The U.S. Food and Drug Administration (FDA) is taking crucial steps toward improving its ability to make hearing aids more accessible to consumers.
In order to do this, the FDA has released a guidance document announcing that it is doing away with the need for individuals who are 18 or older to receive a medical evaluation -- along with signing a waiver -- before they are able to purchase hearing aids.
“Today’s actions are an example of the FDA considering flexible approaches to regulation that encourage innovation in areas of rapid scientific progress,” FDA Commissioner Dr. Robert Califf said. “The guidance will support consumer access to most hearing aids while the FDA takes the steps necessary to propose to modify our regulations to create a category of OTC hearing aids that could help many Americans improve their quality of life through better hearing.”
The guidance released by the FDA is effective immediately.
The administration also plans to consider making hearing aids available over the counter (OTC). This would allow the approximately 30 million people affected by hearing loss to have better access to hearing aids at a lower cost.
