On Friday, President Donald Trump signed into law the Food and Drug Administration Reauthorization Act of 2017, legislation that includes the Over the Counter Hearing Aid Act designed to provide greater public accessibility and affordability with over-the-counter (OTC)  hearing aids.

The OTC Hearing Aid Act is designed to enable adults with perceived mild-to-moderate hearing loss to access OTC hearing aids without being seen by a hearing care professional. The new law, which was introduced in March by Senators Elizabeth Warren (D-Mass) and Chuck Grassley (R-Iowa), was passed by the US House on July 12 and the US Senate on August 3. It also comes on the heels of the elimination of the “physician waiver” system which had required consumers first to seek a physician for a medical evaluation or sign a waiver prior to obtaining a hearing aid.

The new legislation will require the FDA to create and regulate a category of OTC hearing aids to ensure they meet the same high standards for safety, consumer labeling, and manufacturing protection that all other medical devices must meet. It mandates the FDA to 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. However, what level of safety, labeling, and consumer protections will be included are currently being hotly debated (see HR’s Special Report on the recent NASEM Committee workshop) between stakeholders. Consumer Technology Association (CTA) has been pushing for a logo that would signify a voluntary compliance to a performance standard originally intended for personal sound amplification products (PSAPs). At the other end, the Hearing Industries Association (HIA) has been advocating for higher levels of safety and consumer protection, as well as manufacturing and performance standards. It is anticipated that the FDA will host several hearings, as well as a comment period prior to publishing the new regulations.

The American Speech-Language Hearing Association (ASHA) and the HIA have expressed concerns about measures like the new reauthorization legislation that give persons with moderate hearing loss access to OTC hearing aids.

“Greater degrees of hearing loss are serious medical conditions with broader health implications,” ASHA President Gail J. Richard said in a recent statement. “People who experience greater than a mild degree of hearing loss could take the misguided step of trying to seek relief via OTC solutions. A better course of care would involve treatment overseen by a certified and licensed audiologist.”

Richard also said it is in the public’s interest that Congress require the FDA to track the safety and user satisfaction issues that arise with greater access to OTC hearing aids. “That way, they could better assess the implications of a do-it-yourself model for hearing care.”

In a recent article for The Hill, HIA Chairman and President of Starkey Hearing Technologies Brandon Sawalich cautioned, “Like a thumb print, every ear and hearing loss is unique. The greater the degree of hearing loss, (moderate, severe and profound), the greater the need for the services of a hearing professional to properly evaluate the hearing impairment, select the proper hearing aid for their loss, and provide patient education, care, counseling and service. Hearing loss correction with hearing aids is successful when the qualified professional human touch is brought into the process, not the cash register…Hearing loss is a medical issue, not a consumer electronics opportunity.”

The Federal Trade Commission (FTC) may also be involved in the discussions, as the agency held an April workshop that looked at the myriad issues surrounding technology and competition in hearing aid distribution, as well as how OTC  aids might impact customer satisfaction, the use of amplification products, consumer safety, and professional care. Hearing Review published a commentary by HIA in response to the workshop.