Over-the-Counter Hearing Aids

FDA regulated self fit aids for adults with perceived mild to moderate loss

Overview

Over the counter hearing aids are a category of hearing aids that can be sold directly to consumers without a medical evaluation, prescription, or fitting by a hearing professional. In the United States the category was created by the Over the Counter Hearing Aid Act of 2017, and the FDA rule establishing it took effect in October 2022. They are intended for adults 18 and older with perceived mild to moderate hearing loss and must meet FDA requirements for safety, maximum output, and labelling. Many use smartphone apps or built in self tests for set up and adjustment. Their prices are generally lower than those of prescription aids that include professional services, and the category was designed to improve access and affordability. Quality and features vary between products. They are not intended for children, severe or profound loss, or warning signs such as sudden or one sided hearing loss, ear pain, or drainage, which are typically assessed by clinicians.