Tag Archive: PSAPs

Want better sleep? Bose® has you covered

Bose® noise-masking sleepbuds™

by David M Sykes, Vice Chair, The Quiet Coalition

This CNET review is a intriguing article about Bose’s quest to tap into the auditory health and better sleep market.

PSAPs, or personal sound amplification products, is a term brought to public attention in 2015 by the White House President’s Council of Advisors on Science and Technology followed by a report from the National Academy of Medicine last October. PSAPs are an emerging class of products that are also called hearables (think wireless earbuds with extra features) that we’ve been following for the past couple of years.

PSAPs are interesting because they represent a host of tech innovations and innovative young tech companies that promises to disrupt the traditional hearing-aid industry that has been dominated for decades by a hegemonic group of risk-averse manufacturers known as the “Big Six,” a market that is carefully regulated by the FDA. The result of decades of regulation and dominance by a handful of companies is that traditional hearing aids are both absurdly expensive, and also not particularly innovative. No surprise there.

But a couple of months ago, the emerging market for PSAPs blew wide open thanks to bi-partisan legislation (the Over-The-Counter Hearing Aid Act, co-sponsored by Senators Warren and Grassley) which exempts PSAPs from regulation. And that means three things:
1. Now you can buy PSAPs directly from the manufacturers or at CVS/Walgreens etc. (“over the counter”) without a prescription and you don’t have to pay an audiologist to fit them;
2. PSAPs cost a fraction of what a pair of traditional hearing aids costs (PSAPs may cost you $150 to $400, but compare that to $4,000 to $10,000 for conventional hearing aids); and
3. Two dozen hungry, young start-ups funded through crowd-sourcing or by venture capital professionals are charging into this market.

So If you, like me, like to watch a tech-race unfold, then get out your binoculars and join the crowd at this track because its an exciting race in a market that has been moribund and over-regulated for decades.

Watching this restless bunch of young PSAP startups and their colorful jockeys (I mean their CEOs), and eyeing them very carefully, are a small but high-powered group of suits you’ll recognize from consumer electronics: Apple, Sony, Phillips, Bose, et al. Why? Because these are the big guys who are already in the ear business–they sell earbuds and headphones, among other things and wireless hearables is a potentially important new market. The ear is their turf. So if they can grab a piece of the de-regulating market for wireless hearing-assistive devices that’s a great business opportunity, right? After all, 48 million Americans are hearing-impaired so this is potentially a big niche market, and who knows how many Americans are sleep-deprived?

But what about Bose?

Bose—an intensely private, even secretive consumer electronics company headquartered on top of a small mountain near Boston—is the first of these big consumer electronics players to make a move in the PSAP race. Bose’s founder, Amar Bose, died a couple of years ago, but he was a singular, legendary force in consumer electronics and seemed to be the fountain from whom all of the company’s products poured. With his death, ownership of the company was turned over to Amar Bose’s alma mater, MIT (yes, MIT controls the majority stake but has no say in management). But can the company still innovate now that it founder and chief idea-guy is gone?

One approach to innovation is through acquisition. So last year, Bose acquired the San Diego-based startup Hush and recently announced the release of a new Bose-branded product based on the work done by three engineer-entrepreneurs who founded Hush not too long ago. If you’ve been watching this emerging market, you probably noticed that only last week, the self-declared front-runner in PSAPs/hearables a product called “Here One” from the company Doppler Labs, ran out of juice and went out of business. Why? They burned through $50 million trying to win this horse race, but then ran out of money and couldn’t get Apple or Sony or any of the rest of the big guys to pony up and buy them out. Sometimes that happens to front-runners and it’s too bad, but it clears the way for others to emerge. And Bose wants to be one of the next group as these horses round the first corner.

Now Bose, in addition to being intensely secretive, has also always done things differently. And they’re certainly going after this emerging PSAP/hearables market from some intriguing angles. For instance, they recently have launched a crowdfuning campaign for their new Bose® noise-masking sleepbuds™. Another example is their newly announced Hearphones for people who need help understanding speech in noisy environments. Both of these products indicate that Bose is probing the now-deregulated “hearing health market”—a big departure from their traditional focus on consumer electronics. Perhaps they think 48 million Americans is a viable niche market where they can beat Apple, Sony, Phillips and the Big Six hearing aid companies by getting out of the gate faster. Who knows? Bose has succeeded by focusing on niches ignored by others and they’ve got their own retail stores, so keep your eyes on them.

It’s a race. And some of us are watching closely to see what happens. If you placed a bet on Here One and lost, then just swallow hard and keep your eyes on the race. It’s only just begun.

In addition to serving as vice chair of the The Quiet Coalition, David Sykes chairs several professional organizations in acoustical science: The Acoustics Research Council, American National Standards Institute Committee S12, Workgroup 44, The Rothschild Foundation Task Force on Acoustics, and the FGI Acoustics Working Group—a partner of the American Hospital Association. He is the lead author of “Sound & Vibration 2.0 (2012, Springer-Verlag), a contributor to the National Academy of Engineering report “Technology for a Quieter America,” and to the US-GSA guidance “Sound Matters”, and co-founded the Laboratory for Advanced Research in Acoustics (LARA) at Rensselaer Polytechnic Institute. He recently retired from the board of directors of the American Tinnitus Association. 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.

The first one bites the dust

No longer with us

by Daniel Fink, MD, Chair, The Quiet Coalition

Some observers see great potential in a new category of electronic device called hearables, something a little less than a personal sound amplification device, or PSAP, and certainly less than a hearing aid, but designed to help adults understand conversation in noisy places.

Others of us–and I am in this latter category–don’t see much of a future for these products, which are unlikely to work well and unlikely to be attractive to consumers. After all, who wants to be the only one in the room wearing some silly-looking device?

There are several vendors trying to bring these to market but today we learned that the first one of these, Doppler Labs, bit the dust after burning through $51 million of venture capital.

Its product, Here One, only had a two-hour battery life.

One wishes the $51 million had been spent dealing with the root cause of the problem, making restaurants quieter. That’s what’s really needed to help people with hearing loss.

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.

New federal law deregulates and disrupts hearing aid market

Photo of Here One wireless smart earbuds courtesy of Doppler Labs

by David M. Sykes, Vice Chair, The Quiet Coalition

Who says this Congress can’t get anything done? Last week huge news appeared for 48 million Americans with hearing disorders, but the media barely noticed::

A new bipartisan law, the “Over-the-Counter Hearing Aid Act of 2017,” will deregulate the hearing aid market, dramatically lowering costs for consumers and releasing a surge of new technologies that will be sold over the counter, without a prescription. Yes, there will be losers as well as winners, but that’s the nature of change….

The new law responds to two federally sponsored reports issued last year (under the Obama Administration). The first report came from the President’s Council of Advisers on Science and Technology. The second was from the National Academy of Medicine. Passed the day before Congress adjourned, the new law creates opportunities for new technology innovators, eliminates the need to get a prescription, and dramatically cuts the cost by allowing substitutes, called “hearables” and “PSAPs” (Personal Sound Amplification Products), to be sold “over the counter.” The goal? a more efficient market that meets the needs of consumers.

As Noah Kraft, co-founder and CEO of Doppler Labs said, “[t]his industry is going to be completely disrupted. The question is by who?”

We have reported about this on several occasions over the past year, but the market disruption is getting underway much sooner that we anticipated thanks to quick action in the House of Representatives and the Senate, action that has emboldened nearly two dozen new entrants to enter the market ahead of schedule.

Who gains? 48 million Americans with incurable noise-induced hearing loss and millions more who are at risk from noise exposure. Who loses? The Big Six  who have dominated the hearing aid market for decades along with approximately 14,000 audiologists, the medical specialists whose services were previously required by the FDA to dispense and “fit” hearing aids to patients. The new Warren-Grassley OTC Act stipulates that the FDA must create a new category for “over-the-counter” hearing assistive devices and let them be sold freely, without intervention.

It’s no secret that the current Congress and the White House crave deregulation. Is deregulation potentially dangerous? Sure, but this is one instance where consumers will clearly benefit. Until now, hearing aids could cost you between $2,500 and $5,000 per ear, so $5,000 to $10,000 total. No wonder so few people have hearing aids—they weren’t covered by insurance or Medicare/Medicaid, so who could afford them? But now prices will drop to 1/10th of that—about $300 to $350 a pair–so lack of insurance coverage is less of a barrier.

We say thanks to the laudable bi-partisan cooperation between Senator Elizabeth Warren (D-MA) and Iowa Senator Chuck Grassley (R-IA) for getting this done at a time when Washington seems mired in dysfunction.

What’s the downside of this deregulatory innovation? There are many unknowns, so caveat emptor (buyer beware) and stay tuned…. But for now, it’s “Hip Hip Hooray”—or should we say, “Hear Here”!

P.S.: Our chair, Daniel Fink, MD, cautions that the real solution to the epidemic of hearing disorders in America is NOT more affordable hearing aids, but rather, a badly needed and long-awaited public health effort to prevent hearing loss—and we wholeheartedly agree with him. Prevention can be encouraged by three means:

  1. Educating people about the dangers of prolonged exposure to noise above 70 dB (permanent hearing damage occurs at levels much lower than currently recognized);
  2. Resurrecting federal efforts to reduce noise (as is being done in Europe and Asia already, where noise is recognized as a public health hazard) from obvious sources like planes, trains, trucks, consumer appliances, construction and outdoor maintenance equipment, etc.; and
  3. Educating companies in industries like aircraft manufacturing, car and truck manufacturing, mining, construction, HVAC, and appliance manufacturing, etc. that noise is harmful to public health.

Prevention can be done: currently, the European Union regulates noise emissions from 50 classes of products. According to Dr. Fink, “a hearable or PSAP is a poor substitute for well-preserved normal hearing; it’s far better to avoid loud noise or to wear earplugs!”

In addition to serving as vice chair of the The Quiet Coalition, David Sykes chairs several professional organizations in acoustical science: The Acoustics Research Council, American National Standards Institute Committee S12, Workgroup 44, The Rothschild Foundation Task Force on Acoustics, and the FGI Acoustics Working Group—a partner of the American Hospital Association. He is the lead author of “Sound & Vibration 2.0 (2012, Springer-Verlag), a contributor to the National Academy of Engineering report “Technology for a Quieter America,” and to the US-GSA guidance “Sound Matters”, and co-founded the Laboratory for Advanced Research in Acoustics (LARA) at Rensselaer Polytechnic Institute. He recently retired from the board of directors of the American Tinnitus Association. 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.

PSAPs appear to work (but preventing hearing loss is better)

Photo credit: Hadley Paul Garland licensed under CC BY-SA 2.0

By Daniel Fink, MD, Chair, The Quiet Coalition

Personal sound amplification products (PSAPs) appear to work. What is a PSAP? It’s really a hearing aid but it’s called a PSAP to avoid federal and state regulations. PSAPs can be sold directly to consumers without a physician or audiologist evaluation, and they are much cheaper than conventional hearing aids–in the range of $350 a pair instead of $3000 apiece.

This Research Letter in a recent issue of JAMA compared five PSAPs with a conventional hearing aid. The Johns Hopkins research team reported that some of the PSAPs worked quite well. Four of the PSAPs are traditional “behind the ear” devices that look like cheaper, less well made versions of traditional hearing aids, but one, the Etymotic Bean, might be placed into the newer category of “hearables” that are marketed as “smart earbuds.”

Why is this report important? PSAPs were strongly recommended by two recent expert federal reports (a report from the President’s Council of Advisors on Science and Technology in October 2015​ and a report from the National Academy of Medicine) as a solution–perhaps the solution–to the nation’s epidemic of hearing loss in older Americans.

To some they are the holy grail for hearing loss, enabling all to hear well without spending thousands of dollars. To others, especially audiologists and hearing aid dispensers, they are an existential threat. If grandma and grandpa can buy much cheaper hearing aids on their own from Amazon or Costco, why see an audiologist or hearing aid dispenser? Just buy your PSAPs online or at your nearby big box store.

Unfortunately, neither federal report mentioned the prevention as a solution for hearing loss. As I said in my presentation at the 12th Congress of the International Commission on the Biological Effects of Noise in Zurich on June 20, 2017, significant hearing loss is probably not part of normal aging but is noise-induced hearing loss caused by a lifetime of excessive noise exposure.

The inconvenient truth about hearing aids is that they don’t work very well at helping users understand speech in normal, everyday situations. For obvious reasons, there is little peer-reviewed research on this topic in the audiology literature, but two studies report approximately 40% non-usage rates. There is no reason to expect–especially without any training and teaching by an audiologist–that PSAP users will have any greater success.

Needing hearing aids or PSAPs in old age to treat hearing loss is not normal, just as needing complete dentures in old age because of tooth loss from poor dental care is not normal. Both are the only remedies available when we have failed to protect what Mother Nature gave us. But it’s much better to protect your ears and preserve your hearing than to use even the best hearing aid or the less costly PSAP alternatives.

The time to start protecting your ears is now! If it sounds too loud, it IS too loud. Avoid loud noise, and if you can’t avoid it, wear hearing protection.

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.