Listen carefully and you’ll hear something very strange. It’s the unfamiliar sound of political agreement.
Senators Elizabeth Warren (D-MA) and Chuck Grassley (R-IA) put down their sparring gloves in order to co-author the Over-The-Counter Hearing Aid Act several years ago. Donald Trump and Joe Biden have both supported it. Now the FDA finally released the final guidelines.
On Aug. 16, 2022, we witnessed a rare example of truly bipartisan legislation when the FDA issued a final rule enabling millions of Americans with perceived mild-to-moderate hearing impairment to purchase hearing aids directly from stores or online retailers without the need for a medical exam, prescription or a fitting adjustment by an audiologist. The widely supported FDA guidelines are important for those with hearing loss, and a heartening piece of business and political news for those who don’t.
So, what does this mean for consumers who need hearing aids? The new guidelines make it easier and cheaper for everyday Americans to secure hearing aids. More people stand to benefit than you might think: One in ten Americans, or 37 million people, suffer from hearing loss that is severe enough to impact their daily life.
This 10% of the population–which includes me, a 32-year-old with hereditary hearing loss–is in a better position than most to appreciate just how important hearing is. We are probably among those least surprised to learn that hearing correlates with physical health, career success, and happiness in relationships.
Take it from me: It can be hard to admit you need hearing aids, no matter how you get them. I knew from a young age that I had mid-frequency hearing loss. For years, I adapted mostly by lip-reading, until the mask-wearing, and ubiquitous Zoom meetings of the pandemic forced me to bite the bullet.
Many of us also understand that hearing loss does not only affect the elderly. Thanks in large part to the increasing use of loud headphones, it is predicted that approximately one in five of today’s teens will experience some form of hearing loss. That is about 30% more than 20 years ago.
Equally disturbing is that fewer than 25% of those with hearing loss do anything about it. The stigma associated with hearing aids is one reason for this, but so are high costs and lack of access, particularly for rural Americans and housebound older folks.
A win for consumers
Studies show that people with hearing loss often wait 10 years before they get the aids they need. The FDA regulations for over-the-counter hearing aids will allow millions of Americans with perceived mild-to-moderate hearing impairment to purchase hearing aids directly from stores or online retailers without the need for a medical exam, prescription, or a fitting adjustment by an audiologist.
As new OTC entrants come to market, we expect consumer choices to increase exponentially—and costs to go down noticeably. Given that the average pair of hearing aids will set you back $4,800 and that most insurance plans don’t cover them, this is huge.
What we have here is an all-too-rare bright spot in the depressing reality of consumer health costs. Even for those who can afford hearing aids, the OTC options will be a boon. They will cut down on required doctor visits and the long drives and waiting times these often entail.
As hearing aids become more accessible–and more invisible–the stigma associated with using them should evaporate.
While the arrival of OTC hearing aids is an overall win, it will also raise concerns about quality. Established manufacturers and some audiology groups oppose turning hearing aids into a consumer product.
Current market leaders warn that if hearing aids aren’t carefully customized for the wearer, the hard-of-hearing risk paying for products that simply don’t work. It’s the sort of frustrating experience that might make the hard-of-hearing less likely to seek help again.
Given their reservations, expect existing hearing aid manufacturers to push hard for clear labeling and marketing guidelines that set their established products apart from OTC upstarts.
It’s great that lawmakers have stopped lobbing insults at each other to make progress on this issue. Maybe, if the 37 million Americans with hearing loss declare their approval loudly enough, we’ll be treated to the sweet sounds of political cooperation more often.
Blake Cadwell is the founder and CEO of Soundly, a hearing healthcare marketplace that helps consumers find products, compare prices, and find licensed audiologists. Inspired by Blake’s own confusing search for hearing aids, Soundly aims to modernize access to the hearing health industry.
The opinions expressed in Fortune.com commentary pieces are solely the views of their authors and do not reflect the opinions and beliefs of Fortune.
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