“Reducing health care costs in America has been a priority of mine since Day One and this rule is expected to help us achieve quality, affordable health care access for millions of Americans in need,” said Health and Human Services Secretary Xavier Becerra in a statement. “Today’s action by the FDA represents a significant milestone in making hearing aids more cost-effective and accessible.”
The rule applies to certain air-conduction hearing aids, the FDA said in the news release. Hearing aids intended for severe hearing impairment or hearing aids for those under the age of 18 will be prescription devices under the new rule.
“Establishing this new regulatory category will allow people with perceived mild to moderate hearing loss to have convenient access to an array of safe, effective and affordable hearing aids from their neighborhood store or online,” FDA Commissioner Dr. Robert Califf said.