Device Dossier

– Nucleus SmartNav – Cochlear implant intraoperative electrophysiological analysis software

Device Dossier for – Nucleus SmartNav – Cochlear implant intraoperative electrophysiological analysis software (Cochlear implant intraoperative…

Intended purpose

Nucleus SmartNav is intended to be used in combination with other devices to provide intraoperative measurements that aid in monitoring the insertion, placement and functioning of the electrodes during a cochlear implant surgical procedure, and for use in subsequent fitting or programming of a sound processing unit.

Functional description

The Nucleus SmartNav is the application software of the SmartNAV System. It communicates with and controls a compatible Cochlear Surgical Processor so as to perform a range of intraoperative measurements during CI surgery, in order to provide feedback to the surgeon regarding electrode insertion, function and final positioning. Nucleus SmartNav is installed and runs on a compatible tablet computer and communicates wirelessly with the surgical processor

TGA Public Summary