There is an old Yiddish saying that goes something like this, “The only one looking forward to change, is a wet baby.”

Yet change is one of the most common things that all of humanity deals with daily.  However, never before in the history of humanity have we humans had to cope with anymore changes than those occurring right now, in our own time.  Spurred by the collective, and accumulative knowledge, wisdom, and technologies of our past, we find ourselves being hurled into a future that arrives at an ever accelerating pace.  

The hearing aid industry is one such industry that is currently in a general state of total shock, brought on by these rapidly evolving changes. 

From the manufacturing level, right on down to the audiologists, and hearing instrument specialists who’ve traditionally dispensed from behind a set of regulatory gates, through a very regulated delivery pipeline.  The old delivery pipeline that kept competition, and points of access to a minimum, and profit margins high, is breaking down, clogging up, and causing confusion.  Lack of a clear direction permeates, as Smith’s invisible hand moves more, and more of what the industry considers ‘their’ products, around this highly restrictive, regulatory system. 

Now, the majority of manufacturers, middlemen, and dispensers are struggling to cope, and understand this very changed market.  A market where the consumer, equipment and software evolutions have morphed their products into something far beyond anything ever envisioned by the framers of the regulations currently surrounding their sale, and distribution.  

The industry is simultaneously struggling also with the challenges of dealing with direct sales from health insurance giants, warehouse chains, big box retailers, the V.A., Personal Sound Amplification Products, and the Internet.

The disorienting, and disturbing effects that this rapid change has on us all, was termed “Future Shock”, by the first person to study the effect, anthropologist/futurist, Alvin Toffler.

Entire industries, business models, and products are developed, marketed, sold, and become obsolete today, in less time than it took to do the drafting, make the dies, and do the retooling to even enter production, with the products in the past.  From automobiles to refrigerators, to hearing aids, product cycle times, were similar. 

Obviously, the transistor, and the computers it’s discovery made possible, changed all of that.  Remarkably, both transistor, and the computer chips we build with them have grown at a pretty steady rate since their discovery, shrinking by half in size and price about every eighteen months. 

This effect, coined Moore’s law, after a Stanford professor who first used it to describe the phenomenon, has resulted in the evolution of the introduction of the next phase, and evolution of computers, and connectivity in this latest, and most personal of electronics, that the industry is calling wearables. 

The two leaders in the field today are Google, with their Glass product, and Apple with their new iWatch.  However, most often overlooked, is the original wearable electronic device, the hearing aid.

While Google seems to be focusing on the visual, and information retrieval side, and Apple appears to be focusing on entertainment, and the emerging field of health reporting, the Hearing Aid Industry has been focusing on sound processing.

The two things that all of these new ‘wearables’ have in common is that first they are application driven, ultra miniature computers, and second, they are capable of communicating with other electronic devices, and themselves.  They are networkable.

The FDA, and Apple are well aware of this, as they grapple with the extent of the agency’s authority, and reach in the regulations of applications that measure, and report bodily functions, or drive other devices that administer medications, such as insulin. 

The idea of the FDA, applying it’s Byzantine rule making, and product authorization process to Apple’s, or Google’s products is both frightening, and absolutely ridiculous.

That is why the discussions aren’t centered around the devices at all, but around the applications, running on the devices.   A clear distinction is being made between hardware and software.  The FDA already recognizes that these devices can have multiple uses.

This agency is trying to define, and clarify their authority, as beginning when an application on the device is used for some medical purpose, over which they currently have, or are declaring scope.

Yet, because hearing aids have evolved from single use medical devices they have evolved within a highly regulated distributions system.  A system with vested stakeholders, at every level.  This includes the FDA, as long as these devices are marketed with the intent to correct a hearing loss.

Because of this closed evolution, complete with an entire academic PHD curricula sold at many universities, surrounding the evolution of both the instruments, and protocols associated, with their delivery, from within such a regulated system, all of the players, have continued to think of these wearable electronic systems, as simply hearing aids.

It suits the hands that all of these stakeholders currently hold, within this highly regulated, and controlled delivery system.  It’s easy, and comfortable to continue to see things as we have in the past.  We’ve evolved entire educational programs around seeing things just this way.  We’ve systems in place to manage the ways of doing business, selling and delivering the products of the past.

When in fact, what these devices actually are, is ear level, ultra miniature, high speed, dual input, audio processing computers.  Each now with either ultra-low drain FM, or near field magnetic induction communications capabilities, running a series of applications.  They come complete with removable ear worn receivers, designed to shape, and enhance the wearer’s listening experience, or stream His/Her cell phone calls, personal concerts, TV, or gaming, hands free, in high definition stereo.

When talking on the phone, they are a pair of wireless dongles.  When streaming what’s going on in an online game, they are a pair of wireless stereo headphones, the same when streaming TV, or a spoken book from a Kindle, or iPad.

When used to enhance the sound of a distant bird call, or improve the signal to noise ratio in a busy meeting, or broaden the base, of a concert, they are a PSAP.

Only when they are sold, and used to correct a hearing loss, do these computer products become hearing aids. 

The claims being made for them, what they are to be used for, and the fact that a hearing loss has been designated a serious health issue, all conspire to morph these products into medical devices, and bring them under the purview of all of the regulations, from Federal, right on down to the individual State level.

But, what if the same device is sold to enhance only that bird call, or stream their cell phone calls, or enhance the signal to noise ratio of conversations in a noisy meeting, or restaurant?

Those are all features, and benefits that define dongles, wireless headphones, and personal sound amplification products.  That they share many of the same technologies, both hardware and software, is both coincidental, and key to an understanding of the crossroads our industry is at.

The very same software processing algorithms, and applications of today’s industry leading hearing aids, provide the same exact benefits that are outlined in the FDA’s guidelines for Personal Sound Amplification Products.  The only differences being the intent with which they are sold.  A legal distinction absolutely without a difference, when it comes to the actual equipment, or applications being used for either.

This puts the leadership of our professions and manufacturers in a real quandry.  Continue to support only the known, highly regulated, and profitable business model where they move their products, as regulated medical devices, in small numbers at a higher profit?

Or, do they seize the opportunity to open entirely new markets, by going after the non-regulated personal sound amplification, wireless dongle, and headset market?

Continuing along the known, highly regulated distribution path currently provides the greatest profit per unit, and therefore greatest return on investment.  But, it risks not recognizing the huge changes occurring across the entire market for personal electronic communications devices, as well as risking the emergence of an upstart who doesn’t play by their current rules.

Stepping out, and offering products that have traditionally been marketed through this highly regulated system allows the company who does so to move potentially factors greater in volume, of their products, but at a much lower initial per unit profit.

Doing so would also be guaranteed to alienate a large percentage of those current customers who are used to the products only being marketed, as regulated medical devices.  The short term would be very uncomfortable for the first manufacturer to make that jump.

It often is.  Being different, going against the flow is uncomfortable, and not every company has the leadership, vision, courage, grit, or resources to see such an industry changing business plan through. 

Yet, that’s what being an agent of change is all about.  Seeing the opportunities that the future presents, where others don’t, and then having the courage to become those changes, even in the face of ridicule by colleagues, competitors, and customers alike, until they catch the vision, and begin to see the future that you’ve created.

The potential for becoming a household name in ear level electronics, has never been greater.  But, it won’t be by selling hearing aids, even if that is what the devices are ultimately performing as.

But, a pair of ear level, dual input, ultra-fast audio computers that allow for hands free, stereo communications, cell calls, streaming information, or entertainment, and controlled by their own smartphone, or tablet.  That is a whole different proposition, and one that appeals to a much wider market.

Such devices would enrich not only their users near field communications capabilities, but their far field, electronic ones, as well, bringing them into the world of streaming entertainment, and effortless personal communications in every environment.

That these same products are capable of measuring hearing thresholds, ear canal resonance and correcting for a hearing loss, is purely coincidental, and is only due to a suite of additional applications, that may, or may not be purchased, and loaded, as the customer of the future will pick the suite of applications that are most appropriate for them, by running an company informational, and programing interface application from their own iPhone, iPad, Smartphone, or Android Tablet. 

If, the consumer gets in a jam, the application will link them with a touch of the screen, automatically to where they can get help, either locally, or via video link, through yet another application.

These devices will not only provide all of the benefits we’ve come to expect from the highest end audio gear, but with communicating interface, and additional applications, be able to record, and identify, the music playing, or the bird singing, where it is relative to the listener, and then plot and record it on the accompanying Ornithology application and log.

Each of these devices is surrounded by a rich code halo, that these savvy agents of change will continue to mine, not just to continue to enhance their customer’s product experience, but to be able to suggest further enhancements, and added value propositions, as they evolve. 

Further opportunities for customer interaction will become common, as more, and better audio applications are written and become available, and customer feedback, and usage provide the data needed to grow into that piece of ear gear that everyone just has to have.  Along with these after initial sale opportunities will come, new and different ways to interact with customers, and consumers alike.  From service facilities, to upgrade opportunities.

This will happen, when one agent of change looks closely at our market, our products, our consumers and what they really want, and then acts against the grain, and does anything, but business as usual.

Until then, we remain an industry in future shock, trying to fit yesterday’s regulations, and business models into the very changed market, and consumers of today.  An industry where twenty percent of the equipment fit is done by the V.A., and the nation’s largest health insurer has just bought their own hearing aid company, and decided to be the change in the provision of hearing aids under insurance policies.

Until then, we will remain an industry where professional control is more important than the consumer’s experience, or choices, and where we hover at twenty percent market penetration, and leave eighty percent of the people who could benefit from our gear unreached.

Until then, I’ll continue to dream, and write, and poke, and prod, while looking for those other agents of change.  Those with vision, who want to proceed in faith, rather than fear.

Because, until a major manufacturer steps up, as that agent of change, we as an industry and profession simply won’t be all we could be, nor help all the folks we might reach otherwise.