Over the Counter Hearing Aids (OTC)
Over the counter (OTC) hearing aids are hearing devices that can be purchased directly by consumers without a prescription or professional fitting. In the United States, the FDA established a formal OTC hearing aid category in 2022, permitting adults with perceived mild to moderate hearing loss to purchase certain hearing aids without a clinical assessment. This regulatory change was intended to improve access and affordability.
In Canada, hearing aids remain regulated as Class II medical devices under Health Canada's Medical Devices Regulations. As of the time of writing, Health Canada had not created an equivalent OTC category. Hearing aids in Canada require dispensing by a registered and appropriately trained hearing healthcare professional, typically an audiologist or hearing instrument specialist, depending on the province. The distinction between clinically dispensed and OTC devices is relevant when patients present having purchased devices online or during travel in the US.
The clinical risk of unsupervised hearing aid use includes inadequate amplification for the actual degree of hearing loss, failure to detect medically significant conditions that a clinical assessment would identify, and lack of proper fitting verification. People interested in OTC hearing aids should be aware that audiological assessment before any amplification decision remains clinically recommended, regardless of regulatory category.
