21 CFR 874.1100
§ 874.1100 Earphone cushion for audiometric testing.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 874.1100, § 874.1100 Earphone cushion for audiometric testing, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90197
- Permanent ID
ys:prov:90197@1- SHA-256
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Full text
(a) Identification. An earphone cushion for audiometric testing is a device that is used to cover an audiometer earphone during audiometric testing to provide an acoustic coupling (sound connection path) between the audiometer earphone and the patient's ear.
(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 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.