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.