The FDA Wants OTC Hearing Aids? Good One!

NPR reports that -- after only four years of inaction after being told to do so, something of a land speed record for a bureaucracy, I guess -- the FDA may finally permit some people to buy hearing aids over-the-counter.

As soon as I saw that headline, I laughed, and remembered the following exchange from some years back:

The FDA is coming for them. (Image by Nilay Kamu, via Unsplash, license.)

Jim May: ...Regarding high cost niche markets created by government, here's one that has been sticking in my craw of late: hearing aids. $6000 for the entry level Beltone, in this era of $15 bluetooth earpieces?!? Horsehockey. There is a dedicated storefront near here that sells nothing but these things. Can you say fat margins? Parasitical industry? Sinecures? It's entirely a product of government intervention in the market. Shocking, I know.

I've been thinking of contacting some hardware and software hackers to design and build cheap, open-source replacement devices, complete with software that you can use to evaluate your hearing loss/frequency attenuation at home, and it simply feeds the filter information into the device via USB.

Me: No surprise there.

Your idea for a solution may surprise many in this day and age since it doesn't involve lobbying for government hearing aid subsidies, and it carries with it the risk of jail time for yourself unless you attach a huge label to the device saying that it is intended neither to be a hearing aid nor a medical device. [identifiers and bold added, link changed to Internet Archive]

Someone on the tech forum where I encountered this story has pretty well summed up what I think has happened -- which is to say that everything bolded above has basically come true:

We are seeing a long term consolidation between hearing devices and headphones.

On the headphones side, we are getting smaller, truly-wireless headphones with some ambient sound features (such as noise cancellation, and iOS hearing features). New trends like AR would just accelerate the change due to the need to solve all day worn audio devices.

On the hearing aids side, almost every hearing aid today acts as an always connected set of headphones for your mobile phone (and has been like that for years on iOS).

Deregulating this could bring the tech industry innovation to hearing aids through natural progression of headphones technology...

Yes and yes. Sadly (and back to NPR), deregulation is exactly what isn't happening:

For decades, the FDA has regulated hearing aids as prescription medical devices -- an arrangement that adds to the cost and effort people must expend to get them. The new proposal would shake that arrangement up. The FDA says people who have trouble hearing will now face fewer hurdles to improving their lives.

On the market side of things, the FDA says the change will boost competition -- and also put regulators' scrutiny on companies that aren't approved to sell hearing aids but are effectively already doing so by marketing "personal sound amplification products" (PSAPs). [bold added]

In other words, people don't need the FDA to find a good, cheap way to improve their hearing. Isn't it funny that it's only now that the FDA is acting interested in people buying such devices over the counter?

What's that DC word again? Optics!

From a longer-term perspective, this looks a hell of a lot more like the FDA is pissed about people making an end run around it -- or afraid of being shown to be irrelevant to health (at best) -- than interested in helping the hard-of-hearing easily be able to do something about it.

Or maybe, by loudly stepping in, it's their way of claiming credit for all the technological progress that actually is already making such a dream come true.

-- CAV