- The FDA now allow hearing aids to be sold over the counter.
- This can make hearing aids more accessible and affordable for many people.
- These OTC hearing aids are for adults with mild-to-moderate hearing loss
For the first time hearing aids are now available over the counter (OTC) at many major drug stores or other retailers.
This comes months after Food and Drug Administration (FDA) issued a new ruling this summer that allowed hearing aids to be sold without a doctor’s prescription.
The move removes some of the barriers — including high costs and medical exam requirements — that have historically prevented many Americans with hearing loss from being able to access hearing aids.
Hearing aids are now available in many local pharmacies, drug stores, and online retail stores.
The rule applies to air-conduction hearing aids, a common type of hearing aid that amplifies sound, for people 18 and older with mild-to-moderate hearing loss.
“Hearing loss is a critical public health issue that affects the ability of millions of Americans to effectively communicate in their daily social interactions. 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.” FDA Commissioner Dr. Robert M. Califf, stated in a
In 2017, Congress passed legislation requiring the FDA to permit the sale of OTC hearing aids without a prescription.
In June 2021, President Joe Biden signed an executive order instructing the Health and Human Services Department to improve the availability of low-cost hearing aids.
In October 2021, the FDA reviewed thousands of public comments from patients, public health organizations, and advocacy groups on the proposed rule.
The final rule was published on August 16, 2022 and OTC hearing aids became available this month.
There are many requirements regarding the hearing aids, including the maximum sound output, how deep the aid can be inserted in the ear canal, the need for a user-adjustable volume control, and the inclusion of clear, simple instructions for use.
Hearing aid manufacturers will have until April 2023 to comply with the new requirements.
Rebecca Lewis, an audiologist and Audiology Director of the Adult & Pediatric Cochlear Implant Program at Pacific Neuroscience Institute at Providence Saint John’s Health Center in Santa Monica, CA, says the OTC hearing aids are best for adults with mild-to-moderate hearing loss.
“If an individual hears reasonably well in quiet but struggles in background noise, they may be a good candidate for an OTC hearing aid,” Lewis said.
Because the OTC hearing aids do not require a medical evaluation, audiologists are concerned that some people with serious hearing loss or treatable health conditions, such as impacted ear wax or asymmetric hearing loss, may not get the care they need.
“Individuals with unilateral hearing loss, sudden hearing loss, tinnitus in one or both ears, history of ototoxic medications, pain in the ears or those with frequent dizziness should absolutely see a licensed audiologist and physician before using OTC products,” Lewis said.
For those with more serious hearing loss issues, an audiologist can conduct an assessment and provide counseling to ensure their hearing aids are functioning best for their personal needs and type of hearing loss, says Pamela Marx, a senior audiologist at Staten Island University Hospital.
Estimates show that among adults aged 70 and older with hearing loss, only one in three (30 percent) have ever used hearing aids.
Only about 16 percent of adults between the ages of 20 to 69 who would benefit from hearing aids have ever used them.
“People with hearing loss tend to isolate more, have less interaction with family and friends, have difficulty in public areas such as grocery stores,” says Marx.
According to Marx, Medicare does not reimburse patients for routine hearing testing and patients must cover the cost for the evaluation if they are prescribed hearing aids.
White House National Economic Council director Brian Deese said that government estimated that the FDA’s ruling will save people about $2,800 per set of hearing aids, Reuters reported.
“Hopefully, OTCs will improve access and encourage individuals to treat their communication difficulties. However, there are absolutely still valid reasons to see a hearing healthcare professional,” says Lewis.
Over-the-counter hearing aids at local drugstores are now available thanks to a new ruling from the Food and Drug Administration (FDA). The hearing aids are available for adults with mild-to-moderate hearing loss. People with more serious hearing loss issues should see an audiologist to get the care they need.