Device Dossier

Audiometer, pure-tone

Device Dossier for Audiometer, pure-tone (Audiometer, pure-tone, Class IIa, sponsor Natus Medical). ARTG record, intended purpose, GMDN category —…

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 Pure Tone Audiometer function which is used in the assessment of a patients hearing.

TGA Public Summary