Hearing Aids Will Soon be Available Everything You Need to Know About OTC.
Hearing aids will be sold over the counter, according to the FDA.
Many people may find hearing aids more accessible and affordable as a result of this.
Hearing aids will be available over-the-counter beginning in October.
The Food and Drug Administration (FDA) has issued a new rule that will make over-the-counter (OTC) hearing aids more accessible.
The move will remove some of the barriers that have previously prevented many Americans with hearing loss from accessing hearing aids, such as high costs and medical exam requirements.
When the rule goes into effect in mid-October, the hearing aids should be available in local pharmacies, drug stores, and online retail stores.
The rule applies to people 18 and older with mild-to-moderate hearing loss who use air-conduction hearing aids, a common type of hearing aid that amplifies sound.
“Hearing loss is a critical public health issue that affects millions of Americans’ ability to communicate effectively in their daily social interactions.” The creation of this new regulatory category will provide people with perceived mild to moderate hearing loss with easy access to a variety of safe, effective, and affordable hearing aids from their local store or online.” Dr. Robert M. Califf, FDA Commissioner, stated in a press releaseTrusted Source.
How the rule will improve hearing aid access
Congress passed legislation in 2017 requiring the FDA to allow the sale of over-the-counter hearing aids without a prescription.
President Joe Biden issued an executive order in June 2021 instructing the Health and Human Services Department to increase the availability of low-cost hearing aids.
The FDA will review thousands of public comments on the proposed rule from patients, public health organizations, and advocacy groups in October 2021.
The final rule, published on August 16, 2022, will take effect in mid-October 2022.
There are numerous requirements for hearing aids, such as maximum sound output, how deep the aid can be inserted in the ear canal, the inclusion of a user-adjustable volume control, and the inclusion of clear, simple instructions for use.
Hearing aid manufacturers will have until April 2023 to meet the new standards.
What you should know about over-the-counter hearing aids
According to Rebecca Lewis, an audiologist and the Audiology Director of the Adult & Pediatric Cochlear Implant Program at Pacific Neuroscience Institute at Providence Saint John’s Health Center in Santa Monica, CA, 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 over-the-counter hearing aid,” Lewis said.
Because over-the-counter 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 receive the necessary care.
Individuals with unilateral hearing loss, sudden hearing loss, tinnitus in one or both ears, a history of ototoxic medications, ear pain, or frequent dizziness should consult a licensed audiologist and physician before using OTC products, according to Lewis.
According to Pamela Marx, a senior audiologist at Staten Island University Hospital, for those with more serious hearing loss issues, an audiologist can conduct an assessment and provide counseling to ensure their hearing aids are functioning optimally for their personal needs and type of hearing loss.
Millions of people who have hearing loss have never used hearing aids.
Approximately 30 million Americans have hearing loss in both ears, and estimates show that a significant portion of people with hearing loss who could benefit from hearing aid use have never used them.
According to estimates, only one-third (30%) of adults aged 70 and older with hearing loss have ever used hearing aids.
Only about 16% of adults aged 20 to 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, and have difficulty in public places like grocery stores,” Marx explains.
Several barriers to hearing aid use have previously been identified. They include stigma, underestimation of hearing loss, high cost, and low benefits expectations.
According to Marx, Medicare does not reimburse patients for routine hearing testing, and patients must pay for the evaluation if hearing aids are prescribed.
According to Reuters, White House National Economic Council Director Brian Deese estimated that the FDA’s ruling will save people about $2,800 per set of hearing aids.
“We hope that OTCs will improve access and encourage people to treat their communication problems.” “However, there are still compelling reasons to consult with 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.