21 C.F.R. § 874.1120 Electronic noise generator for audiometric testing.
Title 21 - Food and Drugs
(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.
Title 21: Food and Drugs
PART 874—EAR, NOSE, AND THROAT DEVICES
Subpart B—Diagnostic Devices
§ 874.1120 Electronic noise generator for audiometric testing.
