New University of Michigan Tinnitus Discovery — Signal Timing

I also think they are aware that people with tinnitus are HIGHLY suspicious about treatments (case in point :)), so I'm sure they don't think we're easy 'targets' to sell something that doesn't work. .
You can ask head of Neuromod how easy it is to sell a scam to desperate people. :)
At the very least I don't think you can say with certainty it's a scam! Unless you know something I don't :)
OK, I give you that. It think it's a scam for 95%. For 5% it's not. I think that like many other researchers, Susan Shore started something, then it didn't go well but there were still years before retirement so why not pull it for longer. And here we are. She can't go now and say: "Hey, I'm sorry, but this was something that fed me and my family but it doesn't really work."
 
To think that Auricle or Dr. Shore's work is a scam, is preposterous. This is decades worth of research. It would be the world's most idiotic long con. They know tinnitus patients would quickly spread word if the device doesn't work. It's not an automatic millionaire maker when it's not even out yet. And they are privately funded with not that much money apparently so I bet they are bootstrapping it with very little salary if any for now.

I understand we're all pessimistic by now with all the failed treatments but god almighty, can we at least have some common sense and not call things scams when they so obviously are not?
I posted a huge reply to that post but I decided to delete it. Glad I did as this says it better.
 
You can ask head of Neuromod how easy it is to sell a scam to desperate people. :)

OK, I give you that. It think it's a scam for 95%. For 5% it's not. I think that like many other researchers, Susan Shore started something, then it didn't go well but there were still years before retirement so why not pull it for longer. And here we are. She can't go now and say: "Hey, I'm sorry, but this was something that fed me and my family but it doesn't really work."
Okay, but what are you basing that on? Do you have some inside knowledge? Dr. Shore has been working on this for over 20 years and she's just joined another prestigious university to continue her work with another prominent researcher.

You have a very interesting definition of what a scam is. If this is a scam, it's the longest con ever!
 
Okay, but what are you basing that on? Do you have some inside knowledge? Dr. Shore has been working on this for over 20 years and she's just joined another prestigious university to continue her work with another prominent researcher.

You have a very interesting definition of what a scam is. If this is a scam, it's the longest con ever!
I thought Dr. Shore joining the same faculty as Dr. Hamid Djalilian was pretty interesting actually.

I don't know if there are any possible conflicts of interest or proprietary NDAs, due to Auricle, but Dr. Shore obviously has a lot of (hands-on) experience that could he helpful in assisting Dr. Hamid Djalilian's device.

Auricle might not work for everyone (if at all), but perhaps Dr. Djalilian's device might aid a different subset of tinnitus sufferers.

Moreover, if Auricle does work (for some), then wouldn't it be all the better that Dr. Shore is still out there fighting the good fight?
 
You can ask head of Neuromod how easy it is to sell a scam to desperate people. :)

OK, I give you that. It think it's a scam for 95%. For 5% it's not. I think that like many other researchers, Susan Shore started something, then it didn't go well but there were still years before retirement so why not pull it for longer. And here we are. She can't go now and say: "Hey, I'm sorry, but this was something that fed me and my family but it doesn't really work."
This seems to come from a severe misunderstanding of grant funding. She definitely wouldn't be feeding her family off of a national grant-funded research project that is not yet public and has been stuck in a mire of research for decades.
 
Anyone who thinks that a device created by an esteemed Michigan Professor who has been in the field for 30 years is a scam needs to get off these forums.

And this is coming from an inherently cynical person who became even more so after tinnitus. You are not thinking straight. It might not be as EFFECTIVE AS YOU hope which is a very real possibility but it's not a scam.
 
I think one thing we can all agree on is that it would be nice if Auricle had a bit more outreach and communication with the tinnitus community. I think all this nervousness and speculation comes from Auricle not really being communicative. Hopefully this changes soon once the FDA process is done.
 
Okay, but what are you basing that on? Do you have some inside knowledge? Dr. Shore has been working on this for over 20 years and she's just joined another prestigious university to continue her work with another prominent researcher.
20 years of research that crystallized into a beeper/EMS device whose protocol of function is nowhere to be found.

The words like "prestigious" don't really mean anything. You can say that Hubert Lim is a prestigious researcher and use it as a sales point for Lenire, but only until the truth is revealed, and that what is happening right know. The truth needs to be postponed. Given Dr. Shore's skill, indefinitely.

Don't think I'm writing this with pleasure. I also wish we had some effective relief. Given what I learnt from using Lenire and my own self-made device, I think that bimodal stimulation is a myth. That doesn't stop people from capitalizing on it. If I recall correctly, there were two other companies discussed on Tinnitus Talk that made their own bimodal stimulators. None of them were effective but somehow the device from Dr. Shore, of which you don't even have to feel the zapping, will work.
 
Does anyone know anybody that was in one of the two human trials? If 100 people went through the trials and at least 50% had a reduction in the loudness of their tinnitus, I'm just curious why we never see posts from any of the other participants? I know there was @linearb who posted a year or so ago a couple of times but what about the other successes? If their tinnitus was severe enough where they elected to participate in a research trial, you'd think they would be members of Tinnitus Talk. Yet, we never see or hear any first-hand reports about their experiences with the device.

Do you think they signed a non-disclosure agreement and they can't talk about the trial?

I also wonder if they are still involved in the study and are required to update Dr. Shore's team on any changes in their tinnitus since they stopped using the device?
 
@linearb who posted a year or so ago a couple of times but what about the other successes? If their tinnitus was severe enough where they elected to participate in a research trial, you'd think they would be members of Tinnitus Talk. Yet, we never see or hear any first-hand reports about their experiences with the device.

Do you think they signed a non-disclosure agreement and they can't talk about the trial?

I also wonder if they are still involved in the study and are required to update Dr. Shore's team on any changes in their tinnitus since they stopped using the device?
I would definitely say it's safe to assume they had to sign an NDA or Master Service Agreement. Just look at how easy it is to ruin a company's reputation these days (Budlight for example).
 
She doesn't know any more than you or I do. She's speculating. That's practically all this thread is, just speculation. Some are more informed than others however!
When I asked my Audiologist about Dr. Shore and Auricle, he responded, "Who and what?"

Unless they worked for the University of Michigan or knew Dr. Shore personally, I agree there is no way they could know anything about the release date.
 
20 years of research that crystallized into a beeper/EMS device whose protocol of function is nowhere to be found.
You mean 20 years of research that crystalized into two double-blinded, placebo-controlled trials with proven results.

The device worked so well that the crossover was invalidated because the improvements continued through the washout phase.
The words like "prestigious" don't really mean anything. You can say that Hubert Lim is a prestigious researcher and use it as a sales point for Lenire, but only until the truth is revealed, and that what is happening right know. The truth needs to be postponed. Given Dr. Shore's skill, indefinitely.
Dr. Shore is one of the most respected researchers in her field, and she's working in the same department as Dr. Hamid Djalilian who is almost as accomplished. I expect great things from them working together. Yes, UCI is a very respected institution.
Don't think I'm writing this with pleasure. I also wish we had some effective relief. Given what I learnt from using Lenire and my own self-made device, I think that bimodal stimulation is a myth. That doesn't stop people from capitalizing on it. If I recall correctly, there were two other companies discussed on Tinnitus Talk that made their own bimodal stimulators. None of them were effective but somehow the device from Dr. Shore, of which you don't even have to feel the zapping, will work.
What you learned from using Lenire has absolutely nothing to do with the Shore device and whatever it is you made. Lenire is only superficially similar to the Shore device, the two devices work completely differently.
When I asked my Audiologist about Dr. Shore and Auricle, he responded, "Who and what?"

Unless they worked for the University of Michigan or knew Dr. Shore personally, I agree there is no way they could know anything about the release date.
It's shocking that people in the ENT / Audiology business still have no about Dr. Shore or her work. But there's plenty out there!
 
You can ask head of Neuromod how easy it is to sell a scam to desperate people. :)
Don't think I'm writing this with pleasure. I also wish we had some effective relief. Given what I learnt from using Lenire and my own self-made device, I think that bimodal stimulation is a myth. That doesn't stop people from capitalizing on it. If I recall correctly, there were two other companies discussed on Tinnitus Talk that made their own bimodal stimulators. None of them were effective but somehow the device from Dr. Shore, of which you don't even have to feel the zapping, will work.
From your earlier comment about Neuromod, I thought maybe you had used and been burned by Lenire. So, I was not surprised to see your follow up and pessimism after wasting all that time and money. But, the study for the Shore/Auricle device looks more convincing, and that it could work. Results with the bimodal stimulation were up to 40% more successful than the control/placebo group in the first part of the study. You can't make assumptions about its effectiveness based on your self-made device or Lenire.
I spoke to an audiologist today and she said the device is not coming out for years.
That means nothing. Take it with a grain of salt, just as if any random person on the internet said it.
 
You mean 20 years of research that crystalized into two double-blinded, placebo-controlled trials with proven results.

The device worked so well that the crossover was invalidated because the improvements continued through the washout phase.

Dr. Shore is one of the most respected researchers in her field, and she's working in the same department as Dr. Hamid Djalilian who is almost as accomplished. I expect great things from them working together. Yes, UCI is a very respected institution.

What you learned from using Lenire has absolutely nothing to do with the Shore device and whatever it is you made. Lenire is only superficially similar to the Shore device, the two devices work completely differently.

It's shocking that people in the ENT / Audiology business still have no about Dr. Shore or her work. But there's plenty out there!
I hope you are right, although I think that next year this time there will still be nothing.

Also since you seem to have knowledge on Dr. Shore's work, can you tell me how they made it so that the control group didn't know they were receiving the treatment?
 
I hope you are right, although I think that next year this time there will still be nothing.
Cool, I think/hope I am. However, I think if it gets approved soon, we may see it be available THIS year. No one knows for sure of course.
Also since you seem to have knowledge on Dr. Shore's work, can you tell me how they made it so that the control group didn't know they were receiving the treatment?
Yes, the electrical signal is so faint that it can't really be felt. So it was easy for her to create a placebo group since no one knew really what they were getting.
 
Yes, the electrical signal is so faint that it can't really be felt. So it was easy for her to create a placebo group since no one knew really what they were getting.
It is fascinating how signal that cannot be felt makes a difference in bimodal stimulation. Imagine what it must do if you turn it up and you really feel it. Strangely though the sound must be heard. I can not wrap my head around that and it just seems to be very convenient for the study design.

I learnt that when you place electrodes and you set the EMS strength right below what you can perceive, after some time you start sensing the EMS pulses again. They can be lowered again and again and the body seems to adjust until some point where the pulses cannot be felt any longer. The strength values differ from day to day as the body conductivity and maybe other body attributes change.

I have trouble believing that the study participants didn't know what group they were in. That of course doesn't mean that the device is ineffective but given the pace everything takes, while other companies are able to accomplish much bigger things in a fraction of time, is rather strange. 20+ years of development of something is a rather negative thing. The final product of the research seems simple to be implemented on hardware and software level. Why am I offered 10 years old videos on YouTube where the EMS beeper seems to be almost ready for the market?

I hope I'm completely false in my assumptions. Lets' see next year this time. If there is still nothing, I will consider the outcome of the study as fraud.
 
The detection of stimulus and study participants' knowledge of what group they were in was covered in the Q&A.
Question said:
The paper states "In the pilot and the present studies, all participants reported quickly habituating to the electrical stimulus, which was close to threshold, making the stimulus difficult to detect. Participants stated that they could not tell whether they were receiving the control or active treatment". This statement appears contradictory, i.e. how can you habituate to the stimulus if you can't detect it, and anecdotal. Is there a more scientific way of assessing the degree to which participants could detect the stimulus?
Dr. Shore said:
Prior to using the device subjects were tested to find out their electrical stimulation thresholds. The stimulation level was then set to just above the threshold, which was barely detectible or perceptible. We didn't have an objective test for detection. We interpreted subject statements that they could not tell which treatment they were getting to be evidence that they had habituated to (or become accustomed to) the electrical stimulus. Keep in mind that the electrodes were in place for the active and sham treatments and the tape itself produced some sensation, likely helping with the blinding.
 
It's shocking that people in the ENT / Audiology business still have no about Dr. Shore or her work. But there's plenty out there!
I imagine that most of them shun the tinnitus market because they prefer to concern themselves with patients they can help with treatments that are effective.

But watch, if the device works nearly as well as advertised, every Audiologist/ENT will suddenly advertise themselves as "tinnitus experts".
 
The detection of stimulus and study participants' knowledge of what group they were in was covered in the Q&A.
Question said:
The paper states "In the pilot and the present studies, all participants reported quickly habituating to the electrical stimulus, which was close to threshold, making the stimulus difficult to detect. Participants stated that they could not tell whether they were receiving the control or active treatment". This statement appears contradictory, i.e. how can you habituate to the stimulus if you can't detect it, and anecdotal. Is there a more scientific way of assessing the degree to which participants could detect the stimulus?
Dr. Shore said:
Prior to using the device subjects were tested to find out their electrical stimulation thresholds. The stimulation level was then set to just above the threshold, which was barely detectible or perceptible. We didn't have an objective test for detection. We interpreted subject statements that they could not tell which treatment they were getting to be evidence that they had habituated to (or become accustomed to) the electrical stimulus. Keep in mind that the electrodes were in place for the active and sham treatments and the tape itself produced some sensation, likely helping with the blinding.
Thank you for sharing Susan Shore's answer. It helped me to understand things better.

There are nice cheap gel pads to be used as electrodes available. People in Susan Shore's team decided to tape the wire to the skin. This then has a huge impact on the study participants as the tape helps habituate to the electric pulses which don't need to be felt at all for the device to work. After all, they feel the tape so how could they feel electric pulses... you cannot make this shit up. :)

You can get yourself a cheap EMS device and check if it is possible for you to habituate to your threshold signal level. I can tell you cannot. But prove me wrong.

A couple of pages back somebody shared a link to GitHub for the source of TinnTester (or whatever it is called). He said that the project was bit of a mess. I downloaded the project and after spending some time trying to figure out what it was actually doing, I came to conclusion that the "bit of a mess" is a huge understatement. I've been coding in IT for over 20 years and have never seen anything like that. The zipped up project package was 1 GB. If I figured correctly, the software is a questionnaire playing sounds. A couple of screens with buttons and radio boxes. 1 GB of compressed data for that! The code by itself was written by somebody one step above Hello World skill proudly presenting himself as PhD. Although this software has probably nothing to do with Susan Shore's team, it shows how ineffective and incompetent a part of the academia is.
 
I imagine that most of them shun the tinnitus market because they prefer to concern themselves with patients they can help with treatments that are effective.

But watch, if the device works nearly as well as advertised, every Audiologist/ENT will suddenly advertise themselves as "tinnitus experts".
There is a huge gap between advancement in medical research and clinical practice. I read the gap is thought to be ~17 years.
 
Thank you for sharing Susan Shore's answer. It helped me to understand things better.

There are nice cheap gel pads to be used as electrodes available. People in Susan Shore's team decided to tape the wire to the skin. This then has a huge impact on the study participants as the tape helps habituate to the electric pulses which don't need to be felt at all for the device to work. After all, they feel the tape so how could they feel electric pulses... you cannot make this shit up. :)

You can get yourself a cheap EMS device and check if it is possible for you to habituate to your threshold signal level. I can tell you cannot. But prove me wrong.

A couple of pages back somebody shared a link to GitHub for the source of TinnTester (or whatever it is called). He said that the project was bit of a mess. I downloaded the project and after spending some time trying to figure out what it was actually doing, I came to conclusion that the "bit of a mess" is a huge understatement. I've been coding in IT for over 20 years and have never seen anything like that. The zipped up project package was 1 GB. If I figured correctly, the software is a questionnaire playing sounds. A couple of screens with buttons and radio boxes. 1 GB of compressed data for that! The code by itself was written by somebody one step above Hello World skill proudly presenting himself as PhD. Although this software has probably nothing to do with Susan Shore's team, it shows how ineffective and incompetent a part of the academia is.
Chances are that Auricle might hire a professional software engineer to put together a more finalised version.

Having worked at a university for a few years, I also wouldn't be surprised if the compressed screenshots are 50 MB files, or worse. That'll add up quickly.

In my experience, the people putting this together often aren't really concerned with smaller footprints or the difference between WebP/PNG/JPG/RAW.
 
Thank you for sharing Susan Shore's answer. It helped me to understand things better.

There are nice cheap gel pads to be used as electrodes available. People in Susan Shore's team decided to tape the wire to the skin. This then has a huge impact on the study participants as the tape helps habituate to the electric pulses which don't need to be felt at all for the device to work. After all, they feel the tape so how could they feel electric pulses... you cannot make this shit up. :)

You can get yourself a cheap EMS device and check if it is possible for you to habituate to your threshold signal level. I can tell you cannot. But prove me wrong.

A couple of pages back somebody shared a link to GitHub for the source of TinnTester (or whatever it is called). He said that the project was bit of a mess. I downloaded the project and after spending some time trying to figure out what it was actually doing, I came to conclusion that the "bit of a mess" is a huge understatement. I've been coding in IT for over 20 years and have never seen anything like that. The zipped up project package was 1 GB. If I figured correctly, the software is a questionnaire playing sounds. A couple of screens with buttons and radio boxes. 1 GB of compressed data for that! The code by itself was written by somebody one step above Hello World skill proudly presenting himself as PhD. Although this software has probably nothing to do with Susan Shore's team, it shows how ineffective and incompetent a part of the academia is.
You've obviously completely made your mind up, no matter what answers people try to give you.

Not really sure what you're getting out of staying on here to be honest.
 
There is a huge gap between advancement in medical research and clinical practice. I read the gap is thought to be ~17 years.
That might be true. It won't take that long for the Audiology profession to jump on board with the Auricle device once it's released. The entire product rollout depends on the Medical industry embracing and training to administer the device.

Doctors are in the treatment business, which equates to making money. And they know if there is a legitimate treatment for tinnitus, their calendars are going to be booked solid trying to keep up with the demand.
 
Didn't Lenire roll out super quickly in the US after they got FDA approval? I assume Auricle will be the same if not faster? (I'm referring to the comments above about how quickly audiologists are likely to embrace it).

Do I understand correctly that once something has been submitted to the FDA (as we hope to see end of March), it will become visible on their database so we can "check"...?
 
That code is hella old. I hear a lot of research projects have crappy software like that. Don't judge them on that, judge them on the success of the trial! I'm quite sure they'll be updating that code for release!
If they update the code, that is a fundamental product change and will need to be resubmitted for FDA approval.
 
A couple of pages back somebody shared a link to GitHub for the source of TinnTester (or whatever it is called). He said that the project was bit of a mess. I downloaded the project and after spending some time trying to figure out what it was actually doing, I came to conclusion that the "bit of a mess" is a huge understatement. I've been coding in IT for over 20 years and have never seen anything like that. The zipped up project package was 1 GB. If I figured correctly, the software is a questionnaire playing sounds. A couple of screens with buttons and radio boxes. 1 GB of compressed data for that! The code by itself was written by somebody one step above Hello World skill proudly presenting himself as PhD. Although this software has probably nothing to do with Susan Shore's team, it shows how ineffective and incompetent a part of the academia is.
Code written by scientists is always a mess, that's just how it is. It doesn't necessarily correlate with the quality of the research. A Ph. D. doesn't automatically give 10 years of software development experience.
 
A comment on software quality makes people react but pointing out a fundamental flaw in the clinical study design is not worth talking about.
 
Regarding TinnTester, I think writing a complete programme with 1000s of lines of code and comparing it with Hello World is a bit of a stretch. It'll undoubtedly go to an external developer to probably rework from the ground up.

If you ask me, as frustrating as it is, the silence, the delays and the long lead time are a good thing. It'd have been easy to rush any old crap onto the market, they could've gone the Lenire way and said "screw the double-blinded, placebo-controlled trial, let's get it marketed as soon as possible", but Dr. Shore hasn't done that.

Everything on this thread is mostly guesswork other than the study interpretation. In 12-18 months' time this thread will reveal whether it's a historical moment in tinnitus treatment or filed with one of the many failed treatments.

I don't see the need to try and sow so much doubt in people's minds about it. Come back in 18 months and say "I told you so" if it makes you feel better.
 
Regarding TinnTester, I think writing a complete programme with 1000s of lines of code and comparing it with Hello World is a bit of a stretch. It'll undoubtedly go to an external developer to probably rework from the ground up.

If you ask me, as frustrating as it is, the silence, the delays and the long lead time are a good thing. It'd have been easy to rush any old crap onto the market, they could've gone the Lenire way and said "screw the double-blinded, placebo-controlled trial, let's get it marketed as soon as possible", but Dr. Shore hasn't done that.

Everything on this thread is mostly guesswork other than the study interpretation. In 12-18 months' time this thread will reveal whether it's a historical moment in tinnitus treatment or filed with one of the many failed treatments.

I don't see the need to try and sow so much doubt in people's minds about it. Come back in 18 months and say "I told you so" if it makes you feel better.
I agree! And I also have to say, isn't it exciting that we can even say there is SOMETHING that we are waiting on? Back in 2016 when my tinnitus started, there was nothing I was remotely excited about and now we are talking about m o n t h s! :) Yes, I'm trying not to put all my eggs in one basket but still, there is something percolating!
 

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