The Over the Counter Hearing Aid Act of 2017 was passed as part of the 115th United States Congress as a rider on the FDA Reauthorization Act of 2017. This law requires the Food and Drug Administration (FDA) to propose a rule that would establish an OTC hearing aid category for adults with “perceived” mild-to-moderate hearing loss within 3 years of passage of the legislation and finalize a rule within 180 days after the close of the comment period. The provisions of the OTC Hearing Aid Act implement major recommendations from the President’s Council of Advisors on Science and Technology (PCAST) and the National Academies of Science, Engineering, and Medicine (NASEM).
In 2018, The Academy also teamed up with other members of the hearing health community to draft consensus recommendations for this new class of devices. The consensus recommendations address: 1) the product requirements appropriate for OTC hearing devices targeting mild-to-moderate hearing impairment; 2) outside-of-the-box labeling appropriate for medical devices sold over-the-counter; 3) comprehensive inside-the-box labeling; 4) naming the products Self-Fit Over-the-Counter Hearing Devices, adopting risk classifications consistent with air conduction hearing aids, and limiting 510(k) exemptions; and 5) establishing strong consumer protection laws.
Proposed regulations were slated to be released in August of 2020 but were delayed due to the Pandemic. Once proposed regulations are issued by the FDA, there will be a period of notice and comment that will allow all stakeholders to submit comments and suggestions in reaction to the proposal. The Academy is watching this situation very closely and will be poised to review the proposed regulations, confer with members and respond accordingly.