Hearing and Quality-of-Life Outcomes After Cochlear Implantation in Adult Hearing Aid Users 65 Years or Older: A Secondary Analysis of a Nonrandomized Clinical Trial

Abstract

Importance: Hearing loss, especially moderate to severe forms, has the potential to negatively affect an individual's physical, social, emotional, and cognitive well-being. Moreover, having ineffective binaural hearing increases difficulty understanding speech in noise and leads to a greater degree of social isolation and loneliness and a reduced quality of life (QoL).

Objective: To explore the audiometric and holistic effects of cochlear implantation in a group of adults 65 years or older compared with an optimized bilateral hearing aid condition.

Design, setting, and participants: This ad hoc secondary analysis of a prospective, single-subject, repeated-measures nonrandomized clinical trial included 13 cochlear implantation centers across the United States. Participants 65 years or older with postlingual bilateral moderate-to-profound sensorineural hearing loss with aided Consonant-Vowel Nucleus-Consonant (CNC) word scores in quiet of 40% or less in the ear to undergo implantation and 50% or less in the contralateral ear were included in the analysis. Baseline QoL testing was performed after 1 month of optimized bilateral hearing aid use. Participants were enrolled from February 20, 2017, to May 3, 2018, and follow-up was completed December 21, 2018. Data were analyzed from March 25, 2019, to March 31, 2020.

Interventions: Unilateral implantation with a slim, modiolar cochlear implant device. Hearing aid use in the contralateral ear was required through the 6-month primary end-point interval.

Main outcomes and measures: The primary objective was to evaluate speech perception before and 6 months after activation of a new cochlear implant. Secondary objectives were QoL metrics in the everyday listening condition before and 6 months after implantation.

Results: Seventy participants (51 men [73%]) with a median age of 74 (range, 65-91) years were included in the analysis. No major adverse events occurred. Mixed-model analysis with estimated marginal means and 95% CIs compared preimplantation baseline performance with 6-month postimplantation performance. A clinically important improvement in CNC words was shown in the bimodal condition, with a mean difference of 37.2% (95% CI, 32.0%-42.4%), and in the unilateral (cochlear implant only) condition, with a mean difference of 44.1% (95% CI, 39.0%-49.2%). A clinically important improvement in noise (AzBio sentences signal-to-noise ratio of +10 dB) was also shown, with a mean difference of 21.6% (95% CI, 15.7%-27.5%) in the bimodal condition and 24.5% (95% CI, 18.3%-30.7%) in the unilateral condition. The Health Utilities Index Mark 3 multiple-attribute score improved by 0.186 (95% CI, 0.136-0.234); the Speech, Spatial, and Qualities of Hearing Scale total score improved by 2.58 (95% CI, 2.18-2.99); and a novel Device Use Questionnaire reported 94% of participants were satisfied with overall hearing in the everyday listening condition.

Conclusions and relevance: This subgroup analysis of patients 65 years or older enrolled in a within-subject clinical trial of cochlear implantation demonstrated clinically meaningful audiometric and QoL benefit with an acceptable risk profile. These findings suggest that cochlear implantation in older adults may facilitate the concept of healthy aging.

Trial registration: ClinicalTrials.gov Identifier: NCT03007472.

Conflict of interest statement

Conflict of Interest Disclosures: Dr Wick reported serving as a consultant for Stryker Corp. Dr Kallogjeri reported serving as a consultant for and having stock ownership in PotentiaMetrics, Inc. Dr McJunkin reported serving as a consultant for Cochlear Ltd. Dr Herzog reported serving as a consultant for Cochlear Ltd. Dr Firszt reported serving as a consultant for Cochlear Ltd and Advanced Bionics LLC. Dr Buchman reported serving as a consultant for Advanced Bionics LLC, Cochlear Ltd, IotaMotion, and Envoy; receiving research support from Advanced Bionics LLC, Cochlear Ltd, and MedEL; obtaining a 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.. Study Flow Diagram

Figure 2.. Baseline and 6-Month Postoperative Estimated Marginal Mean Consonant-Vowel Nucleus-Consonant (CNC) Word Scores in Quiet

Bilateral everyday condition indicates hearing aid use in both ears (BI); unilateral condition, cochlear implant use only (CI).