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

Abstract

Importance: Current indications for Medicare beneficiaries to receive a cochlear implant are outdated. Multichannel cochlear implant systems may be effective when provided to Medicare beneficiaries using expanded indications.

Objective: To examine the effectiveness of cochlear implants, as measured by improvement on the AzBio Sentence Test, for newly implanted Medicare beneficiaries who meet the expanded indications of an AzBio Sentence Test score of 41% to 60% in their best-aided condition.

Design, setting, and participants: A multicenter nonrandomized trial examined preoperative and postoperative speech recognition, telephone communication, hearing device benefit, health utility, and quality of life for 34 participants enrolled at 8 different centers who received a cochlear implant between September 17, 2014, and July 10, 2018. All participants were 65 years or older, had bilateral moderate to profound hearing loss, and had a best-aided preoperative AzBio Sentence Test score in quiet of 41% to 60%. Analysis was performed on an intention-to-treat basis. Statistical analysis of final results took place from July 29 to October 1, 2019.

Intervention: Multichannel cochlear implants.

Main outcomes and measures: The study examined the a priori hypothesis that the cochlear implant would improve the AzBio Sentence Test score in the best-aided condition by 25% or more and in the implanted ear-alone condition by 30% or more. The study additionally examined word and telephone recognition and examined device benefit, health utility, and quality of life.

Results: A total of 34 participants received a cochlear implant; 31 (23 men [74%]; median age, 73.6 years [range, 65.7-85.1 years]) completed testing through the 6-month evaluation, and 29 completed testing through the 12-month evaluation. Median preoperative AzBio Sentence Test scores were 53% (range, 26%-60%) for the best-aided condition and 24% (range, 0%-53%) for the cochlear implant-alone condition; median scores 12 months after implantation improved to 89% (range, 36%-100%) for the best-aided condition and 77% (range, 13%-100%) for the cochlear implant-alone condition. This outcome represents a median change of 36% (range, -22% to 75%) for the best-aided condition (lower bound of 1-sided 95% CI, 31%) and a median change of 53% (range, -15% to 93%) for the cochlear implant-alone condition (lower bound of 1-sided 95% CI, 45%).

Conclusions and relevance: Intervention with a cochlear implant was associated with improved sentence, word, and telephone recognition in adult Medicare beneficiaries whose preoperative AzBio Sentence Test scores were between 41% and 60%. These findings support expansion of the Center for Medicare & Medicaid current indications for cochlear implants.

Trial registration: ClinicalTrials.gov Identifier: NCT02075229.

Conflict of interest statement

Conflict of Interest Disclosures: Dr Zwolan reported serving as a consultant and advisory board member for Cochlear Americas and Envoy Medical and receiving grants and personal fees from Cochlear Americas and consulting fees from Envoy Medical outside the submitted work. Dr Kallogjeri reported serving as a consultant and owning stocks with PotentiaMetrics outside the submitted work. Dr Firszt reported serving as a member of the Audiology advisory board for Advanced Bionics and Cochlear Americas and receiving personal fees from Cochlear Americas and Advanced Bionics outside the submitted work. Dr Buchman reported serving as a consultant for Advanced Bionics, Cochlear Ltd, IotaMotion, and Envoy; receiving research support from Advanced Bionics, Cochlear Ltd, and MedEL; obtaining grant from the US Department of Defense; having a patent to US9,072,468B2; and owning stock in Advanced Cochlear Diagnostics LLC. No other disclosures were reported.

Figures

Figure 1.. Participant Flow Diagram

Figure 2.. Change in Each Speech Perception Outcome Measure Through Study Visits for the Group

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.