Device Dossier

Osia 2(I) Sound Processor Kit - Cochlear implant system sound processor

Device Dossier for Osia 2(I) Sound Processor Kit - Cochlear implant system sound processor (Cochlear implant system sound processor, Class III, sponsor…

Intended purpose

The Cochlear Osia System uses bone conduction to transmit sounds to the cochlea (inner ear) with the purpose of enhancing hearing. The Osia Sound Processor is intended to be used as part of the Cochlear Osia System to pick up surrounding sound and transfer it to the implant through a digital inductive link. The Cochlear Osia System is indicated for patients with conductive, mixed hearing loss and single-sided sensorineural deafness (SSD). Patients should have sufficient bone quality and quantity to support successful implant placement. The Osia System is indicated for patients with up to 55 dB SNHL.

Functional description

The Osia 2(I) Sound Processor is the external battery powered sound processing unit for compatible bone conduction implants. It performs signal processing and deliver power and an audio stream to the implant via a transcutaneous inductive link. It processes and converts sounds from the environment and from compatible audio sources for transfer to compatible implants. The device is an off-the-ear (OTE) unit that sits over and attaches to the implant via an integrated coupling magnet.

TGA Public Summary