Device Dossier

CI512 - Cochlear implant system electrode array assembly

Device Dossier for CI512 - Cochlear implant system electrode array assembly (Cochlear implant system electrode array assembly, Class III, sponsor…

Intended purpose

The intended purpose of the CI512 cochlear implant is the restoration of hearing sensation via electrical stimulation of the auditory nerve to subjects with moderate to profound hearing loss in the low frequencies and profound hearing loss in the mid to high speech frequencies, suitable for adults and children.

Functional description

The CI512 electrically stimulates the auditory nerve to subjects with moderate to profound hearing loss in the low frequencies and profound hearing loss in the mid to high speech frequencies.

TGA Public Summary