Clinical Performance, Safety, and Patient-Reported Outcomes of an Active Osseointegrated Steady-State Implant System

Abstract

Objective To investigate the clinical performance, safety, and patient-reported outcomes of an active osseointegrated steady-state implant system that uses piezoelectric technology. Study Design A prospective, multicenter, open-label, single-arm, within-subject clinical investigation. Setting Three tertiary referral clinical centers located in Melbourne, Sydney, and Hong Kong. Patients Twenty-nine adult subjects, 24 with mixed hearing loss or conductive hearing loss and 5 with single-sided sensorineural deafness. Intervention Implantation with the Cochlear Osia 2 System. Main Outcome Measures Audiological threshold evaluation and speech recognition in quiet and in noise. Patient satisfaction..