21 CFR § 874.3300 - Air-conduction hearing aid.
---
identifier: "/us/cfr/t21/s874.3300"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 874.3300 - Air-conduction hearing aid."
title_number: 21
title_name: "Food and Drugs"
section_number: "874.3300"
section_name: "Air-conduction hearing aid."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "874"
part_name: "EAR, NOSE, AND THROAT DEVICES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 351, 360, 360c, 360e, 360j, 360 371."
regulatory_source: "51 FR 40389, Nov. 6, 1986, unless otherwise noted."
cfr_part: "874"
---
# 874.3300 Air-conduction hearing aid.
(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.
[87 FR 50762, Aug. 17, 2022]