Device Dossier

CI-1601-xxx - HiRes Ultra 3D Cl HiFocus (xxx denotes shape of tip) - Cochlear implant system electrode array assembly

Device Dossier for CI-1601-xxx - HiRes Ultra 3D Cl HiFocus (xxx denotes shape of tip) - Cochlear implant system electrode array assembly (Cochlear…

Intended purpose

The HiResolution Bionic Ear System is a cochlear implant system designed to provide useful hearing to individuals with severe-to-profound hearing loss via electrical stimulation of the auditory nerve. The HiResolution Bionic Ear System is intended to restore a level of auditory sensation.

Functional description

The implant includes a receiver and electrode array. The electrode array has 16 contacts and is connected to the implant through the electrode lead. The receiver stimulator titanium case houses the electronics. The antenna coil allows bidirectional communication between the implant and external parts. A magnet assists retention of the external headpiece.

TGA Public Summary