Device Dossier

Measure / Unity 4 2000-1 Fitting Unit - Audiometric measuring instrument

Device Dossier for Measure / Unity 4 2000-1 Fitting Unit - Audiometric measuring instrument (Audiometric measuring instrument, Class IIa, sponsor…

Intended purpose

45241 - Audiometric/hearing aid tester, modular based audiometric testing platform consisting of the Measure / Unity 4 Unit which can include, (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