New University of Michigan Tinnitus Discovery — Signal Timing

#3,424
It doesn't work. They just need time to figure out how to deliver the results so they can get funding for another decade to develop V2.

Please let my cynicism be entirely misguided.
 
#3,426
kingsfan said:
Has something changed? I thought results were estimated to be given summer of 2023 after peer review and published to a journal?
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What? Will the results only be made publicly available after other researchers have reviewed the results? It makes no sense. Sometimes I think that Dr. Shore's research is simply a scam.
 
#3,427
junior ramano said:
Will the results only be made publicly available after other researchers have reviewed the results? It makes no sense.
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Dr. Shore sent the following in late April 2022 (it was already discussed here), so we are in for a long wait:

Greetings to everyone who has requested updates on the tinnitus clinical trial at the University of Michigan.

Given the high volume of inquiries that we receive and our desire to provide a timely and consistent response, we are sending this message to all whom have contacted us.

Clinical Trial Update

After publishing our first human pilot study in 2018, we commenced a second, larger clinical trial. Despite COVID-19 pandemic impacts, the study participants and our staff worked diligently so that the clinical trial could continue. Although our second human trial will conclude shortly, we cannot make those study results public until it is appropriate to do so.

Sharing Results from the Second Human Trial

We understand the desire to know results as soon as possible, but the release of clinical-trial results is constrained. First, as reputable scientists, we will publish the findings in a relevant journal after proper peer review. Second, regulatory agencies (e.g., FDA, NIH) are careful in their reviews of novel therapies, as they should be, so all of us must be patient.

We are dedicated to bringing this novel therapy to the millions of global sufferers of this terrible affliction. As such, we have established a private company (Auricle, Inc.) with the goal of obtaining regulatory clearance to commercialize the treatment.

Please understand that we cannot provide any additional information at this time, so we will not be responding to additional queries for results.

Our very best wishes,
Susan E. Shore, PhD, and The Shore Lab
 
#3,429
junior ramano said:
Were the results of the 2018 study good?
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Read yourself:

Auditory-somatosensory bimodal stimulation desynchronizes brain circuitry to reduce tinnitus in guinea pigs and humans

Important part (20 participants in the trial):

Mean overall TFI scores decreased from baseline of 29.2±2.6 to 22.9±1.8 units during the active treatment, but remained unchanged during sham treatment. Improvements in TFI scores were sustained beyond the active treatment and into the washout period, unlike the changes in loudness matching. As treatment order also had no significant effect on TFI scores (GLMM; P=0.819), both groups were pooled for statistical analysis. The mean TFI scores across the different study periods were significantly improved (i.e., reduced relative to baseline) for both active and active washout periods (but not sham periods) (7.33±0.956 TFI units; two-way ANOVA, F(3,1)=7.712, P=6.14e-5) indicating a diminished impact on daily life with mean reductions of 7.51 and 6.71 points, respectively. Eleven participants noted subjective changes in volume, pitch, or quality that resulted in their tinnitus becoming less "harsh" or "piercing" and more "mellow." Even participants who did not experience a complete elimination of their tinnitus reported anecdotally that their tinnitus was noticeably less obtrusive and easier to ignore.

Ten of the 20 subjects had a clinically significant reduction of at least 13 points in their TFI scores during active treatment, which is considered clinically meaningful for this questionnaire. There were no demographic differences across subjects showing significant TFI changes compared to stable subjects. Four participants had clinically significant drops during the sham treatment, but two of these also showed significant decreases in TFI during the active treatment. Further, both participants reported that their tinnitus improved more during the active treatment. The two participants who stated that the sham treatment was more effective also had the shortest tinnitus duration (less than 1 year).​
 
#3,431
kingsfan said:
Has something changed? I thought results were estimated to be given summer of 2023 after peer review and published to a journal?
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For those that have missed this .PDF containing some of the steps on software development and market launch:

https://www.tinnitustalk.com/attachments/shore-flyer-pdf.51214/

I would be surprised if they wouldn't speak a full year on these results. Keep in mind that they have probably found a licensee for the commercialisation part.

I work in pharmaceutical manufacturing myself (although pharmaceuticals, not medical devices). The requirements for supplier management and quality are very extensive.

You will have to audit the manufacturers of the devices, set up a quality system within your organization to manage the quality, validate the devices per batch that comes out of the factory, validate the software, change control systems, etc etc. A start up is simply not going to be able to do this for a global scale. The name "Auricle" will likely not even be on the device is my best guess. That name purely exists for the licensing of the technology. If you will try to do this independently you will have no network, small quantities and are not being able to get proper approvals (look at Lenire's terrible rollout - after 2-3 years they are country by country rolling Lenire out in the EU and lost all their momentum because of that).

The ones that will actually be commercializing, and I sincerely hope that big pharma neuromodulation will have jumped on the bandwagon, will have an extensive infrastructure in place to launch such a device more rapidly, accurately and on a larger scale. Such investor is not going to first wait for Dr. Shore's good intentions with peer reviewing, followed by publication of results. If the results are known already, they would have started with their FDA approval documentation after the summer holidays at latest, and will do everything to ramp up and get first to market as soon as possible. And if it actually is big pharma, we will see a publication of a license deal or acquisition pretty soon - not after FDA approval or after a bloody peer reviewed study. Look at Oblato/Hough Ear Institute/Astellas/Boehringer and all other deals that have been made and public in the last two years - none of them awaited any publication or market approval.

And to close my story:

I think the Phase 2 protocol is not extensive enough as I said earlier. They should have added a group with a maintenance protocol for keeping the results intact. What happens if you have s significant decrease in tinnitus but again it comes back after ceasing the treatment, just like in Phase 1? Do you use the device every weekend? Every month? Every other day? Continuously? It has not been tested how to deal with it and this is going to leave a huge gap behind.
 

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#3,432
ajc said:
Ten of the 20 subjects had a clinically significant reduction of at least 13 points in their TFI scores during active treatment, which is considered clinically meaningful for this questionnaire. There were no demographic differences across subjects showing significant TFI changes compared to stable subjects. Four participants had clinically significant drops during the sham treatment, but two of these also showed significant decreases in TFI during the active treatment. Further, both participants reported that their tinnitus improved more during the active treatment. The two participants who stated that the sham treatment was more effective also had the shortest tinnitus duration (less than 1 year).
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It does not look that promising. 50/50 chance of getting a meaningful reduction in symptoms. Small group. Average reduction in the group 6-7 points.

Also, the TFI scores of participants at baseline seems low. Isn't the TFI out of a 100?
 
#3,433
I think it's important to remember that the University of Michigan (UoM) is very much linked to this device. UoM is a high profile, somewhat prestigious university in the United States. They're not going to what their name linked with some half-assed, snake oil device.

I think that's why we are seeing this incredibly slow pace, peer reviews on top of more peer reviews etc. UoM wants to be sure this thing is legit before they sign off on it.

That said, I really hope the Phase 2 trial was a success. If there's even a 40% chance this device can help us, I know everyone will be lined up to get it.
 
#3,435
Of all the other research topics this is the only one researched for tinnitus out there so I hope it's successful.

We can waffle on and speculate about hearing loss treatments, off label Trobalt types, electricuting the brain and blocking nerves with Lidocaine all we like, however the fact remains it's this or nothing at the moment.

One down (OTO-313) and one to go (DRM Shore).
 
#3,436
Nick47 said:
Of all the other research topics this is the only one researched for tinnitus out there so I hope it's successful.

We can waffle on and speculate about hearing loss treatments, off label Trobalt types, electricuting the brain and blocking nerves with Lidocaine all we like, however the fact remains it's this or nothing at the moment.

One down (OTO-313) and one to go (DRM Shore).
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:cyclops: Ditto. No matter all the other potential treatments for tinnitus, the Dr. Susan Shore project has always been the one I have kept a watchful eye on, as it's been worked on for the longest and is also exclusively for tinnitus so I not only feel more invested in it but also that there's more at stake in it.
Nick47 said:
It does not look that promising. 50/50 chance of getting a meaningful reduction in symptoms. Small group. Average reduction in the group 6-7 points.

Also, the TFI scores of participants at baseline seems low. Isn't the TFI out of a 100?
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Do you think it's possible that it could be one of those things where some users have to use it much more than others or is it dangerous?
Boone said:
I think it's important to remember that the University of Michigan (UoM) is very much linked to this device. UoM is a high profile, somewhat prestigious university in the United States. They're not going to what their name linked with some half-assed, snake oil device.

I think that's why we are seeing this incredibly slow pace, peer reviews on top of more peer reviews etc. UoM wants to be sure this thing is legit before they sign off on it.
Click to expand...
Let's say Dr. Susan Shore's device worked, would we still have been kept in the dark or not? That is my only question. If the university knew for certain that it worked, would it really be this slow or what :nailbiting:

:arghh: The tension and anxiety is so much.

Overall :mad: We need something to objectively track tinnitus, once that's made, then doctors can truly start testing stuff out.
 
#3,437
KoolKat said:
:cyclops: Ditto. No matter all the other potential treatments for tinnitus, the Dr. Susan Shore project has always been the one I have kept a watchful eye on, as it's been worked on for the longest and is also exclusively for tinnitus so I not only feel more invested in it but also that there's more at stake in it.

Do you think it's possible that it could be one of those things where some users have to use it much more than others or is it dangerous?

Let's say Dr. Susan Shore's device worked, would we still have been kept in the dark or not? That is my only question. If the university knew for certain that it worked, would it really be this slow or what :nailbiting:

:arghh: The tension and anxiety is so much.

Overall :mad: We need something to objectively track tinnitus, once that's made, then doctors can truly start testing stuff out.
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Well, this is not just about what University of Michigan wants to associate itself with and such, it is also about the commercialization portion.

I can see this going two ways:

Way 1: Last phase with more patients did not prove what smaller study had pointed out to.

Way 2: Last phase did prove this works as it did in previous trial. Now it is question of not revealing technical details of how this works because it can be replicated (like imagine you have a technical standard or protocol that has description of how things needs to be programmed for it to work) aaaaaannndd posting findings in scientific papers is basically like giving your recipe out for free to the public. So from that perspective, I can see them delaying release of papers and such while they are figuring out HOW can they get production going. Remember, they would need good amount of these devices ready as soon as possible. I am not sure if their device FDA stuff will be work on at the same time as peer review and all of that scientific papers stuff, but one thing is known for sure - once papers are out with how exactly it works, then welcome AliExpress tinnitus relief devices.
 
#3,438
lolkas said:
Well, this is not just about what University of Michigan wants to associate itself with and such, it is also about the commercialization portion.

I can see this going two ways:

Way 1: Last phase with more patients did not prove what smaller study had pointed out to.

Way 2: Last phase did prove this works as it did in previous trial. Now it is question of not revealing technical details of how this works because it can be replicated (like imagine you have a technical standard or protocol that has description of how things needs to be programmed for it to work) aaaaaannndd posting findings in scientific papers is basically like giving your recipe out for free to the public. So from that perspective, I can see them delaying release of papers and such while they are figuring out HOW can they get production going. Remember, they would need good amount of these devices ready as soon as possible. I am not sure if their device FDA stuff will be work on at the same time as peer review and all of that scientific papers stuff, but one thing is known for sure - once papers are out with how exactly it works, then welcome AliExpress tinnitus relief devices.
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1) A major institution such as the University of Michigan would most assuredly retain a Patent Attorney who would assign a Pending Number that would very much protect such Intellectual Property from being appropriated by any outside party.

2) There is already a photo of this device on Dr. Shore's Webpage. This is not that complex an electronic device, and given the speed of any production process that utilizes robotics, the company who produced this photographed prototype could replicate these units en masse very quickly.

There is still an unknown, but nonetheless very nagging, discomfiting Worm In The Apple regarding the seemingly endless postponements of bringing this to full release.

The worst would be that, in spite of their development started since 2013, it is still no more effective than the placebo duds Desyncra and Lenire. And you have no idea how much I hope to Hell that I am wrong.
 
#3,439
I'm not sure why people are speculating given there have been 0 updates regarding clinical efficacy, although I understand people wanting to know. Bottom line is we won't know, until she released the trial data.

People are also seemingly overlooking that 2 patients out of that small group had complete remission. Gone. No more tinnitus.

I think that is better than any user reports we heard from Lenire.
 
#3,442
DaveFromChicago said:
1) A major institution such as the University of Michigan would most assuredly retain a Patent Attorney who would assign a Pending Number that would very much protect such Intellectual Property from being appropriated by any outside party.

2) There is already a photo of this device on Dr. Shore's Webpage. This is not that complex an electronic device, and given the speed of any production process that utilizes robotics, the company who produced this photographed prototype could replicate these units en masse very quickly.

There is still an unknown, but nonetheless very nagging, discomfiting Worm In The Apple regarding the seemingly endless postponements of bringing this to full release.

The worst would be that, in spite of their development started since 2013, it is still no more effective than the placebo duds Desyncra and Lenire. And you have no idea how much I hope to Hell that I am wrong.
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Gotcha, but what would prevent someone in Mainland China for example cloning Dr. Shore's device and sell it on AliExpress? US laws don't spread everywhere and I do think they are considering this.

Look man, we still have no idea if Dr. Shore's device even remotely works for sure. No results and updates for quite some time. It may not be any better than placebo...

Everything is possible here no matter how we are looking at this because they are really keeping this a "secret".
 
#3,444
lolkas said:
Gotcha, but what would prevent someone in Mainland China for example cloning Dr. Shore's device and sell it on AliExpress? US laws don't spread everywhere and I do think they are considering this.

Look man, we still have no idea if Dr. Shore's device even remotely works for sure. No results and updates for quite some time. It may not be any better than placebo...

Everything is possible here no matter how we are looking at this because they are really keeping this a "secret".
Click to expand...
You are entirely correct regarding the very real danger that China represents regarding the theft of any innovator's intellectual property (and there have been several quite scandalous examples).

However, this cannot be cited indefinitely as being the justification for these endless postponements (how do all sorts of new devices, revised models of current ones, etc. get released that seem to have protections against such thefts?).

I recall that when my Desyncra iPad was timed out, there were encryptions that made it impossible for me to reactivate it for someone else's use (and why bother, since it affected my tinnitus as much as shining a flashlight on my head would have had).

Also, the device may be useless unless it is calibrated for each specific patient by a trained audiologist. Only a fool would play around on a do-it-yourself basis with something that produced timed electrical impulses to the head and/or neck.

My ENT Doctor said that the pain resulting from an electrical overstimulation of the trigeminal nerve dwarfs the discomfort that even severe tinnitus produces.

This being kept a "secret" this long is arousing so many suspicions.

There is still that posting on September 7, 2021 that states that this is "nearly market ready." Do they realize how foolish and unreliable they will look if over a year elapses with this same commentary being posted?
 
#3,445
I would think there is a lot to sort out. Results of trials are basically run through an SPSS program. There are several programs within this. 'Annova' is an example of just one. So they may be running the numbers through several programs to see which represents the best, most favorable 'looking' outcome. Added to this there is the user guides, training and marketing to sort out. Peer reviewing before all this.
 
#3,447
Nick47 said:
It does not look that promising. 50/50 chance of getting a meaningful reduction in symptoms. Small group. Average reduction in the group 6-7 points.
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I agree.
ajc said:
Eleven participants noted subjective changes in volume, pitch, or quality that resulted in their tinnitus becoming less "harsh" or "piercing" and more "mellow."
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OK. I and many others who use various white noise and other neuromodulation sounds and supplements etc can achieve this with varying degrees of success or failure. It all seems very vague - which is par for the course with tinnitus treatments - from what I have been observing since I arrived on the scene.

So commercialisation is to follow peer review. Of course $14M has gone into this. Research funding needs to be recouped. Why is the sample size so small? Not as if there are a shortage of tinnitus volunteers. If it is a 50/50 chance then it is no better nor worse than many other treatments offered claiming similar - except it usually ends up far less effective than claimed when people on this board start trying it.
DaveFromChicago said:
how do all sorts of new devices, revised models of current ones, etc. get released that seem to have protections against such thefts?
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Patented devices etc ripped off by the Chinese would not be sold in the West - where patents are defended. They would be sold in China - Russia - Iran etc where copyright and patents are more or less ignored.
DaveFromChicago said:
There is still that posting on September 7, 2021 that states that this is "nearly market ready." Do they realize how foolish and unreliable they will look if over a year elapses with this same commentary being posted?
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The website www.auricleinc.com started in 2021 in connection with the device is hosted on GoDaddy but has no content.

I think a lot of chin scratching is going on. There may be a lack of enthusiasm to get going with commercialisation if this device is just not getting the resulted they wanted.
 

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