21 CFR 874.1120
§ 874.1120 Electronic noise generator for audiometric testing.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 874.1120, § 874.1120 Electronic noise generator for audiometric testing, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90198
- Permanent ID
ys:prov:90198@1- SHA-256
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Full text
(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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.