TY - JOUR
T1 - 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
AU - CI532 Study Group
AU - Wick, Cameron C.
AU - Kallogjeri, Dorina
AU - McJunkin, Jonathan L.
AU - Durakovic, Nedim
AU - Holden, Laura K.
AU - Herzog, Jacques A.
AU - Firszt, Jill B.
AU - Buchman, Craig A.
AU - Buchman, Craig A.
AU - McJunkin, Jonathan L.
AU - Drescher, Andrew
AU - Durakovic, Nedim
AU - Firszt, Jill B.
AU - Holden, Laura K.
AU - Dwyer, Noel
AU - Beyer, Lydia
AU - Rathgeb, Susan
AU - Potts, Lisa
AU - Mispagel, Karen
AU - Peters, Bob
AU - Hahn, Yoav
AU - King, Kristin
AU - Lianos, Leslie
AU - Wood, Mark
AU - Baker, Stan
AU - Duke, Mila
AU - Neumann, Sara
AU - Wolfe, Jace
AU - Perry, Brian
AU - King, Susan
AU - Evans, Jerome
AU - Luduena, Linda
AU - Cullen, Robert
AU - Ursick, Joe
AU - Lewis, Kristen
AU - Zlmoke, Sarah
AU - Nelson, Morgan
AU - Waltzman, Susan
AU - Roland, Tom
AU - Jethanamest, Daniel
AU - Friedman, David
AU - Mahoney, Laurel
AU - Rigby, Alison
AU - Shapiro, Bill
AU - Adunka, Oliver F.
AU - Moberly, Aaron
AU - Dodson, Edward
AU - Vasil, Kara
AU - Kelsall, David
AU - Lupo, Eric
N1 - Publisher Copyright:
© 2020 American Medical Association. All rights reserved.
PY - 2020/10
Y1 - 2020/10
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=85092232997&partnerID=8YFLogxK
U2 - 10.1001/jamaoto.2020.1585
DO - 10.1001/jamaoto.2020.1585
M3 - Article
C2 - 32857114
AN - SCOPUS:85092232997
SN - 2168-6181
VL - 146
SP - 925
EP - 932
JO - JAMA Otolaryngology - Head and Neck Surgery
JF - JAMA Otolaryngology - Head and Neck Surgery
IS - 10
ER -