FDA Finalizes Rule to Deregulate Hearing Aids

Congress actually passed a law in 2017 ordering them to sell them over the counter.<p><a href="https:&#x2F;&#x2F;en.wikipedia.org&#x2F;wiki&#x2F;Over-the-Counter_Hearing_Aid_Act_of_2017" rel="nofollow">https:&#x2F;&#x2F;en.wikipedia.org&#x2F;wiki&#x2F;Over-the-Counter_Hearing_Aid_A...</a>

I&#x27;m seeing this amidst a lot of pundit complaints that the FDA and similar regulatory organizations are hopelessly restrictionist. Because of their incentives, because they only add new regulations and never remove old and ill-suited ones, etc.<p>I&#x27;m not saying the pundits are wrong in general, but this seems to be an exception. What went right here and why? Is there anything to learn?

This is from a year ago.<p>Here&#x27;s a website that lets you compare over-the-counter hearing aids:<p><a href="https:&#x2F;&#x2F;www.soundly.com&#x2F;shop" rel="nofollow">https:&#x2F;&#x2F;www.soundly.com&#x2F;shop</a>

&gt; In response to public comments and to assure the safety and effectiveness of OTC hearing aids, the final rule incorporates several changes from the proposed rule, including 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<p>Translation: people with severe hearing loss don&#x27;t have the same right to purchase OTC hearing aids. Are they <i>trying</i> to get Fourteenth Amendment (equal protection of the laws) lawsuits??<p>Further translation: we&#x27;ll let you buy OTC hearing aids, but only ones that are easily knocked out of the ear canal. Forget about participating in team or contact sports, or going to dances, etc.<p>As someone with a moderate-severe hearing loss all my life, <i>this is bullshit!</i>

What are the odds Apple moves the AirPods Pro into this space?

Can we do contact lenses next please?

I use some oticon opn s series hearing aids as open hearing headphones. We need this to become cheaper and more ubiquitous as hearing aids provide open hearing and quiet sound without people necessarily even being aware that you have electronic music going on

Literally just spoke to my mom who is considering buying hearing aids. Does anyone have any informed outlook on when we can see lower prices? I’m assuming we will know more in 3-6 months but any more information would be appreciated. Thank you!

I’m looking forward to what Etymotic and Shure field in this market. Bose currently has the product that most closely approaches a hearing aid but isn’t.<p>Hugh end hearing aids are just ridiculously expensive.

As a user of hearing aids, profoundly deaf from birth, I am against the philosophy of purchasing hearing aids over the counter, unencumbered from audiology prescription fittings and diagnostics. There is absolutely no come-back on this. Sure, hearing aids have come on in leaps and bounds since the digitization of the chip, and it was not so long ago either, two decades ago there was a switch over from analog to digital, well, in Europe that is. This is just opening up potential lawsuits against hearing aid manufacturers - &quot;I bought this hearing aid from place X for Y dollars and now my hearing has detoriarated, am going to sue for damages&quot;, this could be unprecedented and sustained damage to the manufacturer&#x27;s reputation. Each and everyone who does endevour to purchase over the counter, it does take at least a few weeks for the brain to adapt to the new sounds and could raise false hope &quot;I bought this hearing aid X days ago and not noticing any improvement&quot;. Not to mention, that audiologists have spent years to study and how to fit&#x2F;diagnose&#x2F;troubleshoot hearing aids based off manufacturers specifications. The human side of getting a skilled opinion from a qualified audiologist on the diagnosis for loss of hearing will be effectively lost. Just no, this is just a recipe for disaster.

Next up: glasses. Glasses are crazy overpriced and optometry is a peculiar US impediment to buying glasses.

CPAP should be next.

Mr. Beast lobby w

&gt; <i>In response to public comments and to assure the safety and effectiveness of OTC hearing aids, the final rule incorporates several changes from the proposed rule, including 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. The final rule also includes performance specifications and device design requirements specific to OTC hearing aids.</i><p>The previous version of this rule sounds pretty bad!<p>Imagine the OTC hearing aids all being instantly permanently deafening with no volume control, and, on top of that, they puncture your eardrum and only produce feedback whine!