Joe Biden Tyrannizing Hearing Aid Manufacturers Now By Letting Them Sell Over-The-Counter

WHAT? WE CAN'T HEAR YOU.

Joe Biden came through with another Nice Thing yesterday, as the Food and Drug Administration issued a final rule that will allow folks with perceived mild to moderate hearing impairment to purchase a new class of hearing aids without a doctor's visit, prescription, or a fitting with an audiologist. The FDA said in a press release that the new rules could bring down the cost of hearing aids for millions of Americans; the rule goes into effect in 60 days, so the first sales of the new hearing aids in stores and online can begin in October.

In a statement, President Biden said families can look forward to saving about $3,000 on the cost of hearing aids, and touted the new rules' prospects for lowering prices by encouraging competition:

When too few companies dominate, American consumers pay higher costs. We’re finally building an economy that works for working families.

This is a big heckin' deal, since hearing aids are not currently covered at all by Medicare. Hey! How about we campaign for Democrats to hold the House and add a few seats in the Senate? Then they can take another shot at Build Back Better, which in its initial form would have expanded Medicare to cover vision, hearing, and dental care. We oughta do that!

Now, the new rule only applies to people over 18 who need assistance with "mild to moderate" hearing loss; people with more serious hearing loss will still need to see a doctor and get a prescription, as will parents of kids with hearing impairment. The rule also doesn't apply to "Personal Sound Amplification Products," which are devices that allow people with normal hearing to amplify sounds.

 The New York Times notes that the FDA

cited studies estimating that about 30 million Americans experience hearing loss, but only about one-fifth of them get help. The changes could upend the market, which is dominated by a relatively small number of manufacturers, and make it a broader field with less costly, and perhaps, more innovative designs. Costs for hearing aids, which tend to include visits with an audiologist, range from about $1,400 at Costco to roughly $4,700 or more.

As to that competition and innovation stuff Biden talked about, Nicholas Reed, an audiologist in the Epidemiology Department of the Johns Hopkins Bloomberg School of Public Health, told the Times, 

This could fundamentally change technology. [...] We don’t know what these companies might come up with. We may literally see new ways hearing aids work, how they look.

FDA Commissioner Robert Califf, MD, said in the FDA press release,

Hearing loss is a critical public health issue that affects the ability of millions of Americans to effectively communicate in their daily social interactions. Establishing this new regulatory category will allow people with perceived mild to moderate hearing loss to have convenient access to an array of safe, effective and affordable hearing aids from their neighborhood store or online.

Congress passed a law in 2017 authorizing the FDA to create rules for over-the-counter hearing aids, but the process took a while; Joe Biden issued an executive order last year telling the agency to hurry the fuck up already, and here we are. After the draft rule was published last fall, the FDA received over a thousand public comments, and unlike some agencies in another recent presidential administration we could name, the FDA actually paid attention to the comments and improved the rules, by

lowering the maximum sound output to reduce the risk to hearing from over-amplification of sound, revising the insertion depth limit in the ear canal, requiring that all OTC hearing aids have a user-adjustable volume control, and simplifying the phrasing throughout the required device labeling to ensure it is easily understood.

Those all seem like really good ways to make regulations better. It's almost as if the public comment process can be used to improve how government writes regulations, instead of being treated as an impediment to giving industry exactly what it wants. Weird, but we'd like to see that catch on.

Now, while people won't need a doctor's appointment or prescription, that doesn't mean the new class of hearing aids will be an unregulated wild west, either. Makers of hearing aids that have already been on the market before the rule goes into effect will have to comply with the new regulations within 240 days to sell them over the counter, and any new devices will have to be compliant with the rules before they go on the market.

As a 60-year-old who really prefers to watch movies with the captions on, this just might be something I'll want to look into in a few years. Yay for big government, and get off my lawn.

[ FDA Press release / NYT / Photo:  Joe Haupt, Creative Commons License 2.0 ]

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