Device Dossier

Stimulator, evoked response, auditory

Device Dossier for Stimulator, evoked response, auditory (Stimulator, evoked response, auditory, Class IIb, sponsor GE Healthcare). ARTG record, intended…

Intended purpose

This is a mains electricity (AC-powered) device that is intended to apply sound stimuli (e.g., pure tones, speech) to a patient's acoustic system. It is typically used as a component of several types of devices such as audiometers, auditory evoked-potential recording systems, and auditory function screening devices.

TGA Public Summary