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, 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—that 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—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 cost 1/10th the cost of 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.

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. 

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