Device Dossier

CI-1412 - HiRes 90K Replacement Magnet - Cochlear implant implantable magnet

Device Dossier for CI-1412 - HiRes 90K Replacement Magnet - Cochlear implant implantable magnet (Cochlear implant implantable magnet, Class III, sponsor…

Intended purpose

It is a magnet within the implanted receiver used to hold and secure the external headpiece in alignment with the receiver so that signals can be transmitted to the cochlear implant. It is used as a replacement magnet when a patient has had the original magnet removed for an MRI.

Functional description

The HiRes 90K Replacement Magnet is a sterile and single-use magnet. The HiRes 90K Replacement Magnet fits within the magnet pocket of the HiRes 90K and HiRes 90K Advantage implants.

TGA Public Summary