Device Dossier

CI632 - Cochlear implant system electrode array assembly

Device Dossier for CI632 - Cochlear implant system electrode array assembly (Cochlear implant system electrode array assembly, Class III, sponsor…

Intended purpose

Intended for restoration of hearing sensation by electrical stimulation of the auditory nerve in patients with moderately severe to profound sensorineural hearing loss.

Functional description

The CI632 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