Clinical Performance Assessment of a New Active Osseointegrated Implant System in Mixed Hearing Loss: Results From a Prospective Clinical Investigation.

OBJECTIVE Evaluation of a new active osseointegrated bone-conduction hearing implant in moderate to severe mixed-hearing loss. STUDY DESIGN Prospective observational study of a series of cases. SETTING Tertial referral center. PATIENTS Twenty patients with moderate mixed-hearing loss were evaluated (10 Cochlear Osia group and 10 Baha 5 Power Connect -control group). INTERVENTION Rehabilitative. MAIN OUTCOME MEASURES Hearing performance in quiet and in noise and quality-of-life were evaluated. RESULTS Improvements in audibility, speech-understanding, speech-recognition, and quality-of-sound in noise and quiet were found for the Osia System compared with preoperative unaided hearing and performance was similar to that obtained with Baha 5 Power Connect. CONCLUSIONS The new active transcutaneous bone conduction system provided a tonal improvement in free-field at middle and high frequencies. The performance in speech recognition in quiet and in noise was similar to control group outcomes.