21 CFR 874.3305
§ 874.3305 Wireless air-conduction hearing aid.
United States · 21 CFR — Food and Drugs · Status: effective
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- Citation
- 21 CFR 874.3305, § 874.3305 Wireless air-conduction hearing aid, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90209
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Full text
(a) Identification. A wireless air-conduction hearing aid is a wearable sound-amplifying device, intended to compensate for impaired hearing that incorporates wireless technology in its programming or use. A wireless air-conduction hearing aid is subject to the requirements in § 800.30 or § 801.422 of this chapter, as applicable.
(b) Classification. Class II (special controls). The special controls for this device are:
(1) Performance data must demonstrate the electromagnetic compatibility (EMC), electrical safety, and thermal safety of the device;
(2) Performance testing must validate safety of exposure to non-ionizing radiation; and
(3) Performance data must validate wireless technology functions.
(c) Premarket notification. The wireless air-conduction hearing aid 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.