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.
