Hi, I’m Anne Marie Egan from Now Hear This©, and today I’d like to talk to you about the recent FDA approval of over-the-counter hearing aids and what that even means.
On August 16th, 2022, the FDA established a new category of hearing aids—over-the-counter (OTC) hearing aids. These are to be sold as regulated devices to adults with perceived mild to moderate hearing loss. We recommend a diagnostic hearing test for those who think they have mild to moderate hearing loss before purchasing over-the-counter devices in case they are inappropriate for their hearing loss. For example, someone might think that they have a moderate hearing loss, but it’s actually severe to profound. It’s always good to know what you’re looking at before finding a solution. A person with moderate to profound hearing loss should still seek the services of a hearing healthcare provider, and we recommend doctors of audiology.
Basically, the FDA will regulate the “reader glasses” version of hearing aids for people that are in the early stages of hearing loss. These devices have always existed but were never regulated by the government as a medical device until now.
Why is federal regulation that important? Well, FDA regulation is truly critical because these are medical devices that need to be safe and effective for use and wear. These are things going in our ears every single day, and we want to make sure they are not going to be harmful and further damage our hearing.
Over-the-counter hearing aids will be available hopefully as early as October of 2022. We, as a clinic, are looking to research these, so that we can find good quality over-the-counter hearing aids to recommend for patients who come in and would be good fits for these devices.
We are excited that the FDA is working to improve accessibility and affordability of hearing healthcare, and we hope that this will push the hearing aid industry as a whole to reduce costs for the individual person. Right now, there are seven major hearing aid manufacturers, and that’s not a lot of competition. They’ve all been around for a really long time. So, we’re excited!
I’m hoping that this gets more companies into the hearing aid industry, creates more innovation, and also helps reduce costs, so that we can make hearing healthcare more affordable for our patients. Our clinic plans on, like I said, doing continued research and education on these devices, so stay tuned as we learn more about them and provide you with information, so that you can be informed to make the best decision for yourself.
I hope you learned something in this video, and of course, have a wonderful rest of your day!
