Device Dossier

Primus Fitting Pro - Audiometric measuring instrument

Device Dossier for Primus Fitting Pro - Audiometric measuring instrument (Audiometric measuring instrument, Class IIa, sponsor Auditdata). ARTG record,…

Intended purpose

The Primus Fitting Unit is a module based audiometric testing platform for real-ear-measurements to verify hearing aid performance when the hearing aid is worn on the patient's ear. The hardware is connected to a computer and is controlled by a suite of dedicated software loaded on to the same computer.

TGA Public Summary