Hearing instruments or hearing aids are regulated at the federal level as medical devices by the U.S. Food and Drug Administration (FDA). Changes are being made at the federal level regarding hearing instruments that will affect two of TDLR’s programs, the Hearing Instrument Fitters and Dispensers program and the Speech-Language Pathologists and Audiologists program. These two programs regulate the fitting and dispensing of hearing instruments by Texas licensees.
In August 2017, the U.S. Congress passed the FDA Reauthorization Act of 2017 (FDARA) | FDA, which in part defined “over-the-counter hearing aid,” required the FDA to establish a category of over-the-counter (OTC) hearing aids, and specified certain requirements that must be included in the FDA regulations. On October 20, 2021, the FDA published proposed regulations for public comment. These proposed regulations establish the OTC category and realign other regulations for hearing aids. The FDA will eventually publish final regulations, taking public comments into account.
You will find the proposed regulations published in the Federal Register, 86 FR 58150. Electronic or written comments on the proposed regulations must be submitted to the FDA by January 18, 2022. The Federal Register notice includes all the details about submitting public comments.
The FDA has issued a letter clarifying that the over-the-counter category of hearing aids does not exist until the effective date of published final regulations. Licensed Hearing Instrument Fitters and Dispensers and licensed Audiologists may wish to visit the FDA’s website on hearing aids for additional information.