Device Dossier

CI422 - Cochlear implant system electrode array assembly

Device Dossier for CI422 - Cochlear implant system electrode array assembly (Cochlear implant system electrode array assembly, Class III, sponsor…

Intended purpose

The intended purpose of the CI422 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 Nculeus CI422 cochlear implant with straight electrode 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