Senate bill to allow OTC hearing aids has bipartisan support
by MedPage Today Staff
April 24, 2017
Bipartisan legislation to allow manufacturers of so-called “personal sound amplification products” to market them as over-the-counter hearing aids for people with mild to moderate hearing loss is receiving widespread support from consumer and patient’s rights groups.
The Over-the-Counter Hearing Aid Act of 2017 (HR 1652 and S 670) would direct the FDA to categorize the devices as a new class of hearing aid, allowing federal regulators to develop safety and effectiveness standards for them, NPR reports.
The FDA currently does not allow the sale of hearing aids over the counter, so the devices can only be marketed as sound amplifiers for people with normal hearing.
They range in cost from between $250 to $350, compared to thousands of dollars for traditional hearing aids.