Clinical performance of the Osia™ system, a new active osseointegrated implant system. Results from a prospective clinical investigation.

Background: Bone-conduction hearing implants are standard of care devices. Aims/Objectives: Evaluation of a new active magnetic bone-conduction hearing implant: Cochlear Osia™ system. Material and methods: This device uses a transcutaneous connection between an external sound-processor and an osseointegrated implant that generates vibrations using a piezoelectricity-based internal bone-conduction system. Nine patients with conductive-hearing loss were implanted. Surgical efficacy, hearing performance and quality-of-life were evaluated. Hearing performance in quiet and in noise was compared with unaided hearing and hearing with the Baha 5 Power® Sound Processor on a softband. Results: Surgery and healing were uneventful. Statistically significant improvements in audibility, speech-understanding, speech-recognition and quality-of-sound in noise and quiet were found for the Osia™ compared to preoperative unaided hearing and aided hearing with the Baha 5 Power® Sound Processor on a softband. The active vibration system provided improvement at low and high frequencies. At 6 months postoperatively, all patients continue to use the device. Conclusions and significance: The Osia™ is safe and effective, improving speech-recognition in quiet and in noise, at low and high frequencies, thus delivering better quality-of-hearing than passive devices.