Medicare and most insurance policies don’t cover hearing aids. That’s why healthcare advocates are happy about the new Food and Drug Administration (FDA) rule announced Tuesday that adults with mild to moderate hearing impairment will be able to buy hearing aids directly from stores, pharmacies and other online retailers with no prescription or doctor’s appointment required as soon as mid-October.
But according to NPR, there are important points to consider when planning to buy these over-the-counter (OTC) hearing aids. The new rule applies only to certain air-conduction hearing aids for adults 18 years and older who perceive they have mild to moderate hearing loss. Children, and people with severe hearing loss, will still need to have a prescription.
The new FDA guidelines do not apply to “personal sound amplification products,” or PSAPs. It is estimated that 30 million U.S. adults could benefit from the use of hearing aids but only 14% of those with hearing loss use them.
The high cost, ranging from $1,000 to $6,000 per ear without figuring in the cost of being seen, evaluated, and fitted by a hearing specialist can be prohibitive for potential users. Experts say that the new rule could lower the cost of hearing aids by hundreds or even thousands of dollars, says NPR.
Barbara Kelley, executive director of the Hearing Loss Association of America says that while the association is excited over the move, “we think it’s going to be confusing for consumers.” Correcting hearing loss is important, notes Dr. Debera Tucci, director of the National Institute on Deafness and Other Communication Disorders.
“Hearing loss is associated with dementia, increased risk of falling, reduced mobility, depression, social isolation, and anxiety,” she pointed out on her federal agency’s website. Correcting or treating hearing loss can produce life-changing results, says the Hearing Industries Association, according to NPR.
The FDA is giving consumers a new category to help treat hearing loss aside from PSAPs. While PSAP’s amplify a normal person’s hearing, they don’t help the many people who simply have trouble hearing whether in person or when watching TV.
With the change, PSAPs will still exist but they will have to meet the FDA’s standards in order to be labelled an OTC hearing aid.
“The truth is, in that category, there are some very good devices that will cross over to the over-the-counter market and meet the criteria,” said Kelley. “The difference is they can now market them to people with hearing loss.”
Experts warn that buying a hearing aid is not the same as buying a pair of glasses.
“When you put on a pair of glasses, typically they correct our vision,” explained Kelley. “When you put on a hearing aid, it doesn’t always correct your hearing.”
Hearing loss is a very individualized condition and may be caused by something as simple as a buildup of ear wax. It may be that consumers will use a trial-and-error approach to find a corrective hearing aid and in that case, some experts say they should be able to return the device if it doesn’t work.
But the FDA has declined to ensure an easy return or exchange for these products, citing existing consumer laws. But its final rule does require manufacturers to clearly state their return policies.
If you buy a hearing aid without a prescription, the Hearing Industries Association suggests you should hang on to your receipt and be aware of the device’s warranty and return details. It also cautions consumers against using devices that overamplify sound, as too much volume can further damage hearing.
© 2022 NewsmaxHealth. All rights reserved.