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Over-the-Counter Hearing Aids
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Hearing instruments or hearing aids are regulated at the federal level as medical devices by the U.S. Food and Drug Administration (FDA). Changes have been made at the federal level to create an over-the-counter category of hearing instruments (hearing aids), and the FDA rules implementing these changes are now in effect. The changes in the FDA Hearing Aid rule were designed to provide easier access to over-the-counter hearing aids by removing restrictions on the sale of those devices.
In August 2017, the U.S. Congress passed the FDA Reauthorization Act of 2017, 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 established the OTC category and realigned other regulations for hearing aids.
The FDA published the final regulations in the Federal Register (87 FR 50698) on August 17, 2022, with an effective date of October 17, 2022.
The FDA also has issued a final guidance document to clarify the regulatory requirements for hearing aids and personal sound amplification products. Additional information may be found on the FDA’s website on hearing aids.
Prescription Hearing Aid Labeling
The Speech-Language Pathologists and Audiologists rule, 16 TAC §111.201. General Practice Requirements of Audiologists and Interns in Audiology Who Fit and Dispense Hearing Instruments, and the Hearing Instrument Fitters and Dispensers rule, 16 TAC §112.96. Conditions of Sale, both require licensees to comply with the federal regulations adopted by the U.S. Food and Drug Administration (FDA) at Title 21 Code of Federal Regulations §801.422, Prescription hearing aid labeling. FDA rule 21 CFR §801.422 specifies the labeling requirements for prescription hearing aids and includes requirements regarding “red flag” conditions, medical evaluations and fitting devices for people younger than 18, and selecting and fitting high-output devices.
TDLR Adopted Rules
On December 1, 2023, the Texas Commission of Licensing and Regulation adopted rules at 16 TAC, Chapter 111, Speech-Language Pathologists and Audiologists and at 16 TAC, Chapter 112, Hearing Instrument Fitters and Dispensers. The adopted rule changes are effective January 1, 2024, and include changes to make the rules consistent with recent legislation and federal regulations concerning over-the-counter hearing aids and exempt certain activities involving over-the-counter hearing aids, such as sales, from the Department rules in Chapter 111 and 112.