The Food and Drug Administration wants to make hearing aids available without a medical exam or fitting.
According to the proposal, the FDA would create a new category of over-the-counter hearing aids that could be sold at traditional retail stores and online.
“Approximately 15% of American adults (37.5 million) age 18 and over report some trouble hearing,” the FDA stated. “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 FDA says the new rule will drive innovation and increase competition while also making hearing aids more accessible.
“Reducing health care costs for everyone in America is a top priority,” said Health and Human Services Secretary Xavier Becerra. “Today’s move by FDA takes us one step closer to the goal of making hearing aids more accessible and affordable for the tens of millions of people who experience mild to moderate hearing loss.”
No timeline was given for when over-the-counter hearing aids will be available for purchase.
