Millions of Americans will have access to more affordable hearing aids, after the U.S. Food and Drug Administration issued a final rule Tuesday allowing devices to be sold over the counter.
Americans may have access to these hearing aids by mid-October when the rule takes effect, the agency said.
Hearing aids have been a long desired, but usually expensive, device for millions of Americans with mild to moderate hearing impairments. Only 3.7% of people with hearing difficulty own these gadgets, although about one in 10 individuals have some sort of hearing loss that affects their communication, according to a 2019 MarkeTrak report. Hearing aids can cost thousands of dollars per pair, while over-the-counter aids will be a fraction of that cost.
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“Hearing loss is a critical public health issue that affects the ability of millions of Americans to effectively communicate in their daily social interactions,” FDA Commissioner Robert M. Califf said in a statement. “Establishing this new regulatory category will allow people with perceived mild to moderate hearing loss to have convenient access to an array of safe, effective and affordable hearing aids from their neighborhood store or online.”
Hearing impairment not only affects communication, but physical and cognitive abilities as well. Hearing loss has been associated with falls and dementia, Johns Hopkins Medicine found. In one study conducted over 12 years, researchers found mild hearing loss doubled the risk of dementia.
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The move comes years after Congress passed bipartisan legislation for the FDA to create a category solely for over-the-counter hearing aids.
With the FDA’s final rule, individuals will not need a prescription or medical exam to buy hearing aids from stores or online retailers. Prescriptions will still be required for more severe hearing impairments or for individuals younger than 18 years old, the FDA said. After taking into consideration public commentary about over-the-counter hearing aids, the FDA’s final rule included lowering the maximum sound output for these devices and adding a user-adjustable volume control.