Hearing aids without a prescription or an exam? The FDA takes big step toward making that happen.
Source: Washington Post
A long-awaited Food and Drug Administration proposal would allow millions of consumers to buy over-the-counter hearing aids in stores or online without a prescription or medical exam. More than four years after Congress ordered the agency to allow over-the-counter hearing aids, it took the first step Tuesday to broaden access to more accessible and affordable devices for millions of patients with mild to moderate hearing loss. The agency’s proposal would create a new category of over-the-counter hearing aids and supersede state-level regulations that require patients to go through physicians or audiologists to get prescriptions and fittings for them.
Hearing aids cost an average more than $5,000 per pair, are not typically covered by traditional Medicare or other insurers, while advocates argue that over-the-counter models could be a fraction of that cost. “Reducing health care costs for everyone in America is a top priority,” said Health and Human Services Secretary Xavier Becerra said in a statement on Tuesday. “Today’s move by FDA takes us one step closer to the goal of making hearing aids more accessible and affordable for the tens of millions of people who experience mild to moderate hearing loss.”
Although 15 percent of adults in the United States report having some trouble hearing, according to the National Institute on Deafness and Other Communication Disorders, only about 1 in 5 use hearing aids. Cost and stigma associated with the medical devices stand in the way of some patients’ access. “More than 30 million people suffer from some sort of hearing loss and hearing is so vital to what we do, your ability to communicate with others is a huge part of your quality of life,” said Vinay Rathi, a physician at Massachusetts Eye and Ear. “We’re really denying people that sort of basic right, which is the ability to communicate with others, because of issues related to cost and access to audiologists."
The FDA said on Tuesday that its new rule aims to spark innovation and increase competition by lowering barriers for new companies to enter the market while simultaneously regulating the new category of over-the-counter hearing aids to ensure the devices are safe and effective. “Over the years, our number one call, email [and] letter is from people who can’t afford hearing aids, or they don’t have access to an audiologist or hearing aid specialist," said Barbara Kelley, executive director of the Hearing Loss Association of America. “Now, not all of those people would benefit from an over-the-counter product. We know that. But … this is going to help those people who might be able to benefit.”
Read more: https://www.washingtonpost.com/health/2021/10/19/fda-over-the-counter-hearing-aids/
Well as a medical device with so much technology innovation due to miniaturization that has happened over the past couple decades, one would think this is do-able (at least with enough surveillance and testing of such as a faulty speaker could damage the ear drum).
There have been "reading glasses" (magnifiers) sold OTC for many many years and they are exempt from certain FDA device regs (although manufacturers/importers still must be registered).
= new reply since forum marked as read
what would be the difference between this and those "reading glasses" that you see in drug stores? 
It's apparent that anyone who might be "farsighted" may need some type of "correction" that can be evaluated through extensive eye exams, and then optometrists and/or ophthalmologists might then recommend "prescription" reading glasses, with lenses that can cost big bucks, were the frames are often even worse in terms of cost.
But does that preclude throwing on a pair of "magnifier" eyeglasses (or even pulling out an old-fashioned magnifying glass, which is obviously an alternative) to magnify writing? As it is, the ADA has prompted use of "accessibility" features (e.g., screen magnification) for many computing/mobile devices.
Until/unless the health insurance laws are modified to require coverage, people often have no choice and are forced to live with reduced or no hearing, and if there is a move towards allowing "generic" (but substantially equal) parts that can be manufactured for less than a progenitor's patented hearing aid device parts, then this would go a long way to reduce the cost, thus allowing ENTs to perhaps recommend an inexpensive or even OTC "generic".
Didn't include it in the LBN excerpt as it can be a PITA to add links there, but here is that section of the excerpt with the link -
This is the link (not embedded) - https://www.whitehouse.gov/briefing-room/statements-releases/2021/07/09/fact-sheet-executive-order-on-promoting-competition-in-the-american-economy/
where the relevant part in the Fact Sheet says this -
In 2017, Congress passed a bipartisan proposal to allow hearing aids to be sold over the counter. However, the Trump Administration Food and Drug Administration failed to issue the necessary rules that would actually allow hearing aids to be sold over the counter, leaving millions of Americans without low-cost options.
That section in turn has links (that I added above) where the "$5000" reference itself links to a Consumer Reports page - https://www.consumerreports.org/hearing-aids/best-and-worst-hearing-aid-brands-and-retailers-a1115767262/
I didn't dive into CR's huge survey to get all the details but it's possible there is an assumption being made that when someone is buying a hearing aid, it's often just a single one, and the CR article indicates this -
where it's possible the interpretation was that the listed cost was for "one" and thus a "pair" would be twice that.
Just a guess on my part.
