Title 21: Food and Drugs
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/ PART 874 - EAR, NOSE, AND THROAT DEVICES
/ Subpart B - Diagnostic Devices / § 874.1120 Electronic noise generator for audiometric testing.
§ 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 (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9.