Cochlear Implantation

I am happy to see CMS broaden the range of speech recognition ability hearing-impaired people who will be eligible for cochlear implants under Medicare. I would encourage CMS to broaden the inclusion criteria further to match the current FDA guidlines of < or = 50% in the ear to be implanted and < or = 60% in the nonimplanted ear, or binaurally. The VA & DoD have adopted these guidelines in our Clinical Practice Recommendations for Cochlear Implants. Veterans Hospitals have the unique situation in which hearing-impaired patients 65 or older are covered for cochlear implants if they meet the FDA criteria. Below are the pre-op & postop speech recognition scores (HINT sentences in quiet) for veterans 65 or older implanted at the VA Puget Sound Health Care System. Included are all of our patients 65 or over who had better pre-op scores than CMS recommends:

Age: Pre-op: Pre-op: Post-op: Binaural: Ear to be implanted:74 59% 36% 100%72 53% 0% 100%82 47% 13% 70%65 53% 0% 100%80 58% 42% 71%**

**Post-op score is using cochlear implant only. When this last pt. was tested using a hearing aid on the nonimplanted ear in combination with the cochlear implant, he scored 95% correct.I have left out no patients that fall into this category. As you can see all of our patients who were 65 or older with a binaural or better ear speech recognition score of 40-60% pre-op, could recognize speech much better after they received the cochlear implant. Most are performing in the 90-100% range now. Many are using a hearing aid in one ear and a cochlear implant in the other. All use their implant during most waking hours and report a great improvement in quality of life.

We have more cochlear implant users 65 or older that score in the 90-100% range that were not included here because their pre-implant scores were actually poorer than 40%. I would be happy to provide those data if you are interested.

Please consider the above data so this life-changing device can be provided to more of our senior Americans.

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Thank you for your decision to expand the criteria closer to the FDA guidelines for Medicare beneficiaries. As an Audiologist working with adult cochlear implant recipients there is a dramatic difference in quality of life for the severe to profoundly hearing impaired. As the criteria expands a greater number of older adults can obtain this benefit as well. I hope that CMS will continue to work with cochlear implant professionals to monitor the outcomes of these patients who fall under the expanded criteria.

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The following are my comments to the CMS'draft conclusions. First, I commend CMS for requesting to expand the candidacy coverage and eligibility guidlines for cochlear implantation and for providing the opportunity for public comment prior to a final decision being made. It is a step in the right direction to recommend the elibility criteria be increased from less than or equal to 30% to less than or equal to 40% for adults 65 years of age and older, and to include Medicare patients participating in Medicare approved clinical trials who have preimplant speech perception scores of greater than 40% and less than or equal to 60%. These preimplant scores are obtained in the best aided listening condition on tape recorded tests of open-set sentence recognition. The CD recording of the Hearing in Noise Test (HINT) is the most widely used sentence test for this clinical assessment with cochlear implant candidates and recipients in the United States.

Second, the following is a summary of data obtained from 21 adults whose cochlear implant surgeries occurred between January 1, 2001 and December 31, 2003 in our Adult Cochlear Implant Program at Washington University School of Medicine in St. Louis, Missouri AND whose pre- implant sentence scores on the HINT CD recording were between 30 and 60% correct. This group is approximately one-quarter of a total of 80 patients implanted in our program during this time period. Five of these patients were 65 years or older (age range: 74 to 81 years).

Their pre-implant scores ranged from 33 to 57% (mean: 45.6%), and their post-implant scores at 3 months post-implant ranged from 76 to 94% (mean: 86.4%). For the whole group of 21 patients, the age range was from 23 to 81 years, the mean pre- implant score was 45.6%, and the mean post- implant score was 88.7%. Although a statistical test for significance has not been run, there does not appear to be a significant difference in the performance between the older group of 5 patients and the whole group. That is, those 65 years of age and older performed as well as the whole group. The mean improvement in percentage points from pre-implant to 3 months post-implant for the whole group was 43.1 (range: 5 to 61 percentage points); for the 5 older patients, it was 40.8 (range: 34 to 59 percentage points). According to the FDA guideline of 20% improvement for the sentence score to be clinically significant, only one of the 21 adults did not have a clinically significant improvement at 3 months post-implant. He had never worn hearing aids except during a few months prior to implantation, and he was 44 years old when he was implanted. His pre-impant score with binaural hearing aids was 51%. His 3 months post-implant sentence score was 56%, and his 6 months post- implant score was 90%. Because he had not used hearing aids from grade school until just before he was implanted, it took longer for him to acclimate to hearing speech with the implant than other patients in this group. I am sending an email today to CAGinquiries@cms.hhs.gov briefly to which I am attaching a table with the following information on each of the 21 subjects: age at surgery, pre-implant HINT score, post- implant HINT score at 3 months, percentage point improvement at 3 months, and whether there was a clinically significant improvement.

Third, it is very important to note that the amount of improvement in score on the CD recording of the HINT sentences cannot be adequately assessed if the post-implant scores are above approximately 90% (that is, there is a ceiling effect). For example, if a patient has a post-implant score of 100%, then it is impossible to know how much better a score the patient would have had if a more difficult test had been used. Thirteen of the 21 patients had 3 month post- implant scores of 90 to 100%; for them, improvement in sentence score is probably underestimated. The major reasons the HINT test is too easy for this assessment is that the sentences are short (5-7 words), their grammatical structure is simple, the vocabulary is that of a grade-school child, and they are spoken by a single talker. In the future, it will be important to use more difficult tests (e.g., more difficult vocabulary and sentence structure, spoken by multiple talkers) to assess amount of improvement from pre-implant to post- implant performance. These more difficult tests will reflect more fully the listening conditions in which adult cochlear implant recipients endeavor to communicate.

Finally, our experience over the last 17 years with adults who are 65 years of age and older and are implanted in our program is that they get (on average) as much benefit as those who are younger. Hopefully, the results I have described above and the table that I am sending today as an attachment to an email to CAGinquiries@cms.hhs.gov will lend support to consideration by CMS of even higher criteria than the proposed less than or equal to 40% pre- implant scores on recorded, open-set sentence tests in the best aided condition.

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Advanced Bionics Corporation, a leading manufacturer of cochlear implants, and a Boston Scientific company appreciates the opportunity to comment on the draft Centers for Medicare and Medicaid Services (CMS) proposal to expand the national Medicare coverage criteria for cochlear implantation (CAG-00107N).

Advanced Bionics appreciates the comprehensive review undertaken by CMS of this coverage policy. We commend CMS for taking steps to expand coverage for Medicare beneficiaries toward the FDA-approved criteria used by most private insurers and to further extend coverage to a broader population of cochlear implant candidates within the context of approved clinical studies.

While we believe that this CMS proposal represents a step in the right direction to expand access for Medicare beneficiaries to cochlear implants, we remain committed to ensuring that all Medicare beneficiaries who would benefit from cochlear implants have access to this treatment option. While today’s published literature supports the efficacy of cochlear implantation among people with severe hearing loss, the agency’s extension of coverage within approved clinical studies for patients with up to 60% sentence discrimination scores provides an opportunity to demonstrate the benefit of cochlear implantation for additional beneficiaries. Advanced Bionics looks forward to working with CMS and cochlear implant programs on data collection requirements that are reasonable and appropriate so it is feasible to conduct these clinical studies for eligible beneficiaries.

Advanced Bionics Corporation appreciates the agency’s attention to this important issue that significantly impacts beneficiary access to cochlear implantation. Please feel free to contact me or Tom Walsh if you have any questions.

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I would like to applaud CMS for recognizing the limitation put on individuals who were seeking cochlear implants. By expanding the coverage, you will greatly help older citizens receive this amazing and life changing technology. Not only will it help them hear but can provide a route back into the hearing world and out of isolation.

However, there is still a population that you have left out. The FDA guidelines puts it's criteria at up to 50% or 60% depending on ear, etc. CMS still does not recognize this group unless they enroll in a clinical trial. Clinical trials are not always occuring so once again there is a discrepancy!

While applauding CMS for their efforts, we in the cochlear implant community hope that CMS continues to evaluate the candidacy criteria and not discriminate against people in the future.

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On behalf of MED-EL Corporation, a world-wide manufacturer and distributor of cochlear implants, I support CMS’ proposed decision memorandum to revise the current candidacy criteria for cochlear implantation. As a result of the time, effort and resources dedicated by CMS and various stakeholder groups to the analysis and formulation of this proposal, if adopted, Medicare beneficiaries with hearing loss will experience improved access to cochlear implants.

As evidenced by statistical data contained in the peer-reviewed literature, the Medicare population represents a significant portion of the greater than 25 million Americans affected by hearing loss. It is critical that these individuals have the same access to the cochlear technology as the privately insured. Substantial literature exists that report the benefits of cochlear implants in the senior population. As stated in the literature, seniors experience improvements in hearing comparable to younger adults. CMS’ proposed decision to expand pre-implant test scores to 40% and >40% and < 60% for patients participating in an approved clinical trial, should work to bridge the gap in coverage between younger adults and seniors.

As cochlear implant technology advances, we trust that CMS will continue to recognize the value of this life-changing technology. It is our belief that this proposed revision serves as the platform for future considerations. MED-EL Corporation appreciates your interest and commitment to revising the current candidacy criteria for cochlear implantation to better meet the needs of Medicare beneficiaries.

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The cochlear implant team at Johns Hopkins is comprised of 23 staff members representing five clinical specialities. We would like to offer a multiperspective view that the CMS has demonstrated remarkable insight and leadership in draft decision CAG-00107N. CMS has critically reviewed clinical research of candidacy criteria with a balance of optimism for Medicare recipients' potential and caution for their well- being and cost-effective use of federal monies. CAG-00107N also describes the principles and standards for future reviews of candidacy criteria. Patients and providers can find guidance in such a data-based approach to coverage decisions. We believe that in CAG- 00107N, CMS has demonstrated national leadership and a valuable model of linking policy with research.

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I would like to take this opportunity to endorse CMS's current proposal to expand the candidacy criteria for cochlear implantation and express appreciation for your efforts. We at Washington University School of Medicine in St. Louis, Missouri will do our best to participate in this effort by supplying any data you may need as you come to make your final conclusion. In addition, we would like to encourage further expansion of the criteria to match the current FDA guidelines so that all of those who are in need of this advanced technology will have access to it. So they, too, can experience improvements in quality of life and independence. Thank you again for your consideration of this very important health issue.
Brenda Gotter,M.S.
Cochlear Implant and Hearing Rehabilitation Program
Washington University School of Medicine
St. Louis, Missouri

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The Alexander Graham Bell Association for the Deaf and Hard of Hearing (AG Bell) is pleased to submit comments in response to The Centers for Medicare and Medicaid Services (CMS) proposed decision memorandum and conclusions regarding the revision of coverage policy for cochlear implantation prior to final determination.

The Alexander Graham Bell Association for the Deaf and Hard of Hearing (AG Bell) is a lifelong resource, support network, and advocate for listening, learning, talking and living independently with hearing loss. Through publications, outreach, training, scholarships and financial aid, AG Bell promotes the use of spoken language and hearing technology. Headquartered in Washington, DC with chapters located in the United States and Canada and a network of international affiliates, AG Bell's global presence provides its members and the public with the support they need-close to home. With over a century of service, AG Bell supports its mission: Advocating Independence through Listening and Talking!

AG Bell applauds CMS proposal to expand existing requirements for cochlear implantation to broaden eligibility determinations in concluding that there is sufficient evidence for defining limited benefit from amplification by test scores of £ 40 % correct in the best-aided listening condition on tape-recorded tests of open-set sentence cognition.

Cochlear implants continue to provide individuals with hearing loss with increased benefits by improving daily functioning and overall quality of life. Your decision to expand eligibility requirements continues to ensure accessibility to this life-enhancing technology for individuals with hearing loss.

In addition, AG Bell strongly supports CMS' decision to conclude that a cochlear implant is reasonable and necessary for individuals with hearing test scores of > 40 % £ 60 % only when the provider is participating in and patients are enrolled in approved clinical trials as outlined by the proposed decision memorandum. The decision encourages professionals in the field to participate in data collection on an ongoing basis and supports ongoing dialogue with CMS. AG Bell commends CMS' willingness to collaborate and cooperate with providers to collect data on the Medicare population and views this as a significant step forward and a major opportunity to impact research on future determinations and expansion of eligibility requirements for beneficiaries.

The Alexander Graham Bell Association for the Deaf and Hard of Hearing appreciates The Centers for Medicare and Medicaid Services for their time and attention to review this important request for a coverage decision.

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On behalf of Self Help for Hard of Hearing People (SHHH), the nation's largest consumer advocacy organization for people with hearing loss, I would like to comment on the CMS decision summary for proposed revisions to the current coverage policy for cochlear implantation.

SHHH supports CMS' proposed revisions and is grateful for the careful and thorough review undertaken in this process. We appreciate the willingness of CMS to consider the current and needed data related to successful outcomes associated with cochlear implants.

Thousands of our members have a cochlear implant, or are considering one, and we know from their stories that this a life changing technology. Hearing loss can have a dramatic impact, especially for seniors, who are seeking to remain active participants in their communities.

This technology is constantly improving and improved data would allow for an even clearer idea of the successful outcomes for cochlear implantation. We were pleased to see CMS recognize this and allow for separate eligibility criteria for Medicare patients participating in approved clinical trials.

Thank you for your consideration in this important issue which affects the lives of so many people.

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I am a Cochlear Implant surgeon in Illinois and the creator and director of adult and pediatric cochlear implant programs. I have been actively involved in research and clinical use of implants for over 20 years.

I would like to thank CMS for addressing and proposing up-dating the cochlear implant candidacy policy. I know a lot of work goes into any effort like this, and it is often difficult to find definitive answers in the literature to the questions of candidacy. I understand how hard a task implant candidacy is, since when others ask us our criteria, there are many factors involved and some of them are difficult to quantify. I wholeheartedly agree with the proposed changes in policy as it is a more accurate reflection of current clinical use of cochlear implants in adults. In fact, our data from our center (which has been presented at major conferences, and is nearing publication) would suggest even broader criteria can result in huge improvements in auditory performance for older adults. We plan to continue to work with the implant manufacturers to help verify that even more inclusive criteria can be safe and very beneficial to patients.Thank you for your efforts, and I applaud your planned decision to expand criteria to allow more patients to be brought back into more useful, independent lives.Michael Novak, MD

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I write on behalf of 5 audiologists whose collective CI experience spans 2.5-21.5 years. We would like to thank CMS for considering the expansion of the pre-implant criteria for Medicare patients to receive a cochlear implant. Your willingness to work with professionals in this field with the intent of improving access to hearing through a cochlear implant for the beneficiaries’ of Medicare demonstrates an appreciation for the positive effects this technology is having in our elder population. With the accepted expansion the pre-implant sentence scores to that our elder population should have the same access cochlear implantation as any privately insured persons who qualifies for a cochlear implant under the current FDA criteria of pre- implant sentence scores of < 60. It remains important that we continue to move forward bringing Medicare criteria in line with the current FDA criteria of sentence score In our experience, the improvement in the quality of life of an elderly patient goes far beyond simply how much the patient is able to understand with a cochlear implant. It represents awareness of environmental sounds important to the patients’ feelings of security, enhancements in communication for those who may still rely to some extent on lip-reading and the fatigue associated with lip-reading.

Thank you for your consideration in this important healthcare issue.

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The American Speech-Language Hearing Association (ASHA) is a professional and scientific association of more than 115,000 speech-language pathologists, audiologists, and speech-language- hearing scientists. ASHA supports the Centers for Medicare and Medicaid Services’ (CMS) draft decision to expand the eligibility requirements for Medicare coverage of cochlear implantation, and urges CMS to finalize this national coverage determination. This proposal to update the coverage criteria recognizes advancements in cochlear implantation technology since Medicare’s original coverage decision in 1986 and will allow more individuals with hearing loss to access the device.

ASHA also supports the agency’s decision to allow coverage for patients enrolled in either FDA or CMS approved clinical trials. Inclusion of clinical trial participants with moderate to profound hearing loss and open set sentence recognition scores of >40 and for Medicare reimbursement will provide for better data collection on the effectiveness of cochlear implantation.

We appreciate the opportunity to provide feedback on the draft decision memo for cochlear implantation, and look forward to the publication of the final coverage decision memorandum. If you have any questions regarding ASHA’s position on coverage criteria for cochlear implantation, please contact Ingrida Lusis, ASHA’s Director of Health Care Regulatory Advocacy, via e-mail at ilusis@asha.org or by phone at 800-498-2071 ext. 4482
Sincerely,
Dolores E. Battle, PhD, CCC-SLP
President

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As an otologist and neurotologist involved with cochlear implantation, I applaud CMS for their recent review and revision of candidacy criteria for Medicare patients. A number of my patients have been frustrated with the outdated guidelines, needlessly suffering with severe hearing loss that would benefit from a CI using FDA guidelines, but not being quite severe enough for the previous criteria. The advances in this technology have vastly increased the number of severe hearing loss patients that can benefit. The willingness of CMS to consider these changes is commendable.

It is my sincere hope that CMS will not drop this issue, but continue to work with cochlear implant clinics and companies to generate more data to support even further expansion of candidacy criteria, especially as the technology continues to advance yearly.

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We, at Midwest Ear Institute, are truly appreciative of CMS agreeing to adjust the candidacy criteria.

Often we see patients who have gotten 38% speech understanding and had to turn them away just because they have Medicare. Meanwhile, the next patient walks in the door understands 45% on a sentence test and can have an implant just because he has different insurance coverage.

We are in full support of raising the candidacy criteria for implantation. On a weekly basis we see patients with more residual hearing perform very well with the cochlear implant.

Imagine only hearing 33% percent of what is said and being told you are not eligible for a cochlear implant. Imagine only hearing 1/3 of the next meeting you go into; 1/3 of your next telephone conversation with your child; now imagine someone telling you that you had TOO MUCH hearing to be a candidate for a cochlear implant. We absolutely support CMS making their guidelines match the FDA criteria.

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Thank you for your consideration of the proposal to expand the coverage criteria for cochlear implantation from the current level of 30% or less on sentence recognition to scores of 40% or less. This is a step in the right direction to improve the quality of service for people seeking treatment for hearing loss.

In my experience as a professional working to assist the needs of people with hearing impairment I have often observed the frustration and anguish that is felt by people who lose their hearing. One of the areas where the needs of the patient can often not be met is when there speech discrimination scores fall into the 30 - 60% category.

If there scores are poorer than 30% they are candidates for cochlear implants, and therefore we are able to provide some care and service for them, which can potentially improve the quality fo their life. If there scores are better than 60%, we can usually provide traditional hearing aids, which will be very beneficial. Unfortunately, when the scores are poorer than 60%, the benefit that the patient can receive from hearing aids is very limited. This can be devistating to a person who is trying to work or function day-to-day. It is frustrating as a health care professional not to have the ability to help this patients, especially when we know that a cochlear implant would probably be benefitial, but is just not an option because of the current guidelines.

Thank you for considering this proposal.

Sincerely,
Lisa Dahlstrom
Audiologist

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I am a practicing audiologist in Minnesota. Thank you for expanding current preimplant speech recognition scores to 40% or less. This is a positive step in the right direction for our older population. I fully suport CMS' proposed conclusions and ask that this expanded eligibility guideline be adopted. We know that cochlear aimplant provides excellent benefit for many people with severe to profound hearing loss. I also want to encourage CMS to continue gathering outcomes on performance for individuals who have even greater preimplant speech recognition scores. This information is readily available for patients who are younger than Medicare age as the criteria for this population allows up to 60 % in the non-implant ear and 50% in the implant ear for one of the implant devices. Thank you for this excellent work and for a positive decision.

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First, I want to thank CMS for considering the expansion of the pre-implant criteria for Medicare patients to receive a cochlear implant. I have worked as an audiologist for 40 years and since 1978, I have focused my primary clinical and research interests with cochlear implant patients. The improvements in technology have been exciting and wonderful for these patients. About 10 years ago, I co-authored a peer reviewed paper on cochlear implants in the elderly. Kelsall DC, Shallop JK, Burnelli T. Cochlear implantation in the elderly. Am J Otol 1995 Sep; 16(5):609-15. Our conclusion was that patients over the age of 70 did equally well with cochlear implants in comparison to patients under the age of 60. As I continue my work here at Mayo Clinic, we take pride in our "elder" population for the excellent benefits they receive with their cochlear implant. Our oldest patient is now 96 and he has been using his cochlear implant daily for the past 4 years. It is very important that we bring the Medicare criteria in line with the current FDA criteria. Those of us over the age of 65 deserve the same opportunities to communicate with our family and friends as privately insured persons of any age who qualify for a cochlear implant under the FDA criteria of pre-implant sentence scores of < 60%. I will send another article regarding the expansion of criteria via email. Shallop JK, Arndt PL, Turnacliff KA. Expanded indications for cochlear implantation: perceptual results in seven adults with residual hearing. J Speech Lang Pathol Audiol 1992; 16-2:141-8.

Please consider the adoption of these proposed revised CMS criteria that will afford an opportunity to improve the quality of life for Medicare patients who can benefit significantly from receiving a cochlear implant. Thank you for your consideration in this important healthcare issue.

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We are writing on behalf of The American Otological Society and wish to convey our complete support for the Draft Decision on coverage for Cochlear Implantation (CAG-00107N).

The American Otological Society represents over 300 senior specialists who provide ear and hearing care on a daily basis. For screened patients who are unable to use amplification to effectively access voiced and environmental sounds, the availability of the cochlear implant has been a lifeline.

The Council of The American Otological Society has reviewed CAG-00107N. We concur with its conclusion that expanding the criterion of HINT scores to < 40% reflects a threshold based on best evidence of effectiveness to date.

As clinical research increasingly underscores the importance of continued engagement with social networks in aging, The American Otological Society believes that this draft decision will enable a small, but significantly disabled population of seniors to now consider an important option. As evidence suggests, doing so may promote general and emotional health and help to avert global cognitive declines. We concur with the recommendation that consideration of further expanded criteria should await direct clinical study. The decision’s proposal of IDE studies to generate such data are well justified. This proposal offers a responsible plan for gaining further information.

The American Otological Society wishes to express its appreciation for the opportunity to make our views known in deliberating this coverage decision. Your acknowledgement of our correspondence and consideration of published data from members of The American Otological Society in CAG-00107N represents an exemplary model of interaction with the clinical community. We are encouraged and appreciative of these efforts on behalf of the Medicare beneficiaries we see.

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I serve children birth to three. The implanted children are far out performing the children with hearing aids in terms of language acquisition. They have larger vocabulary, better speech, and far more advanced structure.The question will soon be: Why should a child with a moderate to moderate severe hearing loss be saddled with poor language acquisition and lower academic performance and negative future earnings potential when an implant can provide superior performance to his hearing aids?

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As an audiologist at the House Ear Clinic, a leader in the field of cochlear implants, I endorse CMS’ proposed revision to the coverage policy for cochlear implantation. I realize that this has been an arduous task and appreciate the effort that CMS has put forth to revise the present criteria.

I have seen first hand how this wonderful technology has improved the lives of many people and believe that Medicare patients should have equal access to this technology. As a large implant center, we will work diligently with the implant manufacturers in collecting data in the older population of clinical study subjects. Thank you for your consideration in improving access to cochlear implant technology to Medicare beneficiaries.

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Cochlear™ Americas, the largest manufacturer and distributor of cochlear implants in the world, welcomes the opportunity to comment on CMS’ decision summary concerning proposed revisions to the current coverage policy for cochlear implantation. Cochlear Americas endorses CMS’ proposed revisions and appreciates the considerable effort invested in the development of this unique proposal. We value your willingness to work with us to preserve and improve Medicare beneficiaries’ access to the truly wonderful outcomes associated with cochlear implantation.

Expanding current preimplant speech recognition scores to 40% or less represents a great stride in achieving parity of access for the senior population. Cochlear is particularly pleased with the separate eligibility guidelines for Medicare patients participating in approved clinical trials. We welcome the opportunity to collect outcomes data in the older population who present with more preimplant residual hearing. We will work with cochlear implant programs and CMS to finish the job by undertaking the needed studies. We will also investigate methods to retrieve existing patient data reflecting candidacy and outcomes with particular emphasis on the older population.

Cochlear implants have improved the health, functioning, independence, and overall well-being of many Americans. Cochlear Americas appreciates the diligence, cooperation and progressiveness exhibited by the CMS reviewing staff. We look forward to working with CMS and are confident our combined efforts will result in continued access for Medicare beneficiaries who can benefit from this life changing technology. Thank you for your attention and consideration in this vital issue of public health.

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As a speech-language therapist working with children who are hearing impaired, I fully support these changes. Children with a severe hearing loss, enrolled in appropriate auditory based intervention with parent committment often far exceed expectations with their hearing aids and perform above current speech perception criteria for a cochlear implant. However, these children also struggle in many settings. They have difficulty listening in noise (i.e. classroom) and demonstrate significant auditory fatigue from effort it takes to gain information. They also often miss many high frequency sounds which impacts their language (i.e. plurals and verb tense endings). They have to fill in missing information and often do so incorrectly. This can also affect their literacy skills due to difficulty with sound/symbol association. A child can not report what they are not hearing, because they did not hear it. Therefore, many of these children do not know they are missing information but continue to fall behind in language development.

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Cochlear implants have been wonderful helping severe-to-profound people hear. As a teacher, however, I see students who qualifywhatever qualifications were in existence or will be in existencebut who don't go for the follow-up therapy. Follow-up therapy, I hear from parents, is not covered by Medicaid. The implant, I hear from therapists, is USELESS without the therapy afterwards. Personally, I have had two students who had the government pay for their $50,000 implants, didn't get the follow-up therapy, and do not benefit from their implants now, two years later. :-( I appreciate your wanting to change the requirements for qualifying, but until the entire proceduresurgery AND therapyis addressed, it doesn't matter a bit.

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This decision, if made, will provide help to thousands of patients who at this point are unable to access cochlear implant technology due to the current coverage criteria.

Most postlingual patients with cochlear implants are achieving speech perception far above the levels noted in these new recommendations. It has been very difficult for adults with hearing loss significant enough to cause serious problems with communication and yet be denied coverage because it must be even worse in order to be approved. Their friends with implants are using the phone and communicating with so much more ease, that it's created a difficult situation for those with slightly more residual hearing. My thanks go to all the people involved in initiating this recommendation.

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I am a SLP and Teacher of the Deaf who works with many cochlear implant clients. I worked at Manhattan Eye Ear and Throat Hospital as an Educational Consultant as well as in a University setting training Graduate Students to work with cochlear implant clients. I also work in the mainstream with young CI recipients.

Cochlear Implants are an amazing technologic advancement. I worked for 17 years with deaf children and the progress they are making now with implants is insurpassable by the use of hearing aids alone. These children are learning to communicate orally and are becoming fully integrated into mainstreamed schools at very early ages.

Insurance coverage is essential for us to reach as many people as we can with Cochlear Implants.

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The American Neurotology Society is comprised of 495 neurotologists who provide care for patients with disorders of the ear and skull base. In this capacity we are called on to consider options for patients who, despite using powerful hearing aids, have lost the ability to effectively communicate.

The ANS Executive Council has reviewed the Draft Decision Memo for Cochlear Implantation (CAG- 00107N) provided by the CMS. We are impressed with the level of scrutiny given to the existing literature on outcomes for seniors with cochlear implants by CMS.

We believe the conclusion that a level of best- aided performance at or below 40% HINT sentence scores, represents a well reasoned criterion for implant candidacy consideration. We recognize this is but one of several criteria to be considered before cochlear implantation is pursued.

The ANS applauds the CMS for the care and balanced perspective used in reviewing this coverage decision. We believe American seniors are well served by such efforts.

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Otologic Reimbursment Management is a free information resource for persons seeking health plan payment of cochlear implant services. We fully support the proposed expansion of Medicare coverage criteria. However, it is important to note to that requstor of the expansion, Cochlear Americas, is currently under Federal investigation for civil and criminal violations of Medicare regulations. Cochlear's well-chronicled control of physician and audiologist referrals through illegal kickback schemes (see http://www.cochlear.org/sys-tmpl/paymentstophysicians) are the primary reason why the vast majority of Medicare beneficiaries that currently qualify for cochlear implants are unable to receive them (as recognized by RAND in 2000.)

Until this problem is corrected, exanding the Medicare implantation criteria will simply expand the opportunties for fraud by Cochlear Americas.

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