All you need to know

  • The FDA will allow the sale of over-the-counter hearing aids.
  • This could make hearing aids more accessible and affordable for many people.
  • Hearing aids will begin to be available over-the-counter in October.

The Food and Drug Administration (FDA) has released 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 kept many hearing-impaired Americans from accessing hearing aids.

Hearing aids are expected to be available at local pharmacies, pharmacies and online retail stores by 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 communicate effectively in their daily social interactions. The establishment of this new regulatory category will allow people with hearing loss perceived as mild to moderate to ‘have convenient access to a range of safe, effective and affordable hearing aids at their neighborhood store or online.’FDA Commissioner Dr. Robert M. Califf said in a Press release.

In 2017, Congress passed a law requiring the FDA to allow over-the-counter hearing aids to be sold without a prescription.

In June 2021, President Joe Biden signed an executive order directing the Department of Health and Human Services 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 posted on August 16, 2022, will go into effect in mid-October 2022.

There are many requirements for hearing aids, including maximum sound output, the depth of insertion of the aid into the ear canal, the need for user-adjustable volume control, and the inclusion of clear and simple instructions for use.

Hearing aid manufacturers will have until April 2023 to comply with the new requirements.

Rebecca Lewis, audiologist and director of audiology for the adult and pediatric cochlear implant program at the Pacific Neuroscience Institute at Providence Saint John’s Health Center in Santa Monica, Calif., says over-the-counter hearing aids are best for adults with mild to moderate hearing loss.

“If a person hears reasonably well in quiet but struggles in background noise, they may be a good candidate for an OTC hearing aid,” Lewis said.

Because over-the-counter hearing aids do not require a medical evaluation, audiologists are concerned that some people with severe hearing loss or treatable health conditions, such as impacted earwax or asymmetric hearing loss, may receive the care they need.

“People with unilateral hearing loss, sudden hearing loss, tinnitus in one or both ears, a history of ototoxic medications, pain in the ears, or frequent dizziness should definitely see a licensed audiologist and physician before to use over-the-counter products,” Lewis said.

For those with more severe hearing issues, an audiologist can perform an assessment and provide counseling to ensure their hearing aids work best for their personal needs and type of hearing loss, says Pamela Marx, senior audiologist at the Staten Island University Hospital.

Approximately 30 million Americans suffer from hearing loss in both ears, and estimates show that a significant portion of deaf people who may benefit from the use of hearing aids have never used them.

Estimates show that among adults aged 70 and over with hearing loss, only one in three (30%) have ever used hearing aids.

Only about 16% of adults aged 20-69 who would benefit from hearing aids have ever used them.

“People with hearing loss tend to isolate themselves more, have less interaction with family and friends, have difficulty in public places such as grocery stores,” Marx explains.

Several barriers to the use of hearing aids have already been documented. They include stigma, underestimation of hearing loss, high cost, and low expectations of benefits.

According to Marx, Medicare does not reimburse patients for routine hearing tests, and patients must cover the cost of the evaluation if hearing aids are prescribed for them.

White House National Economic Council Director Brian Deese said the government estimates the FDA’s decision would save people about $2,800 per set of hearing aids, Reuters reported.

“Hopefully CTOs will improve access and encourage individuals to address their communication difficulties. However, there are still valid reasons to see a hearing care professional,” says Lewis.

Over-the-counter hearing aids will be available at local pharmacies this fall due to a new Food and Drug Administration (FDA) ruling. Hearing aids will be available for adults with mild to moderate hearing loss. People with more serious hearing problems should see an audiologist to get the care they need.

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