Revised Medical Criteria for Evaluating Hearing Loss, 47103-47113 [E8-18718]

Download as PDF Federal Register / Vol. 73, No. 157 / Wednesday, August 13, 2008 / Proposed Rules of the safety, power quality, or reliability on the borrower’s electric power system or other electric power systems interconnected to the borrower’s electric power system. The Agency encourages borrowers to consider model policy templates developed by knowledgeable and expert institutions, such as, but not limited to, the National Association of Regulatory Utility Commissioners, the Federal Energy Regulatory Commission and the National Rural Electric Cooperative Association. The Agency encourages all related electric borrowers to cooperate in the development of a common Distributed Resource policy. § 1730.62 Definitions. ‘‘Distributed Resources’’ as used in this subpart means sources of electric power that are not directly connected to a bulk power transmission system, having an installed capacity of not more than 10 MVA, connected to the borrower’s electric power system through a point of common coupling. Distributed resources include both generators and energy storage technologies. ‘‘Responsible Party’’ as used in this subpart means the owner, operator or any other person or entity that is accountable to the borrower under the borrower’s interconnection policy for Distributed Resources. hsrobinson on PROD1PC76 with PROPOSALS § 1730.63 IDR policy criteria. (a) General. (1) The borrower’s IDR policy and procedures shall be readily available to the public and include, but not limited to, a standard application, application process, application fees, and agreement. (2) All costs to be recovered from the applicant regarding the application process or the actual interconnection are to be clearly explained to the applicant and authorized by the applicant prior to the borrower incurring these costs. The borrower may require separate nonrefundable deposits sufficient to insure serious intent by the applicant prior to proceeding either with the application or actual interconnection process. (3) IDR policies must be approved by the borrower’s Board of Directors. (4) The borrower may establish a new rate classification for customers with Distributed Resources. (5) IDR policies must provide for reconsideration and updates every three years or more frequently as circumstances warrant. (b) Technical requirements. (1) IDR policies must be consistent with prudent electric utility practice. VerDate Aug<31>2005 15:58 Aug 12, 2008 Jkt 214001 (2) IDR policies must incorporate the standard 1547 as promulgated and amended by the Institute of Electrical and Electronic Engineers (IEEE). The title of IEEE Standard 1547 is ‘‘IEEE Standard for Interconnecting Distributed Resources with Electric Power Systems’’. You may obtain a copy of IEEE Standard 1547 from: IEEE, 3 Park Avenue, New York, NY 10016–5997. (3) IDR policies must provide for appropriate electric power system disconnect facilities, as determined by the borrower, which shall include a lockable disconnect, a visible open, and fusing, that are readily accessible to and operable by authorized personnel at all times. (4) IDR policies must provide for borrower access to the Distributed Resources facility during normal business hours and all emergency situations. (c) Responsible party obligations. IDR policies must provide for appropriate Responsible Parties to assume the following risks and responsibilities: (1) A Responsible Party must agree to maintain appropriate liability insurance as outlined in the borrower’s interconnection policy. (2) A Responsible Party must be responsible for the Distributed Resources compliance with all national, State, local government requirements and electric utility standards for the safety of the public and personnel responsible for utility electric power system operations, maintenance and repair. (3) A Responsible Party must be responsible for the safe and effective operation and maintenance of the facility. (4) Only Responsible Parties may apply for interconnection and the Responsible Party must demonstrate the financial and managerial capability to develop, construct and operate the distributed resources. § 1730.64 Power purchase agreements. Nothing in this subpart requires the borrower to enter into purchase power arrangements with the owner of the Distributed Resources. § 1730.65 Effective dates. (a) Each electric program borrower with an approved electric program loan as of [DATE OF PUBLICATION OF THE FINAL RULE] shall have an IDR policy board approved and in effect no later than [DATE 2 YEARS FROM DATE OF PUBLICATION OF THE FINAL RULE]. (b) An electric program borrower that submits an application to the Agency for financial assistance on or after [DATE 2 YEARS FROM DATE OF PUBLICATION PO 00000 Frm 00003 Fmt 4702 Sfmt 4702 47103 OF THE FINAL RULE] shall include with its application package a letter of certification executed by the General Manager that the borrower meets the requirements of this subpart. § 1730.66 Administrative waiver. The Administrator may waive in all or part, for good cause, the requirements and procedures of this subpart. §§ 1730.67–1730.99 [Reserved] Dated: July 11, 2008. James M. Andrew, Administrator, Rural Utilities Service. [FR Doc. E8–18800 Filed 8–12–08; 8:45 am] BILLING CODE 3410–15–P SOCIAL SECURITY ADMINISTRATION 20 CFR Part 404 [Docket No. SSA–2008–0016] RIN 0960–AG20 Revised Medical Criteria for Evaluating Hearing Loss Social Security Administration. Notice of proposed rulemaking. AGENCY: ACTION: SUMMARY: We propose to revise the criteria in the Listing of Impairments (the listings) that we use to evaluate claims involving hearing loss. We apply these criteria when you claim benefits based on disability under title II and title XVI of the Social Security Act (the Act). The proposed revisions reflect current medical knowledge, treatment, and methods of evaluating hearing loss, as well as our adjudicative experience since the publication of the current rules. To be sure that your comments are considered, we must receive them by October 14, 2008. ADDRESSES: You may submit comments by any one of four methods—Internet, facsimile, regular mail, or handdelivery. Commenters should not submit the same comments multiple times or by more than one method. Regardless of which of the following methods you choose, please state that your comments refer to Docket No. SSA–2008–0016 to ensure that we can associate your comments with the correct regulation: 1. Federal eRulemaking portal at http://www.regulations.gov. (This is the most expedient method for submitting your comments, and we strongly urge you to use it.) In the Comment or Submission section of the webpage, type ‘‘SSA–2008–0016,’’ select ‘‘Go,’’ and then click ‘‘Send a Comment or DATES: E:\FR\FM\13AUP1.SGM 13AUP1 47104 Federal Register / Vol. 73, No. 157 / Wednesday, August 13, 2008 / Proposed Rules Submission.’’ The Federal eRulemaking portal issues you a tracking number when you submit a comment. 2. Telefax to (410) 966–2830. 3. Letter to the Commissioner of Social Security, P.O. Box 17703, Baltimore, MD 21235–7703. 4. Deliver your comments to the Office of Regulations, Social Security Administration, 922 Altmeyer Building, 6401 Security Boulevard, Baltimore, MD 21235–6401, between 8 a.m. and 4:30 p.m. on regular business days. All comments are posted on the Federal eRulemaking portal, although they may not appear for several days after receipt of the comment. You may also inspect the comments on regular business days by making arrangements with the contact person shown in this preamble. Caution: All comments we receive from members of the public are available for public viewing in their entirety on the Federal eRulemaking portal at http://www.regulations.gov. Therefore, you should be careful to include in your comments only information that you wish to make publicly available on the Internet. We strongly urge you not to include any personal information, such as your Social Security number or medical information, in your comments. FOR FURTHER INFORMATION CONTACT: Diane Braunstein, Director, Office of Compassionate Allowances and Listings Improvement, 6401 Security Boulevard, Baltimore, MD 21235–6401, (410) 965– 1020. For information on eligibility or filing for benefits, call our national tollfree 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. hsrobinson on PROD1PC76 with PROPOSALS Why are we proposing to revise the listings for hearing loss? We are proposing to revise the listings for hearing loss to update the medical criteria in the listings, to provide more information about how we evaluate hearing loss, and to reflect our adjudicative experience. The listings for hearing loss are in the special senses and speech body system. That body system also includes listings for visual disorders, disturbances of labyrinthinevestibular function, and loss of speech. In this Notice of Proposed Rulemaking (NPRM), we are proposing changes only VerDate Aug<31>2005 15:58 Aug 12, 2008 Jkt 214001 to the listings for hearing loss. We published final rules revising the listings for visual disorders in the Federal Register on November 20, 2006 (71 FR 67037). We intend to publish separately proposed rules that would update the criteria for disturbances of labyrinthine-vestibular function and loss of speech. Prior to the publication of the final rules for evaluating visual disorders mentioned above, we last published final rules making comprehensive revisions to the part A special senses and speech listings in the Federal Register on March 27, 1979 (44 FR 18170), and final rules making comprehensive revisions to the part B special senses and speech listings in the Federal Register on March 16, 1977 (42 FR 14705). The current special senses and speech listings will no longer be effective on February 20, 2015, unless we extend them, or revise and issue them again. How did we develop these proposed rules? We developed these proposed rules based on our adjudicative experience and advances in medical knowledge, treatment, and methods of evaluating hearing loss. These proposed rules also reflect comments we asked the public to provide to help us develop the proposals. We published an advance notice of proposed rulemaking (ANPRM) in the Federal Register on April 13, 2005 (70 FR 19353). The purpose of the ANPRM was to inform the public that we were planning to update and revise the rules we use to evaluate hearing impairments and disturbance of labyrinthinevestibular function and to invite interested individuals and organizations to send us comments and suggestions for updating and revising the listings for these disorders. In the ANPRM, we provided a 60-day period for comments and suggestions; that period ended on June 13, 2005. We received 13 letters and e-mails from medical experts, advocates, and State agencies that adjudicate claims for us, commenting on our criteria for hearing loss. Although we are not summarizing or responding to the comments in this notice, we read and considered them carefully. We are proposing changes to our rules for evaluating hearing loss based on some of the suggestions we received. We also hosted a policy conference on ‘‘Hearing Impairments and Disturbance of Labyrinthine-Vestibular Function’’ at Gallaudet University in Washington, DC, on November 7 and 8, 2005. At this conference, we heard comments and suggestions for updating and revising PO 00000 Frm 00004 Fmt 4702 Sfmt 4702 the rules we use to evaluate these disorders from individuals who have hearing loss or vestibular disorders, their family members, physicians who treat them, other professionals who work with them, and advocates who represent them. The transcript of this conference is available on our Web site at http://policy.ssa.gov/erm/rules.nsf/ 5da82b031a6677dc85256b41006b7f8d/ 9314dd803ad5579885256fe200496264 !OpenDocument. Several of the changes to the criteria for evaluating hearing loss that we propose in these rules are based on information we obtained from individuals at this conference. How are we proposing to change the introductory text to the special senses and speech listings for adults? 2.00 Special Senses and Speech We propose to reorganize and expand the second through fifth paragraphs of current 2.00B1, ‘‘Hearing impairment,’’ to provide additional guidance. We propose to remove the guidance in the first paragraph of current 2.00B1, which states that hearing ability should be evaluated in terms of the person’s ability to hear and distinguish speech. Because our current and proposed listings provide for using tones to evaluate hearing loss, this language may be misleading. We also propose to remove the guidance in the last paragraph of current 2.00B1, which provides that cases of alleged ‘‘deaf mutism’’ should be documented by a hearing evaluation. This guidance refers only to the evaluation of deaf mutism as a hearing impairment; however, we can also evaluate cases of alleged mutism under listing 2.09, for loss of speech. In that case, we would not need a hearing test. We are not proposing special requirements for evaluating hearing loss if you have deaf mutism; we would require the same documentation as for other hearing disorders. We also propose to redesignate current 2.00B2, ‘‘Vertigo associated with disturbances of labyrinthine-vestibular function, including Meniere’s disease,’’ as proposed 2.00C, and to redesignate current 2.00B3, ‘‘Loss of speech,’’ as proposed 2.00D. We are proposing separate sections for these disorders to recognize that they are not always associated with hearing loss. Although we are not proposing any substantive changes to these sections at this time, we are proposing to make minor editorial changes so that the format of these sections will be consistent with other sections of the introductory text in these proposed rules. Because of these changes, we also propose to redesignate E:\FR\FM\13AUP1.SGM 13AUP1 Federal Register / Vol. 73, No. 157 / Wednesday, August 13, 2008 / Proposed Rules current 2.00C, ‘‘How do we evaluate impairments that do not meet one of the special senses and speech listings?’’ as proposed 2.00E. The following is a detailed explanation of proposed 2.00B. Proposed 2.00B—How do we evaluate hearing loss? hsrobinson on PROD1PC76 with PROPOSALS Proposed 2.00B1—What evidence do we need to evaluate hearing loss? This proposed section revises the fourth and fifth paragraphs of current 2.00B1as follows: • The fourth paragraph of current 2.00B1 provides that an otolaryngologic examination should precede audiometric testing. We propose to remove the requirement for an otolaryngologic examination and instead require a complete otologic examination. We would make this change because an otolaryngologic examination contains elements, such as an evaluation of the head, face, and neck, that are not needed to assess hearing loss. As we describe in proposed 2.00B1b, a complete otologic examination must include the medical history, a description of how the hearing loss affects the individual, a description of the appearance of the external ear (pinna and the external ear canal), an evaluation of the tympanic membrane, and an assessment of any middle ear abnormalities. • We also propose to revise the guidance in the current rules that the otolaryngologic examination should precede the audiometric testing and instead provide that the audiometric testing should be performed within 2 months of the complete otologic examination. Having the otologic examination precede the audiometric testing can help identify conditions that could interfere with the audiometric testing. However, having the otologic examination follow the audiometric testing will allow the physician to consider the results of that testing in reaching his or her conclusions about the individual’s hearing loss. We believe that either sequence is acceptable for determining whether the individual has a medically determinable impairment that has resulted in hearing loss. However, we would appreciate having specific comments on this change, replacing an otolaryngologic examination with an otologic examination. • Lastly, we propose to revise the current requirement in the fifth paragraph of 2.00B1 that an otolaryngologic examination be performed in conjunction with any audiometric testing used to assess the VerDate Aug<31>2005 15:58 Aug 12, 2008 Jkt 214001 severity of the hearing loss. As indicated above, we propose to require a complete otologic examination instead of an otolaryngologic examination. Additionally, we propose that the complete otologic examination be required only to establish that a medically determinable impairment exists. After the impairment is established, we propose to allow the severity of the hearing loss to be determined based on audiometric testing without another complete otologic examination. Proposed 2.00B2—What audiometric testing do we need when you do not have a cochlear implant? This proposed section expands and clarifies the guidance in the second, third, and fifth paragraphs of current 2.00B1 as follows: • We would replace the term ‘‘speech discrimination’’ with ‘‘word recognition testing’’ to reflect current medical terminology. In addition, we would add a parenthetical statement to explain that this testing may also be referred to as word discrimination or speech discrimination testing. • We would clarify that we require that pure tone air conduction and bone conduction testing must be conducted in accordance with the most recently published American National Standards Institute (ANSI) standards for air conduction and bone conduction stimuli. Our current rules provide that audiometric testing be conducted in accordance with the 1969 and 1972 ANSI standards or subsequent comparable revisions. • We would clarify that each ear must be tested separately and that hearing aids must not be worn during the testing. Our reasons for proposing to remove the current requirement that hearing be tested with aids in place are discussed in our explanation of proposed listing 2.10 below. We also propose to require that the testing be conducted in a soundproof booth. Our current rules require that hearing measurements be performed in an environment which meets the 1977 ANSI standard for maximal permissible background sound. • We would require that an otoscopic examination be performed immediately before the audiometric testing to ensure that there are no conditions present that would prevent valid testing. In proposed 2.00B2b, we explain that an otoscopic examination provides a description of the appearance of the external ear canal and an evaluation of the tympanic membrane. PO 00000 Frm 00005 Fmt 4702 Sfmt 4702 47105 • We would describe the frequencies at which pure tone air conduction and bone conduction are usually measured. • We would incorporate the guidance in current listing 2.08A that explains that we average the pure tone hearing thresholds for air conduction and bone conduction at 500, 1000, and 2000 Hertz (Hz) to determine whether the listing criteria are met. • We would explain that the speech reception threshold (SRT) is generally within 10 decibels (dB) of the average pure tone air conduction hearing thresholds at 500, 1000, and 2000 Hz. If it is not, the reason for the discrepancy should be documented. • We would expand the guidance on word recognition testing and clarify that the words should be presented at a level of amplification that will measure your maximum discrimination ability, which is usually 35 to 40 dB above your SRT. We would also provide that the amplification level used in the testing must be medically appropriate and that you must be able to tolerate it. Proposed 2.00B3—What audiometric testing do we need when you have a cochlear implant? In this new section, we propose to explain that we will consider you to be disabled until 1 year after implantation of a cochlear implant. We propose to add this criterion to recognize the length of the rehabilitation and training period needed to use a cochlear implant effectively. After that period, we propose to evaluate your hearing loss by measuring your word recognition ability on the Hearing in Noise Test (HINT). We propose to use the HINT because the American Academy of Neurology indicated in their comments in response to our ANPRM that the HINT is the ‘‘accepted standard used to assess hearing outcome after cochlear implantation.’’ We would also explain our requirements for how that testing should be conducted. Our proposed requirements are based on recommendations we received at our policy conference. Proposed 2.00B4—How do we evaluate your word recognition ability if you are not fluent in English? Word recognition testing should be conducted using an appropriate word list. If you are not fluent in English, the testing should be conducted using an appropriate word list for the language in which you are most fluent. However, appropriate word lists are not available in all languages. Additionally, the individual conducting the test should also be fluent in the language used for E:\FR\FM\13AUP1.SGM 13AUP1 47106 Federal Register / Vol. 73, No. 157 / Wednesday, August 13, 2008 / Proposed Rules the test. If the test needs to be conducted in a language other than English, there may not be individuals available who are qualified to perform the testing in that language. Therefore, we propose to add this section to provide guidance on how we would evaluate your word recognition ability if you are not fluent in English. In this new section, we would provide that, if you are not fluent in English, it may not be possible to measure your word recognition ability. We would also explain that, if we cannot measure your word recognition ability because you are not fluent in English, your hearing loss cannot meet listing 2.10B or 2.11B. In this situation, we would 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 listing 2.10B or 2.11B. For example, we will consider how you interact with family members, interpreters, and other individuals who speak the language in which you are most fluent. We welcome and are very interested in receiving comments about other methods that you think we can use to evaluate word recognition ability for individuals who are not fluent in English and who have listing-level hearing disorders. How are we proposing to change the criteria in the special senses and speech listings for adults? hsrobinson on PROD1PC76 with PROPOSALS 2.01 Category of Impairments, Special Senses and Speech Under our current listings, we do not consider the effects of treatment with cochlear implantation on an individual’s hearing loss. Due to advances in the technology used in cochlear implants, we believe it is now appropriate to consider the effects of cochlear implantation on an individual’s hearing loss. Therefore, we propose to add a separate listing to evaluate hearing loss treated with cochlear implantation. Because we are proposing to add a listing, we also propose to renumber the listings for ease of reference. We would revise current listing 2.08, ‘‘Hearing impairments,’’ renumber it as listing 2.10, ‘‘Hearing loss not treated with cochlear implantation,’’ and add listing 2.11, ‘‘Hearing loss treated with cochlear implantation.’’ Proposed Listing 2.10—Hearing Loss Not Treated With Cochlear Implantation In this proposed listing, we would revise current listing 2.08, ‘‘Hearing impairments,’’ and specify that these VerDate Aug<31>2005 15:58 Aug 12, 2008 Jkt 214001 criteria apply to individuals who do not have cochlear implants. Current listing 2.08 provides that a hearing loss is of listing-level severity when ‘‘hearing [is] not restorable by a hearing aid’’ and satisfies either of the criteria in the listing. Our longstanding interpretation of the phrase ‘‘hearing not restorable by a hearing aid’’ is that the hearing loss is so severe that a hearing aid would not improve it to a level at which it no longer satisfies the listing criteria. To determine this, we need testing with a hearing aid. We propose to remove the requirement for testing with hearing aids for the following reasons: • At our policy conference, we were advised that aided hearing testing is not usually performed in clinical practice. • Audiometric testing with a hearing aid does not demonstrate whether the individual will be able to use the aid effectively. • When we published the current listings, generic hearing aids were available for testing purposes. However, advances in technology have resulted in hearing aids that are programmed to address each individual’s specific hearing loss. Due to this degree of specificity, generic aids are no longer widely available. Although we propose to no longer require aided testing, we are not proposing to change the level of hearing loss needed to demonstrate a listinglevel impairment. Based on our adjudicative experience and the comments we received in response to our ANPRM and at our policy conference, we have determined that individuals with this level of hearing loss do not usually obtain significant improvement in their ability to hear and communicate from hearing aids. Therefore, we believe that without a cochlear implant, a hearing loss at the level specified in the current listing is indicative of listing-level severity even if the individual were to use hearing aids. Current listing 2.08A requires ‘‘[a]verage hearing threshold sensitivity for air conduction of 90 decibels or greater, and for bone conduction to corresponding maximal levels, in the better ear, determined by the simple average of hearing threshold levels at 500, 1000, and 2000 hz.’’ We would clarify the criterion in current listing 2.08A for ‘‘bone conduction to corresponding maximal levels’’ by specifying that this means that the average bone conduction hearing threshold must be 60 dB or greater in the better ear. Current listing 2.08B requires ‘‘[s]peech discrimination scores of 40 PO 00000 Frm 00006 Fmt 4702 Sfmt 4702 percent or less in the better ear.’’ As we mentioned above, ‘‘speech discrimination’’ is now referred to as ‘‘word recognition testing.’’ When we published the current rules, word recognition testing was usually conducted using a standardized list of phonetically balanced monosyllabic words. Other types of word recognition testing, such as sentence testing, are now available. Therefore, we propose to specify the type of word recognition testing to be used. Proposed Listing 2.11—Hearing Loss Treated With Cochlear Implantation We propose to add criteria to evaluate individuals who have cochlear implants. Cochlear implants are devices that attempt to replace the function of damaged inner ear hair cells. The implant may destroy any remaining hearing in the implanted ear. Cochlear implants are not hearing aids. Hearing aids amplify sound, while cochlear implants provide direct electrical stimulation of the auditory nerve. Therefore, even individuals with profound hearing loss may receive enough benefit from a cochlear implant to be able to engage in gainful activity. However, we recognize that if you are treated with cochlear implantation, you will need a period of rehabilitation and training to use the implant effectively. Therefore, if you have a cochlear implant, we propose to consider you to be under a disability for one year from the date of implantation. After the 1-year period, we propose to determine whether your hearing loss meets the listing by assessing your word recognition ability using the HINT. We propose to use the HINT to assess your word recognition ability because, as mentioned in our discussion of proposed section 2.00B3, the American Academy of Neurology indicated in their comments in response to our ANPRM that the HINT is the ‘‘accepted standard used to assess hearing outcome after cochlear implantation.’’ The HINT is a sentence test. Individuals generally have higher word recognition scores when tested with a sentence test as opposed to a monosyllabic word test because sentences provide context for the words in them. Therefore, we propose to find that your hearing loss meets the listing if your word recognition score on the HINT is 60 percent or less. E:\FR\FM\13AUP1.SGM 13AUP1 Federal Register / Vol. 73, No. 157 / Wednesday, August 13, 2008 / Proposed Rules How are we proposing to change the introductory text to the special senses and speech listings for children? 102.00 Special Senses and Speech We have repeated much of the introductory text of proposed 2.00B in the introductory text to proposed 102.00B. This is because the same basic rules for evaluating hearing loss in adults also apply to evaluating hearing loss in children age 5 and older. Because we have already described these provisions under the explanation of proposed 2.00B, the following discussion of proposed 102.00B describes only those provisions that apply to children under age 5, are unique to the childhood rules, or require further explanation specific to evaluating disability in children. We propose to remove the first paragraph of current 102.00B, ‘‘Hearing impairments in children.’’ This paragraph explains that the criteria for hearing impairments in children take into account that a lesser impairment in hearing which occurs at an early age may result in a severe speech or language disorder. While this paragraph does explain why we use a lower threshold for children, it is not needed in the introductory text as it does not provide any guidance about how to evaluate hearing loss under these listings. We also propose to remove the second paragraph of current 102.00B. This paragraph provides guidance on how to consider improvement in hearing due to use of a hearing aid. As we discussed in our explanation of proposed listing 2.10 above, we are proposing to remove the requirement for aided hearing testing. Therefore, this guidance is no longer needed. hsrobinson on PROD1PC76 with PROPOSALS Proposed 102.00B2—What audiometric testing do we need when you do not have a cochlear implant? This proposed section expands and clarifies the guidance in the third and fourth paragraphs of current 102.00B as follows: • We would clarify that we generally need behavioral or physiologic testing (other than screening testing) that is appropriate for your age at the time of testing. • We would clarify that we require that audiometric testing be conducted in accordance with the most recently published American National Standards Institute (ANSI) standards for air conduction and, if appropriate, bone conduction stimuli. Our current rules provide that audiometric testing be conducted in accordance with the 1969 VerDate Aug<31>2005 15:58 Aug 12, 2008 Jkt 214001 and 1972 ANSI standards or subsequent comparable revisions. • We would provide that hearing aids not be used during audiometric testing. • We would require that an otoscopic examination be performed immediately before the audiometric testing to ensure that there are no conditions present that would prevent valid testing. • We would provide that we will not purchase physiologic testing. We are proposing this rule because such testing may require sedation. • We would describe the hearing testing that is appropriate for children in the age ranges of birth to the attainment of age 6 months, age 6 months to the attainment of age 2, age 2 to the attainment of age 5, and age 5 to the attainment of age 18. The proposed guidance for hearing testing for children age 5 to the attainment of age 18 is similar to the proposed guidance for hearing testing in adults, except for the frequencies needed to determine the hearing threshold. • We would revise the frequency levels used to determine the pure tone air conduction or bone conduction threshold from 500, 1000, 2000, and 3000 Hz to 500, 1000, 2000, and 4000 Hz. We received several comments in response to our ANPRM recommending that we make this change in how we determine the hearing threshold. Additionally, our adjudicative experience has shown that testing is often not done at 3000 Hz. We considered using the same hearing thresholds as in adults, but propose to continue to use 4000 Hz because of the importance of hearing at higher frequencies to a child’s ability to learn speech. • We would describe screening tests, such as otoacoustic emissions (OAE), and explain how we use them. We propose to provide this guidance because hearing screening tests are commonly given to children in newborn nurseries and schools. We do not propose to add this guidance to the introductory text for adults because hearing screening tests are not commonly given to adults. Proposed 102.00B3—What audiometric testing do we need when you have a cochlear implant? This new section is similar to proposed 2.00B3 except that we provide that a child who has a cochlear implant will be disabled until age 5 or until 1 year after implantation, whichever is later. We propose to consider children with cochlear implants to be disabled until age 5 because of the extensive rehabilitation and training needed for PO 00000 Frm 00007 Fmt 4702 Sfmt 4702 47107 young children with cochlear implants to acquire speech and language skills. We would also explain that after that period, we will evaluate your hearing loss by measuring your word recognition ability on the HINT or the Hearing in Noise Test for Children (HINT–C). Proposed 102.00B5—What do we mean by a marked limitation in speech or language as used in 102.10B2? In this new section, we explain when we will consider you to have a marked limitation in speech or language. How are we proposing to change the criteria in the special senses and speech listings for children? 102.01 Category of Impairments, Special Senses and Speech For the reasons mentioned in our discussion of 2.01 above, we propose to add a separate listing to evaluate hearing loss treated with cochlear implantation. Because we are proposing to add a listing, we also propose to renumber the listings for ease of reference. We would revise current listing 102.08, ‘‘Hearing impairments,’’ renumber it as listing 102.10, ‘‘Hearing loss not treated with cochlear implantation,’’ and add listing 102.11, ‘‘Hearing loss treated with cochlear implantation.’’ Proposed 102.10—Hearing Loss Not Treated With Cochlear Implantation This proposed listing would revise current listing 102.08, ‘‘Hearing impairments,’’ and specify that it applies to children who do not have cochlear implants. The current childhood listing requires that we assess your ability to hear with a hearing aid unless we determine that you are not able to use the aid effectively. For the reasons we stated in the discussion of proposed listing 2.10 above, we propose to no longer require aided hearing testing to determine if your hearing loss meets the listing. Proposed listing 102.10A would replace current listing 102.08A. This proposed listing contains the criterion for evaluating hearing loss in children under age 5 who do not have a cochlear implant. We propose to replace the current criterion for an aided average hearing threshold of 40 dB in the better ear with a criterion for an unaided average air conduction hearing threshold of 50 dB or greater in the better ear. We propose to use a threshold of 50 dB because we believe that, even with the use of a hearing aid, a child under age 5 who has a 50 dB hearing loss will also have a marked limitation in speech or language. E:\FR\FM\13AUP1.SGM 13AUP1 47108 Federal Register / Vol. 73, No. 157 / Wednesday, August 13, 2008 / Proposed Rules Proposed listing 102.10B would replace current listing 102.08B. This proposed listing contains the criteria for evaluating hearing loss in children from age 5 to the attainment of age 18. For the reasons we explained earlier, we propose to no longer require aided hearing testing. Proposed listing 102.10B1 would correspond to current listing 102.08B1. Current listing 102.08B1 generally requires an aided average air conduction hearing threshold of 70 dB or greater in the better ear. We would expect hearing loss at that level to have a sensorineural component. (A sensorineural hearing loss is caused by permanent damage to the inner ear or to the nerve pathways from the inner ear to the brain.) We propose to replace the criterion in current listing 102.08B1 with an unaided average air conduction hearing threshold of 70 dB or greater in the better ear. In order to ensure that hearing loss at this level has a sensorineural component, we also propose to add a criterion in proposed listing 102.10B1 for an average bone conduction hearing threshold of 40 dB or greater in the better ear. We would continue to use a 70 dB average air conduction hearing threshold because we believe a hearing loss with a sensorineural component at this level will significantly affect a child’s ability to engage in learning. Also, we do not use the same hearing threshold levels for children from age 5 to the attainment of age 18 as we use for adults because of the importance of hearing to a child’s ability to communicate and learn. Proposed listing 102.10B2 would correspond to current listing 102.08B2. We propose to make the same editorial changes as we did in proposed listing 2.10B. Proposed listing 102.10B3 would correspond to current listing 102.08B3. As we discussed in our explanation of proposed listing 102.10A above, we propose to use an unaided hearing threshold of 50 dB in the better ear. Because children typically acquire basic speech and language skills by age 5, we believe that it is not appropriate to presume that a child over age 5 who has a 50 dB hearing loss will also have a marked limitation in speech or language. Therefore, for children over age 5, we also propose to require an assessment of speech and language skills. Proposed 102.11—Hearing Loss Treated With Cochlear Implantation This proposed listing is similar to proposed listing 2.11 except that we propose to consider you to be under a disability until age 5, or for 1 year after implantation, whichever is later. We also propose to use either the HINT or the HINT–C to assess your word recognition ability. What programs would these proposed regulations affect? These proposed rules would affect disability determinations and decisions that we make under titles II and XVI of the Act. In addition, to the extent that Medicare entitlement and Medicaid eligibility are based on whether you qualify for disability benefits under title II or title XVI, these proposed rules would also affect the Medicare and Medicaid programs. Who can get disability benefits? Under title II of the Act, we provide for the payment of disability benefits if you are disabled and belong to one of the following three groups: • Workers insured under the Act, • Children of insured workers, and • Widows, widowers, and surviving divorced spouses (see § 404.336) of insured workers. Under title XVI of the Act, we provide for Supplemental Security Income (SSI) payments on the basis of disability if you are disabled and have limited income and resources. How do we define disability? Under both the title II and title XVI programs, disability must be the result of any medically determinable physical or mental impairment or combination of impairments that is expected to result in death or which has lasted or can be expected to last for a continuous period of at least 12 months. Our definitions of disability are shown in the following table: If you file a claim under . . . And you are . . . Disability means you have a medically determinable impairment(s) as described above and that results in . . . title II ................................................ title XVI ............................................ title XVI ............................................ an adult or a child .......................... an individual age 18 or older ......... an individual under age 18 ............ the inability to do any substantial gainful activity (SGA). the inability to do any SGA. marked and severe functional limitations. hsrobinson on PROD1PC76 with PROPOSALS How do we decide whether you are disabled? If you are applying for benefits under title II of the Act, or if you are an adult applying for payments under title XVI of the Act, we use a five-step ‘‘sequential evaluation process’’ to decide whether you are disabled. We describe this fivestep process in our regulations at §§ 404.1520 and 416.920. We follow the five steps in order and stop as soon as we can make a determination or decision. The steps are: 1. Are you working, and is the work you are doing substantial gainful activity? If you are working and the work you are doing is substantial gainful activity, we will find that you are not disabled, regardless of your medical condition or your age, VerDate Aug<31>2005 15:58 Aug 12, 2008 Jkt 214001 education, and work experience. If you are not, we will go on to step 2. 2. Do you have a ‘‘severe’’ impairment? If you do not have an impairment or combination of impairments that significantly limits your physical or mental ability to do basic work activities, we will find that you are not disabled. If you do, we will go on to step 3. 3. Do you have an impairment(s) that meets or medically equals the severity of an impairment in the listings? If you do, and the impairment(s) meets the duration requirement, we will find that you are disabled. If you do not, we will go on to step 4. 4. Do you have the residual functional capacity (RFC) to do your past relevant work? If you do, we will find that you PO 00000 Frm 00008 Fmt 4702 Sfmt 4702 are not disabled. If you do not, we will go on to step 5. 5. Does your impairment(s) prevent you from doing any other work that exists in significant numbers in the national economy, considering your RFC, age, education, and work experience? If it does, and it meets the duration requirement, we will find that you are disabled. If it does not, we will find that you are not disabled. We use a different sequential evaluation process for children who apply for payments based on disability under SSI. If you are already receiving benefits, we also use a different sequential evaluation process when we decide whether your disability continues. See §§ 404.1594, 416.924, 416.994, and 416.994a of our regulations. However, all of these E:\FR\FM\13AUP1.SGM 13AUP1 Federal Register / Vol. 73, No. 157 / Wednesday, August 13, 2008 / Proposed Rules processes include steps at which we consider whether your impairment(s) meets or medically equals one of our listings. What are the listings? The listings are examples of impairments that we consider severe enough to prevent you as an adult from doing any gainful activity. If you are a child seeking SSI payments based on disability, the listings describe impairments that we consider severe enough to result in marked and severe functional limitations. Although the listings are contained only in appendix 1 to subpart P of part 404 of our regulations, we incorporate them by reference in the SSI program in § 416.925 of our regulations and apply them to claims under both title II and title XVI of the Act. How do we use the listings? The listings are in two parts. There are listings for adults (part A) and for children (part B). If you are an individual age 18 or over, we apply the listings in part A when we assess your claim, and we never use the listings in part B. If you are an individual under age 18, we first use the criteria in part B of the listings. Part B contains criteria that apply only to individuals who are under age 18. If the criteria in part B do not apply, we may use the criteria in part A when those criteria give appropriate consideration to the effects of the impairment(s) in children. (See §§ 404.1525 and 416.925.) If your impairment(s) does not meet any listing, we will also consider whether it medically equals any listing; that is, whether it is as medically severe as an impairment in the listings. (See §§ 404.1526 and 416.926.) hsrobinson on PROD1PC76 with PROPOSALS What if you do not have an impairment(s) that meets or medically equals a listing? We use the listings only to decide that you are disabled or that you are still disabled. We will not deny your claim or decide that you no longer qualify for benefits because your impairment(s) does not meet or medically equal a listing. If you have a severe impairment(s) that does not meet or medically equal any listing, we may still find you disabled based on other rules in the ‘‘sequential evaluation process.’’ Likewise, we will not decide that your disability has ended only because your impairment(s) no longer meets or medically equals a listing. VerDate Aug<31>2005 15:58 Aug 12, 2008 Jkt 214001 Also, when we conduct reviews to determine whether your disability continues, we will not find that your disability has ended because we have changed a listing. Our regulations explain that, when we change our listings, we continue to use our prior listings when we review your case, if you qualified for disability benefits or SSI payments based on our determination or decision that your impairment(s) met or medically equaled a listing. In these cases, we determine whether you have experienced medical improvement, and if so, whether the medical improvement is related to the ability to work. If your condition(s) has medically improved so that your impairment(s) no longer meets or medically equals the prior listing, we evaluate your case further to determine whether you are currently disabled. We may find that you are currently disabled, depending on the full circumstances of your case. See §§ 404.1594(c)(3)(i) and 416.994(b)(2)(iv)(A). If you are a child who is eligible for SSI payments, we follow a similar rule when we decide that you have experienced medical improvement in your condition(s). See § 416.994a(b)(2). When will we start to use these rules? We will not use these rules until we evaluate the public comments we receive on them, determine whether they should be issued as final rules, and issue final rules in the Federal Register. If we publish final rules, we will explain in the preamble how we will apply them, and summarize and respond to the public comments. Until the effective date of any final rules, we will continue to use our current rules. How long would these proposed rules be effective? If we publish these proposed rules as final rules, they will remain in effect for 8 years after the date they became effective, unless we extend them, or revise and issue them again. Clarity of these proposed rules Executive Order 12866, as amended, requires each agency to write all rules in plain language. In addition to your substantive comments on these proposed rules, we invite your comments on how to make them easier to understand. For example: • Have we organized the material to suit your needs? • Are the requirements in the rules clearly stated? PO 00000 Frm 00009 Fmt 4702 Sfmt 4702 47109 • Do the rules contain technical language or jargon that is not clear? • Would a different format (grouping and order of sections, use of headings, paragraphing) make the rules easier to understand? • Would more (but shorter) sections be better? • Could we improve clarity by adding tables, lists, or diagrams? • What else could we do to make the rules easier to understand? Regulatory Procedures Executive Order 12866 We have consulted with the Office of Management and Budget (OMB) and determined that these proposed rules meet the requirements for a significant regulatory action under Executive Order 12866, as amended. Thus, they were subject to OMB review. Regulatory Flexibility Act We certify that these proposed rules would not have a significant economic impact on a substantial number of small entities because they affect only individuals. Thus, a regulatory flexibility analysis as provided in the Regulatory Flexibility Act, as amended, is not required. Paperwork Reduction Act In these regulations, we are proposing to: (1) Revise the listings for hearing loss to update the medical criteria in the listings; (2) provide more information about how we evaluate hearing loss; and (3) reflect our adjudicative experience. The listings for hearing loss are in the special senses and speech body system. That body system also includes listings for visual disorders, disturbances of labyrinthine-vestibular function and loss of speech. In this NPRM, we are proposing changes only to the listings for hearing loss. As part of the listings, we identify specific documentation requirements used in evaluating impairments within a body system, including medical and other evidence. The documentation and evidentiary requirements are public reporting burdens that must be cleared by OMB under the Paperwork Reduction Act. However, the public reporting burdens are accounted for in the Information Collection Requests for the various forms that the public uses to submit the information to SSA. Consequently, we are reporting no burden for this regulation aside from a 1-hour placeholder burden shown in the chart below, for the sections listed. E:\FR\FM\13AUP1.SGM 13AUP1 47110 Federal Register / Vol. 73, No. 157 / Wednesday, August 13, 2008 / Proposed Rules PART 404—FEDERAL OLD-AGE, SURVIVORS AND DISABILITY INSURANCE Title/section & collection description Annual number of respondents Frequency of response Average burden per response (minutes) Hearing Loss (2.00B and 102.00B) ................................................................. ........................ ........................ ........................ An Information Collection Request has been submitted to OMB for clearance. We are soliciting comments on the burden estimate; the need for the information; its practical utility; ways to enhance its quality, utility and clarity; and ways to minimize the burden on respondents, including the use of automated collection techniques or other forms of information technology. Requests for the Information Collection Request package and/or comments should be directed to SSA and OMB at the following addresses/phone numbers: Office of Management and Budget, Attn: Desk Officer for SSA, Fax Number: 202–395–6974, E-mail address: OIRA_ Submission@omb.eop.gov. Social Security Administration, Attn: Reports Clearance Officer, 1333 Annex Building, 6401 Security Blvd., Baltimore, MD 21235, Fax: 410–965– 6400, E-mail address: OPLM.RCO@ssa.gov. Comments on the paperwork burdens associated with this rule can be received for up to 60 days after publication of this notice and will be most useful if received within 30 days of publication. This does not affect the deadline for the public to comment to SSA on the proposed regulations. These information collection requirements will not become effective until approved by OMB. When OMB has approved these information collection requirements, SSA will publish a notice in the Federal Register. List of References hsrobinson on PROD1PC76 with PROPOSALS During the development of these proposed rules, we reviewed the following information: American Speech-Language-Hearing Association (ASHA). (2004). Guidelines for the audiologic assessment of children from birth to 5 years of age [Guidelines]. (Available at http://www.asha.org/NR/ rdonlyres/0BB7C840–27D2–4DC6–861B– 1709ADD78BAF/0/v2GLAudAssess Child.pdf.) ASHA. (2004). Technical report: Cochlear implants. ASHA Supplement 24. (Available at http://www.asha.org/NR/ rdonlyres/215CC9B8–6831–494F–83ED– E02A6832A8A9/0/v2TRcochlear implants.pdf.) Centers for Medicare & Medicaid Services. (2005). MLN Matters Number MM3796: Cochlear Implantation. (Available at http:// VerDate Aug<31>2005 15:58 Aug 12, 2008 Jkt 214001 www.cms.hhs.gov/MLNMattersArticles/ downloads/MM3796.pdf.) Cunningham. M. and Cox, E.O. (2003). Hearing assessment in infants and children: Recommendations beyond neonatal screening. Pediatrics, 111(2), 436– 440. Dale, D.C. and Federman, D.D., eds. Neurology. ACP Medicine. (2004) Elliot M. Frohman, New York: WebMD Professional Publishing. Gifford, R.H. and Shallop, J.K. (2007). Hearing preservation in patients with a cochlear implant. The ASHA Leader, 12(14), 15, 17, 34. Gorga, M.P., et al. (2006). Using a combination of click- and tone burstevoked auditory brain stem response measurements to estimate pure-tone thresholds. Ear & Hearing, 27(1), 60–74. Joint Committee on Infant Hearing. (2000). Year 2000 position statement: Principles and guidelines for early hearing detection and intervention programs. Pediatrics, 106(4), 798–817. Joint Committee on Infant Hearing. (2007). Year 2007 position statement: Principles and guidelines for early hearing detection and intervention programs. Pediatrics, 120(4), 898–921. National Research Council (NRC): Committee on Disability Determination for Individuals with Hearing Impairments. (2005). Hearing Loss: Determining Eligibility for Social Security Benefits. Washington, DC: National Academy Press. (Available at http://www.nap.edu/ catalog.php?record_id=11099#toc.) Pittman, A.L., & Stelmachowicz, P.G. (2003). Hearing loss in children and adults: Audiometric configuration, asymmetry, and progression. Ear & Hearing, 24(3), 198–205. U.S. Food and Drug Administration, Center for Devices and Radiological Health. (2007). Benefits and Risks of Cochlear Implants. (Available at: http:// www.fda.gov/cdrh/cochlear/ RiskBenefit.html.) These references are included in the rulemaking record for these proposed rules and are available for inspection by interested individuals making arrangements with the contact person shown in this preamble. (Catalog of Federal Domestic 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) PO 00000 Frm 00010 Fmt 4702 Sfmt 4702 Estimated annual burden (hours) 1 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. Dated: May 12, 2008. Michael J. Astrue, Commissioner of Social Security. Editorial Note: This document was received at the Office of the Federal Register on August 8, 2008. For the reasons set out in the preamble, we propose to amend 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– ) 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] 2. Appendix 1 to subpart P of part 404 is amended as follows: a. Revise item 3 of the introductory text before part A of appendix 1. b. Revise section 2.00B of part A of appendix 1. c. Redesignate section 2.00C of part A of appendix 1 as section 2.00E. d. Add new sections 2.00C and 2.00D to part A of appendix 1. e. Remove listing 2.08 of part A of appendix 1. f. Add listings 2.10 and 2.11 to part A of appendix 1. g. Revise section 102.00B of part B of appendix 1. h. Remove listing 102.08 of part B of appendix 1. i. 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 * E:\FR\FM\13AUP1.SGM * * 13AUP1 * * Federal Register / Vol. 73, No. 157 / Wednesday, August 13, 2008 / Proposed Rules 3. Special Senses and Speech (2.00 and 102.00): [Insert date 8 years from the effective date of the final rules]. * * * * * Part A * * * * * 2.00 Special Senses and Speech hsrobinson on PROD1PC76 with PROPOSALS * * * * * B. How do we evaluate hearing loss? 1. What evidence do we need to evaluate hearing loss? a. To establish that you have a medically determinable impairment that causes your hearing loss, we require both a complete otologic examination and audiometric testing. The audiometric testing should be performed within 2 months of the complete otologic examination. b. A complete otologic examination must include your medical history, your description of how your hearing loss affects you, a description of the appearance of the external ear (pinna and the external ear canal), an evaluation of the tympanic membrane, and an assessment of any middle ear abnormalities. c. After your impairment has been established, we can use the results of subsequent audiometric testing to assess the severity of your hearing loss without another complete otologic examination. d. Audiometric testing must be performed by, or under the supervision of, an otolaryngologist or by an audiologist qualified to perform such tests. We consider an audiologist to be qualified if the audiologist is currently and fully licensed or registered as a clinical audiologist by the state or U.S. territory in which he or she practices. If no licensure or registration is available, the audiologist must be currently certified by the American Board of Audiology or have a Certificate of Clinical Competence (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, and word recognition testing. (Word recognition testing may be referred to as word discrimination or speech discrimination testing.) This testing must be conducted in a soundproof booth and each ear must be tested separately. Pure tone air conduction and bone conduction testing must be conducted in accordance with the most recently published standards of the American National Standards Institute (ANSI) for air conduction and bone conduction stimuli. VerDate Aug<31>2005 15:58 Aug 12, 2008 Jkt 214001 b. You must not wear hearing aids during the testing. Additionally, we require that an otoscopic examination be performed immediately before the audiometric testing. An otoscopic examination provides a description of the appearance of the external ear canal and an evaluation of the tympanic membrane. The otoscopic examination must also show that there are no conditions present that would prevent valid audiometric testing. Examples of such conditions are fluid in the ear, an ear infection, or an obstruction in the ear canal. c. An audiological examination usually includes pure tone air conduction and bone conduction testing measured at 250, 500, 1000, 2000, and 4000 Hertz (Hz). To determine whether your hearing loss meets the air conduction criterion in 2.10A, we will average the air conduction hearing thresholds at 500, 1000, and 2000 Hz. To determine whether your hearing loss meets the bone conduction criterion in 2.10A, we will average the bone conduction hearing thresholds at 500, 1000, and 2000 Hz. d. The SRT is the minimal decibel (dB) level required for you to recognize a standard list of words. 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 should be documented. 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 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. The individual 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 implantation. b. After that period, we need word recognition testing performed with the Hearing in Noise Test (HINT). This testing must be conducted in quiet in a sound field with your implant adjusted to your normal settings. The sentences should be presented at 60 dB HL PO 00000 Frm 00011 Fmt 4702 Sfmt 4702 47111 (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, 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 individuals 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? 1. These disturbances of balance are characterized by a hallucination of motion or a loss of position sense and a sensation of dizziness which may be constant or may occur in paroxysmal attacks. Nausea, vomiting, ataxia, and incapacitation are frequently observed, particularly during the acute attack. It is important to differentiate the report of rotary vertigo from that of ‘‘dizziness,’’ which is described as light-headedness, unsteadiness, confusion, or syncope. 2. Meniere’s disease is characterized by paroxysmal attacks of vertigo, tinnitus, and fluctuating hearing loss. Remissions are unpredictable and irregular, but may be long-lasting; hence, the severity of the impairment is best determined after prolonged observation and serial reexaminations. 3. The diagnosis of a vestibular disorder requires a comprehensive neuro-otolaryngologic examination with a detailed description of the vertiginous episodes, including notation of frequency, severity, and duration of the attacks. Pure tone and speech audiometry with the appropriate special examinations, such as Bekesy audiometry, are necessary. Vestibular function is assessed by positional and caloric testing, preferably by electronystagmography. When polytomograms, contrast radiography, or other special tests have been performed, copies of the reports of these tests should be obtained in addition to appropriate medically acceptable imaging reports of the skull and temporal bone. Medically acceptable imaging includes, but is not limited to, x-ray imaging, computerized axial tomography (CAT scan) or magnetic resonance imaging (MRI), with or E:\FR\FM\13AUP1.SGM 13AUP1 47112 Federal Register / Vol. 73, No. 157 / Wednesday, August 13, 2008 / Proposed Rules without contrast material, myelography, and radionuclear bone scans. ‘‘Appropriate’’ means that the technique is the proper one to support the evaluation and diagnosis of the impairment. D. Loss of speech. In evaluating the loss of speech, the ability to produce speech by any means includes the use of mechanical or electronic devices that improve voice or articulation. Impairments of speech may also be evaluated under the body system for the underlying disorders, such as neurological disorders, 11.00ff. * * * * * 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 implantation; or B. If more than 1 year after implantation, a word recognition score of 60 percent or less determined using the HINT (see 2.00B3b). * * * * * Part B * * * * * 102.00 Special Senses and Speech hsrobinson on PROD1PC76 with PROPOSALS * * * * * B. How do we evaluate hearing loss? 1. What evidence do we need to evaluate hearing loss? a. To establish that you have a medically determinable impairment that causes your hearing loss, we require both a complete otologic examination and audiometric testing. The audiometric testing should be performed within 2 months of the complete otologic examination. b. A complete otologic examination must include your medical history, your description of how your hearing loss affects you, a description of the appearance of the external ear (pinna and the external ear canal), an evaluation of the tympanic membrane, and an assessment of any middle ear abnormalities. c. After your impairment has been established, we can use the results of VerDate Aug<31>2005 15:58 Aug 12, 2008 Jkt 214001 subsequent audiometric testing to assess the severity of your hearing loss without another complete otologic examination. d. Audiometric testing must be performed by, or under the supervision of, an otolaryngologist or by an audiologist qualified to perform such tests. We consider an audiologist to be qualified if the audiologist is currently and fully licensed or registered as a clinical audiologist by the state or U.S. territory in which he or she practices. If no licensure or registration is available, the audiologist must be currently certified by the American Board of Audiology or have a Certificate of Clinical Competence (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 generally need behavioral or physiologic testing (other than screening testing, see 102.00B3g) that is appropriate for your age at the time of testing. We will make every reasonable effort to obtain the results of physiologic testing that has been done. However, if this testing has not been done, or, if we cannot obtain the results, we will not purchase it. In these situations, we will evaluate your hearing loss based on the other evidence in your case record. b. Testing requirements. The testing must be conducted in accordance with the most recently published standards of the American National Standards Institute (ANSI) for air conduction stimuli, and if appropriate, bone conduction stimuli. You must not wear hearing aids during the testing. Additionally, we require that an otoscopic examination be performed immediately before the audiometric testing. An otoscopic examination provides a description of the appearance of the external ear canal and an evaluation of the tympanic membrane. The otoscopic examination must also show that there are no conditions present that would prevent valid audiometric testing. Examples of such conditions are fluid in the ear, an ear infection, or an obstruction in the ear canal. c. Children from birth to the attainment of age 6 months. i. We need physiologic testing, such as auditory brainstem response (ABR) testing, that measures the frequencies needed to recognize speech; that is, the range from 500 to 4000 Hertz (Hz). We also need an acoustic immittance assessment; that is, a tympanogram and acoustic reflex testing. ii. To determine whether your hearing loss meets listing 102.10A, we will PO 00000 Frm 00012 Fmt 4702 Sfmt 4702 average the hearing thresholds at 500, 1000, 2000, and 4000 Hz. 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), and an acoustic immittance assessment. We can use ABR testing results if the behavioral assessment cannot be completed or if the results of the behavioral assessment are inconclusive or unreliable. ii. To determine whether your hearing loss meets listing 102.10A, we will average the hearing thresholds at 500, 1000, 2000, and 4000 Hz. 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, and an acoustic immittance assessment. We can use ABR testing results if the behavioral assessment cannot be completed or if the results of the behavioral assessment are inconclusive or unreliable. ii. To determine whether your hearing loss meets listing 102.10A, we will average the hearing thresholds at 500, 1000, 2000, and 4000 Hz. 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, and word recognition testing. (Word recognition testing may be referred to as word discrimination or speech discrimination testing.) This testing must be conducted in a soundproof booth and each ear must be tested separately. ii. An audiological examination usually includes pure tone air conduction and bone conduction testing measured at 250, 500, 1000, 2000, and 4000 Hz. To determine whether your hearing loss meets the air conduction criterion in 102.10B1 or 102.10B3, we will average the air conduction hearing thresholds at 500, 1000, 2000, and 4000 E:\FR\FM\13AUP1.SGM 13AUP1 hsrobinson on PROD1PC76 with PROPOSALS Federal Register / Vol. 73, No. 157 / Wednesday, August 13, 2008 / Proposed Rules Hz. To determine whether your hearing loss meets the bone conduction criterion in 102.10B1, we will average the bone conduction hearing thresholds at 500, 1000, 2000, and 4000 Hz. iii. The SRT is the minimal decibel (dB) level required for you to recognize a standard list of words. 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 should be documented. iv. 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 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. The individual who performs the test should report your word recognition testing score at your highest comfortable level of amplification. g. Screening Testing. ABR and other physiologic testing, such as otoacoustic emissions (OAE), can be used as hearing screening tests. When such testing is used as hearing screening tests, we will not use the results to determine that your hearing loss meets or medically equals a listing, or to assess functional limitations due to your hearing loss. We can, however, consider normal results from hearing screening tests to determine whether your hearing loss is severe when these test results are consistent with the other evidence in your case record. See § 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 implantation, whichever is later. b. After that period, we need word recognition testing performed with the Hearing in Noise Test (HINT) or the Hearing in Noise Test for Children (HINT–C). This testing must be conducted in quiet in a sound field with your implant 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, it may not be possible to measure your word recognition ability. VerDate Aug<31>2005 15:58 Aug 12, 2008 Jkt 214001 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 individuals 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. According to the unfamiliar listener, entire phrases or sentences in your conversation are intelligible approximately 60 percent of the time or less on the 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 PO 00000 Frm 00013 Fmt 4702 Sfmt 4702 47113 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 implantation, whichever is later; or B. Upon the attainment of age 5 or 1 year after 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. E8–18718 Filed 8–12–08; 8:45 am] BILLING CODE 4191–02–P LIBRARY OF CONGRESS Copyright Office 37 CFR Part 201 and 255 [Docket No. RM 2000–7] Compulsory License for Making and Distributing Phonorecords, Including Digital Phonorecord Deliveries Copyright Office, Library of Congress. ACTION: Extension of time to file comments and reply comments; Notice of Hearing. AGENCY: SUMMARY: The Copyright Office is extending the time in which comments and reply comments may be filed in response to its Notice of Proposed Rulemaking proposing to amend its regulations to clarify the scope and application of the Section 115 compulsory license to make and distribute phonorecords of a musical work by means of digital phonorecord deliveries. 73 FR 40802. The Office is also announcing a hearing on the proposed rulemaking to take place on September 19, 2008. DATES: Comments must be received in the Office of the General Counsel of the Copyright Office no later than Thursday, August 28, 2008 at 5:00 p.m. Reply Comments must be received no later than Monday, September 15, 2008 at 5:00 p.m. The hearing will take place on Friday, September 19, 2008, commencing at 10:00 a.m. in the Copyright Hearing Room at the Library of Congress, Room LM–408, 4th Floor, James Madison Building, 101 Independence Avenue, SE, Washington, DC. Requests to testify at the hearing must be received in writing no later E:\FR\FM\13AUP1.SGM 13AUP1

Agencies

[Federal Register Volume 73, Number 157 (Wednesday, August 13, 2008)]
[Proposed Rules]
[Pages 47103-47113]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-18718]


=======================================================================
-----------------------------------------------------------------------

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: Notice of proposed rulemaking.

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

SUMMARY: We propose to revise the criteria in the Listing of 
Impairments (the listings) that we use to evaluate claims involving 
hearing loss. We apply these criteria when you claim benefits based on 
disability under title II and title XVI of the Social Security Act (the 
Act). The proposed revisions reflect current medical knowledge, 
treatment, and methods of evaluating hearing loss, as well as our 
adjudicative experience since the publication of the current rules.

DATES: To be sure that your comments are considered, we must receive 
them by October 14, 2008.

ADDRESSES: You may submit comments by any one of four methods--
Internet, facsimile, regular mail, or hand-delivery. Commenters should 
not submit the same comments multiple times or by more than one method. 
Regardless of which of the following methods you choose, please state 
that your comments refer to Docket No. SSA-2008-0016 to ensure that we 
can associate your comments with the correct regulation:
    1. Federal eRulemaking portal at http://www.regulations.gov. (This 
is the most expedient method for submitting your comments, and we 
strongly urge you to use it.) In the Comment or Submission section of 
the webpage, type ``SSA-2008-0016,'' select ``Go,'' and then click 
``Send a Comment or

[[Page 47104]]

Submission.'' The Federal eRulemaking portal issues you a tracking 
number when you submit a comment.
    2. Telefax to (410) 966-2830.
    3. Letter to the Commissioner of Social Security, P.O. Box 17703, 
Baltimore, MD 21235-7703.
    4. Deliver your comments to the Office of Regulations, Social 
Security Administration, 922 Altmeyer Building, 6401 Security 
Boulevard, Baltimore, MD 21235-6401, between 8 a.m. and 4:30 p.m. on 
regular business days.
    All comments are posted on the Federal eRulemaking portal, although 
they may not appear for several days after receipt of the comment. You 
may also inspect the comments on regular business days by making 
arrangements with the contact person shown in this preamble.
    Caution: All comments we receive from members of the public are 
available for public viewing in their entirety on the Federal 
eRulemaking portal at http://www.regulations.gov. Therefore, you should 
be careful to include in your comments only information that you wish 
to make publicly available on the Internet. We strongly urge you not to 
include any personal information, such as your Social Security number 
or medical information, in your comments.

FOR FURTHER INFORMATION CONTACT: Diane Braunstein, Director, Office of 
Compassionate Allowances and Listings Improvement, 6401 Security 
Boulevard, Baltimore, MD 21235-6401, (410) 965-1020. 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.

Why are we proposing to revise the listings for hearing loss?

    We are proposing to revise the listings for hearing loss to update 
the medical criteria in the listings, to provide more information about 
how we evaluate hearing loss, and to reflect our adjudicative 
experience. The listings for hearing loss are in the special senses and 
speech body system. That body system also includes listings for visual 
disorders, disturbances of labyrinthine-vestibular function, and loss 
of speech. In this Notice of Proposed Rulemaking (NPRM), we are 
proposing changes only to the listings for hearing loss. We published 
final rules revising the listings for visual disorders in the Federal 
Register on November 20, 2006 (71 FR 67037). We intend to publish 
separately proposed rules that would update the criteria for 
disturbances of labyrinthine-vestibular function and loss of speech.
    Prior to the publication of the final rules for evaluating visual 
disorders mentioned above, we last published final rules making 
comprehensive revisions to the part A special senses and speech 
listings in the Federal Register on March 27, 1979 (44 FR 18170), and 
final rules making comprehensive revisions to the part B special senses 
and speech listings in the Federal Register on March 16, 1977 (42 FR 
14705). The current special senses and speech listings will no longer 
be effective on February 20, 2015, unless we extend them, or revise and 
issue them again.

How did we develop these proposed rules?

    We developed these proposed rules based on our adjudicative 
experience and advances in medical knowledge, treatment, and methods of 
evaluating hearing loss. These proposed rules also reflect comments we 
asked the public to provide to help us develop the proposals.
    We published an advance notice of proposed rulemaking (ANPRM) in 
the Federal Register on April 13, 2005 (70 FR 19353). The purpose of 
the ANPRM was to inform the public that we were planning to update and 
revise the rules we use to evaluate hearing impairments and disturbance 
of labyrinthine-vestibular function and to invite interested 
individuals and organizations to send us comments and suggestions for 
updating and revising the listings for these disorders. In the ANPRM, 
we provided a 60-day period for comments and suggestions; that period 
ended on June 13, 2005. We received 13 letters and e-mails from medical 
experts, advocates, and State agencies that adjudicate claims for us, 
commenting on our criteria for hearing loss. Although we are not 
summarizing or responding to the comments in this notice, we read and 
considered them carefully. We are proposing changes to our rules for 
evaluating hearing loss based on some of the suggestions we received.
    We also hosted a policy conference on ``Hearing Impairments and 
Disturbance of Labyrinthine-Vestibular Function'' at Gallaudet 
University in Washington, DC, on November 7 and 8, 2005. At this 
conference, we heard comments and suggestions for updating and revising 
the rules we use to evaluate these disorders from individuals who have 
hearing loss or vestibular disorders, their family members, physicians 
who treat them, other professionals who work with them, and advocates 
who represent them. The transcript of this conference is available on 
our Web site at http://policy.ssa.gov/erm/rules.nsf/
5da82b031a6677dc85256b41006b7f8d/
9314dd803ad5579885256fe200496264!OpenDocument.
    Several of the changes to the criteria for evaluating hearing loss 
that we propose in these rules are based on information we obtained 
from individuals at this conference.

How are we proposing to change the introductory text to the special 
senses and speech listings for adults?

2.00 Special Senses and Speech

    We propose to reorganize and expand the second through fifth 
paragraphs of current 2.00B1, ``Hearing impairment,'' to provide 
additional guidance. We propose to remove the guidance in the first 
paragraph of current 2.00B1, which states that hearing ability should 
be evaluated in terms of the person's ability to hear and distinguish 
speech. Because our current and proposed listings provide for using 
tones to evaluate hearing loss, this language may be misleading. We 
also propose to remove the guidance in the last paragraph of current 
2.00B1, which provides that cases of alleged ``deaf mutism'' should be 
documented by a hearing evaluation. This guidance refers only to the 
evaluation of deaf mutism as a hearing impairment; however, we can also 
evaluate cases of alleged mutism under listing 2.09, for loss of 
speech. In that case, we would not need a hearing test. We are not 
proposing special requirements for evaluating hearing loss if you have 
deaf mutism; we would require the same documentation as for other 
hearing disorders.
    We also propose to redesignate current 2.00B2, ``Vertigo associated 
with disturbances of labyrinthine-vestibular function, including 
Meniere's disease,'' as proposed 2.00C, and to redesignate current 
2.00B3, ``Loss of speech,'' as proposed 2.00D. We are proposing 
separate sections for these disorders to recognize that they are not 
always associated with hearing loss. Although we are not proposing any 
substantive changes to these sections at this time, we are proposing to 
make minor editorial changes so that the format of these sections will 
be consistent with other sections of the introductory text in these 
proposed rules. Because of these changes, we also propose to 
redesignate

[[Page 47105]]

current 2.00C, ``How do we evaluate impairments that do not meet one of 
the special senses and speech listings?'' as proposed 2.00E.
    The following is a detailed explanation of proposed 2.00B.
Proposed 2.00B--How do we evaluate hearing loss?
Proposed 2.00B1--What evidence do we need to evaluate hearing loss?
    This proposed section revises the fourth and fifth paragraphs of 
current 2.00B1as follows:
     The fourth paragraph of current 2.00B1 provides that an 
otolaryngologic examination should precede audiometric testing. We 
propose to remove the requirement for an otolaryngologic examination 
and instead require a complete otologic examination. We would make this 
change because an otolaryngologic examination contains elements, such 
as an evaluation of the head, face, and neck, that are not needed to 
assess hearing loss. As we describe in proposed 2.00B1b, a complete 
otologic examination must include the medical history, a description of 
how the hearing loss affects the individual, a description of the 
appearance of the external ear (pinna and the external ear canal), an 
evaluation of the tympanic membrane, and an assessment of any middle 
ear abnormalities.
     We also propose to revise the guidance in the current 
rules that the otolaryngologic examination should precede the 
audiometric testing and instead provide that the audiometric testing 
should be performed within 2 months of the complete otologic 
examination. Having the otologic examination precede the audiometric 
testing can help identify conditions that could interfere with the 
audiometric testing. However, having the otologic examination follow 
the audiometric testing will allow the physician to consider the 
results of that testing in reaching his or her conclusions about the 
individual's hearing loss. We believe that either sequence is 
acceptable for determining whether the individual has a medically 
determinable impairment that has resulted in hearing loss. However, we 
would appreciate having specific comments on this change, replacing an 
otolaryngologic examination with an otologic examination.
     Lastly, we propose to revise the current requirement in 
the fifth paragraph of 2.00B1 that an otolaryngologic examination be 
performed in conjunction with any audiometric testing used to assess 
the severity of the hearing loss. As indicated above, we propose to 
require a complete otologic examination instead of an otolaryngologic 
examination. Additionally, we propose that the complete otologic 
examination be required only to establish that a medically determinable 
impairment exists. After the impairment is established, we propose to 
allow the severity of the hearing loss to be determined based on 
audiometric testing without another complete otologic examination.
Proposed 2.00B2--What audiometric testing do we need when you do not 
have a cochlear implant?
    This proposed section expands and clarifies the guidance in the 
second, third, and fifth paragraphs of current 2.00B1 as follows:
     We would replace the term ``speech discrimination'' with 
``word recognition testing'' to reflect current medical terminology. In 
addition, we would add a parenthetical statement to explain that this 
testing may also be referred to as word discrimination or speech 
discrimination testing.
     We would clarify that we require that pure tone air 
conduction and bone conduction testing must be conducted in accordance 
with the most recently published American National Standards Institute 
(ANSI) standards for air conduction and bone conduction stimuli. Our 
current rules provide that audiometric testing be conducted in 
accordance with the 1969 and 1972 ANSI standards or subsequent 
comparable revisions.
     We would clarify that each ear must be tested separately 
and that hearing aids must not be worn during the testing. Our reasons 
for proposing to remove the current requirement that hearing be tested 
with aids in place are discussed in our explanation of proposed listing 
2.10 below. We also propose to require that the testing be conducted in 
a soundproof booth. Our current rules require that hearing measurements 
be performed in an environment which meets the 1977 ANSI standard for 
maximal permissible background sound.
     We would require that an otoscopic examination be 
performed immediately before the audiometric testing to ensure that 
there are no conditions present that would prevent valid testing. In 
proposed 2.00B2b, we explain that an otoscopic examination provides a 
description of the appearance of the external ear canal and an 
evaluation of the tympanic membrane.
     We would describe the frequencies at which pure tone air 
conduction and bone conduction are usually measured.
     We would incorporate the guidance in current listing 2.08A 
that explains that we average the pure tone hearing thresholds for air 
conduction and bone conduction at 500, 1000, and 2000 Hertz (Hz) to 
determine whether the listing criteria are met.
     We would explain that the speech reception threshold (SRT) 
is generally within 10 decibels (dB) of the average pure tone air 
conduction hearing thresholds at 500, 1000, and 2000 Hz. If it is not, 
the reason for the discrepancy should be documented.
     We would expand the guidance on word recognition testing 
and clarify that the words should be presented at a level of 
amplification that will measure your maximum discrimination ability, 
which is usually 35 to 40 dB above your SRT. We would also provide that 
the amplification level used in the testing must be medically 
appropriate and that you must be able to tolerate it.
Proposed 2.00B3--What audiometric testing do we need when you have a 
cochlear implant?
    In this new section, we propose to explain that we will consider 
you to be disabled until 1 year after implantation of a cochlear 
implant. We propose to add this criterion to recognize the length of 
the rehabilitation and training period needed to use a cochlear implant 
effectively.
    After that period, we propose to evaluate your hearing loss by 
measuring your word recognition ability on the Hearing in Noise Test 
(HINT). We propose to use the HINT because the American Academy of 
Neurology indicated in their comments in response to our ANPRM that the 
HINT is the ``accepted standard used to assess hearing outcome after 
cochlear implantation.'' We would also explain our requirements for how 
that testing should be conducted. Our proposed requirements are based 
on recommendations we received at our policy conference.
Proposed 2.00B4--How do we evaluate your word recognition ability if 
you are not fluent in English?
    Word recognition testing should be conducted using an appropriate 
word list. If you are not fluent in English, the testing should be 
conducted using an appropriate word list for the language in which you 
are most fluent. However, appropriate word lists are not available in 
all languages. Additionally, the individual conducting the test should 
also be fluent in the language used for

[[Page 47106]]

the test. If the test needs to be conducted in a language other than 
English, there may not be individuals available who are qualified to 
perform the testing in that language. Therefore, we propose to add this 
section to provide guidance on how we would evaluate your word 
recognition ability if you are not fluent in English.
    In this new section, we would provide that, if you are not fluent 
in English, it may not be possible to measure your word recognition 
ability. We would also explain that, if we cannot measure your word 
recognition ability because you are not fluent in English, your hearing 
loss cannot meet listing 2.10B or 2.11B. In this situation, we would 
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 
listing 2.10B or 2.11B. For example, we will consider how you interact 
with family members, interpreters, and other individuals who speak the 
language in which you are most fluent.
    We welcome and are very interested in receiving comments about 
other methods that you think we can use to evaluate word recognition 
ability for individuals who are not fluent in English and who have 
listing-level hearing disorders.

How are we proposing to change the criteria in the special senses and 
speech listings for adults?

2.01 Category of Impairments, Special Senses and Speech

    Under our current listings, we do not consider the effects of 
treatment with cochlear implantation on an individual's hearing loss. 
Due to advances in the technology used in cochlear implants, we believe 
it is now appropriate to consider the effects of cochlear implantation 
on an individual's hearing loss. Therefore, we propose to add a 
separate listing to evaluate hearing loss treated with cochlear 
implantation. Because we are proposing to add a listing, we also 
propose to renumber the listings for ease of reference. We would revise 
current listing 2.08, ``Hearing impairments,'' renumber it as listing 
2.10, ``Hearing loss not treated with cochlear implantation,'' and add 
listing 2.11, ``Hearing loss treated with cochlear implantation.''
Proposed Listing 2.10--Hearing Loss Not Treated With Cochlear 
Implantation
    In this proposed listing, we would revise current listing 2.08, 
``Hearing impairments,'' and specify that these criteria apply to 
individuals who do not have cochlear implants.
    Current listing 2.08 provides that a hearing loss is of listing-
level severity when ``hearing [is] not restorable by a hearing aid'' 
and satisfies either of the criteria in the listing. Our longstanding 
interpretation of the phrase ``hearing not restorable by a hearing 
aid'' is that the hearing loss is so severe that a hearing aid would 
not improve it to a level at which it no longer satisfies the listing 
criteria. To determine this, we need testing with a hearing aid.
    We propose to remove the requirement for testing with hearing aids 
for the following reasons:
     At our policy conference, we were advised that aided 
hearing testing is not usually performed in clinical practice.
     Audiometric testing with a hearing aid does not 
demonstrate whether the individual will be able to use the aid 
effectively.
     When we published the current listings, generic hearing 
aids were available for testing purposes. However, advances in 
technology have resulted in hearing aids that are programmed to address 
each individual's specific hearing loss. Due to this degree of 
specificity, generic aids are no longer widely available.
    Although we propose to no longer require aided testing, we are not 
proposing to change the level of hearing loss needed to demonstrate a 
listing-level impairment. Based on our adjudicative experience and the 
comments we received in response to our ANPRM and at our policy 
conference, we have determined that individuals with this level of 
hearing loss do not usually obtain significant improvement in their 
ability to hear and communicate from hearing aids. Therefore, we 
believe that without a cochlear implant, a hearing loss at the level 
specified in the current listing is indicative of listing-level 
severity even if the individual were to use hearing aids.
    Current listing 2.08A requires ``[a]verage hearing threshold 
sensitivity for air conduction of 90 decibels or greater, and for bone 
conduction to corresponding maximal levels, in the better ear, 
determined by the simple average of hearing threshold levels at 500, 
1000, and 2000 hz.'' We would clarify the criterion in current listing 
2.08A for ``bone conduction to corresponding maximal levels'' by 
specifying that this means that the average bone conduction hearing 
threshold must be 60 dB or greater in the better ear.
    Current listing 2.08B requires ``[s]peech discrimination scores of 
40 percent or less in the better ear.'' As we mentioned above, ``speech 
discrimination'' is now referred to as ``word recognition testing.'' 
When we published the current rules, word recognition testing was 
usually conducted using a standardized list of phonetically balanced 
monosyllabic words. Other types of word recognition testing, such as 
sentence testing, are now available. Therefore, we propose to specify 
the type of word recognition testing to be used.
Proposed Listing 2.11--Hearing Loss Treated With Cochlear Implantation
    We propose to add criteria to evaluate individuals who have 
cochlear implants. Cochlear implants are devices that attempt to 
replace the function of damaged inner ear hair cells. The implant may 
destroy any remaining hearing in the implanted ear.
    Cochlear implants are not hearing aids. Hearing aids amplify sound, 
while cochlear implants provide direct electrical stimulation of the 
auditory nerve. Therefore, even individuals with profound hearing loss 
may receive enough benefit from a cochlear implant to be able to engage 
in gainful activity. However, we recognize that if you are treated with 
cochlear implantation, you will need a period of rehabilitation and 
training to use the implant effectively. Therefore, if you have a 
cochlear implant, we propose to consider you to be under a disability 
for one year from the date of implantation.
    After the 1-year period, we propose to determine whether your 
hearing loss meets the listing by assessing your word recognition 
ability using the HINT. We propose to use the HINT to assess your word 
recognition ability because, as mentioned in our discussion of proposed 
section 2.00B3, the American Academy of Neurology indicated in their 
comments in response to our ANPRM that the HINT is the ``accepted 
standard used to assess hearing outcome after cochlear implantation.''
    The HINT is a sentence test. Individuals generally have higher word 
recognition scores when tested with a sentence test as opposed to a 
monosyllabic word test because sentences provide context for the words 
in them. Therefore, we propose to find that your hearing loss meets the 
listing if your word recognition score on the HINT is 60 percent or 
less.

[[Page 47107]]

How are we proposing to change the introductory text to the special 
senses and speech listings for children?

102.00 Special Senses and Speech

    We have repeated much of the introductory text of proposed 2.00B in 
the introductory text to proposed 102.00B. This is because the same 
basic rules for evaluating hearing loss in adults also apply to 
evaluating hearing loss in children age 5 and older. Because we have 
already described these provisions under the explanation of proposed 
2.00B, the following discussion of proposed 102.00B describes only 
those provisions that apply to children under age 5, are unique to the 
childhood rules, or require further explanation specific to evaluating 
disability in children.
    We propose to remove the first paragraph of current 102.00B, 
``Hearing impairments in children.'' This paragraph explains that the 
criteria for hearing impairments in children take into account that a 
lesser impairment in hearing which occurs at an early age may result in 
a severe speech or language disorder. While this paragraph does explain 
why we use a lower threshold for children, it is not needed in the 
introductory text as it does not provide any guidance about how to 
evaluate hearing loss under these listings.
    We also propose to remove the second paragraph of current 102.00B. 
This paragraph provides guidance on how to consider improvement in 
hearing due to use of a hearing aid. As we discussed in our explanation 
of proposed listing 2.10 above, we are proposing to remove the 
requirement for aided hearing testing. Therefore, this guidance is no 
longer needed.
Proposed 102.00B2--What audiometric testing do we need when you do not 
have a cochlear implant?
    This proposed section expands and clarifies the guidance in the 
third and fourth paragraphs of current 102.00B as follows:
     We would clarify that we generally need behavioral or 
physiologic testing (other than screening testing) that is appropriate 
for your age at the time of testing.
     We would clarify that we require that audiometric testing 
be conducted in accordance with the most recently published American 
National Standards Institute (ANSI) standards for air conduction and, 
if appropriate, bone conduction stimuli. Our current rules provide that 
audiometric testing be conducted in accordance with the 1969 and 1972 
ANSI standards or subsequent comparable revisions.
     We would provide that hearing aids not be used during 
audiometric testing.
     We would require that an otoscopic examination be 
performed immediately before the audiometric testing to ensure that 
there are no conditions present that would prevent valid testing.
     We would provide that we will not purchase physiologic 
testing. We are proposing this rule because such testing may require 
sedation.
     We would describe the hearing testing that is appropriate 
for children in the age ranges of birth to the attainment of age 6 
months, age 6 months to the attainment of age 2, age 2 to the 
attainment of age 5, and age 5 to the attainment of age 18. The 
proposed guidance for hearing testing for children age 5 to the 
attainment of age 18 is similar to the proposed guidance for hearing 
testing in adults, except for the frequencies needed to determine the 
hearing threshold.
     We would revise the frequency levels used to determine the 
pure tone air conduction or bone conduction threshold from 500, 1000, 
2000, and 3000 Hz to 500, 1000, 2000, and 4000 Hz. We received several 
comments in response to our ANPRM recommending that we make this change 
in how we determine the hearing threshold. Additionally, our 
adjudicative experience has shown that testing is often not done at 
3000 Hz. We considered using the same hearing thresholds as in adults, 
but propose to continue to use 4000 Hz because of the importance of 
hearing at higher frequencies to a child's ability to learn speech.
     We would describe screening tests, such as otoacoustic 
emissions (OAE), and explain how we use them. We propose to provide 
this guidance because hearing screening tests are commonly given to 
children in newborn nurseries and schools. We do not propose to add 
this guidance to the introductory text for adults because hearing 
screening tests are not commonly given to adults.
Proposed 102.00B3--What audiometric testing do we need when you have a 
cochlear implant?
    This new section is similar to proposed 2.00B3 except that we 
provide that a child who has a cochlear implant will be disabled until 
age 5 or until 1 year after implantation, whichever is later. We 
propose to consider children with cochlear implants to be disabled 
until age 5 because of the extensive rehabilitation and training needed 
for young children with cochlear implants to acquire speech and 
language skills.
    We would also explain that after that period, we will evaluate your 
hearing loss by measuring your word recognition ability on the HINT or 
the Hearing in Noise Test for Children (HINT-C).
Proposed 102.00B5--What do we mean by a marked limitation in speech or 
language as used in 102.10B2?
    In this new section, we explain when we will consider you to have a 
marked limitation in speech or language.

How are we proposing to change the criteria in the special senses and 
speech listings for children?

102.01 Category of Impairments, Special Senses and Speech

    For the reasons mentioned in our discussion of 2.01 above, we 
propose to add a separate listing to evaluate hearing loss treated with 
cochlear implantation. Because we are proposing to add a listing, we 
also propose to renumber the listings for ease of reference. We would 
revise current listing 102.08, ``Hearing impairments,'' renumber it as 
listing 102.10, ``Hearing loss not treated with cochlear 
implantation,'' and add listing 102.11, ``Hearing loss treated with 
cochlear implantation.''
Proposed 102.10--Hearing Loss Not Treated With Cochlear Implantation
    This proposed listing would revise current listing 102.08, 
``Hearing impairments,'' and specify that it applies to children who do 
not have cochlear implants.
    The current childhood listing requires that we assess your ability 
to hear with a hearing aid unless we determine that you are not able to 
use the aid effectively. For the reasons we stated in the discussion of 
proposed listing 2.10 above, we propose to no longer require aided 
hearing testing to determine if your hearing loss meets the listing.
    Proposed listing 102.10A would replace current listing 102.08A. 
This proposed listing contains the criterion for evaluating hearing 
loss in children under age 5 who do not have a cochlear implant. We 
propose to replace the current criterion for an aided average hearing 
threshold of 40 dB in the better ear with a criterion for an unaided 
average air conduction hearing threshold of 50 dB or greater in the 
better ear. We propose to use a threshold of 50 dB because we believe 
that, even with the use of a hearing aid, a child under age 5 who has a 
50 dB hearing loss will also have a marked limitation in speech or 
language.

[[Page 47108]]

    Proposed listing 102.10B would replace current listing 102.08B. 
This proposed listing contains the criteria for evaluating hearing loss 
in children from age 5 to the attainment of age 18. For the reasons we 
explained earlier, we propose to no longer require aided hearing 
testing.
    Proposed listing 102.10B1 would correspond to current listing 
102.08B1. Current listing 102.08B1 generally requires an aided average 
air conduction hearing threshold of 70 dB or greater in the better ear. 
We would expect hearing loss at that level to have a sensorineural 
component. (A sensorineural hearing loss is caused by permanent damage 
to the inner ear or to the nerve pathways from the inner ear to the 
brain.) We propose to replace the criterion in current listing 102.08B1 
with an unaided average air conduction hearing threshold of 70 dB or 
greater in the better ear. In order to ensure that hearing loss at this 
level has a sensorineural component, we also propose to add a criterion 
in proposed listing 102.10B1 for an average bone conduction hearing 
threshold of 40 dB or greater in the better ear. We would continue to 
use a 70 dB average air conduction hearing threshold because we believe 
a hearing loss with a sensorineural component at this level will 
significantly affect a child's ability to engage in learning. Also, we 
do not use the same hearing threshold levels for children from age 5 to 
the attainment of age 18 as we use for adults because of the importance 
of hearing to a child's ability to communicate and learn.
    Proposed listing 102.10B2 would correspond to current listing 
102.08B2. We propose to make the same editorial changes as we did in 
proposed listing 2.10B.
    Proposed listing 102.10B3 would correspond to current listing 
102.08B3. As we discussed in our explanation of proposed listing 
102.10A above, we propose to use an unaided hearing threshold of 50 dB 
in the better ear. Because children typically acquire basic speech and 
language skills by age 5, we believe that it is not appropriate to 
presume that a child over age 5 who has a 50 dB hearing loss will also 
have a marked limitation in speech or language. Therefore, for children 
over age 5, we also propose to require an assessment of speech and 
language skills.
Proposed 102.11--Hearing Loss Treated With Cochlear Implantation
    This proposed listing is similar to proposed listing 2.11 except 
that we propose to consider you to be under a disability until age 5, 
or for 1 year after implantation, whichever is later. We also propose 
to use either the HINT or the HINT-C to assess your word recognition 
ability.

What programs would these proposed regulations affect?

    These proposed rules would affect disability determinations and 
decisions that we make under titles II and XVI of the Act. In addition, 
to the extent that Medicare entitlement and Medicaid eligibility are 
based on whether you qualify for disability benefits under title II or 
title XVI, these proposed rules would also affect the Medicare and 
Medicaid programs.

Who can get disability benefits?

    Under title II of the Act, we provide for the payment of disability 
benefits if you are disabled and belong to one of the following three 
groups:
     Workers insured under the Act,
     Children of insured workers, and
     Widows, widowers, and surviving divorced spouses (see 
Sec.  404.336) of insured workers.
    Under title XVI of the Act, we provide for Supplemental Security 
Income (SSI) payments on the basis of disability if you are disabled 
and have limited income and resources.

How do we define disability?

    Under both the title II and title XVI programs, disability must be 
the result of any medically determinable physical or mental impairment 
or combination of impairments that is expected to result in death or 
which has lasted or can be expected to last for a continuous period of 
at least 12 months. Our definitions of disability are shown in the 
following table:

------------------------------------------------------------------------
                                                    Disability means you
                                                      have a medically
 If you file a claim under . .  And you are . . .       determinable
               .                                      impairment(s) as
                                                    described above and
                                                   that results in . . .
------------------------------------------------------------------------
title II......................  an adult or a      the inability to do
                                 child.             any substantial
                                                    gainful activity
                                                    (SGA).
title XVI.....................  an individual age  the inability to do
                                 18 or older.       any SGA.
title XVI.....................  an individual      marked and severe
                                 under age 18.      functional
                                                    limitations.
------------------------------------------------------------------------

How do we decide whether you are disabled?

    If you are applying for benefits under title II of the Act, or if 
you are an adult applying for payments under title XVI of the Act, we 
use a five-step ``sequential evaluation process'' to decide whether you 
are disabled. We describe this five-step process in our regulations at 
Sec. Sec.  404.1520 and 416.920. We follow the five steps in order and 
stop as soon as we can make a determination or decision. The steps are:
    1. Are you working, and is the work you are doing substantial 
gainful activity? If you are working and the work you are doing is 
substantial gainful activity, we will find that you are not disabled, 
regardless of your medical condition or your age, education, and work 
experience. If you are not, we will go on to step 2.
    2. Do you have a ``severe'' impairment? If you do not have an 
impairment or combination of impairments that significantly limits your 
physical or mental ability to do basic work activities, we will find 
that you are not disabled. If you do, we will go on to step 3.
    3. Do you have an impairment(s) that meets or medically equals the 
severity of an impairment in the listings? If you do, and the 
impairment(s) meets the duration requirement, we will find that you are 
disabled. If you do not, we will go on to step 4.
    4. Do you have the residual functional capacity (RFC) to do your 
past relevant work? If you do, we will find that you are not disabled. 
If you do not, we will go on to step 5.
    5. Does your impairment(s) prevent you from doing any other work 
that exists in significant numbers in the national economy, considering 
your RFC, age, education, and work experience? If it does, and it meets 
the duration requirement, we will find that you are disabled. If it 
does not, we will find that you are not disabled.
    We use a different sequential evaluation process for children who 
apply for payments based on disability under SSI. If you are already 
receiving benefits, we also use a different sequential evaluation 
process when we decide whether your disability continues. See 
Sec. Sec.  404.1594, 416.924, 416.994, and 416.994a of our regulations. 
However, all of these

[[Page 47109]]

processes include steps at which we consider whether your impairment(s) 
meets or medically equals one of our listings.

What are the listings?

    The listings are examples of impairments that we consider severe 
enough to prevent you as an adult from doing any gainful activity. If 
you are a child seeking SSI payments based on disability, the listings 
describe impairments that we consider severe enough to result in marked 
and severe functional limitations. Although the listings are contained 
only in appendix 1 to subpart P of part 404 of our regulations, we 
incorporate them by reference in the SSI program in Sec.  416.925 of 
our regulations and apply them to claims under both title II and title 
XVI of the Act.

How do we use the listings?

    The listings are in two parts. There are listings for adults (part 
A) and for children (part B). If you are an individual age 18 or over, 
we apply the listings in part A when we assess your claim, and we never 
use the listings in part B.
    If you are an individual under age 18, we first use the criteria in 
part B of the listings. Part B contains criteria that apply only to 
individuals who are under age 18. If the criteria in part B do not 
apply, we may use the criteria in part A when those criteria give 
appropriate consideration to the effects of the impairment(s) in 
children. (See Sec. Sec.  404.1525 and 416.925.)
    If your impairment(s) does not meet any listing, we will also 
consider whether it medically equals any listing; that is, whether it 
is as medically severe as an impairment in the listings. (See 
Sec. Sec.  404.1526 and 416.926.)

What if you do not have an impairment(s) that meets or medically equals 
a listing?

    We use the listings only to decide that you are disabled or that 
you are still disabled. We will not deny your claim or decide that you 
no longer qualify for benefits because your impairment(s) does not meet 
or medically equal a listing. If you have a severe impairment(s) that 
does not meet or medically equal any listing, we may still find you 
disabled based on other rules in the ``sequential evaluation process.'' 
Likewise, we will not decide that your disability has ended only 
because your impairment(s) no longer meets or medically equals a 
listing.
    Also, when we conduct reviews to determine whether your disability 
continues, we will not find that your disability has ended because we 
have changed a listing. Our regulations explain that, when we change 
our listings, we continue to use our prior listings when we review your 
case, if you qualified for disability benefits or SSI payments based on 
our determination or decision that your impairment(s) met or medically 
equaled a listing. In these cases, we determine whether you have 
experienced medical improvement, and if so, whether the medical 
improvement is related to the ability to work. If your condition(s) has 
medically improved so that your impairment(s) no longer meets or 
medically equals the prior listing, we evaluate your case further to 
determine whether you are currently disabled. We may find that you are 
currently disabled, depending on the full circumstances of your case. 
See Sec. Sec.  404.1594(c)(3)(i) and 416.994(b)(2)(iv)(A). If you are a 
child who is eligible for SSI payments, we follow a similar rule when 
we decide that you have experienced medical improvement in your 
condition(s). See Sec.  416.994a(b)(2).

When will we start to use these rules?

    We will not use these rules until we evaluate the public comments 
we receive on them, determine whether they should be issued as final 
rules, and issue final rules in the Federal Register. If we publish 
final rules, we will explain in the preamble how we will apply them, 
and summarize and respond to the public comments. Until the effective 
date of any final rules, we will continue to use our current rules.

How long would these proposed rules be effective?

    If we publish these proposed rules as final rules, they will remain 
in effect for 8 years after the date they became effective, unless we 
extend them, or revise and issue them again.

Clarity of these proposed rules Executive Order 12866, as amended, 
requires each agency to write all rules in plain language. In addition 
to your substantive comments on these proposed rules, we invite your 
comments on how to make them easier to understand.

    For example:
     Have we organized the material to suit your needs?
     Are the requirements in the rules clearly stated?
     Do the rules contain technical language or jargon that is 
not clear?
     Would a different format (grouping and order of sections, 
use of headings, paragraphing) make the rules easier to understand?
     Would more (but shorter) sections be better?
     Could we improve clarity by adding tables, lists, or 
diagrams?
     What else could we do to make the rules easier to 
understand?

Regulatory Procedures

Executive Order 12866

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

Regulatory Flexibility Act

    We certify that these proposed rules would not have a significant 
economic impact on a substantial number of small entities because they 
affect only individuals. Thus, a regulatory flexibility analysis as 
provided in the Regulatory Flexibility Act, as amended, is not 
required.

Paperwork Reduction Act

    In these regulations, we are proposing to: (1) Revise the listings 
for hearing loss to update the medical criteria in the listings; (2) 
provide more information about how we evaluate hearing loss; and (3) 
reflect our adjudicative experience. The listings for hearing loss are 
in the special senses and speech body system. That body system also 
includes listings for visual disorders, disturbances of labyrinthine-
vestibular function and loss of speech. In this NPRM, we are proposing 
changes only to the listings for hearing loss. As part of the listings, 
we identify specific documentation requirements used in evaluating 
impairments within a body system, including medical and other evidence. 
The documentation and evidentiary requirements are public reporting 
burdens that must be cleared by OMB under the Paperwork Reduction Act. 
However, the public reporting burdens are accounted for in the 
Information Collection Requests for the various forms that the public 
uses to submit the information to SSA. Consequently, we are reporting 
no burden for this regulation aside from a 1-hour placeholder burden 
shown in the chart below, for the sections listed.

[[Page 47110]]



                          Part 404--Federal Old-Age, Survivors and Disability Insurance
----------------------------------------------------------------------------------------------------------------
                                                                                      Average
                                                  Annual  number   Frequency  of    burden per       Estimated
     Title/section &  collection description             of          response        response     annual  burden
                                                    respondents                      (minutes)        (hours)
----------------------------------------------------------------------------------------------------------------
Hearing Loss (2.00B and 102.00B)................  ..............  ..............  ..............               1
----------------------------------------------------------------------------------------------------------------

    An Information Collection Request has been submitted to OMB for 
clearance. We are soliciting comments on the burden estimate; the need 
for the information; its practical utility; ways to enhance its 
quality, utility and clarity; and ways to minimize the burden on 
respondents, including the use of automated collection techniques or 
other forms of information technology. Requests for the Information 
Collection Request package and/or comments should be directed to SSA 
and OMB at the following addresses/phone numbers:

Office of Management and Budget, Attn: Desk Officer for SSA, Fax 
Number: 202-395-6974, E-mail address: OIRA_Submission@omb.eop.gov.
Social Security Administration, Attn: Reports Clearance Officer, 1333 
Annex Building, 6401 Security Blvd., Baltimore, MD 21235, Fax: 410-965-
6400, E-mail address: OPLM.RCO@ssa.gov.

    Comments on the paperwork burdens associated with this rule can be 
received for up to 60 days after publication of this notice and will be 
most useful if received within 30 days of publication. This does not 
affect the deadline for the public to comment to SSA on the proposed 
regulations. These information collection requirements will not become 
effective until approved by OMB. When OMB has approved these 
information collection requirements, SSA will publish a notice in the 
Federal Register.

List of References

    During the development of these proposed rules, we reviewed the 
following information:

American Speech-Language-Hearing Association (ASHA). (2004). 
Guidelines for the audiologic assessment of children from birth to 5 
years of age [Guidelines]. (Available at http://www.asha.org/NR/
rdonlyres/0BB7C840-27D2-4DC6-861B-1709ADD78BAF/0/
v2GLAudAssessChild.pdf.)
ASHA. (2004). Technical report: Cochlear implants. ASHA Supplement 
24. (Available at http://www.asha.org/NR/rdonlyres/215CC9B8-6831-
494F-83ED-E02A6832A8A9/0/v2TRcochlearimplants.pdf.)
Centers for Medicare & Medicaid Services. (2005). MLN Matters Number 
MM3796: Cochlear Implantation. (Available at http://
www.cms.hhs.gov/MLNMattersArticles/downloads/MM3796.pdf.)
Cunningham. M. and Cox, E.O. (2003). Hearing assessment in infants 
and children: Recommendations beyond neonatal screening. Pediatrics, 
111(2), 436-440.
Dale, D.C. and Federman, D.D., eds. Neurology. ACP Medicine. (2004) 
Elliot M. Frohman, New York: WebMD Professional Publishing.
Gifford, R.H. and Shallop, J.K. (2007). Hearing preservation in 
patients with a cochlear implant. The ASHA Leader, 12(14), 15, 17, 
34.
Gorga, M.P., et al. (2006). Using a combination of click- and tone 
burst-evoked auditory brain stem response measurements to estimate 
pure-tone thresholds. Ear & Hearing, 27(1), 60-74.
Joint Committee on Infant Hearing. (2000). Year 2000 position 
statement: Principles and guidelines for early hearing detection and 
intervention programs. Pediatrics, 106(4), 798-817.
Joint Committee on Infant Hearing. (2007). Year 2007 position 
statement: Principles and guidelines for early hearing detection and 
intervention programs. Pediatrics, 120(4), 898-921.
National Research Council (NRC): Committee on Disability 
Determination for Individuals with Hearing Impairments. (2005). 
Hearing Loss: Determining Eligibility for Social Security Benefits. 
Washington, DC: National Academy Press. (Available at http://
www.nap.edu/catalog.php?record_id=11099#toc.)
Pittman, A.L., & Stelmachowicz, P.G. (2003). Hearing loss in 
children and adults: Audiometric configuration, asymmetry, and 
progression. Ear & Hearing, 24(3), 198-205.
U.S. Food and Drug Administration, Center for Devices and 
Radiological Health. (2007). Benefits and Risks of Cochlear 
Implants. (Available at: http://www.fda.gov/cdrh/cochlear/
RiskBenefit.html.)

    These references are included in the rulemaking record for these 
proposed rules and are available for inspection by interested 
individuals making arrangements with the contact person shown in this 
preamble.

(Catalog of Federal Domestic 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.

    Dated: May 12, 2008.
Michael J. Astrue,
Commissioner of Social Security.

    Editorial Note: This document was received at the Office of the 
Federal Register on August 8, 2008.

    For the reasons set out in the preamble, we propose to amend 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- )

    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]
    2. Appendix 1 to subpart P of part 404 is amended as follows:
    a. Revise item 3 of the introductory text before part A of appendix 
1.
    b. Revise section 2.00B of part A of appendix 1.
    c. Redesignate section 2.00C of part A of appendix 1 as section 
2.00E.
    d. Add new sections 2.00C and 2.00D to part A of appendix 1.
    e. Remove listing 2.08 of part A of appendix 1.
    f. Add listings 2.10 and 2.11 to part A of appendix 1.
    g. Revise section 102.00B of part B of appendix 1.
    h. Remove listing 102.08 of part B of appendix 1.
    i. 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

* * * * *

[[Page 47111]]

    3. Special Senses and Speech (2.00 and 102.00): [Insert date 8 
years from the effective date of the final rules].
* * * * *
    Part A
* * * * *
2.00 Special Senses and Speech
* * * * *
    B. How do we evaluate hearing loss?
    1. What evidence do we need to evaluate hearing loss?
    a. To establish that you have a medically determinable impairment 
that causes your hearing loss, we require both a complete otologic 
examination and audiometric testing. The audiometric testing should be 
performed within 2 months of the complete otologic examination.
    b. A complete otologic examination must include your medical 
history, your description of how your hearing loss affects you, a 
description of the appearance of the external ear (pinna and the 
external ear canal), an evaluation of the tympanic membrane, and an 
assessment of any middle ear abnormalities.
    c. After your impairment has been established, we can use the 
results of subsequent audiometric testing to assess the severity of 
your hearing loss without another complete otologic examination.
    d. Audiometric testing must be performed by, or under the 
supervision of, an otolaryngologist or by an audiologist qualified to 
perform such tests. We consider an audiologist to be qualified if the 
audiologist is currently and fully licensed or registered as a clinical 
audiologist by the state or U.S. territory in which he or she 
practices. If no licensure or registration is available, the 
audiologist must be currently certified by the American Board of 
Audiology or have a Certificate of Clinical Competence (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, and word recognition 
testing. (Word recognition testing may be referred to as word 
discrimination or speech discrimination testing.) This testing must be 
conducted in a soundproof booth and each ear must be tested separately. 
Pure tone air conduction and bone conduction testing must be conducted 
in accordance with the most recently published standards of the 
American National Standards Institute (ANSI) for air conduction and 
bone conduction stimuli.
    b. You must not wear hearing aids during the testing. Additionally, 
we require that an otoscopic examination be performed immediately 
before the audiometric testing. An otoscopic examination provides a 
description of the appearance of the external ear canal and an 
evaluation of the tympanic membrane. The otoscopic examination must 
also show that there are no conditions present that would prevent valid 
audiometric testing. Examples of such conditions are fluid in the ear, 
an ear infection, or an obstruction in the ear canal.
    c. An audiological examination usually includes pure tone air 
conduction and bone conduction testing measured at 250, 500, 1000, 
2000, and 4000 Hertz (Hz). To determine whether your hearing loss meets 
the air conduction criterion in 2.10A, we will average the air 
conduction hearing thresholds at 500, 1000, and 2000 Hz. To determine 
whether your hearing loss meets the bone conduction criterion in 2.10A, 
we will average the bone conduction hearing thresholds at 500, 1000, 
and 2000 Hz.
    d. The SRT is the minimal decibel (dB) level required for you to 
recognize a standard list of words. 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 should be 
documented.
    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 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. The 
individual 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 implantation.
    b. After that period, we need word recognition testing performed 
with the Hearing in Noise Test (HINT). This testing must be conducted 
in quiet in a sound field with your implant 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, 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 individuals 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?
    1. These disturbances of balance are characterized by a 
hallucination of motion or a loss of position sense and a sensation of 
dizziness which may be constant or may occur in paroxysmal attacks. 
Nausea, vomiting, ataxia, and incapacitation are frequently observed, 
particularly during the acute attack. It is important to differentiate 
the report of rotary vertigo from that of ``dizziness,'' which is 
described as light-headedness, unsteadiness, confusion, or syncope.
    2. Meniere's disease is characterized by paroxysmal attacks of 
vertigo, tinnitus, and fluctuating hearing loss. Remissions are 
unpredictable and irregular, but may be long-lasting; hence, the 
severity of the impairment is best determined after prolonged 
observation and serial reexaminations.
    3. The diagnosis of a vestibular disorder requires a comprehensive 
neuro-otolaryngologic examination with a detailed description of the 
vertiginous episodes, including notation of frequency, severity, and 
duration of the attacks. Pure tone and speech audiometry with the 
appropriate special examinations, such as Bekesy audiometry, are 
necessary. Vestibular function is assessed by positional and caloric 
testing, preferably by electronystagmography. When polytomograms, 
contrast radiography, or other special tests have been performed, 
copies of the reports of these tests should be obtained in addition to 
appropriate medically acceptable imaging reports of the skull and 
temporal bone. Medically acceptable imaging includes, but is not 
limited to, x-ray imaging, computerized axial tomography (CAT scan) or 
magnetic resonance imaging (MRI), with or

[[Page 47112]]

without contrast material, myelography, and radionuclear bone scans. 
``Appropriate'' means that the technique is the proper one to support 
the evaluation and diagnosis of the impairment.
    D. Loss of speech. In evaluating the loss of speech, the ability to 
produce speech by any means includes the use of mechanical or 
electronic devices that improve voice or articulation. Impairments of 
speech may also be evaluated under the body system for the underlying 
disorders, such as neurological disorders, 11.00ff.
* * * * *
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 implantation; or
    B. If more than 1 year after implantation, a word recognition score 
of 60 percent or less determined using the HINT (see 2.00B3b).
* * * * *
    Part B
* * * * *
102.00 Special Senses and Speech
* * * * *
    B. How do we evaluate hearing loss?
    1. What evidence do we need to evaluate hearing loss?
    a. To establish that you have a medically determinable impairment 
that causes your hearing loss, we require both a complete otologic 
examination and audiometric testing. The audiometric testing should be 
performed within 2 months of the complete otologic examination.
    b. A complete otologic examination must include your medical 
history, your description of how your hearing loss affects you, a 
description of the appearance of the external ear (pinna and the 
external ear canal), an evaluation of the tympanic membrane, and an 
assessment of any middle ear abnormalities.
    c. After your impairment has been established, we can use the 
results of subsequent audiometric testing to assess the severity of 
your hearing loss without another complete otologic examination.
    d. Audiometric testing must be performed by, or under the 
supervision of, an otolaryngologist or by an audiologist qualified to 
perform such tests. We consider an audiologist to be qualified if the 
audiologist is currently and fully licensed or registered as a clinical 
audiologist by the state or U.S. territory in which he or she 
practices. If no licensure or registration is available, the 
audiologist must be currently certified by the American Board of 
Audiology or have a Certificate of Clinical Competence (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 generally need behavioral or physiologic testing 
(other than screening testing, see 102.00B3g) that is appropriate for 
your age at the time of testing. We will make every reasonable effort 
to obtain the results of physiologic testing that has been done. 
However, if this testing has not been done, or, if we cannot obtain the 
results, we will not purchase it. In these situations, we will evaluate 
your hearing loss based on the other evidence in your case record.
    b. Testing requirements. The testing must be conducted in 
accordance with the most recently published standards of the American 
National Standards Institute (ANSI) for air conduction stimuli, and if 
appropriate, bone conduction stimuli. You must not wear hearing aids 
during the testing. Additionally, we require that an otoscopic 
examination be performed immediately before the audiometric testing. An 
otoscopic examination provides a description of the appearance of the 
external ear canal and an evaluation of the tympanic membrane. The 
otoscopic examination must also show that there are no conditions 
present that would prevent valid audiometric testing. Examples of such 
conditions are fluid in the ear, an ear infection, or an obstruction in 
the ear canal.
    c. Children from birth to the attainment of age 6 months.
    i. We need physiologic testing, such as auditory brainstem response 
(ABR) testing, that measures the frequencies needed to recognize 
speech; that is, the range from 500 to 4000 Hertz (Hz). We also need an 
acoustic immittance assessment; that is, a tympanogram and acoustic 
reflex testing.
    ii. To determine whether your hearing loss meets listing 102.10A, 
we will average the hearing thresholds at 500, 1000, 2000, and 4000 Hz.
    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),