Device Dossier

CI612 - Cochlear implant system electrode array assembly

Device Dossier for CI612 - Cochlear implant system electrode array assembly (Cochlear implant system electrode array assembly, Class III, sponsor…

Intended purpose

The cochlear implant is intended to be used in combination with other devices as part of a cochlear implant system to provide hearing sensation via electrical stimulation of the auditory nerve.

Functional description

The CI612 cochlear implant is implanted in the mastoid region of either side or both sides of the head. The cochlear implant receives electrical power and data from an external sound processor via electromagnetic induction to the coil. The implanted magnet ensures that the external sound processor is correctly attached and aligned relative to the implant coil.

TGA Public Summary