Starting later this month, people with hearing loss can purchase hearing aids over the counter at local pharmacies and drugstores across the country or online, without a prescription.
The hearing aids will be available as soon as Oct. 17 after the Food and Drug Administration finalized a ruling in August allowing the devices to be sold without a prescription, medical exam, or trip to the audiologist.
The long-awaited ruling comes on the heels of an executive order President Joe Biden issued earlier this year calling for the FDA to take action to provide hearing aids over the counter within 120 days. Congress previously passed bipartisan legislation in 2017 requiring the FDA to make hearing aids available without a prescription.
Who can purchase one?
People 18 years and older who have “perceived” mild to moderate hearing impairment will be able to buy certain air-conduction hearing aids over the counter, which are typically worn inside or on the ear. A person with mild hearing loss may have difficulty hearing some speech but not other speech, while someone with moderate hearing loss may have increased difficulty hearing speech even in a quiet room with a person talking at a normal level.
Indicators of hearing loss include speech or sounds being muffled, trouble hearing when in a group or noisy area, and having to turn up the volume when other people when watching TV or listening to music, according to the National Institute on Deafness and Other Communication Disorders.
“It’s also important for people to recognize that hearing loss could be a sign of an easily treatable problem like built-up earwax or a more serious problem like a benign tumor on the hearing nerve. See a doctor when things don’t feel right, when your hearing loss is progressing, or if you are having associated symptoms like dizziness, ear pain, or drainage from the ear canal,” said Eric Mann, a senior adviser at the FDA.
An estimated 30 million adults in the U.S. could benefit from a hearing aid, according to the National Institute on Deafness and other Communication Disorders. Hearing aids meant for people with severe hearing impairment or people under 18 years old will still require a prescription. In some states, prescription hearing aids can only be sold from licensed retailers as well.
How much will over-the-counter hearing aids cost?
Hearing aids sold over the counter are expected to be offered at a lower cost.
Hearing aids, which typically cost anywhere around $5,000 a pair, could be lowered to nearly $2,800 a pair, the FDA estimates. The cost of the devices is generally not covered by medical insurance, though some insurers offer separate plans for hearing.
FDA Commissioner Robert Califf said the decision to allow certain hearing aids to be sold over the counter will provide people with “convenient access to an array of safe, effective and affordable hearing aids.”
How will this ruling affect prescription hearing aids?
As part of the ruling, it amends 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 lowering the maximum sound output and revising the insertion depth in the ear canal.
Hearing aid manufacturers will have 240 days to meet the new or revised requirements for devices already on the market.