Abstract
To evaluate speech understanding outcomes in a large adult cohort who demonstrated poor hearing performance with well fit hearing aids in the unilateral and bilateral or bimodal listening conditions at preimplant, 3-, 6- and 12-months. Post-linguistically deafened adults (N=100) with bilateral moderate-to-profound sensorineural hearing loss and limited functional benefit from well fit bilateral hearing aids. A multicenter, prospective, repeated-measures, within-subject controlled study was conducted. All subjects were implanted with a Slim Modiolar cochlear implant and were required to use bimodal stimulation (cochlear implant and hearing aid in contralateral ear) for 6-months postimplant and optionally to 12-months. Evaluations included: speech recognition for monosyllabic consonant-nucleus-consonant (CNC) words in quiet; AzBio sentences in coincident noise (at +5 and +10dB signal-to-noise ratio (SNR)), in implant ear and bimodal conditions. All speech tests were performed at preimplant and 6-months postimplant for primary endpoint outcomes, and a subset of speech tests at 3- and 12-months. In the implant ear only, at 3-, 6- and 12-months postimplant, 84%, 93% and 97% of subjects respectively, demonstrated significantly improved monosyllabic word scores in quiet compared to preimplant hearing aid scores (p<0.05). At 12-months, a mean gain of 51% points, for monosyllabic words and 32% points for sentences in noise was observed (p<0.001). In the bimodal condition, at 6-months postimplant, 87% of subjects demonstrated significantly improved monosyllabic word scores in quiet compared to preimplant bilateral hearing aid scores (p<0.05). At 6-months, a mean gain of 40% points, for monosyllabic words was observed (p<0.001). Speech scores for sentences in noise significantly improved for the bimodal condition at 6- and 12-months (p<0.001). In addition to speech scores for the implanted ear, bimodal condition scores demonstrated further increments, especially for sentences in noise at 6- and 12-months (p<0.001). Results support that bimodal hearing is superior to bilateral hearing aids in this cohort of bilateral moderate-to-profound adult hearing aid users. Our study cohort demonstrated significant improvements for speech scores for the cochlear implant (CI) ear only and bimodal conditions compared to the baseline preimplant unilateral and bilateral hearing aid conditions respectively. The greatest gain in performance was in the first three months of device use with incremental improvement through 12months. These findings indicate that when hearing aids fit to National Acoustics Laboratory (NAL-1) targets do not provide the necessary audibility needed for speech recognition, referral for CI-candidacy evaluation is strongly recommended. Clintrial.govNCT03007472. Registered 01/02/2017, https://clinicaltrials.gov/ct2/show/NCT03007472?term=clinical+evaluation+of+the+nucleus+CI532&draw=2&rank=2.
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