Buying hearing aids could soon become as easy as buying reading glasses.
In a surprise announcement yesterday, the Food and Drug Administration (FDA) said that, effective immediately, it would no longer require adults to get a medical evaluation before buying most hearing aids.
The agency 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 a meeting of the National Academies of Sciences, Engineering and Medicine on hearing health care. Previous recommendations from this group, as well as from a White House advisory panel on science and technology, and consumer and some 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.
Age-related hearing loss affects some 30 million Americans, affecting not only their work and social interactions but also their overall health and quality of life. For most, the hearing loss begins before the age of 60. 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.
The ruling was one of several recommended by the Hearing Loss Association of America and other consumer groups. HLAA Executive Director Barbara Kelley commented, “We applaud the FDA’s decision to remove this requirement and believe it is a step forward to remove barriers and make hearing health care for consumers more affordable and accessible.”
“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.
This post was first published on AARP Heath on December 8, 2016.
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