Hearing Aids

Understandary Cascade

Hearing Aids

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Hearing Aids

Colin Wright

Oct 28, 2021

This month we talk about ear horns, Multitone of London, and regulations.

We also discuss multi-channel amplitude compression, speaking tubes, and the King of Portugal.

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Transcript

The word 'hearing aid' is a catchall term for a collection of different devices that can help amplify or clarify sound for people who have trouble hearing for one reason or another.

The earliest hearing aids we have evidence for were called ear trumpets, and they were exactly what they sound like: a device that flared outward at one end to collect sound, and conically squeezed that down down through a smaller hole on the other end—if you imagine a trumpet or other brass horn instrument, the place where you would put your lips to play the horn goes in the user's ear, and the other end, where the instrument's sound would come out, is aimed at the sound the ear horn wielder wants to hear more clearly.

This approach to making sound louder for folks who are hard of hearing didn't amplify the sounds they were aimed at, but instead collected more air vibrations—which is what sound is, fundamentally—over a larger air surface area, and then condensed it down to a smaller area, in essence delivering more vibrations, more sound, to a smaller amount of space: the little hole where the sound entered the user's ear.

The earliest ear trumpets date back to the mid-17th century, and though we don't know much about who came up with the method or devised the original devices—the earliest recorded description of one actually comes from a mathematical work by a French Jesuit priest in 1634—we do know that a little over 100 years later, in the late-18th century, they were fairly common to the point where there were multiple manufacturers, usually making them to order for customers, and a style of ear trumpet that was collapsible and thus, more portable, spread the tool still further, and allowed its use in more circumstances.

In the year 1800, a man named Frederick Rein began producing ear trumpets on scale in London, alongside primitive megaphones called speaking tubes, and other sorts of hearing aid devices, like so-called hearing fans, which concealed what amounted to small ear trumpets in foldable hand-held fans, of the sort a fashionable lady would hold.

Other makers and manufacturers followed the same trend, working hearing aid devices into elaborate hats and turbans and headbands and even a fancy chair built especially for the King of Portugal in 1819, with lion's mouths built into the armrests which served the same purpose as the wider end of an ear trumpet, the sounds captured by those mouths carried to the king's ears via a concealed tube that wove its way up the back of the chair, to his ear.

By the end of the 19th century, early electronics were used in hearing aids to amplify acoustic signals, in part because such technologies have proven so useful in the development of the telephone—a field focused on figuring out how to alter acoustic signals for loudness and clarity, with the lowest possible level of sound-distortion.

The first, true electronic hearing aid, which hit the market in 1898, was called the Akouphone, and it used a carbon transmitter—the same sort of device used in the mouthpiece of early telephones—with an electrical current running through it, which served to amplify the volume of noise passing through it.

Such devices started out fairly large, because electronics at that point were still pretty rudimentary, so they were typically carried in handbags and purses until they became small enough that they could be hidden amongst normal clothing.

As the technology matured and got smaller in 1913, a company called Siemens started producing these devices at scale, starting with cigar-box sized devices, but over time reducing their scale and improving their effectiveness.

Vacuum-tubes were used instead of carbon transmitters beginning in 1920; this allowed for the creation of electronic hearing aids that only weighed about 7 pounds, and this approach to hearing aid devices really took off when other companies, including Western Electric in the US, began producing them for global sale in the mid-1920s.

The first hearing aid with automatic gain control—meaning, you could keep it at a suitable, desired volume level, regardless of how low or high the sound you were amplifying was, naturally—was produced by a British company called Multitone of London in the 1930s, and they started selling a wearable version of the same in 1948.

The same year, 1948, is when Bell Labs in the US developed transistors, which changed pretty much everything because transistors are what allowed for the creation of modern, electronic computers, but early on this technology also allowed for the miniaturization of electronic hearing aids, replacing larger vacuum tubes and requiring less battery power to function, while also offering higher clarity and less distortion because of how they handled electrical signals.

Bell Labs experimented in the 1960s with the concept of creating digital audio signals that would process audio in computers, rather than using an analog signal amplified by electrical gimmickry; but the process took so long on the highest-end machines of their day, that it was considered to be a dead-end path, and they set it aside.

In the 1970s, though, the microprocessor came along, which allowed a great deal of computational power to be crammed into a very small device, and this, alongside a series of audio-specific innovations related to the sorting and separating and managing and optimizing of different sound frequencies, eventually led to the creation of a hybrid hearing aid that used traditional analog components alongside digital optimizing components, like multi-channel amplitude compression, which in practice allowed the user to adjust what they were hearing, in particular reducing loud sounds and increasing the volume of harder-to-hear sounds.

The first completely digital hearing aid, which was able to operate in real-time, rather than at a delay, was produced in 1982 at City University in New York as an experimental device; and one that was far from being practical for commercial application, as the components were finicky and had to be connected to a computer to function.

Other groups created more practical digital hearing aids by the mid-1980s, and in 1987, the first commercial, fully digital hearing aid was released by the Nicolet Corporation; and though this device failed on the market, it spurred something of a gold-rush amongst other electronics makers, and that enthusiasm led to the first behind-the-ear, fully digital hearing aid in 1989.

What I'd like to talk about today is hearing aids, and in particular a change that may soon occur in the hearing aid market, due to a proposed adjustment to how this industry legally operates.

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The article I'd like to start with today comes from the New York Times, and it's entitled:

F.D.A. Moves to Make Some Hearing Aids Available Without a Prescription

This piece provides an overview of a plan that was recently announced by the US Food and Drug Administration to make hearing aids available to people with mild to moderate hearing loss without requiring they undergo, and pay for, a medical exam, prescription, and fitting—all of which are today typically required for anyone, with any type of hearing loss, who wants to procure such a device.

This plan has not been finalized yet, and it's not clear when it would go into effect if it is enacted, but it's the consequence of several years' worth of effort by scientists, medical practitioners, and politicians who were keen to adjust a 40-year-old regulation that requires people in the US go through a tedious and expensive process if they want to buy a hearing aid; and in the US at least, these are devices that most health insurance won't cover, so the end-price for people wanting some kind of hearing aid device in the US is today often something like $5,000 or more, though that can vary a bit, down to the low thousands, or up to over $10,000, depending on the specifics of the device acquired.

In 2015, during the Obama administration, a scientific advisory committee suggested that it would be prudent to create a new category of hearing aid that would help shake up a dusty, overfed industry, protected by these regulations and in turn not innovating much at all, and charging exorbitant prices for largely outdated technology, while also lowering prices for a substantial percentage of the public that suffers from lesser, but still impactful levels of hearing loss.

According to the National Institute of Deafness and Other Communication Disorders, about 15% of Americans ages 18 and over report some trouble hearing, which adds up to about 37.5 million people in the US, alone, and only slightly less than that, 13% of people ages 12 and up have hearing loss in both ears, based on data collected via standard hearing exams.

It's estimated that about 28.8 million US adults would benefit from hearing aids, but in people 70 years old and older with hearing loss, fewer than one in three people have ever used a hearing aid, and only about 16% of those in the age 20 to 69 demographic who could likewise benefit from a hearing aid has ever used one.

In 2017, carrying the torch forward from the 2015 suggestion, congress authorized the creation of a new hearing aid category that would allow for the production and marketing of over the counter hearing aids, and then-President Trump signed off on it.

As of the day I'm recording this, there are a few US states that allow citizens to purchase some types of hearing aid and hearing aid-like devices online, but federal law still prohibits the marketing and sale of non-prescription devices throughout the country.

This is expected to change in the near-future, however, and though it's difficult to say for certain when that might be, good money is being invested in the likelihood of it being sometime relatively soon.

For instance, audio device-maker Bose released a direct-to-consumer hearing aid device in the US back in May of 2021, providing essentially what we're talking about here—a hearing aid that is high-quality, but which bypasses the typical hoops and expenses one must jump through and pay to get such a device, as long as one has mild or moderate hearing loss—and they were able to do so because they had an earlier, similar device that was approved by the FDA under their De Novo classification system: basically, companies can request what amounts to pre-authorization to start selling their products in some cases, as long as the product is considered to be very low-risk to folks who might buy it before the full FDA authorization process can be completed.

They produced what amounts to a self-fitting, self-programming digital hearing aid back in 2018, and then were able to get a de facto De Novo approval for this new product, which is basically a new model of the same product, in mid-2021. As a consequence, there's now a device called Bose SoundControl HearingAids that US citizens can buy for $850 a pair, and they look a bit like traditional hearing aids in that they've got an over-the-ear form-factor, but they're also a little snazzier, less beige and medical-looking, almost like a more commonly seen wireless earbud—and in fact the carrying case looks exactly like the charging cases in which you see those little earbuds being toted these days.

A few other companies are already selling rival, direct-to-consumer versions of what amounts to the same thing—usually with less flare and more of the traditional, bought from an infomercial or a magazine ad sort of look—but they're typically only able to sell in the aforementioned states that allow such marketing and sales to occur, at the moment—Massachusetts, Montana, North and South Carolina, and Texas.

This space could get a lot hotter in the near-future, though, as it's been reported by The Wall Street Journal that Apple has been investigating whether and how they can use their popular AirPod earbuds as health devices, tracking users' temperatures and heartbeats through their ears, but also as hearing aids: either as some kind of add-on or upgrade model, or by implementing hearing aid functionality directly into the core product, using attached iPhones and Apple watches to help calibrate and adjust their settings.

Important to this conversation is understanding the distinction between hearing aids and what are generally called Personal Sound Amplification Products, or PSAPs.

A PSAP, according to the FDA, is a hearing-augmentation product that is not marketed for hearing-impaired consumers. And in its purest form represents little hearing-aid-looking devices that help hunters hear nearby prey, bird watchers listen for birds, and which can allow folks wearing headphones to turn up or down the volume of stuff happening around them—increasing the voice of a distant lecturer in class, for instance, while turning down the volume of the wind just outside the classroom.

PSAPs are not regulated by the FDA, because they're not considered medical devices.

But interestingly, research conducted in 2017 found that while the accuracy of speech-perception in hard-of-hearing 60-to-85-year-old test subjects went from 76.5%, unaided, to 88.4% in those wearing real-deal, medical hearing-aids, their accuracy went up an average of nearly the same—within just a few percentage points, the exact amount varying based on the brand used—when subjects were wearing PSAPs.

In other words, although hearing aids of the more expensive, prescribed and professionally fitted and calibrated variety have some clear benefits, the gap between what they provide and what the far cheaper and more widely available PSAPs provide is very, very small, at least for some purposes. And that was in 2017, before the current earbud, sound-reduction, personal audio revolution had fully taken off. So there's a chance that what's available today, and what may be available soon, could even bypass what's currently on the market in the pro-level hearing aid catalog.

And this, again—if it does happen—would probably be the consequence of the very problem the FDA is hoping to solve with this plan.

The companies making professional hearing aids today are protected by a 40-year-old regulation that eliminates the threat of mainstream competitors, and their prices and deals with the audiologist industry have stabilized to the point where they're not being forced to really compete or innovate anymore.

As a consequence, although they were once state of the art in terms of their technology, by some metrics, at least, they're being challenged or even surpassed by hundred or two-hundred dollar, over the counter consumer grade devices; devices that seem to do most of what people suffering from mild to moderate hearing loss need them to do, already, without them having been optimized for those purposes. So there's a good chance that just by tweaking them to focus on those needs, the existing tech will get that much better, and whatever's coming down the innovation pipeline next will simply add to that surprisingly elevated, contemporary foundation.

Now all that said, there is a chance that this plan's implementation could drag on a bit; it could be quite beneficial for this market, and for people suffering from hearing loss who have never considered hearing aids because they're so expensive and relatively difficult to acquire at the moment, but there's a lot else on the FDA's collective mind right now, so this may not take the precedence it might otherwise receive.

Also, and I alluded to this a moment ago, but it's worth providing some specifics on, I think, the current over the counter options here, even the relatively refined and hearing-aid specific Bose option that managed to get on the market early, lacks some quality of life refinements like a rechargeable battery and the ability to connect to Bluetooth devices and listen directly to music. The explanation from Bose about why such features are lacking in this device is that they wanted to get the fundamentals right, first, before diving into the add-ons more thoroughly, which makes sense, as the bluetooth and music-listening experience on many high-end, prescription hearing-aids is reportedly quite bad, so Bose not wanting to taint what's apparently an otherwise pretty solid voice-perception experience with a very mediocre music-listening experience maps to that fundamentals-first approach.

There's also a nonzero possibility here that the threat of this plan from the FDA a few years back, and its seemingly imminent arrival, now, could have jump-started the prescription hearing aid industry in such a way that they'll refine their designs, lower their profit-inflated prices, and get in the game again for the first time in decades.

Rather than the savior of this industry being a company like Bose or Apple, then, it may be that the mere presence of these fancy pants consumer electronics companies forces the medical companies to get their act together and produce some really great stuff—for their traditional, very hard-of-hearing patients, but also for this potentially quite vast new audience of mild and moderately hard of hearing people who might, for the first time, consider a hearing aid, because they no longer seem so expensive, and no longer seem to suck as bad as they have even in recent memory—both in terms of performance, and in terms of their aesthetics and form factor.

Whatever the case, this is generally considered to be heartening news, as even mild hearing loss has been associated with social withdrawal, depression, depletion in self-esteem and confidence, reduced job opportunities, and anxiety.

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Show Notes

https://en.wikipedia.org/wiki/History_of_hearing_aids

https://beckerexhibits.wustl.edu/did/19thcent/index.htm

https://en.wikipedia.org/wiki/Carbon_microphone

https://en.wikipedia.org/wiki/Ear_trumpet

https://en.wikipedia.org/wiki/Hearing_aid

https://www.nytimes.com/2021/10/19/health/hearing-aid-fda.html

https://www.nytimes.com/2021/10/20/technology/hearing-aids-fda.html

https://mattstoller.substack.com/p/silencing-the-competition-inside

https://www.npr.org/2021/10/19/1047303559/fda-hearing-aid-prescription-over-the-counter

https://www.nidcd.nih.gov/health/over-counter-hearing-aids