Daily Rules, Proposed Rules, and Notices of the Federal Government
The electronic file of this document is available on the date of publication in the
We are revising and making final the rules for evaluating hearing loss we proposed in an NPRM we published in the
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.
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
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.
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.
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
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.
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.
A commenter recommended that we specify that otolaryngologists certified by the American Board of Otolaryngology should perform otologic
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.
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.
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 §§ 404.1513(d) and 416.913(d) of our regulations and Social Security Ruling (SSR) 06-3p.
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
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.”
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
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.
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.
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,
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
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.”
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.
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
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:
• Use the average air conduction threshold criteria in Table 7-2 of the NRC report;
• Use the speech and language criteria in Tables 7-2 and 7-3 of the NRC report;
• 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
• 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.
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.
We received several comments about our proposal to find disability for 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.
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
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.
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.
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.
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,
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.
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.
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).
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.
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.
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.