New University of Michigan Tinnitus Discovery — Signal Timing

#2,945
Bambam0 said:
it's hard for me to see her still working and participating in things like this if she wasn't on to something huge.
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I believe she was supposed to be a speaker at the Tinnitus Research Initiative conference in Vancouver this June, but it was cancelled about a month ago.
 
#2,948
Bambam0 said:
It's hard for me to see her still working and participating in things like this if she wasn't on to something huge.
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I have two thoughts on this. One... Lenire appeared to be HUGE disappointment. And people like Hubert Lim put their names on the line. Unless Lenire's efficacy turns around, I would have a hard time taking Lim seriously in the future, so people can and do put their names out there for products/services that aren't great. Not saying that's 100% what he did, but right now it doesn't look so good.

That said, she is speaking along with two other researchers, presenting their data to a panel of expert judges and event attendees will vote. If she would be willing to get up there and promote a sham, that would reek of some sort of personality pathology and would be absolutely disgraceful after decades of work. While it's "possible" I don't see that as the likely scenario. So to your point, this likely something that is very ground breaking, otherwise she would be jumping the shark to which there's probably no recovery. I for one couldn't fathom promoting something along with two other researches to a conference of scientific researching peers and it mean virtually nothing.

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#2,949
Watasha said:
I have two thoughts on this. One... Lenire appeared to be HUGE disappointment. And people like Hubert Lim put their names on the line. Unless Lenire's efficacy turns around, I would have a hard time taking Lim seriously in the future, so people can and do put their names out there for products/services that aren't great. Not saying that's 100% what he did, but right now it doesn't look so good.

That said, she is speaking along with two other researchers, presenting their data to a panel of expert judges and event attendees will vote. If she would be willing to get up there and promote a sham, that would reek of some sort of personality pathology and would be absolutely disgraceful after decades of work. While it's "possible" I don't see that as the likely scenario. So to your point, this likely something that is very ground breaking, otherwise she would be jumping the shark to which there's probably no recovery. I for one couldn't fathom promoting something along with two other researches to a conference of scientific researching peers and it mean virtually nothing.

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This is great insight. Does anyone know if anything from the STAT will be made publicly available after the presentation? I'm tempted to buy a ticket even though it is steep but I am very curious.
 
#2,950
Dr. Shore is doing a lot more research than just this tinnitus project. Don't forget she is also a Professor teaching students. Since she already won the competition with the Auricle device last year, I doubt she is allowed to win it again with the same subject. Don't get overly excited on that presentation.

On topic, I wouldn't be suprised if another clinical trial was needed to determine the best protocol. This clinical trial has a 6-week protocol and follow-up up to 38 weeks. It is supposed to stop cells from firing by using neuroplasticity. In guinea pigs tinnitus vanished. In humans it did not. If the tinnitus comes back after the 6-week treatment again, it means that at 38 weeks there might not be any reduction and a new protocol has to be defined etc.

Not sure if that would block FDA approval but if the treatment is not sustainable over time, clearly a new protocol needs to be designed.
 
#2,951
InNeedOfHelp said:
Dr. Shore is doing a lot more research than just this tinnitus project. Don't forget she is also a Professor teaching students. Since she already won the competition with the Auricle device last year, I doubt she is allowed to win it again with the same subject. Don't get overly excited on that presentation.

On topic, I wouldn't be suprised if another clinical trial was needed to determine the best protocol. This clinical trial has a 6-week protocol and follow-up up to 38 weeks. It is supposed to stop cells from firing by using neuroplasticity. In guinea pigs tinnitus vanished. In humans it did not. If the tinnitus comes back after the 6-week treatment again, it means that at 38 weeks there might not be any reduction and a new protocol has to be defined etc.

Not sure if that would block FDA approval but if the treatment is not sustainable over time, clearly a new protocol needs to be designed.
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A couple of points.

1) She won STAT Madness in 2019. Did she also win something with Auricle last year? I was not aware?

2) In the early pilot trial, tinnitus vanished for a few, and reduced for others, and no change for others.

Michigan tops STAT Madness voting with a potential treatment for tinnitus

"Those who received the electrical stimulation said their tinnitus was reduced, lessening with each week the trial went on. Their psychological distress was relieved for even longer, after the trial was over.

"The exciting part of this work is that whatever we did in the human was taken from very solid, rigorous basic science work in animals," Shore said about her team's 2018 paper in Science Translational Medicine. "I think that is a big strength because not many treatments for tinnitus are actually developed directly out of the basic science by the same researcher."

Another larger clinical trial will yield results next year, Shore said. She holds a patent on the device. "It's always hard to predict how long commercialization can take, but I would say if we get as encouraging results in the next trial that we will work very hard to get this to people.""​

Below is another article with the results of the first trial. I also believe the purpose of this latest trial was to refine the protocols further (which I'm sure will be an ongoing process), so fingers crossed it is even more effective. It's a large trial so the proof should be in the pudding.

Study Shows Specially Timed Signals Ease Tinnitus Symptoms
 
#2,952
InNeedOfHelp said:
Dr. Shore is doing a lot more research than just this tinnitus project. Don't forget she is also a Professor teaching students.
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I wouldn't be so sure about this. My cousin is a researcher/Professor in the Neuroscience dept. at U of M and he only teaches one class each year. Susan's time might be divided to a certain extent, but I'm sure her lab/team would be focused on this project exclusively. My cousin does spend a ton of time applying for grants, though.
 
#2,953
Watasha said:
A couple of points.

1) She won STAT Madness in 2019. Did she also win something with Auricle last year? I was not aware?

2) In the early pilot trial, tinnitus vanished for a few, and reduced for others, and no change for others.

Michigan tops STAT Madness voting with a potential treatment for tinnitus

"Those who received the electrical stimulation said their tinnitus was reduced, lessening with each week the trial went on. Their psychological distress was relieved for even longer, after the trial was over.

"The exciting part of this work is that whatever we did in the human was taken from very solid, rigorous basic science work in animals," Shore said about her team's 2018 paper in Science Translational Medicine. "I think that is a big strength because not many treatments for tinnitus are actually developed directly out of the basic science by the same researcher."

Another larger clinical trial will yield results next year, Shore said. She holds a patent on the device. "It's always hard to predict how long commercialization can take, but I would say if we get as encouraging results in the next trial that we will work very hard to get this to people.""​

Below is another article with the results of the first trial. I also believe the purpose of this latest trial was to refine the protocols further (which I'm sure will be an ongoing process), so fingers crossed it is even more effective. It's a large trial so the proof should be in the pudding.

Study Shows Specially Timed Signals Ease Tinnitus Symptoms
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Sorry 2019 indeed, but it wouldn't make sense to win with the same innovation. You could be winning prize money every year for the same thing over and over.

All of the people treated, none had sustainable relief. All bounced back to baseline, even the people with vanished tinnitus.
 
#2,954
Most Professors rarely teach anymore. Their focus is on research. I recently was operated on by a Professor from Cambridge University. He is a practicing surgeon, but his work in Cambridge University is all research. I had a nice chat with him regards this. He is working on genetics for hearing loss and has had Bob Langer over a few times as a guest speaker.
 
#2,956
Upon checking various articles and papers I was not able to locate any information regarding multi-tonal type of tinnitus and if this has been included in the study.

Do you think that multi-tonal tinnitus sufferers may benefit from this device? It would seem really difficult for an audiologist to set up the device matching all various tones.
 
#2,957
Padraigh Griffin said:
Source please? Interesting.
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This Small Device Could Silence the Maddening Symptoms of Tinnitus

This is why I assume that a switch from 30 to 60 days is the first step in treatment optimization of the protocol.

But assuming tinnitus will remain (as it did so after 30 days...!), a new protocol has to be made, e.g. use the equipment every other week for 60 days, 30 days rest, repeat...

This current study will likely not give answers to this and will leave questions open for follow up. What we will know is which subgroups of somatic tinnitus will benefit from such approach.

I'm not a pessimist but by far there are some gaps which will remain open after this study, and people who are expecting a cure will have a big chance of coming out disappointed. Needless to say it will offer relief which we all crave for - I am very excited and confident that the majority of tinnitus sufferers will benefit.
 
#2,958
Freerunner said:
Upon checking various articles and papers I was not able to locate any information regarding multi-tonal type of tinnitus and if this has been included in the study.

Do you think that multi-tonal tinnitus sufferers may benefit from this device? It would seem really difficult for an audiologist to set up the device matching all various tones.
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I attempted to join the study. I was turned down due to my location being slightly too far from their cut off for commuting and Clonazepam use at the time. They did not ask about how many tinnitus tones I had as part of the criteria to participate.
 
#2,960
GoatSheep said:
I attempted to join the study. I was turned down due to my location being slightly too far from their cut off for commuting and Clonazepam use at the time. They did not ask about how many tinnitus tones I had as part of the criteria to participate.
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That is interesting. Did they ask about hyperacusis? I don't see it listed in the exclusion criteria. However, I am sceptical about severe or even moderate hyperacusis patients being able to use the device. I really hope I am wrong. I am just judging by myself - at the moment I would not be able to put anything in my ear.
 
#2,961
@Freerunner, I've brought up that subject here, considering how difficult it is to identify and pitch match multi-tonal, broadband, fluctuating etc tinnitus, even for sound engineers to match their own (me included). However, the answer I got was, that most likely they couldn't pitch match guinea pigs' tones as well, but it was somewhat effective anyway.

Maybe they use a broadband noise around the approximate pitch? Or take one tone at a time? I don't know, but let's hope it will work for that as well.
 
#2,962
Freerunner said:
That is interesting. Did they ask about hyperacusis? I don't see it listed in the exclusion criteria. However, I am sceptical about severe or even moderate hyperacusis patients being able to use the device. I really hope I am wrong. I am just judging by myself - at the moment I would not be able to put anything in my ear.
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They didn't ask me. It's possible there would have been further questions if I wouldn't have been denied for those initial things. I honestly don't think multiple tones would have been a disqualifier still.
 
#2,963
InNeedOfHelp said:
This Small Device Could Silence the Maddening Symptoms of Tinnitus

This is why I assume that a switch from 30 to 60 days is the first step in treatment optimization of the protocol.

But assuming tinnitus will remain (as it did so after 30 days...!), a new protocol has to be made, e.g. use the equipment every other week for 60 days, 30 days rest, repeat...

This current study will likely not give answers to this and will leave questions open for follow up. What we will know is which subgroups of somatic tinnitus will benefit from such approach.

I'm not a pessimist but by far there are some gaps which will remain open after this study, and people who are expecting a cure will have a big chance of coming out disappointed. Needless to say it will offer relief which we all crave for - I am very excited and confident that the majority of tinnitus sufferers will benefit.
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Correct me if I'm wrong but I don't recall this being promoted as a cure, but rather as a treatment that could be reproducible. I really hope that this wouldn't result in an FDA block/delay as you mentioned, what is the rationale behind that?
 
#2,964
Padraigh Griffin said:
Source please? Interesting.
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IntotheBlue03 said:
Correct me if I'm wrong but I don't recall this being promoted as a cure, but rather as a treatment that could be reproducible. I really hope that this wouldn't result in an FDA block/delay as you mentioned, what is the rationale behind that?
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They are trying to achieve a sustainable solution ("semi-cure/long term suppression") I would say. Not a cure, but a structural lowering of tinnitus symptoms.

The goal is inducing neuroplasticity (long term/permanent changes in the brain), not short term suppression. You are teaching cells to react differently and if I understand correctly you hope cells remain firing differently.

If they didn't strive for a cure, why do a protocol with 1x 60 days treatment with a follow-up of 38 weeks? What do you expect to find in week 37/38 so late in? If this was designed as a maintenance - continuous treatment, you would expect a different protocol over 38 weeks - 45 days treatment, 20 days rest, 45 days treatment, 20 days rest etc with several subgroups/timings to find the ideal protocol, duration etc. Not one group with one treatment session.

No, I don't think it will delay FDA, and no, I don't think it will delay production either but the treatment protocol might need optimization on the go.

ylv1xyy2hjt4xzc2olkm.jpg
 
#2,965
InNeedOfHelp said:
They are trying to achieve a sustainable solution ("semi-cure/long term suppression") I would say. Not a cure, but a structural lowering of tinnitus symptoms.

The goal is inducing neuroplasticity (long term/permanent changes in the brain), not short term suppression. You are teaching cells to react differently and if I understand correctly you hope cells remain firing differently.

If they didn't strive for a cure, why do a protocol with 1x 60 days treatment with a follow-up of 38 weeks? What do you expect to find in week 37/38 so late in? If this was designed as a maintenance - continuous treatment, you would expect a different protocol over 38 weeks - 45 days treatment, 20 days rest, 45 days treatment, 20 days rest etc with several subgroups/timings to find the ideal protocol, duration etc. Not one group with one treatment session.

No, I don't think it will delay FDA, and no, I don't think it will delay production either but the treatment protocol might need optimization on the go.

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I think the question is they don't know yet. So they did 12 weeks or so the first time around. They said they were going to test out longer periods in future trials as it seemed to have a cumulative effect. I mean ultimately I think that's the goal, to induce as long a change as possible using this technology. They won't really know until they try... and we'll find out soon enough.
 
#2,966
Watasha said:
I think the question is they don't know yet. So they did 12 weeks or so the first time around. They said they were going to test out longer periods in future trials as it seemed to have a cumulative effect. I mean ultimately I think that's the goal, to induce as long a change as possible using this technology. They won't really know until they try... and we'll find out soon enough.
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Thanks for chiming in everyone.

I think this question might have been answered already but I hope future trials do not mean halting FDA approval or production, correct? They can continue concurrently?
 
#2,969
Just a recent study on prevalence of somatic tinnitus, since this topic has been discussed in this thread in connection with Susan Shore's device.

At least half of the veterans screened had somatic/somatosensory tinnitus, even though one might rather expect noise exposure than orthopedic issues in this group, I suppose.

Prevalence of Somatosensory Tinnitus in Veterans With Tinnitus
 
#2,970
Harder Calm said:
At least half of the veterans screened had somatic/somatosensory tinnitus, even though one might rather expect noise exposure than orthopedic issues in this group, I suppose.
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Why is it so hard for people to understand that most who have noise-induced tinnitus ALSO have somatosensory tinnitus. Somatosensory tinnitus means that you are able to increase the loudness or pitch of your tinnitus by head and neck movements.

If you got your tinnitus from a concert or a bomb going off next to your ear, you can still very likely have somatosensory tinnitus. It has nothing to do with "orthopedic issues"!!!
 

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