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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21
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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).

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 8]
[CITE: 21CFR874.3325]
 See Related Information on Self-fitting air-conduction hearing aid. in CDRH databases



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. 874.3325 Self-fitting air-conduction hearing aid.

(a) Identification. A self-fitting air-conduction hearing aid is a wearable sound amplifying device that is intended to compensate for impaired hearing and incorporates technology, including software, that allows users to program their hearing aids. This technology integrates user input with a self-fitting strategy and enables users to independently derive and customize their hearing aid fitting and settings. A self-fitting 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) Clinical data must evaluate the effectiveness of the self-fitting strategy.

(2) Electroacoustic parameters, including maximum output limits, distortion levels, self-generated noise levels, latency, and frequency response, must be specified and tested.

(3) Performance data must demonstrate the electromagnetic compatibility (EMC), electrical safety, and thermal safety of the device.

(4) Software verification, validation, and hazard analysis must be performed.

(5) If the device incorporates wireless technology:

(i) Performance testing must validate safety of exposure to non-ionizing radiation; and

(ii) Performance data must validate wireless technology functions.

(6) Usability testing must demonstrate that users can correctly use the device as intended under anticipated conditions of use.

[84 FR 57612, Oct. 28, 2019, as amended at 87 FR 50762, Aug. 17, 2022]

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