager, and up to 150 hours for one technical writer; a 
total of 275 hours for revising guidelines or standard operating 
procedures. Our estimate assumes that, as a standard business practice 
and in compliance with the existing requirements, a company has 
guidelines or standard operating procedures in place and that the 
burden estimate represents only the time to revise existing 
documentation to be consistent with the rulemaking. We believe this 
estimate reflects an appropriate amount of time for understanding and 
implementing the new regulatory requirements.
    Additionally, the comment expressed concern about the time to write 
``the user instructional brochure from scratch.''
    We have included a 68-hour, one-time burden estimate for the 
relabeling necessitated by the rulemaking. This estimate includes, 
among other things, time for updating the user instructional brochure 
and providing the required content online. Our recordkeeping burden 
estimate of 1 hour for ``Labeling disclosures under Sec. Sec.  
800.30(c)(2) and 801.422(c)(2); Hearing aids; electronic version of 
user instructional brochure'' is an annual estimate, intended to 
reflect the maintenance of records associated with the requirement in 
Sec. Sec.  800.30(c)(2) and 801.422(c)(2) to make an electronic version 
of a user instructional brochure available for download.
    We have not revised our burden estimate based on this comment.
    The information collection provisions in this final rule have been 
submitted to OMB for review as required by section 3507(d) of the 
Paperwork Reduction Act of 1995.
    Before the effective date of this final rule, FDA will publish a 
notice in the Federal Register announcing OMB's decision to approve, 
modify, or disapprove the information collection provisions in this 
final rule. An Agency may not conduct or sponsor, and a person is not 
required to respond to, a collection of information unless it displays 
a currently valid OMB control number.

X. Federalism

    FDA has analyzed this final rule in accordance with the principles 
set forth in Executive Order 13132. Section 4(a) of the Executive order 
requires Agencies to ``construe . . . a Federal statute to preempt 
State law only where the statute contains an express preemption 
provision or where there is some other clear evidence that the Congress 
intended preemption of State law, or where the exercise of State 
authority conflicts with the exercise of Federal authority under the 
Federal statute.'' Federal law includes an express preemption provision 
that preempts certain State requirements ``different from, or in 
addition to, any requirement applicable under'' the FD&C Act that is 
applicable to devices. (See section 521 of the FD&C Act; Medtronic v. 
Lohr, 518 U.S. 470 (1996); and Riegel v. Medtronic, 552 U.S. 312 
(2008).) Federal law also preempts State or local laws ``specifically 
related to hearing products that would restrict or interfere with the 
servicing, marketing, sale, dispensing, use, customer support, or 
distribution of [OTC hearing aids] through in-person transactions, by 
mail, or online, that [are] different from, in addition to, or 
otherwise not identical to, the regulations promulgated under'' section

[[Page 50748]]

709(b) of FDARA (see section 709(b)(4) of FDARA).
    Section 521(b) of the FD&C Act provides that the Commissioner of 
Food and Drugs may, upon application of a State or local government, 
exempt a requirement from preemption, if the State or local requirement 
for the device is more stringent than the requirement under the FD&C 
Act, or if the requirement is necessitated by compelling local 
conditions and compliance with it would not cause the device to be in 
violation of a requirement under the FD&C Act. Following this process, 
a State or local government may request an exemption from preemption 
for those State or local requirements pertaining to hearing aid 
products that are preempted by the Agency's final rule under section 
521 of the FD&C Act. However, because FDARA does not provide a parallel 
mechanism to exempt State or local requirements from its express 
preemption provision, FDA is not considering exemptions under section 
709(b)(4) of FDARA for OTC hearing aids.
    Thus, this final rule will create requirements that fall within the 
scope of section 521 of the FD&C Act and/or section 709(b)(4) of FDARA. 
It also amends Sec.  801.420 and repeals Sec.  801.421, and such 
changes affect many of the decisions on applications for exemption from 
preemption that were issued in relation to these two regulations under 
section 521(b) of the FD&C Act, resulting in the removal of the 
regulations codifying such decisions, as discussed further in section 
V.I. above. The scope of preemption of this final rule is discussed in 
more detail in sections III.G through I, above.

XI. Consultation and Coordination With Indian Tribal Governments

    We have analyzed this rule in accordance with the principles set 
forth in Executive Order 13175. We have determined that the rule does 
not contain policies that would have a substantial direct effect on one 
or more Indian Tribes, on the relationship between the Federal 
Government and Indian Tribes, or on the distribution of power and 
responsibilities between the Federal Government and Indian Tribes. 
Accordingly, we conclude that the rule does not contain policies that 
have tribal implications as defined in the Executive order and, 
consequently, a tribal summary impact statement is not required.

XII. References

    The following references marked with an asterisk (*) are on display 
at the Dockets Management Staff (see ADDRESSES) and are available for 
viewing by interested persons between 9 a.m. and 4 p.m., Monday through 
Friday; they are also available electronically at https://www.regulations.gov. References without asterisks are not on public 
display at https://www.regulations.gov because they have copyright 
restriction. Some may be available at the website address, if listed. 
References without asterisks are available for viewing only with the 
Dockets Management Staff. FDA has verified the website addresses, as of 
the date this document publishes in the Federal Register, but websites 
are subject to change over time.

1. Lin, F., J. Niparko, and L. Ferruci, ``Hearing Loss Prevalence in 
the United States.'' Archive of Internal Medicine, 171:1851-1853, 
2011.
2. Dalton, D.S., ``The Impact of Hearing Loss on Quality of Life in 
Older Adults.'' The Gerontologist, 43(5):661-668, 2005.
*3. National Institutes of Health (NIH). Hearing Aids Fact Sheet. 
National Institute on Deafness and Communication Disorders. 2010. 
Available at: https://www.nidcd.nih.gov/health/statistics/quick-statistics-hearing.
4. Maharani, A., P. Dawes, et al., ``Longitudinal Relationship 
Between Hearing Aid Use and Cognitive Function in Older Americans.'' 
Journal of the American Geriatrics Society, 66(6):1130-1136, 2018.
5. Mahmoudi, E., T. Basu, et al., ``Can Hearing Aids Delay Time to 
Diagnosis of Dementia, Depression, or Falls in Older Americans?'' 
Journal of the American Geriatrics Society, 67(11):2362-2369, 2019.
6. McCormack, A. and H. Fortnum, ``Why Do People Fitted With Hearing 
Aids Not Wear Them?'' International Journal of Audiology, 52(5):360-
368, 2013.
7. NASEM, ``Hearing Health Care for Adults: Priorities for Improving 
Access and Affordability.'' Board on Health Sciences Policy, 
Committee on Accessible and Affordable Hearing Health Care for 
Adults; Blazer, D.G., S. Domnitz, and C.T. Liverman, Eds., 2016. 
DOI: 10.17226/23446. Available at: https://www.nap.edu/catalog/23446/hearing-health-care-for-adults-priorities-for-improving-access-and.
8. ANSI/CTA 2051: Personal Sound Amplification Performance Criteria 
(voluntary consensus standard). January 2017. Available at: https://webstore.ansi.org/standards/ansi/cta20512017ansi.
*9. NIOSH, Occupational Noise Exposure, publication number 98-126. 
June 1998. Available at: https://www.cdc.gov/niosh/docs/98-126/pdfs/98-126.pdf.
10. Johnson, E.E., ``Safety Limit Warning Levels for the Avoidance 
of Excessive Sound Amplification to Protect Against Further Hearing 
Loss.'' International Journal of Audiology, 56(11):829-836, 2017.
11. Tedeschi, T., C. Jones, and E. Stewart. ``Real World Evidence on 
Gain and Output Settings for Individuals with Mild-to-Moderate 
Hearing Loss.'' Hearing Review, 27(7):9-11, 2020.
12. Ahmad, I., W.C. Lee, and J.D. Binnington. ``External Auditory 
Canal Measurements: Localization of the Isthmus.'' 
Otorhinolaryngologia Nova, 10:183-186, 2000.
13. Grewe, J., C. Thiele, et al. ``New HRCT-Based Measurement of the 
Human Outer Ear Canal as a Basis for Acoustical Methods.'' American 
Journal of Audiology, 22:65-73, 2013.
14. NASEM, ``Over-The-Counter Hearing Devices Discussion: Safety and 
Quality Requirements and Considerations Session.'' MP3, 1:15:39 
(English). National Academies' Hearing Health Care Report: June 2017 
Dissemination Meeting; Washington, DC, 2017.
*15. FDA, ``Streamlining Good Manufacturing Practices (GMPs) for 
Hearing Aids,'' public workshop. Silver Spring, MD; April 21, 2016. 
Available at: https://wayback.archive-it.org/7993/20171114234227/https://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm480336.htm.
*16. FDA, ``Regulatory Impact Analysis; Regulatory Flexbility 
Analysis; Unfunded Mandates Reform Act Analysis.'' 2022. Available 
at: https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm.

List of Subjects

21 CFR Part 800

    Administrative practice and procedure, Medical devices, Ophthalmic 
goods and services, Packaging and containers, Reporting and 
recordkeeping requirements.

21 CFR Part 801

    Labeling, Medical devices, Reporting and recordkeeping 
requirements.

21 CFR Part 808

    Intergovernmental relations, Medical devices.

21 CFR Part 874

    Medical devices.
    Therefore, under the Federal Food, Drug, and Cosmetic Act, and 
under authority delegated to the Commissioner of Food and Drugs, 21 CFR 
parts 800, 801, 808, and 874 are amended as follows:

PART 800--GENERAL

0
1. The authority citation for part 800 is revised to read as follows:

    Authority:  21 U.S.C. 321, 334, 351, 352, 355, 360e, 360i, 360j, 
360k, 361, 362, 371.

    Section 800.30 also issued under Sec. 709, Pub. L. 115-52, 131 
Stat. 1065-67.

0
2. Add Sec.  800.30 to subpart B to read as follows:

[[Page 50749]]

Sec.  800.30  Over-the-counter hearing aid controls.

    (a) Scope. This section specifies the requirements for over-the-
counter (OTC) air-conduction hearing aids. Air-conduction hearing aids 
that satisfy the requirements in paragraphs (c) through (f) of this 
section are considered ``available'' over the counter as section 
520(q)(1)(A)(v) of the Federal Food, Drug, and Cosmetic Act uses the 
term. Air-conduction hearing aids that do not meet the definition in 
section 520(q) of the Federal Food, Drug, and Cosmetic Act or do not 
satisfy the following requirements are prescription hearing aids. 
Unless otherwise specified, the requirements in this section are in 
addition to other applicable requirements, including but not limited to 
special controls found in the applicable classification regulation in 
part 874 of this chapter.
    (b) Definitions for the purposes of this section. This section uses 
the following definitions:
    Air-conduction hearing aid. An air-conduction hearing aid is a 
hearing aid that conducts sound to the ear through the air.
    Hearing aid. A hearing aid is any wearable device designed for, 
offered for the purpose of, or represented as aiding persons with or 
compensating for, impaired hearing.
    Licensed person. A licensed person is a person as defined in 
section 201(e) of the Federal Food, Drug, and Cosmetic Act that holds a 
license or degree for the diagnosis, assessment, or treatment of 
hearing loss; or that holds a license to sell or distribute hearing 
aids. A person that must meet generally applicable licensing or 
operating requirements such as annual health and safety inspections, 
provided the generally applicable licensing or operating requirement is 
consistent with this section and other applicable requirements under 
the Federal Food, Drug, and Cosmetic Act, is not a ``licensed person'' 
solely for that reason. A person that represents as a marketer, seller, 
dispenser, distributor, or customer support representative (or an 
equivalent description) is not a ``licensed person'' solely by making 
such representations.
    Over-the-counter hearing aid. An over-the-counter (OTC) hearing aid 
is an air-conduction hearing aid that does not require implantation or 
other surgical intervention, and is intended for use by a person age 18 
or older to compensate for perceived mild to moderate hearing 
impairment. The device, through tools, tests, or software, allows the 
user to control the hearing aid and customize it to the user's hearing 
needs. The device may use wireless technology or may include tests for 
self-assessment of hearing loss. The device is available over-the-
counter, without the supervision, prescription, or other order, 
involvement, or intervention of a licensed person, to consumers through 
in-person transactions, by mail, or online, provided that the device 
satisfies the requirements in this section.
    Prescription hearing aid. A prescription hearing aid is a hearing 
aid that is not an OTC hearing aid as defined in this section or a 
hearing aid that does not satisfy the requirements in this section.
    Rebuilt hearing aid. An OTC hearing aid is ``rebuilt'' if the 
manufacturer has inspected and tested the device, made any necessary 
modifications to ensure it meets applicable regulatory requirements, 
including the requirements in this section to be available OTC, and 
adequately reprocessed the device for the next user.
    Sale. Sale includes a lease, rental, or any other purchase or 
exchange for value.
    Tools, tests, or software. Tools, tests, or software are components 
of the device that, individually or in combination, allow a lay user to 
control the device and customize it sufficiently, such as the device's 
output, to meet the user's hearing needs.
    Used hearing aid. A hearing aid is ``used'' if a user has worn it 
for any period of time. However, a hearing aid shall not be ``used'' 
merely because a prospective user wore it as part of a bona fide 
hearing aid evaluation to determine whether to select that particular 
hearing aid for that prospective user. A hearing aid evaluation is 
``bona fide'' if it was conducted in the presence of the dispenser or a 
hearing health professional selected by the dispenser to assist the 
prospective user in making a determination.
    (c) Labeling. An OTC hearing aid shall bear all of the following in 
the labeling:
    (1) Outside package labeling. The outside package of an OTC hearing 
aid shall bear all of the following:
    (i) Warnings and other important information. All of the following 
shall appear on the outside package:
    (A) (A) Warning against use in people younger than 18.
BILLING CODE 4164-01-P
[GRAPHIC] [TIFF OMITTED] TR17AU22.000

    (B) Symptoms suggesting perceived mild to moderate hearing loss.
    [GRAPHIC] [TIFF OMITTED] TR17AU22.001
    

[[Page 50750]]

    (C) Advice of availability of professional services.
    [GRAPHIC] [TIFF OMITTED] TR17AU22.002
    
    (D) ``Red flag'' conditions.
    [GRAPHIC] [TIFF OMITTED] TR17AU22.003
    
    (E) Notice of contact information.
    [GRAPHIC] [TIFF OMITTED] TR17AU22.004
    
    (F) Notice of manufacturer's return policy.

[[Page 50751]]

[GRAPHIC] [TIFF OMITTED] TR17AU22.005

    (ii) Statement of build condition. If the OTC hearing aid is used 
or rebuilt, the outside package shall declare that fact. A sticker 
under and visible through the outer wrapper will suffice to declare 
such fact.
    (iii) Statement of OTC availability. The principal display panel 
shall bear the marks ``OTC'' and ``hearing aid'' with the same 
prominence required under Sec.  801.61(c) of this chapter for the 
device's statement of identity. The device's common name on the 
principal display panel may satisfy all or part of this requirement to 
the extent the common name includes the marks.
    (iv) Indication of battery information. The outside package shall 
indicate the type and number of batteries and whether batteries are 
included in the package.
    (v) Indication of control platform. The outside package shall 
indicate whether a mobile device or other non-included control platform 
is required. The indication must include the type of platform and how 
the platform connects to the device.
    (2) Labeling, inside the package. The manufacturer or distributor 
of an OTC hearing aid shall include a user instructional brochure 
inside the package and shall make an electronic version available for 
download without site or customer registration and without requiring 
purchase of any product or service. The user instructional brochure 
shall include all of the following:
    (i) The following warnings, which shall appear in the following 
order and prior to any content except the cover page:
    (A) Warning against use in people younger than 18.
    [GRAPHIC] [TIFF OMITTED] TR17AU22.006
    
    (B) ``Red flag'' conditions.
    [GRAPHIC] [TIFF OMITTED] TR17AU22.007
    

[[Page 50752]]

    (C) Warning about pain from device placement.
    [GRAPHIC] [TIFF OMITTED] TR17AU22.008
    
    (ii) Any additional warnings the manufacturer may include prior to 
the cautions and notices to users in paragraph (c)(2)(iii) of this 
section.
    (iii) The following cautions and notices for users, which shall 
appear prior to any content except the cover page and the warnings 
under paragraphs (c)(2)(i) and (ii) of this section:
    (A) Caution about hearing protection.
    [GRAPHIC] [TIFF OMITTED] TR17AU22.009
    
    (B) Caution about excessive sound output.
    [GRAPHIC] [TIFF OMITTED] TR17AU22.010
    
    (C) Caution about components lodging in ear.
    [GRAPHIC] [TIFF OMITTED] TR17AU22.011
    
    (D) Advice to seek professional services.
    [GRAPHIC] [TIFF OMITTED] TR17AU22.012
    

[[Page 50753]]

    (E) Note about user expectations.
    [GRAPHIC] [TIFF OMITTED] TR17AU22.013
    
    (E) Note about reporting adverse events to FDA.
    [GRAPHIC] [TIFF OMITTED] TR17AU22.014
    
BILLING CODE 4164-01-C
    (iv) An illustration(s) of the OTC hearing aid that indicates 
operating controls, user adjustments, and the battery compartment.
    (v) Information on the function of all controls intended for user 
adjustment.
    (vi) A description of any accessory that accompanies the OTC 
hearing aid, including but not limited to wax guards and accessories 
for use with a computer, television, or telephone.
    (vii) Specific instructions for all of the following:
    (A) Instructions for sizing or inserting the eartip of the OTC 
hearing aid to prevent insertion past the depth limit and damage to the 
tympanic membrane.
    (B) The tools, tests, or software that allow the user to control 
the OTC hearing aid, including self-selection and self-checking the 
performance of the OTC hearing aid, and customize it to the user's 
hearing needs, including information about properly fitting eartips.
    (C) Use of the OTC hearing aid with any accompanying accessories.
    (D) Maintenance and care of the OTC hearing aid, including how a 
lay user can clean, disinfect, and replace parts or how to seek 
replacements, as well as how to store the hearing aid when it will not 
be used for an extended period of time.
    (E) If the battery is replaceable or rechargeable, how to replace 
or recharge the battery, including a generic designation of replacement 
batteries.
    (F) Expected battery life.
    (G) Any other information necessary for adequate directions for use 
as defined in Sec.  801.5 of this chapter.
    (viii) Identification of any known physiological side effects 
associated with the use of the OTC hearing aid that may warrant 
consultation with a physician, referring to an ear-nose-throat doctor 
when preferable, including if applicable, skin irritation and 
accelerated accumulation of cerumen (ear wax).
    (ix) The technical specifications required by paragraph (c)(4) of 
this section.
    (x) A description of commonly occurring, avoidable events that 
could adversely affect or damage the OTC hearing aid, including but not 
limited to, as applicable, ear wax buildup, drops, immersion in water, 
or exposure to excessive heat.
    (xi) If the hearing aid incorporates wireless technology in its 
programming or use, appropriate warnings, instructions, and information 
relating to electromagnetic compatibility and wireless technology and 
human exposure to non-ionizing radiation.
    (xii) Information on how and where to obtain repair service or 
replacements, including at least one specific address where the user 
can go or send the OTC hearing aid to obtain such repair service or 
replacements.
    (xiii) If clinical or non-clinical studies were conducted by or for 
the manufacturer to support the

[[Page 50754]]

performance of the OTC hearing aid, a summary of all such studies.
    (3) Labeling on the device. The labeling on an OTC hearing aid 
itself shall bear all of the following clearly and permanently, except 
as provided in paragraph (c)(3)(iii) of this section:
    (i) The serial number.
    (ii) If the battery is removable, a ``+'' symbol to indicate the 
positive terminal for battery insertion unless the battery's physical 
design prevents inserting the battery in the reversed position.
    (iii) If the OTC hearing aid is used or rebuilt, the manufacturer 
shall physically attach a removable tag to the hearing aid declaring 
that fact.
    (4) Technical specifications. All of the following technical 
specifications shall appear in the user instructional brochure that 
accompanies the device. You may additionally include it on the outside 
package:
    (i) The maximum output limit value (Output Sound Pressure Level 90 
(OSPL90)).
    (ii) The full-on gain value, which is the gain with a 50 decibel 
(dB) Sound Pressure Level (SPL) pure-tone input and volume set to full 
on.
    (iii) The total harmonic distortion value.
    (iv) The self-generated noise value.
    (v) The latency value.
    (vi) The upper and lower cutoff frequencies for bandwidth.
    (5) Software device labeling. OTC hearing aid software that is not 
distributed with the hearing aid or amplification platform shall meet 
all of the following labeling requirements. With respect to the 
information required under paragraphs (c)(1) through (4) of this 
section, the information must be provided in the software device 
labeling, as specified in paragraphs (c)(5)(i) through (v) of this 
section, rather than the locations (e.g., outside package labeling) 
specified in paragraphs (c)(1) through (4):
    (i) Prior to first use of the software or obtaining payment 
information for the software, whichever occurs first, the labeling must 
clearly and prominently present all of the following to the prospective 
user. For each, the labeling must remain visible until the user 
dismisses it or proceeds to the next step:
    (A) Compatibility and minimum operating requirements for the 
software device.
    (B) Disclosures of any fees or payments after first use or initial 
payment, including but not limited to any fees or payments relating to 
subscriptions, add-on features, or continued access to features or 
services. The disclosures must name and briefly describe what each fee 
or payment covers.
    (C) The information required under paragraphs (c)(1)(i), (iii), and 
(v) of this section.
    (ii) Prior to first use of the software, the labeling must clearly 
and prominently present all of the following to the prospective user:
    (A) The information required under paragraph (c)(2)(i)(A) of this 
section, and it must remain visible until the user acknowledges it.
    (B) The information required under paragraphs (c)(2)(i)(B) and (C), 
(c)(2)(ii), (iii), and (v), (c)(2)(vii)(B) and (G), and (c)(2)(viii) 
and (ix) of this section, and the information must remain visible until 
the user dismisses it or proceeds to the next step.
    (C) All other information required under paragraph (c)(2) of this 
section, to the extent applicable, and the information must remain 
visible until the user dismisses it or proceeds to the next step.
    (iii) The software device labeling must include the information 
required under paragraphs (c)(3)(i) and (c)(4) of this section.
    (iv) All of the software device labeling must be accessible for 
review after acknowledgment, dismissal, or proceeding to the next step.
    (v) If there are changes to any of the labeling required under 
paragraph (c)(5) of this section, the labeling with the changed 
information must be presented to the user until the user dismisses it.
    (d) Output limits. The output limit for an OTC hearing aid shall be 
the device maximum acoustic output sound pressure level (SPL) with an 
acoustic coupler as described in paragraph (e)(6) of this section when 
the device input is a 90 dB SPL pure-tone, and the gain/volume control 
is full on. An OTC hearing aid shall not exceed the following limits at 
any of the frequencies at which the device is intended to operate:
    (1) General output limit. An OTC hearing aid shall not exceed an 
output limit of 111 dB SPL at any frequency except as provided in 
paragraph (d)(2) of this section.
    (2) Output limit for a device with activated input-controlled 
compression. An OTC hearing aid that has input-controlled compression 
activated shall not exceed an output limit of 117 dB SPL at any 
frequency.
    (e) Electroacoustic performance limits. An OTC hearing aid shall 
perform within all of the following electroacoustic limits. Measure 
each electroacoustic performance characteristic using an acoustic 
coupler as described in paragraph (e)(6) of this section, where 
applicable:
    (1) Output distortion control limits. Test the output distortion of 
the OTC hearing aid as follows to ensure that it does not exceed the 
limit specified in paragraphs (e)(1)(i) through (iii) of this section.
    (i) The total harmonic distortion plus noise shall not exceed 5 
percent for output levels within one of the following sets of levels, 
depending on the test method:
    (A) Using sine wave-based testing, measure at 70 dB SPL and 100 dB 
SPL; or
    (B) Using a 500-hertz (Hz) one-third-octave pulsed-noise signal, 
measure at 67 dB SPL and 97 dB SPL.
    (ii) You must measure the total harmonic distortion using a 500-Hz 
input tone with an analyzer that has a bandwidth at least as wide as 
the frequency limits of the OTC hearing aid.
    (iii) You must measure the output distortion at the OTC hearing 
aid's maximum volume and the input sound level to the OTC hearing aid 
adjusted to produce the required outputs.
    (2) Self-generated noise level limits. Self-generated noise shall 
not exceed 32 dBA. You must disable any methods that artificially lower 
the apparent noise floor for the measurement. Such methods would 
include but are not limited to auto-muting and downward expansion.
    (3) Latency. Latency shall not exceed 15 ms. You must measure the 
latency with a method that is accurate and repeatable to within 1.5 ms.
    (4) Frequency response bandwidth. The lower cutoff frequency shall 
extend to 250 Hz or below, and the upper cutoff frequency shall extend 
to 5 kHz or greater. You must measure the frequency response bandwidth 
as specified in the Method for clause 4.1 in ANSI/CTA-2051:2017.
    (5) Frequency response smoothness. No single peak in the one-third-
octave frequency response shall exceed 12 dB relative to the average 
levels of the one-third-octave bands, two-thirds octave above and below 
the peak. You must measure the frequency response smoothness using 
values for a diffuse field and the corrected one-third-octave frequency 
insertion response as specified in the Method for clause 4.1 in ANSI/
CTA-2051:2017.
    (6) Acoustic coupler choice. Where applicable, use one of the 
following acoustic couplers to measure electroacoustic performance:
    (i) When compatible with the device design, a 2-cubic centimeter 
(cm\3\) acoustic coupler; or

[[Page 50755]]

    (ii) When a 2-cm\3\ acoustic coupler is not compatible with the 
device design, an acoustic coupler that is a scientifically valid and 
technically equivalent alternative. You must document the rationale for 
using an alternative acoustic coupler.
    (f) Design requirements. An OTC hearing aid must conform to all of 
the following design requirements:
    (1) Insertion depth. The design of an OTC hearing aid shall limit 
the insertion of the most medial component so that, when inserted, the 
component is reasonably expected to remain at least 10 millimeters (mm) 
from the tympanic membrane.
    (2) Use of atraumatic materials. The material for the eartip of an 
OTC hearing aid shall be atraumatic.
    (3) Proper physical fit. The design of an OTC hearing aid shall 
enable consumers to readily achieve a safe, customized, acoustically 
favorable, and comfortable physical fit in the ear canal and/or 
external ear.
    (4) Tools, tests, or software. The OTC hearing aid shall, through 
tools, tests, or software, permit a lay user to control the device and 
customize it to the user's hearing needs.
    (5) User-adjustable volume control. The OTC hearing aid shall have 
a user-adjustable volume control.
    (6) Adequate reprocessing. If the OTC hearing aid is used or 
rebuilt, it must be adequately reprocessed for the next user prior to 
sale.
    (g) Conditions for sale of an OTC hearing aid. The sale of an OTC 
hearing aid is subject to all of the following conditions:
    (1) Age minimum. Sale to or for a person younger than 18 years of 
age is prohibited.
    (2) Statement of OTC availability. Sale of an OTC hearing aid is 
prohibited unless its labeling bears the statement of OTC availability 
required under paragraph (c)(1)(iii) of this section.
    (h) Effect on State law. Any State or local government requirement 
for an OTC hearing aid is preempted to the following extent:
    (1) Preemption. No State or local government shall establish or 
continue in effect any law, regulation, order, or other requirement 
specifically related to hearing products that would restrict or 
interfere with the servicing, marketing, sale, dispensing, use, 
customer support, or distribution of OTC hearing aids through in-person 
transactions, by mail, or online, that is different from, in addition 
to, or otherwise not identical to, the regulations promulgated under 
section 709(b) of the FDA Reauthorization Act of 2017, including any 
State or local requirement for the supervision, prescription, or other 
order, involvement, or intervention of a licensed person for consumers 
to access OTC hearing aids.
    (2) Professional requirements--(i) General rule. The servicing, 
marketing, sale, dispensing, customer support, or distribution of OTC 
hearing aids, or an equivalent activity, whether through in-person 
transactions, by mail, or online, shall not cause, require, or 
otherwise obligate a person providing such services to obtain 
specialized licensing, certification, or any other State or local 
sanction unless such requirement is generally applicable to the sale of 
any product or to all places of business regardless of whether they 
sell OTC hearing aids. However, although a State or local government 
may not require the order, involvement, or intervention of a licensed 
person for consumers to access OTC hearing aids, a licensed person may 
service, market, sell, dispense, provide customer support for, or 
distribute OTC hearing aids.
    (ii) Sale of OTC hearing aids is not an exemption. The servicing, 
marketing, sale, dispensing, customer support, or distribution of OTC 
hearing aids does not exempt a person from any State or local 
government's professional or establishment requirements that are 
consistent with this section.
    (iii) Representations may create professional obligations. A person 
shall not incur specialized obligations by representing as a servicer, 
marketer, seller, dispenser, customer support representative, or 
distributor (or an equivalent description) of OTC hearing aids. 
However, a person representing as any other defined professional or 
establishment, or as a State licensed dispenser, is subject to 
applicable State and local requirements even if the person undertakes 
commercial or professional activities only in relation to OTC hearing 
aids.
    (3) Private remedies. This section does not modify or otherwise 
affect the ability of any person to exercise a private right of action 
under any State or Federal product liability, tort, warranty, contract, 
or consumer protection law.
    (i) Incorporation by reference. ANSI/CTA-2051, ``Personal Sound 
Amplification Performance Criteria,'' dated January 2017 (ANSI/CTA-
2051:2017), is incorporated by reference into this section with the 
approval of the Director of the Office of the Federal Register under 5 
U.S.C. 552(a) and 1 CFR part 51. This material is available for 
inspection at the Food and Drug Administration and at the National 
Archives and Records Administration (NARA). Contact the Dockets 
Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 
240-402-7500. For information on the availability of this material at 
NARA, email: [email protected], or go to: www.archives.gov/federal-register/cfr/ibr-locations.html. The material may be obtained 
from Consumer Technology Association (CTA), Technology & Standards 
Department, 1919 S Eads Street, Arlington, VA 22202; phone: 703-907-
7600; fax: (703) 907-7693; email: [email protected], website: 
www.cta.tech.

PART 801--LABELING

0
3. The authority citation for part 801 is revised to read as follows:

    Authority: 21 U.S.C. 321, 331-334, 351, 352, 360d, 360i, 360j, 
371, 374.

Sec.  801.420  [Removed]

0
4. Remove Sec.  801.420.

Sec.  801.421  [Removed]

0
5. Remove Sec.  801.421.

0
6. Add Sec.  801.422 to subpart H to read as follows:

Sec.  801.422  Prescription hearing aid labeling.

    (a) Scope. This section specifies the labeling requirements for 
prescription hearing aids. Any hearing aid that does not satisfy the 
requirements of Sec.  800.30 of this chapter shall be a prescription 
device. Unless otherwise specified, the requirements in this section 
are in addition to other applicable requirements, including but not 
limited to special controls found in the applicable classification 
regulation in part 874 of this chapter. This section does not apply to 
group auditory trainers.
    (b) Definitions for the purposes of this section. This section uses 
the following definitions:
    Dispenser. A dispenser is any person, as defined in section 201(e) 
of the Federal Food, Drug, and Cosmetic Act, engaged in the sale of 
hearing aids to any member of the consuming public or any employee, 
agent, salesperson, and/or representative of such a person.
    Hearing aid. A hearing aid is any wearable device designed for, 
offered for the purpose of, or represented as aiding persons with or 
compensating for, impaired hearing.
    Prescription hearing aid. A prescription hearing aid is a hearing 
aid that is not an over-the-counter (OTC) hearing aid as defined in 
Sec.  800.30 of this chapter or a hearing aid that does not satisfy the 
requirements in Sec.  800.30 of this chapter.

[[Page 50756]]

    Rebuilt hearing aid. A prescription hearing aid is ``rebuilt'' if 
the manufacturer has inspected and tested the device, made any 
necessary modifications to ensure it meets applicable regulatory 
requirements, including the requirements in this section, and 
adequately reprocessed the device for the next user.
    Sale. Sale includes a lease, rental, or any other purchase or 
exchange for value.
    Used hearing aid. A hearing aid is ``used'' if a user has worn it 
for any period of time. However, a hearing aid shall not be ``used'' 
merely because a prospective user wore it as part of a bona fide 
hearing aid evaluation to determine whether to select that particular 
hearing aid for that prospective user. A hearing aid evaluation is 
``bona fide'' if it was conducted in the presence of the dispenser or a 
hearing health professional selected by the dispenser to assist the 
prospective user in making a determination.
    (c) Labeling. A prescription hearing aid shall bear all of the 
following labeling:
    (1) Outside package labeling. The outside package of a prescription 
hearing aid shall bear all of the following:
    (i) Warnings and other important information. All of the following 
shall appear on the outside package:
    (A) Warning against use in people younger than 18 without prior 
medical evaluation.
BILLING CODE 4164-01-P
[GRAPHIC] [TIFF OMITTED] TR17AU22.015

    (B) ``Red flag'' conditions.
    [GRAPHIC] [TIFF OMITTED] TR17AU22.016
    
    (C) Note about device trial options.

[[Page 50757]]

[GRAPHIC] [TIFF OMITTED] TR17AU22.017

    (ii) Statement of build condition. If the prescription hearing aid 
is used or rebuilt, the outside package shall declare that fact. A 
sticker under and visible through the outer wrapper will suffice to 
declare such fact.
    (iii) Indication of battery information. The outside package shall 
indicate the type and number of batteries and whether batteries are 
included in the package.
    (iv) Indication of control platform. That outside package shall 
indicate whether a mobile device or other non-included control platform 
is required. The indication must include the type of platform and how 
the platform connects to the device.
    (2) Labeling, inside the package. The manufacturer or distributor 
of a prescription hearing aid shall include a user instructional 
brochure inside the package and shall make an electronic version 
available for download without site or customer registration and 
without requiring purchase of any product or service. The user 
instructional brochure shall include all of the following:
    (i) The following warnings, which shall appear in the following 
order and prior to any content except the cover page:
    (A) Warning against use in people younger than 18 without prior 
medical evaluation.
[GRAPHIC] [TIFF OMITTED] TR17AU22.018

    (B) ``Red flag'' conditions, addressed to dispensers.

[[Page 50758]]

[GRAPHIC] [TIFF OMITTED] TR17AU22.019

    (C) Warning to dispensers about very high-output devices.
    [GRAPHIC] [TIFF OMITTED] TR17AU22.020
    
    (D) Additional warnings. Any additional warnings the manufacturer 
may include prior to the cautions and notices to users in paragraph 
(c)(2)(ii) of this section.
    (ii) The following cautions and notices for users, which shall 
appear prior to any content, except the cover page and the warnings 
under paragraph (c)(2)(i) of this section:
    (A) Caution about hearing protection.
    [GRAPHIC] [TIFF OMITTED] TR17AU22.021
    
    (B) Caution about excessive sound output.

[[Page 50759]]

[GRAPHIC] [TIFF OMITTED] TR17AU22.022

    (C) Caution about components lodging in ear.
    [GRAPHIC] [TIFF OMITTED] TR17AU22.023
    
    (D) Note about user expectations.
    [GRAPHIC] [TIFF OMITTED] TR17AU22.024
    
    (E) Note about reporting adverse events to FDA.
    [GRAPHIC] [TIFF OMITTED] TR17AU22.025
    
    (F) Note about hearing loss in people younger than 18 and fitting 
devices.

[[Page 50760]]

[GRAPHIC] [TIFF OMITTED] TR17AU22.026

BILLING CODE 4164-01-C
    (iii) An illustration(s) of the prescription hearing aid that 
indicates operating controls, user adjustments, and the battery 
compartment.
    (iv) Information on the function of all controls intended for user 
adjustment.
    (v) A description of any accessory that accompanies the 
prescription hearing aid, including but not limited to wax guards, and 
accessories for use with a computer, television, or telephone.
    (vi) Specific instructions for all of the following:
    (A) Use of the prescription hearing aid with any accompanying 
accessories.
    (B) Maintenance and care of the prescription hearing aid, including 
how a user can clean, disinfect, and replace parts or how to seek 
replacements, as well as how to store the hearing aid when it will not 
be used for an extended period of time.
    (C) If the battery is replaceable or rechargeable, how to replace 
or recharge the battery, including a generic designation of replacement 
batteries.
    (D) Expected battery life.
    (vii) Identification of any known physiological side effects 
associated with the use of the prescription hearing aid that may 
warrant consultation with a physician, referring to an ear-nose-throat 
doctor when preferable, including if applicable, skin irritation and 
accelerated accumulation of cerumen (ear wax).
    (viii) The technical specifications required by paragraph (c)(4) of 
this section unless such specifications appear in separate labeling 
accompanying the prescription hearing aid.
    (ix) A description of commonly occurring, avoidable events that 
could adversely affect or damage the prescription hearing aid, 
including but not limited to, as applicable, ear wax buildup, drops, 
immersion in water, or exposure to excessive heat.
    (x) If the hearing aid incorporates wireless technology in its 
programming or use, appropriate warnings, instructions, and information 
relating to electromagnetic compatibility and wireless technology and 
human exposure to non-ionizing radiation.
    (xi) Information on how and where to obtain repair service or 
replacements, including at least one specific address where the user 
can go or send the prescription hearing aid to obtain such repair 
service or replacements.
    (xii) If clinical or non-clinical studies were conducted by or for 
the manufacturer to support the performance of the prescription hearing 
aid, a summary of all such studies.
    (3) Labeling on the device. The labeling on a prescription hearing 
aid itself shall bear all of the following clearly and permanently, 
except as

[[Page 50761]]

provided in paragraph (c)(3)(iii) of this section:
    (i) The serial number.
    (ii) If the battery is removable, a ``+'' symbol to indicate the 
positive terminal for battery insertion unless the battery's physical 
design prevents inserting the battery in the reversed position.
    (iii) If the prescription hearing aid is used or rebuilt, the 
manufacturer shall physically attach a removable tag to the hearing aid 
declaring that fact.
    (4) Technical specifications. You must determine the technical 
specification values for the prescription hearing aid labeling in 
accordance with the test procedures of ANSI/ASA S3.22-2014 (R2020), 
except as provided in paragraph (c)(4)(ix) of this section for latency. 
Technical specifications and their associated values that are useful in 
selecting, fitting, and checking the performance of the prescription 
hearing aid shall appear in the user instructional brochure or in 
separate labeling that accompanies the device, including all of the 
following:
    (i) Saturation output curve (Saturation Sound Pressure Level (SSPL) 
90 curve).
    (ii) Frequency response curve.
    (iii) Average saturation output (High Frequency (HF)-Average SSPL 
90).
    (iv) Average full-on gain (HF-Average full-on gain).
    (v) Reference test gain.
    (vi) Frequency range.
    (vii) Total harmonic distortion.
    (viii) Equivalent input noise.
    (ix) Latency, measured using a method that is accurate and 
repeatable to within 1.5 ms.
    (x) Battery current drain.
    (xi) Induction coil sensitivity (telephone coil aids only).
    (xii) Input-output curve (only for hearing aids with automatic gain 
control).
    (xiii) Attack and release times (only for hearing aids with 
automatic gain control).
    (5) Software device labeling. Prescription hearing aid software 
that is not distributed with the hearing aid or amplification platform 
shall meet all of the following labeling requirements. With respect to 
the information required under paragraphs (c)(1) through (4) of this 
section, the information must be provided in the software device 
labeling, as specified in paragraphs (c)(5)(i) through (v) of this 
section, rather than the locations (e.g., outside package labeling) 
specified in paragraphs (c)(1) through (4).
    (i) Prior to first use of the software or obtaining payment 
information for the software, whichever occurs first, the labeling must 
clearly and prominently present all of the following to the prospective 
user. For each, the labeling must remain visible until the user 
dismisses it or proceeds to the next step:
    (A) Compatibility and minimum operating requirements for the 
software device.
    (B) Disclosures of any fees or payments after first use or initial 
payment, including but not limited to any fees or payments relating to 
subscriptions, add-on features, or continued access to features or 
services. The disclosures must name and briefly describe what each fee 
or payment covers.
    (C) The information required under paragraphs (c)(1)(i) and (iv) of 
this section.
    (ii) Prior to first use of the software, the labeling must clearly 
and prominently present all of the following to the prospective user:
    (A) The information required under paragraph (c)(2)(i)(A) of this 
section, and it must remain visible until the user acknowledges it.
    (B) The information required under paragraphs (c)(2)(i)(B) through 
(D) and (c)(2)(ii), (iv), (vii), and (viii) of this section, and the 
information must remain visible until the user dismisses it or proceeds 
to the next step.
    (C) All other information required under paragraph (c)(2) of this 
section, to the extent applicable, and the information must remain 
visible until the user dismisses it or proceeds to the next step.
    (iii) The software device labeling must include the information 
required under paragraphs (c)(3)(i) and (c)(4) of this section.
    (iv) All of the software device labeling must be accessible for 
review after acknowledgment, dismissal, or proceeding to the next step.
    (v) If there are changes to any of the labeling required under 
paragraph (c)(5) of this section, the labeling with the changed 
information must be presented to the user until the user dismisses it.
    (6) Misbranding. A prescription hearing aid that is not labeled as 
required under this section and Sec.  801.109 is misbranded under 
sections 201(n), 502(a), and/or 502(f) of the Federal Food, Drug, and 
Cosmetic Act.
    (d) Incorporation by reference. ANSI/ASA S3.22-2014 (R2020), 
``AMERICAN NATIONAL STANDARD Specification of Hearing Aid 
Characteristics,'' dated June 5, 2020, is incorporated by reference 
into this section with the approval of the Director of the Office of 
the Federal Register under 5 U.S.C. 552(a) and 1 CFR part 51. This 
material is available for inspection at the Food and Drug 
Administration and at the National Archives and Records Administration 
(NARA). Contact the Dockets Management Staff, 5630 Fishers Lane, Rm. 
1061, Rockville, MD 20852, 240-402-7500. For information on the 
availability of this material at NARA, email: [email protected], 
or go to: www.archives.gov/federal-register/cfr/ibr-locations.html. The 
material may be obtained from the Acoustical Society of America (ASA), 
1305 Walt Whitman Road, Suite 300, Melville, NY 11747; phone: (631) 
390-0215; fax: (631) 923-2875; email: [email protected].

PART 808--EXEMPTIONS FROM FEDERAL PREEMPTION OF STATE AND LOCAL 
MEDICAL DEVICE REQUIREMENTS

0
7. The authority citation for part 808 is revised to read as follows:

    Authority:  21 U.S.C. 360j, 360k, 371.
    Section 808.1 also issued under Sec. 709, Public Law 115-52, 131 
Stat. 1065-67.

0
8. In part 808, remove the words ``the act'' and add in their place 
``the Federal Food, Drug, and Cosmetic Act''.

0
9. In Sec.  808.1, add headings to paragraphs (a) through (f) and add 
paragraph (g) to read as follows:

Sec.  808.1  Scope.

    (a) Introduction. * * *
    (b) General rule for State and local requirements respecting 
devices. * * *
    (c) Exempting from preemption certain State or local requirements 
respecting devices. * * *
    (d) Meaning of ``requirements applicable to a device.'' * * *
    (e) Determination of equivalence or difference of requirements 
applicable to a device. * * *
    (f) Applicability of Federal requirements respecting devices. * * *
    (g) Exemptions not applicable to certain State or local government 
requirements specifically related to hearing products. An exemption 
under this part shall not apply to any State or local government law, 
regulation, order, or other requirement specifically related to hearing 
products, including any requirement for the supervision, prescription, 
or other order, involvement, or intervention of a licensed person for 
consumers to access over-the-counter hearing aids, that:
    (1) Would restrict or interfere with the servicing, marketing, 
sale, dispensing, use, customer support, or distribution of over-the-
counter hearing aids, as defined under section 520(q) of the Federal 
Food, Drug, and Cosmetic Act, through in-person transactions, by mail, 
or online; and
    (2) Is different from, in addition to, or otherwise not identical 
to, the

[[Page 50762]]

regulations issued under section 709(b) of the FDA Reauthorization Act 
of 2017.

0
10. Revise Sec.  808.3 to read as follows:

Sec.  808.3  Definitions.

    Compelling local conditions includes any factors, considerations, 
or circumstances prevailing in, or characteristic of, the geographic 
area or population of the State or political subdivision that justify 
exemption from preemption.
    More stringent refers to a requirement of greater restrictiveness 
or one that is expected to afford to those who may be exposed to a risk 
of injury from a device a higher degree of protection than is afforded 
by a requirement applicable to the device under the Federal Food, Drug, 
and Cosmetic Act.
    Political subdivision or locality means any lawfully established 
local governmental unit within a State which unit has the authority to 
establish or continue in effect any requirement having the force and 
effect of law with respect to a device intended for human use.
    State means any State or Territory of the United States, including 
but not limited to, the District of Columbia and the Commonwealth of 
Puerto Rico.
    Substantially identical to refers to the fact that a State or local 
requirement does not significantly differ in effect from a Federal 
requirement.

Sec.  808.53  [Removed and Reserved]

0
11. Remove and reserve Sec.  808.53.

0
12. Revise Sec.  808.55 to read as follows:

Sec.  808.55  California.

    The following California medical device requirements are preempted 
under section 521(a) of the Federal Food, Drug, and Cosmetic Act, and 
FDA has denied them exemption from preemption:
    (a) Medical devices; general provisions. Sherman Food, Drug, and 
Cosmetic Law, Division 21 of the California Health and Safety Code, 
sections 26207, 26607, 26614, 26615, 26618, 26631, 26640, and 26441, to 
the extent that they apply to devices; and
    (b) Ophthalmic devices; quality standards. California Business and 
Professions Code, section 2541.3 to the extent that it requires 
adoption of the American National Standards Institute standards Z-80.1 
and Z-80.2.

Sec. Sec.  808.57 through 808.101  [Removed and Reserved]

0
13. Remove and reserve Sec. Sec.  808.57 through 808.101.

PART 874--EAR, NOSE, AND THROAT DEVICES

0
14. The authority citation for part 874 continues to read as follows:

    Authority:  21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.

0
15. Revise Sec.  874.3300 to read as follows:

Sec.  874.3300  Air-conduction hearing aid.

    (a) Identification. An air-conduction hearing aid is a wearable 
sound-amplifying device intended to compensate for impaired hearing 
that conducts sound to the ear through the air. An air-conduction 
hearing aid is subject to the requirements in Sec.  800.30 or Sec.  
801.422 of this chapter, as applicable. The air-conduction hearing aid 
generic type excludes the group hearing aid or group auditory trainer, 
master hearing aid, and the tinnitus masker, regulated under Sec. Sec.  
874.3320, 874.3330, and 874.3400, respectively.
    (b) Classification. Class I (general controls). This device is 
exempt from premarket notification procedures in subpart E of part 807 
of this chapter, subject to the limitations in Sec.  874.9.

0
16. Add Sec.  874.3302 to read as follows:

Sec.  874.3302  Bone-conduction hearing aid.

    (a) Identification. A bone-conduction hearing aid is a wearable 
sound-amplifying device intended to compensate for impaired hearing and 
that conducts sound to the inner ear through the skull. The non-
implantable components of a bone-conduction hearing aid, such as the 
external sound processor, are subject to the requirements in Sec.  
801.422 of this chapter.
    (b) Classification. Class II.

0
17. In Sec.  874.3305, add a sentence at the end of paragraph (a) and 
revise paragraph (b) to read as follows:

Sec.  874.3305  Wireless air-conduction hearing aid.

    (a) * * * A wireless air-conduction hearing aid is subject to the 
requirements in Sec.  800.30 or Sec.  801.422 of this chapter, as 
applicable.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Performance data must demonstrate the electromagnetic 
compatibility (EMC), electrical safety, and thermal safety of the 
device;
    (2) Performance testing must validate safety of exposure to non-
ionizing radiation; and
    (3) Performance data must validate wireless technology functions.
* * * * *

0
18. In Sec.  874.3315, revise paragraph (a) to read as follows:

Sec.  874.3315  Tympanic membrane contact hearing aid.

    (a) Identification. A tympanic membrane contact hearing aid is a 
prescription wearable device that compensates for impaired hearing. 
Amplified sound is transmitted by vibrating the tympanic membrane 
through a transducer that is in direct contact with the tympanic 
membrane. A tympanic membrane contact hearing aid is subject to the 
requirements in Sec.  801.422 of this chapter.
* * * * *

0
19. In Sec.  874.3325:
0
a. Add a sentence at the end of paragraph (a);
0
b. Revise paragraph (b)(5); and
0
c. Remove paragraph (b)(7).
    The addition and revision read as follows:

Sec.  874.3325  Self-fitting air-conduction hearing aid.

    (a) * * * A self-fitting air-conduction hearing aid is subject to 
the requirements in Sec.  800.30 or Sec.  801.422 of this chapter, as 
applicable.
    (b) * * *
    (5) If the device incorporates wireless technology:
    (i) Performance testing must validate safety of exposure to non-
ionizing radiation; and
    (ii) Performance data must validate wireless technology functions.
* * * * *

0
20. In Sec.  874.3950, add a sentence at the end of paragraph (a) to 
read as follows:

Sec.  874.3950  Transcutaneous air conduction hearing aid system.

    (a) * * * A transcutaneous air conduction hearing aid system is 
subject to the requirements in Sec.  801.422 of this chapter.
* * * * *

    Dated: August 5, 2022.
Robert M. Califf,
Commissioner of Food and Drugs.
[FR Doc. 2022-17230 Filed 8-16-22; 8:45 am]
BILLING CODE 4164-01-P