An estimated 37.5 million adults in the United States deal with some degree of hearing loss. But studies by the National Institutes of Health (NIH) show only one-fifth of them seek the help they need to correct the problem. Now, under a new rule, the Food and Drug Administration (FDA) is poised to allow the over-the-counter (OTC) sale of hearing aids. “The most important thing about this new rule is that it increases access and awareness about these devices,” says Kate Johnson, AUD, CCC-A, an audiologist in the Department of Otolaryngology – Head & Neck Surgery at University of Utah Health.
Johnson knows from experience that the high cost of hearing aids has discouraged many of those who need them from buying the devices. “Historically, insurance does not cover hearing aids, which are very expensive, and therefore patients are paying for them out of pocket,” she says. “This OTC rule has made it so that they will hopefully be significantly cheaper.”
Right now, Johnson estimates that only 30 percent of people aged 70 and older who could use hearing aids are wearing them. And only about 16 percent under the age of 70 who need their hearing corrected are wearing the devices. These numbers are particularly alarming to Johnson for an aging population. “Untreated hearing loss has a significantly higher correlation to increased dementia, cognitive decline, and depression,” she says.
Why are hearing aids being offered over the counter?
A new FDA rule, which goes into effect in mid-October 2022, will allow people with mild to moderate hearing loss to buy hearing aids online and in retail stores without the requirement to have a doctor’s exam and a prescription for the device. This part of the rule has some medical professionals, including Johnson, concerned. They urge caution.
Hearing loss is incredibly unique to each person, which is why audiologists pushed for the FDA to guarantee the OTC devices would never be harmful to a person’s hearing. “The way the FDA has worked with these OTC manufacturers is that they have made them safe,” Johnson says. “These devices will never hurt someone, and you can’t worsen your hearing with them. However, you could be what we describe as under- or over-amplified, which means that you don’t know exactly how that device is supposed to be set.”
Most importantly, Johnson is encouraged by the positive impact the OTC sale of hearing aids could have on Americans’ health and overall quality of life.
Why are there concerns with OTC hearing aids?
“Everyone’s perception of their hearing loss is a little bit different,” Johnson says. “There are people who have a severe hearing loss, but if you ask them about it they will say, ‘Oh, my hearing loss is not that bad.’ Or vice versa, some say, ‘I have a horrible hearing loss,’ but then as we do the testing, we find it is just a mild hearing loss.”
Barbara Kelly, the executive director of the Hearing Loss Association of America, echoes the sentiments of Johnson and other audiologists. She warns that anyone who thinks getting an OTC hearing aid will help them in the same way a cheap pair of reading glasses can boost their sight is oversimplifying the hearing loss problem.
The biggest concern is that people will start self-treating a medical issue that often requires a professional diagnosis to correct. That’s why Johnson suggests that patients undergo a diagnostic hearing test with an audiologist to determine if they would be a good candidate for an OTC hearing aid. She adds that some causes of hearing loss are truly medical problems, and an OTC hearing aid will not help or correct them. Those include ear wax build up, benign auditory nerve tumors, and ear infections. Of course, if you experience a sudden hearing loss, it should be considered a medical emergency.
Johnson emphasizes that doctors at the University of Utah do not work on any type of commission. They will never push someone to purchase a device they do not need or one that will not improve their overall hearing. In fact, Johnson adds, “When these OTC devices become available, we are going to do a little bit of research and investigation of our own. Then, we will decide which hearing aids to recommend and which hearing aids to keep in stock and recommend for people.”
How to get help
Professionals like Johnson will always be available to patients who may need help programming OTC devices, along with those who prefer to have an exam before purchasing any type of hearing aid.
“If you have hearing loss, it is recommended you get your hearing tested once a year or sooner if any changes are noted,” Johnson says. “And we say that regardless of whether you are getting a hearing aid or not. We believe it is important to do those annual checks. Hearing loss can often happen very slowly and subtly over time, and you don’t even notice that it is changing.”