---
kind: "section"
citation: "21 C.F.R. § 874.3305"
title: "21"
number: "874.3305"
heading: "Wireless air-conduction hearing aid."
url: "https://uscodex.org/cfr/21/874.3305"
---

# §874.3305. Wireless air-conduction hearing aid.

- (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](/cfr/21/800.30.md) or [§ 801.422](/cfr/21/801.422.md) 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](/cfr/21/part807-subpartE.md) of this chapter subject to [§ 874.9](/cfr/21/874.9.md).

## Notes

### Amendments

[76 FR 34846, June 15, 2011, as amended at 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

[76 FR 34846, June 15, 2011, as amended at 87 FR 50762, Aug. 17, 2022]