New University of Michigan Tinnitus Discovery — Signal Timing

[stophiss]

Ha, I managed to make my account here a little TOO hard to access and locked myself out, don't have time to sort that out with the admins now.

Anyway -- just wanted to chime in on a couple points:
w/r/t the timing -- I communicated with someone at UMich a year or so ago about the length of the trial, and what she said was

IIRC they are expecting multiple rounds of human experimentation, probably trying to sort out differences between slightly different protocols?

Secondly, having used an earlier version of this tech in the first trial, I'm still enthusiastic about it, want to to come to market fast, etc... but I think some people here need to cool their jets a little bit, at least as far as this being "a cure" / leading to "silence" or anything like it. At the point in time that I think I was responding most heavily to the protocol, it seemed to make a significant difference but I still had tinnitus that I could hear in most environments. It was both less shrill and less intrusive, to the point that I personally felt a lot more capable of simply not thinking about it at all, but it wasn't anything like curative. It was like taking some opioids after having surgery: on some level you still know that things hurt, but there's a layer over them that makes that seem less bothersome.

Sure, it's possible that a better protocol, or longer term use, would have a more dramatic effect -- but if we accept that as a possibility, I think we also have to accept the idea that maybe the effect wears off over time / some kind of tolerance to the technology develops. There's a lot about all this that we just don't know, also I believe it was some (significant) minority of people who responded to the thing at all, meaning there's a lot of people with tinnitus out there that this simply is not likely to help. The main reason for my own optimism is that I have concrete reason to believe I am one of the people who can manipulate their tinnitus with this tech -- but if I hadn't been in that study and had just read the various whitepapers, I would think "eh, seems like a total crapshoot, it will be nice if it comes to market but I can't live my life as though it's going to be some kind of fix, because there's no reason to think that's the case". Hell, even though I did have a positive experience on it, I'm lukewarm at best on hoping it's going to cause any sustained relief. There's simply no way to know, and so it seems like a poor use of time to think about.

I think that hope and faith are useful and important things to have, probably necessities for any kind of happy life with a painful chronic condition, but don't put all your eggs in one basket. This is just one of a large number of different modalities and technologies that might eventually lead to some kind of relief from the noise.

linearb,
In your informed opinion, is Somatic tinnitus the type of tinnitus potentially most improved by this technology?
Thank you.

 

[linearb]

linearb,
In your informed opinion, is Somatic tinnitus the type of tinnitus potentially most improved by this technology?
Thank you.

I'm not that informed Definitely not a neuroscientist, nor do I really understand how spike-timing induced plasticity works at a cellular level, so take this with a big grain of salt.

My understanding is that Shore's working model of noise-trauma induced tinnitus, is that touch-sensing nerves which pass through the temporomandibular junction, get incorrectly "wired in" to audio perception at the level of the dorsal cochlear nucleus. Hence people being able to modulate their tinnitus with neck and jaw movements.

In this model, most noise-induced tinnitus is "somatic", in that people can change the sound with muscle movements. There may also be tinnitus that is purely somatic -- tense muscles putting pressure on the auditory nerve. If that's a real thing I don't think it effects very many people, though; people with tinnitus almost invariably show some amount of high-frequency loss if you test them up to 16 or 18khz. (Of course, so do most people over the age of 20 without tinnitus -- and my own hearing, while it has a notch at 14khz, has been described by multiple audiologists as "excellent").

So, all that in mind -- the current device works by stimulating the auditory nerve along with those touch-sensing nerves, in a way that's very precisely timed, to exploit a brain plasticity mechanism and try to unwire those connections between touch-sensing nerves and audio precepts. Hence, what is required, is the ability to modulate the sound, using muscles of the face and neck. If you can do so, then you are a potential candidate for this kind of treatment... if they're right about how all this works, if the effect can be demonstrated in a larger and more long term sample body than they worked with in the first trial, etc.

 

[linearb]

If they can start the trial and it shows efficacy then it should reach the market a lot sooner than 2024. If they are successful they can spin out the idea to a private company or at least the production of the device (lets hope it will not be too expensive).

If these have been proven to work and are widely available by 2024 I would take that as a big win; it's possible we'll see something earlier than that, but it's also possible that it's all smoke and mirrors and never comes to market. No way to know, not very useful to agonize over.

If it does work, my guess is that it will be like most medical devices; extremely cheap to make per-unit, but extremely expensive to pioneer and the costs of development and ongoing study will be folded into the device cost. I don't think it's going to be a $20000, since the actual cost of production is probably a hundred bucks or something, but I would imagine that in the US it's still going to be a $2-3000 deal because that just seems to be how these things work. It would be nice to be wrong about that, we'll see...

 

[stophiss]

I'm not that informed Definitely not a neuroscientist, nor do I really understand how spike-timing induced plasticity works at a cellular level, so take this with a big grain of salt.

My understanding is that Shore's working model of noise-trauma induced tinnitus, is that touch-sensing nerves which pass through the temporomandibular junction, get incorrectly "wired in" to audio perception at the level of the dorsal cochlear nucleus. Hence people being able to modulate their tinnitus with neck and jaw movements.

In this model, most noise-induced tinnitus is "somatic", in that people can change the sound with muscle movements. There may also be tinnitus that is purely somatic -- tense muscles putting pressure on the auditory nerve. If that's a real thing I don't think it effects very many people, though; people with tinnitus almost invariably show some amount of high-frequency loss if you test them up to 16 or 18khz. (Of course, so do most people over the age of 20 without tinnitus -- and my own hearing, while it has a notch at 14khz, has been described by multiple audiologists as "excellent").

So, all that in mind -- the current device works by stimulating the auditory nerve along with those touch-sensing nerves, in a way that's very precisely timed, to exploit a brain plasticity mechanism and try to unwire those connections between touch-sensing nerves and audio precepts. Hence, what is required, is the ability to modulate the sound, using muscles of the face and neck. If you can do so, then you are a potential candidate for this kind of treatment... if they're right about how all this works, if the effect can be demonstrated in a larger and more long term sample body than they worked with in the first trial, etc.

Thanks for the comprehensive response linearb, much appreciated.

Do you know what the procedure is for using the device?

How much time during a day the black box must be used to decouple the cross-talk of touch-sensing nerves which pass through the temporomandibular junction from audio perception at the level of the dorsal cochlear nucleus changing the arc of plasticity within the brain?

Thanks again.

 

[ee9892]

I really hope someone on TT is accepted into the trial. Maybe be like another Kelpie who can give us an eye-on the process. We definitely need that now more than ever, especially with this.

I live 20 mins away from them and have requested to be part of the trial. I'm hoping I get in

 

[threefirefour]

I live 20 mins away from them and have requested to be part of the trial. I'm hoping I get in

I really hope you pull it off. Good luck

 

[linearb]

Do you know what the procedure is for using the device?

In the phase-I it was 30 mins 1x a day, but they told me openly they didn't know if that was optimal, or if 15mins 2x/day could be better, or what. They were guessing based on the animal research they'd done, and I got the impression that one of the goals of the current study would be to figure out if there was a more efficient protocol.

 

[JohnAdams]

If these have been proven to work and are widely available by 2024 I would take that as a big win; it's possible we'll see something earlier than that, but it's also possible that it's all smoke and mirrors and never comes to market. No way to know, not very useful to agonize over.

If it does work, my guess is that it will be like most medical devices; extremely cheap to make per-unit, but extremely expensive to pioneer and the costs of development and ongoing study will be folded into the device cost. I don't think it's going to be a $20000, since the actual cost of production is probably a hundred bucks or something, but I would imagine that in the US it's still going to be a $2-3000 deal because that just seems to be how these things work. It would be nice to be wrong about that, we'll see...

2024!!!?!? There is absolutely no good reason why it should take that long.

 

[linearb]

2024!!!?!? There is absolutely no good reason why it should take that long.

I wish we could all have something useful in our hands yesterday, but the reality is that we need to find out if the idea actually works before we allow people to just start selling medical devices. The only way to do this is a series of randomized controlled studies. Trying to speed up the timeline at the expense of doing real science is counterproductive; there are already a lot of things on the market which don't actually work, another one isn't going to help any.

Unfortunately, there are a lot of good reasons that it could take that long, If we really end up with a device on the market in 2024 that helps 1/3 of people with tinnitus to some extent, the people doing this research would see that as a huge win, and so would I. Seems unwise to spend too much time obsessing about this, or any other particular tech. If something works, we'll find out. Any treatment that helps a lot of us here on this forum, is also likely going to not help a lot of other people here on this forum. Tinnitus is a complex symptom that seems to arise from a bunch of different underlaying etiologies. I am glad that I participated in this research, but at some point I had to take a step back and basically ignore that it's continuing to happen, because thinking about it all the time made me feel crazier than just assuming the noise in my head is there to stay, better move on with life.

When they did the Phase-I I participated in, they literally told me "well, use this a half hour a day. That's a guess based on our animal work. You can do it at whatever time of day you want, because we have no idea whether it makes a difference, or if evening would work better than morning, or anything. We're going to set the voltage just below the level where you can easily feel it, because that makes it easier to have a placebo control, and we don't actually have any idea what voltage level is optimal or if it makes any difference".

There are a ton of unknowns in that, and we definitely do not want something on the market that has that many question marks around it. Gotta do the work to get the numbers to crunch, then crunch the numbers.

 

[JohnAdams]

I wish we could all have something useful in our hands yesterday, but the reality is that we need to find out if the idea actually works before we allow people to just start selling medical devices. The only way to do this is a series of randomized controlled studies. Trying to speed up the timeline at the expense of doing real science is counterproductive; there are already a lot of things on the market which don't actually work, another one isn't going to help any.

Unfortunately, there are a lot of good reasons that it could take that long, If we really end up with a device on the market in 2024 that helps 1/3 of people with tinnitus to some extent, the people doing this research would see that as a huge win, and so would I. Seems unwise to spend too much time obsessing about this, or any other particular tech. If something works, we'll find out. Any treatment that helps a lot of us here on this forum, is also likely going to not help a lot of other people here on this forum. Tinnitus is a complex symptom that seems to arise from a bunch of different underlaying etiologies. I am glad that I participated in this research, but at some point I had to take a step back and basically ignore that it's continuing to happen, because thinking about it all the time made me feel crazier than just assuming the noise in my head is there to stay, better move on with life.

When they did the Phase-I I participated in, they literally told me "well, use this a half hour a day. That's a guess based on our animal work. You can do it at whatever time of day you want, because we have no idea whether it makes a difference, or if evening would work better than morning, or anything. We're going to set the voltage just below the level where you can easily feel it, because that makes it easier to have a placebo control, and we don't actually have any idea what voltage level is optimal or if it makes any difference".

There are a ton of unknowns in that, and we definitely do not want something on the market that has that many question marks around it. Gotta do the work to get the numbers to crunch, then crunch the numbers.

They need to tell us the timing info. They also already did a blind placebo test and people reported a reduction. It's just sounds and zaps, no need for years and years of testing.

 

[threefirefour]

I wish we could all have something useful in our hands yesterday, but the reality is that we need to find out if the idea actually works before we allow people to just start selling medical devices. The only way to do this is a series of randomized controlled studies. Trying to speed up the timeline at the expense of doing real science is counterproductive; there are already a lot of things on the market which don't actually work, another one isn't going to help any.

Unfortunately, there are a lot of good reasons that it could take that long, If we really end up with a device on the market in 2024 that helps 1/3 of people with tinnitus to some extent, the people doing this research would see that as a huge win, and so would I. Seems unwise to spend too much time obsessing about this, or any other particular tech. If something works, we'll find out. Any treatment that helps a lot of us here on this forum, is also likely going to not help a lot of other people here on this forum. Tinnitus is a complex symptom that seems to arise from a bunch of different underlaying etiologies. I am glad that I participated in this research, but at some point I had to take a step back and basically ignore that it's continuing to happen, because thinking about it all the time made me feel crazier than just assuming the noise in my head is there to stay, better move on with life.

When they did the Phase-I I participated in, they literally told me "well, use this a half hour a day. That's a guess based on our animal work. You can do it at whatever time of day you want, because we have no idea whether it makes a difference, or if evening would work better than morning, or anything. We're going to set the voltage just below the level where you can easily feel it, because that makes it easier to have a placebo control, and we don't actually have any idea what voltage level is optimal or if it makes any difference".

There are a ton of unknowns in that, and we definitely do not want something on the market that has that many question marks around it. Gotta do the work to get the numbers to crunch, then crunch the numbers.

I understand how awful the FDA can be, but seriously if they wait until 2024 to release I'm just going to boycott this device and get something else. At this point it's just researcher error. The Minnesota device is going to be out earlier and it looks like it's better anyways. If Susan Shore is really releasing this in 2024 then I don't know what to say. She missed her opportunity.

 

[linearb]

They need to tell us the timing info.

Well, for one thing, the timings used are not a secret; go read the full text of the research they've published from animal and human work, and you can get a good sense of what the variables are.

For another thing, they don't "need" to do anything, they're trying to pioneer a product and they've spent a lot of time and money doing so. It would be great if research like this was all publicly funded and public domain, but this country would rather spend billions on drone-bombing mud huts, so here we are.

It's just sounds and zaps, no need for years and years of testing.

I understand that we're all in a very difficult situation and wish we could speed the timeline on all this up, but this just isn't how science works. At best, we now have some idea that this tech seems to do something in some people. That's a lot of ifs and buts. It would be extremely irresponsible to put something on the market with that many question marks around it (especially since they think incorrect protocols stand a good chance of literally making the problem worse!)

They also already did a blind placebo test and people reported a reduction.

I know dude, like I said, I was one of them, and having seen that work first hand I am telling you in no uncertain terms that there is not nearly enough data there to put a product together. They tested something like 20 people total and saw an unpredictable effect in half of them, or something? That's a tiny, tiny sample size.

Please try to have some patience, and do whatever you can to maximize your quality of life in the mean time. I can tell you from experience that sitting around feeling desperate for vaporware technologies that might not actually work at all, is not a good way to live.

 

[linearb]

I understand how awful the FDA can be, but seriously if they wait until 2024 to release I'm just going to boycott this device and get something else. At this point it's just researcher error. The Minnesota device is going to be out earlier and it looks like it's better anyways. If Susan Shore is really releasing this in 2024 then I don't know what to say. She missed her opportunity.

...and with that, I just remembered why I stopped logging in to this place, lol. See y'all another 2-4 months down the road, I wish everyone the very best and may you all find silence and self-love soon. I can't engage with stuff that makes me feel irritable, tinnitus does a good enough job of that on its own.

 

[JohnAdams]

Well, for one thing, the timings used are not a secret; go read the full text of the research they've published from animal and human work, and you can get a good sense of what the variables are.

For another thing, they don't "need" to do anything, they're trying to pioneer a product and they've spent a lot of time and money doing so. It would be great if research like this was all publicly funded and public domain, but this country would rather spend billions on drone-bombing mud huts, so here we are.


I understand that we're all in a very difficult situation and wish we could speed the timeline on all this up, but this just isn't how science works. At best, we now have some idea that this tech seems to do something in some people. That's a lot of ifs and buts. It would be extremely irresponsible to put something on the market with that many question marks around it (especially since they think incorrect protocols stand a good chance of literally making the problem worse!)


I know dude, like I said, I was one of them, and having seen that work first hand I am telling you in no uncertain terms that there is not nearly enough data there to put a product together. They tested something like 20 people total and saw an unpredictable effect in half of them, or something? That's a tiny, tiny sample size.

Please try to have some patience, and do whatever you can to maximize your quality of life in the mean time. I can tell you from experience that sitting around feeling desperate for vaporware technologies that might not actually work at all, is not a good way to live.

So is it as simple as zap on/sound on zap off/sound off? Man you could just tell us in a little more detail how the process works.

 

[threefirefour]

View attachment 22700

...and with that, I just remembered why I stopped logging in to this place, lol. See y'all another 2-4 months down the road, I wish everyone the very best and may you all find silence and self-love soon. I can't engage with stuff that makes me feel irritable, tinnitus does a good enough job of that on its own.

I didn't say that this will succeed/fail. I just said that this is taking a damn long time. Nice ancient meme btw.

 

[JohnAdams]

View attachment 22700

...and with that, I just remembered why I stopped logging in to this place, lol. See y'all another 2-4 months down the road, I wish everyone the very best and may you all find silence and self-love soon. I can't engage with stuff that makes me feel irritable, tinnitus does a good enough job of that on its own.

Will you please tell us how the sounds work with the timing of the zaps. Please.

 

[Otana]

Will you please tell us how the sounds work with the timing of the zaps. Please.

This is the results publication from the previous trial. Lots of good info on how this device works.
http://stm.sciencemag.org/content/scitransmed/10/422/eaal3175.full.pdf

 

[kelpiemsp]

Will you please tell us how the sounds work with the timing of the zaps. Please.

The guinea pig paper is published and contains the data. I think that is public (you may have to pay). Also FWIW, I saw this question asked elsewhere but recent research in neural plasticity suggests a compounding effect on the brain, that may eventually drive permanent change.

If you are super interested in Neural Plasticity checkout the book "the brain that changes itself" by norman doidge. It is super important as we all think about "curing tinnitus". Accepting the premise of the neural plastic brain (which is still a controversial topic) completely changes the way we think about a "cure".

For example, in one experiment they wired a ferret's optical nerve to its auditory cortex. And guess what? Within 1 year the brain's auditory cortex rewired itself and the ferret was able to see. This means the brain can adapt and change to input (duh, that is how tinnitus even starts) but also gives clues how to unravel it as changing the brain may be abundantly easier than changing the device (i.e. ear or eye) that perceives the external world.

Sorry for the plug, but this book is really tying together the missing gaps in my knowledge.

 

[Silvio Sabo]

I understand how awful the FDA can be, but seriously if they wait until 2024 to release I'm just going to boycott this device and get something else.

So you would boycott a device that could help you with the very same issue that you're so desperate to resolve or alleviate, and not get any relief from it, because you think it took them too long to make it? Makes perfect sense!?

 

[ee9892]

Got a message from the people running the trial. They are going to begin calling applicants for screenings in the next couple weeks.

 

[threefirefour]

So you would boycott a device that could help you with the very same issue that you're so desperate to resolve or alleviate, and not get any relief from it, because you think it took them too long to make it? Makes perfect sense!?

Only if they take as long as they say they will. I'm going to because there's probably going to be a better device out there. I'm being completely fair.

It's not like I don't support her anymore. I absolutely hope she succeeds and releases her device. I'm just not married to this. If another similar product comes out before hers, then I'll get that device. That's how capitalism works.

 

[MickV]

How long is this trial going to last? Anyone knows? A month? 3 months?

 

[ee9892]

How long is this trial going to last? Anyone knows? A month? 3 months?

I believe the next phase is 6 months

 

[parsky]

@kelpiemsp can you ask them if they plan on treating multiple tones? Suppose different tones in each ear or multiple tones in the same ear.

 

[kelpiemsp]

@kelpiemsp can you ask them if they plan on treating multiple tones? Suppose different tones in each ear or multiple tones in the same ear.

There is a lot happening around sound, I can't comment much on that, other than the sound I hear during stimulation is nothing like the sound(s) of my T. For me it reduces both.

 

[Manny]

There is a lot happening around sound, I can't comment much on that, other than the sound I hear during stimulation is nothing like the sound(s) of my T. For me it reduces both.

Interesting. I had thought I read that they used a sound similar to your T for the stimulation sound.

 

[kelpiemsp]

Interesting. I had thought I read that they used a sound similar to your T for the stimulation sound.

I went through a sound matching phase where I chose what was closest to my T. But that wasn't the sound chosen for the stimulation. Then again, I am a test subject...so who knows where they could be going with that.

 

[MickV]

I believe the next phase is 6 months

So that is enough time for us to finally know if it is a make or break device?

Maybe a final solution!

 

[parsky]

There is a lot happening around sound, I can't comment much on that, other than the sound I hear during stimulation is nothing like the sound(s) of my T. For me it reduces both.

Can you ask them if they are considering this?

 

[kelpiemsp]

Can you ask them if they are considering this?

I don't fully follow. This device doesn't work by just matching a tinnitus tone and notching it out, say like neuro monics.