Device Dossier

CI-1419 - HiRes Ultra 3D Replacement Magnet - Cochlear implant implantable magnet

Device Dossier for CI-1419 - HiRes Ultra 3D Replacement Magnet - Cochlear implant implantable magnet (Cochlear implant implantable magnet, Class III,…

Intended purpose

The Ultra 3D Replacement Magnet is intended to be installed in the HiRes Ultra 3D cochlear implant magnet pocket as a replacement magnet following the removal of the Temporary Non-Magnetic Plug to couple with a magnet in the external component to hold implantable and external components in place.

Functional description

The HiRes Ultra 3D Replacement Magnet is a non-reusable, single-use sterile component of the HiRes Ultra 3D cochlear implant. The Replacement Magnet fits within the magnet pocket of the HiRes Ultra 3D cochlear implant.

TGA Public Summary