People 18 or older with mild-to-moderate hearing loss will soon be able to buy hearing aids directly from stores or online retailers, without the need for a medical exam, prescription or seeing an audiologist. The policy shift is designed to broaden availability of the devices, lower the cost and facilitate technology improvements, the Food and Drug Administration said Tuesday.
Nearly 30 million adults in the U.S. are candidates for hearing aids due to permanent hearing impairment, but many models are expensive. Only about 16% of adults use one, due to the social stigma associated with the devices, lack of insurance coverage and other access issues.
To effect the change, the FDA established a new category of OTC hearing aids, personal sound amplification products (PSAPs). With the final rule set to take effect in 60 days, consumers could see the devices become available in traditional retail and drugstores as soon as mid-October.
“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,” said FDA commissioner Dr. Robert Califf.
It applies to certain air-conduction hearing aids, which use air to transfer sound into the ear canal. They’re typically the initial option for people with hearing loss. Devices intended for severe hearing impairment or for users under 18 will continue to require a prescription.
The price of a single hearing aid can range from less than $1,000 to $4,000, according to the Hearing Industries Association (HIA), the trade group representing hearing aid manufacturers. The FDA estimated that the price of the devices could come down by about $2,800 a pair once the rule kicks in.
“HIA supports the final rule and recommends that the best treatment for hearing loss involves seeing a hearing professional,” the group’s president said Tuesday.
The FDA said it received more than 1,000 public comments on the proposed rule issued in October. The final rule reflects input from consumers, professional associations and manufacturers, and includes labeling requirements and a limit on the sound volume of each device.