New University of Michigan Tinnitus Discovery — Signal Timing

A Tinnitus Talk member developped trigeminal neuralgia 6 days after using Lenire. So even though I'm not a specialist, I would say there might be a risk.
I can totally get how a negative outcome could come out of such a device. I would have thought that a stimulation device using sound seems like something that might make tinnitus worse.
 
I wrote to Dr. Susan Shore today.

She said they won't finish their trial now till the end of 2021 due to COVID-19.
Thanks for updating us @DebInAustralia. It's pretty darn sad news to be honest.
OMG at this rate Dr. Shore's device is out when we're already able to regrow new ears from scratch!

My guess is her device won't be out before she's retired. Isn't she old already?

It's like Duke Nukem Forever (which was delayed and delayed for decades).
 
Years later...

Susan Snore.gif
 
Might as well invent our own device and do our own trials, and it should be open-source this time.
Let's take our fate into our own hands!
 
https://gizmodo.com/this-small-device-could-silence-the-maddening-symptoms-1821739320

"Wonderful as an noninvasive and practically risk-free device (unless you can't stand mild shocks) to treat tinnitus could be, it might not come without its limitations. The subjects' tinnitus largely returned a week after they stopped using the device, even for the two people who reported losing it completely. The researchers also only used volunteers with a particular form of tinnitus. These sufferers are able to soften their episodes by applying pressure to their head or clenching their jaw—a rudimentary version of keeping their fusiform cells in check, it's thought. That could mean the device won't work for the 20 percent to 40 percent of tinnitus sufferers without that particular quirk."

If I'm understanding correctly, does the device only work on people who are able to soften/decrease their tinnitus through jaw/neck/head movements?
I have never heard of being able to soften/decrease tinnitus with jaw/neck/head movements. Does anyone here have this particular quirk?

Like another user mentioned, I can briefly make my tinnitus worse with certain jaw movements, but nothing I do can decrease the sound. I'm very suspicious of the 20% to 40% statistic.

If it turns out this device works, it sounds like it will be only for a small slice of tinnitus sufferers. Sort of like how ear wax removal will cure tinnitus for certain people.
 
If this device has is such potential for success, then why has it only been undertaken in Dublin, Ireland and in the university of a small city in Michigan? If it possesses such potential then why haven't, for example, Harvard, Boston Mass, etc. joined with and accelerated this methodology?

Also, is COVID-19, which is cited as the cause of this sluggish activity, frankly a self-serving alibi for other reasons?

Our Chicago Tribune had a feature article about this on 01/05/18 indicating that substantial trials had already been conducted. There is now this announcement of another 15 month extension. And that only means that trials should be concluded; who knows how many years will elapse before my audiologist can report it's availability.

All this has very troublingly aroused my suspicions. Perhaps the results have been as questionable as those of Lenire's such that there will be the Law of Diminishing Returns on further fruitless trials and it will be quietly terminated.

I still submit that innovations in drugs will be the ultimate answer towards a treatment.

Or, to be painfully blunt, I have gotten fed up with these endless delays, no longer expect any real outcome, and have dismissed having any faith in it.
 
I have never heard of being able to soften/decrease tinnitus with jaw/neck/head movements. Does anyone here have this particular quirk?

Like another user mentioned, I can briefly make my tinnitus worse with certain jaw movements, but nothing I do can decrease the sound. I'm very suspicious of the 20% to 40% statistic.

If it turns out this device works, it sounds like it will be only for a small slice of tinnitus sufferers. Sort of like how ear wax removal will cure tinnitus for certain people.
Yes, I really hope her device doesn't only work on people who are able to decrease their tinnitus with movements.
 
To patorjk and Lilah:

Why theorize about its applicability if, given the year-after-year continuous procrastination, there is a good possibility that either it will never be commercialized and, even if it ultimately is, by then effective drugs will already have been available?
 
Like another user mentioned, I can briefly make my tinnitus worse with certain jaw movements, but nothing I do can decrease the sound. I'm very suspicious of the 20% to 40% statistic.
I can do this as well. I don't do it as my tinnitus is bad enough already.

Unless I'm trying to persuade it to switch to a less shrill sound, which has worked in the odd occasion in the past.
 
@linearb was in the original study. In reviewing his comments early in this thread, there are three things to note:

1. He makes no mention of suppressing his tinnitus through modulation.

2. He makes no mention of suppressing your tinnitus through modulation as being a criteria for the trial.

3. All references to modulation are general. Not specific to increasing or decreasing your tinnitus through modulating it. The specifics he mentions relate to where the modulation occurs.

Here are the relevant quotes for review:
This device is a "reductionist" or ground-up model: they started by doing research that led them to identify one very specific mechanism that seems to relate to tinnitus, then devised a technology aimed at targeting that mechanism in a very specific way. On the other hand, AFAIK VNS has been a "holistic" or top-down approach: they started with the observation that some people who get VNS for other reasons reported a reduction in their tinnitus.

There are advantages and disadvantages to either approach.

Yes, and probably only a subset of even those people. However, 80% of tinnitus patients have some degree of somatic involvement. If Dr. Shore's model of noise-induced tinnitus is remotely accurate, it basically means that essentially all noise-induced tinnitus has a somatic component (though in some people the sensory component could relate to nerves which are not directly accessible through basic movements or poking yourselves).

Having basically decent hearing as well as a somatic component that can be manipulated through muscle movement is necessary for using this device, because the theory is that the device works by stimulating the same muscles that are connected to the tinnitus hyperactivity along with the auditory nerve with noise, in a way which is very precisely timed and causes a homeostatic mechanism called "spike-timing dependent plasticity" to reorganize information pathways in the dorsal cochlear nucleus in a way that reduces the tinnitus hyperactivity.
I remain bullish on this one, but I don't want anyone to come to unrealistic conclusions based on bad data from me. I think it's better than anything else on the market; how much that means depends on one's perspective.

I documented this elsewhere but I can't find it and I post too much. In general, the trial required keeping twice-daily subjective self-ratings of tinnitus volume and distress on a 10-point scale. My usual rating for volume flutters between 4 and 8, and distress between maybe 3 and 7. There's a lot of variation there, I get 2 days once in a while, but during the second 2 weeks of the experimental period I flatlined, never noting anything higher than 4 for volume or 5 for distress. That was significant enough that by the end I was (very cautiously, at a low volume) using earbuds again without any distress, which is basically unprecedented over the last ~10 years.

They also attempted to do objective volume matching in the lab, using sound generators in a sound-proof booth, but I have no idea how my scores on that changed (or not) because I was not given access to my full data.

Because of how the tech is supposed to work (details further back in this thread, search for my username), it's critical that patients are able to modulate their tinnitus with muscle movements of a muscle which is innervated by nerves that pass through the temporomandibular junction. This means that if you cannot change the sound or volume of your tinnitus by moving your jaw or neck, it is not likely that this tech will help you. I believe that ~80% of tinnitus patients are able to do this; this tech is likely to help some subset of those people, if it works as the developers believe.
Perhaps the Gizmodo article is inaccurate, or @linearb can shed some light on these concerns. Alternatively, someone could email Dr. Shore for clarification and cite the article. She seems to have been responsive in the past.
 
If this device has is such potential for success, then why has it only been undertaken in Dublin, Ireland and in the university of a small city in Michigan? If it possesses such potential then why haven't, for example, Harvard, Boston Mass, etc. joined with and accelerated this methodology?

Also, is COVID-19, which is cited as the cause of this sluggish activity, frankly a self-serving alibi for other reasons?

Our Chicago Tribune had a feature article about this on 01/05/18 indicating that substantial trials had already been conducted. There is now this announcement of another 15 month extension. And that only means that trials should be concluded; who knows how many years will elapse before my audiologist can report it's availability.

All this has very troublingly aroused my suspicions. Perhaps the results have been as questionable as those of Lenire's such that there will be the Law of Diminishing Returns on further fruitless trials and it will be quietly terminated.

I still submit that innovations in drugs will be the ultimate answer towards a treatment.

Or, to be painfully blunt, I have gotten fed up with these endless delays, no longer expect any real outcome, and have dismissed having any faith in it.
I also think that there is something strange about this Michigan device. Although we could actually all be wrong. There is something strangely similar about the development process and also the information released between the Michigan device and also the Hough Ear Institute Pill too.

We know the Michigan device has been in development for quite a long time now and seemingly there has been no really meaningful results or beneficial information released. Furthermore the information which has been released is rather vague and also confusing. Contrast this to Hough Ear Institute where there has also been the same sort of vagueness and confusion around their pill until very recently when it got its trials underway. Even though Hough Ear Institute has given us some more information on the pill there is still lots of confusion on it.

I strangely suspect that the Michigan device might go one of two ways:

The first is they may see promise or good outcomes with it and they are staying silent since they are looking to commercialise it post phase 2 trials.

The second is that this device is not achieving results like had been expected and that they are staying silent on the progress thus far.

I must say that I find it very interesting that Susan Shore seems to be avoiding answering questions on the device and its progress. This reminds me a lot like how Hough Ear Institute had selectively answered questions on elements of the pill and has actually avoided answering some key questions which relate to the reasons behind putting the pill through the trials the way that they are and also their need to do certain research first.

Still something seems to suggest to me that this Michigan device might get beaten by regenerative medicine first and that it might also actually be better at resolving tinnitus than the Michigan device.
 
If we go back, we will find that Susan Shore has been talking about her device since 2010. Why all this delay now? If the device worked, why would they not release a trial version in the market for the purpose of studying and helping people?
 
IIRC "2020-2024" was what they told me as a target date for an approved productized thing, back in 2015. So, we're not even 1/4 through that window, and I expect that their trials have been disrupted to some extent by COVID-19.

Anyone who's real suspicious or whatever should just look into the history of other devices and stuff, let alone drugs; it's highly unusual for this stuff to move faster than years to decades. University of Michigan is a decade plus invested in this work. There's inertia there, just not the sort of burning urgency that drives patients mad but introduces bias into process if you let it impact how your process works.
Did you ever get around to sourcing an engineer to create a device?
I've discussed this with various people but I'm not really comfortable tinkering with amateur implementations of things that we have reason to think cause structural brain changes, even if they are short lived.

I have reason to believe some number of people have done this, and there are accounts of a couple attempts here that at least seemed to elicit some sort of response.

The relevant engineering is less daunting than understanding how it's interacting with the nervous system. That's over my pay grade.
 
Yeah I fully agree, I supose neuromodulation is a totally new field and serious researchers want to make sure their outcomes are both safe and effective. I'd rather wait than put my hopes/health on a half cooked solution equivalent to tossing a coin (who said Lenire?).
 
I have never heard of being able to soften/decrease tinnitus with jaw/neck/head movements. Does anyone here have this particular quirk?

Like another user mentioned, I can briefly make my tinnitus worse with certain jaw movements, but nothing I do can decrease the sound. I'm very suspicious of the 20% to 40% statistic.

If it turns out this device works, it sounds like it will be only for a small slice of tinnitus sufferers. Sort of like how ear wax removal will cure tinnitus for certain people.
I can soften my tinnitus just by clenching my jaw. I don' t know how common this form of tinnitus is. Sometimes, my tinnitus gets pulsatile especially when I do sports, or when I stand up.
 
To tommyd87:

Someone on Tinnitus Talk mentioned that Dr. Shore will be interviewed on Monday Oct. 5.

We should then be able to determine whether this also (to quote Lenin) belongs in "The Dustbin of History" (along with AM-101, Neuromonics, SoundCure, Desyncra, Lenire, Lipoflavonoid, etc.).
 
We should then be able to determine whether this also (to quote Lenin) belongs in "The Dustbin of History" (along with AM-101, Neuromonics, SoundCure, Desyncra, Lenire, Lipoflavonoid, etc.).
What do you expect one watered-down-for-laymen's-consumption presser to tell you, that you couldn't learn in much more detail from reading their considerable body of published whitepapers and preprints?

How will one single interview tell you whether a technology belongs in the "dustbin of history" when it's still at least a couple years away from being ready for consumer adoption?

I totally understand impatience and skepticism, but some of the doomerism around here is ridiculous to me.

Anyone who wants to know the current status of this research, whether COVID-19 has impacted their trajectory, and what they see as their current target window for a potential launch should just email them; I've had nothing but good interactions with that lab over the past few years. Most of my emails to Dr. Shore ended up getting deflected to PhDs and research assistants, but, if I was a tenured professor working on a tinnitus thing, I would no doubt do the same...
I can totally get how a negative outcome could come out of such a device. I would have thought that a stimulation device using sound seems like something that might make tinnitus worse.
The sound itself is actually not the problem, at all -- we're rewiring the brain here, kiddos, and making the impossible possible. (The idea of eliciting structural brain changes using noninvasive bimodal stimulation to exploit spike-timing dependent plasticity in a very specific way would have been pure science fiction 20 years ago).

I've been impressed with the normal research-institution patience and safety protocols UMich has used, including publishing basically all their data in a pretty expedient way.

Lenire is a venture capital backed for-profit enterprise. They have a very different set of constraints, goals and resources than a research university, and I inherently distrust that world because I have worked in it a lot. Additionally, they are selling a device in Ireland based on an approval that was granted for a different, earlier device, and they haven't remotely cleared the approval hurdles in the US.

I think these things should make us deeply suspicious of Lenire. At the same time, if we're messing around with DCN wiring, and one of the companies doing it is a VC-backed place doing a halfass job publishing their data.... well, I'd more or less expect some amount of adverse outcomes?

That is, if someone got trigeminal neuralgia from this, that's awful, and if that would have been avoidable with safer / better research on behalf of Lenire then it sounds criminal. But, that's only possible if this technology is, in general, doing what it claims to: rewiring the brain at the DCN level.
 
To tommyd87:

Someone on Tinnitus Talk mentioned that Dr. Shore will be interviewed on Monday Oct. 5.

We should then be able to determine whether this also (to quote Lenin) belongs in "The Dustbin of History" (along with AM-101, Neuromonics, SoundCure, Desyncra, Lenire, Lipoflavonoid, etc.).
That is excellent. Essentially I had heard reports of people asking for information about this device/attempting to contact Dr. Shore but have been getting no response.
 
What do you expect one watered-down-for-laymen's-consumption presser to tell you, that you couldn't learn in much more detail from reading their considerable body of published whitepapers and preprints?

How will one single interview tell you whether a technology belongs in the "dustbin of history" when it's still at least a couple years away from being ready for consumer adoption?

I totally understand impatience and skepticism, but some of the doomerism around here is ridiculous to me.

Anyone who wants to know the current status of this research, whether COVID-19 has impacted their trajectory, and what they see as their current target window for a potential launch should just email them; I've had nothing but good interactions with that lab over the past few years. Most of my emails to Dr. Shore ended up getting deflected to PhDs and research assistants, but, if I was a tenured professor working on a tinnitus thing, I would no doubt do the same...

The sound itself is actually not the problem, at all -- we're rewiring the brain here, kiddos, and making the impossible possible. (The idea of eliciting structural brain changes using noninvasive bimodal stimulation to exploit spike-timing dependent plasticity in a very specific way would have been pure science fiction 20 years ago).

I've been impressed with the normal research-institution patience and safety protocols UMich has used, including publishing basically all their data in a pretty expedient way.

Lenire is a venture capital backed for-profit enterprise. They have a very different set of constraints, goals and resources than a research university, and I inherently distrust that world because I have worked in it a lot. Additionally, they are selling a device in Ireland based on an approval that was granted for a different, earlier device, and they haven't remotely cleared the approval hurdles in the US.

I think these things should make us deeply suspicious of Lenire. At the same time, if we're messing around with DCN wiring, and one of the companies doing it is a VC-backed place doing a halfass job publishing their data.... well, I'd more or less expect some amount of adverse outcomes?

That is, if someone got trigeminal neuralgia from this, that's awful, and if that would have been avoidable with safer / better research on behalf of Lenire then it sounds criminal. But, that's only possible if this technology is, in general, doing what it claims to: rewiring the brain at the DCN level.
Excellent explanation, thanks. There is something funny about Lenire too. There's no problem with the fact that they are venture capital backed, as a number of medical companies are. However it is the way which Lenire is going about their operations which is the concern, as they seem to have not been as measured and detailed as most medical companies are when they go through the process to release something.

I too trust the Michigan device much more than Lenire.
 
To linearb:

My only rejoinder can be an old Jewish saying quoted by Saul Bellow in his novel "The Victim":

"Call me Ikey,
Call me Moe:
What's it to me-
Where's the dough."

I rest my position until (if ever) this device is on my head and really reducing (let alone eliminating) the tinnitus.

I'm 66 and haven't got the patience to wait the apparently necessary Eons until this is available.
 
Upon hearing from Dr. Shore about this delay, I contacted Dina Kutinsky (Associate Director of Development at the University of Michigan Medicine Office of Development.)

She was also aware of this delay.

Dina stated that Shore, along with other researchers, will still be presenting at the Kresge Hearing Research Institute Hearing webinar. Shore will be presenting a general overview of her lab's work.

I am waiting on more info regarding joining this webinar in October. Maybe we will have a Q and A opportunity?
 
I rest my position until (if ever) this device is on my head and really reducing (let alone eliminating) the tinnitus.

I'm 66 and haven't got the patience to wait the apparently necessary Eons until this is available.

I sympathize.

I'm ~25 years younger and I've had the device on my head and experienced the benefit. So, obviously I am looking at this through a pretty different lens. On the other hand, the fact that I used it and believe it works also gives a large amount of energy to my impatience. For the moment, medication makes life quite acceptable, but who knows how long that will last?

Excellent explanation, thanks. There is something funny about Lenire too. There's no problem with the fact that they are venture capital backed, as a number of medical companies are.

I agree, having worked for a couple ethical VC-backed adventures. It does move the goalposts substantially in a way that's not necessarily beneficial to patients, though. Research institutions want to produce groundbreaking research which withstands peer review and reproduction. VCs want an exit which allows them to make ~10-100x back on their initial investment. This could lead to a product that's so good it's super profitable, but it can also lead to all kinds of shenanigans to hit a certain valuation and hold it long enough for the backers to, essentially, pump and dump. That's not my forte, but at the risk of namedropping someone I namedrop too much, I bet @Greg Sacramento has some thoughts here.
 
I sympathize.

I'm ~25 years younger and I've had the device on my head and experienced the benefit. So, obviously I am looking at this through a pretty different lens. On the other hand, the fact that I used it and believe it works also gives a large amount of energy to my impatience. For the moment, medication makes life quite acceptable, but who knows how long that will last?

I agree, having worked for a couple ethical VC-backed adventures. It does move the goalposts substantially in a way that's not necessarily beneficial to patients, though. Research institutions want to produce groundbreaking research which withstands peer review and reproduction. VCs want an exit which allows them to make ~10-100x back on their initial investment. This could lead to a product that's so good it's super profitable, but it can also lead to all kinds of shenanigans to hit a certain valuation and hold it long enough for the backers to, essentially, pump and dump. That's not my forte, but at the risk of namedropping someone I namedrop too much, I bet @Greg Sacramento has some thoughts here.
I literally look at what companies like Otonomy are doing with their research (which is backed by capital investment too) and actually see how you can establish a happy medium between getting a commercial medicine which may make investors a return on their investment and also produce the quality and novel research required to demonstrate it meets the FDA requirements. I then look at Lenire and see a completely profit driven product which has not demonstrated any real research outcomes at all.

Furthermore, it is obvious that Otonomy is striving to ensure that their product(s) comply with all requirements set by the regulators like FDA and that includes making sure they conduct the necessary research to demonstrate this. Lenire on the other hand seems to have chosen to go down a path where they can bypass as many requirements as possible and minimise the research that they need to complete.

The fact that Lenire misses many of the compliance requirements for FDA approval simply tells me that the work into getting their product out there must not have been very complete or extensive. Essentially the best thing about FDA approval is you know that the evidence required to pass approval is extensive, reviewed and complete. This means you know that your product will stand up over time and that it is suitable for its purpose as well.

The choice Lenire made to go down the path they did in order to gain approval doesn't make me feel confident in anyway with Lenire's product overall. This is especially the case when you compare it to other profit focused medical products which have obtained the research outcomes to back their product.

While Dr. Shore's work has taken time, it is incredibly evident that she is putting the work in to try and achieve the right outcomes to make her product successful and this includes research to demonstrate that her product works. We can be almost guaranteed that Shore's product will provide better outcomes for patients and probably attain more consistent and more superior results too.
 
If you read some of the studies that Susan Shore and others were involved in from years ago, there has been some questioning as to what parts of the midbrain auditory nuclei where the cell body receives input from cartwheels and stellate cells. fMRI was used, but that has been shown not to be so useful. Some of more previous studies, but still before device development shows that only a small fraction of PF inputs are needed. So for now, until we can discover more, her device may be helpful. I do wonder if continued use will be functional as at least the facial nerve and certain nerves in jaw and neck can only take so much electrical stimulus.

Research indicate that fusiform apical dendrites receive excitatory inputs from parallel fibers and inhibitory inputs from midbrain auditory nuclei and neighboring cartwheel and stellate cells (Rubio and Wenthold, 1999). On the other hand, the cell body receives inhibitory inputs from nearby cartwheel cells, vertical cells, ventral cochlear nucleus, and midbrain auditory nuclei (Zhang and Oertel, 1994).

https://collected.jcu.edu/cgi/viewc...ttpsredir=1&article=1057&context=honorspapers

Somatosensory input from one particular source or modality could reduce the ability of inputs from another source to influence the firing rate of a CWC. Activation of as few as three PF synapses is sufficient to significantly elevate spontaneous CWC firing rates (Roberts and Trussell, 2010), suggesting that activity of only a small fraction of the total population of PF inputs to a CWC would be required to elevate firing rates to levels that would evoke endocannabinoid release.

https://www.jneurosci.org/content/31/44/15807

Susan Shore Study - Summary text.
Overall, the loudness of phantom sounds decreased only after the actual, or bimodal, treatment, but not the sham treatment of sound only. For some the decrease was around 12 decibels, about the magnitude of an electric light bulb's hum.

https://www.aau.edu/research-schola...lly-timed-signals-ease-tinnitus-symptoms-test

Other Susan Shore research support:
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3234102/
 
If you read some of the studies that Susan Shore and others were involved in from years ago, there has been some questioning as to what parts of the midbrain auditory nuclei where the cell body receives input from cartwheels and stellate cells. fMRI was used, but that has been shown not to be so useful. Some of more previous studies, but still before device development shows that only a small fraction of PF inputs are needed. So for now, until we can discover more, her device may be helpful. I do wonder if continued use will be functional as at least the facial nerve and certain nerves in jaw and neck can only take so much electrical stimulus.

Research indicate that fusiform apical dendrites receive excitatory inputs from parallel fibers and inhibitory inputs from midbrain auditory nuclei and neighboring cartwheel and stellate cells (Rubio and Wenthold, 1999). On the other hand, the cell body receives inhibitory inputs from nearby cartwheel cells, vertical cells, ventral cochlear nucleus, and midbrain auditory nuclei (Zhang and Oertel, 1994).

https://collected.jcu.edu/cgi/viewc...ttpsredir=1&article=1057&context=honorspapers

Somatosensory input from one particular source or modality could reduce the ability of inputs from another source to influence the firing rate of a CWC. Activation of as few as three PF synapses is sufficient to significantly elevate spontaneous CWC firing rates (Roberts and Trussell, 2010), suggesting that activity of only a small fraction of the total population of PF inputs to a CWC would be required to elevate firing rates to levels that would evoke endocannabinoid release.

https://www.jneurosci.org/content/31/44/15807

Susan Shore Study - Summary text.
Overall, the loudness of phantom sounds decreased only after the actual, or bimodal, treatment, but not the sham treatment of sound only. For some the decrease was around 12 decibels, about the magnitude of an electric light bulb's hum.

https://www.aau.edu/research-schola...lly-timed-signals-ease-tinnitus-symptoms-test
If regenerative hearing treatments targets the cochlear side and the Dr. Shore device targets jaw and similar instigated tinnitus then this will be a winner without a doubt.
 

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