Assessment of Speech Understanding After Cochlear Implantation in Adult Hearing Aid Users: A Nonrandomized Controlled Trial

Abstract

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.

Trial registration: ClinicalTrials.gov Identifier: NCT03007472.

Conflict of interest statement

Conflict of Interest Disclosures: Dr Buchman reported serving as a consultant for Advanced Bionics, Cochlear Ltd, Iotamotion, and Envoy Medical; receiving research support from Advanced Bionics, Cochlear Ltd, and MedEL; obtaining grants from the US Department of Defense; having a patent to US9,072,468B2; and owning stock in Advanced Cochlear Diagnostics, LLC. Drs Herzog, McJunkin, and Firszt reported serving as consultants for Cochlear Ltd. Dr Herzog reported receiving grants from Cochlear Americas. Dr McJunkin reported receiving consultant fees for a video from the Cochlear Corporation. Dr Wick reported receiving research support from the Cochlear Corporation and serving as a consultant for Stryker. Dr Firszt reported serving as a consultant for Advanced Bionics, receiving grants and personal fees from Cochlear Americas, and receiving personal fees from Advanced Bionics. Dr Kallogjeri reported serving as a consultant for and owning stock in PotentiaMetrics. No other disclosures were reported.

Figures

Figure 1.. CONSORT Diagram of Study Participation

CNC indicates Consonant-Vowel Nucleus-Consonant; HA, hearing aid.

Figure 2.. Baseline Audiogram

Shown are individual and group (black line) mean thresholds at baseline for the implant ear (A) and the nonimplant ear (B).

Figure 3.. Speech Understanding by Cognitive Impairment

Shown is a comparison of the change in Consonant-Vowel Nucleus-Consonant (CNC) word score and AzBio +10 SNR (speech understanding in noise at a signal-to-noise ratio of +10 dB) sentence lists between study visits in the implant ear (A), bimodal condition (B), and best-aided condition (C) in participants with and without mild cognitive impairment. MoCA indicates Montreal Cognitive Assessment.