The US Food and Drug Administration has finalized a new rule that makes over-the-counter (OTC) hearing aids available.
Until recently, hearing aids required doctor approval in the US, adding to the cost and inconvenience. Following President Biden’s Executive Order directing the agency to do so, the FDA proposed a new rule that would eliminate that requirement, putting affordable hearing aids within reach of far more people.
The new rule has now been finalized, opening the market to additional low-cost options.
“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. “Today’s action by the FDA represents a significant milestone in making hearing aids more cost-effective and accessible.”
“Hearing loss is a critical public health issue that affects the ability of millions of Americans to effectively communicate in their daily social interactions,” said FDA Commissioner Robert M. Califf, M.D. “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.”
Companies have already been working to bring OTC hearing aids to the US market, with Sony introducing its first late last year.
