Assistive Listening Knowledge Base
  • Regulation (final rule)

Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the-Counter Hearing Aids (final rule, 87 FR 50698)

From https://assistivelisteningknowledgebase.org/evidence/fda-2022-otc-hearing-aids/ · record checked 9 October 2026

  • US Food and Drug Administration
  • Federal Register, Vol. 87, No. 158

Government (US Food and Drug Administration)

Summary

The US rule that created over-the-counter hearing aids, including the FDA's reasons for not requiring telecoils or telecoil labelling.

Key findings

  • Establishes the over-the-counter (OTC) hearing aid category for people aged 18 or older with perceived mild to moderate hearing loss; the rule took effect on 17 October 2022.
  • Responding to some comments that asked for OTC packaging to explain telecoils, the FDA declined because not all OTC hearing aids will have one; where an aid does have a telecoil, its labelling must explain it as part of adequate directions for use (Comment 47).
  • Responding to a comment that OTC aids should be required to include Bluetooth or a telecoil, the FDA declined, saying telecoils may be practical for larger devices but users may prefer smaller ones, and that requiring such features could raise cost and hinder innovation and adoption (Comment 94).
  • Asked by a few comments to require a list of basic features, including any telecoil, on the outside package, the FDA declined, pointing to the outside-package requirements it did adopt on batteries and smartphone compatibility (Comment 55).

Limits

The rule neither requires nor forbids telecoils and gives no figures on how many OTC hearing aids have them. The record attributes the telecoil requests to "some comments" and "a comment" and does not say how many there were.

Read the original

www.federalregister.gov/documents/2022/08/17/2022-17230/medical-devices-ear-nose-and-throat-devices-establishing-over-the-counter-hearing-aids

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

Cited in

Cite this source

US Food and Drug Administration. Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the-Counter Hearing Aids (final rule, 87 FR 50698). Federal Register, Vol. 87, No. 158. 17 August 2022. https://www.federalregister.gov/documents/2022/08/17/2022-17230/medical-devices-ear-nose-and-throat-devices-establishing-over-the-counter-hearing-aids (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-otc-hearing-aids/

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.