New University of Michigan Tinnitus Discovery — Signal Timing

[Piney]

For this study the exclusion criteria is:

• No greater than a mild hearing loss up to 6 kHz, and no greater than a moderate hearing loss at the tinnitus frequencies.

I don't know if this is necessarily going to be a hard limit in a commercialized product.

Correct, and it seems we always end up knowing nothing since all groups and variations are never allowed in a trial. I relish that day when someone says come everyone with tinnitus, put these headphones on and let's see if this works for 6 weeks.

Otolith Labs is the only one who has done this and I knew it didn't work in a week. Here's your headphones back, change it up and let me know.

It's all red tape, and building up funds, funds which has produced not much of a cure. This device has worked for people, what are we doing taking decades to produce something? This isn't a drug. What are you worried about safety? You know what's not safe? Having tinnitus.

 

[AfroSnowman]

Correct, and it seems we always end up knowing nothing since all groups and variations are never allowed in a trial. I relish that day when someone says come everyone with tinnitus, put these headphones on and let's see if this works for 6 weeks.

Otolith Labs is the only one who has done this and I knew it didn't work in a week. Here's your headphones back, change it up and let me know.

It's all red tape, and building up funds, funds which has produced not much of a cure. This device has worked for people, what are we doing taking decades to produce something? This isn't a drug. What are you worried about safety? You know what's not safe? Having tinnitus.

I wouldn't take much guidance from Lenire but I think their limit in a standard audiogram was below severe hearing loss.

 

[Mentos]

Recently I asked Dr. Shore in an email how do they stand with clinical trials and if they are on track to finish it by the end of this year. Here's what she replied:
"Yes we are on track. We will send an update early next year."

There's nothing conclusive in her answer but still it seems she is progressing with her trails after the COVID-19 pause as expected.

 

[Kam75]

How long has Dr. Shore been working on this device exactly? More than 15 years, right?

Let's really hope that it will considerably reduce our tinnitus if not completely eliminate it.

It is quite possible to live well with almost inaudible tinnitus, which was my case for 6 years.

 

[Piney]

I have been exposed to another account of a single-sided deaf person getting a cochlear implant and it totally eliminating their 15 year 24/7 tinnitus. Electrical current and sound definitely has potential to do something, until a drug can open a channel or repair connections etc. This method needs to stay on the drawing board.

 

[linearb]

Correct, and it seems we always end up knowing nothing since all groups and variations are never allowed in a trial. I relish that day when someone says come everyone with tinnitus, put these headphones on and let's see if this works for 6 weeks.

They have the exclusion criteria they do because tinnitus patients are a wildly heterogeneous group with a huge variety of underlying causes and possible mechanisms, and demonstrating conclusively that the thing works well and safely in the specific group that you'd expect it to work the best in is a very logical way to approach testing. Saying "all comers welcome" leads to terrible data that won't stand up to reproduction or FDA scrutiny.

It's all red tape, and building up funds, funds which has produced not much of a cure. This device has worked for people, what are we doing taking decades to produce something? This isn't a drug. What are you worried about safety? You know what's not safe? Having tinnitus.

Nah, I think this is a paranoid take. I've been to UMich, I've seen this lab, I used the device for a month, I think it works, I want to buy one ASAP so I can get off the god damn meds I take instead, but I want it to have all the usual FDA scrutiny for something that's doing lightweight brain rewiring using a new and novel mechanism.

I have at times been active in groups of people who do stuff like DIY rTMS and tDCS, and I've definitely seen stories of basically well qualified people with EE backgrounds etc, inducing temporary blindness and doing all sorts of other horseshit.

 

[Sironketchup]

If I knew that it works, I could easily wait until 2022 to fly to US and A for having much fun and sexy time.

 

[AfroSnowman]

I used the device for a month, I think it works, I want to buy one ASAP so I can get off the god damn meds I take instead.

I'm sure you answered this somewhere, but what difference did it make? Was it a pretty definitive improvement or more or an ethereal feeling better response?

 

[Spiral]

If I knew that it works, I could easily wait until 2022 to fly to US and A for having much fun and sexy time.

 

[Piney]

If I knew that it works, I could easily wait until 2022 to fly to US and A for having much fun and sexy time.

If you have been on Tinnitus Talk even for a little while, you know that there is absolutely nothing that is on time. Some say Dr. Shore's device works, yet delays are in years --- not months --- for this.

 

[F-u-T]

How long has Dr. Shore been working on this device exactly? More than 15 years, right?

This thread's first couple of posts from 2013 referenced 15 years of research. If that is the case, it is more like 23 years at this point.

If they haven't figured it out in 23 years then I don't think another year or two is going to make much of a difference.

 

[kingsfan]

This thread's first couple of posts from 2013 referenced 15 years of research. If that is the case, it is more like 23 years at this point.

If they haven't figured it out in 23 years then I don't think another year or two is going to make much of a difference.

At least it proves she is no quitter.

 

[linearb]

I'm sure you answered this somewhere, but what difference did it make? Was it a pretty definitive improvement or more or an ethereal feeling better response?

Definitive and unmistakable; what I had to say at the time is likely more relevant than memories now. I was in the trial from ~January to May of 2015 and posted in this thread during that timeframe.

 

[AfroSnowman]

Definitive and unmistakable; what I had to say at the time is likely more relevant than memories now. I was in the trial from ~January to May of 2015 and posted in this thread during that timeframe.

What a long time to wait.

 

[egs]

My cousin is a researcher in the neurology dept. at the University of Michigan (he's met Susan Shore a couple of times, but he doesn't work with her directly). Since establishing his lab a couple of years ago, he's spent a majority of his time (or something close to it) writing grant proposals and acquiring funding for his research. Just one of the reasons science moves slooooooowly. I know we're all anxious for a cure (or new treatment options), but she wouldn't still be in the game if she didn't have something.

 

[Padraigh Griffin]

What are the prospects of Neuromod, who appear to be trying to build a brand and distribution model with Lenire, trying to acquire this tech from Dr. Shore if the trial is successful? They already poached Hubert Lim, so it might be a possibility.

 

[AfroSnowman]

What are the prospects of Neuromod, who appear to be trying to build a brand and distribution model with Lenire, trying to acquire this tech from Dr. Shore if the trial is successful? They already poached Hubert Lim, so it might be a possibility.

Oh, I imagine somewhere near impossible. I've read that Shore already has a manufacturing contract in place plus if the results come in solid I can't imagine Neuromod has the cash to buy anyone out.

 

[linearb]

What are the prospects of Neuromod, who appear to be trying to build a brand and distribution model with Lenire, trying to acquire this tech from Dr. Shore if the trial is successful? They already poached Hubert Lim, so it might be a possibility.

I think zero.

Neuromod is venture capital backed sketchy company operating out of Ireland based on an EU approval for a previous generation of their technology and user reports on here have not been especially inspiring.

Neuromod appears to have raised a total of just under $30 million in funding. That's a little bit over 10% of the University of Michigan's annual budget.

 

[Mentos]

I think zero.

Neuromod is venture capital backed sketchy company operating out of Ireland based on an EU approval for a previous generation of their technology and user reports on here have not been especially inspiring.

Neuromod appears to have raised a total of just under $30 million in funding. That's a little bit over 10% of the University of Michigan's annual budget.

@linearb, which one in the end cured/improved your tinnitus, the Minnesota or Michigan device? I thought you used both.

 

[linearb]

@linearb, which one in the end cured/improved your tinnitus, the Minnesota or Michigan device? I thought you used both.

I only used UMich and it was temporary suppression, nothing lasting. You may have me confused with someone else who I think did Minnisota and saw a lasting improvement.

 

[Kam75]

I only used UMich and it was temporary suppression, nothing lasting. You may have me confused with someone else who I think did Minnisota and saw a lasting improvement.

If I'm correct, the guy who had his tinnitus completely suppressed with the University of Minnesota device is @kelpiemsp.

So sad @linearb that your suppression was temporary

 

[Kam75]

By the way, I was wondering, @linearb (perhaps you have already been asked this question), are you one of the two people whose tinnitus has been completely eliminated as mentioned in this article?

 

[linearb]

By the way, I was wondering, @linearb (perhaps you have already been asked this question), are you one of the two people whose tinnitus has been completely eliminated as mentioned in this article?

No... I still have tinnitus and take a couple meds as a result.

I patiently await the results of this research. At the moment and at my present level of disability life is still pretty wonderful and I'm not complaining about much.

 

[Mentos]

I only used UMich and it was temporary suppression, nothing lasting. You may have me confused with someone else who I think did Minnisota and saw a lasting improvement.

Indeed I confused you with @kelpiemsp...

Anyway, how long did your temporary suppression last after using Michigan device? Was it complete suppression to the level of pure silence?

 

[Kam75]

No... I still have tinnitus and take a couple meds as a result.

I patiently await the results of this research. At the moment and at my present level of disability life is still pretty wonderful and I'm not complaining about much.

May I ask why are you patiently awaiting the results of this research since the device didn't give you long-lasting relief?

Are you planning to use the device regularly, if it is finally put to market, or do you believe that the commercialised version of the device will be better than the one used in the trial?

 

[linearb]

May I ask why are you patiently awaiting the results of this research since the device didn't give you long-lasting relief?

Are you planning to use the device regularly, if it is finally put to market, or do you believe that the commercialised version of the device will be better than the one used in the trial?

Waiting patiently is better than waiting anxiously, and waiting is the only option here

The device was not expected to give long lasting relief, it's intended for symptom suppression and the expectation is that it would need to be used on an ongoing basis. As I presently take medication on an ongoing basis which I would prefer not to, substituting that for a daily non-drug non-invasive treatment seems fine.

There is certainly the possibility that longer term use of the device will cause a more significant and longer term change, but, based on what I understand of how it works, I would expect the majority of tinnitus patients for whom it is effective, to need to use it on some kind of ongoing basis.

This is NOT a cure and is NOT intended as one. I've said that over and over and over in this thread. Also it's not going to work for everyone, people should definitely not be hanging all their hopes for a normal life over the bimodal tech, sorry, I don't think it's good enough, yet anyway.

Indeed I confused you with @kelpiemsp...

Anyway, how long did your temporary suppression last after using Michigan device? Was it complete suppression to the level of pure silence?

@kelpiemsp had a fairly remarkable and transformative experience from a similar device that also corresponded to benzo withdrawal, IIRC. I am not aware, personally, of anyone else being long-term fixed by relatively short term use of the device, but there's so much variance in tinnitus, this may well happen in some other cases.

It was not complete suppression to the level of pure silence, but I haven't known what pure silence is since at least 1998, and I'm not fixated on having perfect hearing. I had a history of severe ear infections as a kid and I remember tinnitus with fevers going back to when I was very small. I don't really give a shit that I have tinnitus at this point, 22 years is too long to live with something and give a shit about it to that degree. I just see it as a thing I'll be living with and managing until they burn my corpse and shoot the ashes out of a cannon shaped like a DMT molecule, so I am trying to find the safest and most effective way to do that and also try to keep it from progressing any faster than it has to.

I can always hear my tinnitus if I look for it, and it's generally one of the louder things I am aware of because it is so high pitched. The drugs I take, to some extent reduce the pitch and sound, and to a more radical extent, reduce my tendency to look for or care about the sound.

The device seemed to work "better" because it had no chemical effect on my anxiety, it just seemed to reduce the intensity of the sound and my awareness of it without doing anything else at all to me.

 

[Kam75]

This is NOT a cure and is NOT intended as one. I've said that over and over and over in this thread. Also it's not going to work for everyone, people should definitely not be hanging all their hopes for a normal life over the bimodal tech, sorry, I don't think it's good enough, yet anyway.

Since the disappointment of the FX-322 Phase 2a results, my last hopes were for Susan Shore's device, and your post just dashed those last hopes

I really thought that her device would help us because this woman seems to be rigorous and she has been working on her subject for decades.

I hope you are wrong, but the fact that you were one of the participants in the tests adds credibility to your words.

Finally, we have to face the facts, bimodal neuromodulation is a very recent technique on which we have no experience, so it is normal to think that this kind of device will not help us, just as it is not abnormal to think that this device will help us since it has apparently completely eliminated the tinnitus of 2 patients.

I myself am on the verge of taking medication because of the lack of sleep due to tinnitus. I have an appointment with a psychiatrist soon.

What a mess.

 

[linearb]

Since the disappointment of the FX-322 Phase 2a results, my last hopes were for Susan Shore's device, and your post just dashed those last hopes

I really thought that her device would help us because this woman seems to be rigorous and she has been working on her subject for decades.

Er, I think there's some confusion, and maybe I didn't communicate clearly.

I very much want one of these devices and think they will be helpful to a large number of people with tinnitus, in some cases probably pretty substantially so.

The question I was responding to asked whether this was a "permanent cure". It's not, it's never been presented as one. It's a "palliative treatment", meaning something that helps provide comfort and reduce severity of symptoms without actually fixing the underlying problem (hearing damage).

That doesn't mean we shouldn't be hopeful about it. There are all sorts of medical conditions for which there is presently no cure, but for which there are treatments which make the conditions a lot more manageable.

Truly finding a cure for a multisystem problem like tinnitus, which causes progressive brain changes over time, is a pretty tough nut to crack. This work might be a step down one of the roads necessary to get there.

So sad @linearb that your suppression was temporary

I'm not; the trial was very much presented as "this has basically no chance of causing any permanent changes to your tinnitus" so if it had I think I would have been fairly disturbed, even if it had happened to work out in the correct direction.

You don't need to be sad about this, it's the expected result of short term use of one of these devices, it's consistent with the animal model observations, etc.

The bottom line is I think the shit works and I hope they sell it sooner than later.

 

[ThomasC]

I think you will have to use the device over and over to get permanents results. Lenire gives permanent results for those it works.

However, I agree it's not a cure.

Unless your tinnitus is mild, it won't disappear with this treatment but its severity may reduce.

It also only works for those who can modulate their tinnitus with jaw and neck movements which comprises around 60% of tinnitus sufferers.

 

[Lukee]

Er, I think there's some confusion, and maybe I didn't communicate clearly.

I very much want one of these devices and think they will be helpful to a large number of people with tinnitus, in some cases probably pretty substantially so.

The question I was responding to asked whether this was a "permanent cure". It's not, it's never been presented as one. It's a "palliative treatment", meaning something that helps provide comfort and reduce severity of symptoms without actually fixing the underlying problem (hearing damage).

That doesn't mean we shouldn't be hopeful about it. There are all sorts of medical conditions for which there is presently no cure, but for which there are treatments which make the conditions a lot more manageable.

Truly finding a cure for a multisystem problem like tinnitus, which causes progressive brain changes over time, is a pretty tough nut to crack. This work might be a step down one of the roads necessary to get there.

I'm not; the trial was very much presented as "this has basically no chance of causing any permanent changes to your tinnitus" so if it had I think I would have been fairly disturbed, even if it had happened to work out in the correct direction.

You don't need to be sad about this, it's the expected result of short term use of one of these devices, it's consistent with the animal model observations, etc.

The bottom line is I think the shit works and I hope they sell it sooner than later.

There are many similar types of units out there in testing as we speak. I think whether or not the treatments prove to be permanent is still open for discussion. My personal opinion is that the results will be permanent but living regular life will cause for further tinnitus/damage which will need to be treated. I think the maintenance sessions will he few and far apart but likely constantly needed.

@linearb, did you have any other symptoms like pressure, TTTS, hyperacusis, etc? If so, how did they react to the treatment?