Device Dossier
Audiometer, pure-tone
Device Dossier for Audiometer, pure-tone (Audiometer, pure-tone, Class IIa, sponsor Sonova). ARTG record, intended purpose, GMDN category — compiled by…
- GMDN category: Audiometer, pure-tone
Intended purpose
An audiometer capable of both air conduction measurements and bone conduction measurements. It is typically equipped with earphones and headband, which provide pure tones of specified frequencies at known sound pressure levels, one ear at a time. It may also be equipped with a bone vibrator. For clinical use, both facilities are required, as well as means of generating calibrated masking noise. An external-input port is usually provided for connection to an external signal source.