Device Dossier

Audiometer, auditory evoked response

Device Dossier for Audiometer, auditory evoked response (Audiometer, auditory evoked response, Class IIa, sponsor Natus Medical). ARTG record, intended…

Intended purpose

Sentiero devices marketed with Bio-Logic branding can have a combination of functions including: Pure Tone Audiometer, Speech Audiometer, Battery-powered Otoacoustic Emission System, Auditory Evoked Response Audiometer, and Impedance Audiometer. This registration covers the Auditory Evoked Response function which is used in the assessment of a patients hearing.

TGA Public Summary