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Are Over The Counter (OTC) Hearing Aids Legal & Available?



OTC, What You Need to Know

I have noticed quite a bit going on the internet recently in relation to OTC hearing aids and their availability with increasing irritation. Generally, it's a crock of shit (Irish technical term). Firstly, there is no such thing as an OTC hearing aid right now (Aug 2018), so they are neither legal or available. While the legislation to introduce OTC hearing aids has passed, the FDA has yet to specify what an OTC hearing aid actually is. So, therefore, the current crop of devices available that are being labelled OTC hearing aids, simply aren't. 

OTC Hearing Aids Don't Exist

Over The Counter hearing aids don't actually exist as a product line. The FDA first has to tell us what OTC hearing aids are. Until it does, which is expected to happen perhaps in 2019, they can't exist. Yes, there are plenty of PSAPs and even a few hearing aids being sold online, but they can not be labelled OTC hearing aids legally.

OTC Hearing Aids are Not Legal or Available

As I have said before, OTC hearing aids are a brand new product concept, a product concept that there are no guidelines for. Once the FDA has finished its work though, I would expect to see many of them hit the market pretty quickly. Up until then, OTC hearing aids are neither legal or available.

At present, you can buy devices like Eargo, which I discussed in Eargo, Do They Live Up To The Hype? and iHear. Just to be clear, neither of these companies have labelled themselves OTC. However, both offer online delivery of hearing aids. While both offer pretty good products, it remains to be seen whether either of them will fit into this new category.   

Eargo in charger

No Guidance So Far

We have no guidance so far on what an OTC hearing aid should be, we understand that the devices should be able to help people with mild to moderate hearing loss. We also believe that the hearing aids will have to have some sort of self-fit and fine tune ability. That's about it, we know no more because the FDA hasn't reached its conclusions.

So if you see a product right now, labelling itself as an OTC hearing aid, that's bullshit (another Irish technical term). Consider everything else that they say about the product as probable bullshit as well. We will be closely following the OTC hearing aid story here on Know, and when and as it develops, we plan to inform you in an in-depth manner.

I have spoken about online hearing aids sales and what you need to think about here before in Buying Hearing Aids Online? Here is What You Need To Know. The article is worth your time if you are considering the purchase of hearing aids online. 

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Posted by

Geoffrey Cooling

Geoffrey Cooling

LinkedIn Twitter Facebook GooglePlus Amazon Author Page Co Founder geoff@audiologyengine.com
Geoffrey (Geoff, anything else makes him nervous) Cooling is an Irish hearing aid blogger and has been involved with the hearing aid industry for over ten years. He has worked in private practice dispensing hearing aids and as a manufacturer's rep. He has written two books and they are both available on Amazon. He loves technology, passing on knowledge and is legendary for many other things, primarily the amount he curses, his dry and mischievous sense of humour and his complete intolerance of people who are full of themselves. Please feel free to connect with him

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