[Federal Register Volume 75, Number 105 (Wednesday, June 2, 2010)]
[Rules and Regulations]
[Pages 30693-30704]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-13094]


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SOCIAL SECURITY ADMINISTRATION

20 CFR Part 404

[Docket No. SSA-2008-0016]
RIN 0960-AG20


Revised Medical Criteria for Evaluating Hearing Loss

AGENCY: Social Security Administration.

ACTION: Final rules.

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SUMMARY: We are revising the criteria in the Listing of Impairments 
(the listings) that we use to evaluate claims involving hearing loss 
under titles II and XVI of the Social Security Act (Act). The revisions 
reflect our adjudicative experience, advances in medical knowledge, 
treatment, and methods of evaluating hearing loss, and public comments 
we received in response to a Notice of Proposed Rulemaking (NPRM).

DATES: These rules are effective August 2, 2010.

FOR FURTHER INFORMATION CONTACT: Tiya Marshall, Social Insurance 
Specialist, Office of Medical Listings Improvement, Social Security 
Administration, 6401 Security Boulevard, Baltimore, Maryland 21235-
6401, (410) 965-9291. For information on eligibility or filing for 
benefits, call our national toll-free number, 1-800-772-1213, or TTY 1-
800-325-0778, or visit our Internet Web site, Social Security Online, 
at http://www.socialsecurity.gov.

SUPPLEMENTARY INFORMATION:

Electronic Version

    The electronic file of this document is available on the date of 
publication in the Federal Register at http://www.gpoaccess.gov/fr/index.html.

Background

    We are revising and making final the rules for evaluating hearing 
loss we proposed in an NPRM we published in the Federal Register on 
August 13, 2008 (73 FR 47103). The preamble to the NPRM discussed the 
changes from the current rules and our reasons for proposing those 
changes. To the extent that we are adopting the proposed rules as 
published, we are not repeating that information here. Interested 
readers may refer to the preamble to the NPRM, available at http://www.regulations.gov.
    We are making a number of changes from the NPRM as a result of 
public comments. We explain those changes in our summary of the public 
comments and our responses later in this preamble.

Why are we revising the listings for hearing loss?

    We are revising the listings for hearing loss to update the medical 
criteria, provide more information about how we evaluate hearing loss, 
and reflect our adjudicative experience. The listings for hearing loss 
are in the special senses and speech body system, which also includes 
listings for visual disorders, disturbances of labyrinthine-vestibular 
function, and loss of speech. In the NPRM, we proposed changes only to 
the listings for hearing loss and their accompanying introductory text. 
We published final rules revising the listings for visual disorders in 
the Federal Register on November 20, 2006 (71 FR 67037). We intend to 
separately publish proposed rules for disturbances of labyrinthine-
vestibular function and loss of speech.

When will we use these final rules?

    We will use these final rules beginning on their effective date. We 
will continue to use the current listings until the date these final 
rules become effective. We will apply the final rules to new 
applications filed on or after the effective date of the final rules 
and to claims that are pending on and after the effective date.\1\
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    \1\ This means that we will use these final rules on and after 
their effective date in any case in which we make a determination or 
decision. We expect that Federal courts will review our final 
decisions using the rules that were in effect at the time we issued 
the decisions. If a court reverses the Commissioner's final decision 
and remands a case for further administrative proceedings after the 
effective date of these final rules, we will apply these final rules 
to the entire period at issue in the decision we make after the 
court's remand.
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How long will the rules in the special senses and speech body system be 
in effect?

    We are extending the effective date of the special senses and 
speech body system in parts A and B of the listings until 5 years after 
the effective date of these final rules, except we intend to revise the 
Disturbance of labyrinthine-vestibular function and Loss of speech 
listings before then. The rules will remain in effect only until that 
date unless we extend them. We will continue to monitor the rules and 
may revise them before the end of the 5-year period.

Public Comments on the NPRM

    In the NPRM, we provided the public with a 60-day comment period, 
which ended on October 14, 2008. We received 17 public comment letters. 
The comments came from national medical organizations, advocacy groups, 
a national group representing Social

[[Page 30694]]

Security disability consultants, a national group representing 
disability examiners in the State agencies that make disability 
determinations for us, individual State agencies, and members of the 
public.
    We provide below summaries of the significant comments that were 
relevant to this rulemaking and our responses to those comments. We 
tried to present the commenters' concerns and suggestions accurately 
and completely.
    Some commenters supported the proposed changes and noted provisions 
with which they agreed. We appreciate those comments, but have not 
summarized or responded to them below because they do not require a 
response. Some commenters also sent us comments on subjects that were 
unrelated to the proposed rules; for example, several commenters 
suggested changes to the rules we use to evaluate claims involving 
vertigo and speech disorders. As we have already noted, we intend to 
publish a separate NPRM for disturbances of labyrinthine-vestibular 
function and loss of speech.\2\
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    \2\ While we included the sections on vertigo associated with 
disturbances of labyrinthine-vestibular function and loss of speech 
in the NPRM, we indicated that we were not proposing any substantive 
changes. 73 FR at 47104. Although we are not responding to comments 
on those sections, we will consider them as we develop NPRMs for the 
disorders they address.
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Establishing the Existence and Severity of Impairments That Cause 
Hearing Loss

    Three commenters thought that our proposed requirements to 
establish that a person has a medically determinable impairment that 
causes hearing loss were unclear. The commenters pointed out that we 
referred to both audiometric testing within 2 months of a complete 
otologic examination and ``subsequent'' audiometric testing. Another 
commenter asked whether we would use otoscopy (a description of the 
appearance of the external ear canals and an evaluation of the tympanic 
membrane) performed by an audiologist to establish a medically 
determinable impairment.
    We agreed with the commenters that the proposed provisions could 
have been clearer and revised and reorganized proposed 2.00B1 and 
102.00B1 in response to these comments. Proposed (now final) 2.00B1 and 
102.00B1 provided information about two issues regarding evidence under 
these listings: How we establish a medically determinable impairment 
that causes hearing loss and how we establish the severity of that 
impairment. We generally require both a complete otologic examination 
and audiometric testing within 2 months of the complete otologic 
examination to establish a medically determinable impairment. After 
that, we do not require a complete otologic examination to assess the 
severity of the hearing loss; audiometry is sufficient. Otoscopy is 
part of the complete otologic examination, and we require otoscopy 
before audiometry to determine if there are any conditions that would 
prevent valid testing.
    We will not substitute otoscopy performed by an audiologist for a 
complete otologic examination performed by a licensed physician 
(medical or osteopathic doctor) to establish a medically determinable 
impairment. We also will not use audiometric testing that was performed 
without otoscopy to find that a hearing impairment meets or medically 
equals a listing.
    In revising proposed 2.00B1 and 102.00B1 in response to these 
comments and a comment we summarize below, we realized that our 
proposal to require both a complete otologic examination and 
audiometric testing to establish a medically determinable impairment 
would be unnecessary in some cases. For example, there are some 
impairments, such as congenital abnormalities, that are clearly 
observable by otologic examination. In the final rules, therefore, we 
provide that we ``generally'' require a complete otologic examination 
and audiometry to establish that you have a medically determinable 
impairment that causes your hearing loss.
    Several commenters recommended that we use audiometric testing 
performed more than 2 months from the complete otologic examination in 
determining whether there is a medically determinable impairment that 
causes hearing loss. Some of these commenters recommended alternative 
periods. A commenter also asked whether a report of audiometry in a 
person's existing medical evidence (that is, one that we did not 
purchase by consultative examination (CE)) would be acceptable if there 
were no recent otologic examination.
    We did not adopt these comments because the proposed (now final) 
rules already allow use of audiometric testing performed more than 2 
months from the date of the otologic examination in determining whether 
you have a medically determinable impairment that causes hearing loss. 
The rules provide that the testing ``should'' be performed within 2 
months of the complete otologic examination to allow our adjudicators 
to use evidence that is outside the period in appropriate cases. Such 
cases could include the situation mentioned by one of the commenters in 
which there is properly performed audiometric testing in a person's 
evidence that is not within 2 months of an otologic examination. We use 
the word ``should'' in these rules to indicate our preference and 
``must'' to indicate an absolute requirement. We prefer the 2-month 
rule because it ensures the most accurate and reliable findings about 
the existence of the impairment.
    In the NPRM, we invited the public to comment on a proposed change 
to our prior rule that provided that an otolaryngologic examination 
should precede audiometric testing. The proposed rules for adults and 
children provided that a person could have audiometric testing either 
before or after the complete otologic examination to establish a 
medically determinable impairment. Two commenters recommended that this 
audiometric testing always precede the complete otologic examination. 
They indicated that physicians generally need the results of 
audiometric testing to make comprehensive findings about a person's 
hearing loss. They believed that such a rule would be more efficient 
because a physician would likely order audiometric testing if he or she 
did not already have it.
    After considering these comments, we decided to make final the 
proposed rule that allows audiometric testing either before or after 
complete otologic examination. We believe this rule will provide 
flexibility for our adjudicators to establish the existence of a 
medically determinable impairment as soon as practicable. The purpose 
of the rule is only to establish the presence of some medically 
determinable impairment that would account for the hearing loss, and as 
we explained in the preamble to the NPRM, there are advantages to 
audiometric testing before or after the otologic examination. In 
addition, we realized that, in some cases, we could establish the 
medically determinable impairment based on the otologic examination 
alone. As we indicated above, we made a revision in final 2.00B1 and 
102.00B1 to recognize this possibility.\3\
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    \3\ The revision is also consistent with the statement we made 
in the NPRM that ``[h]aving the otologic examination precede the 
audiometric testing can help identify conditions that could 
interfere with the audiometric testing.'' 73 FR 47103, 47105 (2008).
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Otologic Examinations

    A commenter recommended that we specify that otolaryngologists 
certified by the American Board of Otolaryngology should perform 
otologic

[[Page 30695]]

examinations. We partially adopted the comment by specifying in final 
2.00B1b and 102.00B1b that a licensed physician (medical or osteopathic 
doctor) must perform the complete otologic examination to establish 
whether a person has a medically determinable impairment. For our 
purposes, licensed physicians have the necessary education, training, 
and experience to perform the otologic examination.
    One commenter recommended that we remove from proposed 2.00B1b and 
102.00B1b the description of the pinnae (the outer, visible parts of 
the ears) from the requirements for a complete otologic examination. 
The commenter believed that the pinnae do not contribute to hearing 
disability. We did not adopt the comment because abnormalities of the 
pinnae are associated with a number of conditions that affect hearing, 
and such abnormalities may be signs of a medically determinable 
impairment. Abnormalities of the pinnae can also influence how sound 
waves are directed to the middle ear.
    Another commenter said that our description of an otologic 
examination was incomplete. The commenter said that otologists do, and 
should, examine the nasopharynx, nose, oral pharynx, mouth, and neck 
when they evaluate hearing loss. While we agree that otologists do 
examine these areas, we do not include them in these final rules 
because we are describing only findings that we need to determine 
whether a person has a medically determinable impairment that could 
cause hearing loss. A physician does not need to examine the areas 
suggested by the commenter to establish such an impairment.

Otoscopic Examinations

    Two commenters recommended that we specify who may perform the 
otoscopic examination described in final 2.00B2b and 102.00B2b. We 
adopted the recommendation by stating in 2.00B2b and 102.00B2b that the 
medical professional described in final 2.00B1c and 102.00B1c must 
conduct the audiometric testing. In addition, in response to a comment 
pointing out that ``otoscopic inspection'' is the term usually used 
when audiologists conduct otoscopic examinations, we explain in final 
2.00B2b and 102.00B2b that our term ``otoscopic examination'' includes 
``otoscopic inspection.'' This addition clarifies that audiologists and 
other non-physicians may do the otoscopic examination that we require 
before audiometric testing.
    One commenter said that the requirement for an evaluation of the 
tympanic membrane immediately before an audiometric examination might 
add expense and time to a CE. The commenter was especially concerned 
that, when the otoscopic examination shows cerumen (earwax), we would 
need to ask a physician or audiologist to remove it before we could 
continue with the audiological testing. In particular, the commenter 
was concerned about cerumen that only partially obscures the view of 
the tympanic membrane. The commenter said that this condition does not 
necessarily equate to invalid audiometric testing. We agree that 
cerumen can, but does not always, interfere with audiometric testing, 
and we will rely on the person who conducts the test to decide whether 
to remove cerumen. We will address this issue in our internal operating 
instructions.

Audiometric Testing

    One commenter recommended that we clarify the provision in proposed 
2.00B1d and 102.00B1d (final 2.00B1c and 102.00B1c) that permitted 
audiometric testing by a non-audiologist ``under the supervision of'' 
an otolaryngologist. The commenter recommended that we require non-
audiologists to conduct testing only under ``direct'' supervision, in 
accordance with Medicare regulations requiring the physician to be 
present in the office suite when the service is being performed and to 
assist if necessary. We adopted the recommendation. We will provide 
guidance to our adjudicators on how to apply the rule in our 
instructions and training.
    Two commenters recommended that we accept the results of 
audiometric testing conducted independently by hearing aid 
specialists--also called Hearing Instrument Specialists (HIS)--in 
addition to the professionals described in proposed 2.00B1d and 
102.00B1d. We did not adopt this comment because the educational and 
other qualifications required for licensure or certification as an HIS 
are less comprehensive than those of otolaryngologists and audiologists 
and can vary from place to place. Therefore, we cannot be assured that 
all HISs would have the expertise needed to independently perform the 
audiometric testing we require under these listings. If an HIS conducts 
the testing under the direct supervision of an otolaryngologist, the 
evidence would be acceptable audiometric testing both for establishing 
a medically determinable impairment and for assessing its severity. We 
may also consider an HIS' evidence when we assess severity in the same 
way that we consider evidence from other sources who are not acceptable 
medical sources as defined in Sec. Sec.  404.1513(d) and 416.913(d) of 
our regulations and Social Security Ruling (SSR) 06-3p.\4\
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    \4\ SSR 06-3p: Titles II and XVI: Considering Opinions and Other 
Evidence from Sources Who Are Not ``Acceptable Medical Sources'' in 
Disability Claims; Considering Decisions on Disability by Other 
Governmental and Nongovernmental Agencies, 71 FR 45593 (2006), also 
available at: http://www.socialsecurity.gov/OP_Home/rulings/di/01/SSR2006-03-di-01.html.
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    Another commenter recommended that we accept the results of 
audiometric testing conducted solely by clinical audiologists. We did 
not adopt this comment because otolaryngologists have the requisite 
education, training, and experience to perform and supervise the 
audiometric testing we require.
    A few commenters questioned our requirement in proposed 2.00B2a and 
102.00B2f(i) for audiometric testing in a soundproof booth. Some of 
these commenters suggested we revise our rules to require testing in a 
sound-treated booth or room. We agreed with these commenters and made 
this change in final 2.00B2a and 102.00B2f(i).
    One commenter noted that several types of sound are used for 
audiometric testing in a sound field. The commenter also noted that air 
and bone conduction testing is not sound field testing and asked us to 
clarify the type of sound that we require for air and bone conduction 
testing. The type of sound used for air and bone conduction testing is 
referred to as ``pure tone'' sound. Our rules require that air and bone 
conduction testing be conducted in accordance with the most recently 
published standards of the American National Standards Institute 
(ANSI). Those standards describe the type of sound that should be used. 
Therefore, we do not believe it is necessary to specify the type of 
sound used.
    One commenter asked us to clarify how we would evaluate tests that 
report a vibrotactile (VT) response, rather than a hearing response, at 
500 Hertz (Hz) during bone conduction testing, or no response at one or 
more frequencies during air or bone conduction testing. A VT response 
may occur during bone conduction testing when the person does not have 
an auditory response but perceives the sensation from the oscillator; 
we consider a VT response to be a ``no response.'' To address this 
issue, we added guidance in final 2.00B2c, 102.00B2c(ii), 
102.00B2d(ii), 102.00B2e(ii), and 102.00B2f(ii). In the final rule, we 
now clarify that when there is no response at one or more frequencies 
during air or bone conduction testing, we will use 5 dB

[[Page 30696]]

over the limit of the audiometer used for the test to compute the 
average threshold.
    One commenter indicated that our definition of speech reception 
threshold (SRT) in proposed 2.00B2d and 102.00B2f(iii) was not entirely 
correct. The commenter stated that SRT is the minimum dB level required 
to recognize ``spondee words 50 percent of the time,'' not ``the 
minimal decibel (dB) level required * * * to recognize a standard list 
of words.'' \5\ The commenter also recommended that we replace the term 
``speech reception threshold'' with ``spondee threshold'' to ensure 
standardization of testing material. We agreed with the first comment 
and revised the definition of SRT in final 2.00B2d and 102.00B2f(iii) 
accordingly. We also added a parenthetical statement in final 2.00B2a 
and 102.00B2f(i) explaining that SRT is also called ``spondee 
threshold'' or ``ST.'' We did not change the term SRT because it is the 
more common name for this type of testing, and we believe our 
adjudicators are more likely to see it in the medical evidence.
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    \5\ Spondee words, such as ``baseball'' and ``airplane,'' have 
equal stress on each syllable.
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    One commenter recommended that we require certain specific 
Department of Veterans Affairs' recordings of 50-word lists, presented 
at 70 dB in quiet, for measuring the word recognition ability of 
persons with hearing loss not treated with cochlear implantation. 
Another commenter also recommended that, for children, the word list 
should be appropriately normed. We did not adopt the first 
recommendation because there are several appropriate tests available to 
measure a person's word recognition ability, and we want to provide our 
adjudicators with flexibility in obtaining this evidence to determine 
disability. We adopted the suggestion to provide that word lists for 
children must be appropriately normed. In the NPRM, we said that the 
lists must be ``standardized.'' We intended this word to include the 
idea that the tests must be appropriately normed for age. However, to 
be clearer, we are adding the words ``age-appropriate'' in response to 
this comment.
    One commenter asked us to clarify whether the word recognition 
testing in proposed 2.00B2e and 102.00B2f(iv) should be done using live 
presentation or recorded material. Another commenter suggested we 
require testing with recorded material, unless there is documentation 
indicating why live presentation was necessary. In the proposed rules, 
we did not specify the method of presentation because we will accept 
either method; however, we added text to final 2.00B2e and 
102.00B2f(iv) to clarify this intent. Although word recognition testing 
usually uses recorded material, we do not believe that the method of 
presentation will affect our ability to determine whether a person has 
a listing-level hearing loss. Therefore, we did not adopt the second 
comment.
    Two commenters recommended that we require word recognition testing 
conducted with background noise, not only in quiet (see final 2.00B2e, 
2.00B3b, 102.00B2f(iv), and 102.00B3b). These commenters also 
recommended that the words be presented at a normal conversational 
level. We did not adopt the comments. We require testing under optimal 
circumstances (that is, in quiet and at a level of amplification that 
allows us to measure a person's maximum ability to discriminate words) 
to ensure that the impairment is of listing-level severity.
    One commenter suggested that we replace the term ``amplification 
level'' in proposed 2.00B2e and 102.00B2f(iv) with ``presentation 
level.'' The commenter asked whether we require that word recognition 
testing be done at the ``phonetically balanced maximum'' (PB Max), 
which the commenter believed is equivalent to the ``most comfortable 
level'' (MCL). Another commenter recommended that we use the term 
``supra-threshold'' instead of specifying the level of amplification we 
require for word recognition testing.
    We did not adopt the first suggestion because we believe that 
``amplification level'' describes more precisely the test parameters we 
require for word recognition testing. With respect to the second 
comment, we note that PB Max and MCL are not the same. PB Max is the 
hearing level at which the maximum percentage of words is correctly 
repeated during testing with a list of phonetically balanced 
monosyllabic words, such as ``chew'' and ``knees.'' It may not be the 
listener's MCL, which is the hearing level at which speech is most 
comfortable for the listener. As we indicate in final 2.00B2e and 
102.00B2f(iv), the words must be presented at a level of amplification 
that will measure a person's ``maximum ability'' to discriminate words, 
usually 35 to 40 dB above the SRT. This level of amplification is often 
a person's PB Max; when it is not, it is still sufficient for us to 
determine whether there is listing-level hearing loss. However, in 
response to this comment, we clarified in final 2.00B2e and 
102.00B2f(iii) that, if a person cannot be tested at 35 to 40 dB above 
his or her SRT, the person who performs the test should report the word 
recognition testing score at the highest comfortable level of 
amplification. We did not adopt the comment to refer to testing at 35 
to 40 dB above the SRT as ``supra-threshold'' testing because we prefer 
to specify our criteria for word recognition testing.
    We received several comments about acoustic immittance assessment 
(AIA), that is, a tympanogram and acoustic reflex testing. In the 
proposed rules, we required an AIA for children from birth to the 
attainment of age 5. One commenter recommended that we require an AIA 
for adults to rule out conductive pathology, which is amenable to 
treatment, and to aid in detecting situations in which a person may be 
feigning a serious hearing loss. Another commenter questioned our 
proposal to require an AIA for children because listing 102.10A uses 
only air conduction thresholds. A third commenter recommended that we 
require high-frequency tympanometry for children under age 5 months.
    We did not adopt the comment to require an AIA for adults because 
the bone conduction criterion in final listing 2.10A ensures that there 
is a significant sensorineural component to the hearing loss. 
Sensorineural hearing loss results from permanent damage to the inner 
ear or to the nerve pathways from the inner ear to the brain. Persons 
with the degree of sensorineural hearing loss required in final listing 
2.10A do not usually obtain significant improvement with hearing aids. 
We also believe that an AIA is unnecessary to detect deception because 
the professionals referenced in final 2.00B1c who may conduct 
audiometric testing are trained to detect whether a person is feigning 
hearing loss and to recognize test results that may suggest such 
deception. We agreed with the second commenter that we do not need an 
AIA to determine disability for children under age 5 and did not 
include it in final 102.00B2c(i), 102.00B2d(i), and 102.00B2e(i). We 
proposed to require an AIA for these children to identify conditions 
that would prevent valid audiometric testing. However, the otoscopic 
examination we require will detect any conditions revealed by AIA. 
Since we removed the requirement for an AIA for children under age 5 we 
are not adopting the third comment.
    Two commenters recommended that we require audiologists who conduct 
audiometric testing for us to complete hearing checklists recommended 
in a 2005 National Research Council report

[[Page 30697]]

(``NRC report'').\6\ The commenters said the checklists would ensure 
the quality of the data collected and provide useful information for 
evaluating disability at later steps in the sequential evaluation 
process. We considered these checklists at the time we developed the 
proposed rules and determined we did not need them. We believe we have 
adequately specified in these final rules the information we need to 
evaluate whether a person's hearing impairment meets or medically 
equals one of the hearing listings. Finally, we also specify 
qualifications for audiologists that will ensure the quality of the 
data they collect.
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    \6\ National Research Council (NRC): Committee on Disability 
Determination for Individuals with Hearing Impairments. (2005). 
Hearing Loss: Determining Eligibility for Social Security Benefits. 
Action Recommendation 4-5. (Complete citation at 73 FR at 47110.)
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Issues Specific to Audiometric Testing of Children

    One commenter recommended that we should strongly prefer 
audiometric testing by an experienced pediatric audiologist when 
evaluating hearing loss in children. While we generally agree with the 
comment, we did not make any changes in the final rules because we do 
not believe it is necessary to include this guidance in the 
regulations. We have a general preference for obtaining evidence from 
appropriate specialists in childhood cases, and we believe that our 
internal operating instructions are sufficient for this purpose.\7\
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    \7\ See, for example, Program Operations Manual Systems (POMS) 
DI 25205.015, available at: https://secure.ssa.gov/apps10/poms.nsf/lnx/0425205015!opendocument.
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    One commenter recommended that we reference the American Academy of 
Audiology's pediatric protocols for audiological evaluation of 
children. We did not adopt the comment because we believe the 
audiometric testing we require in these final rules is sufficient for 
evaluating hearing loss in children.
    Two commenters wrote about our statement in proposed 102.00B2a that 
we would not purchase physiologic hearing tests for children and would 
instead consider ``other evidence'' when such testing was not done or 
when it was done, we could not obtain the results. One of these 
commenters requested clarification of what ``other evidence'' we would 
consider and asked whether we may purchase physiologic testing that 
does not require sedation. The other commenter stated that physiologic 
testing would be necessary for infants, some toddlers, and some 
children with certain developmental disorders that preclude 
participation in behavioral testing. This commenter also recommended 
that we should use all information gathered during testing to evaluate 
functioning if the impairment does not meet or medically equal a 
listing.
    When we evaluated these comments, we determined that our guidance 
in proposed 102.00B2a was unclear and contrary to our intent because it 
implied that a hearing impairment could meet listing 102.10 without 
physiological or behavioral testing. The proposed guidance was not for 
determining whether hearing loss met a listing; we intended it to apply 
only to evaluations of medical and functional equivalence. To clarify 
that listing 102.10 requires physiologic testing, we removed the word 
``generally'' from proposed 102.00B2a and removed the proposed guidance 
indicating that we will evaluate a person's hearing loss based on other 
evidence in the case record.
    We also removed unnecessary and potentially confusing language in 
102.00B2a. In the proposed rules, we said that we would use other 
evidence when physiologic testing had not been done or we could not 
obtain the results of testing that had been done. However, there was a 
third possibility: We have the results of physiologic testing, but we 
need new testing. Since our intent was only to say that we would not 
purchase physiologic testing, we simplified the rule to say just that. 
This rule applies regardless of whether such testing requires sedation.
    We did not adopt the comment that recommended we use all 
information gathered during testing to evaluate functioning if the 
impairment does not meet or medically equal a listing. We already use 
all of the relevant information we gather in connection with testing 
when we determine whether a child's impairment(s) functionally equals 
the listings. We have other rules that explain how we consider medical 
and other evidence when we evaluate a child's functioning. See 
Sec. Sec.  416.924a and 416.926a, and SSR 09-2p.\8\
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    \8\ SSR 09-2p: Title XVI: Determining Childhood Disability--
Documenting a Child's Impairment-Related Limitations, 74 FR 7625 
(2009), also available at: http://www.socialsecurity.gov/OP_Home/rulings/ssi/02/SSR2009-02-ssi-02.html.
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    One commenter recommended that we require otoacoustic emissions 
(OAE) testing in addition to the physiologic testing we required in 
proposed 102.00B2c(i) for children from birth to the attainment of age 
6 months to identify children with auditory dyssynchrony or auditory 
neuropathy. Another commenter pointed out that, when testing indicates 
that an infant may have auditory neuropathy (that is, normal OAE but no 
response on Auditory Brainstem Response (ABR) testing), we should 
presume the child disabled until it is possible to perform age-
appropriate behavioral testing, generally by age 6 months. We did not 
adopt these comments. Test results showing normal OAE, but no response 
on ABR testing are uncommon and nearly always involve children who have 
other impairments that we would find disabling under the criteria of a 
listing in another body system. We will evaluate the small number of 
children who do not have such other impairments on an individual basis. 
If we cannot make a fully favorable determination in those cases, we 
will defer them until the child is age 6 months and can participate in 
behavioral testing.
    One commenter suggested that it would be helpful to list some of 
the other types of physiologic testing--such as Brainstem Auditory 
Evoked Response (BAER)--in addition to ABR testing. We did not adopt 
the recommendation. We cite only the ABR because, as the commenter 
noted, ABR testing is the most commonly used physiologic test and is 
the one that adjudicators are most likely to see.
    One commenter recommended that we determine the pure tone air and 
bone conduction thresholds in children by testing at 3000 Hz in 
addition to 500, 1000, 2000, and 4000 Hz. We did not adopt the comment 
because, as we explained in the NPRM,\9\ our adjudicative experience 
has shown that testing is often not done at 3000 Hz. Moreover, several 
commenters on the April 13, 2005, Advance Notice of Proposed Rulemaking 
\10\ recommended that we remove the current requirement to test at 3000 
Hz. We agreed with those commenters and believe the findings we require 
in these final rules are adequate for our purposes.
---------------------------------------------------------------------------

    \9\ 73 FR 47107 (2008).
    \10\ 70 FR 19353 (2005).
---------------------------------------------------------------------------

    One commenter noted that we provided in proposed 102.00B2g that we 
can consider normal results from hearing screening tests, such as OAE, 
to determine that a child's hearing loss is not ``severe'' when these 
test results are consistent with the other evidence in the case record. 
The commenter asked whether we could use normal results from a pure 
tone screen by a speech-language pathologist in the same way. We can 
use such evidence in the same way as other screening tests. In response 
to this comment, we revised the guidance in final 102.00B2g to include

[[Page 30698]]

pure tone testing as a type of screening test.

Validity of Audiometric Testing

    One commenter commented on our proposed requirements for otoscopic 
examination together with pure tone average and SRT testing to document 
the validity of audiometry and suggested that we instead require only a 
statement of reliability, validity, or inter-test reliability. The 
commenter believed that such a statement would also cover issues such 
as patient cooperation and the attention of a child. We partially 
adopted the comment:
    We do not consider test results in isolation. Therefore, in 
response to this comment and another comment we describe later, we 
added a sentence in final 2.00B1a and 102.00B1a stating that we will 
consider your test scores together with any other relevant information 
we have about your hearing, including information from outside of the 
test setting. This is our basic policy for considering any test 
results.
    In final 2.00B2b and 102.00B2b, we provide that the person who 
performs the audiometry should report on any factors in addition to the 
factors observable on otoscopy that can affect the interpretation of 
the test results. As this commenter suggested, we used patient 
cooperation as an example in the adult rule and a child's ability to 
maintain attention as an example in the childhood rule. It is common 
practice to report such observations, so the provisions in the final 
rules will not be an additional burden on our CE providers. We also 
expect to find such observations in existing reports of audiometric 
testing.
    We did not adopt the general statement the commenter suggested, 
because general statements about reliability and validity are too vague 
to assure us that the results of audiometric testing are reliable and 
valid.
    One commenter asked whether adjudicators must reject the results of 
all audiometric testing when the person's SRT is not within 10 dB of 
the average pure tone air conduction thresholds at 500, 1000, and 2000 
Hz. In proposed 2.00B2d and 102.00B2f(iii), we indicated only that the 
reason for such a discrepancy should be documented. Another commenter 
suggested that we highlight or strengthen the guidance in these 
sections. In response to these comments, we revised the guidance in 
final 2.00B2d and 102.00B2f(iii) to explain that, if we cannot 
determine a medical basis for the discrepancy we will not use the 
results of the testing to determine that a person's hearing loss meets 
the listing. We also clarified that we require an explanation of the 
discrepancy, by using ``must'' in the final rule instead of the 
proposed ``should.''
    Two commenters recommended that we require a check of the cochlear 
implant before testing to ensure that it is turned on and functioning 
properly. One of these commenters also recommended that we require 
corroborating behavioral evidence that correlates with the Hearing in 
Noise Test (HINT) results to ensure the validity and reliability of the 
testing. In the NPRM, we said that word recognition testing ``must be 
conducted in quiet in a sound field with your implant adjusted to your 
normal settings.'' \11\ We intended this requirement to include 
verification that the person's cochlear implant is turned on and 
functioning properly. However, to be clearer, we added in final 2.00B3b 
and 102.003B3b a requirement that the person's implant must be 
functioning properly. In response to the second comment and another 
comment we have already described, we added sentences in final 2.00B1a 
and 102.00B1a providing that we consider test results together with all 
relevant evidence in the case record.
---------------------------------------------------------------------------

    \11\ 73 FR at 47111.
---------------------------------------------------------------------------

Issues Regarding Audiometric Testing of Persons Who Are Not Fluent in 
English

    Several commenters responded to our request in the NPRM for 
suggestions about other methods we could use to evaluate the word 
recognition ability of persons who are not fluent in English.\12\ One 
commenter noted that our proposed rules did not recognize recorded 
speech testing in foreign languages. As we have already noted in 
response to an earlier comment, we accept word recognition testing 
using recorded material, and that includes recorded material in a 
foreign language. While considering this comment, however, we noticed 
that we inadvertently omitted requirements for word recognition testing 
when a person is not fluent in English from the proposed rules, 
although we included the requirements in the preamble to the NPRM.\13\ 
We have included the omitted text in the final rules. As in the 
preamble to the NPRM, the final rules explain that testing of a person 
who is not fluent in English should be conducted using an appropriate 
word list for the language in which the person is most fluent, and the 
person conducting the testing should be fluent in the language used for 
the test.
---------------------------------------------------------------------------

    \12\ 73 FR at 47106.
    \13\ 73 FR at 47105-06.
---------------------------------------------------------------------------

    Another commenter suggested that we consider a person's contact 
with treating sources, other health care professionals, and other third 
parties, such as past employers, to see whether the person is able to 
communicate with them either directly or through the use of an 
interpreter. We did not add this guidance. In some cases, the persons 
referenced by the commenter are already included in the clause ``other 
persons who speak the language in which you are the most fluent'' in 
final 2.00B4 and 102.00B4. In other cases, we do not need to consider 
the person's ability to communicate with such persons when we evaluate 
word recognition ability under the final listings.
    A third commenter approved of our guidance in proposed 2.00B4 and 
102.00B4 regarding word recognition testing for a person who is not 
fluent in English, but thought it might be difficult to obtain the 
testing we need. We understand this concern and to address it include 
the guidance in final 2.00B4 and 102.00B4 concerning medical 
equivalence.
    Another commenter recommended that we include physiologic testing, 
such as frequency-specific evoked potentials, for persons who do not 
speak English. We did not adopt this suggestion because this testing 
does not test word recognition ability.
    One commenter noted that, while the HINT is available in 12 
languages, our requirement that a person who performs audiometric 
testing ``must be fluent'' in the claimant's native language would 
create a problem for obtaining the test. As we explained above, the 
person administering the test ``should'' be fluent in the language. We 
do not have an absolute rule that the person who administers the test 
must be fluent in the language, although that is our preference. We 
also provide that the inability to measure a person's word recognition 
ability means only that his or her hearing impairment cannot meet final 
listing 2.11B or 102.11B. If a person with a severe impairment(s) has 
difficulty understanding words in the language in which he or she is 
most fluent and we are unable to measure his or her word recognition 
ability, we will consider whether the degree of difficulty (either 
alone or in combination with another impairment(s)) medically equals 
final listing 2.11B or 102.11B. If not, we consider the person's 
difficulty understanding words when we assess residual functional 
capacity for adults or functional equivalence for children.
    One commenter suggested that we should acknowledge in the childhood

[[Page 30699]]

listings that the ``speech education and articulation'' of children in 
bilingual or multilingual environments differs from those of children 
in monolingual environments. The commenter believed that most speech 
tests conducted for children who are bilingual or multilingual would be 
invalid. We did not adopt this comment. We agree that children who are 
bilingual or multilingual do not always develop in the same way as 
children who are monolingual, but we do not agree that all speech 
testing of such children is invalid. Moreover, we do not rely on test 
scores alone, but consider all of the relevant evidence when we 
evaluate a child's functioning. See Sec.  416.924a(a)(1)(ii).

Listing Criteria for Hearing Loss Not Treated With Cochlear 
Implantation

    We received several comments about the criteria in proposed 
listings 2.10 and 102.10. One commenter said that we should change the 
criteria in listings 2.10B and 102.10B2 from a word recognition score 
of 40 percent or less in the better ear to a score of 70 percent or 
less. Another commenter noted that our proposed listings did not 
address the variability in word recognition scores, that is, that a 
score higher than 40 percent might not be statistically different from 
a score of 40 percent or less. Some commenters also recommended various 
changes to listing 102.10A. They recommended that we:
    <bullet> Use the average air conduction threshold criteria in Table 
7-2 of the NRC report;
    <bullet> Use the speech and language criteria in Tables 7-2 and 7-3 
of the NRC report;
    <bullet> Change the criterion for children from birth to age 5 in 
proposed listing 102.10A to 25-30 dB, and use the same criterion for 
children ages 5-12; and
    <bullet> Use an unaided air conduction threshold of 50 dB for 
children ages 12-18.
    We did not adopt any of these suggestions because we believe they 
would require us to find some adults and children who do not have 
listing-level impairments disabled under the listings. We set the 
levels of hearing loss in these final rules for adults and children at 
levels that reflect very serious hearing loss; we use the listings only 
to deem persons disabled without considering any other factors that may 
contribute to their inability to work or to function age-appropriately 
in the case of children. It is important to remember, however, that we 
do not deny benefits to anyone solely because his or her impairment(s) 
does not meet a listing. We may still find that a person's 
impairment(s) is disabling based on medical equivalence or based on an 
individualized assessment when we evaluate an adult's residual 
functional capacity, age, education, and work experience, or functional 
equivalence in children.
    One commenter requested that we include listing criteria for adults 
with precipitous hearing loss who have an impairment(s) that does not 
meet the pure tone criteria in listing 2.10A but who have significant 
limitations in the ability to discriminate words. The commenter also 
requested that we include criteria for children over age 5 who have an 
unaided hearing threshold of 50 dB in the better ear and normal speech 
and language development but do not have the ability to listen 
accurately in distant and noise- challenged situations. The commenter 
suggested we use the HINT or HINT-C for children to evaluate these 
persons.
    We did not adopt these comments because we had already proposed 
criteria for determining when a limitation in word recognition ability 
is of listing-level severity in listings 2.10B and 102.10B2. The final 
rules, which are the same as the proposed rules, require results from a 
phonetically balanced monosyllabic word list for persons who do not 
have cochlear implants, regardless of the type or level of their 
hearing loss. We specify this type of test because it is the one most 
often used in clinical practice.
    One commenter recommended that we consider first-time hearing aid 
users under a disability for 1 year because they may need a period of 
rehabilitation and training to use the aid effectively. This commenter 
also recommended a 1-year period of disability for persons with sudden 
hearing loss, rapidly deteriorating hearing, or fluctuating hearing 
because they may need time to adjust to the challenges of 
communication. We did not adopt these recommendations because some 
persons with the conditions described by the commenter will not have 
impairments that meet our definition of disability, including the 12-
month duration requirement.
    One commenter noted that visual reinforcement audiometry (VRA), 
which we indicate is the usual method of testing for children from age 
6 months to the attainment of age 2, is only an estimate of the hearing 
threshold. The commenter recommended that we raise the average air 
conduction threshold in proposed listing 102.10A to ensure that 
children in this age range are truly disabled. While we acknowledge 
that VRA provides only an estimate of hearing loss, it is the most 
reliable method for testing children from age 6 months to the 
attainment of age 2, and we believe that--even as an estimate--an 
average air conduction threshold of 50 dB or greater in the better ear 
does indicate listing-level severity in these young children.
    One commenter noted an inconsistency between our definition of 
``marked'' limitation in speech in proposed 102.00B5a and our 
definition of the term in SSR 98-1p.\14\ The commenter recommended that 
we use unintelligibility on the first attempt 67 percent (two-thirds) 
of the time as the threshold for a marked limitation instead of 60 
percent. We adopted the comment by changing the rule to ``at least 50 
percent (half) of the time but no more than 67 percent (two-thirds) of 
the time.'' This is the same range that we use in our definitions of 
``marked'' in SSR 98-1p and other rules, that is, one-half to two-
thirds.
---------------------------------------------------------------------------

    \14\ SSR 98-1p: ``Policy Interpretation Ruling: Title XVI: 
Determining Medical Equivalence in Childhood Disability Claims When 
a Child Has Marked Limitations in Cognition and Speech,'' 63 FR 
15248 (1998), also available at: http://www.socialsecurity.gov/OP_Home/rulings/ssi/02/SSR98-01-ssi-02.html.
---------------------------------------------------------------------------

    One commenter recommended that we consider children with ``marked 
mental retardation'' who cannot be evaluated for speech or language to 
be disabled when their impairment meets the hearing criterion alone. We 
were not certain what the commenter intended by ``marked mental 
retardation'' because the American Psychiatric Association (APA) and 
World Health Organization (WHO) currently use the terms ``mild,'' 
``moderate,'' ``severe,'' and ``profound'' to describe the levels of 
the disorder.\15\ We assume that the commenter meant at least 
``moderate'' mental retardation, which in the APA's definition is 
mental retardation generally with an IQ of 35-55; the WHO's is similar, 
with an IQ of 35-49. In either case, the mental retardation by itself 
meets listing 112.05C in the mental disorders listings, and depending 
on the facts of the case, may meet listing 112.05B. It is not necessary 
for a child to also have hearing loss to qualify under either of those 
listings.
---------------------------------------------------------------------------

    \15\ American Psychiatric Association, Diagnostic and 
Statistical Manual of Mental Disorders, Fourth Edition, Text 
Revision (DSM-IV-TR). Washington, DC (2000); World Health 
Organization, Division of Mental Health and Substance Abuse, ICD-10 
Guide for Mental Retardation, Geneva (1996), available at: http://www.who.int/mental_health/media/en/69.pdf. See also: http://apps.who.int/classifications/apps/icd/icd10online/.
---------------------------------------------------------------------------

Listing Criteria for Hearing Loss Treated With Cochlear Implantation

    We received several comments about our proposal to find disability 
for 1 year

[[Page 30700]]

following cochlear implantation under listing 2.11A and, for some 
children, listing 102.11A.\16\ The commenters said that the 1-year 
period was arbitrary and that it may be insufficient because it does 
not account for variation in treatment outcomes or allow for maximal 
improvement. The commenters recommended that we extend the period by 
various amounts of time ranging from 18 months to 3 years. Another 
commenter suggested that we provide the option of extending the period 
of disability past 1 year as necessary, particularly for persons who 
also have vision impairments and may require a longer period of 
adjustment because of their multiple impairments.
---------------------------------------------------------------------------

    \16\ Like the proposed rule, final listing 102.11A provides for 
a finding of disability after cochlear implantation until age 5 or 
for 1 year after implantation ``whichever is later.'' We will find 
that some children are disabled under this listing for more than 1 
year.
---------------------------------------------------------------------------

    We did not adopt these comments. While some persons will still have 
listing-level impairments 1 year after implantation, many will have 
improved, so we must reexamine their status to see whether they remain 
disabled. Our rule is not arbitrary: most therapy programs following 
cochlear implantation involve a period of rehabilitation and training 
for about 1 year.
    Moreover, the 1-year rule does not mean that disability 
automatically ends after 1 year. Under the Act and our regulations, we 
generally cannot find that a person's disability has ended unless his 
or her impairment has medically improved and the person is no longer 
disabled.\17\ After 1 year, we must consider whether the impairment(s) 
is disabling under the criteria in listing 2.11B or 102.11B, or if not, 
under other listings or our other disability criteria.
---------------------------------------------------------------------------

    \17\ See sections 223(f) and 1614(a)(4) of the Act, and 
Sec. Sec.  404.1594, 416.994, and 416.994a of our regulations.
---------------------------------------------------------------------------

    Two commenters sent us questions about various adjudication 
scenarios involving cochlear implants. With one exception, we did not 
add more detailed guidance to the rules to address these situations 
because they are uncommon and we can address them in training and other 
instructions. We did clarify that we count the 1-year period for which 
we presume disability from the date of the initial implantation 
procedure when a person has had more than one implant. This rule will 
apply regardless of whether the person had an implant in the other ear 
or replacement of the initial implant. See final 2.00B3a and 102.00B3a 
and final listings 2.11 and 102.11.
    Two commenters were concerned about our requirement in proposed 
listings 2.11B and 102.11B that we use the HINT or HINT-C to evaluate a 
person's hearing loss after cochlear implantation. The commenters 
indicated that we would have difficulty obtaining a HINT or HINT-C 
because most audiologists do not have the test. One commenter was 
concerned that residents of rural areas might be disadvantaged because 
these tests are available primarily at medical centers that perform 
cochlear implants. The second commenter, who acknowledged that the HINT 
is the accepted standard for assessing hearing outcome after cochlear 
implantation, indicated that the original CD version of this test was 
noted to have limitations and has been replaced with computerized 
software versions (such as the HINT for Windows and the 
HINT<SUP>[reg]</SUP>Pro) that contain improvements and enhancements. 
The commenter asked what version of the HINT we would accept. The 
commenter further noted that literature from the manufacturer of the 
HINT<SUP>[reg]</SUP>Pro indicates that this test is normed for anyone 
who reads at a first grade level and for children as young as age 6. 
The commenter asked whether this test could also be used for children 
between the ages of 5 and 6 and for adults who have literacy problems. 
The commenter also stated that other speech-in-noise tests are used 
more frequently and asked whether we would use the results of those 
other tests.
    We do not share the commenters' concerns about the availability of 
the HINT or HINT-C. As one of the commenters noted, the HINT is the 
accepted standard for assessing hearing outcome after cochlear 
implantation, and we believe this testing is likely to be in the 
evidence we obtain from a person's medical sources. If not, or if we 
need more recent testing, we believe that in most instances we will be 
able to purchase it from these sources or from audiologists who do have 
the HINT or HINT-C. We acknowledge there may be a few cases in which we 
will not be able to get testing for a resident of a rural area. In 
those cases, we will use other evidence to determine whether the person 
is disabled.
    In response to the concerns raised by the second commenter, we are 
providing in final 2.00B3b and 102.00B3b that we will use ``any 
version'' of the HINT or, for children, any age-appropriate version of 
the HINT or HINT-C. We will use results only from the HINT or HINT-C to 
determine that an impairment meets one of the final listings. We can 
use results from other tests to determine whether the impairment(s) 
medically equals a listing or to assess residual functional capacity in 
adults or functional equivalence in children. With respect to the age 
and literacy issues, we can use versions of the HINT that have been 
normed for children as young as age 6 to test children between age 5 
and 6 and, when appropriate, to test adults with literacy problems.
    One commenter believed that we should use the same word recognition 
tests and test-score criteria to evaluate hearing loss in persons who 
have cochlear implants as we use to evaluate hearing loss in persons 
who have hearing aids. We did not adopt the comment because the final 
listings reflect the way that persons are ordinarily tested. Persons 
who do not have cochlear implants are ordinarily tested with 
phonetically balanced monosyllabic word lists. The HINT is the accepted 
test for assessing persons with cochlear implants. The HINT is a 
sentence test, and persons generally have higher word recognition 
scores when tested with a sentence test because sentences provide 
context for the words used. Therefore, we must require a higher word 
recognition score for cochlear implant users.

Terminology Issues

    One commenter recommended that we use the term ``audiometric 
evaluation'' rather than ``audiometric testing'' throughout these final 
rules to reflect the full scope of the audiologist's identification and 
assessment of hearing disorders. We did not adopt the comment. While we 
recognize that the scope of an audiologist's practice is not limited to 
audiometric testing, the term ``audiometric testing'' describes the 
type of evidence we require from audiologists under these listings.
    Two commenters recommended that we consistently use the 
abbreviation dB HL (decibel hearing level) throughout the final rules 
wherever we used the abbreviation dB (decibel) in the proposed rules. 
We did not adopt the recommendation because, in these final rules, the 
``dB HL'' designation is relevant only to word recognition testing for 
persons with cochlear implants. The sound used to test persons with 
cochlear implants can be delivered by two methods, referred to as 
``HL'' and ``SPL'' (sound pressure level). Both of these methods are 
expressed in dB, but a specific dB HL is not the same level of loudness 
as the same dB SPL. To ensure that we use a consistent standard to 
evaluate every person with a cochlear implant, we use the abbreviation 
``dB HL'' only in final 2.00B3b and 102.00B3b.

[[Page 30701]]

Hearing Loss in Combination With Another Impairment(s)

    One commenter wrote to us about persons with hearing loss together 
with other medical conditions, such as visual or cognitive disorders, 
that compromise their ability to compensate for their hearing loss. The 
commenter said that some of these persons have greater difficulty 
functioning than persons with worse hearing loss but no other 
impairments. The commenter believed that such persons may not be 
disabled under our listings, but would still have difficulty responding 
to the communication challenges of daily living, and that we should 
consider them disabled. This commenter was also concerned that some 
persons with hearing loss whose impairments do not meet the criteria of 
the final listings may have difficulty functioning and should also be 
considered disabled.
    In these final rules, we include revisions only to our listings for 
hearing loss. We have other listings and other rules that we use to 
find many persons disabled, including persons like those described by 
the commenter. In addition, our regulations require us to consider the 
combined impact of multiple impairments throughout the disability 
determination process. See Sec. Sec.  404.1523, 416.923, and 416.924. 
Some persons with a combination of hearing loss and other impairments 
will have impairments that meet or medically equal listings in other 
body systems. Others may be found disabled at a later step of the 
sequential evaluation process.

Accounting for Improvement With Hearing Aids

    While most commenters agreed with our proposal to remove the 
requirement for testing with hearing aids, one commenter believed that 
we should not determine disability without accounting for any 
improvement in functioning that a person may derive from the use of 
such aids. Another commenter suggested that we include some functional 
criteria in the listings to account for persons who have individualized 
hearing aids that improve their functioning.
    As we explained in the NPRM,\18\ we determined that persons with 
the level of hearing loss specified in the listings do not usually 
obtain significant improvement in their ability to hear and communicate 
with the use of hearing aids. In other words, the severity criteria we 
provide in the final listings make testing with a hearing aid 
unnecessary. Therefore, we believe that it is appropriate to eliminate 
the requirement for aided testing and that it is not necessary to add 
functional criteria to the listings for the evaluation of persons with 
listing-level hearing loss who have individualized hearing aids.
---------------------------------------------------------------------------

    \18\ 73 FR 47106 (2008).
---------------------------------------------------------------------------

Need for Listings for Hearing Loss

    Citing testimony from our 2005 policy conference regarding the 
number of persons with deafness who work, one commenter believed that 
we should not presume that all persons whose hearing impairments meet 
the criteria in these listings are disabled. The commenter indicated 
that we should document that the proposed rules correctly identify 
persons who meet the definition of disability in the Act and our 
regulations. When we developed our proposed rules for evaluating claims 
involving hearing loss, we consulted with some of the most renowned 
experts in the field of hearing disorders. We also received comments 
from experts who supported our proposed rules. Based on this 
information, we believe it is appropriate to presume disability in 
persons whose hearing impairments meet the criteria in these final 
rules. In addition, the testimony from our policy conference regarding 
persons with deafness who work did not fully address the issue of work 
independence (for example, special accommodations) and other factors 
(such as levels of earnings); therefore, the testimony was not 
specifically relevant to the issue in this comment. Moreover, when 
persons with listing-level hearing loss work at the substantial gainful 
activity level, we find them not disabled at the first step of the 
sequential evaluation process.

Other Changes From the NPRM

    We made a number of nonsubstantive, editorial corrections and 
changes in the final rules from the language of the NPRM, such as 
changing some sentences from the passive into the active voice.

What is our authority to make rules and set procedures for determining 
whether a person is disabled under our statutory definition?

    Under the Act, we have full power and authority to make rules and 
regulations and to establish necessary and appropriate procedures to 
carry out such provisions. Sections 205(a), 702(a)(5), and 1631(d)(1).

Regulatory Procedures

Executive Order 12866

    We have consulted with the Office of Management and Budget (OMB) 
and determined that these final rules meet the requirements for a 
significant regulatory action under Executive Order 12866 and were 
subject to OMB review.

Regulatory Flexibility Act

    We certify that these final rules have no significant economic 
impact on a substantial number of small entities because they affect 
only individuals. Therefore, a regulatory flexibility analysis was not 
required under the Regulatory Flexibility Act, as amended.

Paperwork Reduction Act

    This rule does not create any new or affect any existing 
collections, and therefore, does not require Office of Management and 
Budget approval under the Paperwork Reduction Act.

(Catalog of Federal Domestic Assistance Program Nos. 96.001, Social 
Security-Disability Insurance; 96.002, Social Security-Retirement 
Insurance; 96.004, Social Security-Survivors Insurance; and 96.006, 
Supplemental Security Income)

List of Subjects in 20 CFR Part 404

    Administrative practice and procedure, Blind, Disability benefits, 
Old-Age, Survivors, and Disability Insurance, Reporting and 
recordkeeping requirements, Social Security.

Michael J. Astrue,
Commissioner of Social Security.

0
For the reasons set out in the preamble, we amend appendix 1 to subpart 
P of part 404 of chapter III of title 20 of the Code of Federal 
Regulations as set forth below:

PART 404--FEDERAL OLD-AGE, SURVIVORS AND DISABILITY INSURANCE 
(1950- )

0
1. The authority citation for subpart P of part 404 continues to read 
as follows:

    Authority: Secs. 202, 205(a), (b), and (d)-(h), 216(i), 221(a) 
and (i), 222(c), 223, 225, and 702(a)(5) of the Social Security Act 
(42 U.S.C. 402, 405(a), (b), and (d)-(h), 416(i), 421(a) and (i), 
422(c), 423, 425, and 902(a)(5)); sec. 211(b), Pub. L. 104-193, 110 
Stat. 2105, 2189; sec. 202, Pub. L. 108-203, 118 Stat. 509 (42 
U.S.C. 902 note).

Appendix 1 to Subpart P of Part 404--[Amended]

0
2. Amend appendix 1 to subpart P of part 404 as follows:
0
a. Revise item 3 of the introductory text before part A of appendix 1.
0
b. Revise section 2.00B of part A of appendix 1.
0
c. Redesignate section 2.00C of part A of appendix 1 as section 2.00E.
0
d. Redesignate section 2.00B2 of part A of appendix 1 as section 2.00C, 
revise the heading, and designate the undesignated paragraphs as 
sections 2.00C1, 2.00C2, and 2.00C3.

[[Page 30702]]

0
e. Redesignate section 2.00B3 of part A of appendix 1 as section 2.00D.
0
f. Remove listing 2.08 of part A of appendix 1.
0
g. Add listings 2.10 and 2.11 to part A of appendix 1.
0
h. Revise section 102.00B of part B of appendix 1.
0
i. Remove listing 102.08 of part B of appendix 1.
0
j. Add listings 102.10 and 102.11 to part B of appendix 1.
    The revised text is set forth as follows:

Appendix 1 to Subpart P of Part 404--Listing of Impairments

* * * * *
    3. Special Senses and Speech (2.00 and 102.00): August 3, 2015.
* * * * *

Part A

* * * * *

2.00 SPECIAL SENSES AND SPEECH

* * * * *

B. How do we evaluate hearing loss?

1. What evidence do we need?

    a. We need evidence showing that you have a medically 
determinable impairment that causes your hearing loss and 
audiometric measurements of the severity of your hearing loss. We 
generally require both a complete otologic examination and 
audiometric testing to establish that you have a medically 
determinable impairment that causes your hearing loss. You should 
have this audiometric testing within 2 months of the complete 
otologic examination. Once we have evidence that you have a 
medically determinable impairment, we can use the results of later 
audiometric testing to assess the severity of your hearing loss 
without another complete otologic examination. We will consider your 
test scores together with any other relevant information we have 
about your hearing, including information from outside of the test 
setting.
    b. The complete otologic examination must be performed by a 
licensed physician (medical or osteopathic doctor). It must include 
your medical history, your description of how your hearing loss 
affects you, and the physician's description of the appearance of 
the external ears (pinnae and external ear canals), evaluation of 
the tympanic membranes, and assessment of any middle ear 
abnormalities.
    c. Audiometric testing must be performed by, or under the direct 
supervision of, an otolaryngologist or by an audiologist qualified 
to perform such tests. We consider an audiologist to be qualified if 
he or she 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 (CCC-A) from 
the American Speech-Language-Hearing Association (ASHA).

2. What audiometric testing do we need when you do not have a 
cochlear implant?

    a. We generally need pure tone air conduction and bone 
conduction testing, speech reception threshold (SRT) testing (also 
referred to as ``spondee threshold'' or ``ST'' testing), and word 
recognition testing (also referred to as ``word discrimination'' or 
``speech discrimination'' testing). This testing must be conducted 
in a sound-treated booth or room and must be in accordance with the 
most recently published standards of the American National Standards 
Institute (ANSI). Each ear must be tested separately.
    b. You must not wear hearing aids during the testing. 
Additionally, a person described in 2.00B1c must perform an 
otoscopic examination immediately before the audiometric testing. 
(An otoscopic examination provides a description of the appearance 
of your external ear canals and an evaluation of the tympanic 
membranes. In these rules, we use the term to include otoscopic 
examinations performed by physicians and otoscopic inspections 
performed by audiologists and others.) The otoscopic examination 
must show that there are no conditions that would prevent valid 
audiometric testing, such as fluid in the ear, ear infection, or 
obstruction in an ear canal. The person performing the test should 
also report on any other factors, such as your cooperation with the 
test, that can affect the interpretation of the test results.
    c. To determine whether your hearing loss meets the air and bone 
conduction criteria in 2.10A, we will average your air and bone 
conduction hearing thresholds at 500, 1000, and 2000 Hertz (Hz). If 
you do not have a response at a particular frequency, we will use a 
threshold of 5 decibels (dB) over the limit of the audiometer.
    d. The SRT is the minimum dB level required for you to recognize 
50 percent of the words on a standard list of spondee words. 
(Spondee words are two-syllable words that have equal stress on each 
syllable.) The SRT is usually within 10 dB of the average pure tone 
air conduction hearing thresholds at 500, 1000, and 2000 Hz. If the 
SRT is not within 10 dB of the average pure tone air conduction 
threshold, the reason for the discrepancy must be documented. If we 
cannot determine that there is a medical basis for the discrepancy, 
we will not use the results of the testing to determine whether your 
hearing loss meets a listing.
    e. Word recognition testing determines your ability to recognize 
a standardized list of phonetically balanced monosyllabic words in 
the absence of any visual cues. This testing must be performed in 
quiet. The list may be recorded or presented live, but in either 
case the words should be presented at a level of amplification that 
will measure your maximum ability to discriminate words, usually 35 
to 40 dB above your SRT. However, the amplification level used in 
the testing must be medically appropriate, and you must be able to 
tolerate it. If you cannot be tested at 35 to 40 dB above your SRT, 
the person who performs the test should report your word recognition 
testing score at your highest comfortable level of amplification.

3. What audiometric testing do we need when you have a cochlear 
implant?

    a. If you have a cochlear implant, we will consider you to be 
disabled until 1 year after initial implantation.
    b. After that period, we need word recognition testing performed 
with any version of the Hearing in Noise Test (HINT) to determine 
whether your impairment meets 2.11B. This testing must be conducted 
in quiet in a sound field. Your implant must be functioning properly 
and adjusted to your normal settings. The sentences should be 
presented at 60 dB HL (Hearing Level) and without any visual cues.

4. How do we evaluate your word recognition ability if you are not 
fluent in English?

    If you are not fluent in English, you should have word 
recognition testing using an appropriate word list for the language 
in which you are most fluent. The person conducting the test should 
be fluent in the language used for the test. If there is no 
appropriate word list or no person who is fluent in the language and 
qualified to perform the test, it may not be possible to measure 
your word recognition ability. If your word recognition ability 
cannot be measured, your hearing loss cannot meet 2.10B or 2.11B. 
Instead, we will consider the facts of your case to determine 
whether you have difficulty understanding words in the language in 
which you are most fluent, and if so, whether that degree of 
difficulty medically equals 2.10B or 2.11B. For example, we will 
consider how you interact with family members, interpreters, and 
other persons who speak the language in which you are most fluent.

C. How do we evaluate vertigo associated with disturbances of 
labyrinthine-vestibular function, including Meniere's disease?

* * * * *

2.01 Category of Impairments, Special Senses and Speech

* * * * *

2.10 Hearing Loss Not Treated With Cochlear Implantation

    A. An average air conduction hearing threshold of 90 decibels or 
greater in the better ear and an average bone conduction hearing 
threshold of 60 decibels or greater in the better ear (see 2.00B2c).
    OR
    B. A word recognition score of 40 percent or less in the better 
ear determined using a standardized list of phonetically balanced 
monosyllabic words (see 2.00B2e).

2.11 Hearing Loss Treated With Cochlear Implantation

    A. Consider under a disability for 1 year after initial 
implantation.

    OR

    B. If more than 1 year after initial implantation, a word 
recognition score of 60 percent or less determined using the HINT 
(see 2.00B3b).
* * * * *

Part B

* * * * *

[[Page 30703]]

102.00 SPECIAL SENSES AND SPEECH

* * * * *

B. How do we evaluate hearing loss?

1. What evidence do we need?

    a. We need evidence showing that you have a medically 
determinable impairment that causes your hearing loss and 
audiometric measurements of the severity of your hearing loss. We 
generally require both a complete otologic examination and 
audiometric testing to establish that you have a medically 
determinable impairment that causes your hearing loss. You should 
have this audiometric testing within 2 months of the complete 
otologic examination. Once we have evidence that you have a 
medically determinable impairment, we can use the results of later 
audiometric testing to assess the severity of your hearing loss 
without another complete otologic examination. We will consider your 
test scores together with any other relevant information we have 
about your hearing, including information from outside of the test 
setting.
    b. The complete otologic examination must be performed by a 
licensed physician (medical or osteopathic doctor). It must include 
your medical history, your description of how your hearing loss 
affects you, and the physician's description of the appearance of 
the external ears (pinnae and external ear canals), evaluation of 
the tympanic membranes, and assessment of any middle ear 
abnormalities.
    c. Audiometric testing must be performed by, or under the direct 
supervision of, an otolaryngologist or by an audiologist qualified 
to perform such tests. We consider an audiologist to be qualified if 
he or she 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 (CCC-A) from 
the American Speech-Language-Hearing Association (ASHA).

2. What audiometric testing do we need when you do not have a 
cochlear implant?

    a. General. We need either physiologic or behavioral testing 
(other than screening testing, see 102.00B2g) that is appropriate 
for your age at the time of testing. See 102.00B2c-102.00B2f. We 
will make every reasonable effort to obtain the results of 
physiologic testing that has been done; however, we will not 
purchase such testing.
    b. Testing requirements. The testing must be conducted in 
accordance with the most recently published standards of the 
American National Standards Institute (ANSI). You must not wear 
hearing aids during the testing. Additionally, a person described in 
102.00B1c must perform an otoscopic examination immediately before 
the audiometric testing. (An otoscopic examination provides a 
description of the appearance of your external ear canals and an 
evaluation of the tympanic membranes. In these rules, we use the 
term to include otoscopic examinations performed by physicians and 
otoscopic inspections performed by audiologists and others.) The 
otoscopic examination must show that there are no conditions that 
would prevent valid audiometric testing, such as fluid in the ear, 
ear infection, or obstruction in an ear canal. The person performing 
the test should also report on any other factors, such as your 
ability to maintain attention, that can affect the interpretation of 
the test results.

c. Children From Birth to the Attainment of Age 6 Months

    (i) We need physiologic testing, such as auditory brainstem 
response (ABR) testing.
    (ii) To determine whether your hearing loss meets 102.10A, we 
will average your hearing thresholds at 500, 1000, 2000, and 4000 
Hertz (Hz). If you do not have a response at a particular frequency, 
we will use a threshold of 5 decibels (dB) over the limit of the 
audiometer.

d. Children From Age 6 Months to the Attainment of Age 2

    (i) We need air conduction thresholds determined by a behavioral 
assessment, usually visual reinforcement audiometry (VRA). We can 
use ABR testing if the behavioral assessment cannot be completed or 
if the results are inconclusive or unreliable.
    (ii) To determine whether your hearing loss meets 102.10A, we 
will average your hearing thresholds at 500, 1000, 2000, and 4000 
Hz. If you do not have a response at a particular frequency, we will 
use a threshold of 5 dB over the limit of the audiometer.
    (iii) For this age group, behavioral assessments are often 
performed in a sound field, and each ear is not tested separately. 
If each ear is not tested separately, we will consider the test 
results to represent the hearing in the better ear.

e. Children From Age 2 to the Attainment of Age 5

    (i) We need air conduction thresholds determined by a behavioral 
assessment, such as conditioned play audiometry (CPA), tangible or 
visually reinforced operant conditioning audiometry (TROCA, VROCA), 
or VRA. If you have had ABR testing, we can use the results of that 
testing if the behavioral assessment cannot be completed or the 
results are inconclusive or unreliable.
    (ii) To determine whether your hearing loss meets 102.10A, we 
will average your hearing thresholds at 500, 1000, 2000, and 4000 
Hz. If you do not have a response at a particular frequency, we will 
use a threshold of 5 dB over the limit of the audiometer.
    (iii) For this age group, behavioral assessments are often 
performed in a sound field and each ear is not tested separately. If 
each ear is not tested separately, we will consider the test results 
to represent the hearing in the better ear.

f. Children From Age 5 to the Attainment of Age 18

    (i) We generally need pure tone air conduction and bone 
conduction testing, speech reception threshold (SRT) testing (also 
referred to as ``spondee threshold'' or ``ST'' testing), and word 
recognition testing (also referred to as ``word discrimination'' or 
``speech discrimination'' testing). This testing must be conducted 
in a sound-treated booth or room and must be in accordance with the 
most recently published ANSI standards. Each ear must be tested 
separately.
    (ii) To determine whether your hearing loss meets the air and 
bone conduction criterion in 102.10B1 or 102.10B3, we will average 
your hearing thresholds at 500, 1000, 2000, and 4000 Hz. If you do 
not have a response at a particular frequency, we will use a 
threshold of 5 dB over the limit of the audiometer.
    (iii) The SRT is the minimum dB level required for you to 
recognize 50 percent of the words on a standard list of spondee 
words. (Spondee words are two-syllable words that have equal stress 
on each syllable.) The SRT is usually within 10 dB of the average 
pure tone air conduction hearing thresholds at 500, 1000, and 2000 
Hz. If the SRT is not within 10 dB of the average pure tone air 
conduction threshold, the reason for the discrepancy must be 
documented. If we cannot determine that there is a medical basis for 
the discrepancy, we will not use the results of the testing to 
determine whether your hearing loss meets a listing.
    (iv) Word recognition testing determines your ability to 
recognize an age-appropriate, standardized list of phonetically 
balanced monosyllabic words in the absence of any visual cues. This 
testing must be performed in quiet. The list may be recorded or 
presented live, but in either case, the words should be presented at 
a level of amplification that will measure your maximum ability to 
discriminate words, usually 35 to 40 dB above your SRT. However, the 
amplification level used in the testing must be medically 
appropriate, and you must be able to tolerate it. If you cannot be 
tested at 35 to 40 dB above your SRT, the person who performs the 
test should report your word recognition testing score at your 
highest comfortable level of amplification.
    g. Screening testing. Physiologic testing, such as ABR and 
otoacoustic emissions (OAE), and pure tone testing can be used as 
hearing screening tests. We will not use these tests to determine 
that your hearing loss meets or medically equals a listing, or to 
assess functional limitations due to your hearing loss, when they 
are used only as screening tests. We can consider normal results 
from hearing screening tests to determine that your hearing loss is 
not ``severe'' when these test results are consistent with the other 
evidence in your case record. See Sec.  416.924(c).

3. What audiometric testing do we need when you have a cochlear 
implant?

    a. If you have a cochlear implant, we will consider you to be 
disabled until age 5, or for 1 year after initial implantation, 
whichever is later.
    b. After that period, we need word recognition testing performed 
with any age-appropriate version of the Hearing in Noise Test (HINT) 
or the Hearing in Noise Test for Children (HINT-C) to determine 
whether your impairment meets 102.11B. This testing must be 
conducted in quiet in a sound field. Your implant must be 
functioning properly and adjusted to your normal settings. The 
sentences should be presented at 60 dB HL (Hearing Level) and 
without any visual cues.

[[Page 30704]]

4. How do we evaluate your word recognition ability if you are not 
fluent in English?

    If you are not fluent in English, you should have word 
recognition testing using an appropriate word list for the language 
in which you are most fluent. The person conducting the test should 
be fluent in the language used for the test. If there is no 
appropriate word list or no person who is fluent in the language and 
qualified to perform the test, it may not be possible to measure 
your word recognition ability. If your word recognition ability 
cannot be measured, your hearing loss cannot meet 102.10B2 or 
102.11B. Instead, we will consider the facts of your case to 
determine whether you have difficulty understanding words in the 
language in which you are most fluent, and if so, whether that 
degree of difficulty medically equals 102.10B2 or 102.11B. For 
example, we will consider how you interact with family members, 
interpreters, and other persons who speak the language in which you 
are most fluent.

5. What do we mean by a marked limitation in speech or language as 
used in 102.10B3?

    a. We will consider you to have a marked limitation in speech 
if:
    (i) Entire phrases or sentences in your conversation are 
intelligible to unfamiliar listeners at least 50 percent (half) of 
the time but no more than 67 percent (two-thirds) of the time on 
your first attempt; and
    (ii) Your sound production or phonological patterns (the ways in 
which you combine speech sounds) are atypical for your age.
    b. We will consider you to have a marked limitation in language 
when your current and valid test score on an appropriate 
comprehensive, standardized test of overall language functioning is 
at least two standard deviations below the mean. In addition, the 
evidence of your daily communication functioning must be consistent 
with your test score. If you are not fluent in English, it may not 
be possible to test your language performance. If we cannot test 
your language performance, your hearing loss cannot meet 102.10B3. 
Instead, we will consider the facts of your case to determine 
whether your hearing loss medically equals 102.10B3.
* * * * *

102.01 Category of Impairments, Special Senses and Speech

* * * * *

102.10 Hearing Loss Not Treated With Cochlear Implantation

    A. For children from birth to the attainment of age 5, an 
average air conduction hearing threshold of 50 decibels or greater 
in the better ear (see 102.00B2).

OR

    B. For children from age 5 to the attainment of age 18:
    1. An average air conduction hearing threshold of 70 decibels or 
greater in the better ear and an average bone conduction hearing 
threshold of 40 decibels or greater in the better ear (see 
102.00B2f); or
    2. A word recognition score of 40 percent or less in the better 
ear determined using a standardized list of phonetically balanced 
monosyllabic words (see 102.00B2f); or
    3. An average air conduction hearing threshold of 50 decibels or 
greater in the better ear and a marked limitation in speech or 
language (see 102.00B2f and 102.00B5).

102.11 Hearing Loss Treated With Cochlear Implantation

    A. Consider under a disability until the attainment of age 5 or 
for 1 year after initial implantation, whichever is later.

OR

    B. Upon the attainment of age 5 or 1 year after initial 
implantation, whichever is later, a word recognition score of 60 
percent or less determined using the HINT or the HINT-C (see 
102.00B3b).
* * * * *
[FR Doc. 2010-13094 Filed 6-1-10; 8:45 am]
BILLING CODE 4191-02-P