New University of Michigan Tinnitus Discovery — Signal Timing

[Harder Calm]

I am not here that often these days.

What is the roadmap (trials, release dates etc.)?

When can we expect to have final trial results and "real world" experiences?

Thanks in advance.

There are delays with the trials and the FDA application. In mid-2022 we should know more. Apparently the company Auricle Inc. is being built up in hopes to commercialize the product.

Furthermore, it seemed they were planning an application to Republic (which supposedly got delayed as well?).

So I guess you can check again in summer 2022 and hopefully there will be good news by then...

 

[Padraigh Griffin]

As I said before, the best solution here is for a company like Lenire to buy Dr. Shore's device for a suitable price. They have a non-performing product, but great marketing and distribution. A combination of Dr. Shore's device and Lenire might work. Either on their own won't. The synergy is strong.

I would be hesitant to invest millions in anything tinnitus related when one clinical breakthrough could KILL your product immediately.

The cure will come, and personally I think it will be through brain interface tech, but hey who am I to predict the future

 

[DimLeb]

The cure will come, and personally I think it will be through brain interface tech, but hey who am I to predict the future

I really hope it comes sooner, but I believe this would take at least 50 years to become a thing unfortunately...

 

[Padraigh Griffin]

I really hope it comes sooner, but I believe this would take at least 50 years to become a thing unfortunately...

No way dude. By 2030 we will be all augmented in some way. Chips in the brain will be routine. If you want one that is. All the gurus are saying it. It will happen.

 

[tokyorequiem]

You make it sound as if I'm the only one on this board who is questioning her level of commitment to this project. Obviously you're biased because you directly benefitted from it, but meanwhile, the rest of us haven't, because it's been in limbo for years. I don't buy the idea that she has invested as much time in it as she should considering how compassionate and concerned she is supposed to be on this issue.

Apples and oranges but we got multiple COVID-19 vaccines in less than a year. I do not think the timeline of Shore's device reflects normalcy. It's been moving in slow-motion. The trial sizes have also been comically small. Lenire's trials, flawed as they may have been, were so much larger. Why? I don't like being a backseat driver but despite being a layman, this project doesn't seem to have been well run.

Doesn't mean it will be a failure, but if it is a success then its release date will have come many years after it theoretically could have due to how it was run. Maybe it's an entitlement mentality or my desperation talking but I can't pin a medal on Susan Shore if I feel that things have been moving needlessly slow for so long, effective or not.

Also, nobody has yet really gotten a suitable explanation from Shore as to why it's taken so long. She is hit mostly by softball questions without any followup, which bothers me. Not that she should be burned at the stake but there has been something fishy going on here for a long time and a bit of braver journalism, someone willing to burn some bridges, would probably have been able to get to the bottom of it by now. Instead we can only speculate. It's the itch that can't be scratched.

Note that mRNA was previously developed tech that has been repurposed. This group is starting from scratch. I have tinnitus. And I work as a college professor. The speed and direction of research is heavily affected by funding. So COVID-19 is not really a useful comparison.

Also, professors spend at most 40 percent of their time on research. The rest is teaching, admin. The more senior you get, the more admin there is. But yes, it is likely true, that grading papers are being given precedence over finding a tinnitus cure for some part of the year, every year.

Lastly, if you're being careful, and you want the results peer-reviewed, it's going to be measured in years, not months, unless you're dealing with something like COVID-19.

All in all folk should respect the work being done here IMHO. They're being careful, and they're operating under funding and time constraints most likely.

 

[Harder Calm]

Note that mRNA was previously developed tech that has been repurposed. This group is starting from scratch. I have tinnitus. And I work as a college professor. The speed and direction of research is heavily affected by funding. So COVID-19 is not really a useful comparison.

Also, professors spend at most 40 percent of their time on research. The rest is teaching, admin. The more senior you get, the more admin there is. But yes, it is likely true, that grading papers are being given precedence over finding a tinnitus cure for some part of the year, every year.

Lastly, if you're being careful, and you want the results peer-reviewed, it's going to be measured in years, not months, unless you're dealing with something like COVID-19.

All in all folk should respect the work being done here IMHO. They're being careful, and they're operating under funding and time constraints most likely.

Fully agree! 40 % time for research might even be optimistic, but it depends and might be better in the US. For the mRNA vaccinations there already existed several well-funded biotech companies backed up with big pharma companies working exclusively on an existing technique for a while, even though they could not commercialize it before COVID-19.

Unfortunately, for tinnitus we are still far away from this. Of course it is just frustrating to see how slow the progress with tinnitus is, but we must be glad some researchers still pursue this (despite the little public funding and attention they get) and don't just give up on it at all and turn to possibly easier and more lucrative things. It is a tough career choice to work on a condition that has tormented mankind for ages, but is still today in our modern age hardly even measurable/diagnosable by doctors (my ENT literally told me after the hearing test when seeing my perfect audiogram that today I have no tinnitus on the day after what felt like a night with a chainsaw in the ears - and there are certainly many similar stories on ENTs here...).

So it's high risk/high gain, for a cure they will get fame and money, but how likely is that? It might be as well just a useless career spend for nothing while your fellows working on cancer (or whatever) make a fortune... So if you look at it from a career-perspective, only few will take this risk, and if they do it's believable that they actually do care about tinnitus sufferers to some extent (or even have it themselves), and despite things going so slowly let's not blame them but be grateful they are doing it and support it (studies, donations, awareness etc.) as well as we can.

 

[Harder Calm]

As I said before, the best solution here is for a company like Lenire to buy Dr. Shore's device for a suitable price. They have a non-performing product, but great marketing and distribution. A combination of Dr. Shore's device and Lenire might work. Either on their own won't. The synergy is strong.

I would be hesitant to invest millions in anything tinnitus related when one clinical breakthrough could KILL your product immediately.

The cure will come, and personally I think it will be through brain interface tech, but hey who am I to predict the future

I get the point, but one can also see it from this perspective: If Dr. Shore is not simply selling her technology to Lenire or trying to "cash in" otherwise, and is even building up a company without an FDA approval yet, it is likely that she is convinced that the treatment is effective and expects to obtain FDA approval, and also optimistic to beat Lenire despite their (preliminary) advantages you mentioned. It's simple business: If you have little to offer, you just try to sell it somehow, if you have something great in store, you want to earn all the reward yourself! I know, maybe I just want to make myself hope... But why else should she want to do something as risky? After people got so sceptical with Lenire, people won't buy just another Lenire, so I expect the ssuccessof Auricle will really depend on the FDA approval.

 

[OptimusPrimed]

I believe Dr. Shore's overactive DCN theory is in the right ball park because my tinnitus is noise induced and the only things that give me temporary relief are neuromodulation, high doses of depressant drugs or long, hot showers where the water strikes the back of my head for many minutes. I get temporary relief from these things, I think her and the others could be onto something.

 

[Padraigh Griffin]

I think she is too. Let's all think positive! Plus I'm having a terrible tinnitus day. My tinnitus is myogenic and I'm having surgeries but I also think my fusiform cells are having a daily party in the DCN. I must have 2/3 types of tinnitus.

I emailed Dr. Shore asking if there was any chance she'd accept international patients for her clinical trial. She responded within hours. Just a testament to her respect for each individual experiencing tinnitus. Unfortunately the answer was no but she made a CBT recommendation.

The fact she responded makes her a legend. Nice lady. Let's get it over the line now!

I was convinced that the somatic modulation of my tinnitus was linked to the hyperactivity in the DCN. Dr. Shore's trial target somatosensory tinnitus. I recently had my middle ears muscles sectioned and the ability to modulate my tinnitus on the operated ear has vanished or at least diminished significantly. There might be a link here somewhere. I must email Dr. Shore again as my case is quite unique.

 

[R0B]

I was curious about the FDA approval process.

Specifically, I was wondering if this is true - Since Lenire has already applied for FDA approval and is first in line (ahead of the University of Michigan), does that mean that if they are approved first then it will make it easier/faster for subsequent devices that rely on similar technology (bimodal I think it's called) to be approved?

I guess my thinking is that if there is some precedence in the technology it would make the approval process quicker.

 

[Gb3]

Specifically, I was wondering if this is true - Since Lenire has already applied for FDA approval and is first in line (ahead of the University of Michigan), does that mean that if they are approved first then it will make it easier/faster for subsequent devices that rely on similar technology (bimodal I think it's called) to be approved?

Of course.

 

[IntotheBlue03]

Tinnitus newbie here.

Does anyone have any of the clinical trial results/pre-clinical trial results of Dr. Susan Shore's device? I can't seem to locate anything and was wondering outside of Susan's very impressive academic background and the rigorousness of the trials why there is so much confidence in it.

Thanks so much and forgive my ignorance.

 

[DebInAustralia]

Does anyone have any of the clinical trial results/pre-clinical trial results of Dr. Susan Shore's device? I can't seem to locate anything and was wondering outside of Susan's very impressive academic background and the rigorousness of the trials why there is so much confidence in it.

Specially timed signals ease tinnitus symptoms in test aimed at condition's root cause

I have followed Dr. Susan Shore since my tinnitus onset in 2013. I believe her device for some subsets of tinnitus has a lot of potential.

We have a poster (@linearb) on here who has participated in the earlier trial, and has reported that the device did reduce his tinnitus and the effects (from memory) persisted for 2 weeks? (Correct me if I am wrong).

@Hazel has announced that Dr. Susan Shore will be participating in the Tinnitus Talk Podcast next year once her trial ends.

 

[AfroSnowman]

Tinnitus newbie here.

Does anyone have any of the clinical trial results/pre-clinical trial results of Dr. Susan Shore's device? I can't seem to locate anything and was wondering outside of Susan's very impressive academic background and the rigorousness of the trials why there is so much confidence in it.

Thanks so much and forgive my ignorance.

Auditory-somatosensory bimodal stimulation desynchronizes brain circuitry to reduce tinnitus in guinea pigs and humans

 

[OptimusPrimed]

Tinnitus newbie here.

Does anyone have any of the clinical trial results/pre-clinical trial results of Dr. Susan Shore's device? I can't seem to locate anything and was wondering outside of Susan's very impressive academic background and the rigorousness of the trials why there is so much confidence in it.

Thanks so much and forgive my ignorance.

Her results were positive, that is about all you need to know. Between her work and a handful of others, they are finding that bimodal stimulation of nerves that connect to the dorsal cochlear nucleus (mainly the trigeminal and vagus) is having a reductive or positive effect on the tinnitus of sufferers. Mainly somatosensory tinnitus, and subjective tinnitus. The theory is that the fusiform cells in the dorsal cochlear nucleus are overactive and respond to a lack of signal from the cochlea following auditory damage. They react by over-reacting, be it through hyperactivity or be it through mal-adaptive plasticity...basically signals from the somatic system (muscles) are picked up by the DCN and passed on as phantom sound - tinnitus. The brain hates gaps, so when it lacks data input from the cochlea it tries to fill those gaps.

 

[IntotheBlue03]

@OptimusPrimed, thank you kindly! I did read some subjects we recruited based on head and neck maneuvers that altered their tinnitus. Curious if anyone can verify if "jaw clenching" that increases tinnitus is known to be somatic in nature? I keep locating this information in random posts across Tinnitus Talk.

 

[AfroSnowman]

Curious if anyone can verify if "jaw clenching" that increases tinnitus is known to be somatic in nature?

Yup.

 

[DimLeb]

I wonder what happens if you have multi-tone tinnitus and some sounds are affected by jaw and neck movements, while others are not.

Maybe the device would only help the first ones? I really hope the device helps the majority of it!

 

[IntotheBlue03]

@DimLeb, yes I'm hoping some folks with more knowledge/experience with Dr. Shore's work can shed light on this but at least from what I'm interpreting from the previous links shared it sounds like this device gets at the root cause of tinnitus regardless of nature of development?

Specially timed signals ease tinnitus symptoms in test aimed at condition's root cause

Auditory-somatosensory bimodal stimulation desynchronizes brain circuitry to reduce tinnitus in guinea pigs and humans

 

[DebInAustralia]

Curious if anyone can verify if "jaw clenching" that increases tinnitus is known to be somatic in nature? I keep locating this information in random posts across Tinnitus Talk.

Yes that is somatic.

 

[IntotheBlue03]

@DebInAustralia, @AfroSnowman, @OptimusPrimed:

I just wanted to send a personal thank you for all of the swift and informative responses. I don't want to take up too much space in such an important forum but as a newbie who's moving through the "grief" process at the moment I am extremely thankful and amazed at the community and resources everyone has put together here.

Wishing you all a peaceful and restful evening from the East Coast.

 

[DebInAustralia]

@DebInAustralia, @AfroSnowman, @OptimusPrimed:

I just wanted to send a personal thank you for all of the swift and informative responses. I don't want to take up too much space in such an important forum but as a newbie who's moving through the "grief" process at the moment I am extremely thankful and amazed at the community and resources everyone has put together here.

Wishing you all a peaceful and restful evening from the East Coast.

You're welcome.

We're all in this together. You're not alone.

 

[Survivor234]

Hi. I was in an email conversation with Dr. Susan Shore and was told that her device works with noise-induced tinnitus as well (I thought it was only tinnitus caused by TMJ and the like since the clinical trials asked for participants whose tinnitus can be changed with a head or jaw movement).

I have responded back by asking to what degree does it work since a minimum amount of hearing loss was required for participation in the clinical trials as well (i.e. "No greater than a mild hearing loss up to 6 kHz, and no greater than a moderate hearing loss at the tinnitus frequencies").

I haven't received a response yet (I just responded this morning when I woke up).

 

[2noist]

was told that her device works with noise-induced tinnitus as well (I thought it was only tinnitus caused by TMJ and the like since the clinical trials asked for participants whose tinnitus can be changed with a head or jaw movement).

Why is it so hard for people to understand what somatic tinnitus is?

Up to 80% of tinnitus sufferers (including noise-induced tinnitus) can modulate their tinnitus pitch and/or loudness by jaw and/or neck movements. And that ability is considered somatic tinnitus.

Dr. Shore's device can work for a lot of people then.

 

[Survivor234]

Why is it so hard for people to understand what somatic tinnitus is?

Up t0 80% of tinnitus sufferers (including noise-induced tinnitus) can modulate their tinnitus pitch or loudness by jaw and/or neck movements. And that ability is considered somatic tinnitus.

Dr. Shore's device can work for a lot of people then.

Yes, that is what I meant. I thought Shore's device could only work with somatic tinnitus but I wanted to know if it would work for noise-induced tinnitus. Considering that the device targets tinnitus-causing neurons, that somewhat makes sense but I am still surprised that it works.

As for noise-induced tinnitus sufferers modulating their pitch with their jaw or neck, that's a surprise to me! I can't do that. My tinnitus is constant. I also only recently realized I had tinnitus so forgive me if I am ignorant.

 

[Survivor234]

She responded to my email with this:

Most people with noise induced hearing loss can modulate their tinnitus.

Moderate hearing loss is a characteristic of those who have benefited in the trial.

Unfortunately I don't have time for ongoing conversations but have added you to our mailing list for updates next summer.

Best wishes,
Susan Shore

"Next summer"? It looks to me that next summer is when they'll start getting ready to commercialize the machine or at least will become public about many things pertaining to it.

 

[IntotheBlue03]

@2noist, this is actually news to me, regarding the 80% can modulate their tinnitus including noise induced stat. Is there any further studies you can point me to regarding this? I'm new to tinnitus as well so forgive the ignorance.

 

[Harder Calm]

Yes, that is what I meant. I thought Shore's device could only work with somatic tinnitus but I wanted to know if it would work for noise-induced tinnitus. Considering that the device targets tinnitus-causing neurons, that somewhat makes sense but I am still surprised that it works.

As for noise-induced tinnitus sufferers modulating their pitch with their jaw or neck, that's a surprise to me! I can't do that. My tinnitus is constant. I also only recently realized I had tinnitus so forgive me if I am ignorant.

No worries!

In the experiments with the guinea pigs, they indeed got noise-induced tinnitus and for them the device apparently also helped in the studies. So even though somatic tinnitus is the main target that is being studied in the trials, there is hope it will help beyond. Furthermore, I think it was posted here before that some people can have somatic tinnitus but they don't know because they don't know how to modulate it.

So altogether, "noise-induced" does not exclude "somatic".

 

[Mathew Gould]

No worries!

In the experiments with the guinea pigs, they indeed got noise-induced tinnitus and for them the device apparently also helped in the studies. So even though somatic tinnitus is the main target that is being studied in the trials, there is hope it will help beyond. Furthermore, I think it was posted here before that some people can have somatic tinnitus but they don't know because they don't know how to modulate it.

So altogether, "noise-induced" does not exclude "somatic".

I wonder if this device helps with eye floaters from neck and jaw issues.

 

[IntotheBlue03]

@Survivor234, I believe @Harder Calm provided an update that the trials and FDA application are delayed but that we could expect an update by mid 2022?

The commercialization process is being setup now I believe in the form of Susan's company Auricle.

Please feel free to correct me anyone who is more in the loop. Hoping that commercialization and completion of the trials in mid 2022 are on parallel tracks.