Neosensory Duo v Lenire: New 2021 Tinnitus Treatments

(suspenseful music) – My name is Dr. Ben Thompson,
and in this presentation, I want to explain my own
independent research, my own investigation into the
two newest tinnitus products, the Neosensory Duo, which is a wristband, and the Lenire device,
which is a combination of something on the ears and something that is placed on the tongue for tongue stimulation. All right, great, so first,
a disclosure is that, yes, I run the tinnitus tele-health
company called Pure Tinnitus, and I help patients using
tinnitus retraining therapy. I was trained at UCSF Medical Center in San Francisco, California,
which is a big hospital, and that's where I completed my residency, some other work experience, and then I was also trained by the founder of tinnitus retraining
therapy, Pawel Jastreboff, who is a researcher in our
field, very well-known, and between those experiences and creating a lot of online
educational information, the past years of my life
have been devoted to tinnitus, so hopefully I can share
some of that knowledge in a way that helps you today.

Also Pure Tinnitus, the
online company that I created, is contracted by Neosensory to provide tinnitus consultations for the pro version of their product, so there is some relationship there, and I wanted to be as transparent
and upfront about that at the beginning, that the
purpose of this presentation is to explain and educate
on these different devices and for who they might be good for and some other information and
science that goes behind it. All right, now that's out of the way, first, let me introduce this topic, called bimodal stimulation. When we think of this
term, bimodal stimulation, and how it can be used for tinnitus, the phrase bimodal essentially
breaks down into two modes. Bimodal, two modes of stimulation. The classic treatments
or therapies for tinnitus are either psychological, which
addresses the limbic system, the emotional charge of
the brain, very important, I see that every day,
that oftentimes that area, that attachment, those
associations with tinnitus, when those are decreased over
time, tinnitus can shift, tinnitus can reduce, tinnitus can get better.

That limbic system connection
and the parts of the brain, very, very important. So classic tinnitus treatments
are either psychological, addressing that aspect, or auditory, like hearing aids or sound
therapy, sound machines, masking devices, ear
level sound generators, and all of that. Now, in recent years, coming
from numerous research mainly from Ireland and from Michigan, from these two various companies, it's focused on can we
stimulate the auditory system and another sense at the same time. Can we stimulate the
auditory nervous system, the auditory pathway, and
simultaneously another sense, another sensation, another nerve signal, which ultimately ends up in the brain. Can we do that all at the same time, and what would that do? So this research has developed over time, and as I said earlier, coming from mainly Ireland and
the University of Michigan. So there's two devices that are available, one is only available in Europe right now and likely to become available
in the next 12 months in the United States, and
that is called Lenire, and that is the device
that is worn on the tongue, I have some pictures here to show you.

This is the Lenire device, and this has been used in
Ireland, has been used in Europe. It's available in European countries, as you can see here. There are headphones that go over the ear and then there's a music player
that's held in your hand, and the headphones and the
music player are synchronized so that when the patient
who's undergoing the therapy is listening to sounds coming from the ear and simultaneously
having tongue stimulation on their tongue, that is creating the bimodal stimulation. All right, so that's
one form of doing this, and the other form of bimodal stimulation that I'll talk about today is
using the paired stimulation of the skin, coming in on the wrist, the arm, kind of the skin, and also the ears at the same time. And that device is called Neosensory. And this is the wristband, so it's called the Neosensory Duo, which is the wristband from this company. And they're based in California.

So those are the two products
that I'll talk about today. On the screen here, you can see that this is a snapshot I
took from my YouTube channel where I have in-depth reviews
of these two products. The Lenire review is 20 minutes long and the Neosensory product
is 14 minutes long, so as you can tell, very
in-depth and a lot to go over, a lot to cover, so let's start, let's, let's get right into it. Lenire is created by a
company called Neuromod and they're coming out of Ireland. And if you're here live,
please leave questions as they come up, please take notes, would be glad to try to
help you out with those.

I have some notes that I'm referencing to make sure I provide the
highest quality information, most up-to-date information for you guys. Okay, Lenire is the company
that has the tongue stimulation, and so hold on a second. Before I get into all of the details about these two different
bimodal stimulation devices, I want to address something that is the most important
thing of this talk, that there are certain therapies that I would consider
fundamental for tinnitus, retraining the brain to have less tinnitus or to think about it, the percentage of time we think about it, that it's on our
concentration, to reduce that, and reduce how annoying the
tinnitus is in our perception, and then eventually hoping
to reduce the volume or shift the volume of that
tinnitus, to attain that, there are certain foundational principles, and most often it is
tinnitus retraining therapy. Tinnitus retraining therapy
is a protocol to follow where there's proper individual education on how tinnitus was created, what it means based on
your history, your hearing, there is the sound therapy plan, which sometimes uses ear level devices like sound generators or hearing aids, and then ongoing professional counseling and support typically by an audiologist, sometimes by a psychologist, and for a period of about six months of following tinnitus
retraining therapy, to me, that is the fundamental foundation.

That is so clear to me that
that's extremely important, is even though we're talking about technology therapies here, is that I have helped people, many audiologists who are
well-trained have helped people without either of these therapies who have gotten better with tinnitus and even, at times, reduced the volume or the perception of tinnitus, so I need to make that very clear, is that sometimes we hope that technology or a pill will solve our problem quickly, and it's usually a supplemental tool. In fact, some of the patients
that I've worked with who are using the wristband device, none of them are using that device in isolation expecting that by itself to change their symptoms,
so this is important because usually we are attracted
to the technology solution, but before we jump ahead with that, I need to make sure someone
has followed the protocol that works for around 80% of
patients with ear tinnitus.

All right, thank you, I need
to make that really clear, it's really important, okay, now, let's start by talking
about the Lenire device. Okay, this is, is the Lenire device, this is made and manufactured by a company called Neuromod,
and they're out of Ireland, and this device uses
bimodal neuromodulation by stimulation of the trigeminal nerve via tongue stimulation. Again, the trigeminal nerve
via tongue stimulation. Auditory stimulation in
the ear simultaneously, which happens through the headphones, that is based on the hearing
test, based on the audiogram. The Lenire device has a tongue tip and it has the headphones. The protocol is that you
wear it for one hour a day. And, for example, it's
recommended you can use it for a half hour in the morning and a half hour in the evening. The training program is
a six-week use period and then your audiologist
would review the progress with you and determine what
needs to happen from there. So overall, it's something that's used for less than two months,
bimodal stimulation of the tongue, affecting the trigeminal
nerve and the ears, affecting the auditory
nerve simultaneously.

The clinical trial or the clinical study that was completed had
over 300 participants, and some notes I have is that,
first, it's relatively hard to independently control and
have a pure double-blind test because it's hard to control
for tongue and ear stimulation. Essentially, how do you
fake tongue stimulation? Obviously you would feel it,
either it's there or it's not. So there's some challenges there with developing a pure
double-blind gold standard study on this. But they had three groups, synchronized stimulation, group one, group two, asynchronous stimulation, meaning playing the
tongue and the ear sound at different times or changing the tones and some variations there.

They used two different outcome measures and they showed improvement
in symptom severity after around three months, and the notes that I have from
the webinar that I attended for that company was that 80% of
treatment-compliant participants showed continued
improvement one year later, 80% said that they would recommend Lenire to others with tinnitus,
that's pretty important, and 65% said that they
benefited from using the device. So some common questions with this, when will it be available in the US, well, it's currently in
the FDA approval process and they're hoping it will be
available by the end of 2021, but don't be surprised if that
becomes available in 2022. It is available in select
countries in Europe right now. Does insurance cover it? Probably not, definitely
not at the beginning, but potentially down the road. Can it be done remotely or in person, those are some good questions.

A recent audiogram or recent
hearing test would be needed to program the device, then adjustments could
theoretically happen via telehealth online. Does it work for hyperacusis,
sound sensitivity? if you have hyperacusis
or sound sensitivity, I know that sometimes that
can be even more debilitating than loud tinnitus, so this device is not designed
for hyperacusis per se, but the results suggest
that it may work for you if you have hyperacusis as well. Now, for tinnitus without hearing loss, yes, you can use the Lenire device without a diagnosed hearing loss. It's still worth trying most likely because an audiogram has limitations, there's another more specific test called the otoacoustic emission test, and that specific test looks
at the outer hair cell function in the cochlea, and it's more specific at understanding what
went wrong in the ear, is there any decline or changes
to the microscopic cells inside of the ear? So this is a common
question, a lot, a big point where people can get stuck on and then go down these rabbit holes of trying alternative
treatments, herbal supplements, acupuncture, all these things that may have some validity independently, but looking down these dark rabbit holes of trying to solve their tinnitus because they may be told
your hearing is normal.

Well, I made a full video on that, essentially, you're hearing
maybe in the normal range, but if we look closer into this OAE test, which most audiology clinics
have you, can ask for it, you'll see some decline,
which might be changes or different hearing than it used to be, that can create the chain of
events that leads to tinnitus, so that is a quick summary
of the Lenire device.

All right, now let's talk
about the Neosensory Duo, formerly known as, formerly
called the Neosensory Buzz, this is a wristband that
you wear on your wrist, and this is another way to present bimodal
stimulation for tinnitus. This device is available
in the United States and let's talk about what it
is and what you need to know. The two modes of stimulation
would be hearing and feeling through the somatosensory system, so through the skin, our
biggest organ, some say, the skin, so it's going
to be feeling beeps and hearing beeps at the same time. There is a training program which the company
recommends for two months, so it's essentially a rental process where you rent this
wristband for two months and you use an app,
the app presents tones, a series of ascending and descending tones of different pitches, and at the same time that
you're hearing the tones, because they're played through a phone, you're also feeling the tones because they're being
played through your skin.

And this is a very interesting product because understanding this, to me, it represents
showing the brain something at a subconscious level. Our thoughts, our
stories, our waking hours, we live in the conscious
part of the brain. When our brain is off,
when we're going to sleep, the conscious part of
our brain is turned off, but our brain's still existing, we're still hearing sounds
while we're sleeping, we're still breathing,
keeping our heart rate going to keeping our breathing going, getting oxygen in our system. The brain is working always to help us, the brain is constantly
processing information 24/7, so there's that conscious and the subconscious parts of the brain.

Now, the automatic reactions from the limbic system,
et cetera, of the brain are mainly happening at
a subconscious level. This means if you were to work
with a tinnitus specialist who was able to explain
how habituation works, how you recover to tinnitus, how the whole system works together, you can understand it
at a cognitive level, and that will definitely have some help, definitely have some effect
in making habituation happen as quickly as it can, but it doesn't necessarily
force or make habituation happen at a fast, fast, fast rate, so there's some dissonance there where people I work with, for example, understand the plan,
understand what to do, they're doing it, they're following tinnitus
retraining therapy, they're also using mindfulness
holistic principles, they're seemingly doing
everything that works, and a month in, two months in, they're not feeling quite
like much has changed, and keep going, keep going,
that's why it's recommended to stay with a professional
for six months, so just wanted to introduce those topics because one important thing from tinnitus retraining therapy
to impress upon the brain is that tinnitus is an internal sound.

By itself, it has no threat, it has no destructive meaning. Make sure you have your medical test, but it's likely not a brain tumor, not something that's going to hurt you, and it's an internal sound,
it's not an actual threat, like the sound of a predator or a snake or a tiger outside of our head, and when the brain fully understands that, the limbic system response, which is the automatic reaction to it, can calm down and can reduce. And when that really happens, there's typically progress
felt by the individual. Feeling better, thinking
about tinnitus less, not as bothered or annoyed by it, and down the road, months, months later, sometimes getting softer to
the sound reducing in volume, so that understanding that
tinnitus is an internal sound is so important, and what
this wristband device is doing through this training program
is it's showing the brain what high pitch tones, high pitch sounds, most people's tinnitus is high pitch, wearing this wristband and listening to about
10 to 20 minutes a day of this training app through
the phone, it's very passive.

When we say it's passive, we mean it's influencing
the, the subconscious parts of the brain, it's passive, it's a passive learning thing. And this shows the brain that tinnitus, the high pitch sound in
the head or the ears, it's an internal sound, and the wristband verifies every sound that's played in the external world. The wristband has microphones on it so that means the
wristband picks up my sound and it turns it into vibrations instantly. That's sort of cool, but you might say how does
that really help with tinnitus? Well, when the brain can
match, oh, that tone sound through the training program
in the app is matching with stimulation on the
wrist at the same time, then it gives the brain a chance to connect, oh, in the gaps,
well, I'm not hearing the tones through the training program and I'm not feeling the
vibration in those gaps, the brain's perceiving
or hearing tinnitus, the buzzy charge, the
electrical brain-charge sound, the high pitched ringing
of the auditory system in the brain, so that is the theory behind how this is going
to help reduce tinnitus by affecting those relationships, and an interesting question is
does the sound therapy matter because the tones, the training program for the Neosensory product
is relatively simple.

So one question myself,
audiology community has is does the sound therapy
need to be complicated or can it be so simple like this? So that's an introduction
into the Neosensory Duo, the wristband product which is formerly called
a Neosensory Buzz, for tinnitus and how it works. I want to read some
information from the company that I was given about
the research so far. To try to make this as
evidence-based as possible with a caveat that both of these products, both of these technologies
that I talked about today are relatively new.

It's not at the level where
we can say you must try this, this is guaranteed to work, to help you. It's not there, but it's
the best thing we have. So we're looking into it more and trying to understand
as much as we can. All right, so the typical performance for someone who improves with
the Neosensory Duo product is around 15 points on the
tinnitus functional index, which is a questionnaire. Some of the subjects, around
15%, were non-responders in the clinical trials or the studies, the internal studies that Neosensory did. And that correlated well
with the Lenire study, which found that 11% of their participants were non-responders to bimodal therapy. So participants who didn't improve and those who did improve almost formed these two different groups, but it's not clear as to why yet, it could be different causes of tinnitus, it could be sustained activation
of anxiety in psychology, which could be affecting the system. Other points of view are, are
still being studied on this. Now, for some overall similarities between the Neosensory Duo
wristband and the Lenire device, the bimodal device with the
tongue and the headphones from the company Neuromod
and the Lenire product, the overall similarity is that they're both using
science of bimodal stimulation.

They're both stimulating
different non-auditory parts of the nervous system to connect it with the
auditory stimulation, hence showing the brain at
different levels of the brain that the tinnitus signal is internal and there are these ways
to verify external sounds. Those are the similarities. They're, another similarity is that both of these are
using around a two-month, six to eight week time window
for the initial analysis of is this working, and potentially that would be the training
program in itself. Neither of these products are
designed to be used forever or designed to be used
for longer than a year.

Even ear level sound generators,
which help with tinnitus, in tinnitus retraining therapy, after one year, after a year and a half, many people do stop using them because they don't need them anymore. So very clear with all of this knowledge that there is some retraining going on and when the brain can
show that neuroplasticity, the plasticity of the neurons, the changes of the
neurons in a healthy way, that once it's changed in a healthy way, you don't need the technology anymore. So those are some similarities
between the products, between the technologies, and it took me a while to learn all this. I'm still learning on these technologies, but I feel that it's important for the audiology
professional community to, especially those who are tinnitus experts, tinnitus specialists, to learn all this as quickly as possible because many people watching
this will have questions and we want to help you
guys as soon as possible and essentially counsel
you on what is reasonable for your expectations of where you're at, what can you expect for
the months, year to come, what is in your control, what can you actively do to improve, and what is out of your control, what is something that's
worth investing your time and energy into and what might be a distraction
or keeping you stuck, so my hope is that this presentation has given you an introduction and potentially a lot of
educational information on what these two technologies are, the theory behind how it works, and answering some of the common questions of if it's right for you.

As the caveat, I also did
two full independent reviews of these products on my YouTube channel, which you can find if
you're looking for more or you can reach out to us via our email and our team can help you. (suspenseful music).

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