What to know about over-the-counter hearing aids
CLEVELAND, OHIO » It’s now possible to pick up a hearing aid at the same places where you buy paper towels and holiday decor.
But are these new overthe-counter hearing aids for you? Will they do the job? What are the cost savings? And, perhaps more importantly, will this new option clear the way for more Americans to more easily solve their hearing problems?
The option is the result of a recent federal rule change, clearing for hearing aid sales — without a prescription — from corner pharmacies to electronic stores.
Now adults over 18 with mild to moderate hearing impairment can purchase hearing aids directly from stores or online retailers without an exam or prescription. Prior to this, most hearing aids were available by prescription, or only via the internet.
The move is meant to lower the cost of hearings aids and expand access to health care, the FDA said in making the announcement. The FDA regulates overthe-counter hearing aids.
The drawback: consumers will be expected to figure out, on their own, how to program the devices, said Bridgid Whitford, director of Hearing Services at the Cleveland Hearing & Speech Center.
Just like prescription hearing aids, over-thecounter hearing aids make sounds louder so that some adults with difficulty hearing can communicate and take part in daily activities more easily, states the National Institute on Deafness and Other Communication Disorders.
The hearing and speech community supports making hearing aids cheaper and easier to purchase.
Making hearing aids more accessible will also help reduce stigma, Whitford said.
“Look at the air pods that the kids are wearing — it’s the cool thing to be walking around with things in your ears,” Whitford said.
How much cost?
A quick online check of over-the-counter hearing aid prices showed a range from $199 at Walmart to $1,950 at Best Buy.
Bose and Sony have launched products ranging from $999 to $1,200.
By comparison, prescription hearing aids can cost at least $4,000 without insurance for devices for a pair, according to a 2020 study published in the medical journal JAMA. Some can cost as much as $6,000 per ear.
At the Cleveland Hearing and Speech Center, prescription devices start at $1,000, Whitford said. The nonprofit organization serves those with special communication needs.
Medicare doesn’t cover hearing aids or exams for fitting hearing aids, according to a Centers for Medicare & Medicaid Services spokesperson. Medicare Advantage plans, which are offered by private companies, can offer coverage for hearing, vision, dental and wellness programs, the spokesperson said.
Ohio Medicaid has not made a final decision regarding coverage of overthe-counter hearing aids, a spokesperson said.
Will they help you?
Over-the-counter hearing aids are only for people with mild to moderate hearing loss. Here are signs that your hearing loss falls in that range.
Even though it’s not a requirement, there are several reasons to consult an audiologist before purchasing an over-the-counter hearing aid, hearing and speech experts say.
An audiologist can determine if hearing loss is caused by a significant medical problem, such as a tumor or middle ear infection, or simple wax buildup in the ear canal.
An exam can also determine if a person’s hearing loss falls in the mild to moderate range. People who struggle to hear conversations in quiet places, or loud sounds such as trucks or noisy appliances, may have more severe hearing loss.
“Generally, the younger population will overestimate a hearing loss and seniors will underestimate their hearing loss,” Trent said.
Get a medical exam if you have blood or pus coming from an ear, fluctuating hearing loss, constant pain in an ear, ringing or buzzing in both ears, vertigo or a plugged feeling inside an ear. These can be signs of a serious medical problem, health experts said.
Test via an app
Once you’ve bought an over-the-counter hearing aid, in most cases the instructions will ask you to download an app and follow directions that allow the consumer to tailor the device to the consumer’s hearing.
Lexi Hearing devices — available in more than 11,000 stores nationwide — come with instructions for downloading an app that self-guides consumers through a hearing test by giving responses during the fitting process, said Seline van der Wat, chief operating officer for Lexie Hearing.
“It does the hearing assessment itself and then you’re good to go,” van der Wat said. “All the help that you need for any finetuning, remote assistance counseling, or day-to-day operations of the hearing aid is right there in the app for you free of charge.”
Lexie Hearing is headquartered in South Africa, with operations in Massachusetts, Illinois and Minnesota.
How are they different?
Before the FDA rule change, companies could sell what they called hearing aids directly to consumers online in certain states, including Ohio, as a consumer electronics product, van der Wat said. Lexie has sold hearing aids via the internet in the past.
“What the FDA guidelines have done is create a nationwide rule to ensure that those devices have a category of their own and that those guardrails are defined,” van der Wat said.
Devices to enhance hearing — called personal sound amplification products — also were available direct to consumers without a prescription before the October rule change, according to the National Institute on Deafness and Other Communication Disorders.
Personal sound amplification products are for people who are not experiencing hearing loss. They boost the ability to hear certain sounds in specific situations, such as while bird watching. These devices are not regulated as medical devices by the FDA, the institute said.
Personal sound amplification products need to be adjusted by an audiologist, which raises the cost, Whitford said.
“In the end, it was more expensive than if you just went to the audiologist and and bought (a prescription hearing aid), so it was all very confusing for the consumer,” Whitford said.