TY - JOUR
T1 - Assessment of speech understanding after cochlear implantation in adult hearing aid users a nonrandomized controlled trial
AU - CI532 Study Group
AU - Buchman, Craig A.
AU - Herzog, Jacques A.
AU - McJunkin, Jonathan L.
AU - Wick, Cameron C.
AU - Durakovic, Nedim
AU - Firszt, Jill B.
AU - Kallogjeri, Dorina
AU - Buchman, Craig A.
AU - Herzog, Jacques A.
AU - McJunkin, Jonathan L.
AU - Durakovic, Nedim
AU - Firszt, Jill B.
AU - Kallogjeri, Dorina
AU - Drescher, Andrew
AU - Holden, Laura
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 - Perry, Brian
AU - King, Susan
AU - Evans, Jerome
AU - Luduena, Linda
AU - Wood, Mark
AU - Baker, Stan
AU - Duke, Mila
AU - Neumann, Sara
AU - Wolfe, Jace
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
N1 - Publisher Copyright:
© 2020 American Medical Association. All rights reserved.
PY - 2020/10
Y1 - 2020/10
N2 - IMPORTANCE Cochlear implants were approved for use in adults in the 1980s, but use remains low owing to a lack of awareness regarding cochlear implantation candidacy criteria and expected outcomes. There have been limited, small series examining the safety and effectiveness of cochlear implantation in adult hearing aid (HA) users with and without mild cognitive impairment (MCI). OBJECTIVE To investigate the safety and effectiveness of a single-ear cochlear implant in a group of optimized adult HA users with and without MCI across a variety of domains. DESIGN, SETTING, AND PARTICIPANTS In this nonrandomized controlled trial, a multicenter, prospective, repeated-measures investigation was conducted at 13 US institutions. The setting was academic and community-based cochlear implant programs. Eligible participants were 100 adults (aged >18 years) with postlinguistic onset of bilateral moderate sloping to profound or worse sensorineural hearing loss (20 years' duration). Fluent English speakers underwent an optimized bilateral HA trial for at least 30 days. Individuals with aided Consonant-Vowel Nucleus-Consonant (CNC) word score in quiet of 40% or less correct in the ear to be implanted and 50% or less correct in the contralateral ear were offered cochlear implants. The first participant was enrolled on February 20, 2017, and the last participant was enrolled on May 3, 2018. The final follow-up was on December 21, 2018. INTERVENTIONS Participants received the same cochlear implant system and contralateral HA. MAIN OUTCOMES AND MEASURES The primary outcome measure was speech understanding in quiet (CNC word score) using both the cochlear implant and opposite ear HA. Secondary outcome measures included the following: adverse events; speech understanding in noise (AzBio signal-to-noise ratio of +10 db [+10 SNR]) Health Utilities Index Mark 3 (HUI3); Speech, Spatial, and Qualities of Hearing Questionnaire 49 (SSQ49); and Montreal Cognitive Assessment (MoCA). RESULTS The median age at cochlear implantation of the 96 patients included in the trial was 71 years (range, 23-91 years), and 62 patients (65%) were male. Three serious adverse events requiring revision surgery occurred, and all resolved without sequelae. By 6 months after activation, the absolute marginal mean change in CNC word score and AzBio +10 SNR was 40.5% (95% CI, 35.9%-45.0%) and 24.1% (95% CI, 18.9%-29.4%), respectively. Ninety-one percent (87 of 96) of participants had a clinically important improvement (>15%) in the CNC word score in the implant ear. Mild cognitive impairment (MoCA total score ≦25) was observed in 48 of 81 study participants (59%) at baseline. Speech perception marginal mean improvements were similar between individuals with and without baseline MCI, with values of 40.9% (95% CI, 35.2%-46.6%) and 39.6% (95% CI, 31.8%-47.4%), respectively, for CNC word score and 27.5% (95% CI, 21.0%-33.9%) and 17.8% (95% CI, 9.0%-26.6%), respectively, for AzBio +10 SNR. Statistically significant and clinically important improvements in the HUI3 and SSQ49 were evident at 6 months. CONCLUSIONS AND RELEVANCE The findings of this nonrandomized controlled trial seem to indicate that cochlear implants are safe and effective in restoring speech understanding in both quiet and noise and improve quality of life in individuals with and without MCI.
AB - IMPORTANCE Cochlear implants were approved for use in adults in the 1980s, but use remains low owing to a lack of awareness regarding cochlear implantation candidacy criteria and expected outcomes. There have been limited, small series examining the safety and effectiveness of cochlear implantation in adult hearing aid (HA) users with and without mild cognitive impairment (MCI). OBJECTIVE To investigate the safety and effectiveness of a single-ear cochlear implant in a group of optimized adult HA users with and without MCI across a variety of domains. DESIGN, SETTING, AND PARTICIPANTS In this nonrandomized controlled trial, a multicenter, prospective, repeated-measures investigation was conducted at 13 US institutions. The setting was academic and community-based cochlear implant programs. Eligible participants were 100 adults (aged >18 years) with postlinguistic onset of bilateral moderate sloping to profound or worse sensorineural hearing loss (20 years' duration). Fluent English speakers underwent an optimized bilateral HA trial for at least 30 days. Individuals with aided Consonant-Vowel Nucleus-Consonant (CNC) word score in quiet of 40% or less correct in the ear to be implanted and 50% or less correct in the contralateral ear were offered cochlear implants. The first participant was enrolled on February 20, 2017, and the last participant was enrolled on May 3, 2018. The final follow-up was on December 21, 2018. INTERVENTIONS Participants received the same cochlear implant system and contralateral HA. MAIN OUTCOMES AND MEASURES The primary outcome measure was speech understanding in quiet (CNC word score) using both the cochlear implant and opposite ear HA. Secondary outcome measures included the following: adverse events; speech understanding in noise (AzBio signal-to-noise ratio of +10 db [+10 SNR]) Health Utilities Index Mark 3 (HUI3); Speech, Spatial, and Qualities of Hearing Questionnaire 49 (SSQ49); and Montreal Cognitive Assessment (MoCA). RESULTS The median age at cochlear implantation of the 96 patients included in the trial was 71 years (range, 23-91 years), and 62 patients (65%) were male. Three serious adverse events requiring revision surgery occurred, and all resolved without sequelae. By 6 months after activation, the absolute marginal mean change in CNC word score and AzBio +10 SNR was 40.5% (95% CI, 35.9%-45.0%) and 24.1% (95% CI, 18.9%-29.4%), respectively. Ninety-one percent (87 of 96) of participants had a clinically important improvement (>15%) in the CNC word score in the implant ear. Mild cognitive impairment (MoCA total score ≦25) was observed in 48 of 81 study participants (59%) at baseline. Speech perception marginal mean improvements were similar between individuals with and without baseline MCI, with values of 40.9% (95% CI, 35.2%-46.6%) and 39.6% (95% CI, 31.8%-47.4%), respectively, for CNC word score and 27.5% (95% CI, 21.0%-33.9%) and 17.8% (95% CI, 9.0%-26.6%), respectively, for AzBio +10 SNR. Statistically significant and clinically important improvements in the HUI3 and SSQ49 were evident at 6 months. CONCLUSIONS AND RELEVANCE The findings of this nonrandomized controlled trial seem to indicate that cochlear implants are safe and effective in restoring speech understanding in both quiet and noise and improve quality of life in individuals with and without MCI.
UR - http://www.scopus.com/inward/record.url?scp=85092239669&partnerID=8YFLogxK
U2 - 10.1001/jamaoto.2020.1584
DO - 10.1001/jamaoto.2020.1584
M3 - Article
C2 - 32857113
AN - SCOPUS:85092239669
SN - 2168-6181
VL - 146
SP - 916
EP - 924
JO - JAMA Otolaryngology - Head and Neck Surgery
JF - JAMA Otolaryngology - Head and Neck Surgery
IS - 10
ER -