The proposed rule comes four years after Congress passed a law mandating that the FDA to establish a category of over-the-counter hearing aids. The agency ran through its August 2020 deadline for doing so, but now has finalized it after a 90-day public commentary period. The FDA’s updated guidelines will create a new category of devices requiring neither a prescription nor a fitting by an audiologist. These will be sold online and at retail stores for adults with mild to moderate hearing loss.
AARP’s recent article entitled “FDA Clears Way for Over-the-Counter Hearing Aids” reports that right now those seeking hearing aids usually must see a health care professional for testing and fitting — a process that can be both costly and lengthy.
“Hearing loss has a profound impact on daily communication, social interaction and the overall health and quality of life for millions of Americans,” Acting FDA Commissioner Janet Woodcock, M.D., said in a statement. “The FDA’s proposed rule represents a significant step toward helping ensure that adults with mild to moderate hearing loss have improved access to more affordable and innovative product options.”
About 15% of U.S. adults (37.5 million) report trouble hearing, according to the National Institute on Deafness and Other Communication Disorders, and fewer than 1 in 3 adults aged 70 and older with hearing loss who could benefit from hearing aids have ever used them. The reason most often cited is the cost. Hearing aids currently cost between $2,000 and $6,000 a pair and are not covered by Medicare or most insurance. The proposed rule is expected to lead to lower prices for consumers, by lowering barriers to entry for hearing aid makers.
The only over-the-counter options now available have been personal sound-amplification products (PSAPs), which increase the volume of all the sounds in a given environment, and which typically cost a hundred dollars a pair.
“Reducing health care costs for everyone in America is a top priority,” Health and Human Services Secretary Xavier Becerra said in a statement. “Today’s move by FDA takes us one step closer to the goal of making hearing aids more accessible and affordable for the tens of millions of people who experience mild to moderate hearing loss.”
Reference: AARP (Oct. 19, 2021) “FDA Clears Way for Over-the-Counter Hearing Aids”