Tommy McDonell used to have her aide take all her phone calls. The 67-year-old artist and retired educator couldn't hear well enough to talk on the phone.
"The volume on my TV could probably kill the people next door," she says of her neighbors in the retirement facility where she lives in Southern Pines, NC. Having multiple sclerosis makes her hearing loss worse. "If you test my hearing when my MS is good, then my hearing isn't absolutely awful, but if you test me when my MS is having a bad day, my hearing gets worse and worse."
When she decided to get hearing aids, McDonell had two choices: the traditional route that requires a medical evaluation and buying through a licensed professional hearing aid dispenser, or the relatively cheaper, but still costly, direct-to-consumer option.
Those costs and hurdles are what led to the passage of a federal law in 2017 that designates a new FDA-regulated category for over-the-counter (OTC) hearing aids. But OTC hearing aids, which will be approved to treat mild to moderate hearing loss in adults ages 18 and older, aren't here just yet. The FDA has until August 2020 to publish proposed guidelines for OTC hearing aids.
After that, the public -- including audiologists, doctors, device makers, people with hearing loss, or anyone else with concerns -- will have time to weigh in before guidelines are finalized. Until then, and perhaps long after, the world of hearing devices might be difficult to navigate.
Why the New Label?
While an estimated 30 million Americans have hearing loss, only about one to three in 10 adults older than age 50 who might benefit from hearing aids use them. This matters because hearing loss can lead to social isolation, a decline in memory and thinking skills, and a higher risk for dementia. But hearing aids -- the primary treatment for hearing loss in older adults -- simply aren't an option for many Americans.
A pair of hearing aids runs $5,600 on average -- a cost that health insurance doesn't typically pick up. In order to get the devices, people with hearing loss must have a medical exam to rule out the slim chance of a serious medical problem that is causing the hearing loss, or they must sign a waiver opting out of the exam. You can only buy hearing aids through an audiologist or a licensed hearing aid dispenser, who is authorized to test hearing and sell hearing aids.
The cost of the hearing aids covers these professional services and may include up to 4 years of follow-up at no extra cost. But hearing professionals usually contract with just a few brands. That means that choosing a hearing professional limits a person's hearing aid choices, and changing audiologists as a result of location or personal preference could require a person to change hearing aids, too.
Due in part to these hurdles, once a person starts to lose their hearing, they wait an average of 7 years before they seek help.
"They've heard horror stories," says Stavros Basseas, PhD, CEO of Sound World Solutions, a hearing aid maker. "They know the hearing aids are very expensive. They know they have to go through an audiologist, and the aesthetics play a role, too. Hearing aids indicate old age."
McDonell's first audiologist fit her with a $5,800 pair of hearing aids, but McDonell wasn't crazy about them. "They didn't seem to fit that well, and since they are so expensive, I was constantly worried they'd fall off my ears," she says. Plus, she didn't feel the audiologist herself was a good fit either, so she tried someone else. But the second audiologist only worked with a type of hearing aid that would cost $10,000 for a pair. McDonell decided to hold off.
Skipping the Middleman
Because OTC hearing aids weren't available, McDonell's only other option was something that falls between OTC and traditional hearing aids. They are direct-to-consumer, self-fit hearing aids. The makers of these hearing aids, which meet all the same FDA regulations as their more expensive counterparts sold from an audiologist's office, save customers a trip to a hearing aid clinic by keeping hearing professionals on staff.
That way, the hearing aids are still dispensed through a licensed professional, but not an expensive middleman. This lowers costs for the device maker, and some of those savings are passed on to the end user.
"You can only buy online or over the phone via a specialist," says Christian Gormsen, CEO of Eargo, which makes hearing aids and sells them direct to consumers. "We have professional audiologists on staff who support clients all over the nation." Eargo hearing aids, he says, will never be sold at a drugstore or big-box store, where you might expect to find over-the-counter hearing aids in late 2020. (Sound World Solutions offers a direct-to-consumer hearing aid, too.)
Over the phone or online, buyers give specialists the same medical information that they would in an audiologist's office and say they understand that this is a medical device and not suited for people younger than 18.
Direct-to-consumer hearing aids come with factory presets for hearing loss, ranging from mild to severe. Audiologists who sell hearing aids in their clinics say factory presets aren't good enough. "A hearing aid that's fit by a professional is fit to a prescriptive target based on scientific research so that the volume is set to how someone hears at those exact frequencies," says Cynthia Hogan, PhD, an audiologist and director of the hearing program at the Mayo Clinic in Rochester, MN.
But, Gormsen of Eargo says, direct-to-consumer hearing aids do almost the same thing. They are pre-tuned to enhance hearing at the frequencies where, according to research, hearing loss most commonly happens at each level of severity. "It's true that we don't go in and individualize each one, but [professional fitting] is an ancient byproduct of a time 30 years ago when [hearing aids] really needed to be tuned," he says. "The presets are based on data and set by experienced audiologists, so it's how you would fit them in a clinic."
Some direct-to-consumer hearing aids, such as Sound World's, allow users to download an app and customize their device beyond out-of-the-box settings. "It's a fitting software just like an audiologist uses, but it's the end user that does it," says Basseas.
McDonell opted to buy Eargo's direct-to-consumer, self-fit hearing aids in lieu of the $10,000 option offered by her audiologist. At $1,450 to $2,550 for the three different models the online company offers, they were less than half the price of her first pair of hearing aids. She didn't feel she was losing out on any support by skirting the typically required face-to-face visit with an audiologist.
"They are great on the phone. Their videos provide the best instruction. The website is easy to navigate. And if needed, they'll talk to you online through Skype," McDonell says. "I personally don't feel any need to see anybody."
Most important, the hearing aids work. "I can hear the heat coming out of the register," she says. "I don't think people with normal hearing can do that."
Direct-to-consumer hearing aids ease some of the cost and access problems that led a team of researchers to recommend that the FDA create the new over-the-counter hearing aid category. They called for more affordable devices that would put control in the user's hands -- control over both the settings of the device itself and their choices.
With official FDA-approved OTC hearing aids still at least a year away, the FDA warned companies in a letter not to call their devices OTC hearing aids prematurely. Not all companies heeded the warning. So, buyers should beware that any device currently labeled as an OTC hearing aid has not been evaluated by the FDA.
"At the moment, there are no OTC hearing aids. If someone labels them as such, that violates the law. There are no official regulations that define OTC hearing aids yet," says Paul Kileny, PhD, an audiologist and director of Michigan Hearing at the University of Michigan. "Anything you buy that is labeled as an OTC hearing aid is not."
Then what are all those devices that look like hearing aids that you can already buy at Walmart, Best Buy, and other box stores and drugstores? No matter what the package calls them -- and you will see many different names -- any hearing devices that you can buy now over the counter, without a specialist, are personal sound amplification products, or PSAPs. They're not regulated by FDA, and the device makers are not supposed to market them for hearing loss. They might instead market them for birdwatching or spying -- activities in which even a person with normal hearing would want to turn up the volume on the sounds around them.
They range in price -- from less than $10 to nearly $1,000 -- as well as in quality, performance, and how well users can program them. Research shows that some perform nearly as well as traditional hearing aids, while others leave the user worse off than without any assistive device at all. Some can't filter out background noise, raising the volume equally on all the sounds around you, not just the ones you want to hear.
It's still anybody's guess as to where an OTC hearing aid will fit into this market. Will it be better than a PSAP but not as good as a traditional hearing aid? Will it simply be a PSAP -- with all its variability in price, quality, and performance -- under a new, more credible name? Or will it be just like a traditional hearing aid without the assessment and support of a hearing professional?
"For people to provide it at a more accessible price point, the easiest thing and the most expensive thing to cut out is the support," says Eargo's Gormsen, whose company will not offer an OTC option.
Sound World, whose PSAP, alongside those of Soundhawk and Etymotic BEAN, performed nearly as well as traditional hearing aids in studies, says its direct-to-consumer hearing aid, PSAP, and forthcoming OTC hearing aid will differ in name only. "Our device is sold as a hearing aid, and the same identical device is sold as a PSAP. We intend to have the same device qualify as an OTC hearing aid," says Basseas. "They're identical devices in any way you look at them. I made them that way to prove a point. There's no difference between the performance of these devices, only the way they are regulated."
The quality of other forthcoming OTC hearing aids remains to be seen.
And hearing care professionals have concerns. First, a medical problem that needs to be addressed could be causing a hearing loss. Both audiologists and licensed hearing aid dispensers are trained to recognize these issues and show clients how to get the right care.
"If someone has an ear deformity, drainage from the ear, sudden hearing loss, dizziness, hearing loss in only one ear -- which could be caused by a tumor on the hearing nerve -- these are things that need to be investigated," says Hogan. She echoes the concerns expressed by four hearing health care associations in a recent consensus paper they wrote in response to the coming OTC hearing aids.
But some hearing aid makers ready to get into the OTC market, including Basseas of Sound World, say audiologists who voice these concerns just want to protect their turf. "Based on this logic, you shouldn't take OTC aspirin for fear it could be a brain tumor causing your headache," he says. "Using this scare tactic, we stop people from using hearing aids as early as they can."
What's more, because so many people waive the recommended medical evaluation, the scientists who recommended the OTC category say there's "no evidence that the evaluation or waiver of that evaluation provides any clinically meaningful benefit."
Another concern among audiologists is that, given full control of their device, users will turn up the volume too high. "We don't know that the volume is both [enough] to really help them the way it should and also at a safe level so that the consumer is protected against further hearing loss," Hogan says.
This, too, is seen by some as turf defense and not a legitimate concern. "There is no documented evidence anywhere of this [type of hearing loss] ever happening," Basseas says. "They are pushing restrictions on maximum volume on OTC hearing aids to protect their market."
By the Numbers
15%: Percentage of U.S. adults ages 18 and older who have some level of hearing loss.
50%: Percentage of U.S. adults older than age 75 who have disabling hearing loss. For adults ages 65 to 74, it's 25%; for 55- to 64-year-olds, it's 8.5%.
2x: Men's chances of hearing loss between the ages of 20 and 69, compared with women's.
28.8 million: Estimated number of Americans who would benefit from hearing aids.
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