In previous blog posts, we examined the pros and cons of the OTC hearing aid market. Also, we looked at some of the possible effects it may have on the hearing health care industry as a whole. This is the second update on the FDA approval process and unfortunately, we’re still in the same boat. As far as I am aware, there has been no update recently, despite the quickly expiring time constraints put on by the passage of the OTC legislation.

The Future of OTC Hearing Aids

I am very curious to see which hearing aid manufacturers jump into the OTC hearing aid market. And, what features will they make available, either direct to consumer or in a self-fit manner? There is currently a second classification of hearing aids available, as approved by the FDA, known as a self-fitted device. Despite this device being approved as self-fitting, it needs to be sold by a licensed provider. Currently, there is only one product, as far as I know, that has been approved under this section. It’s produced by Bose but is not being sold anywhere.

We will have further updates on the OTC hearing aid legislation when they are available. Given everything that is happening with COVID-19 and the current pandemic affecting many Americans, the FDA has their hands full at this time. Unfortunately, this may prolong the process for clarification regarding OTC hearing aids. These OTC products will eventually be available and hopefully, current hearing aid manufacturers will work with the hearing health care providers to help people with mild to moderate hearing loss obtain more affordable amplification.

OTC Hearing Aids vs. In-Person Hearing Loss Treatment

If you’ve had a hearing test and think that you may be a candidate for an OTC device, please feel free to submit your test results to If you haven’t been tested and want to know if you  fall into the mild-moderate category (initially described as the fitting range for OTC hearing devices) or if you should be seeking more traditional amplification for a more significant hearing problem, get evaluated by a hearing healthcare professional. More updates on OTC will follow as they become available.