Did you know that an estimated 37.9 million Americans have some form of bilateral hearing loss? That makes up about 11.6% of the population. And while 24.9 million of these have mild hearing loss, another 13.0 million have a moderate or worse hearing loss situation.(1)
These numbers stress the fact that hearing loss is a worrying public health concern in the country. If left unaddressed, it will continue to affect the quality of life of a significant number of Americans, even in their day-to-day social interactions.
Additionally, there are indications that hearing loss is undertreated, and one of the reasons for this is the high cost of hearing aids.
Fortunately, a recent FDA rule on access to over-the-counter (OTC) hearing aids has sparked a ray of hope for people with perceived hearing loss.
So, what’s this rule about? Keep reading to find out.
The road to affordable OTC hearing aids for Americans can be traced back to the 2017 Congress bipartisan legislation that directed the FDA to establish a new regulation of OTC hearing aids.
It seemed that this road had reached a dead end.
However, in July 2021, a presidential
executive order on Promoting Competition in the American Economy directed the FDA to facilitate the easy availability of affordable hearing aids. The agency had to do this within 120 days from the order date.
In compliance, on August 16, 2022, the FDA established a new regulatory category. The rule was geared at enhancing access to hearing aids by adults 18 years and above with mild or moderate hearing loss. The regulation became effective on October 17, 2022.
To finalize the regulation, the FDA reviewed over 1,000 views to complement its perspective on the proposed regulation. The views came from several categories of people with an interest in the OTC hearing aids, including:
The input from these groups served to incorporate changes to the proposed regulation on aspects related to:
In addition to these specifications, the final regulation gives guidelines on design requirements and performance specs to be followed by manufacturers.