New University of Michigan Tinnitus Discovery — Signal Timing

[AnthonyMcDonald]

I think we have to look at all the data, including Phase 1. Put together and looking at the placebo like you said, it suggests somewhere between 30-40% are going to find this treatment very useful.

When you consider the tinnitus patient population worldwide, that's a lot of patients treated.

I really wish they would have forced the participants to sit in a sound isolation booth for 30 minutes every day while they receive the treatment. It's understandable that doing so for such a large sample size would be impossible, though. We also have to keep in mind that only one ear bud is used for the auditory signals, leaving the other ear open to hear whatever is happening around the user.

I'm sure the device would be even more effective with longer usage & in a strictly controlled environment, which most of us will have no problem with, I'm sure.

 

[Tomas80]

The announcement that they will submit for FDA approval in Q1 means that they will submit March 31st, at 23:59:59?

 

[Pixelito]

It was actually 53% of the full group of 99 participants, and that's before discounting that 20% of the placebo/control group had clinically significant reduction. So, subtracting for placebo/control, that gives you about 33% of the entire group that had clinically significant reduction in tinnitus as a result of the active bimodal treatment.

I'm confused why Dr. Shore would grossly misrepresent (or lie) about the results if that's clearly not the case? Especially when the actual data is out there. That 65% number is mentioned at the forefront of every article and story about the product.

Wouldn't this be a serious issue moving forward, if it hasn't been already?

 

[Tiles]

I'm confused why Dr. Shore would grossly misrepresent (or lie) about the results if that's clearly not the case? Especially when the actual data is out there. That 65% number is mentioned at the forefront of every article and story about the product.

You don't actually subtract your positive controls from the positive treatment group though. If placebo results in 50% of your subjects being cured, but your treatment cures everyone, you don't say that your treatment is only 50% effective.

 

[Nick47]

I'm confused why Dr. Shore would grossly misrepresent (or lie) about the results if that's clearly not the case? Especially when the actual data is out there. That 65% number is mentioned at the forefront of every article and story about the product.

Wouldn't this be a serious issue moving forward, if it hasn't been already?

Dr. Shore has not lied at all. It's our interpretation of the results that sometimes goes awry.

 

[RunningMan]

I'm confused why Dr. Shore would grossly misrepresent (or lie) about the results if that's clearly not the case? Especially when the actual data is out there. That 65% number is mentioned at the forefront of every article and story about the product.

Wouldn't this be a serious issue moving forward, if it hasn't been already?

She's not lying, but it's misleading to use that 65% figure without context because that excludes some (such as those whose tinnitus worsened) as shown in their own documentation, plus we know about 25% would have improved from the control/placebo treatment.

There was a question from the Q&A related to this:

When determining the efficacy of a treatment, the paper compares the TFI, THI, loudness statistics with the baseline rather than the control. Wouldn't it make more sense to compare to the control? Maybe that wasn't statistically significant?

It is important to compare a subject's tinnitus with their own baseline as we want to see if their tinnitus got better. We compared both the active and sham treatments with the subject's baseline at the beginning of the treatment.

So, they just care that it got better, even if from the placebo effect.

Anyway, as someone else said, 33% receiving clinically meaningful reduction in tinnitus would still be pretty good compared to what we have now, but it could come in less when you factor in that the study had more strict criteria for participation that would have ruled out many in the general public that will choose to try it.

We can't assume that longer treatment will improve the success rate. It's possible that the treatment might not be as effective over the long term, just as it wasn't as effective 12 weeks into the study for the original sham treatment group that got switched to active bimodal treatment. They actually threw that out in the study analysis as mentioned in previous comments.

 

[withintention]

What I keep going back to, which gives me hope despite the unanswered questions from the studies, is that UMich has decided to back the device through its Innovation Partnership program.

I would guess that UMich would not give their money and support to fund something they did not think would be successful. To me, that says even more than the pretty positive study results. I bet UMich have access to far more information than was publicly released, and they saw fit to invest.

 

[IYIiKe]

It's not misleading though. Your answer is in the limitations section of the paper. 65% is perfectly reasonable to utilize in this context for comparison of the treatment vs. placebo group. You can't assume 25% placebo just based on the other group -- that's not how it works.

Also, the rationale for somatic tinnitus is pretty obvious from the rationale provided: 60-80% of those suffering from tinnitus have somatic tinnitus. Target the biggest group, fix the biggest group, achieve the greatest benefit, etc.

Unfortunately, studies have budgets based on grants and time, and the ability of an academic university to conduct a flawless, expansive trial is simply unlikely in any regard.

 

[ErikaS]

I just wanted to throw this out there once more:

When I called the FDA provided number and asked about device submissions, I was told that submissions are not publicly provided on their website, nor can they tell you over the phone what has been submitted for approval. That is confidential information for quite a few reasons on their end.

What we will be able to see on the FDA website is when it is approved.

Now will Dr. Shore and team announce the FDA submission on their end? Maybe, who knows.

I just wanted to share again what I shared quite some time ago (this past summer) as I am seeing some say that they have checked the website or will be checking the website for submission.

 

[gameover]

A very interesting quote from the clinical trial doc that I do not remember mentioned. I am quite sure I read the sham was supposed to be auditory stimulation only, but this contradicts it:

The sham protocol uses the same electrical and acoustic levels but the bimodal interval is wider than that used to induce STDP (>100 ms). Based on work in the animal, we expect that using wider bimodal intervals will cause no harm to the subject.

(STDP = Stimulus timing dependent plasticity)

Does that perhaps explain why the sham first/treat second group did not see good results? Perhaps the application of "bad timing" prevented "good timing" from having a positive effect?

 

[RunningMan]

A very interesting quote from the clinical trial doc that I do not remember mentioned. I am quite sure I read the sham was supposed to be auditory stimulation only, but this contradicts it:

The sham protocol uses the same electrical and acoustic levels but the bimodal interval is wider than that used to induce STDP (>100 ms). Based on work in the animal, we expect that using wider bimodal intervals will cause no harm to the subject.

Indeed, it says in quite a few places that the control treatment is auditory only. The Q&A with Dr. Shore also implies that. Even the same document you referred to states:

Imperfect blinding could arise from the presence of the electrical stimulation present during active treatment. To avoid unblinding, subjects will be told that they may or may not feel electrical stimulation during both phases of the study. The previous study suggested that subjects tend to acclimate to the presence or lack of electrical stimulation during a day's treatment. Subjects will be discouraged from divulging whether they can feel the electrical stimulus.

I don't have an explanation for the contradiction. Curious...

 

[Pixelito]

I just wanted to throw this out there once more:

When I called the FDA provided number and asked about device submissions, I was told that submissions are not publicly provided on their website, nor can they tell you over the phone what has been submitted for approval. That is confidential information for quite a few reasons on their end.

What we will be able to see on the FDA website is when it is approved.

Now will Dr. Shore and team announce the FDA submission on their end? Maybe, who knows.

I just wanted to share again what I shared quite some time ago (this past summer) as I am seeing some say that they have checked the website or will be checking the website for submission.

The device could be very well in the process of FDA approval as we speak. Dr. Shore said in her Q&A that they would maintain confidentiality:

I am not in a position to discuss or otherwise confirm or deny anything concerning Auricle and the FDA. The company is certainly working on a regulatory clearance, but it is not making public comments concerning the process.

 

[gameover]

The device could be very well in the process of FDA approval as we speak. Dr. Shore said in her Q&A that they would maintain confidentiality:

Well, just very recently (as of 2 weeks ago or so) a representative of Innovation Partnership divulged Auricle has not submitted yet. Perhaps Auricle does not like that leak, but it did happen. I won't mention the person's name, but it has been confirmed it is an employee of UMich.

Here is the source of this information (from LinkedIn):

 

[Nick47]

Well, just very recently (as of 2 weeks ago or so) a representative of Innovation Partnership divulged Auricle has not submitted yet. Perhaps Auricle does not like that leak, but it did happen. I won't mention the person's name, but it has been confirmed it is an employee of UMich.

It's not the end of Q1 yet, so no issues here.

 

[IYIiKe]

It's not the end of Q1 yet, so no issues here.

I mean, and even if it was delayed a quarter, in the grand scheme of scheduling that would not exactly be bad. My government acquisition would kill for that kind of accuracy in scheduling.

 

[Fields]

Ever since my tinnitus worsened, I've been wondering: would the level in which way or to which extent you can manipulate your somatic tinnitus be indicative of the effect the Auricle device could have?

I can profoundly manipulate my volume/pitch by moving my right eye, my neck, my jaw, brushing my right-hand against textured surfaces, stretching my shoulders and more.

Or is it just a simple question of is your tinnitus somatic in any form, yes/no? I couldn't find anything on it in the Q&A.

 

[Muggumbo]

Ever since my tinnitus worsened, I've been wondering: would the level in which way or to which extent you can manipulate your somatic tinnitus be indicative of the effect the Auricle device could have?

I can profoundly manipulate my volume/pitch by moving my right eye, my neck, my jaw, brushing my right-hand against textured surfaces, stretching my shoulders and more.

Or is it just a simple question of is your tinnitus somatic in any form, yes/no? I couldn't find anything on it in the Q&A.

It's all speculation at this point, but that probably means you have a strong somatic connection. We could assume that would make it easier for the device to work. Dr. Shore assumes the connections are still there even if your tinnitus isn't somatic, based on the animal trials.

 

[gameover]

By the way, below is a video from Gene Parunak, the Managing Director of in2being, the company that built the trial device for Susan Shore's team. They are just outside of Ann Arbor, and probably work a lot with the University of Michigan. They say they specialize in FDA approvals; the guy seems to be an FDA nerd. I have no inside information, but it is quite likely they may be handling the approval process for Auricle. If you search LinkedIn, you will find the guy in the same picture with Jon Pearson, Auricle's CEO.

It's a long video (pretty amazing he can talk about it that long). Around the 25:00 mark he says that last year, the average time for clearance for 510(k) submissions was 140 days.

Damn, I wish they hurried up. The hope is if these are these guys, there is perhaps a chance they know what they're doing.

 

[marathonterri]

Good news from the University of Michigan Accelerate Blue Fund. Auricle is funded.

Accelerate Blue Fund Continues to Provide Vital Funding Support to U-M Startups in 2024

Last week, the Accelerate Blue Fund (ABF), Innovation Partnerships' early stage venture fund that invests in U-M licensed startups, closed 6 new investments:

• Auricle, a medical device company developing treatments for tinnitus, a chronic ringing in the ears that impacts up to 15% of people.

 

[gameover]

Good news from the University of Michigan Accelerate Blue Fund. Auricle is funded.

Ha, maybe this is the "money thing" we were waiting for to happen. And maybe this was the actual blocker for the FDA submission? Who knows. In any case it sounds like the ball should be rolling.

Can you share the link to the actual source? Somehow I am not finding it.

 

[Joshua Macleod]

Good news from the University of Michigan Accelerate Blue Fund. Auricle is funded.

Thank you for sharing this. Great to hear.

 

[gameover]

I went ahead and dug deeper in the TinnTester code on GitHub. It is a mess. David Martel, Susan Shore's student, and Auricle co-founder (and VP) recently (as recently as early January this year) has been doing some cosmetic changes to the code, editing code comments, etc. The code overall is ancient, circa 2003. The repository is a mess, it has executable files and some random output files, some snapshots of circuit design built using some visual tool called TDT's Real-Time Processor Visual Design Studio.

Overall it does not inspire confidence. Why is he tinkering with this code now like this? It does not look like a serious or consistent development effort. Maybe they keep it private, but then what's the point of some changes being done on a public repository? Rather strange.

→ Here you can apparently see a demo of TinnTester in action.

We all wish Auricle would be more forthcoming about their progress. We are left with speculation.

 

[Jonno02]

I went ahead and dug deeper in the TinnTester code on GitHub. It is a mess. David Martel, Susan Shore's student, and Auricle co-founder (and VP) recently (as recently as early January this year) has been doing some cosmetic changes to the code, editing code comments, etc. The code overall is ancient, circa 2003. The repository is a mess, it has executable files and some random output files, some snapshots of circuit design built using some visual tool called TDT's Real-Time Processor Visual Design Studio.

View attachment 56541

Overall it does not inspire confidence. Why is he tinkering with this code now like this? It does not look like a serious or consistent development effort. Maybe they keep it private, but then what's the point of some changes being done on a public repository? Rather strange.

→ Here you can apparently see a demo of TinnTester in action.

We all wish Auricle would be more forthcoming about their progress. We are left with speculation.

I have to say, this means absolutely nothing to me. Gives me zero reason to doubt the device.

I'm an analytical chemist. Not a programmer. But there are times that I need to build a model within software that would give an actual software engineer a stroke. I don't pretend to be a software engineer, but as part of scientific research, we do need to build rudimentary software models from time to time.

If the software works, but is bloated, non-optimised etc., then that's nothing out of the ordinary for my field of work.

I mean the software plays beeps at specific frequencies, does it really matter if it's a mess if it does what it needs to do? If it ain't broke, don't fix it.

P.S. I'm not trying to aggro software engineers with this post, it's a job beyond my capabilities.

 

[Fields]

I have to say, this means absolutely nothing to me. Gives me zero reason to doubt the device.

I'm an analytical chemist. Not a programmer. But there are times that I need to build a model within software that would give an actual software engineer a stroke. I don't pretend to be a software engineer, but as part of scientific research, we do need to build rudimentary software models from time to time.

If the software works, but is bloated, non-optimised etc., then that's nothing out of the ordinary for my field of work.

I mean the software plays beeps at specific frequencies, does it really matter if it's a mess if it does what it needs to do? If it ain't broke, don't fix it.

P.S. I'm not trying to aggro software engineers with this post, it's a job beyond my capabilities.

I'm not worried, either. I've seen some other software that accompanies cutting-edge hospital hardware in action, and, oh boy, it usually looks godawful from a UX point-of-view. If it works, it works – even if it's piles of spaghetti code. If they keep adding incremental updates/improvements it might prove to be an issue later down the line, though.

There could be several reasons why he's cleaning it up now, ranging from handing over an MVP to an actual software engineer to preparing it for an actual release – who knows.

Never heard of TDT (Tucker Davids Technologies) before, but apparently it's a company that specifically targets the neuroscience market. I agree with @gameover that it does look extremely ancient, though. I imagine this is what Power Automate would've looked like if it were designed in the Windows 2000 era :')

 

[gameover]

The software is just one element of the larger picture. The larger picture is we are nowhere near a commercial product.

The company has no employees per LinkedIn. Just founders: CEO - Pearson, CSO (Chief Science Officer) - Dr. Shore and VP - Dr. Martel. Dr. Shore clearly is not spending full time effort with the company, the fact she started the new job at UC Irvine suggests Auricle is not a priority for her (for whatever reason). They only got the 2nd round of funding from the university incubator. I doubt it is in the 10s of millions of dollars which would be required to get the ball rolling. Accelerate Blue Fund only raised a total of $2M by 2021 (see here). They don't even have a webpage. Zero PR/marketing efforts, beyond a couple of articles.

So Dr. Martel tinkering with the old code on GitHub just shows this is not a business that's moving full steam ahead yet. Sorry, no way.

I also add the fact they are not in one physical location does not bode well. Taking a new company off the ground is a LOT of work. I am a big fan of remote work, but if I were starting a new company (and did not have tinnitus and hyperacusis...) I'd definitely would want to be working close with my folks. Dr. Shore is in Irvine, CA, maybe splitting time between there and Ann Arbor, MI. Dr. Martel seems to be in Ann Arbor, and Pearson is located San Francisco. He incorporated the company in California in the fall of last year (the company was registered in Delaware in 2019), indicating that perhaps this will be their primary location. Who knows.

Compare this to the timeline and progression of Neuromod. They have got roughly over 50 million EUR in funding over the years.

I have no doubt Auricle has a superior solution, but the (sad) reality is they are moving slower than we would like, and I don't think it is realistic to expect the product any time soon. A year from now would be too optimistic. Two years? Maybe.

 

[Pinhead]

The software is just one element of the larger picture. The larger picture is we are nowhere near a commercial product.

The company has no employees per LinkedIn. Just founders: CEO - Pearson, CSO (Chief Science Officer) - Dr. Shore and VP - Dr. Martel. Dr. Shore clearly is not spending full time effort with the company, the fact she started the new job at UC Irvine suggests Auricle is not a priority for her (for whatever reason). They only got the 2nd round of funding from the university incubator. I doubt it is in the 10s of millions of dollars which would be required to get the ball rolling. Accelerate Blue Fund only raised a total of $2M by 2021 (see here). They don't even have a webpage. Zero PR/marketing efforts, beyond a couple of articles.

So Dr. Martel tinkering with the old code on GitHub just shows this is not a business that's moving full steam ahead yet. Sorry, no way.

I also add the fact they are not in one physical location does not bode well. Taking a new company off the ground is a LOT of work. I am a big fan of remote work, but if I were starting a new company (and did not have tinnitus and hyperacusis...) I'd definitely would want to be working close with my folks. Dr. Shore is in Irvine, CA, maybe splitting time between there and Ann Arbor, MI. Dr. Martel seems to be in Ann Arbor, and Pearson is located San Francisco. He incorporated the company in California in the fall of last year (the company was registered in Delaware in 2019), indicating that perhaps this will be their primary location. Who knows.

Compare this to the timeline and progression of Neuromod. They have got roughly over 50 million EUR in funding over the years.

I have no doubt Auricle has a superior solution, but the (sad) reality is they are moving slower than we would like, and I don't think it is realistic to expect the product any time soon. A year from now would be too optimistic. Two years? Maybe.

Exactly. The timeline is most likely much longer than most people are blindly hoping for. In my experience, acquiring federal funding and getting those funds actually approved, disbursed, let alone applied to business startup, takes much longer than six months. This doesn't even account for marketing.

I think we're years out, unfortunately.

 

[dd314]

Exactly. The timeline is most likely much longer than most people are blindly hoping for. In my experience, acquiring federal funding and getting those funds actually approved, disbursed, let alone applied to business startup, takes much longer than six months. This doesn't even account for marketing.

I think we're years out, unfortunately.

Lenire didn't take long to get to US market after FDA approval; I think it was about a year? Auricle is seeming like mid-2025.

 

[Pixelito]

I'm not worried, either. I've seen some other software that accompanies cutting-edge hospital hardware in action, and, oh boy, it usually looks godawful from a UX point-of-view. If it works, it works – even if it's piles of spaghetti code. If they keep adding incremental updates/improvements it might prove to be an issue later down the line, though.

There could be several reasons why he's cleaning it up now, ranging from handing over an MVP to an actual software engineer to preparing it for an actual release – who knows.

Never heard of TDT (Tucker Davids Technologies) before, but apparently it's a company that specifically targets the neuroscience market. I agree with @gameover that it does look extremely ancient, though. I imagine this is what Power Automate would've looked like if it were designed in the Windows 2000 era :')

As a programmer, I've worked on some of the biggest systems for some of the biggest companies and the code is always messy.

Messy code works. The markup is the last thing I'm worried about. But I would expect them to be making changes as they move towards FDA submission and production.

None of this equates to additional years added to the release date of the product.

 

[RunningMan]

The software is just one element of the larger picture. The larger picture is we are nowhere near a commercial product.

The company has no employees per LinkedIn. Just founders: CEO - Pearson, CSO (Chief Science Officer) - Dr. Shore and VP - Dr. Martel. Dr. Shore clearly is not spending full time effort with the company, the fact she started the new job at UC Irvine suggests Auricle is not a priority for her (for whatever reason). They only got the 2nd round of funding from the university incubator. I doubt it is in the 10s of millions of dollars which would be required to get the ball rolling. Accelerate Blue Fund only raised a total of $2M by 2021 (see here). They don't even have a webpage. Zero PR/marketing efforts, beyond a couple of articles.

So Dr. Martel tinkering with the old code on GitHub just shows this is not a business that's moving full steam ahead yet. Sorry, no way.

I also add the fact they are not in one physical location does not bode well. Taking a new company off the ground is a LOT of work. I am a big fan of remote work, but if I were starting a new company (and did not have tinnitus and hyperacusis...) I'd definitely would want to be working close with my folks. Dr. Shore is in Irvine, CA, maybe splitting time between there and Ann Arbor, MI. Dr. Martel seems to be in Ann Arbor, and Pearson is located San Francisco. He incorporated the company in California in the fall of last year (the company was registered in Delaware in 2019), indicating that perhaps this will be their primary location. Who knows.

Compare this to the timeline and progression of Neuromod. They have got roughly over 50 million EUR in funding over the years.

I have no doubt Auricle has a superior solution, but the (sad) reality is they are moving slower than we would like, and I don't think it is realistic to expect the product any time soon. A year from now would be too optimistic. Two years? Maybe.

I agree it doesn't inspire confidence. I had been thinking 2 to 3 years before we see wide scale availability in the U.S, but the way this drags out and as details like this come to light, along with the study issues, it makes me wonder if this product will ever see the light of day.

 

[gameover]

Lenire didn't take long to get to US market after FDA approval; I think it was about a year? Auricle is seeming like mid-2025.

Neuromod had everything in place already. Operations, marketing, production. Product in the box. Auricle has hardly anything yet.

Again, I'd kill for it to be available asap, but people are constantly setting themselves up for disappointment re Auricle.