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U.S. House of Representatives Passes the Over-the-Counter Hearing Aid Act of 2017 Bringing Affordable and Accessible Hearing Health Care Closer to Reality

July 12, 2017

The U.S. House of Representatives today passed the Over-the-Counter Hearing Aid Act of 2017. With the passage of 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 Senate should be voting on the bill before the end of the summer.

The Hearing Loss Association of America (HLAA) has supported the Over-the-Counter Hearing Aid Act since it was first 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 in the House by Representatives Joe Kennedy III (D-MA) and Marsha Blackburn (R-TN). Although the hearing health care debate continues, this legislation shows a true Congressional bipartisan effort that will ultimately benefit all consumers with hearing loss, especially the millions of people who currently don’t have access to hearing health care simply because they can’t afford it.

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.

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.

House Subcommittee Hearing Reviews the
Over-the-Counter Hearing Aid Act of 2017

May 2017

On May 2, HLAA Executive Director Barbara Kelley, Director of Public Policy Lise Hamlin, and HLAA Public Policy Advisor Barry Kasinitz attended a hearing held by U.S. House of Representatives Energy and Commerce Subcommittee on Health that reviewed four bills consistent with the committee's bipartisan efforts to support the review and regulation of medical devices as part of the Food and Drug Administration (FDA) user fee reauthorization process. One of the bills discussed was the Over-the-Counter Hearing Aid Act of 2017 (H.R.1652). The meeting was chaired by Representative Michael C. Burgess, M.D. (R-TX), in a room with a hearing induction loop in the House Rayburn House Office Building.

Speaking in support of the bill, HLAA Board of Trustee Member Frank Lin, M.D., Ph.D, highlighted recent reports about hearing loss and some of the possible side effects people with hearing loss have a greater chance of experiencing.

Dr. Lin testified, “These research studies also clearly suggest that hearing loss treatments such as using hearing aids and other forms of amplification could potentially decrease the risks and lead to real and tangible benefits for individuals, families, and society. And yet, presently, less than 20 percent of the nearly 38 million American adults with a significant hearing loss currently have access to hearing aids.”

Representatives Joe Kennedy III (D-Mass., 4th District) and Marsha Blackburn (R-Tenn., 7th District), who introduced the bill, questioned Dr. Jeff Shuren, director, FDA Center for Devices and Radiological Health, and found that the FDA is in support of the bill as it is written.

The Hearing Industries Association (HIA), the national trade association of hearing aid manufacturers, also testified, but spoke of limiting the bill.

More information can be found on the Energy and Commerce website. (Note: there is a video of the hearing on the website but it is not captioned.)