On December 1, 2016, Senate Bill S.9 was introduced by Senators Elizabeth Warren (D-Mass.) and Chuck Grassley (R-Iowa) to provide for the regulation of over-the-counter (OTC) hearing aids. The “Over-the-Counter Hearing Aid Act of 2016” would make certain types of hearing aids available over the counter and remove many of the barriers for consumers who could benefit from hearing aids.
HLAA is a supporter of the bill, along with AARP, the Consumer Technology Association (CTA), Bose Corporation, and the Gerontological Society of America (GSA). HLAA has sent a letter of support to the senators. The full text of the bill has been posted. Senators Warren and Grassley have plans to reintroduce the legislation in the new 2017 Congress. All reports point to solid bipartisan support.
HLAA is the only consumer-group sponsor of the National Academies of Sciences, Engineering, and Medicine (NAS) study and resulting report Hearing Health Care for Adults: Priorities for Improving Access and Affordability. The NAS report outlined 12 recommendations that would make hearing health care more affordable and accessible for consumers. HLAA has come out in support of all the recommendations contained in the report, and Recommendation 7 specifically states, “The Food and Drug Administration [FDA] should establish a new category of over-the-counter (OTC) wearable hearing devices.” The Warren-Grassley bill is one step toward making hearing devices affordable and accessible.
While the Warren-Grassley bill uses the term “hearing aids,” the final name and definition of what qualifies as an OTC device is determined by the FDA. Whether they are called an OTC hearing aid, OTC wearable hearing device, or something else, they would only be for adults with mild-to-moderate hearing loss. If the bill passes - or if the FDA creates this new category before the bill passes - HLAA will work with industry and the FDA to ensure these products are safe and effective; are clearly labeled with information important to consumers, including whether they meet voluntary industry standards; have clear return policies; and outline any red flags that point to the need to see a doctor before purchase.
HLAA will further work to ensure consumers are educated about these and all hearing amplification devices. This aligns with both Recommendation 11 of the NAS report to “Improve publicly available information on hearing health” and HLAA’s mission to “Open the world of communication to people with hearing loss by providing information, education, support and advocacy.”
HLAA has long valued the expertise and care that audiologists and hearing instrument specialists provide to people seeking help for their hearing loss. We expect many people will continue to seek the skill and expertise of a hearing professional. HLAA’s hope is that the availability of OTC devices will intrigue people who would not otherwise get help for their hearing loss. These devices may even end up being purchased through an audiologist or hearing aid specialist. Further, once people have tried an OTC device they might look to upgrade to traditional hearing aids through the care of an audiologist. To give consumers access to the entire spectrum of hearing assistive devices, we hope to see audiologists turn to transparent pricing that unbundles the cost of the hearing aid from the cost of services. We would also like audiologists to incorporate open programming systems, allowing them to adjust any type of hearing aid, anytime.
When only 20 percent of people who need hearing aids purchase them, something must change. Quality OTC devices were not even possible 20 years ago, but with the technology available today, and the greater innovation that is sure to come, it is possible to build a more affordable, quality basic hearing device. We believe the hearing health care industry is at a crossroads; we must seize this opportunity to ensure that people who want do something about their hearing loss are not prevented from doing so by cost or accessibility.
HLAA’s goal is to see more people seek help for any degree of hearing loss. HLAA supports the availability of OTC devices as a first step consumers with mild-to-moderate hearing loss can take to address their hearing loss earlier and more conveniently. We believe audiologists still provide the gold standard of care for people with hearing loss and that complex fittings should only be performed by a hearing professional. However, giving consumers a choice to use less expensive and more readily-available devices will be a huge step toward greater awareness about the need for good hearing health care and greater adoption of hearing aids and hearing technology.