New University of Michigan Tinnitus Discovery — Signal Timing

Discussion in 'Research News' started by Hudson, Jun 20, 2013.

    1. Greg Sacramento

      Greg Sacramento Member Benefactor Ambassador Hall of Fame Advocate

      Tinnitus Since:
      04/2011
      Cause of Tinnitus:
      Syringing + Somatic tinnitus from dental work
      Still think, in completing trial - their judging data for a 513(g), a "request for classification." You can argue for a Class II or III classification from the FDA. The same is not allowed with a pre-submission. The advantage of a 513(g) is that you can go into the De Novo submission with an agreed-upon classification.

      Complete Guide to Bringing a Medical Device to Market

      De Novo Pathway: Explaining the Process for Medical Device Companies



      I don't think patents would be an issue at this point. It's common to share patents.
       
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    2. AfroSnowman
      Balanced

      AfroSnowman Member Podcast Patron Benefactor Hall of Fame

      Tinnitus Since:
      04/2019
      Cause of Tinnitus:
      Nonnatural energy source
      Is it July yet? This is taking forever.
       
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    3. Nick47

      Nick47 Member

      Tinnitus Since:
      2015
      Cause of Tinnitus:
      Viral/noise
      After 20 years in the making and the release of data constantly pushed back, it makes you wonder. Clearly a lot of research and work has gone into this so some anticipation. It is aimed at somatic tinnitus, however, many people with hearing loss have somatic tinnitus. For instance, I can modulate mine by yawning and turning my head and have hearing loss.

      The 12 dB decrease reported in the early trial after 20 minutes of use is significant! How did they measure that though? It can only be subjective surely?
       
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    4. BrysonKingMe

      BrysonKingMe Member

      Location:
      Denver
      Tinnitus Since:
      2016
      Cause of Tinnitus:
      12 gauge shotgun
      Am I right to assume that we won't even be seeing the results until 2023?

      Or will the results be publicly available when they unblind?
       
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    5. AfroSnowman
      Balanced

      AfroSnowman Member Podcast Patron Benefactor Hall of Fame

      Tinnitus Since:
      04/2019
      Cause of Tinnitus:
      Nonnatural energy source
      So many unknowns. I think it is pretty clear that she is not going to just do a quick data dump. Whether we have to wait till 2023 or will she present preliminary results at some symposium later this year, I vote for the latter.

      My concerns are far less about when the results come out and much more whether they confirm or improve on her first study. If this doesn’t work, we might be waiting a very long time. If this does work, whether it is 12 months or 24 before it gets to market, it will be easier to bear when we know help is on the way.
       
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    6. AfroSnowman
      Balanced

      AfroSnowman Member Podcast Patron Benefactor Hall of Fame

      Tinnitus Since:
      04/2019
      Cause of Tinnitus:
      Nonnatural energy source
      The study talked about a TinnMatch (or something like that) software. I imagine it is some sort of self tested MML. @linearb, is this right?
       
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    7. lolkas

      lolkas Member

      Tinnitus Since:
      06/2016
      Cause of Tinnitus:
      Don`t know
      I don’t want to be overly pessimistic, but this thread started around 10 years ago (a fkn decade!) and Dr. Shore is yet to release any information on her research. I am sure that she is WELL AWARE that there are millions of people in the US alone that would do a lot to get rid of their tinnitus or at least make it less intrusive/noticeable. It is either her research is extremely slow (this is beyond slow already) or results are not great.

      This whole thing is weird. Why would they open a company to market this device/treatment if the results weren’t great in the first place?
       
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    8. Nick47

      Nick47 Member

      Tinnitus Since:
      2015
      Cause of Tinnitus:
      Viral/noise
      It is strange I have to admit. I would think if the results were good, this would be known. Unless they are trying to make the results look better by running different statistical analysis and/or looking to adjust parameters and run the trial again. I don't know. It is disappointing to have the long period of silence as we know the trials finished some time ago.
       
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    9. DimLeb

      DimLeb Member

      Tinnitus Since:
      03/2021
      Cause of Tinnitus:
      Idiopathic Cochleopathy or Maybe Loud Music
      Lenire is also shitty af, let alone all the other tinnitus scams over the internet, but they still have companies making them. I hope this is not where Shore's device is going, but I agree the whole thing is sketchy.
       
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    10. AfroSnowman
      Balanced

      AfroSnowman Member Podcast Patron Benefactor Hall of Fame

      Tinnitus Since:
      04/2019
      Cause of Tinnitus:
      Nonnatural energy source
      Aside from her 2018 study detailing the effects on the participants which led to this current larger stud.y
       
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    11. InNeedOfHelp

      InNeedOfHelp Member

      Tinnitus Since:
      08/2021
      Cause of Tinnitus:
      MRI Scan
      Well... at least we know that this is still going strong! On 24th of June there's a Midwest Auditory Research Conference.

      Y'all up for 35 minutes of Dr. Shore discussing the Auricle device?

      1:35-2:10 Precisely-timed sensory stimulation to treat tinnitus
      Susan Shore, PhD, University of Michigan/Auricle

      https://www.midwestauditoryresearchconference.com/
       
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    12. lolkas

      lolkas Member

      Tinnitus Since:
      06/2016
      Cause of Tinnitus:
      Don`t know
      Where did you find that? If I follow your link, it doesn’t even list Susan Shore under keynote speakers.

      Ehhh... I wish this device/approach could silence tinnitus, I really do. But this whole thing with delays and extensions with FDA/clinical trials is just very downing.
       
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    13. Nobody19

      Nobody19 Member Podcast Patron Benefactor

      Tinnitus Since:
      2012
      Cause of Tinnitus:
      Clubbing
      Check the full schedule.
       
    14. Gb3

      Gb3 Member

      Tinnitus Since:
      12/19
      Cause of Tinnitus:
      Sshl
      D9CE86DD-70D5-4292-8E93-92F16130A547.png
       
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    15. FlatDarkEarth

      FlatDarkEarth Member

      Location:
      Tennessee
      Tinnitus Since:
      2017
      Cause of Tinnitus:
      Metal Concert/Endolymphatic Hydrops
      This is never coming out and/or will be a big disappointment. Mark my words. This has become a giant freaking joke.
       
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    16. AfroSnowman
      Balanced

      AfroSnowman Member Podcast Patron Benefactor Hall of Fame

      Tinnitus Since:
      04/2019
      Cause of Tinnitus:
      Nonnatural energy source
      Very possibly but it is probably the only hope for an available treatment of any kind in the next couple years, so...
       
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    17. lolkas

      lolkas Member

      Tinnitus Since:
      06/2016
      Cause of Tinnitus:
      Don`t know
      Yea, few things I wonder:

      a) their results are good and they are taking their time with not leaking any information so that no one copies their approach/device before they hit the “shelves”.
      b) their results are not so good due to either bad trial setup or how quickly result wearers off and how often you have to do it.
      c) they made some changes to their device and now their “good” results from early trials are not so great and they are trying to figure out what is going on to get back to level of success with “a”.
      d) treatment have side effects that while “silencing” tinnitus, introduce a whole new set of issues (which I doubt).

      Dr. Susan Shore is definitely a scientist and a talented one and as we all know - these scientists don’t have immediate sympathy to humans, their main goal is to achieve success in their research in the first place.

      Let’s hear what she has to say during her speech on the 24th of this month or whatever the date is. Perhaps we will hear something new, bad or good.
       
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    18. Nick47

      Nick47 Member

      Tinnitus Since:
      2015
      Cause of Tinnitus:
      Viral/noise
      All very plausible, with the last option perhaps being not. Good points.
       
    19. Chinmoku

      Chinmoku Member Benefactor Hall of Fame

      Tinnitus Since:
      10/2018
      Cause of Tinnitus:
      Started with a cold, possibly worsened by medication/noise
      Interesting set of scenarios.

      As for a), some people already tried and built their own version of the device, using her papers and patents material and experimenting, so I'm not so sure that secrecy is so much of an issue. Maybe their implementation has some proprietary elements that are not in the papers and in the patents, but I doubt they would let something essential out of a patent. So I would exclude a). In fact, if I were them, I would go faster because of a), as reverse engineering and competition is inevitable down the line.

      b) I hope it's not that, but it's a possibility, but I attach a relatively low probability to that. Given the time it took them to complete the trial, I would hope at least they didn't screw it up.

      c) This would be bad, but that would mean the trial basically failed, or did very poorly, there is no going back, they would have to do a new trial, I think this is too pessimistic but who knows.

      d) This is very much a possibility. I'm still wondering if it will be a class II or III device, but when you play with nerves and electricity you need to be very careful. At some point, years ago, I saw a scatterplot of improvements/worsening, from one of the old trials perhaps, I can't remember exactly, but I'm sure it was this and not Lenire, and there were a few people who did worsen. So d) is definitely possible, but fingers crossed it's statistically minimal.

      As for
      I wouldn't extend this to all scientists, but in Shore's case, the wording is clear, her first point is to publish her research in a journal, it says that literally in her joint press release, so I can't say you are wrong there about her. We'll see how long it will take, and how many people will make it there, but this has lasted forever. A sloth under Propofol, as I wrote other times, would have had more urgency in bringing these results to the people. Sadly, it is what it is.
       
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    20. Star64
      Kick ass

      Star64 Member

      Location:
      Melbourne Australia
      Tinnitus Since:
      2001
      Cause of Tinnitus:
      Noise induced
      Very well said. This made me laugh :LOL:

      sloth.gif

      Hopefully it eventually gets a stamp of approval, and more importantly it works :)
       
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    21. Nick47

      Nick47 Member

      Tinnitus Since:
      2015
      Cause of Tinnitus:
      Viral/noise
      We certainly don't want a Lenire Mark 2.
       
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    22. Joeseph Stope
      Innocent

      Joeseph Stope Member

      Tinnitus Since:
      1992
      Cause of Tinnitus:
      noise? infection? negative stress? other?
      Maybe worth considering a few things about Dr. Susan Shore.

      She's an academic who has devoted the last twenty years towards developing a rigorous approach to tinnitus treatment... no short cuts, no sensationalism and while she may like to have some fame and recognition as an academic, she is not out to become a multi billionaire.

      It's quite noticeable how many of the other treatments are accompanied by PR and hoo-hah while she is deliberately low-key.

      ... and that ain't easy if you're pitching for research funding or advertising for participants in your trials.
       
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    23. Nick47

      Nick47 Member

      Tinnitus Since:
      2015
      Cause of Tinnitus:
      Viral/noise
      As I understand it, Dr. Shore's treatment is devised for somatic tinnitus. I have hearing loss and somatic tinnitus. I assume most of us have some hearing loss?
       
    24. DimLeb

      DimLeb Member

      Tinnitus Since:
      03/2021
      Cause of Tinnitus:
      Idiopathic Cochleopathy or Maybe Loud Music
      Most people have some kind of hearing loss in the form of hair cell loss, synapses loss or nerves loss. Even those of us who don't have hearing loss even at extended audiograms, will surely have some hidden hearing loss and proof of that is the tinnitus... Also there is no test that can really determine what's wrong with the ear.

      Now, the device aims at "somatic" tinnitus meaning that you can modulate the sound with some part of the body (jaw, neck etc). And the device uses that to stimulate the nerves of that body part that are "connected" to the tinnitus. For that, I don't think that all tinnitus sufferers have that, but she has said that there might be "hidden" ways to find out how to modulate it that the patient might not know yet.
       
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    25. AfroSnowman
      Balanced

      AfroSnowman Member Podcast Patron Benefactor Hall of Fame

      Tinnitus Since:
      04/2019
      Cause of Tinnitus:
      Nonnatural energy source
      No but I am certainly looking forward to that sense of optimism and possibility on these boards when we were all waiting to try Lenire.
       
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    26. Nick47

      Nick47 Member

      Tinnitus Since:
      2015
      Cause of Tinnitus:
      Viral/noise
      I have read about the mean tinnitus reduction of 12 dB in the first study Dr. Shore conducted.

      Do we know how many participants were in the study? Or anything about the study recently completed in terms of numbers? I presume a placebo would have been possible, however difficult. Also did the participants have hearing loss and, if so, what level?

      EDIT:

      I have just found the study and can answer my questions. Significant results although a small group and a small but meaningful improvement is how I interpreted it. Looks like something an audiologist would need to set up for rather than a DIY thing.
       
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    27. addot

      addot Member

      Location:
      US
      Tinnitus Since:
      Jan 2013
      Cause of Tinnitus:
      Noise exposure
      Would you mind linking the study? I'm having a hard time finding it, and am curious as to how they measured the reduction of tinnitus loudness.
       
    28. Mathew Gould

      Mathew Gould Member Benefactor

      Tinnitus Since:
      6/2017
      Cause of Tinnitus:
      Neck/Jaw misalignment
      I couldn't imagine myself being on the fringe of a breakthrough of something and not wanting to do it 24/7. However, I would be surprised if she was working on this 30 hours a week throughout the year. My ass would be in the lab 80 hours a week.
       
    29. AfroSnowman
      Balanced

      AfroSnowman Member Podcast Patron Benefactor Hall of Fame

      Tinnitus Since:
      04/2019
      Cause of Tinnitus:
      Nonnatural energy source
      80 hours a week on what? The study was ongoing and blinded, hell it might still be blinded for a couple more weeks for all we know. Some of these steps take time... so much time. I don’t despair for forever taking of this study, if the results come in good.

      It sure sounds like she/Auricle/University of Michigan have the pieces to bring this to market.

      For me I just look at all the companies that rushed to market without proper science (Lenire) or leaked tantalizing false promises (Frequency Therapeutics) to pump up stock prices. I’ll take the quiet, methodical, largely academic minded approach because the other sure as hell didn’t work.
       
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    30. InNeedOfHelp

      InNeedOfHelp Member

      Tinnitus Since:
      08/2021
      Cause of Tinnitus:
      MRI Scan
      I'm really not sure on all this negativity/speculation. They created Auricle three years ago, way before any Phase 2 results. Talking about being prepared, launching a company 3 years in advance to get this product to market as soon as possible and taking all that risk. Not like they are sitting still in the background. I'm positively assuming that they are setting up all the infrastructure, production, training programs etc as we speak.

      I would be surprised if they would present the full results of the trial the coming week, but I bet that there will be in-depth information on the trial, the new protocol etc, perhaps even some timelines and preliminary results... Unblinding must have been done by now.

      There will be new information for sure. No way they schedule 35 minutes to rechew on the old 2018 data!

      We need to know how to get the presentation though. As far as I can tell, there is no livestream. Hopefully it is recorded and made available straight after.
       
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