Device Dossier

CI-5317 - AquaMic 3D Headpiece - Cochlear implant system coil

Device Dossier for CI-5317 - AquaMic 3D Headpiece - Cochlear implant system coil (Cochlear implant system coil, Class III, sponsor Advanced Bionics).…

Intended purpose

The AquaMic 3D headpiece is intended to transfer sound signals and power between your Advanced Bionics’ cochlear implant and sound processor and is designed for use in environments with water or particulate matter (e.g. dust, sand).

Functional description

The device contains a magnet well designed to accommodate the necessary magnet with appropriate strength to ensure retention between the cochlear implant and headpiece. A waterproof microphone embedded in the headpiece, if enabled, allows the headpiece to also function as a sound input source. A cable attached to the headpiece transfers sound signals between the headpiece and sound processor. A color cap snaps in place on top of the headpiece securely covering the magnet well and microphone.

TGA Public Summary