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New University of Michigan Tinnitus Discovery — Signal Timing

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"!!!
I am a non-combat vet and I have it. I already had tinnitus but I developed the somatosensory tinnitus after a subsequent work related noise exposure.

Constant hissing that I can modulate with jaw movements. I can also hear my heartbeat "hissing" in sync with it and it's worse when exercising and beating more rapidly, or with stress.

Hoping Dr. Shore's device can help me.
 
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"!!!
Sometimes I think tinnitus is only for dumb people.
 
It is thought that loud noise or repeated noise exposure as well as other factors such as SSRIs can cause hyperexcitability in the dorsal cochlear nucleus. This is the last entry point for sound into the brain. A lot of our somatosensory components are in the DCN as well hence why the focus on somatic tinnitus. The goal of the treatment is to calm these fusiform cells.

However, I had extremely somatic tinnitus where even a subtle movement of my lips would alter the pitch significantly. I had middle ear myoclonus and once I had my Tensor Tympani and Stapedius severed, the somatic tinnitus declined 95%+.

I emailed Dr. Shore my case results but she was not interested.

So it can be muscular (othopedic) as well, which is interesting.
 
What is this surgery called?
It's called a tenotomy of the middle ear muscles. MEM is a very under diagnosed type of severe tinnitus where both the middle ear muscles go into spasm, either continuous or rhythmic. I feel a lot of the severe sufferers on here have MEM and don't realise it. I didn't for nearly 14 months.
 
It's called a tenotomy of the middle ear muscles. MEM is a very under diagnosed type of severe tinnitus where both the middle ear muscles go into spasm, either continuous or rhythmic. I feel a lot of the severe sufferers on here have MEM and don't realise it. I didn't for nearly 14 months.
Why do you say you don't think they realize it? I thought it made a pretty distinctive sound. I've only experienced a loud thumping in my right ear once. It was very fast and lasted a couple seconds, but very different from my other tinnitus.

Now when I wearing hearing protection I can hear a much lower level of thumping periodically going on. I don't have severe tinnitus though. I do have pretty bad noxacusis though, to the point of being in hearing protection 24/7 right now to avoid pain cycles.
 
Why do you say you don't think they realize it? I thought it made a pretty distinctive sound. I've only experienced a loud thumping in my right ear once. It was very fast and lasted a couple seconds, but very different from my other tinnitus.

Now when I wearing hearing protection I can hear a much lower level of thumping periodically going on. I don't have severe tinnitus though. I do have pretty bad noxacusis though, to the point of being in hearing protection 24/7 right now to avoid pain cycles.
From my experience and reading others' experiences, the type of 'tinnitus' or noise associated with MEM is radically different. The thumping/rumbling sound is generally the Tensor Tympani but the Stapedius sound can vary very much from person to person. Mine was a constant buzzing and rhythmic tinnitus misdiagnosed as 'pulsatile tinnitus'.

When I woke up from my first operation the 'pulsatile tinnitus' that was a loud pulsing hiss was completely resolved.

I think a lot of tinnitus sufferers could have a myoclonic Stapedius BUT that is just my theory.

I also think a lot of people who have rhythmic tinnitus or pulsing tinnitus could have MEM. That was my theory pre-op from doing research and was confirmed by the result of the operation.

Either way. No harm if you have tinnitus to get a long time-based Tympanometry test done on top of a hearing exam. Basically a reflex decay test in the absence of sound. Takes a few minutes.

Unfortunately, knowledge of this among ENTs and Audiologists is extremely poor and, according to my surgeon who is a Professor of Neurotology at Cambridge University, MEM is way underdiagnosed, which is unfortunate.

———

DISCUSSION OF PADRAIGH'S MEM EXPERIENCE CONTINUES HERE:
https://www.tinnitustalk.com/posts/640478/
 
Sometimes I think tinnitus is only for dumb people.
The real question is why is Susan Shore the only one making overly-qualifying statements about the efficacy of her treatment if most tinnitus sufferers qualify anyway? That is what is causing people to question whether this treatment will work for them, not us being "dumb".
 
Publish results on April 1 and be able to buy an Auricle device by April 12th. Have my life back by early May.
Misinformation or hopium to the max there bud.

Dr. Shore will be unblinded to the results on April 1, she will take several months to go over and analyze the data before we get to hear preliminary results, and then the study will be published in a peer reviewed journal sometime in 2023, and if all went well, Auricle might release a device sometime in 2023-2024.

It's not really even a question, that's how placebo-controlled trials work. If you expect being zapped before 2023, it's false hope.
 
Are you serious?
No, not at all.
Misinformation or hopium to the max there bud.

Dr. Shore will be unblinded to the results on April 1, she will take several months to go over and analyze the data before we get to hear preliminary results, and then the study will be published in a peer reviewed journal sometime in 2023, and if all went well, Auricle might release a device sometime in 2023-2024.

It's not really even a question, that's how placebo-controlled trials work. If you expect being zapped before 2023, it's false hope.
Though I do hope from her previous comments that a somewhat less leisurely pace is a real possibility. Obviously this is dependent on the actual results coming out clearly positive without side effects and the FDA approval process.

I don't know how long it will really take to get preliminary results. Unblinding should just release the last bit of data into an already developed and cleaned statistical package, right? That is, all the information with the exception of the data field of whether it was placebo or treatment is already in hand and being analyzed, so the unblinding only adds that one critical bit of info, right? Shouldn't all the results basically snap into place instantly for her team, then they just need a bit of time to understand what is shown?
 
No, not at all.

Though I do hope from her previous comments that a somewhat less leisurely pace is a real possibility. Obviously this is dependent on the actual results coming out clearly positive without side effects and the FDA approval process.

I don't know how long it will really take to get preliminary results. Unblinding should just release the last bit of data into an already developed and cleaned statistical package, right? That is, all the information with the exception of the data field of whether it was placebo or treatment is already in hand and being analyzed, so the unblinding only adds that one critical bit of info, right? Shouldn't all the results basically snap into place instantly for her team, then they just need a bit of time to understand what is shown?
I hope so! I think someone who is familiar with this process said they could have someone already working on the paper process and then it's just plugging in the results which should be processed by computing.

I think what is going to vault the process is the FDA. Is this only Phase 2? Do they need to do a Phase 3 for a medical device?
 
I hope so! I think someone who is familiar with this process said they could have someone already working on the paper process and then it's just plugging in the results which should be processed by computing.

I think what is going to vault the process is the FDA. Is this only Phase 2? Do they need to do a Phase 3 for a medical device?
There is a podcast on the American Tinnitus Association's website with Dr. Shore from just before the pandemic froze everything by a year. In that she was discussing trying to rapidly move to commercialization after the conclusion this study. I don't know whether phases apply to devices in the same way they do medicines, I can't recall seeing "phases" attached to any of her studies.
 
Misinformation or hopium to the max there bud.

Dr. Shore will be unblinded to the results on April 1, she will take several months to go over and analyze the data before we get to hear preliminary results, and then the study will be published in a peer reviewed journal sometime in 2023, and if all went well, Auricle might release a device sometime in 2023-2024.

It's not really even a question, that's how placebo-controlled trials work. If you expect being zapped before 2023, it's false hope.
You don't know. It could be the study ended and that they are already unblinded. I would expect some preliminary results within 2-3 months. Keep in mind that hopefully there are investors onboard by now too that would benefit from that.

I would love to know who they managed to get on board (hoping for big pharma, they can scale up and rollout much faster).

The dates on clinical trial page are estimates. The only way to figure it out is to ask.

I do agree on the part that this treatment will not be available in 2022.
 
The dates on clinical trial page are estimates. The only way to figure it out is to ask.
And if you had bothered reading this thread instead of trying to be too clever for your own good, just recently someone asked Dr. Shore and she confirmed they're being unblinded in April. And things don't happen magically fast after that.
 
Will be interesting to see results from an investment perspective. I think they would want to be better than Phase 1. I'm generally optimistic about treatments coming out in the next 2-5 years and the possibility of a Eureka moment always exists. That would make me hesitant to invest as the barriers to entry are low and science is evolving so fast that a new treatment may eclipse Dr. Shore's work before we know it. Just my two cents.
 
Do we know the type of folks in her latest test group? Is she testing people with mild, moderate, and severe tinnitus? Also, is she testing people who have chronic tinnitus or only those with tinnitus for less than a year?
 
Do we know the type of folks in her latest test group? Is she testing people with mild, moderate, and severe tinnitus? Also, is she testing people who have chronic tinnitus or only those with tinnitus for less than a year?
On the clinical trial webpage it says: "Preferably onset of tinnitus less than one year ago, but present for at least 6 months. Tinnitus should be bothersome."

So surely even moderate tinnitus sufferers could have been recruited.
 
On the clinical trial webpage it says: "Preferably onset of tinnitus less than one year ago, but present for at least 6 months. Tinnitus should be bothersome."

So surely even moderate tinnitus sufferers could have been recruited.
I seem to recall in the paper from her first study that participants all had pretty significant THI scores (I hate THI as a metric) like 50-90ish. I can't imagine why she would do a study focused on mild sufferers.
 
I seem to recall in the paper from her first study that participants all had pretty significant THI scores (I hate THI as a metric) like 50-90ish. I can't imagine why she would do a study focused on mild sufferers.
I hate to be the bearer of bad news but the mean TFI score was 29 and reduction was barely 7 points. 10 of the subjects had clinically significant reductions of 13+ points and two had complete elimination of their tinnitus. More detail is needed to see who had 13+ point reductions. I'm sure there is a subset this will work very well for but, as for universally treating all tinnitus, it seems poor. It would be great if we could get results like the Korean study (way worse study) but I don't expect it. That is my take.

To be honest, my TFI changes by 10-30 points day-to-day.
 
I hate to be the bearer of bad news but the mean TFI score was 29 and reduction was barely 7 points. 10 of the subjects had clinically significant reductions of 13+ points and two had complete elimination of their tinnitus. More detail is needed to see who had 13+ point reductions. I'm sure there is a subset this will work very well for but, as for universally treating all tinnitus, it seems poor. It would be great if we could get results like the Korean study (way worse study) but I don't expect it. That is my take.

To be honest, my TFI changes by 10-30 points day-to-day.
My bad.
 
On the clinical trial webpage it says: "Preferably onset of tinnitus less than one year ago, but present for at least 6 months. Tinnitus should be bothersome."
These tight recruitment criteria have always been the turd in the punchbowl for me. There's also the anecdotal evidence (and various study evidence I believe) that suggests natural habituation will often occur for early onset tinnitus sufferers within a year or so. So without disambiguation, the big question will remain, was it the device or natural habituation that remedied the patient?

I honestly think that our (long-terms sufferers) best option at this point will lie with a combination of FX-322 (or FX-345) and perhaps the Shore device or similar if regeneration fails to address the underlying tinnitus to a satisfactory degree.

As a footnote, I lived quite happily with mild tinnitus for 25 years and I can say categorically that I'm not pinning my hopes on total silence, however, a reduction of symptoms would be amazing and I do think this can be a realistic expectation with combination therapy in our lifetime.
 
I hate to be the bearer of bad news but the mean TFI score was 29 and reduction was barely 7 points. 10 of the subjects had clinically significant reductions of 13+ points and two had complete elimination of their tinnitus. More detail is needed to see who had 13+ point reductions. I'm sure there is a subset this will work very well for but, as for universally treating all tinnitus, it seems poor. It would be great if we could get results like the Korean study (way worse study) but I don't expect it. That is my take.

To be honest, my TFI changes by 10-30 points day-to-day.
It's great to see your optimism... but I'd take a more sober view. As you stated, the success stories popping up seem to be for a small sub-set of patients.

I'm not saying that there won't be a cure or a treatment. But curing tinnitus and/or hearing loss would be a massive, new breakthrough for medicine.

I'll be quite content if they come up with a treatment that helps me live with it... and that doesn't break the bank.
 
It's great to see your optimism... but I'd take a more sober view. As you stated, the success stories popping up seem to be for a small sub-set of patients.

I'm not saying that there won't be a cure or a treatment. But curing tinnitus and/or hearing loss would be a massive, new breakthrough for medicine.

I'll be quite content if they come up with a treatment that helps me live with it... and that doesn't break the bank.
Exaflops are currently about 2. In five years time that will be zettaflops or 500 times the supercomputing power of now. Not to mention Quantum computers. This type of processing power allied with AI will bring treatments we find impossible to envisage right now. All in my opinion of course, but I think this is the decade of medical revolution.
 
I hate to be the bearer of bad news but the mean TFI score was 29 and reduction was barely 7 points. 10 of the subjects had clinically significant reductions of 13+ points and two had complete elimination of their tinnitus. More detail is needed to see who had 13+ point reductions. I'm sure there is a subset this will work very well for but, as for universally treating all tinnitus, it seems poor. It would be great if we could get results like the Korean study (way worse study) but I don't expect it. That is my take.

To be honest, my TFI changes by 10-30 points day-to-day.
I will say though the thing that gets me more excited was the mean reduction of tinnitus loudness by ~8 dB. I've read arguments about whether that really would equate to a 50% reduction in loudness as it would for real sounds, but if I could get that kind of response it would make a real difference, maybe even enough of a difference to make the tinnitus more of a shrug event rather than a daily burden.
So without disambiguation, the big question will remain, was it the device or natural habituation that remedied the patient?
That was the exciting thing, right? That there was a true control and that only the real treatment during the treatment had the effect. Afterwards or during the sham treatment people reverted to baseline. I mean we'll see when this big study comes out (maybe the whole thing is a dud), because 20 people is a real small study, but I am optimistic that whatever was seen in this is differentiated from an habituation effect.
 
I will say though the thing that gets me more excited was the mean reduction of tinnitus loudness by ~8 dB. I've read arguments about whether that really would equate to a 50% reduction in loudness as it would for real sounds, but if I could get that kind of response it would make a real difference, maybe even enough of a difference to make the tinnitus more of a shrug event rather than a daily burden.

That was the exciting thing, right? That there was a true control and that only the real treatment during the treatment had the effect. Afterwards or during the sham treatment people reverted to baseline. I mean we'll see when this big study comes out (maybe the whole thing is a dud), because 20 people is a real small study, but I am optimistic that whatever was seen in this is differentiated from an habituation effect.
Great point about the tinnitus loudness. A 50% reduction would be epic.

I definitely think it is more than a habituation device. The science is solid and not like Lenire. I truly believe the DCN is the source of the worst tinnitus and also the majority of it.
 

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