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.
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.