For decades, getting a hearing aid meant a visit to an audiologist, a battery of tests, and often a bill running into the thousands. In October 2022, that changed: regulators in the US created a dedicated over-the-counter (OTC) hearing aid category, allowing adults with perceived mild-to-moderate hearing loss to buy a certified hearing aid directly, without a prescription or a clinic visit.
What makes a hearing aid "OTC"?
An OTC hearing aid is a real, regulated medical device — not a simple sound amplifier. To carry the label, a product has to meet specific technical and safety requirements covering things like maximum output volume, sold specifically for adults with mild-to-moderate hearing loss. That's the key difference from the drugstore amplifiers of the past: OTC hearing aids are built and tested to a defined regulatory standard.
Who is it for?
OTC hearing aids are designed for adults (18+) who perceive themselves as having mild-to-moderate hearing loss — for example, struggling to follow conversations in noisy rooms, frequently asking people to repeat themselves, or turning the TV up louder than others prefer. They are not designed for severe or profound hearing loss, or for children, who should be evaluated by a hearing care professional.
Why it matters
Cost and access have long kept many people from addressing hearing loss: traditional prescription hearing aids and audiologist visits can run from a few hundred to several thousand dollars, and are rarely covered by insurance. The OTC category exists to close that gap — giving people a regulated, lower-cost way to start hearing more clearly, with the option to see a specialist later if their needs turn out to be more complex.
How to choose one
Look for a product that's explicitly certified as an OTC hearing aid (not just labeled a "sound amplifier"), offers a real home trial period so you can test it risk-free, and includes multiple ear tip sizes so you can get a comfortable, secure fit — a poor fit is the number one cause of whistling and discomfort.
Curious whether an OTC hearing aid could be right for you? Take a look at Polaro One, our certified OTC hearing aid.