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…
- GMDN category: Cochlear implant system electrode array assembly
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.