Over-the-counter hearing aids got FDA approval. Millions of Americans will have access to more affordable hearing aids by mid-October when the rule takes effect.
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.
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.
“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.
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