Device Dossier

Fixation Clip - Cochlear implant system electrode array assembly

Device Dossier for Fixation Clip - Cochlear implant system electrode array assembly (Cochlear implant system electrode array assembly, Class III, sponsor…

Intended purpose

The Fixation Clip is intended to stabilize the electrode lead of compatible MED-EL cochlear implants in the mastoid cavity.

Functional description

The Fixation Clip is a single-use long-term passive implantable device to be implanted during MED-EL cochlear implant surgery. The Fixation Clip has two openings: • The larger opening is the bone fixation clip. • The smaller opening is the electrode fixation clip.

TGA Public Summary