A Prospective Multicenter Post-Market Study Evaluating the Safety and Effectiveness of Cochlear Implantation in Adults With Single-Sided Deafness

Daniel M Zeitler; Enrique Perez; Jennifer Alyono; Courtney Broadfoot; Olivia Boothby

doi:10.1097/MAO.0000000000004978

A Prospective Multicenter Post-Market Study Evaluating the Safety and Effectiveness of Cochlear Implantation in Adults With Single-Sided Deafness

Otol Neurotol. 2026 Jun 15. doi: 10.1097/MAO.0000000000004978. Online ahead of print.

Authors

Daniel M Zeitler¹, Enrique Perez², Jennifer Alyono³, Courtney Broadfoot⁴, Olivia Boothby¹

Affiliations

¹ Listen for Life Hearing Implant Center, Department of Otolaryngology-HNS, Virginia Mason Franciscan Health, Seattle, WA.
² Department of Otolaryngology-HNS, New York Eye and Ear of Mount Sinai, New York, NY.
³ Department of Otolaryngology-HNS, Stanford University, Stanford, CA.
⁴ Cochlear Americas, Centennial, CO.

PMID: 42297729
DOI: 10.1097/MAO.0000000000004978

Abstract

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).

Interventions: Unilateral cochlear implantation with an FDA-approved CI system.

Main outcome measures: 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.

Keywords: Binaural benefit; Cochlear implant; Hearing in noise; Minimal clinically important difference; Quality of life; SSQ; Signal to noise ratio; Single-sided deafness; Tinnitus.