October 9, 2008

Michael J. Astrue
Commissioner
Social Security Administration
P.O. Box 17703 
Baltimore, MD 21235-7703

Re: Revised Medical Criteria for Evaluating Hearing Loss (Docket No. SSA-2008-
0016) (73 Fed. Reg. 47103, August 13, 2008)

Dear Commissioner Astrue:

The Social Security Administration (SSA) published this proposed rule to revise the 
criteria in the Listing of Impairments that are used to evaluate claims of hearing loss.  
The SSA will apply the criteria when evaluating claim benefits based on disability under 
title II and title XVI of the Social Security Act.  

The Regulatory Flexibility Act (RFA) requires federal agencies to take small businesses 
into consideration when promulgating rules.  Section 603 of the RFA requires those 
agencies to either certify that the proposed rule will not have a significant impact on a 
substantial number of small entities, or perform an Initial Regulatory Flexibility Analysis 
that describes the impact of the proposed rule on small entities.  In the RFA section of 
this rulemaking, the SSA certified that the proposed rule will not have a significant 
economic impact on a substantial number of small entities because the rule only affects 
individuals.(1)  I am writing because my office has heard from some small health care 
businesses that are concerned that this rulemaking will have a significant economic 
impact on their industry.  

While I do not argue with SSAs position that the effects of this rule are likely to be 
indirect on these small health care providers, I believe it is foreseeable that any rule that 
provides patients with instructions on the criteria that SSA will use to determine their 
disability will impact the health care providers that will perform the testing.  Therefore, 
these small health care providers concerns should be taken into consideration as this rule 
moves towards finalization.

Advocacy Background

Congress established Advocacy under Pub. L. 94-305 to represent the views of small 
business before federal agencies and Congress.  Advocacy is an independent office 
within the U.S. Small Business Administration (SBA); as such the views expressed by 
Advocacy do not necessarily reflect the views of the SBA or of the Administration.  
Section 612 of the RFA also requires Advocacy to monitor agency compliance with the 
RFA, as amended by the Small Business Regulatory Enforcement Fairness Act.(2)

On August 13, 2002, President George W. Bush signed Executive Order 13272, requiring 
Federal agencies to implement policies protecting small businesses when writing new 
rules and regulations.(3)  Executive Order 13272 instructs Advocacy to provide comment 
on draft rules to the agency that has proposed a rule, as well as to the Office of 
Information and Regulatory Affairs (OIRA) of the Office of Management and Budget.(4)  
Executive Order 13272 also requires agencies to give every appropriate consideration to 
any comments provided by Advocacy.  Under the Executive Order, the agency must 
include, in any explanation or discussion accompanying publication in the Federal
Register of a final rule, the agencys response to any written comments submitted by 
Advocacy on the proposed rule, unless the agency certifies that the public interest is not 
served by doing so.(5)

Audiologist and Hearing Instrument Specialists Concerns

In Section 2.00B(2), the proposed rule requires that testing be performed in a 
soundproof booth. The rule infers that patients that do not have the hearing test 
performed in the booths will not meet the criteria for hearing disability.  Therefore, it will 
be incumbent upon health care providers that wish to perform the auditory testing to use 
soundproof booths.  Industry representatives agree that some hearing health care 
providers use such booths.  However, other hearing health care providers use sound- 
proofed operatories to test hearing.  Advocacy understands that the operatories are 
essentially similar to recording studios.  Some small businesses suggest that they should 
not be required to invest in soundproof booths - a cost that will have a significant impact 
on their revenues.  Industry representatives told Advocacy that requiring a specific booth 
would cost up to $6,000 per operatory.  One business that contacted us has five 
operatories, so the rule would result in a $30,000 operating expense.

Stakeholders are also concerned with Section 2.00B(1)(d) requiring that audiometric 
testing be performed by, or under the supervision of, an otolaryngologist or by an 
audiologist qualified to perform such tests.  SSA considers an audiologist to be qualified 
if the audiologist is currently and fully licensed or registered as a clinical audiologist by 
the state or U.S. territory in which he or she practices.  If no licensure or registration is 
available, the audiologist must be currently certified by the American Board of 
Audiology or have a Certificate of Clinical Competence (CCCA) from the American 
Speech-Language-Hearing Association (ASHA).  Stakeholders told Advocacy that few 
audiologists own their own businesses (15% per one Association estimate).  A much 
larger percentage of Hearing Instrument Specialists (HIS) own their practices and most of 
the remaining HIS are employed by small health care businesses.  Stakeholders believe 
that excluding HIS from the rules testing requirements does have an effect on small 
businesses.

Conclusion

It is my hope that the SSA will take these comments into consideration while drafting the 
final rule establishing revised criteria for evaluating hearing loss.  Advocacy appreciates 
being given a chance to provide the SSA with these comments.  If you have any 
questions or concerns, please do not hesitate to contact me or Assistant Chief Counsel 
Linwood Rayford at (202) 401-6880, or via e-mail at linwood.rayford@sba.gov.

Sincerely,

/s/

Thomas M. Sullivan 
Chief Counsel Advocacy

/s/

Linwood L. Rayford, III
Assistant Chief Counsel 

ENDNOTES

1.  73 Fed. Reg. 47109 (August 13, 2008).
2.  Pub. L. No. 96-354, 94 Stat. 1164 (1981) (codified at 5 U.S.C.  601-612) amended by Subtitle II of 
the Contract with America Advancement Act, Pub. L. No. 104-121, 110 Stat. 857 (1996). 5 U.S.C.  
612(a).
3.  Exec. Order No. 13,272  1, 67 Fed. Reg. 53,461 (Aug. 13, 2002).
4.  E.O. 13272, at  2(c), 67 Fed. Reg. at 53,461.
5.  Id. at  3(c), 67 Fed. Reg. at 53,461.