Hearing aids will soon be available for purchase over the counter at a local pharmacy or drugstore.
The Food and Drug Administration finalized a ruling that will allow select hearing aids to be sold at stores or online retailers without a prescription or a medical exam at a lower cost.
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“For many Americans who suffer from hearing loss, safe and effective and high quality hearing aids have been unaffordable. Hearing aids can cost thousands of dollars per pair and they’re not always covered by insurance,” said HHS Secretary Xavier Becerra. “Americans who need help with their hearing aids, and that includes my mom, help is on the way.”
As soon as mid-October, air-conduction hearing aids intended for people 18 years or older with mild to moderate hearing impairment will be available to be bought over the counter. Air-conduction hearing aids are worn inside or on the ear.
Hearing aid devices for those with severe hearing impairment or under the age of 18 will continue to require a prescription.
The introduction of over-the-counter hearing aid devices is expected to stimulate competition among manufacturers in the market and drive prices of the devices down.
Hearing aids, which typically cost anywhere around $5,000 a pair, could be lowered to nearly $2,800 a pair under the new ruling, the FDA estimates. As many as 30 million people in the United States could benefit from a hearing device, though only about a fifth seek help for the issue.
The rule also amends existing regulations for prescription hearing aids already on the market to comply with those for over-the-counter hearing aids, stipulating device and design requirements, such as limits on distortion, noise delay, and the range of frequencies that the device can produce.
The final rule, which is set to take effect in 60 days, follows an executive order from President Joe Biden last July that called for increased competition in the industry and directed the FDA to take steps to make hearing aids available over the counter. Congress passed legislation in 2017 requiring the FDA to make some hearing aids available over the counter, though it had not been implemented until now.
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Hearing aid manufacturers will have 240 days after the rule takes effect to comply with new requirements for devices already on the market.
