Proposal establishes over-the-counter hearing aids

A new proposal published in the Federal Register establishes a new category of over-the-counter (OTC) hearing aids. When finalized, the rule would allow hearing aids within this category to be sold directly to consumers in stores or online without a medical exam or a fitting by an audiologist. The proposed rule is designed to help increase competition in the market while also ensuring the safety and effectiveness of OTC and prescription hearing aids. Hearing loss affects an estimated 38 million people in the United States and can have a significant impact on communication, social participation, and overall health and quality of life.

Approximately 15% of American adults (37.5 million) age 18 and over report some trouble hearing. However, despite the high prevalence and public health impact of hearing loss, only about one-fifth of people who could benefit from a hearing aid use one. The proposed rule aims to address barriers to use, including cost, access, social stigma related to hearing loss, perceived value of the devices or certain state and federal regulations.

Only a small proportion of people who could benefit from a hearing aid seek one. Several barriers prevent hearing-impaired individuals from getting hearing aids, such as: access, social stigma related to hearing loss, perceived value of the devices, cost, and certain state and federal regulations.

To help enhance access to hearing aids for persons age 18 or older with perceived mild to moderate hearing loss, the U.S. Food and Drug Administration (FDA) published a proposed rule, Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the-Counter Hearing Aids. If finalized, it would establish a regulatory category for over-the-counter (OTC) hearing aids and make related amendments to update the regulatory framework for hearing aids.

Federal register release