Device Dossier

CI1012 - Cochlear implant system electrode array assembly

Device Dossier for CI1012 - Cochlear implant system electrode array assembly (Cochlear implant system electrode array assembly, Class III, sponsor…

Intended purpose

The CI1012 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 CI1012 cochlear implant is intended for long term implantation in the mastoid region of the patient's head to restore a level of auditory sensation via electrical stimulation of the cochlea.

TGA Public Summary