CFR - Code of Federal Regulations Title 21

The information on this page is current as of Dec 22, 2023.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

[Code of Federal Regulations]

[Title 21, Volume 8]

[CITE: 21CFR874.3305]

TITLE 21--FOOD AND DRUGS

CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES

SUBCHAPTER H - MEDICAL DEVICES

PART 874 -- EAR, NOSE, AND THROAT DEVICES

Subpart D - Prosthetic Devices

Sec. 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 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.

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