Over-the-Counter Hearing Aid Act of 2017 Signed into Law

You are here

Over-the-Counter Hearing Aid Act of 2017 Signed into Law

Fri, 10/13/2017

On August 18, 2017, President Trump signed the Over-the-Counter Hearing Aid Act of 2017 into law.  With this groundbreaking legislation Congress and the President have 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 has supported the Over-the-Counter Hearing Aid Act of 2017 since it was first introduced in the Senate by Elizabeth Warren (D-MA) and Chuck Grassley (R-IA) in December of last year and then again in March of this year. The companion House bill was introduced by Representatives Joe Kennedy III (D-MA) and Marsha Blackburn (R-TN). 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 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 gives 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.

HLAA has been working diligently with lawmakers on this legislation. It became clear as we spoke to legislators that HLAA – the consumer voice – had a significant say in this conversation. We have no financial interest in this battle, but we do hear over and over from consumers with hearing loss about the trouble they have getting access to hearing aids. We also hear from people who have retired and who feel isolated and alone, simply because they cannot cover the cost of hearing aids.

The next step is for regulations to be written. The FDA has been charged with creating this new category of hearing devices and writing the rules that will ensure the products are safe and effective.

Don’t Wait to Get Your Hearing Checked

If you have been thinking about getting a hearing device, do not wait for over-the-counter hearing aids to come to market. First, there will be an extended rulemaking period – the FDA has up to three years to draft rules, including time to put the draft out for public comment. Second, not everyone will find that an OTC device will work for them. HLAA recommends seeing an audiologist or hearing instrument specialist if you are having trouble with listening on the phone, often asking others to repeat themselves, you need to turn up the volume on your television, or have any other warning signs of hearing loss. (You can find more information on the warning signs of hearing loss at hearingloss.org/content/symptoms-hearing-loss.) Untreated hearing loss can lead to 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.

We are currently working with the FDA on labeling of OTC products, product safety and consumer protection, and we will be among those filing comments when the FDA releases the Notice of Proposed Rulemaking (NPRM) for the new category.

When the new rules are in place, we hope to see increased innovation and new products available at prices people can afford. But with new opportunities come new responsibilities. For consumers, it means you need to do your due diligence before you purchase a hearing device. For HLAA, it means we will be devoted to ensuring that you get as much information as you need before you purchase your device. HLAA is committed to providing consumers with unbiased and factual information and updates about new products, regulations, and legislation as they develop.

The future of hearing health care is changing, allowing people to make more informed choices. Sometimes change is scary, but we choose to look at this change as opening up new possibilities for consumers, bringing in new players to the market and new products to the people. Someday, hearing aids will be as cool and versatile as your newest smartphone. And way smarter.