New University of Michigan Tinnitus Discovery — Signal Timing

[1000]

2024...
They haven't started the clinical trial...

@threefirefour There's definitely some mistakes...

 

[1000]

I don't think I can wait that long...

Seriously... That's like I got you a birthday present but you have to wait 6 more years.

 

[threefirefour]

2024...
They haven't started the clinical trial...

@threefirefour There's definitely some mistakes...

They've done and dusted the clinical trial that's why I'm so surprised. And they're beginning the Pivotal trial now.

Now here's what baffles me. They said the trial itself will last 32 weeks, and it begins very soon. So assuming it begins in October, then 8 months from then is June 2019. Yet according to this site the actual trial itself concludes in 2022. Where's the hold-up?

 

[threefirefour]

I am as surprised as you. Normally I don't get any replies back from researchers.

You're very lucky then. Do you mind screenshotting the email? It would be helpful for other tinnitus communities to see.

 

[Soren]

You're very lucky then. Do you mind screenshotting the email? It would be helpful for other tinnitus communities to see.

 

[1000]

They've done and dusted the clinical trial that's why I'm so surprised. And they're beginning the Pivotal trial now.

Now here's what baffles me. They said the trial itself will last 32 weeks, and it begins very soon. So assuming it begins in October, then 8 months from then is June 2019. Yet according to this site the actual trial itself concludes in 2022. Where's the hold-up?

I'm scared now... Was hoping for 2020 as you mentioned before...

6 more years... Waiting with intrusive tinnitus... that's not cool at all...

Not only thinking of me, but others who are struggling as well, and were hopping to have this to reduce their tinnitus.

What's next? An appointment with a psychiatrist, an appointment with a TRT specialist or a bullet and bye bye, I'm scared to die... I'm now very sad after reading up on this information... 6 more years...

Pivotal trial...
That means they're on phase 2?

 

[threefirefour]

View attachment 22405

Thanks. Well let's keep our fingers crossed.

 

[Silvio Sabo]

I got an answer to my questions from Dr. Shore.

"It is possible that it will come to market before, but this is still in progress and depends on many factors. We are trying our best."​

So there it is we need to give them time and hope for the best. It is a very hard pill to swallow but we have never been this close to silence before with real science backing it up as we are right now.

That, right there made my day!

 

[PDodge]

I'm scared now... Was hoping for 2020 as you mentioned before...

6 more years... Waiting with intrusive tinnitus... that's not cool at all...

Not only thinking of me, but others who are struggling as well, and were hopping to have this to reduce their tinnitus.

What's next? An appointment with a psychiatrist, an appointment with a TRT specialist or a bullet and bye bye, I'm scared to die... I'm now very sad after reading up on this information... 6 more years...

Pivotal trial...
That means they're on phase 2?

I think pivotal means phase 3. Correct me if i'm wrong

 

[threefirefour]

I'm scared now... Was hoping for 2020 as you mentioned before...

6 more years... Waiting with intrusive tinnitus... that's not cool at all...

Not only thinking of me, but others who are struggling as well, and were hopping to have this to reduce their tinnitus.

What's next? An appointment with a psychiatrist, an appointment with a TRT specialist or a bullet and bye bye, I'm scared to die... I'm now very sad after reading up on this information... 6 more years...

Pivotal trial...
That means they're on phase 2?

I think pivotal means phase 3. Correct me if i'm wrong

Pivotal means stage 2, but a device only needs two stages before it can apply for an FDA premarket.

 

[1000]

Pivotal means stage 2, but a device only needs two stages before it can apply for an FDA premarket.

If I could get this tinnitus from 10.9 to a 5, that should be enough... Rather have it all the way removed but a significant reduction can take me back to life.

 

[Spiral]

I don't think I can wait that long...

Seriously... That's like I got you a birthday present but you have to wait 6 more years.

Try not to assume the worst, it's just a waiting game at this point. Hopefully this current trial will go swimmingly and we'll get something out late 2019/early 2020.

 

[threefirefour]

Try not to assume the worst, it's just a waiting game at this point. Hopefully this current trial will go swimmingly and we'll get something out late 2019/early 2020.

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.

 

[Jim51042]

None of these delays surprise me with U-Mich. They have been unreasonably slow given they started work in the early 2010s. Don't worry too much if they are too slow they will be beat to market.

 

[Silvio Sabo]

None of these delays surprise me with U-Mich. They have been unreasonably slow given they started work in the early 2010s. Don't worry too much if they are too slow they will be beat to market.

Well if they weren't slow we might have already had something. That's what's annoying people.

 

[GregCA]

Well if they weren't slow we might have already had something. That's what's annoying people.

You know what speeds up research? Funding!
People are annoyed at the slow speed of progress, but they aren't annoyed enough to fund research. @Ed209 can tell you everything about it.

If the annoyance isn't worth a few bucks (or for the brits, quids), then it's probably not much of an annoyance.

 

[Silvio Sabo]

You know what speeds up research? Funding!
People are annoyed at the slow speed of progress, but they aren't annoyed enough to fund research. @Ed209 can tell you everything about it.

If the annoyance isn't worth a few bucks (or for the brits, quids), then it's probably not much of an annoyance.

That we can agree upon. Everyone that has tinnitus should make it a regular thing to donate money to tinnitus research. I know I do at least. If everyone did that it wouldn't require that much per person to reach substantial amounts.

We have a saying here in Sweden: "Many little creeks make a big river."

 

[Ed209]

You know what speeds up research? Funding!
People are annoyed at the slow speed of progress, but they aren't annoyed enough to fund research. @Ed209 can tell you everything about it.

If the annoyance isn't worth a few bucks (or for the brits, quids), then it's probably not much of an annoyance.

Ain't that the truth.

 

[threefirefour]

You know what speeds up research? Funding!
People are annoyed at the slow speed of progress, but they aren't annoyed enough to fund research. @Ed209 can tell you everything about it.

If the annoyance isn't worth a few bucks (or for the brits, quids), then it's probably not much of an annoyance.

They already have their funding that's no longer an obstacle to speed. This one I assume has to do with the FDA.

 

[linearb]

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

To clarify the study design: it is a 4 year study, combined animal and humans. The first year is animals only. Recruitment of humans begins in Year 2 and will continue to Year 4.

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.

 

[WaqasVic]

I don't mind them taking 6 years. I mean of course they need a lot of time to perfect the device. I would give them as much time they need to make the device perfectly working, in the meanwhile I will manage my tinnitus no matter how severe or rough it can get...

It wouldn't be wise to post stuff that show that they need to hurry up with the device, they should have as much time as they need to complete the studies and get this device rolling in the markets, I hope this device will be a life saver... if not eliminate tinnitus then minimize its intensity. I don't mind having tinnitus at all for all my life, I mean if this device gets my tinnitus severity from 10 to 4 or even 5... I will be freaking happy with that lol

 

[1000]

I don't mind them taking 6 years. I mean of course they need a lot of time to perfect the device. I would give them as much time they need to make the device perfectly working, in the meanwhile I will manage my tinnitus no matter how severe or rough it can get...

It wouldn't be wise to post stuff that show that they need to hurry up with the device, they should have as much time as they need to complete the studies and get this device rolling in the markets, I hope this device will be a life saver... if not eliminate tinnitus then minimize its intensity. I don't mind having tinnitus at all for all my life, I mean if this device gets my tinnitus severity from 10 to 4 or even 5... I will be freaking happy with that lol

In 6 years? I think Shore wants to bring it to market way much sooner. A severe tinnitus can get you into really dark times. 6 year from now, it's just too much to wait.

 

[WaqasVic]

In 6 years? I think Shore wants to bring it to market way much sooner. A severe tinnitus can get you into really dark times. 6 year from now, it's just too much to wait.

Not really, been there done that, severe tinnitus for 5 years now, lol.

 

[Silvio Sabo]

In 6 years? I think Shore wants to bring it to market way much sooner. A severe tinnitus can get you into really dark times. 6 year from now, it's just too much to wait.

Well, I've been waiting for more than 12 years now. There are members in here that have waited for much longer than that. I think the user @Zimichael has had tinnitus since 1958 or something. If anything good ever comes out of having tinnitus it's that you learn patience.

 

[1000]

Well, I've been waiting for more than 12 years now. There are members in here that have waited for much longer than that. I think the user @Zimichael has had tinnitus since 1958 or something. If anything good ever comes out of having tinnitus it's that you learn patience.

I'm sorry for all the sufferers.
Well I've been waiting 12 years also... But I had an acoustic trauma to my good ear...and now it's worse, very loud and intrusive.

 

[kelpiemsp]

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 Were they implementing EEG specific timings at that point?

 

[1000]

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.

Thanks for taking us down from that cloud. I thought this was going to reduce the loudness in tinnitus by a good amount and probably eliminate it in some.

Would you enter in the next trial if needed?

 

[kelpiemsp]

FWIW, in my area of research the end date of the trial is usually the end date of funding. And words are being used in the wrong context. I'm not positive, but 2022 is likely when everything sunsets. Realistically, they would probably like to be to market before that point so people are not looking for other sources of funding, etc. You would want that lined up (the money) before the final year of the award (so likely december 2021 they would want to know 100%). If you follow this logic, that means they probably need everything submitted by the end of 2020 at the latest, with a solid expectation of an answer. So realistically, we should know in the next 2 years, and that follows the timelines.

Also remember that this tech is likely "owned" by the UMich and not Dr. Shore (though I'm sure she'd have a stake, there is some payout policy for patents) herself. The financial implications of this would be huge for her and the Department. I'm sure funding Dr. Shore + staff isn't cheap. You can bet the head of the Otorhinolaryngology Department wants this to go to market as bad as anyone, as that would surely be a political feather in someone's cap.

 

[linearb]

Would you enter in the next trial if needed?

Nah; they asked if I wanted to, because I was one of their more motivated and better responders. I don't say no because of anything to do with the tech, though: at the time of the first study, my partner and I were dual income no kids, and renting an apartment 2 miles from the airport. Now we have a mortgage, a kid, live in the middle of the woods and an hour from an airport, she's not working much, so life circumstances make it pretty hard to justify sinking another ten grand into being a lab rat (I did extensive travel and hotels to make the first study work).

 

[razo]

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).