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# Guidance Relaxes Requirements for Hearing Aids
- URL: https://www.fdaweb.com/guidance-relaxes-requirements-for-hearing-aids/
- Published: 2016-12-12T12:00:00.000Z
- Updated: 2026-09-14T21:53:45.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5137537

*Federal Register* Notice: FDA has made available a guidance entitled “Immediately in Effect Guidance Document: Conditions for Sale for Air-Conduction Hearing Aids.” The document discusses the agency’s intention not to enforce certain conditions for sale for hearing aid devices. Specifically, it does not intend to enforce the medical evaluation or recordkeeping requirements prior to the dispensing of certain hearing aid devices to individuals 18 years of age and older. Additionally, FDA notes it is considering creating a special over-the-counter category for certain hearing aids that will likely lower costs for consumers. To view the guidance, click [here](http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM531995.pdf?ref=fdaweb.com). To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2016-12-12/pdf/2016-29724.pdf?ref=fdaweb.com).