Device Dossier

CI-5293-xxx - Naída™ CI M90 Sound Processor (xxx denotes color) - Cochlear implant system sound processor

Device Dossier for CI-5293-xxx - Naída™ CI M90 Sound Processor (xxx denotes color) - Cochlear implant system sound processor (Cochlear implant system…

Intended purpose

The Naída CI M90 sound processor is an accessory of an auditory active implantable system, the HiResolution Bionic Ear system. The HiResolution Bionic Ear system is intended to provide auditory sensation via electrical stimulation of the auditory nerve for individuals with severe to profound bilateral or unilateral sensorineural hearing loss. Severe hearing loss is defined as audiometric thresholds greater than or equal to 70 dB HL, but less than 90 dB HL. Profound hearing loss is defined as audiometric thresholds greater than or equal to 90 dB HL. The Naída CI M90 sound processor is a behind the ear (BTE) sound processor which works together with the implant to bypass the damaged part of the inner ear and converts sound picked up by the microphone or streamed via wireless communication into electrical signals that are used by the cochlear implant to enable hearing. The Naída CI M90 is the premium version with full access to multiple automatic programs and features, including bimodal and bilateral and supports compatibility with acoustic amplification.

Functional description

The Naída CI M90 is comprised of the following components: Multi-function button, Headpiece cable connector, Light Emitting Diode, Microphone ports, and Battery connector. It features direct connectivity to wireless accessories and Bluetooth® technology enabled devices. The Naída CI M90 offers multiple power options and wearing options for the user.

TGA Public Summary