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In 2022, US regulators allowed certain hearing aids to be sold directly to adults without a prescription or a medical exam.
Over the counter, without a prescription, describes the change the FDA made in 2022. Before that, adults with hearing loss generally needed to see a hearing specialist to be fitted for a device, a process that added cost and inconvenience, so creating an over-the-counter category let adults with mild-to-moderate hearing loss simply buy suitable hearing aids directly, similar to how one might buy reading glasses.
A lottery system and hospital-only sales are not accurate descriptions of the change; the point of the new rule was specifically to make purchasing simpler and more direct, not to add restrictions or randomize access.
The change was driven largely by concerns that cost and the hassle of specialist visits were keeping many people with treatable hearing loss from ever getting help, since untreated hearing loss has been linked to broader effects on quality of life and social engagement as people age.
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