Senate Passes the Over-the-Counter Hearing Aid Act of 2017

Senate Passes the Over-the-Counter Hearing Aid Act of 2017 Bringing Affordable and Accessible Hearing Health Care Closer to Reality

Bethesda, MD: The U.S. Senate today passed the Over-the-Counter Hearing Aid Act of 2017. The bill was already passed by the House of Representatives on July 12. With this groundbreaking legislation Congress has sent a message to America that people with hearing loss need – and deserve – more affordable and accessible hearing health care.

The Hearing Loss Association of America (HLAA) has supported the Over-the-Counter Hearing Aid Act since it was introduced in the Senate by Elizabeth Warren (D-MA) and Chuck Grassley (R-IA) in March of this year. The companion House bill was introduced by Representatives Joe Kennedy III (D-MA) and Marsha Blackburn (R-TN).

“Senators Warren and Grassley and Representatives Kennedy and Blackburn – among many others – have worked tirelessly to ensure passage of this bill,” said Barbara Kelley, HLAA executive director. “It is no secret that passing any type of legislation can many times be a long and laborious process because of party disagreements. However, this bill has moved quickly through Congress because both sides of the aisle realize how critically important and badly needed affordable and accessible hearing health care is to consumers.”

The Over-the-Counter Hearing Aid Act of 2017 would make certain types of hearing aids available over the counter to adults with mild to moderate hearing loss. In addition, the proposed legislation would require 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, which HLAA fully supported.

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.

Kelley continued, “Our consumer voices are powerful. HLAA has led the way for affordable and accessible hearing health care and applauds this historic effort. While it could take several years before the first products come to market we feel it’s important for the FDA to take the time they need to write regulations to ensure safety, efficacy and consumer protection.

“For years, our number one request has been from people who want hearing aids but can’t afford them. This legislation is a step in the right direction and offers hope that the cost of all hearing aids will go down with the anticipated market innovation and competition it will bring. Everyone who needs hearing aids should be able to have them to stay connected to family, remain on the job, and enjoy a high quality of life.”

Now that the Over-the-Counter Hearing Aid Act of 2017 has been passed by both the House and Senate it 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. While the FDA has three years to complete that process we are hopeful that it will be done much sooner.

Don’t Wait to Get Your Hearing Checked

If you think you have a hearing loss, do not wait for over-the-counter hearing aids to come to market. First, there will be an extended rulemaking period where anyone can comment after which the FDA has to evaluate and decide on the standards for an OTC device. Second, not everyone will be able to get help from an OTC device. HLAA recommends seeing an audiologist or hearing instrument specialist if you are having trouble on the phone, asking others to repeat, turning up the volume on your television, or showing other warning signs. Untreated hearing loss can cause falls, isolation, depression, anxiety, and it has been shown that there is a link to cognition. Hearing loss should be prevented, screened for, and treated without delay. HLAA has been working diligently with lawmakers to have the consumer voice heard. We are currently working with the FDA on labeling of OTC products, product safety and consumer protection. The future of hearing health care is changing, allowing people to make informed choices. HLAA will ensure consumers have unbiased and factual information and updates about new products, regulations, and legislation as they develop.

About the Hearing Loss Association of America

The Hearing Loss Association of America (HLAA), founded in 1979, opens the world of communication to people with hearing loss through information, education, support and advocacy. HLAA holds annual conventions (HLAA2018 is in Minneapolis, Minnesota, June 21 – 24), produces Walk4Hearing events in 20 cities, publishes the bimonthly Hearing Loss Magazine, advocates for the rights of people with hearing loss, and has an extensive network of chapters and state organizations across the country. The national headquarters is located at 7910 Woodmont Avenue, Suite 1200, Bethesda, MD 20814. Phone 301.657.2248 or visit hearingloss.org.