New University of Michigan Tinnitus Discovery — Signal Timing

[eagerUser]

But then people would nag and say why are they so slow and don't commercialize their device!

C'mon guys, wouldn't it be better if we waited a bit more to see the results if we're not going to try it out ourselves!

I don't really understand why people are always trying to find a bug in a process.

This kind of negativity can play a huge role in the failure of a business. Don't give off Negative energy guys.

 

[Kam75]

Hi there, it's my very first post here.

I wonder why everybody here seems so excited about Susan Shore's device. This device was tested on people who suffer from somatosensory tinnitus which means basically that can be diminished by moving the jaws.

Yet most of people who have tinnitus have it due to noise. So her device might not work on most of us, if I understood. Or maybe a recent study showed that Susan Shore's device could heal noise induced tinnitus?

Anyway, I'm kind of pessimistic about a device/medicine that would cure 100% of the tinnitus.
I think that there will be peace between Israel and Palestine before we find a cure for our suffering.

 

[Don Tinny]

I wonder why everybody here seems so excited about Susan Shore's device. This device was tested on people who suffer from somatosensory tinnitus which means basically that can be diminished by moving the jaws.

She told me via email that her device "might work" for non-somatic tinnitus patients. But she is not sure.

Noise-induced tinnitus can have a somatic component too.

Mine is non-somatic anyway... I'm more focused on Lenire but any progress is welcome.

 

[Jazzer]

Hi there, it's my very first post here.

I wonder why everybody here seems so excited about Susan Shore's device. This device was tested on people who suffer from somatosensory tinnitus which means basically that can be diminished by moving the jaws.

Yet most of people who have tinnitus have it due to noise. So her device might not work on most of us, if I understood. Or maybe a recent study showed that Susan Shore's device could heal noise induced tinnitus?

Anyway, I'm kind of pessimistic about a device/medicine that would cure 100% of the tinnitus.
I think that there will be peace between Israel and Palestine before we find a cure for our suffering.

Of course - every single one of us needs a an effective treatment to reduce noise, and ideally a cure.
But not everything can be fixed, can it?

At the same time as hoping for a cure, my own emphasis has to be on coping methods.

We have to cope with today and tomorrow - here and now.

That is the absolute reality,
and I am a pragmatist.

 

[Paulmanlike]

Susan Shore making comments that it "might work for non -omatic tinnitus" would not give me reassurance to pay thousands for a treatment. Neuromod need her on board to get the bimodal experts together - this business will explode if it does indeed translate the results from their trials to everyday patients.

But it's too early to tell yet, I am still cautiously optimistic because a few years ago the exact same hype was for ACRN with fancy scientific videos and even to this day that costs thousands but where are the testimonials? Before that there were hopes in AUT-00063, Auris Medical, low level laser therapies. None of them worked for tinnitus except for a rare or 2 positive comments which is to be expected with placebo effect etc. The only thing that has come close was Trobalt - that turned Tinnitus Talk members blue and gave them milky man boobs. I'd rather have tinnitus than be a big titted Smurf (or maybe not!)
It isn't sending negative vibes at all - I understand the history of tinnitus treatments/research and keep up to date with it. There has been nothing but hopes and disapppintments over the last decade (FACT). Potentially Neuromod could work and I hope it does and so does everybody else - but we all got to keep an open mind.

Where I am hoping to see bimodal going:

- Neuromod treats patients and we see the results and get expectations what it's like.
If that turns out to be great - audiologists across the globe adapt to this revolutionary new treatment - it becomes a gold standard for tinnitus care - the company makes lots of money and as time goes on they gather more data and tweak things and have newer improved versions or better ideas who benefits and who won't. That's best case scenario.

On top of that, Susan Shore will be encouraged and go on with studies how she can redefine these things and work as a competitor or possibly Neuromod hire her giving her a huge salary to work for them.

During this time it will be newspaper headlines - but it hasn't at the minute because all these great floods of evidence don't exist yet.

Worst case.

Patients try it, either no effect for a majority or comments like it's made me habituated. Believe it or not, I believe in habituation and I am habituated myself to a degree -THAT DOESN'T MEAN I LIKE IT. Patients like me would merely see it as another sound therapy to help to get me where I am today - habituated- I am after a reduction in volume where I don't hear it over TV, driving on the phone etc.
They will go on selling it, a few audiologists will take on it for the money and no headlines will happen because journalists know it isn't this "breakthrough".

 

[ChrisBoyMonkey]

Hi there, it's my very first post here.

I wonder why everybody here seems so excited about Susan Shore's device. This device was tested on people who suffer from somatosensory tinnitus which means basically that can be diminished by moving the jaws.

Yet most of people who have tinnitus have it due to noise. So her device might not work on most of us, if I understood. Or maybe a recent study showed that Susan Shore's device could heal noise induced tinnitus?

"Patients were chosen who had the ability to alter the sound of their own tinnitus, making it louder or softer by clenching their jaws, flexing their necks or sticking out their tongues – indicating that they'd worked out ways of changing the activity of fusiform cells by themselves."

Source: https://newatlas.com/tinnitus-cure-treatment-headset/52854/

Noise induced tinnitus is not being excluded. By somatosensory tinnitus, she has said she means people who can "modulate" their tinnitus, not only those who can diminish it.

 

[ChrisBoyMonkey]

She told me via email that her device "might work" for non-somatic tinnitus patients. But she is not sure.

Noise-induced tinnitus can have a somatic component too.

Agreed. Mine is noise induced and I can modulate it with somatic maneuvers.

 

[Mathew Gould]

My tinnitus is a result of neck and jaw issues because everything started on the same day.

I used to be able to modulate my tinnitus (secondary sound) and I think I no longer can.

Would the Dr. Susan Shore device work for me?

I still have neck and jaw issues also.

 

[ChrisBoyMonkey]

My tinnitus is a result of neck and jaw issues because everything started on the same day.

I used to be able to modulate my tinnitus (secondary sound) and I think I no longer can.

Would the Dr. Susan Shore device work for me?

I still have neck and jaw issues also.

It seems that would be more of a question for her and her team.

Here's the study, being able to modulate the tinnitus is part of the inclusion criteria, and she has said that she does not yet know if it will work for those who can't modulate the tinnitus.

https://clinicaltrials.gov/ct2/show/NCT03621735

 

[GlennS]

She told me via email that her device "might work" for non-somatic tinnitus patients. But she is not sure. Noise-induced tinnitus can have a somatic component too.
Mine is non-somatic anyway... I'm more focused on Lenire but any progress is welcome.

I really don't care in the end if people file into camp Shore vs. Neuromod although I struggle to accept the logic behind favoring her device other than the "academia = good, capitalism = bad" ideology.

The first post in this thread goes all the way back to 2013. If she's so big on research, why should she be limited to saying her device "might work" for bog standard noise-induced tinnitus? Why would we be able to point to so few test subjects? What else has she been doing with her time these last 7 years that has kept her from running more trials? She's had more than enough time to find out if it works for non-somatic patients.

This is why I accused her of being the sloth from Zootopia. Her now starting to run more trials and pivot towards commercialization in 2019 is all well and good, but it doesn't change the looong timeframe where things seemed to be moving at a snail's pace, and it leaves people wondering how effective it might really be given the lack of test data vs. Neuromod.

So again, I don't understand why people think her device will be more effective. Sure, she's an academic, and maybe they've spent years tweaking the device, but where is the test data to show for all that so-called refinement?

Neuromod, in the PowerPoint presentation, demonstrated that they've been iterating rapidly to try to improve efficacy since Hubert Lim joined the team. So it's not like they stopped researching either.

If you want to point to a rival to Lenire coming out of academia, the device from University of Minnesota seems more promising to me, because we have someone here who was on that trial with bog standard tinnitus who was helped greatly by it. That project also seems to be moving slowly and doesn't have a ton of test subjects but it at least seems to be the real deal.

 

[Piney]

Neuromod is literally putting devices in people's hands. Their's just no concrete updates from these other entities on price, product, new theories, adjustments. Of course I hope they all work and just get better, but it just seems like their light years behind by lack of info. I wish they would bring all their devices, wires and tongue tips into a room with a big round table and build the Tcure 1000 model.

 

[Frédéric]

Mechanisms of Noise-Induced Tinnitus: Insights from Cellular Studies. Susan Shore's team
July 3, 2019 Elsevier Inc

 

[Autumnly]

Mechanisms of Noise-Induced Tinnitus: Insights from Cellular Studies. Susan Shore's team
July 3, 2019 Elsevier Inc

"For those estimated 15 million in the United States and quarter billion people worldwide with debilitating tinnitus (McCormack et al., 2016, Shargorodsky et al., 2010), the sound of silence is a dream out of reach." Really glad to see the word "debilitating" in association with tinnitus more often. Thank you @Frédéric for always looking out for new interesting articles and studies!

 

[GregCA]

"For those estimated 15 million in the United States and quarter billion people worldwide with debilitating tinnitus (McCormack et al., 2016, Shargorodsky et al., 2010), the sound of silence is a dream out of reach." Really glad to see the word "debilitating" in association with tinnitus more often. Thank you @Frédéric for always looking out for new interesting articles and studies!

I agree! Props to @Frédéric for all of the research he spoon-feeds us!

 

[Piney]

That's a lot of info and data, but what's it worth if a cure isn't found for anyone present? I just think they're approach is too delicate for certain people. They need to find a way to short circuit the system through the cochlea. Being severely deaf they comment we don't want to turn the device up too much to damage hearing. Forget that crank up the tones and voltage, I could care less about what hearing I have left I want silence. I contacted Shore and she referred me to her colleague but I can't modulate anything with my jaw or anything else. I guess that's my only worthwhile opinion, let's get a product and get aggressive I will trial it. I tried Otonomys drug trial too but I was denied since it was longer than 6 months.

 

[KMc24]

Just listened to the podcast with Dr. Shore on the ATA website dated July 23, 2018. She said they would be looking at commercialization in the coming year 2019.

Well, this year is half way over, and now she says 2020. Should we just add another year on to that too?

Not very confident that this device will be hitting the clinics as she says anytime soon.

 

[Autumnly]

Just listened to the podcast with Dr. Shore on the ATA website dated July 23, 2018. She said they would be looking at commercialization in the coming year 2019.

She said by the end of 2019 commerzialisation efforts might begin but that doesn't mean the device would be launched in 2019:

"Well, it depends on how the trial – the outcome of the next trial is. And hopefully, by the end of next year, we will have that trial tied up, or we'll at least have a very good idea of how the trial has worked out. And then depending on that, then there would be commercialization efforts to move this to the clinic.

[...] by the end of next year. But I'm saying that's when these efforts would begin. I wouldn't want to promise anything sooner than it might happen." - source

 

[GoatSheep]

I have been in contact with the University of Michigan regarding their trials for their device.

Jacqueline Kjolhede told me taking Clonazepam makes you ineligible unless you've ceased use for at least 6 months.

I don't know if this info is already out there so may be valuable for other hopeful participants to know.

 

[TomBradyGOAT]

I have been in contact with the University of Michigan regarding their trials for their device.

Jacqueline Kjolhede told me taking Clonazepam makes you ineligible unless you've ceased use for at least 6 months.

I don't know if this info is already out there so may be valuable for other hopeful participants to know.

Big surprise. Seems like Clonazepam makes me ineligible for every clinical trial. Made me ineligible for a drug to treat OCD.

 

[Stefaniie]

Since I'm not qualified for Lenire, Susan Shore is my next best bet. Really hoping her device's hearing requirements aren't as strict. I've emailed her about it and will let everyone know what her response is, if I get one.

 

[Alue]

Shore's device has been used on 20 patients with only somatic tinnitus... (and claiming, it so seems, to be on the market next year based on 20 people??)

Neuromod's device has been used on over 500 people with rigorous clinical trials and been submitted for peer review

I would seriously want to see the evidence before parting with a couple thousand... I know what desperation does to one suffering but there's nothing worse than buying things to be disappointed you've been conned (not saying it's a con - but more trials are needed to build an evidence base and likelihood of it working).

The way I see it, Neuromod is rushing things to be first to market. Only time will tell.

 

[Stefaniie]

I recieved a reply from Dr. Shore.

My question:

I am emailing to ask about the hearing requirements for your device. I have been keeping up with Neuromod's Lenire for quite a while and was disappointed to hear that I don't meet the hearing requirements needed in order to qualify for the use of Lenire. Will yours have similar requirements?

Shore's response:

Hello,

I am not aware of restrictions on other products so I cannot comment.
Our main criterion for inclusion in our trial is that the person must
live within 100 miles of Ann Arbor.

Best wishes,

Susan Shore

 

[Sironketchup]

Dear Simon,

Thank you for reaching out to me.

I sympathize with you and other tinnitus sufferers that are in search of a cure, and this is largely what has motivated my research and lead to our current FDA clinical trial.

You are doing what all tinnitus sufferers can do, which is to mitigate and manage symptoms through currently available options. You have also sought care from professional and experienced care providers, and I am hopeful that some course of treatment will mitigate your symptoms.

Although we are still actively recruiting subjects for our pivotal FDA clinical study and I appreciate your interest in participation, our inclusion criteria unfortunately require that participants reside within 100 miles of the study site. The protocol stipulates that participants come to the study site for weekly visits and evaluation during the 6-month treatment period, so this is why we require that participants reside nearby.

Best wishes in managing your tinnitus, and we will be sure to keep you informed of our trial outcome.

Susan Shore

 

[Stefaniie]

I recieved a reply from Dr. Shore.

My question:

I am emailing to ask about the hearing requirements for your device. I have been keeping up with Neuromod's Lenire for quite a while and was disappointed to hear that I don't meet the hearing requirements needed in order to qualify for the use of Lenire. Will yours have similar requirements?

Shore's response:

Hello,

I am not aware of restrictions on other products so I cannot comment.
Our main criterion for inclusion in our trial is that the person must
live within 100 miles of Ann Arbor.

Best wishes,

Susan Shore

I'm not sure how to interpret this. It seems like she's carefully avoiding giving out too much information. Surely at this point she would know how much hearing you need to use her device.

 

[ChrisBoyMonkey]

I'm not sure how to interpret this. It seems like she's carefully avoiding giving out too much information. Surely at this point she would know how much hearing you need to use her device.

It looks like it's not as a big concern for her device to me.

I also think her device is probably being looked at by the FDA right now, or if not will be soon. Maybe if we all email them and blast their higher channels we can influence a faster approval? I've emailed them before, I can provide a rough template from what I've used before.

 

[Cal18]

It looks like it's not as a big concern for her device to me.

I also think her device is probably being looked at by the FDA right now, or if not will be soon. Maybe if we all email them and blast their higher channels we can influence a faster approval? I've emailed them before, I can provide a rough template from what I've used before.

Hi Chris, can you let us know where to send the email for the FDA and also provide your template?

 

[dayma]

I do not believe anything has been submitted to the FDA for pre-market or any type of approval. It would be a Medical Device Class 1. You can search the FDAs site if you get bored.

You can see Michigan submitting other devices but not for Tinnitus. Yet.

https://www.fda.gov/medical-devices

 

[JohnAdams]

Is there an actual explanation about why tinnitus happens and how and why this signal timing stuff is effective?

 

[GregCA]

Is there an actual explanation about why tinnitus happens and how and why this signal timing stuff is effective?

Yes. Watch Dr Shore's presentations.

 

[ChrisBoyMonkey]

I do not believe anything has been submitted to the FDA for pre-market or any type of approval. It would be a Medical Device Class 1. You can search the FDAs site if you get bored.

You can see Michigan submitting other devices but not for Tinnitus. Yet.

https://www.fda.gov/medical-devices

She told me in an email where I was asking about the availabilty of the device and she said it won't be in the next 12 (now 11) months and she can't say much more because it is under investigation.