21 CFR 874.1120 - Electronic noise generator for audiometric testing.
(a)Identification. An electronic noise generator for audiometric testing is a device that consists of a swept frequency generator, an amplifier, and an earphone. It is intended to introduce a masking noise into the non-test ear during an audiometric evaluation. The device minimizes the non-test ear's sensing of test tones and signals being generated for the ear being tested.
(b)Classification. Class II.