A person puts in a hearing aid.
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  • The FDA will allow hearing aids to be sold over the counter.
  • This could make hearing aids more accessible and affordable for many people.
  • The hearing aids will start to be available OTC in October.

The Food and Drug Administration (FDA) has issued a new ruling that will improve access to over-the-counter (OTC) hearing aids. 

The move will remove 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. 

The hearing aids are expected to be available in local pharmacies, drug stores, and online retail stores in mid-October when the rule takes effect.

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 press release

How the rule will improve access to hearing aids

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, which was published on August 16, 2022, will go into effect mid-October 2022.

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.

What to know about the OTC hearing aids 

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.

Millions with hearing loss have never used hearing aids 

Approximately 30 million Americans experience hearing loss in both ears, and estimates demonstrate that a significant portion of people with hearing loss who may benefit from hearing aid use have never used them. 

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.

Several barriers to hearing aid use have previously been documented. They include stigmatization, underestimation of hearing loss, high cost, and low expectations about the benefits. 

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. 

The bottom line:

Over-the-counter hearing aids will be available at local drugstores this fall due to a new ruling from the Food and Drug Administration (FDA). The hearing aids will be 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. 

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