Congress (the U.S. Senate and U.S. House of Representatives) has passed the Over-the-Counter Hearing Aid Act of 2017. The bill will make certain types of hearing aids available over-the-counter to adults with mild to moderate hearing loss. In addition, the legislation requires the Food and Drug Administration (FDA) to regulate this new 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. This will give consumers the option to purchase a safe, high-quality FDA-regulated device at lower cost.
Creating a new category of OTC hearing devices was one of the 12 recommendations in the report, Hearing Health Care for Adults: Priorities for Improving Access and Affordability, issued by the National Academies of Sciences, Engineering and Medicine (NAS) in June 2016. Since this new category has not yet been created it is unclear how the devices will be defined. However, they should not be confused with products already on the market called PSAPs (Personal Sound Amplification Products). PSAPs cannot legally be marketed to people with hearing loss as a “hearing aid,” only to those with normal hearing as an amplification device.
Now, the bill will go to the president to sign into law. Once the bill is signed into law it will go to the FDA, who will begin drafting the rules and regulations for it. The FDA has three years to complete that process.
This information was taken from the Hearing Loss Association of America News Release, Senate Passes the Over-the-Counter Hearing Aid Act of 2017 Bringing Affordable and Accessible Hearing Health Care Closer to Reality, dated August 3, 2017.