The US Food and Drug Administration has finalized rules establishing over-the-counter (OTC) availability for certain types of hearing aids in order to improve public access to these devices.
FDA’s final rule sets general controls for OTC hearing aids in order to “improve access to and foster innovation in hearing aid technology for Americans, thereby promoting the public health,” according to the agency, noting that roughly 30 million US citizens are affected by hearing loss. Allowing OTC sales of these devices will remove barriers to access such as high cost and value in terms perceived benefit of use versus price…
