Now that FDA-approved OTC hearing aids can be bought online without a prescription from an audiologist, there are hundreds of choices out there to consider. Unfortunately, this new market is rife with miscommunication, misleading information, and outright false advertising claims.

I did a search on Amazon this morning for “otc hearing aid fda approved” that turned up137 results ranging in price from $19.90 to $2,450.00. There were some really good products listed there. However, many were not even “FDA-approved” but instead were cheap analog or digital sound amplifiers. If this is the best guidance you get from Amazon, which generally monitors the products on its site pretty well, you will definitely want to do a lot more of your own research before you take the plunge.

Three Trusted Sources of Advice on OTC Hearing Aids

Fortunately, there are plenty of sources of qualified advice and information on buying OTC hearing aids if you know where to look. Here are three trusted, reputable sources of information that are a great place to start:

• Hearing Tracker is one of the best sites on the web for consumers seeking help with their hearing. Founded by a Doctor of Audiology to help consumers find better hearing aids and better hearing professionals, it provides a wealth of rich content and advice on acquiring hearing aids including the new OTC hearing aids. It is an independent site with product reviews by experts, consumer commentary on their hearing aids, a nationwide directory of audiology practices with pricing information, and an extensive updated database of hearing aid products.
• Wirecutter, the electronic products review site owned by the New York Times, has done several deep dives into OTC hearing aids. In the linked article they only recommend the four “best” OTC hearing aids, but even more important than their recommendations are the extensive explanations what to look for, how much to spend, what features and functions are most suitable for people with different levels of hearing loss, and overall background on the OTC hearing aid market. A careful reading of the article will arm you with most of the right questions to ask if you extend your search beyond their recommendations.
• Consumer Reports, the venerable independent guide for consumers of all kinds of household products, began looking closely at hearing aids over a decade ago and currently publishes ratings of more than two dozen traditional hearing aids. Recently it turned its focus to OTC hearing aids with an excellent introductory guide and product overview by health journalist Catherine Roberts.

With so many OTC hearing aids coming on the market at once, it’s important to know where to start and what to look for. These three sources can help. All are independent—they do not sell products and promise objectivity. Plus they have the resources to do their own research to get the best data and insights from qualified professionals. Everyone should have access to better hearing at prices they can afford, and OTC hearing aids will provide that for millions. Starting your search with the best information will help you find the ones that are right for you.

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Now we are entering the over-the-counter hearing aid era, which is supposed to blow the market wide open with low-cost hearing aids that don’t require a visit to the audiologist. Unfortunately, I’m suffering from a strong sense of deja vu. Why? Because many of the same obstacles that limited customer adoption of hearables will slow market acceptance of OTC hearing aids as well. And I’m not just talking about price. Here are three product and technology issues that are forcing manufacturers to make tradeoffs:

• Miniaturization: Jamming good custom amplification, directional microphones, plenty of sound processing power, Bluetooth capability, and long-lasting battery power into a device smaller than the tip of your pinkie finger is very, very, difficult. The smaller the form factor, the more technically challenging and expensive, forcing designers to trade off features and functions that many customers want.
• Sound processing: Good algorithms are available that suppress unwanted sounds and boost speech and other sounds you want to hear. But programming them to each user’s distinct hearing profile is still a challenge that often requires professional help. Only a few OTC hearing aid makers have launched do-it-yourself “self-fitting” apps, and the jury is still out on whether they will be effective or user-friendly enough to catch on with consumers.
• Multifunction applications: The success of Apple’s Airpods and other earbuds designed to stream music and phone calls, monitor your heartbeat, and count your steps has created consumer expectations that whatever goes in their ears should do more than simply help them hear better. OTC hearing aid makers that offer excellent sound processing but none of the other “extras” run the risk of positioning themselves merely as slightly less expensive me-to alternatives to established hearing-aid brands.

Don’t get me wrong. I agree with news outlets such as CNN, which hailed the introduction of lower-cost OTC hearing aids as a potential “game-changer for millions.” With new rules deregulating the U.S. market going into effect today, plenty of new OTC hearing aids are on the way. We will see a lot of innovation combined with lower prices. But I’m betting the game won’t change overnight. It will take a few years for this nascent market to start reaching its full potential.

A Case in Point

On first look, Sony’s collaboration with WS Audiology claiming an early stake in the OTC-market land rush appears to be a potential winner. Here’s how Sony describes it::

Developed in partnership with WS Audiology, this hearing device combines leading audiologist expertise with Sony’s trusted technology to deliver exceptional sound quality in a sleek, discreet design that’s virtually invisible.

Source: Sony product overview

But Sony is actually introducing two products, and the feature mix of each is a good example of the tradeoffs OTC hearing-aid manufacturers must make to deliver quality hearing improvement at lower costs than traditional hearing aids:

• The CRE-E10 has an earbud design that—at least in the eye of this beholder—isn’t quite “virtually invisible.” But it does offer Bluetooth streaming of music and phone calls. Its integrated rechargeable batteries are expected to last all day, but the hearing aids must sit in the charger unused for extended periods.
• The CRE-C10 is a smaller device that sits within the ear canal and comes closer to meeting the invisibility test. For power it relies on disposable hearing aid batteries that must be replaced periodically but promise approximately 70 hours of use. However, there’s no Bluetooth streaming.

The good news is that Sony’s new hearing aids are based on high-end hearing technology from WS Audiology, one of the world’s top five hearing aid manufacturers. The CRE-C10 and CRE-E10 are rumored to utilize technology found in WS Audiology’s proven Signia Active Pro and Signia Silk hearing-aid models. So the hardware is solid. But the effectiveness of the self-fitting Sony Hearing Control app that users can download to program the hearing aids is an open question. (The best review I’ve seen of the new Sony hearing aids comes from Matthew Allsop on Hearing Tracker’s YouTube channel—if you’re thinking about buying an OTC hearing aid, it’s a must.)

The Elephant in the Room

Given their tradeoffs, both Sony products may fall short of the ideal OTC hearing aid. But they are still a promising early entry. Except, perhaps, for one small detail—price. A pair of the smaller CRE-C10 model that use disposable batteries and don’t feature Bluetooth is listed on the Sony website at $999.99. A pair of the larger, earbud-style rechargeable CRCE-E10s with Bluetooth streaming is listed at $1,299.99.

Both prices are somewhat less than what many audiologists in private practices charge for hearing aids with comparable power and features. But prices charged by audiologists include a personal hearing test administered by a medical professional, with multiple visits for updates and adjustments to fit amplification levels to the individual’s unique hearing profile. It’s an open question whether the self-fitting app that comes with the Sony OTC hearing aids will provide equally good results.

Price will remain the elephant in the room until we see one or more OTC hearing aids hit the sweet spot with performance and feature sets at attractive price points that generate massive sales. That scenario may eventually be possible, especially if the OTC self-fitting apps that are less costly and easier to buy actually deliver hearing improvement equal to or better than what customers can get with multiple visits to the audiologist.

Waiting for the First Hit Product

In the meantime, think about what consumers spend on a high-end smartphone these days—somewhere in the range of $500 to $1,200. Which raises a question: will your equally expensive OTC hearing aids provide you with the same satisfaction and quality-of-life improvement that your apps-laden iPhone or Android phone provides?

In fact, the mobile phone market is a good example of how long it can actually take a new, deregulated product to hit critical mass. In the U.S., the phone system started deregulating in 1984, and we saw the the first brick-sized mobile phones like the ones used by the poor guy in the picture at the top of this post. In the 1990s we saw a lot of cell phones from Nokia and Motorola, but service was spotty and apps initially were limited to expensive messaging. It wasn’t until 2007, when Apple introduced its iPhone, that we saw the market explode. Apple finally hit the tipping point with a product that combined multiple functions that users craved while being just affordable enough to reach a global mass market.

But that process took more than 20 years. Will a deregulated U.S. hearing aid industry with a new class of OTC hearing aids hit a tipping point faster? Let’s hope so. But before it does, there’s still plenty of work to be done on both product and price.

The post Are OTC Hearing Aids Ready for Prime Time? appeared first on Hearing Mojo.

The White House celebrated the end of the five-year wait for implementation of the Over-the-Counter Hearing Aid Act of 2017 today with a neat list of big-box retailers and pharmacies already selling OTC hearing aids. Here’s a rundown:

• Walgreens is selling user-adjustable Lexie Lumen OTC hearing aids for $799 at stores across the U.S. as well as online.
• CVS is selling Lexie B1 and Lexie B2 Hearing Aids Powered by Bose on its website for $849.99 and $999 respectively. (The B1 and B2 come with a self-fitting software app and are slightly more advanced models in the Lexie Hearing product line than than the lower-priced Lexie Lumen model sold by Walgreens). CVS says it will supplement its online sales with a rollout to select CVS Pharmacy locations starting in November.
• Walmart is selling an assortment of OTC hearing aids on Walmart.com, SamsClub.com, and in 474 Sam’s Club Hearing Aid Center locations and more than 1,000 Vision Centers in Walmart stores across Colorado, Michigan, Missouri, Ohio, Pennsylvania, Tennessee, and Texas. Available products will range in price from $199 to $999 per pair, including products from Lexie Hearing, Go Hearing, and Lucid Hearing.
• Hy-Vee, the supermarket chain, will sell OTC hearing aids online and in 34 of its pharmacies across Iowa, Kansas, Minnesota, Missouri, Nebraska, and Wisconsin, with up to 100 locations by the end of the year. Hy-Vee will offer four models supplied by iHear Direct ranging in price from $499.99 to $999.99.
• Best Buy is offering nearly 20 different hearing devices online, including models from Jabra, Lexie Hearing, Go Hearing , Eargo, Lucid Hearing, and Hearing Assist. By the end of October, it will sell OTC hearing aids in nearly 300 stores across the country. Devices will range in price between $200 and $3,000.

And that’s just a very early list, which doesn’t mention high-quality OTC hearing aids available (or soon-to-be-available) from experienced manufacturers such as Sony, MD Hearing Aid, and Nuheara, to name just three. We’ll be posting on these and other products as the newly deregulated OTC hearing aid market heats up.

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Olive Union CEO Owen Song founded the company in 2016 after studying architectural design at Samsung Art and Design Institute, the Rhode Island School of Design and Columbia University. He decided to launch the startup after a relative with hearing loss tried and failed to find a hearing aid that provided enough hearing enhancement at an affordable cost.

“A decent hearing aid today costs around $2,000, and high-end devices can go for $6,000 or more” Song says in a video on the company’s Indiegogo fundraising campaign page. “The impairment when it comes to hearing is not physical—it’s financial.”

Attractive Design, High Performance, Low Cost

Song added that because most hearing aids are made to look like medical prosthetics rather than fashion accessories, they needlessly deter younger consumers. So the company made its Olive hearing aids look more like the popular wireless sport earbuds that are now ubiquitous at athletic clubs.

The Olive hearing aids are Bluetooth-enabled for listening to music and making and receiving phone calls. And a smartphone app enables individualized hearing screening and adjustment of personal hearing profiles. Because they are FDA-registered hearing aids, any audiologist or hearing aid dispenser can program and sell them.

Equally important, Olive Union focused its design and development on the lowest possible cost. Its Indiegogo campaign set a goal for a $100 price point for its hearing aid, an order of magnitude lower than many hearing aids with comparable features and performance.

That astoundingly low price may not carry over into the U.S. market, especially after resale by the NationsHearing network of audiologists and hearing aid dispensers. But it does give NationsHearing, which provides its network with numerous brands of premium hearing aids, a lower-cost solution for increasingly price-sensitive consumers.

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The BHearing PSAP features two earbuds hung from a neckband packed with digital hearing enhancement technology and powered by a rechargeable battery. It also comes with an associated smartphone app that enables volume and personal hearing profile adjustments.

Like Alango’s BeHear NOW hearing enhancement headset, it’s positioned to compete against Bose with a similar form factor and many of the same features. And, like the $249 Alango product, the $299 Jabees headset aims to lure customers away from the Bose cult brand with a substantially lower price.

New Technologies Deliver High Performance

Most important, the company points to technology enhancements it says will provide better performance. Louisa Cheng, Co-founder and General Manager of Freetek’s Jabees consumer brand, said one enhancement in particular—millisecond frequency adjustment (MFA)—provides a key advantage.

“MFA makes speech clearer,” she said in a demonstration at the recent CES consumer electronics conference in Las Vegas. “It addresses the biggest problem many people with hearing loss experience.”

MFA identifies high-frequency consonants in less than 2 milliseconds and instantly shifts them to lower frequencies that people with mild hearing loss are able to detect more easily. The feature is especially useful for conversations on mobile phones, which don’t transmit audio information at frequencies higher than 3,400 Hz.

Cheng said other advantages over the Bose Hearphones include dynamic equalization adjustments for phone calls and music through the smartphone app, up to 45 db amplification vs 35 db from Bose, and an additional detachable rechargeable battery.

The new product comes from a proven Jabees design operation, coupled with manufacturing in China mainland. Last year the company introduced wireless earbuds that compete directly with Apple Airpods, Bose SoundSport and other popular Bluetooth ear pieces, at half the price.

The company has also launched an Indiegogo campaign to help expand production and distribution of the BHearing headset.

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One standout was a new version of the Livio AI hearing aid from Starkey Hearing Technologies. It integrates a tiny biometric sensor that enables heart-rate measurement as well as fall-detection alerts from within a hearing aid for the first time. The hearing aid also features wireless streaming of audio from smartphones, integration with Google Assistant and Amazon’s Alexa, voice-to-text transcription from the hearing aid to a smartphone app, and a rechargeable option.

The new biosensor is powerful enough to perform multiple tasks yet small enough to fit inside the ear canal, where blood flow is easily monitored. It makes Starkey a first mover among many hearing aid manufacturers and makers of hearables and personal sound amplifiers that will be delivering their own in-ear biosensor applications between now and next year’s consumer electronics show.

Biosensor-maker Valencell, Inc. showed off the the Livio AI hearing aid at CES along with hearables from Jabra, Bose and other brands that also use its tiny components. At the same time, the North Carolina company highlighted the importance of the emerging hearing enhancement market by announcing a partnership with Sonion, long a leading provider of micro acoustic and micro mechanical technologies hearing aids and earphones. The two companies teamed up to to produce the next-generation BiometRIC sensor for receiver-in-the-canal hearing aids.

Treating a Range of Conditions

Recent hearing research indicates that hearing loss is linked to other chronic health conditions common at older age, including cognitive issues, diabetes, and cardiovascular disease. So if a hearing aid user suffers from cardiovascular issues, continuous biometric monitoring from an in-ear sensor can identify positive or negative trends, enabling more effective disease management at low costs.

“Putting an accurate biometric sensor in a receiver-in-canal hearing aid is a huge step toward mitigating many of the comorbidities involved with hearing loss,” says Dr. Steven LeBoeuf, President & Co-founder of Valencell. “Many of these co-existing conditions can benefit from continually monitoring heart rate, activity levels, and blood pressure.”

Starkey said fall detection is one of many health-related applications enabled by the new biosensors. According to the National Council on Aging, emergency rooms across the country on average treat older adults for fall-related injuries every 11 seconds.  The Livio AI hearing aid can detect falls and send alert messages to selected contacts. Starkey added it incorporated “significant new inventions” to flag only true falls and avoid false-positives.

“Livio AI and its fall-alert feature will not only provide peace of mind to caregivers but could potentially saves lives ,”said Bill Austin, Founder and CEO of Starkey Hearing Technologies.

More Miniaturization Will Deliver More Breakthroughs

What are some of the other tiny components that will enable a new generation of killer hearing apps? Smaller rechargeable batteries, higher bandwidth wireless communication, smaller low-power Bluetooth components, smaller high-function directional microphones, and smaller receivers providing higher fidelity audio are just a few.

Hearing aid component and subsystem developers such as Atlazo, Intricon, and Alango are busy developing chip-based health-monitoring technologies specifically for hearing aids and the emerging hearables market. It’s safe to predict that the innovations announced at this year’s CES conference are only the tip of an iceberg that promises to upend the entire hearing health industry.

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“IQstream TV marks a major milestone in Nuheara’s pursuit to be the leading company providing complete hearing ecosystem solutions that are focused on affordability and accessibility,” said Nuheara CEO Justin Miller. “Currently, this market is under-serviced and overpriced.”

A hardware accessory device that connects directly to the TV, IQstream TV also includes an inbuilt extension for the Nuheara smartphone app. A user can balance the volume of the TV sound—independently from anyone else watching the TV—with ambient sounds and conversations.

TV Listening A Top Concern For Those With Hearing Loss

Difficulty hearing dialogue on the television is among the top concerns of people with hearing loss, next to difficulty with hearing speech in noisy settings such as restaurants. But many hearables don’t offer wireless streaming of TV audio. Why? Because it takes some doing.

Standard Bluetooth streaming creates a delay—“latency”—between what’s being said on the screen and the audio reaching the earbuds. Failure to synch the speech to voice makes watching TV difficult.

One solution is an upgrade to Bluetooth aptX with Low Latency in both the transmitter and the earbuds. That fix eliminates the latency, but it’s relatively new, more expensive, and not yet widely distributed. The other solution is proprietary streaming technology, an engineering challenge that many makers of hearables haven’t tackled.

Nuheara’s proprietary technology works with IQbuds BOOST earbuds to eliminate the latency. Equally important, it enables users to adjust the volume and balance between hearing aids using the Nuheara app. The controls adjust settings for the earbuds only, not the TV. So others in the room can adjust the TV to whatever volume is comfortable for them.

A Product Ecosystem for Hearables

Now Nuheara is building on its own strong technology base to expand its product line and distribution. In its news release, Nuheara says it will develop a line of products to address the array of needs driven by users’ hearing loss:

Nuheara’s multi-functional ecosystem of hearing buds, intelligent software and new hardware accessories have been built to service all major consumer hearing needs. According to a 2018 survey by Eurotrak, the top reasons people seek hearing assistance is for time spent at home with family, group conversations, noisy situations, when talking on the phone and while watching TV.

Nuheara said it just completed its first production run of IQstream TV and will introduce the product at CES in Las Vegas in January. It hasn’t published a price for the TV streamer yet. A pair of IQbuds BOOST earbuds are currently priced at $399.

Hearables Competition Heats Up

Nuheara isn’t the only company creating a product ecosystem for its hearables. Alango Technologies, Ltd., already has a proprietary TV streamer for its BeHear NOW earbuds. And Alango is marketing its earbuds and accessories through its Wear & Hear online store.

The company also recently expanded distribution through partnerships with Clinic Management Services in Canada and with Amplicom USA. CMS sells through audiologists, and Amplicom is a distributor of amplified phones and a broad range of other assistive listening devices to consumers throughout North America.

Both Alango and Nuheara are competing with Bose, the consumer electronics giant best known for its stereo speakers and noise-cancelling headphones. Bose has moved into hearables with its Hearphone product and recently got approval from the FDA to market a Bose Self-Fitting Hearing Aid that can be marketed directly to consumers.

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Bose calls its $499.95 Hearphones “conversation-enhancing headphones” that are “specially designed to help you hear in louder environments.” Like other Bose products, they are loaded with great technology. They feature active noise reduction, directional microphones, wireless Bluetooth streaming of music and phone calls, smartphone app control, and more.

The $249.00 BeHear NOW headset is strikingly similar. First, it features Bluetooth wireless audio streaming. It’s also a personal sound amplifier that is tunable and customizable from a smartphone, tablet or PC. And, like the Bose Hearphones, it features active noise reduction to make understanding speech in noisy environments easier.

Competing on Product, Price and Distribution

But then we get to some additional distinctions.

• Product: BeHear can actually slow down someone else’s voice to make it easier to understand while talking on the phone or listening to voicemail. Alango EasyListen technology slows down speech to improve intelligibility of “fast talkers,” foreign languages, and recorded messages. And BeHear pairs with Alango’s optional $49 HearLink TV transmitter to send the television’s audio signal directly to the paired BeHear NOW headset. Bose isn’t currently offering a TV transmitter for its Hearphones.
• Price: In addition to a single-unit BeHear price that’s $250 less than the Bose Hearphone, Alango’s Wear & Hear online shop sells a “Personal Bundle” for $288 that includes BeHear NOW with the HearLink TV transmitter. It also sells a “Harmony Bundle” for $499 that includes two BeHear headsets and a HearLink transmitter. That’s two headsets plus transmitter for the same price as a Bose Hearphone.
• Distribution: In addition to its online store, Alango is committed to working with audiologists who want to resell its products for patients with mild hearing loss. Alango just inked a deal with Clinic Management Service (CMS)  to sell BeHear NOW through the CMS network of audiologist practices in Canada. I call it a “Trojan Horse” distribution strategy. Once Alango develops a network of audiologists, it will be positioned to follow up with other possible future products. For example, many audiologists are considering selling affordable over-the-counter hearing aids as a first step for customers who eventually might graduate to more expensive customer solutions.

Following the Leader

Does all this mean Alango will leapfrog Bose in the race to establish market leadership in hearables? Not necessarily. As an established leader in consumer electronics, Bose is able to command premium prices. And both companies, along with numerous emerging competitors such as Nuheara (IQ Buds), will tell you the hearables market is still in its infancy. There will be plenty of room in this wide-open, fast-growing market for new competitors with new products at new prices.

In the meantime, Alango is a small company that until recently has mainly developed very high-end audio technologies that other manufacturers integrated into their products. The BeHear NOW headset, the HearLink transmitter, and the Wear & Hear Store are its first ventures into the rough-and-tumble consumer electronics world. But its combination of innovations in product, price and distribution position it to compete successfully with established brands like Bose in the emerging hearables market.

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The company’s overall top- and bottom-line results reflected strength in other regions in the first half of the fiscal year over the same period in the previous year. Consolidated worldwide sales increased by 4.0% in CHF Swiss francs to 1,303 million. And earnings increased 7.6 percent to CHF 251.3 million.

In the U.S., the first-half sales decline to $348 million USD came before the introduction of the Phonak Marvel hearing aids. The new products are the first to stream audio from both iPhone and Android phones directly into both ears.

“The new Phonak Marvel product platform unveiled in October received very strong initial interest from customers,” Kaldowski said in the news release. “I am convinced that the launch of this innovative new product family will drive growth in the hearing instruments business in the second half.”

And in a subsequent conference call with financial analysts, Kaldowski said the product has begun shipping to customers this week, two weeks ahead of schedule.

In addition to a slowdown by U.S. customers awaiting the next-generation Marvel hearing aids, Sonova said that a consolidation of its U.S. retail-store network was responsible for lagging sales. But the company said “the U.S. restructuring has been successfully completed, and the business has shown improving momentum in the second quarter.”

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Günsberg says he first started noticing problems with his hearing in his late teens. By his late twenties, he couldn’t hear the difference between an ‘F’ and an ‘S.’ But it still took another decade before he saw an audiologist.

“I didn’t realize it, but when my hearing loss first started to get quite bad, I would avoid dinner parties or avoid going out,” he says in a video produced by Oticon. “And I didn’t know why I was saying no….I just felt that I didn’t want to do it.”

When he did go out, he wondered, “Why was I sitting alone? Because I can’t hear anybody?” And he realized, “There’s no need for you to go through life like that.” He took the plunge and got hearing aids, and his life immediately improved.

Today Günsberg is an “Oticon Ambassador” who promotes Oticon’s high-end Opn hearing aids. A 44-year-old professional communicator, Günsberg gets every ounce of benefit from the latest-and-greatest features of his premium hearing aids.

Premium Features Make a Difference

Among other things, his next-generation of high-end hearing aids feature:

• Advanced sound processing that makes understanding speech in noise much easier. “I feel so much more present in a room full of people,” he says. “It’s not just hearing that we’re talking about. It’s how you’re connecting with people around you.”
• Wireless streaming of audio directly from his iPhone. “I used to avoid talking on the phone. I would send it to voicemail,” he says. Now he can hear phone calls in both ears and use the phone’s app to turn the volume up or down.
• Rechargeable batteries, which have “really helped me to wear them more regularly. Having the dock right by the bed there, and knowing that I’ve got a full day of charge—no problem at all. That’s been really really great.”

Of course, they’re not cheap. Premium hearing aids from Oticon and other top manufacturers can set you back anywhere from $3,000 to $5,000 a pair. But according to Günsberg, the cost of not addressing the problem can be greater.

Think of the People Around You

“When you first notice that you’re saying ‘what?’ ‘hun?’ ‘pardon?’, you’re degrading your ability to communicate and connect with the people around you,” he says. “You might not realize it, but that’s starting to act like a sandpaper on the interactions that you have with the people around you.”

Perhaps most important of all, Günsberg has seen the biggest benefit at home.

“When I wear these, I feel more connected to the people that I’m spending time with,” he says. “I’ve definitely noticed a difference with my family—just in the way that we interact at home. That’s, that’s everything.”

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