Device Dossier
CI624 - Cochlear implant system electrode array assembly
Device Dossier for CI624 - 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 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 CI624 cochlear implant is implanted in the mastoid region of either side or both sides of the head. The cochlear implant receives electrical power and data from an external sound processor via electromagnetic induction to the coil. The implant converts the digital signals into electric energy, and transmits the pulses via the electrode array placed within the cochlea. The implanted magnet ensures that the external sound processor is correctly attached and aligned relative to the implant coil