Subjects Being Sought
At present, candidacy criteria for cochlear implantation followed by the Centers for Medicare and Medicaid Services (CMS) are more stringent than the FDA guidelines typically followed by most implant centers and also by the majority of health insurance plans. This has resulted in an unfortunate access barrier; older adults do not have the same access to the benefits of cochlear implantation, which may help them remain active and contribute to their overall health status.
The American Cochlear Implant Alliance is conducting a CMS-approved Coverage with Evidence (CED) study to evaluate expansion of CMS candidacy criteria to include adults with better pre-operative speech recognition skills. Presently, CMS indications state that cochlear implantation may be covered for treatment of bilateral pre- or post-linguistic sensorineural moderate to profound hearing loss in individuals who demonstrate limited benefit from amplification as defined by test scores of less than or equal to 40% correct in the best-aided listening condition on tape-recorded tests of open-set sentence recognition. The purpose of this study is to evaluate the safety and efficacy of currently available multichannel cochlear implant systems using expanded CMS criteria that includes newly implanted adults who score up to 60% correct on HINT sentences preoperatively in their best aided condition.
A total of ten CI centers are taking part in this study across the U.S. (Study centers are noted in the adjacent table.) Study participants must have the surgery and specific follow-up appointments at one of the designated study sites. However, many study sites have indicated they are willing to work with referring centers to have patients attend non-study appointments at centers closer to the their home, and to allow patients to transfer back to their home center once they have completed their obligations to the study one year post-implant.
If you are a hearing health professional who has turned away patients who are good candidates for a CI because they do not meet current CMS criteria to receive a cochlear implant, we would like to ask you to consider referring such patients to this study.
If you (or someone you know) are of Medicare age, presently using hearing aids, and still have difficulty hearing, or if you have been evaluated and told that you have too much hearing for a cochlear implant under Medicare’s more stringent criteria, we encourage you to learn more about this study. Studies have found that CI recipients with more residual hearing and shorter periods of deafness at the time of CI tend to have the best outcomes.
For additional information about this study, please contact Donna Sorkin, dsorkin@acialliance.org or visit https://clinicaltrials.gov/ct2/show/NCT02075229. Overview Information on this study can also be found in past issues of the ACI Alliance e-magazine, which can be accessed freely in our Member Center area at www.acialliance.org.
CI Center Study Sites
Johns Hopkins, New York University, University of Iowa, University of Miami, University of Michigan, University of North Carolina, University of Southern California, Vanderbilt, University of Washington (Seattle), Washington University (St. Louis)
Selected References
https://clinicaltrials.gov/ct2/show/NCT02075229: Evaluation of Revised Indications (ERID) for Cochlear Implant Candidacy for the Adult CMS Population. Clinical trials.gov Identifier # NCT02075229
Zwolan T, Henion K, Segel P, Runge C. (2013). The role of age on cochlear implant performance, use, and health utility: a multicenter clinical trial. Otol Neurotol, 2014 Oct;35(9).
Clark JH1, Yeagle J, Arbaje AI, Lin FR, Niparko JK, Francis HW Cochlear implant rehabilitation in older adults: literature review and proposal of a conceptual framework. J Am Geriatr Soc. 2012 Oct;60(10):1936-45.
Cosetti MK & Waltzman SB. Outcomes in cochlear implantation: variables affecting performance in adults and children. Otol N Am, 2012.
Green K et al. Predictors of audiological performance following cochlear implantation in adults, Cochlear Implants International, 2007.
Agency for Healthcare Research and Quality. Technology Assessment: Effect of cochlear implants in adults with sensorineural hearing loss. 2011. https://www.cms.gov/Medicare/Coverage/DeterminationProcess/downloads/id80TA.pdf
Teresa Zwolan, PhD, Director, University of Michigan Cochlear Implant Program and Vice Chair, American Cochlear Implant Alliance
