Tag Archive: hearing health

How research, technology, and finance are fueling the new world of hearables

Copyright 2016 www.hearable.world

By David Sykes, Vice Chair, The Quiet Coalition

“For the last 40 years, there’s been very little movement, if any at all on [hearing loss]… and there [are] fundamental regulatory forces in place here that are subject to inertia. …. Now, just literally within the last year, …we’ve seen more movement on this issue than essentially in the last 50 years of U.S. history.”

–Frank Lin, MD, PhD, Assistant Professor, Otolaryngology, Johns Hopkins Bloomberg School of Public Health (July 2016)

In the U.S. we grew accustomed to noise and noise-induced hearing loss being ignored. Nothing much happened for three and a half decades after 1981 when, for political reasons, noise and its effects became verboten—serious people wouldn’t talk about it and researchers couldn’t find money to explore it. But lately, what venture capitalists call a “convergence” has occurred—a confluence of research, technology development, and novel sources of financial support (i.e., crowdfunding). And this convergence is creating a surge of interest in this long-ignored subject.

What is going on? Why are some of us so excited about this? Where are we headed? How does this help (or hurt) people who are concerned with the need to control noise, peoples’ exposure to noise, and people who suffer from hearing disorders like tinnitus, hyperacusis, and misophonia? If you follow the writing of The Quiet Coalition’s chairman, Daniel Fink, MD, you may recall that he first wrote about this subject last May. In short, personal sound amplification products (PSAPs) are a positive, exciting step in the right direction. But they will not and cannot solve the larger problem of noise and noise-induced hearing loss in America.

First: What’s going on?

Did it start with research? In 2009, two researchers at Harvard’s Massachusetts Eye and Ear, Charles Liberman, PhD, and Sharon Kujawa, PhD, published a paper revealing that “synaptopathy”, i.e., permanent nerve damage to the nerves that connect the ears to the brain, actually happened at lower noise levels than previously assumed and in the neurological circuits that can’t be seen in an audiological exam (audiologists can only see the pinna, the external auditory canal and the tympanic membrane—after that all has been a big mystery).

As a result, something called “hidden hearing loss” suddenly caught the attention of the policy makers who funded the research. Abruptly, the idea that noise caused only “temporary” damage, i.e., that the ear could recover from what has for decades been called a “Temporary Threshold Shift,” appeared to be really wrong. Hearing damage to nerves is always permanent and, at least until cures are found, irreparable. This caused a shift toward neuroscience research and toward the search for potential cures in partnership with the drug industry.

Did it start with technology innovators? Sony’s phenomenally successful Walkman (launched in 1977, forty years ago) started it, but then Apple’s iPod caused an explosion in the use of “earbuds” for “personal listening.” These wired earbuds were incredibly popular but always troublesome to wear because of the wires, so R&D types began trying to figure out how to get rid of the wires. Then “wireless” arrived. Called “Bluetooth,” it was developed in Sweden (the name “Bluetooth” is a tribute to the ancient King Harald Bluetooth of Denmark who unified parts of Scandinavia). But even wireless earbuds were essentially “dumb” speakers. Eventually, other restless R&D types began exploring what else, with increasingly miniaturized circuit designs, those wireless earbuds could do for you if you thought about the ear as a “portal” for transmitting information to the brain. From that work was born the idea of the PSAP.

But how did an idea turn into a blossoming industry called “wearables” or “hearables” in which at least seventeen companies are now scrambling for your attention? The answer? Money.

Did it start with the idea of “crowdsourcing” money to develop next-generation, smart “earbuds”? Look closely at the chart above and you’ll see that many pioneering PSAP companies currently vying for your attention are financed by “crowdsourcing” campaigns (e.g., Kickstarter and others). Another funding approach now available to companies in this emerging sector is the new SEC-approved “equity crowdsourcing” venture-finance companies, which have only been able to operate since late 2016 in the USA (earlier elsewhere). In other words, now there are whole new ways to start and fund a tech company that do not rely on traditional venture capitalists—those people who traditionally funded lots of other tech companies, but who have had, until now, little interest in hearing technologies because the hearing technology market has been stuck in a rut for three and a half decades.

In truth, all three of these phenomena—research, technology innovation, and capital–occurred independently. But now they have converged and are beginning to affect—and disrupt—existing markets, such as the market for hearing aids.  Hearing aids are over-priced, limited production devices generally aimed at older people and manufactured by a group of six companies (“the cartel” or “The Big Six”) who dominate the industry and make 98% of the world’s hearing aids—in other words, this is a market ripe for disruption.

Now add a fourth catalyst: Regulatory change. Eleven months ago (June 2016), the National Academy of Medicine published a significant report about the emerging, disruptive technology of PSAPs and attempted to warn audiologists, hearing aid manufacturers, and others who have been comfortably ensconced in this stable, profitable but uninteresting market that things are about to change. Then, a few months later two U.S. Senators introduced a bi-partisan bill intended to accelerate transformation of this market. It’s called “The Over-The-Counter Hearing Aid Act,” and it was introduced by Senators Warren (D-MA) and Grassley (R-IA). This act specifically seeks to streamline the market for “hearables”/PSAPs by exempting them from FDA regulation and enabling them to be sold direct to consumers, i.e., “over the counter,” without medical intervention.

But wait, what does this story have to do with our interest in noise control, in ending harmful exposure to noise, in your and your family’s hearing health? Do these new PSAP devices provide some relief for people who already suffer from noise-induced hearing loss? Can they prevent further damage from exposure?

Answer: A big maybe.

Keep in mind that the first word in PSAP is “personal”—these devices only address your noise problem, they don’t solve the noise problem for anyone else. If you travel to work on a noisy subway system, it’s possible some of these PSAP devices may provide you with some relief in the form of an active noise cancellation feature. If you can’t understand conversation in a noisy restaurant, some of the PSAP devices may be able to help you screen out background cacophony and focus on the person who’s speaking to you. In short, PSAPs include a wide array of features that might interest you. They are marketed as wireless earbuds that allow you to optimize “the way you hear the world,” and not as hearing aids, because they cannot be advertised as “hearing aids”—the U.S. Food and Drug Administration prohibits that. Only a “hearing aid” from one of “The Big Six” can be sold as a “hearing aid”—and only those six companies worldwide make devices that are labeled that way.

So “Caveat Emptor” (buyer beware) if you’re interested in trying one of the new PSAPs! This is exciting stuff and they cost less than 1/10th the price of conventional hearing aids. Furthermore, at least two of these companies, Doppler Labs (HERE One) and Nuheara (IQbuds), already have products on the market, so you can actually try out a pair of wireless earbuds and see for yourself.

But do they address the larger social problem that noise has gotten out of hand in America? That we’re all besieged, victimized, permanently injured by too much noise? To this, the answer is definitely “no.” You and a few others might get some relief, but PSAPs are not a solution to the noise problem in America.

David Sykes chairs/co-chairs four national professional groups in acoustical science: The Acoustics Research Council, ANSI S12 WG44, The Rothschild Foundation Task Force on Acoustics, and the FGI Acoustics Working Group. He is also a board member of the American Tinnitus Association, co-founder of the Laboratory for Advanced Research in Acoustics (LARA) at Rensselaer Polytechnic Institute, lead author of “Sound & Vibration 2.0 (2012, Springer-Verlag), and a contributor to “Technology for a Quieter America” (2011, National Academy of Engineering). Mr. Sykes spent several decades in private equity, venture finance, and technology development and has a keen interest in how convergence and disruption affect traditional industries.

Originally posted at The Quiet Coalition.

Better Hearing Month 2017 and the problem of noise

By David Sykes, Vice Chair, The Quiet Coalition

Every year since 1927, May has been designated “Better Hearing Month.” What better time to think about what threatens your hearing health? In fact, if you already have some hearing loss you’re one of about 48 million Americans—that’s many more than all of the people with cancer or diabetes combined.

That’s a big number, and yet hearing loss—specifically noise-induced hearing loss (NIHL)–has been overlooked and underfunded for three and a half decades.

Noise is such a simple word–why is it so complex and laden with jargon and specialists who don’t talk to one another? One group is solely concerned with how to measure it (physicists). Other groups focus on specific types and sources of noise, such as jet aircraft, or alarmed medical devices, or leaf blowers, or trains, or highway noise (engineers or advocacy groups). Others concentrate on the effects of noise on humans (doctors and public health researchers), while another group ponders how noise affects organisms other than humans, including plants, birds and other animal species, including those that live underwater (biologists). Still other groups think about how to mitigate noise (architects and designers).

The problem is that over the past three and a half decades, the subject of noise and it’s effects have been systematically ignored and underfunded by Congress and the White House. As a result, “noise”–the cause of NIHL–has become a bewilderingly fragmented field in which few people talk to others outside their own specialities. This has resulted in a subject that is hard to understand and laden with technical jargon. What is “noise”? Why does it matter? Who cares? Has the science progressed? If so, how and where?

But recently that has begun to change thanks to advances in research and to changes in federal policies from several federal agencies that have not traditionally been involved in noise and noise control. These include the Centers for Disease Control and Prevention, NASA, the Department of Health and Humans Services, the Department of Interior, the General Services Administration, the Joint Commission, and others.

In each case, a specific federal department has bitten off a chunk of the noise problem and developed guidelines and programs to fit their own needs. But put all of these disparate pieces together and you will find examples of real progress despite the fragmentation.

To help build general understanding, we ar the The Quiet Coalition have assembled some of these fragments into a diagram or a “Road Map” of noise effects (see chart above) organized by the way they are studied within various specialized fields. We hope this Road Map helps others see the big picture.

In addition to the Road Map, we have also assembled the basic facts about noise into a simple one-page “Fact Sheet” that provides detailed references to scientific literature. Both the Fact Sheet and the Road Map are starting points. At The Quiet Coalition, our goal is to synthesize the underlying scientific research on this complex and fragmented subject into a coherent picture so that we can collectively find ways to talk about it. We hope you find both the Fact Sheet and the Road Map useful as you think about hearing, hearing loss, and that elusive problem, noise.

The underlying question for each of us should be: how can we work together?

David Sykes chairs/co-chairs four national professional groups in acoustical science: The Acoustics Research Council, ANSI S12 WG44, The Rothschild Foundation Task Force on Acoustics, and the FGI Acoustics Working Group. He is also a board member of the American Tinnitus Association, co-founder of the Laboratory for Advanced Research in Acoustics (LARA) at Rensselaer Polytechnic Institute, lead author of “Sound & Vibration 2.0 (2012, Springer-Verlag), and a contributor to “Technology for a Quieter America” (2011, National Academy of Engineering). A graduate of the University of California/Berkeley with graduate degrees from Cornell University, he is a frequent organizer of and speaker at professional conferences in the U.S., Europe, Asia, and the Middle East.

Who should get their hearing checked? Everyone!

By Daniel Fink, MD, Chair, The Quiet Coalition

This local television anchor recommends that everyone get his or her hearing checked.

But this isn’t what the experts at the U.S. Preventive Services Task Force recommend. They reviewed the published medical literature on screening for hearing loss and concluded that, based on the literature, there is no proven benefit to screening for hearing loss in adults. People who complain of not being able to hear should be checked, they cautioned, but they found no benefit in looking for hearing loss is those who don’t have an obvious problem.

Maybe it’s time to rethink that recommendation. A recent report from the Centers for Disease Control and Prevention (CDC), Vital Signs: Noise-Induced Hearing Loss Among Adults, found the following based on recent data from the National Health and Nutrition Survey:

Results: Nearly one in four adults (24%) had audiometric notches, suggesting a high prevalence of noise-induced hearing loss. The prevalence of notches was higher among males. Almost one in four U.S. adults who reported excellent or good hearing had audiometric notches (5.5% bilateral and 18.0% unilateral). Among participants who reported exposure to loud noise at work, almost one third had a notch.

Conclusions and Implications for Public Health Practice: Noise-induced hearing loss is a signficant, often unrecognized health problem among U.S. adults. Discussions between patients and personal health care providers about hearing loss symptoms, tests, and ways to protect hearing might help with early diagnosis of hearing loss and provide opportunities to prevent harmful noise exposures. Avoiding prolonged exposure to loud environments and using personal hearing protection devices can prevent noise-induced hearing loss.

Audiometric notch is the hallmark of noise induced hearing loss.

The CDC information that a quarter of American adults have hearing loss but don’t know it–including those who rate their hearing as good or excellent–indicates a major problem. Experts recommend checking blood pressure at every doctor visit and cholesterol at varying intervals, depending on risk factors, beginning in childhood. Screening for auditory disorders is recommended for children but not for adults. But hearing loss is like high blood pressure or high cholesterol–it is painless and asymptomatic, and unless someone checks, the patient doesn’t know that he or she has it.

Why does this matter? Most Americans, including most doctors and audiologists, don’t know that the only safe noise exposure level to prevent hearing loss is only 70 decibels time weighted average for 24 hours with the real safe noise exposure level probably even lower than that. Most Americans don’t know that we are exposed to dangerous levels of noise every day, which probably explains the recent CDC findings. If people know that they have hearing loss, perhaps they will do more to protect their ears.

Significant hearing loss with age is probably not part of normal physiological aging, but represents noise-induced hearing loss. (I will be presenting a paper on that topic at the 12th Congress of the International Commission on the Biological Effects of Noise.)  Regular hearing testing could prevent current and future generations from losing their hearing.  Why? Because noise-induced hearing loss is 100% preventable, and regular tests would let people know whether and to what degree their hearing is compromised, allowing–and encouraging–them to take action today to avoid significant hearing loss tomorrow.¹

Take the initiative with regard to your hearing health, and have your hearing tested regularly as part of a preventive health plan.

Dr. Daniel Fink is a leading noise activist based in the Los Angeles area.  He serves on the board of the American Tinnitus Association, is the interim chair of Quiet Communities’s Health Advisory Council, and is the founding chair of The Quiet Coalition, an organization of science, health, and legal professionals concerned about the impacts of noise on health, environment, learning, productivity, and quality of life in America.

¹ For those who are concerned about establishing the diagnosis of hearing loss as a pre-existing condition which might increase their insurance rates or exclude coverage for future hearing health care, they should not be worried for two reasons: (1) Medicare and Medicaid don’t have a pre-existing condition exclusion, and (2) federal and commercial insurance plans do not cover audiology services and hearing aids. Which is more important? Not establishing a pre-existing condition for something not covered by insurance, or finding out that your hearing is already being damaged and having the chance to take steps to protect your ears?