Approximately 30 million people in the United States suffer from some level of hearing loss, according to the U.S. Food and Drug Administration (FDA). Hearing problems often significantly impact communication, social participation, health, and overall quality of life. In spite of the prevalence and impact of hearing loss, the FDA states that only about 20 percent of the people who could benefit from intervention actually seek it. The cost of hearing aids, which often cost more than $2,000 each, poses the most significant barrier followed by the cost of evaluations and treatment.

The U.S. government is now stepping in to improve patient access and device affordability and to facilitate hearing device innovation. On December 7, 2016, the FDA announced two important steps to improve consumer access to hearing aids. The first is a “guidance document” that states the FDA will not enforce previous FDA regulations that people 18 and older receive a medical evaluation or sign a waiver before buying hearing aids – the requirements will remain in place for people under 18. This guidance was effective immediately.

The second, but no less dramatic, announcement introduced an FDA commitment to study a category of over-the-counter (OTC) hearing aids to encourage innovation and new lower cost hearing aids to millions of hearing impaired people.

The effect of the two FDA announcements will be a groundswell of new wearable hearing devices. A number of high profile “hearing assist” devices that skirted the label of “hearing aids” are already due to come on the market in the first half of 2017 from companies including Bose, Doppler Labs, Human Inc., and Nuheara. All of these companies will be displaying their products at the upcoming Consumer Electronics Show (CES) in Las Vegas in early January. The FDA’s recent announcement comes too close for anyone not already far along in the development process to show product on the CES convention floor or even in private meetings, but without question, this large, lucrative market, where typical medical devices costs $2,000 per ear and up, will draw many innovative tech companies within the next year. There will likely be an even greater number of unsophisticated ear amplifiers and other that suddenly make preposterous claims, but we’ll be listening.