Over-the-Counter (OTC) Hearing Aids

  • The U.S. Food & Drug Administration established a regulatory category for over-the-counter (OTC) hearing aids and amended certain FDA regulations.

  • The final rule was published on August 17, 2022, and it goes into effect on October 17, 2022.

  • The final rule primarily establishes a category of OTC hearing aids that consumers aged 18 years and older with perceived mild to moderate hearing impairment can purchase without the involvement of a hearing healthcare professional.

  • The final rule also defines non-OTC hearing aids as prescription devices, rather than restricted devices.

  • If you have over-the-counter hearing aids and need help, give our office a call at 281-317-4010 or email us at Info@PearlandHearingAids.com.