Device Dossier

Otoacoustic emission system, battery-powered

Device Dossier for Otoacoustic emission system, battery-powered (Otoacoustic emission system, battery-powered, Class IIa, sponsor Natus Medical). ARTG…

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 Battery-powered Otoacoustic emission system function which is used in the assessment of a patients hearing.

TGA Public Summary