In a surprise announcement this week, the Food and Drug Administration (FDA) announced that, effective immediately, it would no longer require adults to get a medical evaluation before buying most hearing aids.
The FDA is also considering creating a category of over-the-counter hearing aids to encourage more “new, innovative, lower-cost products to millions of consumers,” the agency said in a prepared statement.
The announcement was made at an open meeting of the National Academies of Sciences, Engineering and Medicine. Previous recommendations from this group, as well as from a White House advisory panel on science and technology, and some consumer and audiologist groups, had urged easing this restriction to make hearing aids more affordable and accessible.
The decision does not apply to those ages 18 and under, who still must have a medical evaluation before purchasing hearing aids. It also does not apply to bone-conduction hearing aids or to prescription-use hearing aids that are inserted deep in the ear canal.
Hearing loss affects some 30 million Americans, affecting not only their work and social interactions but also their overall health and quality of life. The isolation and loneliness that can result from serious hearing loss have been linked to a higher risk of cognitive decline and dementia.
Despite the high prevalence and public health impact of hearing loss, only about one-fifth of people who could benefit from wearing a hearing aid actually use one, the FDA noted. The high price of the devices — about $4,600 a set — has been a major barrier. Medicare and many private insurance plans don’t cover the cost of hearing aids, so most consumers are stuck paying for them out of pocket.
In addition, six companies manufacture nearly all the hearing aids sold, and only one is based in the U.S., a White House blog post about the FDA decision said.
The impact of the FDA’s move could open the hearing aid market to new companies and more competition.
“Today’s actions are an example of the FDA considering flexible approaches to regulation that encourage innovation in areas of rapid scientific progress,” said FDA Commissioner Robert Califf, M.D.