It’s Now Possible to Purchase an FDA Approved Hearing Aid Over the Counter

Did you know the FDA has made changes to regulations regarding hearing aids, which now makes it possible to buy an FDA approved device over the counter (OTC)? While many of us have heard about the high cost of prescription hearing aids and that Medicare typically does not cover them, you may want to know whether the experts think an OTC purchase is a good idea. 

The Harvard Medical School went to Dr. James Naples, assistant professor of otolaryngology/head and neck surgery at Harvard-affiliated Beth Israel Deaconess Medical Center, to see if it is a viable option and to explain potential pros and cons. He explains that despite there being several types of hearing aids, they all amplify sound and use a combination of signaling processing and directional microphones to filter out background noise. However, he warns against confusing personal sound amplification products (PSAPs) with hearing aids as they only amplify sound. 

To determine your level of hearing loss, experts recommend you start by getting a hearing test from an audiologist like you would get an exam from an optometrist when buying eyeglasses. This is especially necessary for severe hearing loss, as OTC devices are not appropriate for all types of hearing loss. For mild to moderate hearing loss, it may be possible to get good results by purchasing an OTC device without a hearing exam and fitting by an audiologist. 

The next question routinely asked is if you will save money by purchasing an OTC hearing aid and the answer is most-likely yes as right now the average hearing aid runs anywhere between $2,000 to $4,000 per ear, and age-related hearing loss may be in one or both ears. OTC also helps reduce the price by eliminating the added expense of the hearing test along with the actual device being substantially lower. Doctors say the new regulations should increase competition and some estimates indicate prices could drop by as much as $1,600. 

Dr. Naples cautions that just as drugstore readers are a great option for many, some individuals have more complicated issues that require more precise solutions. Hearing aids are the same. The doctor states the safest bet is to get a hearing test to confirm an OTC device is right for you. 

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Source: health.harvard.edu/blog/should-you-get-an-over-the-counter-hearing-aid-202211162852