21 CFR 874.3300
§ 874.3300 Air-conduction hearing aid.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 874.3300, § 874.3300 Air-conduction hearing aid, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90207
- Permanent ID
ys:prov:90207@1- SHA-256
a6a8e71b2604cd1e1f45baa23317955b2fdfea338eb74d042923e66eaea2a673
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Full text
(a) Identification. An air-conduction hearing aid is a wearable sound-amplifying device intended to compensate for impaired hearing that conducts sound to the ear through the air. An air-conduction hearing aid is subject to the requirements in § 800.30 or § 801.422 of this chapter, as applicable. The air-conduction hearing aid generic type excludes the group hearing aid or group auditory trainer, master hearing aid, and the tinnitus masker, regulated under §§ 874.3320, 874.3330, and 874.3400, respectively.
(b) Classification. Class I (general controls). This device is exempt from 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.