Device Dossier

Audiometric measuring instrument

Device Dossier for Audiometric measuring instrument (Audiometric measuring instrument, Class IIa, sponsor Sonova). ARTG record, intended purpose, GMDN…

Intended purpose

This is a multi-purpose audiometric test platform consisting of the Primus Fitting Unit which includes, (1) an audiometer used to assess hearing, and (2) a real-ear-measurement module (to verify hearing aid performance when the hearing aid is worn on the patient's ear) and the Primus Hearing Instrument Test Unit consisting of (3) a hearing aid test box to measure various hearing aid performance characteristics. The hardware is connected to a computer and is controlled by a suite of dedicated software loaded on to the same computer. The setup can be purchased to perform either one, two or all three of the functions described above.

TGA Public Summary