Untreated, age-related hearing loss is a significant national problem. Untreated hearing loss is statistically associated with higher risks of cognitive decline, dementia; falls with injury; reduced earning potential ability, social isolation and depression. With the population 65+ in the United States expected to reach 80 million in the next 25 years, the number of people with hearing loss will rise dramatically. Already, a quarter of adults between 60-69 years, more than half of adults between 70-79 years, and almost 80 percent older than 80 years have difficulty hearing – nearly 30 million Americans. Consistently, only a small fraction seek out and use hearing aids & assistive hearing technologies, and that rate is even smaller among low income folks. Cost is often cited as the largest barrier to the early adoption of hearing aids to treat hearing loss.
To help address this issue, at the end of President Obama’s 2nd term (seems like ages ago now) the President’s Council of Advisors on Science and Technology (PCAST) recommended the creation of a new classification of OTC (over-the-counter) hearing aid for the treatment of early “age-related mild to moderate hearing loss”. On August 18, 2017, The FDA Reauthorization Act of 2017 (FDARA) was signed into law. Among other things, FDARA authorized the Food & Drug Administration (which regulates hearing aids) to create this new category of OTC hearing aid. A few weeks ago, on July 24th, the FDA sent a letter to the 6 major hearing aid manufacturers, notifying them they will publish proposed guidelines for OTC hearing aids August 18, 2020, and then publish final regulations within 180 days of the close of the “comment period”. Although FDA approved OTC hearing aids are coming, they are not coming very soon.
There are currently products on the market known as ‘personal sound amplification products’ (PSAPs) or ‘hearables’, which have the potential to effectively function as OTC hearing aids, but can’t be touted as treating hearing loss. So for several years hence, since there are no regulations/guidelines, it will be a sort of ‘Wild West’ when it comes to these devices.
I personally believe that creation of an appropriate low-cost OTC option for the treatment of early, age-related mild to moderate hearing loss is absolutely the correct decision. I hope and anticipate it will dramatically increase the early treatment of all types of hearing loss, which research consistently shows is in everyone’s best interest.
For those with more significant degrees of hearing loss, the best treatment will continue to be hearing aids and assistive hearing technologies properly fit by audiologists-providers with advanced degrees, trained in the diagnosis, prevention and treatment of hearing loss.