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