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…
- GMDN category: Audiometric measuring instrument
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.