Device Dossier

CI24RE(ST) - Cochlear implant system electrode array assembly

Device Dossier for CI24RE(ST) - Cochlear implant system electrode array assembly (Cochlear implant system electrode array assembly, Class III, sponsor…

Intended purpose

The Nucleus 24 Cochlear Implant CI24RE(ST) is intended to restore a level of auditory sensation via electrical stimulation of the auditory nerve in adults and children. The cochlear implant is part of a System, connected to a receiver-stimulator that is implanted in the skull near the ear, and a speech processor that is worn externally which converts sound into electrical signals to be transmitted to the receiver-stimulator.

Functional description

The Nucleus 24 Cochlear Implant CI24RE(ST) is intended to restore a level of auditory sensation via electrical stimulation of the auditory nerve in adults and children.

TGA Public Summary