What the 2022 OTC rule changed

For most of their history, hearing aids meant a clinic visit, a hearing test, and a prescription. In 2022 the U.S. FDA created a new over-the-counter (OTC) category for adults 18 and older with perceived mild-to-moderate hearing loss — making it possible to buy and self-fit a hearing aid at home, without a prescription or an in-person exam.

An OTC hearing aid is still a regulated medical device. It is built and cleared to help people with hearing loss hear better, and it is held to the FDA's requirements for that category. What changed in 2022 is access: the path from noticing a difficulty to actually trying a device got much shorter.

Harmonix Elevate is our entry in this category. Elevate is a regulated over-the-counter hearing aid for adults 18+ with perceived mild-to-moderate hearing loss. You set it up yourself at home and tune it with an app, rather than visiting a clinic to be fitted.

A quick but important distinction: a hearing aid is not the same as a hearing enhancement. Elevate is a hearing aid, intended for people with hearing loss. Our SonaVue and TravelerAI products are enhancements — they layer sound and translation onto everyday life and make no medical claims. If you think you may have hearing loss, an OTC hearing aid like Elevate is the category built for that; if you're simply after richer everyday audio, an enhancement is the better fit.

OTC hearing aids aren't right for everyone — severe hearing loss, hearing loss in children, or sudden changes in hearing still call for a professional. This article is general education, not medical advice.