Until recently, candidacy criteria for Medicare beneficiaries who may benefit from cochlear implantation (CI) was more stringent than the FDA guideline, typically followed by private health insurers. The narrow Medicare criteria were changed on September 26, 2022, when the Centers for Medicare & Medicaid Services (CMS) published its final rule under a process called a National Coverage Determination (NCD) to expand coverage for cochlear implants under Medicare. The CMS action facilitates an important improvement in access to CI care for older adults and confirms the benefits of broader criteria for other insurers. Now, older adults are eligible for CI with best-aided hearing test scores of 60% words in sentences. Previously, adults receiving cochlear implants under Medicare were limited to best-aided sentence test scores of 40%. (See Table 1.)
ACI ALLIANCE INTEREST IN CHANGING MEDICARE CRITERIA
The first major initiative undertaken by the then newly organized American Cochlear Implant Alliance (ACI Alliance) in 2013 was a research project designed to evaluate CI candidacy in older adults. Interest was driven by advances in CI outcomes as well as findings that long waits once someone is a CI candidate impact hearing outcomes as well as general health. Older adults deemed to have too much hearing for a CI noted that others, also of Medicare age, had received cochlear implants and were communicating more effectively than they were. The hearing test scores of these ineligible individuals were “too good” for Medicare candidacy—yet many still struggled to communicate in various settings. Research demonstrates important quality-of-life benefits as well as an association between undertreated hearing loss and dementia. In 2012, when ACI Alliance began discussing the need for a change in Medicare candidacy, researchers were exploring such associations in greater detail. 1
Since then, our understanding of the impacts of CI on quality of life and general health, including cognitive status, has deepened and provided increased support for CI consideration for a broader group of adults. 2
Subjects in the study organized by ACI Alliance were required to have a bilateral moderate-to-profound hearing loss and meet other specific criteria defined by CMS. Medicare agreed to cover evaluation, surgery, device, and follow-up care for those in the study; all patients in the study did not meet the (then) current CMS criteria and would not have been approved for a Medicare-funded CI were they not in the study. No funding was provided to ACI Alliance from CMS and the principal investigators (audiologist Terry Zwolan, PhD, and surgeons Craig Buchman, MD, and the late John K. Niparko, MD) led the study effort without compensation.
CMS worked with the study investigators and conducted reviews throughout. Findings were published in JAMA -Otolaryngology-Head & Neck Surgery in 2020 3, and subsequently a formal request to revise the NCD was submitted. In March 2022, CMS initiated a National Coverage Analysis (a formal process of public review and comment) that ACI Alliance, other organizations, individual clinicians, and individuals participated in. The final decision memorandum for reconsideration of CI was published on September 26, 2022. This action by CMS has opened up greater access to CI for Medicare beneficiaries. The new criteria were effective immediately (bit.ly/3U1d7ji).
Benefits Beyond Auditory Rehabilitation
Research conducted by Frank Lin and colleagues found that individuals with untreated mild, moderate, and severe hearing loss had, respectively, a twofold, threefold, and fivefold increased risk of dementia compared with individuals with normal hearing. 4 Research suggests that early auditory rehabilitation is important for people of all ages, including older adults, as it can provide benefits and improvements beyond hearing ability such as cognitive function and mitigation of depression. Lin et al. studied the impact of rehabilitation with hearing aids and the association with cognitive benefit in older adults. 5–7 Based on this research, older adults are at risk for a threefold to fivefold increased risk of dementia associated with their hearing loss—a risk that may also be mitigated via intervention with a cochlear implant.
A number of recent studies examined the specific impact of CI on cognition in older adults. A clinical investigation analyzed long-term cognitive status and function after CI in 70 individuals 65 years of age and older who qualified for cochlear implants. 8 Cognitive testing was performed before and after CI (after one year and after five or more years). Mild cognitive impairment (MCI) was observed in 45% of patients before CI. Post CI, there was a low rate of progression to dementia and cognitive function improved to normal in 32% of individuals with MCI at the time of CI. The study concluded that CI should be routinely discussed as having a possible positive effect on cognitive function in older adults with severe-to-profound hearing loss who are not sufficiently helped with hearing aids. A study of cognitive function in adults who received cochlear implants assessed working memory, concentration, inhibition control, and nonverbal reasoning after six months of CI use. The study supported the premise that CI may lead to improvements in some cognitive domains. 9
Consideration of health-related quality of life as an important outcome of hearing rehabilitation is increasingly recognized as a key reason for improving access to appropriate hearing technology for individuals of all ages. Making CI available to older adults who can benefit from improved access to spoken language and environmental sounds is recognized as an opportunity to improve overall quality of life. A study involving 371 participants from 20 U.S. cochlear implant centers examined the association of demographic and CI-related factors with quality of life. The study found that age did not impact quality-of-life outcomes demonstrating that data from other studies on CI patients from younger demographics could be applied to Medicare beneficiaries. 10
STUDY FINDINGS LEADING TO THE NCD REVISION
The final study findings published in the JAMA Otolaryngology--Head & Neck Surgery paper demonstrated important patient improvement in outcomes following CI. Briefly, a group of 34 CMS beneficiaries (median age 73.6 years [range, 65.7-85.1 years]) were enrolled in the study at 10 different locations across the United States. These individuals had a median duration of hearing loss in the implant ear of 23.9 (range 10.5-62.4) years; a duration of deafness of 10.8 (range 0.2-62.4) years, and a duration of hearing loss in the contralateral ear of 9 (0.2-62.4) years.
Baseline (preoperative CI) AzBio sentence scores for patients in the best aided condition (usually bilateral hearing aids) and the ear to be implanted were 53% and 24%, respectively. At 12 months following implantation, AzBio sentence scores in the best aided condition (usually CI+ contralateral hearing aid) and CI alone was 89% and 77%, respectively. Thus, participants experienced a median change in their best-aided condition and CI alone ear of 36% and 53%, respectively. Similar large-scale changes were seen when tests were conducted using single, monosyllable word tests (CNC words) or when CUNY sentences were administered over a telephone. All the changes in speech perception performance were statistically significant (see Figure 1).
The vertical lines indicate 95% CIs. AzBio indicates AzBio Sentence Test; CNC, Consonant Nucleus Consonant Monosyllabic Word Test; and CUNY, City University of New York sentence test. 11
Maybe more noteworthy, changes (improvements) in speech perception were associated with statistically significant and clinically meaningful positive changes in hearing-related quality-of-life metrics as assessed by the Abbreviated Profile of Hearing Aid Benefit (APHAB) and Health Utilities Index Mark-3 (HUI-3). These benefits were seen at the six-month time interval following implantation and were maintained through the one-year follow up.
Overall, the results of the study clearly demonstrated that current multichannel cochlear implant systems provide meaningful improvements in communication for adult Medicare beneficiaries 65 years or older, with qualifying AZBio sentence recognition scores between 41% and 60%.
STUDY PARTICIPANT’S LIFE-CHANGING OUTCOMES
Participating in the Medicare study afforded an opportunity for Medicare beneficiaries to move forward with CI at study sites. Patricia Ross was a patient at Washington University in St. Louis where she had gone to be evaluated for a cochlear implant. Although she had too much residual hearing to receive a Medicare-funded cochlear implant (with her score of 41% words in sentences she was just over the limit), she learned of her candidacy for the ongoing CED study, which would cover her CI were she a participant.
Patricia notes that the benefits were life-changing within a few weeks of activation. She was thrilled that, for the first time, she could hear her grandchildren. They were pleased to be tasked to assist her with listening exercises. Improvements continued over time. One-on-one in quiet became effortless and she mentions that voices were “amazingly clear.” Conversations with two or more people are also much easier, though like most people with significant hearing loss, she does sometimes ask for clarification.
Negotiating the world is so much easier; now she knows when someone is talking “whether in the grocery store or the condo elevator!” Before, with two hearing aids, “I would just see their lips move if I was looking at them.” There were important emotional benefits as she engaged socially with family and friends, and as part of her new volunteer activities. People who have known her for years were astonished by her improved hearing. In conclusion, Patricia notes that she is thankful each day for the changes in her quality of life and delighted that she was able to contribute, through her participation in the study, to the improvement in access to CI that has now occurred in Medicare.
PATIENT ACCESS OPPORTUNITY
The recent CMS action opens long-awaited (more equivalent) CI access for older adults. Patricia’s experience as a Medicare beneficiary whose test scores were “not quite bad enough” for her to qualify under old criteria demonstrate how much improvement in hearing and overall lifestyle a cochlear implant provided for her under the new criteria. Her experience is typical. With more emphasis on the cochlear implant discussion as part of the hearing health continuum of care for people of all ages, professionals in and out of CI practices are recognizing their key role in using tools like the 60/60 referral guideline for adults for initiating the discussion early as part of the full set of tools that can keep patients of all ages connected to their family, friends, and the world around them. 13 Cochlear implants are not a last resort; rather they provide a means for those who fall within the guideline to experience hearing improvement, rather than continuing to decline.
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1. Birger M, Morten L, Sten H 2005 Cochlear Implants and Quality of Life: A Prospective Study Ear and Hearing 26 186 194 https://doi.org/10.1097/00003446-200504000-00006
2. McRackan TR, Bauschard M, Hatch JL, Franko-Tobin E, Droghini R 2018 Meta-analysis of quality of life improvement after cochlear implantation and associations with speech recognition abilities The Laryngoscope 128 982 990 https://doi.org/10.1002/lary.26738
3. Zwolan TA, Kallogjeri D, Firszt JB, Buchman CA 2020 Assessment of Cochlear Implants for Adult Medicare Beneficiaries Aged 65 Years or Older Who Meet Expanded Indications of Open-Set Sentence Recognition: A Multicenter Nonrandomized Clinical Trial JAMA Otolaryngology Head & Neck Surgery 146 933 941 doi:10.1001/jamaoto.2020.2286
5. Sarant J, Harris D, Busby P, et al. 2020 The Effect of Hearing Aid Use on Cognition in Older Adults: Can We Delay Decline or Even Improve Cognitive Function. Journal of Clinical Medicine 9 254 https://doi.org/10.3390/jcm9010254
6. Tai CJ, Tseng TG, Hsiao YH, et al. 2021 Effects of hearing impairment and hearing aid use on the incidence of cognitive impairment among community-dwelling older adults: evidence from the Taiwan Longitudinal Study on Aging (TLSA) BMC Geriatrics 21 ■ https://doi.org/10.1186/s12877-021-02012-4
7. Maharani A, Dawes P, Nazroo J, Tampubolon G, Pendleton N 2018 Longitudinal Relationship Between Hearing Aid Use and Cognitive Function in Older Americans Journal of the American Geriatrics Society 66 1130 1136 https://doi.org/10.1111/jgs.15363
8. Mosnier I, Vanier A, Bonnard D, Lina-Granade G, et al. 2018 Long-Term Cognitive Prognosis of Profoundly Deaf Older Adults After Hearing Rehabilitation Using Cochlear Implants. Journal of the American Geriatrics Society 66 1553 1561 https://doi.org/10.1111/jgs.15445
9. Zhan KY, Lewis JH, Vasil KJ, et al. 2020 Cognitive Functions in Adults Receiving Cochlear Implants: Predictors of Speech Recognition and Changes After Implantation Otology & Neurotology 41 e322 e329 https://doi.org/10.1111/jgs.15445
10. McRackan TR, Hand BN, Velozo CA, Dubno JR 2019 Association of Demographic and Hearing-Related Factors With Cochlear Implant-Related Quality of Life JAMA Otolaryngology-Head & Neck Surgery 145 422 430 https://doi.org/10.1001/jamaoto.2019.0055
11. Zwolan TA, Kallogjeri D, Firszt JB 2020 ■ JAMA Otolaryngology-Head & Neck Surgery 146 933 941 https://doi.org.10.1001/jamaoto.2020.2286
12. Zwolan TA, Kallogieri D, Firszt JB, Buchman C 2020 Assessment of Cochlear Implants for Adult Medicare Beneficiaries Aged 65 Years or Older Who Meet Expanded Indications of Open-Set Sentence Recognition: A Multicenter Nonrandomized Clinical Trial JAMA Otolaryngology--Head & Neck Surgery ■ ■ https://doi.org/10.1001/jamaoto.2020.2286
13. Zwolan TA, Schvartz-Leyzac K, Pleasant T 2020 Development of a 60/60 Guideline for Referring Adults for a Traditional Cochlear Implant Candidacy Evaluation Otology & Neurotology 41 895 900 https://doi.org.10.1097/MAO.0000000000002664