It’s been less than two years since the U.S. Food and Drug Administration officially cleared the way for over-the-counter hearing aids. Over-the-counter hearing aids are a new type of medical device specifically designed for people with mild to moderate hearing loss. At prices that are sometimes half the cost of traditional prescription hearing aids and without the need to visit an audiologist’s office, these new products are expanding Americans’ access to hearing care.
Approximately 35 million Americans over 12 years of age have mild or moderate hearing loss. However, according to the Hearing Loss Association of America (HLAA), only one in five people can benefit from hearing aids. Given these statistics and the availability of over-the-counter devices, we should be experiencing a new golden age of improved hearing health.
But even though there are now more than 40 companies selling over-the-counter devices, we haven’t seen a significant increase in adoption.
According to statistics collected in January 2024, the U.S. over-the-counter hearing aid market is worth just $123 million. For comparison, if we take the average price of $1,000, that means only 123,000 units were sold. Or to put it another way, only the 0.35% of Americans who could benefit from these devices bought them. Even more troubling, some experts fear that those who choose over-the-counter hearing aids may be at risk of worsening their hearing loss.
“We’ve heard from a lot of people that they don’t understand over-the-counter hearing aids,” HLAA Executive Director Barbara Kelly told Digital Trends. “HLAA recently conducted a survey and we found that 63% of people said they didn’t have enough information about over-the-counter hearing aids to make a purchase.”
The confusion is understandable. The FDA has a clear and concise explanation of what over-the-counter hearing aids are (and what they are not), what they are used for, and how they work—they are intended exclusively for people with mild to moderate hearing loss.
Unfortunately, you’re unlikely to come across one unless you search for “over-the-counter hearing aids.” Plus, by the time you realize you may need an over-the-counter product, it may already be too late.
“Most people taking over-the-counter tests don’t know they have hearing loss,” said Dr. Lee Smith, an audiologist and owner of Florida Audiology Associates. Suitable for over-the-counter hearing aids. “If patients began hearing testing at the recommended age of 65, we would see a wider range of over-the-counter candidates. However, by the time most patients begin hearing testing or suspect hearing loss, many patients go beyond OTC recommendations.”
If your hearing problems have progressed from mild to moderate, which over-the-counter devices are designed to address, you may be disappointed when you finally try them. This is reflected in a 2023 study by the American Speech-Language-Hearing Association (ASHA), which cited effectiveness in addressing hearing problems as the number one reason for dissatisfaction with over-the-counter hearing aids, followed by concerns about poor sound quality.
This may help explain the relatively high return rate of OTC devices to date. Eargo, one of the few hearing aid companies that reports quarterly, reported revenue of 34% in the second quarter of 2023, which is actually up from 24% in 2021.
The yield percentage for the entire OTC category is likely to be higher. “Interestingly, we found that about 50 percent of people who buy over-the-counter devices return them,” Dr. Ruth Reisman, an audiologist, associate professor of audiology and owner of Urban Hearing in Brooklyn, New York, tells us.
Perhaps the biggest hurdle facing the OTC category has emerged on its own. Affordability is seen as one of the biggest barriers to people getting the hearing care they need at the right time. Since over-the-counter hearing aids can now be sold in stores or online without a prescription or professional consultation, their supply has increased dramatically.
Many people compare the situation to being able to buy reading glasses instead of going to the optometrist for a set of prescription frames. Unfortunately, hearing loss can be more complex than simply needing to turn up the volume.
“Falling exactly within the FDA’s [mild to moderate loss] range is rare,” Raisman said. “They may have sloping hearing loss. Their hearing loss may be flat. Their loss may increase and increase. It varies from person to person.”
There is no way to know without a professional hearing test. Some over-the-counter hearing aids have app-based testing capabilities designed to customize the device to meet your specific hearing needs. Notable examples are the Jabra Enhanced Series and Sony CRE-C10/E10. But even they have limitations.
Apps typically offer settings for large frequency ranges such as bass, treble, and midrange. But they lack the precise frequency tuning needed for complex hearing loss, Reichman says.
Some of Raisman’s patients discovered this after purchasing over-the-counter medications. “They said they spent $1,000 on this device and it barely works,” she said.
Smith found the same thing in practice in Florida. “Since the beginning of 2024, our practice has only had two patients with over-the-counter hearing aids, neither of whom were viable candidates for the device or required a hearing aid prescription.”
Needless to say, no one imagines that their hearing loss will get worse after purchasing a hearing aid. However, this is a risk. This happens in two main ways: actively and passively.
If the level of amplification provided by hearing aids is too high, they can cause your hearing loss to become permanently worse over time. This risk is greatest if you purchase a product that is labeled as a hearing aid but is actually a personal sound amplification product (PSAP).
PSAPs are often visually indistinguishable from over-the-counter hearing aids. They sell for much less than over-the-counter hearing aids—sometimes well under $100—making them very attractive. But unlike over-the-counter products, they are completely unregulated and there is nothing stopping them from providing unsafe levels of enhancement.
The FDA has strict rules regarding which product must qualify as an over-the-counter hearing aid. But enforcement has proven lax. Back in November 2022, Amazon was forced to clean up its product listings—many of the so-called over-the-counter hearing aids on its site were actually PSAPs.
Amazon has vowed to address the issue, telling Consumer Affairs: “We have taken proactive steps to prevent prohibited items so customers can shop with confidence.”
However, a quick search for “over-the-counter hearing aids” on Amazon still turns up dozens of devices that use the word OTC along with the word “hearing aid” in their names, but these devices are just PSAPs.
Due to FDA regulations, you might think that real over-the-counter hearing aids would not have problems with excessive amplification. But Raisman said it wasn’t always this way. She regularly tests prescription and over-the-counter hearing aids to see how they perform out of the box, and finds that the devices exceed what she calls “uncomfortable volume levels or the upper end of the ear’s tolerance.”
Even if your over-the-counter hearing aids meet FDA safety guidelines for amplification, they may cause you passive harm. Hearing loss can be caused by many factors. Some hearing losses, such as noise-induced hearing loss, are linear. The louder the sound and the longer you are exposed to it, the worse your hearing becomes. Although the damage caused is irreversible, it does not get worse on its own – it only happens with prolonged exposure to loud noises.
However, some medical conditions can also cause hearing loss. If left unchecked, these problems can progress gradually and eventually lead to permanent and sometimes permanent hearing loss. In the early stages of these conditions, hearing loss may be mild, and over-the-counter medications can provide significant relief. But if this prevents you from getting evaluated by a doctor or audiologist, you may not receive adequate care.
“Home testing does not identify the problem location (outer, middle or inner ear), does not use calibrated equipment or is performed to soundproofing standards, and does not test the patient’s speech or background noise characteristics,” Smith said. “In my professional opinion, there is no upside to home testing.”
Manufacturers of over-the-counter hearing aids appear to be seeking a balance between convenience and quality health care. Sony, the only manufacturer to respond to our questions, has repeatedly said that its customers can benefit from purchasing hearing aids (mostly from online retailers) without a prescription.
However, when we asked specifically about the company’s relationship with audiologists, Takuya Sakamoto, Sony’s director of business development for over-the-counter hearing aids, told us that “they continue to counsel each patient on the right choice and make recommendations on what to buy.” “It remains an important part of a patient’s overall hearing care journey. “
Although the over-the-counter hearing aid market appears to be struggling, there are reasons for optimism.
“It’s still day one of this brand new market,” said Kelly of the Hearing Loss Association of America. Both HLAA and ASHA agree that more needs to be done to improve education.
To that end, HLAA is working with OTC drug manufacturers and healthcare providers to create more resources to help people understand what these devices are used for.
He created a tip sheet and frequently hosts “OTC-101 Ask the Experts” webinars to encourage people to ask questions so they can make informed decisions about their hearing health. All resources can be found at hearingloss.org/OTC, and the next webinars are scheduled for May 22 and June 5, 2024.
Everyone we spoke with agreed that while misconceptions about hearing aids persist, awareness of hearing health issues has increased significantly due to the advertising surrounding over-the-counter products.
“This is great news for the hearing care community as a whole,” Kelly said. “Many of us don’t pay attention to our hearing, even though it is an important part of overall health and well-being.”
Reisman also expressed cautious optimism: “The hearing in general is getting a lot of media attention, which is raising awareness. precautions – get a physical and a hearing test – that’s great.”
More awareness may also help explain one of the main reasons people don’t seek help for hearing loss. According to a 2023 ASHA survey, “More than half of U.S. adults age 40 and older (56%) say they are hard of hearing, but only 8% have received treatment. The main reason for not seeking help is the belief that hearing loss is due to difficulties. is not “severe” enough to require treatment.”
For those who believe their hearing loss cannot be cured, the best advice remains a professional hearing evaluation. Whether this results in purchasing an over-the-counter hearing aid or a prescription device, you’ll know what you’re getting into and can monitor your hearing health progress over time.
It can take a long time for our brains to adjust to hearing aids, so make sure you have adequate recovery time—FDA regulations don’t require this, so you’ll have to do your homework. Both Sony and Eargo offer a 45-day trial period, which seems to have become the norm in the industry. But longer periods are available: Jabra’s free trial is 100 days.
Finally, you may want to consider each company’s support commitments. Since most over-the-counter products cannot be adjusted or fine-tuned by an audiologist, you can only make changes in the companion app (very few adjustments are available without the app). Some companies can connect you through an app with a remote hearing specialist who can further customize your hearing aids based on your data.
Bose has been working on hearing-improving technology for years, but today the company is finally launching SoundControl hearing aids, an $850 set of FDA-approved hearing aids that customers can fit at home without having to buy hearing aids. In-person consultation with an audiologist.
Products will initially be sold directly from Bose starting May 18 in five states: Massachusetts, Montana, North Carolina, South Carolina and Texas, followed by nationwide distribution.
Buyers looking for truly wireless headphones, especially those already deep into the Apple ecosystem, should look to the Apple AirPods Pro 2 with USB-C and MagSafe. Best Buy’s Prime Day price is currently back with a $70 discount, down from $250 to $180, but there isn’t much time left before this deal expires. If you want to take advantage of a great deal, it’s best to buy as soon as possible because after the sale ends, we’re not sure when you’ll get another chance.
Why you should buy the Apple AirPods Pro 2 with USB-C and MagSafe It’s no surprise that the Apple AirPods Pro 2 with USB-C and MagSafe (a mid-cycle update to the Apple AirPods Pro 2) is our recommendation for Apple fans. Our review of the best truly wireless headphones. You’ll get greater compatibility because the charging case moves from the Apple Lightning port to the USB-C port, and the included USB-C to USB-C cable is braided rather than rubberized for added durability. The updated AirPods Pro 2 also add IP54 dust resistance, and iOS 17 adds personalized volume that adjusts to ambient noise levels, Conversation Sense to lower the volume when you start talking, and Adaptive Noise Control that decreases the volume when you start speaking. Block out the noise by letting in the sounds you want to hear.
Marshall is one of the most trusted names in the audio industry, so if you’re thinking about purchasing a new Bluetooth speaker, we highly recommend getting the Marshall Acton II. It’s currently on sale at Best Buy for $100 off, bringing its price down to $150 from its list price of $250. However, there isn’t much time left for this deal, and even then, you shouldn’t wait until the last minute to finalize your purchase of this Bluetooth speaker as stock may be sold out by then.
Why you should buy the Marshall Acton II Bluetooth Speaker. Made by the main brand on our list of the best Bluetooth speakers, the Marshall Acton II is relatively small, measuring about 10 x 6 x 6 inches and weighing only about 6 pounds. . However, it promises high-quality sound thanks to its two-way speaker system, as well as a frequency response of 50Hz to 20kHz for accurate audio reproduction. This Bluetooth speaker also features a bass reflex cabinet and rear firing port for optimal bass performance.
Improve your lifestyle. Digital Trends helps readers stay on top of the fast-changing world of technology with all the latest news, compelling product reviews, insightful editorials, and unique sneak peeks.
Post time: Aug-01-2024