Device Dossier

Magnet Replacement Kit - Surgical procedure kit, ENT, single-use, non-medicated

Device Dossier for Magnet Replacement Kit - Surgical procedure kit, ENT, single-use, non-medicated (Surgical procedure kit, ENT, single-use,…

Intended purpose

The Non-Magnetic Spacer is intended to be used as placeholder for the regular implant magnet of the Mi12xx Series Hearing Implant during MRI procedures, when a reduced image artifact is desirable. The Replacement Magnet is intended to be used after an MRI, as replacement of the original implant magnet of the Mi12xx Series Hearing Implant and to restore full functionality of the Implant. The Non-Magnetic Spacer and the Replacement Magnet are delivered sterile and are intended for single use only.

Functional description

The Magnet Replacement Kit variants consists of the Non-Magnetic Spacer and a Replacement Magnet for the Mi12xx Series Hearing Implant. The Non-Magnetic Spacer, is an empty magnet housing that replaces the implant magnet during MRI scans and reduces image artefacts in the vicinity of the implant. The Replacement Magnet, is inserted after finishing the MRI scans and re-establishes the full functionality of the implant.

TGA Public Summary