New University of Michigan Tinnitus Discovery — Signal Timing

[TheDanishGirl]

Oh boy, here I go answering questions again.


Yes. From what I understand, if it's somasensory and it involves modulating tinnitus via movement, then it involves the DCN. To answer your bottom questions, most likely yes and yes .

Good questions. People with hearing loss that can modulate are somasensory, meaning the brain picks up somatic (body) movement. People with TMD tinnitus have somatic tinnitus, which is tinnitus being caused by the body. In your case, I'm pretty sure it counts.

You're legible, but try other things to see how somasensory your tinnitus is. Try thrusting your jaw outward, and pushing it back inward.

Just tried this several times, no change I am afraid.

 

[threefirefour]

Just tried this several times, no change I am afraid.

Sorry you had no success. It's interesting that you cant do that, but you can modulate it by biting down hard.

Your somasensory tinnitus (assuming it truly is) seems to be linked to your jaw. Try some of these to look for a change:

 

[Markku]

@Steve said that apparently Susan Shore didn't make it to the TRI conference after all (relating to my previous update above where I had been told she would be there for one day). Just an update in case someone was waiting for material about her.

 

[threefirefour]

@Steve said that apparently Susan Shore didn't make it to the TRI conference after all (relating to my previous update above where I had been told she would be there for one day). Just an update in case someone was waiting for material about her.

Thanks for the update. Very unfortunate

 

[reeax]

Now this looks very promising (given the small scale trial results) for people with somatic tinnitus. I have asked if it possible to get a trial device outside of USA.

 

[threefirefour]

Now this looks very promising (given the small scale trial results) for people with somatic tinnitus. I have asked if it possible to get a trial device outside of USA.

The one criteria is that you have to be able to fly to michigan once a week, so practically, no.

 

[reeax]

Ah too bad, however as it is a pretty simple device - sound & electric impulses (there are thousands of these on the market) - it could go on sale very quickly, perhaps even this year.

Susan Shore's thinking is very interesting and simple. She basically postulates that if it is possible for somebody to modulate & reduce tinnitus with pressure & movements, an external device should be able to produce the same effect. The whole issue was to understand the underlying mechanism (what happens when you move jaw or press on the cheek for example) so it could be replicated.

I think that they really have something, but it seems plausible only for people able to reduce their tinnitus with physical manipulations. Pretty excited about this stuff, given the provided results.

 

[threefirefour]

Ah too bad, however as it is a pretty simple device - sound & electric impulses (there are thousands of these on the market) - it could go on sale very quickly, perhaps even this year.

Susan Shore's thinking is very interesting and simple. She basically postulates that if it is possible for somebody to modulate & reduce tinnitus with pressure & movements, an external device should be able to produce the same effect. The whole issue was to understand the underlying mechanism (what happens when you move jaw or press on the cheek for example) so it could be replicated.

I think that they really have something, but it seems plausible only for people able to reduce their tinnitus with physical manipulations.

It's very unlikely it goes on sale this year, but it is in the realm of possibility. The phase-II trials will most likely begin anywhere this September-November, and last for about 9 months to a year.

The most likely year it's released is early or mid 2020, but it could be released in 2019, if they're able to submit their post approval study right after the phase II trials, and the FDA accepts it quickly. The average time for a device like this would be 6 months, or 3 months if it's submitted as a modification.

 

[reeax]

If they go the "regular way" by selling it in USA yes (see https://www.fda.gov/MedicalDevices/...lthandConsumer/ConsumerProducts/ucm142478.htm) . However, EMS devices can be sold in a large number of countries without any particular approval. There are no particular risks anyway, only for people with pacemakers & co.

 

[threefirefour]

If they go the "regular way" by selling it in USA yes (see https://www.fda.gov/MedicalDevices/...lthandConsumer/ConsumerProducts/ucm142478.htm) . However, EMS devices can be sold in a large number of countries without any particular approval. There are no particular risks anyway, only for people with pacemakers & co.

Exactly, and this is their way out of having to wait. However, they still need a distributor. I used to think that hearing aid and WNG producers would try to shut her down if anything, but there's no conflict between these sales and HAs and WNGs. So if anything, they might act as a distributor for her. To sell it though, they would need FDA approval.

 

[reeax]

Manufacturing in China, distributors outside of US, and they can be on the market fairly quickly. If they are in also for the money (and not only research). People in the US could then buy the device on Amazon or wherever.

 

[threefirefour]

Manufacturing in China, distributors outside of US, and they can be on the market fairly quickly. If they are in also for the money (and not only research). People in the US could then buy the device on Amazon or wherever.

I never thought about it that way. I'm making a very large post about the legality of this situation, and will have to think about that.

I think the $1,000,000 question is: "Will Susan Shore choose to go through all those loopholes if she can? Or will she take the path of least resistence and go through the FDA process"?

 

[reeax]

Exact, and that is why I am telling "if they are in for the money". If she is just interested in research, she will probably wait for FDA. That could be an interesting question to raise with Susan and her team directly, preferably over phone if someone is available.

 

[threefirefour]

Exact, and that is why I am telling "if they are in for the money". If she is just interested in research, she will probably wait for FDA. That could be an interesting question to raise with Susan and her team directly, preferably over phone if someone is available.

Here's hoping she's greedy.

 

[Bill Bauer]

it seems plausible only for people able to reduce their tinnitus with physical manipulations

So it is likely not going to work for people like me, who can only get their tinnitus louder by using physical manipulations, right?

 

[threefirefour]

So it is likely not going to work for people like me, who can only get their tinnitus louder by using physical manipulations, right?

I don't understand where he got that idea. She specified that it works for both.

 

[reeax]

I am not sure about that one, just read the research content quickly in few minutes ... What I am thinking is that if you can give your body a signal that reduces the tinnitus, it may be possible to imitate it externally. On the other hand, if you are only able to provide a signal that amplifies tinnitus, perhaps the body is not recognizing a signal that diminishes it - so maybe you cannot imitate it, because there is nothing to imitate.

So it could have a better chance of working if you can do both. Just a thinking, no stress Bill Bauer probably I am wrong.

 

[Paulmanlike]

Here's hoping she's greedy.

Anybody who's worked tirelessly to reduce the volume of tinnitus, deserves every penny and the right to be a multi-millionaire. Good luck to her

 

[Paulmanlike]

Manufacturing in China, distributors outside of US, and they can be on the market fairly quickly. If they are in also for the money (and not only research). People in the US could then buy the device on Amazon or wherever.

Don't think it will be sold directly to the customer, more like through an audiologist that will be trained to configure it to each patient by the sounds of it.

 

[brummygirl]

From reading various research papers I understand that it has, in the past, been easier to help those whose tinnitus decreases on modulation, rather than increases. But still possible to help those where it only increases. That research was not into this treatment of course, though, so this may be different.

(Sorry I don't have the papers to hand but can look them out if anyone wants)

I wonder if it could be to do with specific subgroups within the modulating group, that have as yet not been clearly identified.

I guess it will take the larger trial size to confirm. I do hope they ensure they have well- defined tinnitus subgroups of sufficient size in it.

 

[hans799]

There's some confusion here about the target group of this device. Does it count if you can only worsen (but not improve) your tinnitus through bodily (neck, jaw) manipulation?

The answer is: yes, if you can modify your tinnitus through bodily manipulation (e.g. jaw or neck movements) in any way (either making it worse or making it better), you're in the target group for this device. If you cannot modify it, it does not mean that you're definitely out - it only means that you're in a group on which the device wasn't yet tested.

Reasoning:
The following is an excerpt from the paper: "Our study only tested one subgroup of tinnitus patients, those with somatic tinnitus; thus, it is unknown whether these results would translate to other subgroups."

This means that somatic people are in; non-somatic people are not out, just weren't studied.

The definition of somatic ("bodily") tinnitus is that you can manipulate it in some way through bodily movements. It doesn't matter how you got it (noise trauma, ototoxicity, scratch of a cat). So the cause doesn't matter, being able to improve it doesn't matter, only that you can manipulate it.

I hope this clears it up.

P.S. I'm not an expert, but I did read the research paper, and the datasheet for the clinical trial carefully, and also looked through the patent, and also read this thread from start to end, so I'm reasonably confident about my assessment.

 

[threefirefour]

There's some confusion here about the target group of this device. Does it count if you can only worsen (but not improve) your tinnitus through bodily (neck, jaw) manipulation?

The answer is: yes, if you can modify your tinnitus through bodily manipulation (e.g. jaw or neck movements) in any way (either making it worse or making it better), you're in the target group for this device. If you cannot modify it, it does not mean that you're definitely out - it only means that you're in a group on which the device wasn't yet tested.

Reasoning:
The following is an excerpt from the paper: "Our study only tested one subgroup of tinnitus patients, those with somatic tinnitus; thus, it is unknown whether these results would translate to other subgroups."

This means that somatic people are in; non-somatic people are not out, just weren't studied.

The definition of somatic ("bodily") tinnitus is that you can manipulate it in some way through bodily movements. It doesn't matter how you got it (noise trauma, ototoxicity, scratch of a cat). So the cause doesn't matter, being able to improve it doesn't matter, only that you can manipulate it.

I hope this clears it up.

P.S. I'm not an expert, but I did read the research paper, and the datasheet for the clinical trial carefully, and also looked through the patent, and also read this thread from start to end, so I'm reasonably confident about my assessment.

Wow this comment did a fantastic job of outlining the target demographic and potential groups. Good job.

 

[h-m-1994]

If it lowers after excercises like tai chi or the head stand then does it count as somatic?

 

[Steve]

I expressed this week that all of us with tinnitus find it frustrating just how long these things take to get to launch, but it's unfortunately the way of things.

They have a very promising device and a very good hypothesis. I was just at the talks from Susan Shore's students, it was a packed out room. I kind of felt like I needed half a day of them presenting alone, because there was a lot I wanted to know.

When you hear them talking you realise just how much work needs to go into this before launch. I wish it was as simple as stimulation + tones = results. They have to consider the degree of the stimulus, the length of the signal, the location of the stimulus based on the patient, the tones provided, testing that the timing induces plasticity, the way the stimulus and tones are paired etc...

 

[Paulmanlike]

I expressed this week that all of us with tinnitus find it frustrating just how long these things take to get to launch, but it's unfortunately the way of things.

They have a very promising device and a very good hypothesis. I was just at the talks from Susan Shore's students, it was a packed out room. I kind of felt like I needed half a day of them presenting alone, because there was a lot I wanted to know.

When you hear them talking you realise just how much work needs to go into this before launch. I wish it was as simple as stimulation + tones = results. They have to consider the degree of the stimulus, the length of the signal, the location of the stimulus based on the patient, the tones provided, testing that the timing induces plasticity, the way the stimulus and tones are paired etc...

Best master it with larger reliable studies, if they can do that with positive results we're onto a winner

 

[Greg Sacramento]

@Steve Thanks for all your commitment. From older studies, using just simulation great results have happened for some that received T from a tooth problem, a joint problem, arthritis of the neck - not just muscles.

If Susan Shore and company can put this all together, it should help so many.

 

[threefirefour]

I expressed this week that all of us with tinnitus find it frustrating just how long these things take to get to launch, but it's unfortunately the way of things.

They have a very promising device and a very good hypothesis. I was just at the talks from Susan Shore's students, it was a packed out room. I kind of felt like I needed half a day of them presenting alone, because there was a lot I wanted to know.

When you hear them talking you realise just how much work needs to go into this before launch. I wish it was as simple as stimulation + tones = results. They have to consider the degree of the stimulus, the length of the signal, the location of the stimulus based on the patient, the tones provided, testing that the timing induces plasticity, the way the stimulus and tones are paired etc...

That's great I'm glad her student said showed up. I'm sure Susan ducked out for personal reasons. I look forward to your write up in the TRI thread.

 

[Steve]

@Steve Thanks for all your commitment. From older studies, using just simulation great results have happened for some that received T from a tooth problem, a joint problem, arthritis of the neck - not just muscles.

If Susan Shore and company can put this all together, it should help so many.

I'm personally excited by her work. There was a real sense of energy about the students who presented. When the people who are conducting the studies are that enthused by the work you feel there is something special going on.

 

[pebbles]

Will this device work for people with noise reactive tinnitus

 

[threefirefour]

Will this device work for people with noise reactive tinnitus

Well when my tinnitus is quieter, it's much less reactive. The quieter one's tinnitus is, the less reactive tinnitus is. So it should work.