Rachel White is a Minnesota public school teacher who suffers from severe hearing loss.
Unable to hear her students or afford pricey hearing aids, the 45-year-old contemplated
quitting her job.
I realized how expensive they were, and I knew on my teacher's salary that that wasn't something I
was going to be able to afford to do.
An estimated 37 to 48 million Americans has some form of hearing difficulty.
Despite that, only 14% of people with hearing loss use a hearing aid.
There are barriers to hearing health care.
One of them could be price.
For some people, the cost of hearing aids is not affordable.
But an FDA ruling in the Fall of 2022, allowing for the sale of over-the-counter hearing AIDS
could improve access for millions.
The new devices for adults with mild to moderate hearing loss cost as little as $199 and are sold
at retailers like Best Buy, CVS and Walmart.
Starkey, which got its start in 1967 and has produced tens of millions of hearing aids, said it
has plans for an over-the-counter offering, too.
Starkey will be in the over-the-counter hearing aid market, but we're going to be doing it through
our hearing health care professionals.
A do it yourself approach isn't what we're about, and a hearing aid is not an amplifier, a piece of
plastic you grab off the shelf and you do it yourself.
And it's not just America's aging population that is suffering from hearing loss, with more people
tethered to their smartphones, listening to music and watching videos hearing loss is impacting an
even younger demographic.
One in six US teens has measurable hearing loss likely the result of excessive noise exposure.
We see lots of young adults and teenagers now with noise induced hearing loss.
We see them with tinnitus and things that are the starting points of hearing loss because they do
walk around all day long with some sort of device in their ear.
So why are hearing aids so costly and what impact will over-the-counter devices have on people with
impaired hearing?
To better understand how the devices are made CNBC got a behind the scenes look inside one of
the world's largest hearing aid manufacturers.
Rachel White is a teacher with almost two decades of experience growing up in Minnesota with a
father who was deaf in one ear and a mother who was also hard of hearing the family compensated by
making things louder.
Tv was always really loud.
Radio in the car was always really loud.
So when I listened to things, I did it loud too.
Attending concerts in her teens and early twenties also impacted her hearing, but it was the
resumption of in-person classes with masked students where White discovered how quickly her
hearing had declined.
I even told my students last year, I said, yell if you need to yell, yell.
It's not that I'm not listening to you, it's that I literally can't hear you.
Soon, ice patches began to form.
We worked until we had to give the surface time to freeze solid.
Unable to afford hearing aids, the educator contemplated quitting her job.
White teaches a combined class of fourth and fifth graders, 27 students in total.
You know, next to my family, this is like my whole life.
To think that I would have to completely change everything.
I can't even express how sad it was for me.
A social media post, she sent, got the attention of hearing aid manufacturer Starkey.
The company's CEO responded and offered to outfit White with a pair of new hearing aids.
It was like a whole new world opened up to me that I had never experienced in terms of being able to
hear things. What was our vegetable garden in summer became our skating rink in winter.
In addition to amplifying students voices, her new hearing aids also gave her the ability to
communicate with Spanish speaking parents using the device's translation mode.
You hit a button and as they speak, it translates into my ears in English what they're saying.
Now, obviously I couldn't speak back because I don't speak Spanish, but I think it made a huge
impact on them that I had a way to understand what they were saying.
And it's not just teachers like White who have been impacted by hearing loss of the more than 1.9
million US soldiers who served in the wars in Iraq and Afghanistan.
About 8% have been diagnosed with hearing loss, 6.5% with tinnitus, and 6.2% have both
conditions. But what causes hearing loss in the first place?
We are born with roughly 16,000 tiny hair cells inside our cochlea that allow our brain to detect
sounds. Loud noises, along with aging, can cause wear and tear in those hair cells that, if
damaged, are not able to properly transmit electrical signals.
Damaged hair cells do not regenerate, resulting in permanent hearing loss.
Teenagers are losing their hearing because of headsets gaming, being inside with a TV.
People can experience hearing loss after just an hour on a motorcycle in less than half an hour at
a sports game and in just a few minutes listening to music on your headphones at the highest volume.
Other causes of hearing loss include disease and head injury.
And it doesn't matter whether it's music or machinery or gunfire or lawnmowers.
It's all about the intensity of the sound and the duration of the exposure.
It saddens me a little bit to know how long I went without being able to hear everything going on
around me and how it was like opened up so many new doors around me like, Oh, I didn't even know
that was happening I couldn't hear that.
It's been life changing.
A silicone ear mold is one of the first steps audiologists take to create a custom fit hearing
aid. At Starkey's manufacturing center in Eden Prairie, Minnesota roughly 200 technicians are on
hand to forge those ear molds into functioning devices and ship them to consumers.
Between 25 to 40% of Starkey's hearing aids have some form of personal customization.
Behind the ear devices are generally larger but don't need custom fitting.
After unboxing a silicone impression of the ear, is placed on the turntable of a 3D scanner to
capture its distinct measurements.
We like to say this is where the art and the science come together.
After scanning technicians mold the digital shell using dedicated software to ensure the components
fit properly inside.
You see our parts are circuitry our face plate with our battery.
That digital file is then sent to a 3D printer where the outer casing is produced.
It's almost like an ear print, if you will.
Every shape is different for people, and even between the two ears, they're different.
And in that case, we need a human to assemble those final components.
During assembly, technicians using precision instruments add the final components, including
the microphones, circuits and receivers by hand.
The entire process is completed in a day or two on average.
But why are hearing AIDS so expensive?
The global hearing aid market was valued at over $10 billion in 2021.
Critics argue that the five largest manufacturers who control more than 90% of the market have kept
prices unreasonably high.
A typical pair of hearing aids in the U.S.
goes for between 2000 to 8000, including fitting fees and follow up services.
Medicare and most private insurance plans don't cover the devices.
The hearing industry is always been a monopoly.
Manufacturing costs were low, which allowed the company by virtue of their monopoly, to jack up
prices, making it more expensive for consumers and the monopoly still carries forward to today.
Starkey, which sells its products directly to hearing professionals, says that high price
includes not just the device but the assessment, fitting and follow up fees.
Some of the complaints and misperceptions that often occur about the high cost of hearing aids is
is that in many cases, in the majority of cases, when a patient is paying for their
hearing aids, they're paying for not only the technology but the service.
They are expensive.
But I look at it from the approach of you're not just buying the hearing aid, you're buying the
service of an audiologist.
One of the first hearing aids was invented in 1898, but it wasn't until 15 years later that
German electronics giant Siemens produced a device that was portable and had a speaker in the
ear. Today, tiny sensors and artificial intelligence help hearing aids filter out
background noise and hone in on specific sounds like a voice in a noisy restaurant.
Starkey says the signal processor on its Evolv A.I.
device can make up to 55 million personal adjustments per hour.
It's not your grandfather's or your great grandfather's hearing aid anymore.
These are communication devices, and they're sleek.
And the design is that that nobody will know you're wearing one.
The modern hearing aid, I would say, is a technological marvel.
This device mimics the way that a healthy human hearing system hears and understands sound.
Its hearing aids can also connect to your phone, making it possible to listen to music or make
phone calls, translate over two dozen languages in real time.
And fall detection technology can alert contacts if a person has fallen.
But those technologies have also created additional challenges for engineers who put
hearing aids through a battery of tests.
Hearing aids today come with over 300 components .
Inside the Satimo, an acoustic chamber, engineers test Bluetooth wireless connectivity between two
hearing aids. About 80% of people who have hearing aids wear one in both years.
The biggest challenge to our industry is that small custom devices and Bluetooth don't enable
that communication between the two ears to go through the head.
So we have to radiate that energy around the head.
The larger devices can have larger antennas in them.
The smaller the devices are, the more challenging that is.
Engineers also inspect to see if they can withstand extreme conditions like dust buildup, as
well as impact against a hard surface.
A drop test, which in a calibrated fashion can suspend the device and slam it down into the floor
at a far greater force than would likely happen when a hearing aid user was actually wearing their
devices.
In what company officials refer to as its CSI lab hearing aids are also tested for moisture
resistance by being submerged in a meter deep column of water for half an hour.
Another test gauges the durability of the device's interior components.
Sometimes people get a little careless about ripping them out of their ear.
And so we want to ensure that this very delicate structure, there's actually six little wires that
are inside this tube.
If they get frayed or kinked, it will stop functioning.
The ear is a hostile work environment.
It's exposed to the elements in real world environments where people are perspiring, they're
getting rained on, They're sometimes forgetting and wearing their hearing aids when they step in
the shower.
For the first time, Americans will be able to purchase hearing aids over the counter.
The devices for people with mild to moderate hearing loss will have a lower maximum sound
output than most prescription devices, cost less and not require a medical exam.
Illinois-based Sound World Solutions has been making hearing devices since 2013.
The hope is that in this country, the the new category will have a tremendous effect in
lowering the price, not only for the over-the-counter hearing aids, which will be low,
but for also the traditional hearing aids.
Several other companies have since announced their entry into the market, including Bose, who
partnered with Lexi Hearing and Sony, who teamed up with Denmark's WS Audiology.
Apple has added a hearing assistance feature to its AirPods pro earbuds.
I think we may enter into a garage band era where everyone thinks, Oh, now there's over-the-counter
hearing aids, I can make them and sell them.
But it's a lot harder than it looks.
The unintended consequences of over the counter is that $100 amplifier you see on
Facebook because you looked up hearing aids or whatever it might be.
And they think, wow, I got the deal this is what I need and it's not even close that represents
what is a class II FDA approved medical device.
Starkey said its OTC device called START Hearing One, which will be released towards the end of
2022, will cost $899 a pair.
While over-the-counter hearing aids might be a cost effective entry point for adults with
moderate hearing loss advances in technology and customization features will likely mean the market
for traditional hearing aids continues to grow as well.
Left untreated, adults with hearing loss face significant higher rates of depression, anxiety,
and scientists believe hearing loss might be a cause of dementia, according to a recent study.
Almost 30 million US adults could benefit from the use of a hearing aid.
I've seen Sony, Bosch and Lomb, Johnson and Johnson many, many different good companies come
into this industry and there is always the threat that they're going to take over and because
hearing industry isn't in tune and doesn't know how to provide more access or affordability and
they come and they go.
It's not because there's a stronghold on this industry, it's because it's a very different
industry to what some companies might be used to, or especially consumer electronics.
It's very misunderstood.
I don't know how I did it as long as I did not being able to hear them.