Assistive Listening Knowledge Base
  • Regulation

21 CFR 801.422: Prescription hearing aid labeling

From https://assistivelisteningknowledgebase.org/evidence/fda-2022-prescription-labeling/ · record checked 9 October 2026

  • US Food and Drug Administration
  • Electronic Code of Federal Regulations, Title 21

Government (US Food and Drug Administration)

Summary

The US labelling rule for prescription hearing aids, which requires telecoil sensitivity, measured to the ANSI hearing aid standard, and latency to be given in the user brochure.

Key findings

  • Requires the technical specification values for prescription hearing aids to be determined with the test procedures of ANSI/ASA S3.22-2014 (R2020), which the rule incorporates by reference, except for latency.
  • Requires specifications "useful in selecting, fitting, and checking the performance" of the aid to appear in the user brochure or accompanying labelling, including induction coil sensitivity for aids with a telephone coil.
  • Lists latency among the required specifications, "measured using a method that is accurate and repeatable to within 1.5 ms", the one value not determined with the ANSI standard's test procedures.
  • The matching section for over-the-counter hearing aids, 21 CFR 800.30(c)(4), lists six technical specifications (maximum output, full-on gain, harmonic distortion, self-generated noise, latency and bandwidth) and no induction coil sensitivity; its paragraph (e)(3) limits the latency of an over-the-counter aid to 15 ms, measured with a method accurate and repeatable to within 1.5 ms, among electroacoustic limits that are measured with an acoustic coupler where applicable.

Limits

Read from the eCFR text current in October 2026; the section's latest amendment is dated 17 October 2022, the date used here. The rule requires a reported value, not a minimum sensitivity or a check of the telecoil as fitted. The ANSI standard itself is sold and was not read. Neither section deals with latency over a wireless link, such as streaming to the aid; 21 CFR 800.30 was read in the eCFR text current in October 2026 (latest amendment 17 October 2022).

Read the original

www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-801/subpart-H/section-801.422

Link checked . We link to the original and do not host copies.

Cited in

Cite this source

US Food and Drug Administration. 21 CFR 801.422: Prescription hearing aid labeling. Electronic Code of Federal Regulations, Title 21. 17 October 2022. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-801/subpart-H/section-801.422 (accessed 9 October 2026).

The accessed date is when this library last checked the link; use the date you read it. To point readers to this summary instead, link to https://assistivelisteningknowledgebase.org/evidence/fda-2022-prescription-labeling/

Every finding here cites its source, and who funded each source is labelled. This site does not recommend products. Found an error or a missing study? Suggest a correction.