The status quo for the majority of about 37.5 million Americans adults with hearing loss is to do nothing about it. But a new rule from the Food and Drug Administration (FDA) could be good business for audiologists, who have largely been vocal in embracing the establishment of the over-the-counter (OTC) hearing-devices category.
“On average, in this country, only one out of every five individuals that could benefit from hearing-loss treatment is actually seeking treatment,” said Lindsay Creed, associate director of audiology practices at the American Speech-Language-Hearing Association. “Our goal is to increase that number.”
Creed sees OTC hearing aids as “gateway” devices for many people with hearing loss. (Unlike gateway drugs, gateway devices are apparently a good thing.)
“It’s getting them to enter the market, get their toes wet, experience what hearing amplification could do for them, [and] how their quality of life might improve,” she said.
With that gateway device, a person might later seek out technology that’s higher quality or their hearing loss may progress to a level where they get prescription hearing aids, Creed added.
OTC, sure…but maybe you should see the audiologist first
Not everyone who has hearing loss will benefit from an OTC hearing aid.
The devices are designed for people with “perceived mild to moderate” hearing loss, according to the FDA, and they are not intended for severe hearing impairment. The degree of hearing loss is based on how loud a sound needs to be for a person to hear it.
But Kristin Davis, the president of the Academy of Doctors of Audiology, said her experience as an audiologist is that a patient’s perception of their deficit can be very different from their actual hearing loss.
“The most important thing is to first get that diagnostic hearing evaluation, so we’re working with real data,” Davis said. She noted that an audiologist can provide this, along with assessing a patient’s needs, so that a person can ultimately make an educated hearing-aid purchase—if they need to purchase a device at all.
The American Speech-Language-Hearing Association also “emphasized the need for safety — and strongly recommended that consumers obtain a hearing assessment before purchasing an OTC hearing aid” in its statement supporting the FDA’s rule.
However, Barbara Kelley, executive director of the Hearing Loss Association of America, stressed that the whole idea behind creating the OTC category was to remove the step of having to see someone before getting a hearing aid.
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“That’s not to say a hearing healthcare professional won’t carry OTC [hearing aids] or won’t help somebody for a fee with an OTC,” Kelley said. “That’s what I think is going to be exciting, is to see how the market plays out.”
OTC hearing aids aren’t exactly non-prescription reading glasses
The price tag on OTC hearing aids can vary anywhere from $99 to $3,400, though the average is around $1,600. Kelley estimated a person could probably buy an OTC device for $300 to $500.
By comparison, a bipartisan Congressional report puts the average cost of prescription hearing aids at about $4,600, and that’s not covered by Medicare or most insurance plans.
Still, the money paid for OTC hearing aids is an investment, and there’s no guaranteed ROI for the consumer. That’s another reason Davis hopes people will seek out an audiologist beforehand or after they buy an OTC hearing aid to make sure they’re getting what they need.
“It takes time for people to adjust to a hearing aid,” Kelley added. “It’s not like a pair of glasses.”
More ways to pay
To compete for business in the brave new OTC world, audiologists are also having to rethink how they charge for prescription hearing aids and related services. Traditionally, the cost of a device and services like the initial assessment, hearing-aid fitting, regular checkups, and device cleaning have been bundled, but that’s changing, said Davis, who owns a private practice with three locations in South Carolina.
The practice considered unbundling all charges, but there are still patients who prefer the bundled model, she said.
“So we offer both,” Davis said.
That means a patient could purchase a device (prescription or OTC, she’ll be offering the latter, too, in her offices), separately or together with audiologic services.
In keeping with the times to offer people more affordable ways to access hearing healthcare, Davis is hopeful that demand for audiologists will only increase. Creed expects the same.
“We need to continue to grow our profession, we need to continue to educate the public on the benefits of seeking hearing loss treatment, and hopefully OTCs [are] just one step in that direction,” Creed said. “One of the best things about this whole movement is that it’s gotten so many more people to talk about hearing loss.”