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 and safety. RESULTS: At 6-month follow-up after surgery, a mean improvement in pure-tone average of 26.0 dB hearing level and a mean improvement of 8.8 dB signal-to-noise ratio in speech reception threshold in noise was achieved with the investigational device as compared with the unaided situation. Usability of the investigational device was rated 71.4/100 mm for sound processor retention and 81.4/100 mm for overall comfort using a visual analog scale. CONCLUSION: These outcomes confirm the clinical safety, performance, and benefit of an innovative active transcutaneous bone conduction implant using a piezoelectric transducer design in subjects with conductive hearing loss, mixed hearing loss, or single-sided sensorineural deafness.