---
kind: "section"
citation: "21 C.F.R. § 874.3300"
title: "21"
number: "874.3300"
heading: "Air-conduction hearing aid."
url: "https://uscodex.org/cfr/21/874.3300"
---

# §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](/cfr/21/800.30.md) or [§ 801.422](/cfr/21/801.422.md) 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](/cfr/21/874.3320.md), [874.3330](/cfr/21/874.3330.md), and [874.3400](/cfr/21/874.3400.md), respectively.
- (b) **Classification.** Class I (general controls). This device is exempt from premarket notification procedures in [subpart E of part 807](/cfr/21/part807-subpartE.md) of this chapter, subject to the limitations in [§ 874.9](/cfr/21/874.9.md).

## Notes

### Amendments

[87 FR 50762, Aug. 17, 2022]

### Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.

### Source

Source: 51 FR 40389, Nov. 6, 1986, unless otherwise noted.

### Amendments

[87 FR 50762, Aug. 17, 2022]