The Food and Drug Administration (FDA) is publishing a new rule that lets companies sell non-prescription, over-the-counter hearing aids. These devices, which can be marketed to any American with a little bit of hearing loss, will slowly become a fact of life moving forward.
The new rule took effect on Oct. 17, and companies then have 240 days to achieve compliance for existing devices.
As companies retool their product lineup, we’ll see ads for the devices filled with smiling people. We’ll walk by displays of them at our Wal-Mart. We’ll notice more 40-something-and-up Americans wearing what we think are earbuds but could actually be OTC hearing aids. And we’ll see well-known and reliable brands such as Bose, Jabra, Nuheara, and Sony pitching their OTC devices to the masses.
But behind that familiar creep of a product almost imperceptibly shifting from behind-the-counter to the shelves and wider use — as Advil did, as the acid reducers did — tens of millions of specific lives are forever if privately, changed by this decision.
Around 48 million people — including two out of every three aged 70 or older — currently face some hearing loss, whether mild, moderate or severe. And there will be countless millions of future Americans who will someday notice they can no longer follow the conversation across the Thanksgiving table.
Each of them — and likely you someday, too — face myriad new options in addressing hearing loss, and each option arrives with thorny new questions and complications attached.
“Huh?”: One man’s hearing aid journey
New options aren’t necessarily a bad thing, but they make a jangled situation even noisier. Hearing loss doesn’t have a one-size-fits-all solution, and finding the right one for your needs can be complicated. It was messy enough to get a working hearing aid when you needed a prescription to order a device.
That, I know. Even though I knew something was wrong with my hearing in my 40s — and was made painfully aware of that fact by my girlfriend who said I asked “Huh?” way too many times — I dragged my feet on getting hearing aids.
Once I got over the negative perception of hearing aids and bought some, things improved — but it’s been more than 15 years of fits and starts. I’ve dealt with nearly a dozen audiologists, had at least six hearing tests, and worn seven different hearing aids from five different companies.
I’ve run the gamut: $5,000 hearing aids, implanted devices that I “leased” for $300/month, in-ear models that cost less than $2,000 and app-based models that were “tuneable” for directionality in conversations that I purchased at Costco for $1,799.
Some of them worked well; most didn’t. The issues were always different – squealing, charging issues, bleeding because an audiologist was a little too forceful inserting one of the aids, problems connecting with my phone, good service, deplorable service; you name an issue, and a hearing aid user has probably dealt with it
That’s the problem with a world of prescription-only hearing aids that the FDA sought to address: Each option you choose along your journey requires an audiology test, visits to get fitted, training, and enough money that paying for a pair over a three-year period can cost as much or more than a car loan.
Beyond the often frustrating trial-and-error process, there’s also been a persistent stigma to deal with. Unlike glasses or orthopedic braces, hearing aids still trigger negative perceptions, according to studies. No wonder only about 20% of Americans with some degree of hearing loss got prescription hearing aids when those were the only devices available.
The promise of an uncustomized solution to hearing loss
The addition of OTC devices may help more people over some of these humps.
Some of the new offerings look like the earbuds that are so commonplace in today’s device-connected society, which lowers the stigma and removes the necessity of seeing an audiologist to get tested or fitted.
The change may also lower the cost barrier for those who need hearing aids. The U.S. government figures Americans could save up to $3,000 on hearing aids if they choose the OTC variety, lowering the ballpark price to somewhere around $1,600.
But the even bigger hump to a successful match between a hearing aid and its wearer has only gotten higher. Hearing loss is entirely individual, and each journey to a device can be as full of twists and turns as mine. What works for one person may not work for another, no matter the price or the bells and whistles.
“Getting many millions of new people to start that journey without the onerous guardrails of seeing a doctor democratizes the effort to help more people with hearing loss,” Tim Wright at Embrace Hearing, a prescription hearing aid retailer, said in an email to ConsumerAffairs.
“However, it won't be for everyone. As many hearing aid users know, getting a hearing aid to really work for them can be tricky and can require a lot of support and service. I think this could lead to a lot of disappointed OTC customers who think they are getting full service $3,000 hearing aids for $300.”
Given my own experience with the hearing-aid market, including trying devices that are similar to what can now be sold without a prescription, I want to help consumers avoid the many new potential pitfalls. So I analyzed the FDA rule and the process of arriving at it, spoke with many hearing professionals and experts, and zeroed in on the biggest questions.
What are the differences between prescription hearing aids and the ones now being sold over the counter?
The new rule allows specific models of air-induction hearing aids designed for mild to moderate hearing loss to be sold over the counter and without a prescription. Most new hearing aid users choose air-induction models; the alternative, a bone-induction hearing device, requires a surgical implant.
Many similar models are currently available with a prescription; under the new rules, customers will fit the model themselves rather than have it fit by an audiologist. The hearing aids must follow specific rules, including complying to a set maximum volume and limiting how far the device may extend into the user’s ear.
The rule is not intended to apply to devices intended for those with severe hearing loss; if you fall in this category, you’ll likely need to visit an audiologist to find a device that will work for your needs.
The FDA decided what performance was necessary for OTC hearing aids to be defined as “medical devices.” They did so by relying on open standards, including those set by the Consumer Technology Association (CTA), and through a rulemaking process that included input from scientific academies, hearing loss advocacy groups, consumer technology groups, the President’s Council of Advisors on Science and Technology, and technology device manufacturers.
Brian Markwalter, senior vice president of Research and Standards for the CTA, told me: “Someone buying OTC hearing aids can rest assured that the performance serves the needs of those with mild to moderate hearing loss in the judgment of the FDA and the professional community that contributed to the new rules."
What about hearing amplifiers or enhancers?
OTC hearing aids should not be confused with personal sound amplification products (PSAPs). These devices, which do not require a prescription, are designed to amplify sounds for those with unimpaired hearing and should not be used as a solution to hearing loss, according to the FDA.
John R. Luna, CEO at Nuheara, an OTC hearing aid manufacturer and chair of the CTA’s Over-The-Counter Hearing Aid Working Group, told me, “Some are excellent and provide sound enhancement as advertised, others do not.”
The ones that don’t, he added, could present dangers.
“The challenge [with PSAPs] is that it is up to the manufacturers to adhere or not to the [American National Standards Institute and CTA] standards and guidelines. When makers fall short, Luna said, “This can prove both misleading to the consumer and then possibly a safety hazard with regard to loud sounds and maximum gain or output.”
In other words, these devices may be capable of achieving volume that would cause additional damage to someone’s hearing — a worst-case scenario that could be made likely if someone is attempting to use the device for the unintended use of correcting hearing loss.
Who is a candidate for OTC hearing aids? Who isn’t?
The primary dividing line between people who need prescription hearing aids and those who can benefit from OTC hearing aids is simple. According to the Hearing Loss Association of America (HLAA), if you experience any of the following:
Trouble understanding conversations in groups, with background noise, or when you can’t see who is talking.
Trouble hearing on the telephone.
You need to turn up the volume of television, or radio loud enough for others to complain.
Your friends or family complain that you don’t understand speech, and ask them to repeat often.
In any of these situations, you may qualify as having mild to moderate hearing loss and be a good candidate for OTC models.
But – and it’s a big but – if you also have trouble hearing conversations in quiet environments or trouble hearing loud sounds like power tools or motor vehicles, you may qualify as having severe hearing loss.
Because the rule doesn’t require customers to visit an audiologist, it may be difficult for many people — especially first-time hearing aid wearers — to know how severe their hearing loss is and whether an OTC device will work for them.
What are the pitfalls of OTC hearing aids?
The biggest upside of OTC devices is that they increase accessibility to hearing devices for the 20% of the population with mild to moderate hearing loss. These devices may let many people improve their quality of life without spending as much money as they might for prescription versions.
However, there are many factors to consider and several red flags to watch for if you choose to purchase OTC hearing aids.
Slippery marketing and blurred lines
There are already companies and third-party sellers trying to wedge “hearing” and “aid” somewhere in the title or description of their non-hearing aid product to show up in searches or catch someone’s eye. When I searched for “hearing aids” on Amazon, there were many – mostly very inexpensive – devices that don’t meet the standards as defined in the FDA’s rule.
Even before the FDA lifted the curtain on OTC hearing aids, media product reviews were also blurring the line by using terms like “hearing aid-like adjustments.” A recent New York Times article suggests that the AirPods Pro offers these features.
Another review of the AirPods 2 in AppleInsider said that they “may act as hearing aids.” The truth is that while earbuds such as Apple’s can be “tuned” with an app (as other conventional earbuds and earphones can), and Apple’s AirPods do offer “accessibility features,” Apple does not make any actual hearing aids or PSAPs at present.
Markwalter told ConsumerAffairs that several OTC models will offer some of the same features that regular earbuds do, such as active noise canceling and Bluetooth call connectivity. Still, anyone considering purchasing an OTC hearing aid needs to know the distinction between devices intended to correct hearing loss and those intended to make listening easier for those without hearing impairments. This table from the FDA lays out the difference.
Consumers cautioned about misleading claims
Scamming someone by selling them a bogus hearing aid may sound like the lowest of lows, but the attorneys general in Arizona, Louisiana, South Carolina, and Georgia have already picked up the scent of deceptive sales tactics regarding OTC hearing aids.
Chief among the tricks: Using the FDA’s logo or claims of “FDA approval” to position their devices as up to the standards of the new law.
If consumers see any OTC hearing aid that declares it has the blessing of the FDA, they should run fast in the other direction. And I can tell you that, after umpteen email volleys with the FDA, the agency takes false claims seriously.
“Neither registration with FDA nor clearance of a product indicates that FDA endorses the product or that the product is in compliance with all applicable requirements for marketing the product,” a spokesperson for the FDA told ConsumerAffairs.
“A representation that creates an impression of FDA’s endorsement could be false or misleading and, if so, would constitute a prohibited act. Similarly, FDA’s logo [cannot be used on] device packaging, and the use of FDA’s logo may also create a false or misleading impression.”
That said, a company that registers its products with the FDA seems more likely to have honest intentions. Consumers can find out if a hearing aid is registered by searching the FDA’s registration and device database using the manufacturer’s name or “hearing aid” in the “Classification Device Name” field.
Anyone who decides to buy OTC while skipping the evaluation formerly required to obtain a hearing aid might get lucky playing doctor — or they could end up wasting time and money and potentially cause further hearing damage by miscalculating the severity of their hearing loss.
“Since a professional is not involved in the buying or fitting process, the customer will be required to self-diagnose and read the manual and figure out how to use and maintain the device,” cautioned Dr. Sreek Cherukuri, a board-certified ENT surgeon and founder of MDHearingAid. “A large segment of the population will not be able to be helped by the limited power (gain or volume) of these OTC devices.”
How large? The Johns Hopkins Cochlear Center for Hearing and Public Health estimates that 25.4 million people suffer from mild hearing loss and an additional 12.8 million have moderate or more severe hearing loss, but severity differs by age.
The first alternative to the crapshoot of self-diagnosis is a traditional audiogram, usually performed by an audiologist, in a soundproof booth, with headphones and a calibrated audiometer. Audiologists are different from a “hearing aid dispenser” who often lacks advanced degrees in audiology.
Audiologists’ screenings are free at local health fairs or clinics, and many insurance policies provide at least partial coverage for hearing tests.
The second alternative is a self-test called “Pure Tone Average” (PTA) – an abbreviated audiogram that some OTC manufacturers are suggesting. As an example, the Know Your Hearing Number project from the Johns Hopkins Cochlear Center for Hearing and Public Health uses a four-frequency PTA that the Center claims is an average of the four frequencies that most speech falls within.
The argument against PTAs is that the test uses uncalibrated tones, while an audiogram can measure other aspects of hearing, including speech clarity in quiet and in noise. Dr. Bria Collins, audiologist and associate director of Audiology Practice at the American Speech-Language-Hearing Association (ASHA), recommended seeing a licensed audiologist for a comprehensive audiogram.
“Performing a PTA alone would mean ONLY completing a portion of a full audiogram,” she said, though she added that “[PTA] tests have their place as a good starting point to identify hearing difficulties.”
Trial periods, refunds, returns, and losing the hearing aids
Buyer beware: The FDA is staying hands-off about post-sale requirements for manufacturers or sellers of OTC hearing aids. Consumers are at the mercy of those products’ trial periods, return policies, and repair/warranty policies.
Though a 30-day trial period seems to be typical for OTC hearing aids, HLAA’s stance is that it’s crucial to test out hearing aids for 30 to 45 days. That’s how long it takes for a person’s hearing to adjust and the device to adapt to various situations — or not. Some states mandate 45-day trial periods for prescription hearing aids. The bottom line: Purchasers of OTC aids would be wise to ask the seller for an extended trial.
HLAA also fought for a black-and-white money-back return guarantee in the FDA ruling. That didn’t happen, although the FDA did require manufacturers that offer a return policy to print it on the outside of the OTC hearing aid box. The agency urges consumers to make sure they check for the trial period before they purchase an OTC hearing aid.
Lastly, I can tell you from personal experience that if anything can be lost, hearing aids can. Some prescription hearing aid manufacturers and vendors allow you one free replacement per ear in those situations, but from all indications, OTC manufacturers are not offering that same mulligan.
So, if you bought a new pair of fancy OTC hearing aids for $1,000 and you lose them, then you’re probably out another $1,000 to replace them. At that point, you could’ve bought prescription hearing aids that came with loss replacement assurance.
What the new rule means for consumers
Statistics from the National Centers for Disease Control show the importance of increasing access to hearing aids: While around 28.8 million Americans could benefit from using hearing aids, fewer than 30% of those who are 70 or older have ever used them. Numbers drop significantly among younger people — only around 16% of Americans between the ages of 20 and 69 who could benefit from hearing aids have used them.
While access to OTC hearing aids could lower the cost barrier for many people and increase the number of hearing device choices on the market, it’s crucial to be aware of the potential drawbacks of skipping an evaluation administered by a medical professional. If you choose to purchase OTC hearing aids, take some time to see what’s available, research your options and read the fine print carefully to ensure you’re trying a device designed to correct hearing loss.
However, also be sure you understand what you’re not getting if you skip professional testing and fitting — especially if you’re a first-time hearing aid wearer. While the journey to find the right hearing aid for you may not be quick or simple, it’s a critical purchase that can greatly improve your quality of life.