New OTC hearing aids will call out existing ear care solutions
The Trump Administration in August signed legislation mandating that devices addressing mild-to-moderate hearing loss be made available over the counter, which will create a new in-store destination center for an entire class of products once only available by prescription.
That new destination center also will call out the OTC ear care set, specifically earwax removal solutions, as a natural adjacency. “When you wear a hearing aid [your ear] tends to create more wax,” said Yann Pigeaire, director marketing at Similasan USA. “That’s going to be an area that will continuously grow. The dynamics are favorable to that.” Similasan recently augmented its ear care appeal with its Ear Wax Removal Kit, which includes a one-time use bulb to assist with removal.
“[Ear care] is going to be an area that will continuously grow. The dynamics are favorable to that.”
In addition to Similasan realizing an ear care opportunity, hearing aid manufacturer Starkey Hearing Technologies launched its Ear Health product line, which includes solutions for earwax, earaches, itchy ears, dry ears and protecting ears from damaging sounds. This move creates a brand resonance for Starkey in the ear care aisle, which may see more hearing aid manufacturers enter the space as hearing aids indicated for mild-to-moderate hearing loss migrate into OTC sets.
“[Starkey] Ear Health products were designed to give consumers an easy way to take care of their ears,” said Chris McCormick, chief marketing officer at Starkey. “It is our hope that because of these products, we will see more people take an earlier and more proactive approach to ear and hearing health, which will in turn lead to overall improved health and wellness.”
It wouldn’t make much sense to require employees at Best Buy to understand the inner workings of vacuum tubes. Or to mandate that Apple Store staffers be fluent in the ancient language of telephone switchboards. Yet Florida says “hearing aid specialists” must pass multiple tests and be certified to conduct a full audiological exam, essentially quizzing them on skills and tech dating back to the 1950s.
Those requirements are completely unnecessary for the proper fitting and testing of modern hearing aids, which are radically different than the obtrusive, potentially painful devices of your grandparents’ era. Today’s aids are sleek mini-speakers that nestle inside the ear canal. They can be configured over a Bluetooth connection with a computer or smartphone.
And making people take antiquated classes limits access to hearing assistance providers and drives up the costs of hearing care, according to one practitioner.
Dan Taylor has been a hearing aid specialist in Florida for more than 30 years. Last year, he declined to renew his license in protest of the onerous licensing rules. In response, the Sunshine State slapped him with a cease-and-desist letter, threatening to force him into an early retirement. In a federal lawsuit filed in April, Taylor challenged the legitimacy of Florida’s hearing aid licensing scheme.
Taylor’s lawsuit notes that he’s not challenging the idea that hearing aids are medical devices. He continues to comply with many layers of federal rules.
But Florida’s laws aren’t merely out of step with the times. They’re also at odds with those from the Food and Drug Administration (FDA). In 2016, that agency abolished a requirement that hearing aid specialists give comprehensive exams before fitting patients with devices. The FDA now says only that patients must have a prescription from a medical doctor before seeking out a specialist for a fitting.
“The federal government has studied and determined that the type of hearing aids Dan sells pose no meaningful health or safety risks,” says Larry Salzman, an attorney with the Pacific Legal Foundation, which is representing Taylor.
The FDA is now actively urging states to kill rules like the one in Florida, which it says are “a barrier to access with no substantial enhancement of patient safety.”
Our brains have a remarkable knack for picking out individual voices in a noisy environment, like a crowded coffee shop or a busy city street. This is something that even the most advanced hearing aids struggle to do. But now Columbia engineers are announcing an experimental technology that mimics the brain’s natural aptitude for detecting and amplifying any one voice from many. Powered by artificial intelligence, this brain-controlled hearing aid acts as an automatic filter, monitoring wearers’ brain waves and boosting the voice they want to focus on.
Though still in early stages of development, the technology is a significant step toward better hearing aids that would enable wearers to converse with the people around them seamlessly and efficiently. This achievement is described today in Science Advances.
“The brain area that processes sound is extraordinarily sensitive and powerful; it can amplify one voice over others, seemingly effortlessly, while today’s hearings aids still pale in comparison,” said Nima Mesgarani, Ph.D., a principal investigator at Columbia’s Mortimer B. Zuckerman Mind Brain Behavior Institute and the paper’s senior author. “By creating a device that harnesses the power of the brain itself, we hope our work will lead to technological improvements that enable the hundreds of millions of hearing-impaired people worldwide to communicate just as easily as their friends and family do.”
Modern hearing aids are excellent at amplifying speech while suppressing certain types of background noise, such as traffic. But they struggle to boost the volume of an individual voice over others. Scientists calls this the cocktail party problem, named after the cacophony of voices that blend together during loud parties.
“In crowded places, like parties, hearing aids tend to amplify all speakers at once,” said Dr. Mesgarani, who is also an associate professor of electrical engineering at Columbia Engineering. “This severely hinders a wearer’s ability to converse effectively, essentially isolating them from the people around them.”
The Columbia team’s brain-controlled hearing aid is different. Instead of relying solely on external sound-amplifiers, like microphones, it also monitors the listener’s own brain waves.
“Previously, we had discovered that when two people talk to each other, the brain waves of the speaker begin to resemble the brain waves of the listener,” said Dr. Mesgarani.
Using this knowledge the team combined powerful speech-separation algorithms with neural networks, complex mathematical models that imitate the brain’s natural computational abilities. They created a system that first separates out the voices of individual speakers from a group, and then compares the voices of each speaker to the brain waves of the person listening. The speaker whose voice pattern most closely matches the listener’s brain waves ¬is then amplified over the rest.
The researchers published an earlier version of this system in 2017 that, while promising, had a key limitation: It had to be pretrained to recognize specific speakers.
“If you’re in a restaurant with your family, that device would recognize and decode those voices for you,” explained Dr. Mesgarani. “But as soon as a new person, such as the waiter, arrived, the system would fail.”
Today’s advance largely solves that issue. With funding from Columbia Technology Ventures to improve their original algorithm, Dr. Mesgarani and first authors Cong Han and James O’Sullivan, Ph.D., again harnessed the power of deep neural networks to build a more sophisticated model that could be generalized to any potential speaker that the listener encountered.
“Our end result was a speech-separation algorithm that performed similarly to previous versions but with an important improvement,” said Dr. Mesgarani. “It could recognize and decode a voice—any voice—right off the bat.”
To test the algorithm’s effectiveness, the researchers teamed up with Ashesh Dinesh Mehta, MD, Ph.D., a neurosurgeon at the Northwell Health Institute for Neurology and Neurosurgery and coauthor of today’s paper. Dr. Mehta treats epilepsy patients, some of whom must undergo regular surgeries.
“These patients volunteered to listen to different speakers while we monitored their brain waves directly via electrodes implanted in the patients’ brains,” said Dr. Mesgarani. “We then applied the newly developed algorithm to that data.”
The team’s algorithm tracked the patients’ attention as they listened to different speakers that they had not previously heard. When a patient focused on one speaker, the system automatically amplified that voice. When their attention shifted to a different speaker, the volume levels changed to reflect that shift.
Encouraged by their results, the researchers are now investigating how to transform this prototype into a noninvasive device that can be placed externally on the scalp or around the ear. They also hope to further improve and refine the algorithm so that it can function in a broader range of environments.
“So far, we’ve only tested it in an indoor environment,” said Dr. Mesgarani. “But we want to ensure that it can work just as well on a busy city street or a noisy restaurant, so that wherever wearers go, they can fully experience the world and people around them.”
C. Han el al., “Speaker-independent auditory attention decoding without access to clean speech sources,” Science Advances (2019). DOI: 10.1126/sciadv.aav6134 , https://advances.sciencemag.org/content/5/5/eaav6134
Experimental brain-controlled hearing aid decodes, identifies who you want to hear (2019, May 15)
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ATLANTA – Hearing loss is the most prevalent birth defect for children. And believe it or not, most insurance carriers in Georgia didn’t cover the cost of a hearing device. That is until parents pushed back. But January marks a big change.
In full disclosure, my daughter wears a hearing aid and I tell you I nearly fell off my chair when I was told by my insurance company, ‘No, we don’t cover hearing aids for children.’ Because – get this is – it was considered cosmetic. When children can’t hear they fall behind in so many ways. And boy are they expensive.
Hearing aids can cost up to $6,000. And you can imagine how often kids need new ones. They lose them. They break them. Yes, the dog eats them. And they simply grow out of them. If all goes well they’ll last 3 to 5 years.
Well, two moms with hearing impaired children about six years ago pushed back, and they got the job done. Starting this January, private insurance companies now cover the cost of hearing aids.
The “Hearing Aid Coverage for Children Act” covers young people 18 and under. You can get coverage for a replacement for one hearing aid per hearing-impaired ear every 48 months – or the length of the warranty. And, it’s not to exceed $3,000. It also covers evaluation, fittings, and maintenance that would include repairs.
HEARING AID COVER FOR CHILDREN ACT – 48 months or length of warranty – Up to $3,000 per ear – evaluations, maintenance
This is really a big deal. for every child with hearing issues who doesn’t get a hearing aid, it costs the state up to $420,000 through age 18 for special education costs. Hearing aids for children over that same period cost about $40,000. Big difference.
Alongside its artificial intelligence coach, Apple Health and Google Fit integrations, activity-tracking sensors and language translation functionalities, the Livio AI connected hearing aid has a new slew of feature to brag about — chief among which is automatic fall detection and alerts.
As of an update announced yesterday, Minnesota-based Starkey Hearing Technologies’ device can now identify when its user has suffered a fall and send secure a warning notification to as many as three preselected emergency contacts. After confirming their identity, the system’s location tracking allows the emergency contact to see on a map where the wearer has fallen. Additionally, users can manually trigger an emergency alert by tapping a button on the device itself, with an option to cancel the alert if needed using the paired app.
“We’ve built in a number of ways that people can use the technology right on their ears to notify, either automatically in the case of a fall or manually in the case of if they need help, one of those contacts. And they in turn will receive that alert and know right where you were when you initiated that alert,” Chief Innovation Officer Dr. Dave Fabry, said in a video provided to MobiHealthNews by Starkey Hearing Technologies. “We think that it’s not a stretch to [say this technology] will save lives.”
Beyond the fall detection, the system’s updates also include a Google-powered virtual assistant. According to Starkey, the app-based Thrive Virtual Assistant can answer questions from the wearer — for instance, “what’s today’s weather forecast?” — as well as guide the user though troubleshooting with the device itself. Additionally, the hearing aid is now rechargeable and supports voice-to-text transcription through the paired app.
Hearing loss is prevalent among older demographics, and roughly 3 million seniors are treated in emergency departments for fall injuries each year according to a 2016 estimate from the CDC. Livio AI’s update addresses both issues within a single device, with a collection of quality-of-life features to boot.
Decline in hearing and vision can add to overall mental decline.
Hearing aids can slow cognitive decline by 75%.
Similarly, cataract surgery can help cognitive decline by 50%.
Cognitive decline is something that happens to all of us as we age, to varying degrees. But new research is showing that taking care of your eyes and ears as you age could help keep your brain sharp for longer than previously thought.
The joint study from the University of Michigan in the U.S. and the University of Manchester in the U.K. found that by simply by wearing hearing aids, the rate of cognitive decline was reduced by 75%. The study was conducted on approximately 2,000 older Americans (as part of a wider study, the University of Michigan’s Health & Retirement Study) whose hearing was measured every two years for 18 years. The participants’ cognition was measured using a range of tests, for example a word recall task of 10 words. One measure was taken directly after the words were read aloud, and another measure was taken after the participants were made to perform other small tasks (in order to distract them from the word-memorization). In people with hearing aids, the rate of decline was 75% slower than those without hearing aids.
Photo: Keith Bedford/The Boston Globe via Getty Images
The study shows hearing loss and cognitive decline are linked, and maintaining healthy hearing can keep you sharper for longer.
Likewise, cataract surgery can slow cognitive decline by 50%, according to a separate study performed by the same team as the hearing study. The study consisted of about 5,000 people in their sixties, with 2,068 of them receiving cataract surgery and 3,636 of them having no cataracts. In those who had cataract surgery, cognitive decline slowed down over the course of 13 years of follow-up testing. Their mental function became more equal to the control group, who had no cataracts. While decline is still expected as people age, this is promising in the fight against dementia.
At the conclusion of the study, the researchers highlighted that further research is needed to find out exactly what the link is between cataract surgery and potentially decreasing the risk of dementia:
A positive impact of cataract surgery on cognitive decline would support the presence of a direct or indirect causal impact of visual impairment on cognitive ageing. Further research may test the potential for treatment and/or prevention of vision impairment to lower the risk of dementia.
Photo: Lin Yunlong/Zhejiang Daily Press Group/VCG
A 3D display screen of three-dimensional display system for cataract extraction surgery is seen at the Second Affiliated Hospital of Zhejiang University School of Medicine on July 17, 2018 in Hangzhou, Zhejiang Province of China.
Take care of your eyes and ears as you age
The reason cognitive decline is affected by vision and hearing may be due to the nerve stimulation provided to the brain by those sensory inputs, which disappear as you age. These studies hint that stimulation can be returned through interventions like hearing aids and eye surgery. There may also be something psychological at play, as audiologist Dina Rollins notes to NPR:
“Social isolation is a huge part of hearing loss, and people will notice their loved ones withdrawing from conversation, or not going to family or social functions like they used to.”
That social isolation can kick-start a hastening spiral of loneliness that fuels further cognitive decline. In fact, loneliness is a more accurate predictor of early death than obesity, so watch out for reclusive signs in your loved ones and yourself. There’s also plenty of evidence to show that feeling old and resigning yourself to aging is what actually ages you prematurely.
The big takeaway from these companion studies? Get hearing aids as soon as you need them, and take care of your vision with regular checkups.
Hearing improvement technology has marched forward at a slow-but-steady pace, but a new recent law has opened the floodgates. In a rare bipartisan consensus, Congress approved and President Trump signed into law legislation that includes the Over the Counter (OTC) Hearing Aid Act. The act stipulates consumers can directly purchase hearing improvement devices without seeing a medical professional. It also means companies can sell products that claim to improve your hearing without going through the process of qualifying them as medical devices. While the devices will still be FDA regulated, the greater access to consumers is already leading to increased innovation and lower prices. Many current units sell for less than $500 now (while medical device hearing aids can cost from $2,000 to $10,000), and some are planned for as little as $150.
This new class of device is aimed at users with mild to moderate hearing loss — which statistically is most people as they age. For those with major hearing loss, the medical route will still make the most sense. After trying out many of this year’s crop of devices, a few stood out that we’ll cover here. Note that most of the exciting new devices I demoed at CES 2018 aren’t available just yet, but should begin rolling out soon.
Hearing Versus Listening
Many traditional hearing products simplify amplify everything. If you’re one of those people who can’t hear someone speaking otherwise, that makes perfect sense. But a much larger group of people can hear pretty well in a quiet environment, but have trouble listening to and understanding conversations in noisy environments. In this case, amplification only makes everything louder, not easier to understand. So companies are now touting their ability to intelligently separate background noise from conversation and help you hear the latter without being distracted by the former. In previous years at CES I’ve been disappointed with the devices I was able to test, but there were several exciting new products this year that gave me a lot of reason for optimism.
Almost all of the below devices rely on recent versions of the Bluetooth spec to serve a range of applications, including listening to music, making phone calls, and listening better.
Nuheara entered the market a year ago with its IQbuds; now the company will be expanding its product line with higher-end models this year. The current $300 product is positioned as a fairly traditional set of Bluetooth wireless earbuds that also include what Nuheara calls noise control. You can even use their smartphone app to create your own mix of ambient sound and whatever you’re listening to on your phone. Its new products move upmarket, closer to $500 — taking advantage of the Hearing Aid Act — to provide hearing assistance as a primary goal, in addition to allowing phone calls and listening to music. Its IQbuds Boost model, due out this spring, employs AI to build a personal hearing profile for each user; the profile can then be loaded into the ear buds for optimum soundfield modification.
Startup Lizn takes the conventional approach of amplification a little further with a couple twists. First, it has a directional microphone, so it is able to focus on amplifying the conversation in front of you — hopefully including the person you are listening to. Second, because they’re fitting in-ear units, they will automatically block some of the ambient noise. Finally, the company offers some type of selectivity in its amplification, as they stress it amplifies consonants in speech to best improve intelligibility.
I tried a pre-production pair of the Lizn hearing devices at a press event, and was quite impressed given the price. For the limited use of better understanding the person I was speaking with, they provided a good experience. They’re not invisible, but are fairly non-intrusive, depending on your choice of red, gray, or black models. The best part is that the Lizn is only $149 if you pre-order, and is expected to ship “around March.”
Eargo’s Max hearing aids are all but invisible. They are not only super-tiny, but most of the unit sits well inside your ear. The well-funded startup is directly aimed at disrupting the traditional hearing aid market and its $2,000+ products. When I demoed a pair, the noise reduction and speech amplification were both quite impressive. However, the resulting sound field seemed somewhat unnatural, and even a bit uncomfortable, to me. From the limited time I used them I don’t know whether that is something people will get used to.
Since it was a demo situation, I was also unable to take advantage of the company’s audiologists and hearing test to customize the units to my hearing and preferences. I’m also sure sound quality is something the company will continue to tweak as it ships its new Eargo Max units this month. If you really don’t want anyone to know you’re wearing a hearing device, this is the one for you. If not, I think you’ll be able to get surprisingly similar performance in a slightly larger form factor later this year from some of the other companies we looked at.
Dutch research spin-out Samplified Audio is working on the problem from a different angle. It’s building a sound processing platform called Clementine, which can intelligently amplify conversations while suppressing background noise. However, the signal processing platform won’t necessarily be built directly into a hearing aid. Instead, it can instead be run on a tiny device you can clip on to your shirt or even place on the table in front of you, which then communicates the modified soundfield over Bluetooth to a standard pair of earphones or earbuds.
While in some ways this adds complexity for the user, it has a couple nice advantages. First, you can use your favorite earphones with it. Second, you can place the “listening device” near the person you are listening to — perhaps on the table in front of you. That gives it a leg up compared with the results from a device simply sitting in your ear. I tried a prototype of the sound processor and was very impressed by how well it performed, even on the noisy show floor. But until Clementine is actually available in a consumer product, it’ll be hard to evaluate its real-world performance.
Medical device maker Resound continues to pursue many of these same innovations, although through the more complicated, and more expensive, channel of medical professionals. Perhaps the biggest advantage Resound has is it provides a whole family of hearing improvement products, for just about any type or degree of hearing loss. Unfortunately I didn’t get a chance to demo their Linx 3D in-ear offering this year; last year I found it amplified well, but didn’t reduce the noise as much as the company claimed it would. We look forward to giving it another go-around at the earliest opportunity.
Is Now the Time to Look for Help for Your Hearing?
If you’ve been put off by the hassle and expense of a full-fledged medical device hearing aid, but know you want some help hearing in tough environments, I’d definitely give one or more of these products a try. However, based on my experience demoing quite a few of them, make sure you have a chance to evaluate them personally before you commit to purchasing one of them (although I guess the Lizn is inexpensive enough you might just take the risk). That said, the technology is also moving quickly, so if you can wait a year or two you’ll see some major improvements and possibly more price reductions. You’re also likely to see the integration of more active hearing technology in “everyday” headphones and earbuds. Even IoT devices and smartphones that support voice recognition are likely to start to incorporate more of these technologies over time.
Google is partnering with GN Hearing to create a new hearing aid spec called ASHA, or Audio Streaming for Hearing Aids. The goal is to make Bluetooth hearing streams easily compatible with Android devices.
Charging a smartphone is simple: Plug in a cable or place it on a wireless charging pad.
Hearing-aid users often have a tougher time of it. Many still have to swap out little pill-shaped metal batteries that are maddeningly easy to drop and lose in the carpet or couch cushions. It’s a pain.
Now Eden Prairie-based Starkey is offering relief. Earlier this month, the hearing-aid giant announced a new model that recharges much like phones, smartwatches and other consumer devices do.
The Muse iQ Rechargeable hearing aids look nearly identical to other Starkey models, but they ditch the pill batteries for internal lithium-ion batteries that are good for up to 30 hours of use.
The hearing aids are bundled with a charging cradle onto which the audio devices adhere magnetically.
The cradle is compact enough to take on the road, much like the charging cases for Apple’s popular AirPods and other consumer-grade earbuds. And since the cradle itself has an integrated battery, it can charge the hearing aids fully three times without needing to be plugged back into the wall.
Rechargeable hearing aids aren’t new, but are still novel enough to generate excitement among those who have come to hate those pill batteries, said Jason Galster, Starkey’s senior manager of audiology research.
“Everyone struggles with replacing those batteries,” Galster said. “You can imagine an older person with vision impairment and poor manual dexterity dropping and losing them.”
The Muse iQ Rechargeable was until recently impossible to create. Starkey had to work on making the lithium-ion batteries small enough to keep hearing aids at their current sizes, yet maintain enough of a charge for all-day use, Galster said. It helps that hearing aids sip power instead of gulping it like smartphones and tablets do, he noted.
“We had to have the lithium-ion batteries last minimally 12 to 16 hours,” he said. “What we’ve done is design a hearing aid that is the exact same size as our old hearing aids but can last up to 30 hours on one charge.”
Getting older is a part of life, but for some people that means hearing loss, which results in the need for hearing aids.
Hearing aids can cost thousands of dollars, but a new bill will allow stores to sell hearing aids over the counter for a more affordable price in August of 2020.
“There’s a lot of variability in how much a hearing aid cost,” said Dr. John Mason. “The factors that go into it include the technology and the location where it’s purchased so its range is broad.”
For those with mild to moderate hearing loss, like Louis Carr, an expensive hearing aid from the doctor isn’t needed.
Louis Carr, who has mild hearing loss said, “I saw an advertisement on television for it and the price was very reasonable compared to some of the extreme costs that the hearing doctor.”
The price Carr paid?
“$200 and it has at least a year to two worth of batteries,” said Carr.
The new bill in Congress will allow companies to sell generic hearing aids over the counter that are similar to custom made ones.
“The FDA is studying these. In their study, they require that the scientific technology is similar and although that’s broad language. That gives directions for manufacturers so they’re supposed to be similar in their scientific technology in a hearing aid,” said Dr. Mason.
Carr said although his hearing aid is generic, it works just fine for what he needs it for.
“They do amplify the volume on the television and my phone calls.”
The hearing aids that are set to become available in 2020 are only for adults and will be for those who have mild to moderate hearing loss.
CVS closes hearing centers as FDA readies rules for over-the-counter sales of hearing aids
CVS Health is closing its roughly 30 hearing centers. Next year, the FDA will introduce regulations to bring hearing aids over the counter. CVS is experimenting with new store formats, including HealthHUBs in Houston, Texas.
Angelica LaVito | @angelicalavito Published 3:15 PM ET Fri, 1 March 2019 Updated 6:58 PM ET Fri, 1 March 2019 CNBC.com
The Livio AI hearing aid from Starkey Hearing Technologies has received an update that adds fall detection, heart rate measurement, a new assistant built on Google Assistant, and other new features. The abilities put Livio AI hearing aids nearly on par with smartwatches and activity trackers, bringing advanced features and functionality not available on competing hearing aid products.
Livio AI is, first and foremost, a hearing aid device. As we’ve previously explained, the inclusion of artificial intelligence has opened the door for functionality beyond what is available in traditional hearing aid products, including direct access to Amazon Alexa and activity tracking for use with Apple Health and Google Fit.
The most recent update revealed at CES 2019 has built upon that foundation, bringing a number of changes that put the hearing aids somewhere near the same abilities as a smartwatch or dedicated fitness tracking device. In addition to Alexa, tap control, and the ability to translate in 27 languages, Livio AI can now monitor the user’s heart rate, engage in voice-to-text translation, and both detect and issue alerts about falls.
The fall detection feature is exactly what it sounds like: the ability to detect when the user falls and send an alert to pre-selected contacts. The company says that it has used “significant new inventions” that will avoid issuing false-positive alerts, making it a reliable detection system for elderly users and those with mobility problems.
In addition to the new tracking ability, Livio AI now features Thrive Virtual Assistant, which is integrated with Google Assistant to provide hands-free support for the user. With this, wearers can get answers to information they seek, such as what the day’s weather will be.
The model works with the new mobile app, a product called Thrive Hearing Control, and the company now offers four compatible wireless accessories, among them being a remote, mini remote microphone, a TV, and the Remote Microphone+. Livio AI hearing aids are currently available in Canada and the United States.