Device Dossier

CI522 - Cochlear implant system electrode array assembly

Device Dossier for CI522 - Cochlear implant system electrode array assembly (Cochlear implant system electrode array assembly, Class III, sponsor…

Intended purpose

The CI522 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 Nucleus CI522 cochlear implant 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