Leading scientists, technologists, and hearing health care experts have collaborated with researchers, health professionals, and consumers to find safe and effective ways to improve adult access to hearing health care. They proposed changing some regulations that studies revealed were impediments to adults receiving necessary hearing aids. They also suggested that the FDA develop guidelines and quality standards for over-the-counter hearing aids.
The FDA was directed by a law enacted as part of the FDA Reauthorization Act of 2017 to create a category of OTC hearing aids for adults with perceived mild to moderate hearing loss. As part of this process, the FDA will formally propose a rule to establish the new OTC hearing aids category in October 2021. The final rule, which will be finalized in August 2022, will allow hearing aids in this category to be sold directly to consumers in stores or online without a medical exam or a fitting by an audiologist. Hearing aids for more severe hearing loss or for users under the age of 18 must still be prescribed.
