21 CFR 874.1050
§ 874.1050 Audiometer.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 874.1050, § 874.1050 Audiometer, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90192
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Full text
(a) Identification. An audiometer or automated audiometer is an electroacoustic device that produces controlled levels of test tones and signals intended for use in conducting diagnostic hearing evaluations and assisting in the diagnosis of possible otologic disorders.
(b) Classification. Class II. Except for the otoacoustic emission device, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, if it is in compliance with American National Standard Institute S3.6-1996, “Specification for Audiometers,” and 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.