Splitting Hairs: FDA Still Struggling To Explain The Difference Between Hearing Aids And Personal Sound Amplification Products (PSAPs)
The U.S. Food and Drug Administration (FDA) is continuing to split hairs as it attempts to draw a clear distinction between hearing aids, which are Class I medical devices subject to government regulatory oversight, and personal sound amplification products (PSAPs), which are not. While its recent draft guidance document updating its 2009 Regulatory Requirements has more emphatic wording, it continues to draw the same inadequate distinction between the two types of devices. Unfortunately, the new guidance as currently drafted seems destined only to exacerbate the simmering conflict between hearing aid makers and PSAP marketers.
In 2009, the FDA said the difference was in the intended use of each product. It said because hearing aid makers market their products as a way to alleviate a medical problem — hearing loss — they should be subject to government regulations. But as long as PSAP makers only market their products for recreational uses such as ”hunting (listening for prey), bird watching, listening to lectures with a distant speaker, and listening to soft sounds that would be difficult for normal hearing individuals to hear,” they are not selling medical devices and need not be regulated.
In other words, if the PSAP is not sold as a way to correct hearing loss, it’s not a medical device subject to regulatory oversight.
But PSAPs use the same technologies as hearing aids, they look like hearing aids, and they amplify environmental sound like hearing aids. And the new FDA document does little to resolve the question that’s bothering everyone: “If it quacks and has a bill, wings, white feathers and webbed feet, isn’t it a duck?” Read more
Naming Names: Hearing Health Groups Ask FDA To Force Four Personal Amplifier Marketers To Stop Calling Their Products Hearing Aids
Many of the established players in the hearing industry have long been upset about lack of clarity in the lines drawn between hearing aids, which are regulated medical devices, and personal sound amplification products (PSAPs), which are unregulated. Now three major hearing health organizations are tackling the issue head on by calling on the U.S. Food and Drug Administration to have four PSAP providers “cease and desist” from marketing their products as hearing aids intended to rectify hearing loss.
The joint letter from the Academy of Doctors of Audiology, American Speech-Language-Hearing Association, and International Hearing Society said companies selling the Neutronic Ear, RCA Symphonix Sound Amplifier, Lee Majors Bionic Hearing Aid, and TV Ears Sports Amplifier may be violating FDA and state regulations requiring marketers of hearing aids to request a full medical evaluation from customers–including a recent hearing test administered by a licensed hearing aid fitter or audiologist–or have them sign an explicit waiver. Read more
Now that private equity firm CID Capital has made a major investment in Westone Laboratories, watch for the Colorado company turn on the burners with a further expansion of its hearing-assistance products into new consumer markets beyond the hearing-aid industry.
Not that long ago, Westone was little more than a staid maker of ugly but essential custom ear molds for hearing aids. But in recent years the company has introduced a slew of new products including earpieces for professional musicians, custom earplugs for swimmers, hearing-protection technologies for military and industrial applications, assistive listening products for hard-of-hearing consumers, and more. If you’ve been to AudiologyNOW or one of the other big hearing-aid conventions, you’ve probably enjoyed Westone’s product demonstrations where you can hear live musicians perform as you listen through the same kinds of headphones and custom earpieces professionals use on stage.
Westone CEO Lynn Kehler says the private equity investment will enable the current management team “to rapidly accelerate new product development, aggressively expand distribution and pursue potential acquisition opportunities. We also have a unique opportunity to leverage our extensive hearing healthcare and professional audio music background to offer the same premium quality products and listening experience to the broader consumer earphone market.”
All of which is music to my ears, as I continue to look for examples of companies born in the hearing aid business that are willing to commit management energy and financial capital to delivering great technology and products to a much broader base of consumers. Westone was founded in 1959 and prospered under several generations of Morgan family leadership. But several years ago the family owners named Kehler CEO. A professional manager who had previously been CFO of Westone, Kehler led the expansion drive while seeking a way to provide liquidity for the family. According to the news release from Westone and CID Capital, the investment “will allow the Westone management team to continue to build the company with a new investment partner while allowing members of the family that founded Westone to diversify and pursue personal interests.”
An Indianapolis investment firm with deep Midwest roots, CID Capital takes majority positions in small firms and often helps family-owned companies transition to professional management while providing the financial backing management needs to invest in growth over the long term. While the parties didn’t disclose the size of the investment, the Westone deal appears to be a great marriage of an investor with deep pockets and staying power with a management team committed to a long-term strategy to create new markets with new products and technologies.
Rather than trying to go public or being acquired by a much larger company, staying independent with the backing of an equity partner is a great strategy for success in the hearing-technology business. More innovation is needed and markets need to be created and given time to build, and patient capital is just what the doctor would prescribe for a management team that’s on a roll and only in need of some financial backing to move ahead with its long-term strategy.
All too often a private equity investment foreshadows major negative changes. When the equity firm finances its investment with debt to be repaid through the company’s current cash flow, management often needs to cut overhead dramatically, selling off lower-profit lines of business, and milking the cash-cow profit lines to pay off the debt. With short-term increases in profit margins, the company may increase in value, and the equity firm can make a quick killing by taking the company public or selling off what’s left. But if the company fails to increase in value quickly, the venture can lose market share and gradually waste away. In either case, lines of business with great long-term prospects but low current profits are often simply shuttered and employees with irreplaceable experience cast aside.
But CID Capital appears to be anything but a Wall Street slash-and-burn private equity player. It’s nice to see a private equity deal that rewards family owners for their years of hard work, leaves a strong current management team in place, and provides incentives for a good company to make an even bigger mark on a business that is positioned to drive positive change for an entire industry. Especially when it’s a company doing interesting new things in the hearing assistance business. Let’s keep an eye on Westone Laboratories.
Why Lantos Technologies’ Search For The Perfect Earmold Is A Game-Changer For The Hearing Aid And High-End Audio Industries
Lantos Technologies, a Cambridge, Massachusetts startup company working with patented technology developed at MIT, is on a quest for the perfect ear mold fitting.
With $1.6 million in venture capital funding, the company is developing a unique scanner that will create an exact digital image of the inner ear, enabling ear mold manufacturers to produce hearing-aid shells, earphones, and other in-ear devices that provide a perfect custom fit for the wearer.
If Lantos is successful, its product could be a game-changer not only for the hearing-aid industry, but also for makers of a broad array of high-end audio electronics and hearing protection equipment. Perfect-fitting earmolds enabled by the Lantos scanner could pave the way for entirely new consumer products that are currently impractical to bring to bring to market, because the cost of ensuring an accurate fit for every user would be prohibitive.
Audiologists and hearing-aid customers put up with the necessary evil of taking ear mold impressions for hearing aids and other select products only when they must, because there is currently no alternative. Getting a good ear mold is a messy process that involves injecting soft silicone putty into your ear down to within millimeters of your ear drum, leaving it there for several minutes until it starts to dry and harden, and then pulling it out and sending it to an ear mold manufacturer. All the while you keep your fingers crossed, hoping the impression doesn’t have so many flaws that you have to perform the procedure all over again. Read more
Manufacturers of personal hearing protection solutions are missing an opportunity by not raising their voices to be heard in the debate over government regulations limiting noise in the workplace. When two U.S. Senators this week persuaded the U.S. Labor Department to back off from proposed rule changes that would have required large and small companies to more aggressively manage noise levels in the workplace, they put their finger on a critical question: Should the government force companies to limit the overall noise they create, or should government instead simply require companies to provide their employees with effective personal hearing protection?
When the government tells manufacturers to lower overall workplace noise volume, it forces businesses to install expensive sound-dampening systems that can amount to huge capital investments. But when the government simply tells businesses to protect the hearing of their workers in the most effective way possible, the first move is to outfit workers with highly effective (and highly cost-effective) ear plugs, ear muffs, or more sophisticated hearing protection devices that allow them to communicate even as their hearing is protected from over-loud noise.
Unfortunately, government bureaucrats often are more interested in fast but expensive one-size-fits-all solutions than they are in getting up to speed on things like the variety of new personal hearing protection technologies that can do the job better and less expensively. Therefore, if makers of personal hearing protection devices want to increase their market and sales, they should be advocating for sensible hearing-protection rules that require companies to issue the right kind of hearing protection equipment to their employees, over rules that require more expensive investments in overall workplace noise reduction. Read more
Doing Well By Doing Good: Etymotic Research Wins CES Award For High-Tech Ear Plugs Protecting Soldiers’ Hearing In War Zones
Serious hearing loss is an all-too-common problem besetting U.S. military veterans and is the number-one cause of disability among those soldiers returning from Afghanistan. The problem is all the more tragic because for the most part hearing loss is preventable: a simple, inexpensive set of good earplugs can protect your hearing from the damage caused by even explosions and gunshot blasts. Unfortunately, many of the earplugs available to soldiers today frequently suffer the same fate as hearing aids worn by the rest of us: too often they sit in the drawer, unused. That’s not because soldiers are vain or lazy. The sad truth is that traditional ear plugs are unsafe in combat zones. When you can’t hear your colleagues in a firefight, chain-of-command breaks down pretty quickly, and people can get killed.
What’s needed is intelligent, active hearing protection. A new class of hearing-aid-like devices can dampen too-loud noise and filter out unwanted noise while amplifying and clarifying speech. A number of hearing-technology companies have tackled the challenge of hearing protection for soldiers, and one of them, Etymotic Research, just won a “Best of Innovations” award at the 2011 Consumer Electronics Show (CES) in Las Vegas. Etymotic’s Electronic Blast PLG Earplugs won a coveted Best of Innovations in Health and Wellness award at a ceremony yesterday. The Etymotic blast earplugs allow normal detection and localization of even the softest sounds, provide optional gain for (only) soft sound, and protect ears from firearms and explosive blast. And they’re not just for soldiers, as hunters and workers in noisy industrial environments can find them equally useful.
Phonak’s Hear the World initiative got so much attention from its announcement that vuvuzela horns were damaging World Cup attendees’ hearing that the hearing aid company’s product designers sprung into action to adapt Phonak’s popular Serenity industrial hearing-protection products with a new line of consumer devices for fans who need to protect their hearing at stadium events such as major league sports events and rock and roll concerts. Hear the World announced that Phonak customized a new version of its Serenity state-of-the-art hearing protection systems–typically used by helicopter pilots, fire-fighters, industrial staff and security professionals–and sent it to World Cup journalists in Johannesburg, South Africa, to see how well it would filter out the endless drone of the vuvuzela. The noise makers emit sound at an ear-splitting 127 decibels (dB), louder than a lawnmower (90 dB) and chain saw (100 dB). Continuous exposure to noise at more than 85 dB will cause permanent hearing damage, so virtually all fans in a stadium enduring an extended chorus of vuvuzela noise are at serious risk of hearing loss. Read more
Phonak’s Hear The World Foundation touched a nerve when it warned World Cup fans of the damage stadium noise can cause to your hearing, especially if you’re in the midst of a chorus of vuvuzela horns. It turns out that, at 127 decibels (dB), a vuvuzela is louder than an air horn. On top of normal cheering in a heated match, the sound can quickly do permanent damage to your hearing. After Hear The World issued its statement, the news of potential hearing loss spread across the media and the web like wildfire — Google the phrase “vuvuzela hearing loss” and you will see 71,000 entries. What’s the best way to prevent hearing loss from noisy stadiums? There’s been talk of banning vuvuzela horns at the World Cup and other sporting events. My preference, though, is to see everyone start using simple ear plugs, which can protect you from all stadium noise at any sporting event, which, vuvuzela or no vuvuzela, often surpasses decibel levels loud enough to cause hearing damage.