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New University of Michigan Tinnitus Discovery — Signal Timing

After 10 years of research, the two graphs from December 2022 Palm Springs Hearing Seminar showed that the device increased the volume of tinnitus in some people.
I think we'll need the full paper to come out to fully understand this graph. According to the graph, there were also people in the control arm who had similar increases. Maybe the device was not responsible for the increases. It could be that some people in the trial had tinnitus volume that varies by the day (like mine) and the graph is just catching them on a bad day. On some days I can hardly hear my tinnitus and on others it's quite loud...
 
Why should I even worry about frequencies above 8000 Hz if they don't affect communication anyway?
Because hearing involves more than communication. Even if EHFs don't "affect communication", they are still involved in everyday sounds. Please put an EQ on your favorite song and brickwall out all the information above 8 kHz. While you will still be able to discern the lyrics, how does the rest of the piece sound to you now?
 
Because you just made it up.
The figure I've seen (and I can't find the source for) was that 30% of people with hearing loss have tinnitus. That's purely from memory though, and I wish there was better data on the proportionality.

EDIT:

There are at least studies on the cohorts...
Conclusion
Hearing loss with tinnitus has a considerable impact on HRQoL in the Korean population. In our study, the hearing loss without tinnitus group showed better a HRQoL than the normal hearing with tinnitus group.
 
The figure I've seen (and I can't find the source for) was that 30% of people with hearing loss have tinnitus. That's purely from memory though, and I wish there was better data on the proportionality.

EDIT:

There are at least studies on the cohorts...
Conclusion
Hearing loss with tinnitus has a considerable impact on HRQoL in the Korean population. In our study, the hearing loss without tinnitus group showed better a HRQoL than the normal hearing with tinnitus group.
I just can't. So you're saying people with tinnitus and hearing loss have lesser QoL than those with just hearing loss. That doesn't mean a lot of people with hearing loss don't have tinnitus.
 
Dr. Shore's device won't work for everyone
Not to be a Negative Nelly, but I truly think it won't help everyone, at least to an extent. While I appreciate the perspective, I would like to point out that Susan Shore's research takes into account the critical role of trigeminal somatic crossfire in determining the severity of tinnitus. This is a crucial aspect that is often overlooked when discussing the efficacy of the device. While fusiform cells in the DCN are a very important factor, it's not mutually exclusive.

"The trigeminal and dorsal root ganglia relay afferent somatosensory information from the periphery to secondary sensory neurons in the brainstem, specifically, the spinal trigeminal nucleus and dorsal column nuclei, respectively. Each of these structures has been shown to send excitatory projections to the cochlear Nucleus." (Neural mechanisms underlying somatic tinnitus Susan Shore et al. Prog Brain Res. 2007.)​

Massively decreasing hyperactivity/excitatory signals and crossfire of the Nucleuses (DCN, HCN, TGN, etc) is what can lead catastrophic tinnitus to become mild, to the point of it being a non-issue as well.

Due to the device having electrical stimulation, I believe that this provides neuronal activation by external electrical stimulation is governed by voltage-gated ion channels. Hence:

"Activation of metabotropic (P2Y) purinergic receptors by ATP increases type II afferent excitability by the closure of KCNQ-type potassium channels. Thus a noise-induced hyperexcitability of type II fibers, due to the closure of KCNQ channels, may underlie the increased sensitivity or intolerance to sounds that are normally not perceived as loud, which is a hallmark of hyperacusis. Alternatively, this mechanism may also be involved in hyperacusis with pain (noxacusis)."​

I do not, however, think that this device will "give us silence". But after 2 years of 70+ dB tinnitus, living with a quiet room hiss/squeak would be a blessing. I also believe this device has the potential to "cure" hyperacusis as well, or massively suppress it to a point of it being a non-issue.

Not everyone has these somatic co-factors, hence why I believe the device won't massively benefit everybody (non somatic tinnitus to be precise).
 
I also believe this device has the potential to "cure" hyperacusis as well, or massively suppress it to a point of it being a non-issue.
Like many here, I have severe tinnitus with about 20 different tones wreaking havoc in my ears, but man I'd do anything to significantly recover from hyperacusis and noxacusis. Those are the conditions that have fully destroyed my life for the time being.

I'm fortunate to be living in a time when so many advancements are right around the corner. You can just sense this explosion of technological progress getting ready to take off.

Psychologically I'm treating my tinnitus and hyperacusis as a sort of temporary prison sentence. Eventually it will end and I'll be normal and healthy again. We all will. I fully believe that, given the advancements I've seen in regenerative medicine this past year.

Hoping Dr. Shore's device is the first step to helping us get our lives back.
 
@chinup, whilst Dr. Shore's device showed good preliminary data that will help a percentage with tinnitus, regenerative medicine is decades away.
I really hope you're wrong. It seems everything will fail this decade but I'm going to wait for the FX-322 results to come out. If it fails, yeah, we won't have anything until next decade.
 
I really hope you're wrong. It seems everything will fail this decade but I'm going to wait for the FX-322 results to come out. If it fails, yeah, we won't have anything until next decade.
Yeah. I think the Michigan Device is our best shot. I cannot for the life of me see this obsession with FX-322 or whatever. Just shows how messed up we all can be.

This Michigan Device thread has only a little over 4,000 posts and it's a treatment we know will work for some for what we want it to treat (tinnitus).

In the FX-322 thread there is nearly 20,000 posts on something that has limped around with the vast majority having no improvement and a small % leaving with the same audiogram but hearing 10 more words in background noise.

I think technology will beat regenerative therapy. Cochlear implants are always improving along with brain stem implants and even Elon Musk's Neuralink.
 
Yeah. I think the Michigan Device is our best shot. I cannot for the life of me see this obsession with FX-322 or whatever. Just shows how messed up we all can be.

This Michigan Device thread has only a little over 4,000 posts and it's a treatment we know will work for some for what we want it to treat (tinnitus).

In the FX-322 thread there is nearly 20,000 posts on something that has limped around with the vast majority having no improvement and a small % leaving with the same audiogram but hearing 10 more words in background noise.

I think technology will beat regenerative therapy. Cochlear implants are always improving along with brain stem implants and even Elon Musk's Neuralink.
Same here. I definitely think bimodal stimulation will be the way to go. Regenerative medicine is still far away, and for many other diseases as well. I hope to be wrong and FX-322 to be a success.

But right now I believe all these devices will be the best shot for us.
 
I cannot for the life of me see this obsession with FX-322 or whatever. Just shows how messed up we all can be.

This Michigan Device thread has only a little over 4,000 posts and it's a treatment we know will work for some for what we want it to treat (tinnitus).

In the FX-322 thread there is nearly 20,000 posts on something that has limped around with the vast majority having no improvement and a small % leaving with the same audiogram but hearing 10 more words in background noise.

I think technology will beat regenerative therapy. Cochlear implants are always improving along with brain stem implants and even Elon Musk's Neuralink.
Because people hope/wish that regenerative therapies will cure them while Susan Shore's device will "only" be a treatment.
 
Because people hope/wish that regenerative therapies will cure them while Susan Shore's device will "only" be a treatment.
Additionally, tinnitus is only a subset of hearing loss. The Tinnitus Talk members are the minority when it comes to tinnitus, most people just don't notice it as it may be so mild or they don't care about it. But many people on here suffer multiple symptoms e.g., hyperacusis.

Susan Shore's device may work for a portion of the members on here, most likely people that have tinnitus and no other symptoms. If regeneration of hair cells is viable and they can link to the nerve, we may be able to regain hearing to 100% and solve a much wider array of auditory issues, if not all of them.

That's why people are 'obsessed' with regenerative medicine. Just because there is a treatment imminent, doesn't mean it's going to be 100% relevant to every member on here. Regenerative medicine may be able to cure conditions like Ménière's disease, it's a totally different ball game.

It's a bit flippant to state people are obsessed with FX-322, especially when mentioning Elon Musk's Neuralink in the same breath which has done absolutely nothing for tinnitus, except from successfully killing thousands of test animals. This is not a one-size-fits-all condition and neither will the treatments be.
 
@Jonno02, I agree. It's just the results from Frequency Therapeutics have been quite underwhelming and show we are far off. Maybe I'm negative but the optimism I sometimes see here doesn't fit the reality of the trial results.

On the Dr. Shore method I was a bit pessimistic, but the trial results exceeded my expectations. I haven't seen that level of clinical benefit in any of the regeneration treatments so far.
 
Yeah. I think the Michigan Device is our best shot. I cannot for the life of me see this obsession with FX-322 or whatever. Just shows how messed up we all can be.

This Michigan Device thread has only a little over 4,000 posts and it's a treatment we know will work for some for what we want it to treat (tinnitus).

In the FX-322 thread there is nearly 20,000 posts on something that has limped around with the vast majority having no improvement and a small % leaving with the same audiogram but hearing 10 more words in background noise.

I think technology will beat regenerative therapy. Cochlear implants are always improving along with brain stem implants and even Elon Musk's Neuralink.
Well, remember they need to get the ball rolling for those regenerative drugs. It's the same thing as any other therapy or treatment, it will only help a little in the beginning, then drugs being made over time will keep getting better and better.

The problem is people thinking only 10 word score or a little improvement on an audiogram is negligible. The truth is any true improvement at all is an amazing breakthrough in science. Regenerating even a few hair cells is a win because it's thought of to be impossible since the beginning of time. And a few articles I read and people I talked to, hearing just a little more can allow a person to qualify for hearing aids instead of a cochlear implant. These people talked about how it changed their life and allowed them to hear better in background noises. So I think it's important for everybody, including the FDA, to realize these drugs won't cure deafness right away, that's an unrealistic expectation. Any ancient hearing tests we have today are garbage and are completely inaccurate, sadly. I'm proof of a person with pretty bad tinnitus in both ears, and catastrophic noxacusis, who has perfect audiograms up to 16 kHz and perfect speech-in-noise tests.

Technology does need to improve in order to actually see inside a live cochlea. But you're right, I do think technology is closer. And I think brain chips could be a game changer. I'm not sure about Neuralink, that might be a ways away but Synchron is way closer. I don't think these fixing neurological conditions will happen this decade, but it definitely will happen.
 
Yeah. I think the Michigan Device is our best shot. I cannot for the life of me see this obsession with FX-322 or whatever. Just shows how messed up we all can be.

This Michigan Device thread has only a little over 4,000 posts and it's a treatment we know will work for some for what we want it to treat (tinnitus).

In the FX-322 thread there is nearly 20,000 posts on something that has limped around with the vast majority having no improvement and a small % leaving with the same audiogram but hearing 10 more words in background noise.

I think technology will beat regenerative therapy. Cochlear implants are always improving along with brain stem implants and even Elon Musk's Neuralink.
Humans always want more than what they have. This is not a bad thing either - it's how progress happens. If tinnitus becomes treatable with Dr. Shore's treatment, then we're all better off, but there is more work to do with auditory issues in general.

Tinnitus isn't the only thing most of us are dealing with - inability to hear conversations in noisy environments, noxacusis, hyperacusis, balance issues - these all can be treated with advancements to auditory regeneration therapies.

Be glad that we've made so many advancements so recently and continue pushing for further advancements. It's how we will continue improving our quality of life as a society.
 
@Jonno02, I agree. It's just the results from Frequency Therapeutics have been quite underwhelming and show we are far off. Maybe I'm negative but the optimism I sometimes see here doesn't fit the reality of the trial results.

On the Dr. Shore method I was a bit pessimistic, but the trial results exceeded my expectations. I haven't seen that level of clinical benefit in any of the regeneration treatments so far.
@Brian Newman covered it quite well, but we need to remember a treatment for a condition is a whole lot 'easier' than a cure. Easier in quotations because a treatment for tinnitus is not easy at all, but it's all relative.

Susan Shore's device is a treatment, and treatments are only ever partially effective, and in some cases, not effective at all. That's not to take away from what Susan Shore's team have achieved, if their device really is as good as the results seem to show, that's a monumental breakthrough in the treatment of tinnitus and will bring relief to potentially hundreds of millions of people worldwide over the next few years. That is a staggering achievement and I hope each and every person that worked on that device become millionaires, many times over. And I'm sure once they collect more data, the treatment will get even more effective.

With that said, a drug that goes against our very genetic makeup and allows us to regenerate cells that have never been restored in a single human before us is in a totally different league to a treatment. The first instance may not be hugely fruitful, but proving we can in fact regenerate these cells as any level whatsoever in human patients will be a breakthrough on the scale that is extremely rare in medicine. I don't think anybody is under the illusion that FX-322 is going to give people perfect audiograms and cure their tinnitus, it's just the cornerstone of the technology. The proof of principle.

What's currently thought to be impossible and a money-sink, once proven possible, garners the interest of those with the capital and means to catapult this type of research to a pace that we can only dream about right now.
 
@Jonno02, you've summed up my thoughts pretty well.

1) Susan Shore's lab has produced a treatment that we on this board want, that will work well for a subset of us. Clinically very meaningful.

2) FX-322 may have developed something more unlikely to be possible that works, but seems unlikely to be clinically meaningful, except marginally in a very small percentage of people.
 
Look at the green dots. These represent readings for people without the treatment.

There are many more green dots on the left of the vertical line than the right. This means that TFI is improving. But there are about the same number of green dots below and above the horizontal line, meaning that loudness is not changing.

I think that's encouraging because it is showing that the loudness measure is an objective measure (doesn't change during the control phase), and TFI is not (does change during the control phase, something we might expect from a self-assessment questionnaire).
Hey, I just worked out why the TFI was relatively low compared to the decrease in loudness. Feel free to correct, but most people with tinnitus don't consider it greatly affecting their quality of life to begin with. People with severe tinnitus and people like us are in the minority.
 
Hey, I just worked out why the TFI was relatively low compared to the decrease in loudness. Feel free to correct, but most people with tinnitus don't consider it greatly affecting their quality of life to begin with. People with severe tinnitus and people like us are in the minority.
@Fightthearmy, in Phase 1 the starting TFI was also quite low. Off the top of my head, 30 ish. So even if it was higher around 50, then a reduction of 15-20 points is a lot.
 
Hey, I just worked out why the TFI was relatively low compared to the decrease in loudness. Feel free to correct, but most people with tinnitus don't consider it greatly affecting their quality of life to begin with. People with severe tinnitus and people like us are in the minority.
Some people don't even know they have tinnitus.
 
except from successfully killing thousands of test animals
You do understand that's the case for most trials, this one included. Very hypocritical to acknowledge the suffering of animals from Neuralink, but disregard the countless animals that have been blasted with incredibly loud sounds to give them tinnitus in this scientific study.
 
You do understand that's the case for most trials, this one included. Very hypocritical to acknowledge the suffering of animals from Neuralink, but disregard the countless animals that have been blasted with incredibly loud sounds to give them tinnitus in this scientific study.
I work for a company that test pharmaceuticals on animals. What we don't do, however, is exactly what Neuralink have done and test products on animals that are rushed and absolutely not fit for animal studies yet.

Dec 5 (Reuters) - Elon Musk's Neuralink, a medical device company, is under federal investigation for potential animal-welfare violations amid internal staff complaints that its animal testing is being rushed, causing needless suffering and deaths, according to documents reviewed by Reuters and sources familiar with the investigation and company operations.

So no, it's no hypocritical at all.
 
In light of the bad news, doing a bump on this thread so we can all remember that there is a treatment in the pipeline that has been shown to work.

Here's hoping the Michigan device is as good as we hope!
 
In light of the bad news, doing a bump on this thread so we can all remember that there is a treatment in the pipeline that has been shown to work.

Here's hoping the Michigan device is as good as we hope!
Yes - we have hope. Never before has any tinnitus trial been this successful at such an advanced stage, nor has there been any with such rigorous design and deep pre-trial basic science done. I'm personally very confident this will bring us at least some kind of relief.
 
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These are the mean baseline values for chronicity of tinnitus, TFI etc.

We can see that the mean TFI scores are around 40-ish, so 15-20 point reductions are about in line with 50% loudness reduction after 6 weeks.
 
One of our researcher contacts commented on the results presented at the Palm Springs Hearing Seminar as follows. I can't wait for the paper to be published and having Dr. Shore on the Tinnitus Talk Podcast!

In the end, it is a solid study, although the devil is in the details (which I hope will be addressed in the paper).

1) The fact that the correlation between the TFI and dBSL is not so high does not surprise me. These two are usually poorly correlated to begin with, the TFI in my opinion is much more influenced by psychosomatics (sleep problems, anxiety, depression, stress, etc, etc) than the loudness itself.

2) Speaking of psychosomatics, I wonder whether these very important confounders were accounted in the study's criteria whatsoever (I will have to read the paper).

3) I am skeptical to the fact that patients kept improving during washout (?)

4) I am not familiar with cross-over designs, but the fact that she doesn't show the results from the second arm (especially for those who started arm 1 with the sham and then got treatment) doesn't feel right. I noticed that she did show this for the pilot study, although she also admits that there was some cross-over.

5) I would like to see how many dropouts they had, and how this was treated. If a considerable number of patients leave the treatment, and you only analyse the ones that remained, then of course your effect sizes will look huge.

6) This TinnTester seems to play a BIG role in the study, but I can't find any validation of the tool. For instance: if I measure my tinnitus every week for 6 weeks, will I get the same results, or will I get trained? This could explain why even the sham got a 5 pts reduction in dBSL (something I have never seen tbh, with or without treatment). If this is the "default" (I would not expect the sham to reduce loudness whatsoever), the prudent approach would be to out of the bat remove 5 dBSL from both sham and treatment and interpret the results accordingly.​
 
View attachment 53442

These are the mean baseline values for chronicity of tinnitus, TFI etc.

We can see that the mean TFI scores are around 40-ish, so 15-20 point reductions are about in line with 50% loudness reduction after 6 weeks.
Where is this chart from? It is quite incomprehensible. What does active first mean? Control first? Why do columns start at zero? Anyone had zero tinnitus years? Can someone explain in detail what data this chart shows?

I don't understand why everyone still has such high hopes for this device. After 10 years of development, we still have no relevant data. Only guesses, assumptions, hope. Nothing more.
 

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