When President Trump signed into law the Food and Drug Administration Reauthorization Act of 2017, one of the pieces of that legislation included the Over the Counter Hearing Aid Act. For those Americans who are hard of hearing, this is great news because the law provides greater public accessibility and affordability with over-the-counter hearing aids.
Specifically, the Act will help adults with mild to moderate hearing loss to access over-the-counter hearing aids without being seen by a hearing care professional. With as many as 30 million Americans and 80% of all seniors experiencing hearing loss, this will mean a significant savings while improving the overall health of those in this situation.
Creating a new and lower priced hearing aid marketplace
Prescription hearing aids cost as much as $2,500 per ear, and can cause a severe strain for Americans living on fixed or low incomes. This has been compounded by the fact that Medicare currently does not cover the cost of hearing aids. Medicare also does not cover routine hearing exams, hearing aids or hearing aid fittings. Medicare Part B does cover diagnostic hearing and balance exams if a doctor or other health care provider orders these tests to see if treatment is needed for a recent injury or illness, such as vertigo or other balance problems.
As a result, it’s estimated that about 70% of Americans between 65 and 84 with hearing loss do not use hearing aids. Prior to passage of this law, obtaining hearing aids was an economic impossibility for many of those affected.
With the passage of this Act, a new generation of hearing aids will be created and regulated by the Food and Drug Administration (FDA) to ensure they meet the same high standards for safety, manufacturing quality, consumer labeling and other regulations that all medical devices must meet.
The FDA is now mandated to establish an over-the-counter hearing aid category for adults with perceived mild to moderate hearing loss within the next three years. By opening the market up to more free enterprise, manufacturers of consumer electronics ranging from tech giants such as Apple and Samsung, to small start-ups could enter this new segment of the market and sell directly to consumers. It is estimated that the retail price for this new category of hearing aids could be set at between $150 and $300.
But cost is only one important factor that led to the passage of this Act. Hearing loss is considered a gateway to other potential medical problems such as depression, memory loss, fatigue, and stress, among others. Easier access to affordable and high quality hearing aids means that millions of people will not only hear better, but will improve their overall health as well. It’s important to note that those Americans with more serious hearing impairments should still seek the help of an audiologist to obtain an prescription hearing aid if needed.
Passage of the Act is not without controversy
Since the passage of the Act, trade industry groups and consumer stakeholder groups have been debating various details related to implementation.
The level of safety, labeling and consumer protections have pushed for less stringent regulation by the Consumer Technology Association, while the Hearing Industries Association (HIA) has been advocating for higher levels of safety and consumer protection. Prior to implementation, the FDA is expected to host several hearings and provide a comment period before finalizing new regulations.
The HIA and the American Speech Language Hearing Association have also expressed concerns that persons with moderate hearing loss could be put at risk by attempting to solve their hearing health problem on their own. They are arguing that those people would be in much better hands with treatment being overseen by a certified and licenses audiologist.
The Federal Trade Commission may also become involved at some point, looking at several issues surrounding technology and competition in hearing aid distribution, customer satisfaction, consumer safety and other related issues.