OTC Hearing Aids ...Again

I haven’t paid much attention to “hearing aid” discussions since it was announced that the FDA would disseminate edicts concerning the capabilities and sales of them about the 1st of the year.
Now, I see it’s been pushed back to Aug.'20.
I’ve been avoided all discussions on hearing aids until the OTC’s are available, another 9 months [or more] until they figure out what they’ll determine them to be, followed by a discussion period.
It could be a lot longer before they become available to the public.
My only concern is with OTC, nothing else.

In the meantime I’ve watched my hearing ability slowly fade.
In response, I’ve taken another cruise around the i-net checking for info on OTC hearing aids.

Now, I have seen at least one ad for OTC hearing aids.
They advertise 16 sound channels, a guaranty, and other things of potential interest to me.
They’re beginning to sound more like Hearing Aids, not simply just PSAs.

My major questions so far are:

  1. My understanding is that it’s not yet legal to advertise OTC hearing aids in the US, correct?

  2. They say nothing about user control of the sound channels.
    After the hearing loss is determined, the sound channels will need to be adjusted to compensate, correct?

The particular company I’m thinking of is located in the UK.

  1. How can a warranty for an item supplied from outside the US be enforced?

A quick cruise of the i-net tells me that OTC hearing aids are not available in Europe.
They’re watching what happens here in the US before they make any decisions.

The UK is no longer in the European Union.

  1. How can they advertise and supply the sale of OTC hearing aids?

That is just the beginning of my questions on this subject.
Not much use in asking more until these are sorted out.

One question: Why are you so SOLD on OTC aids? Do you live in a remote location where access to a qualified dispenser or audiologist is impractical? Is it all about saving money?

I guess I’d back up further and say that while you are witnessing the decline of your own hearing - based on what evidence? Have you had a hearing test done so you can actually SEE how fast and how far the hearing has faded?

Putting the cart BEHIND the horse … I’d first get a qualified hearing test and maybe get some “best options” suggestions from the individual who performs that test. Take it from there, and don’t just DIVE into a pool of solution before knowing what might be the very best device to suit your needs and listening preferences!

GOOD luck in this endeavor and keep us posted on what you go with. You may even find an affordable, enjoyable solution BEFORE 2021.

1 Like

Personal sound amplifiers (PSAPS) have been available over-the-counter for years (since the 1970s). There are some differences between PSAPS and the new OTC/DTC that the FDA is now proposing. PSAPS are for persons with normal hearing ability, to enhance their listening experience. They are not made for the treatment of hearing loss. The new OTC devices are approved for mild up to moderate hearing losses and will be self-fitting or self-programmable. We do not know much more than that, because the FDA has until August of 2020 to release what the regulations and capabilities of these devices will be.
You pose some good questions, but until the FDA makes a determination, we just don’t have answers. If you think that someone is illegally advertising devices, you can report it to the FDA and the FTC. Links to do so can be found here:

Because of FDA restrictions manufacturers of the new OTC devices are not allowed to call their devices hearing aids.

But we can.

OTC is only for mild to moderate hearing loss. Most patients are not able to self diagnose their degree of loss without an audiogram. When the OTC becomes available I am sure there will be a lot of moderately severe, severe and profound hearing losses trying to wear the cheap OTC, only to be very disappointed. Then unfortunately they will probably blame the hearing aid instead of themselves.

1 Like

I went to a Bose store to try the Hearphones. The sales guy spent almost an hour with me doing various demonstrations. At the end, he said that with my hearing loss they would not be appropriate for me. I bought them anyway and they were GREAT! Far better then the top-of-the-line Siemens HAs I was wearing.

But, not as great as the Phonak M90s I have now.

I was going to say what @gorgeguy posted.

You need to have some testing done, get your audiogram with word recognition scores. That is the only way to know the extent of your hearing loss.

And the OTC hearing aids will ONLY be for mild to moderate hearing loss. If you have severe or profound hearing loss, they won’t be enough for you. The only way to know if you should continue to wait or not is to go get tested.

Article says the FDA is still shilly-shallying over implementing Over-The-Counter hearing aids.

For a direct link to the original NEJM editorial on which the Medical Express commentary is based, see the following Abram Bailey post: Regulation of Over-the-Counter Hearing Aids — Deafening Silence from the FDA (requires setting up a free NEJM access account)

Interesting that “most hearing aids sold through clinics are exempt from FDA premarket review, and manufacturers are not required to submit evidence of their safety and effectiveness in order to receive clearance for marketing.”

1 Like