Hearing aids in the US have traditionally only been available to consumers who sought audiology consultations with licensed hearing care professionals. Only those who received prescriptions for hearing aids could obtain such devices from medical clinics. As these devices are still not covered under Medicare, their high cost has deterred millions of people from accessing them. To lower such barriers and to spur competition within the hearing aids market in the US, the Food and Drug Administration (FDA) issued a final ruling in August 2022 to establish a regulatory category for over-the-counter (OTC) hearing aids.
