Objective: To assess the safety and efficacy of cochlear implantation in adult patients with single-sided deafness (SSD) through a post-market approval study. Study design: Prospective, nonrandomized, single-arm multicenter post-market clinical investigation. Setting: Five tertiary referral cochlear implant (CI) centers. Patients: Thirty adults older than or equal to 18 years with profound unilateral sensorineural hearing loss (pure-tone average ≥ 80 dB HL and CNC ≤ 5%) and normal/near-normal hearing in the contralateral ear (pure-tone average ≤ 30 dB HL). Intervention(s): Unilateral cochlear implantation with an FDA-approved CI system. Main outcome measure(s): Changes in speech recognition in quiet and noise, binaural hearing in noise, spatial hearing, tinnitus reduction, and quality of life. Results: Significant improvements in speech perception in quiet and noise were demonstrated from the preoperative to the 12-month postoperative timepoint. Target-to-masker separated hearing tasks showed significant improvements for both head shadow and binaural squelch at the 12-month postoperative timepoint. Significant effects of the CI were also seen for tinnitus reduction, quality of life improvement, fatigue reduction, and self-reported benefits. Conclusions: This prospective, multicenter post-market approval study reports on the outcomes of CI for SSD in a cohort of adult patients. Significant improvements in speech in quiet and noise at 12 months were demonstrated. In addition, significant benefit was observed for all patient-reported outcome measures including tinnitus reduction, listening fatigue, quality of life, and spatial hearing. Cochlear implantation is an excellent treatment option for SSD patients and has a positive impact on many aspects of patients’ lives and well-being.
Zeitler et al. (Mon,) studied this question.