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Updated: Jun 17, 2026
Systematic Hearing Performance Evaluation Process for Adolescents with Cochlear Implantation at Early Ages
Published on: March 24, 2023
A Prospective Multicenter Post-Market Study Evaluating the Safety and Effectiveness of Cochlear Implantation in
Daniel M Zeitler1, Enrique Perez2, Jennifer Alyono3
1Listen for Life Hearing Implant Center, Department of Otolaryngology-HNS, Virginia Mason Franciscan Health, Seattle, WA.
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.
