New University of Michigan Tinnitus Discovery — Signal Timing

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

    1. dj_newark

      dj_newark Member Benefactor

      Tinnitus Since:
      1990
      I'd like to attend virtually. But apparently you need to be a licensed audiologist in order to register.

      So unless you are on familiar terms with an audiologist who would let you use their license number to register, or unless you had a way of faking the audiologist's license number, you can't register!

      upload_2022-9-9_11-42-7.png

      Those asterisks next to the places you enter information mean they are mandatory entries! You can't register unless you input this information!
       
      • Informative Informative x 1
    2. CRGC

      CRGC Member

      Location:
      Montreal
      Tinnitus Since:
      06/2022
      Cause of Tinnitus:
      SNRI/Noise
      Here is a link to the registration page for other interest parties. It can also be found at the bottom of the main registration page.
       
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    3. Padraigh Griffin

      Padraigh Griffin Member Podcast Patron Benefactor

      Tinnitus Since:
      05/2020
      Cause of Tinnitus:
      Unknown/Stress
      Trying to figure out the commercialisation strategy here.

      Basically Auricle is a company set up to commercialise Dr. Shore’s work BUT:

      1.) Is it just a company that intends to licence out the technology.
      2.) Is it a company set up to handle all aspects of manufacture to distribution.

      My thoughts are that it is 1.

      Let’s look at the basics.

      The device is a simple device and manufacturing will be outsourced.

      Who then will handle the distribution and promotion?

      If it is a licensee, then it is quite possible we could see the device roll out much faster.

      Plus, jurisdictions like the EU could see the device first if there is an agreement in place.

      From Dr. Shore’s perspective, surely building a company and rapid rollout will need significant capital, whereas Auricle as the licensing vehicle, will need to only handle manufacturing (outsourced) and enjoy revenue from two prime sources with limited capital investment: Revenue from device sale % and royalty payments.

      This is my vision for commercialisation.

      For example, in the EU, why would a company like Neuromod not cull its own device (Lenire) and license the MTD if it shows excellent results.

      Neuromod has everything in place, marketing, brand, distribution.

      Auricle potentially has what Lenire doesn’t. A product that works!
       
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    4. Nick47

      Nick47 Member

      Tinnitus Since:
      2015
      Cause of Tinnitus:
      Viral/noise
      Taken from a report on the Phase 1 study.
      Ok, I get the pitch matching. When the article mentions the electrical impulses applied to the 'area' of the head involved in tinnitus modulating, this seems vague.

      For instance if turning the head to look up increases the loudness and pitch, how would you determine where on the neck to place the electrodes?

      If yawning increases the pitch, where would you place electrodes?

      I presume from descriptions they would locate the nerves. Would need a well trained audiologist that's for sure with patients coming in with different somatic forms of tinnitus.
       
    5. InNeedOfHelp

      InNeedOfHelp Member

      Tinnitus Since:
      08/2021
      Cause of Tinnitus:
      MRI Scan
      https://innovation.medicine.umich.edu/wp-content/uploads/2019/03/Shore-flyer-1.pdf

      This flyer shows the development and commercialization strategy. Here it clearly states "launch strategy to be determined by licensee". My bet is that the name Auricle will be nowhere near the actual device.
       
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    6. Padraigh Griffin

      Padraigh Griffin Member Podcast Patron Benefactor

      Tinnitus Since:
      05/2020
      Cause of Tinnitus:
      Unknown/Stress
      That is why I wouldn’t rule out a EU release before a US one.

      A CE would be faster to achieve than FDA approval and the treatment isn’t ‘novel’ in the EU as Lenire is established.

      Hopefully Auricle CEO has a licensee ready to go in the EU.
       
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    7. Hottopic29

      Hottopic29 Member Benefactor

      Location:
      Niagara falls
      Tinnitus Since:
      11/2013
      Cause of Tinnitus:
      Zithromycin acoustic trauma 2022
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    8. DimLeb

      DimLeb Member

      Tinnitus Since:
      03/2021
      Cause of Tinnitus:
      Idiopathic Cochleopathy or Maybe Loud Music
      That's amazing. Were those people part of the 20 people of the first study in 2017? Or was that some independent study?
       
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    9. dj_newark

      dj_newark Member Benefactor

      Tinnitus Since:
      1990
      The rules for FDA approval for medical devices are not the same for medicinal use and devices. For medicinal use it takes years, even over a decade to bring a device to market. For devices the rules are very different and a device can be approved in as little as 6 months! I wouldn't bank on an EU release before a US release given that it's being developed in the US and FDA approval device was already set in motion years ago. It can't be finalized of course until the device is released!
       
    10. @dam

      @dam Member

      Tinnitus Since:
      5/22
      Cause of Tinnitus:
      Unknown
      Will Dr. Shore's device go through a Phase 3 (if Phase 2 was successful) before they sell it, or will they sell it whilst getting FDA approval?
       
      • Good Question Good Question x 2
    11. dj_newark

      dj_newark Member Benefactor

      Tinnitus Since:
      1990
      They can't sell it before it gets FDA approval. But there will be no Phase III before it's sold.
       
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    12. Padraigh Griffin

      Padraigh Griffin Member Podcast Patron Benefactor

      Tinnitus Since:
      05/2020
      Cause of Tinnitus:
      Unknown/Stress
      I know, but EU CE is even more relaxed and shorter timeframes than FDA rules for Grade 2 devices.

      Depends a lot on who is interested in licensing the technology.
       
    13. dj_newark

      dj_newark Member Benefactor

      Tinnitus Since:
      1990
      Ok. That's true. It does depend a lot on who licenses the technology. I still think it's going to be a US first product though, and that's not just wishful thinking. They are pursuing the equivalent organizations to the FDA in a lot of countries, I think they'll want to roll it out to as much of the world as quickly as they can. I know they have patents for the device in a number of countries around the world.
       
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    14. Padraigh Griffin

      Padraigh Griffin Member Podcast Patron Benefactor

      Tinnitus Since:
      05/2020
      Cause of Tinnitus:
      Unknown/Stress
      No. Only two phases for medical devices. They will have to get FDA approval. The process is under the DeNovo pathway. Details of that are here:

      https://www.fda.gov/medical-devices...cation-request#FDA_Review_and_Review_Timeline

      How far they are through the process is something we don’t know.
       
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    15. BadNeighbors

      BadNeighbors Member

      Tinnitus Since:
      11/2020
      Cause of Tinnitus:
      loud noise/construction
      They say that Dr. Shore's device may help people with somatic tinnitus, I worry that this is going to leave a lot of us out of the picture.

      Is there any research on her device for those of us who have tinnitus caused by loud noises?
       
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    16. Lurius
      Sad

      Lurius Member Benefactor Hall of Fame

      Location:
      Oslo, Norway
      Tinnitus Since:
      September 2018
      Cause of Tinnitus:
      Valsalva maneuver
      That question has already been asked a dozen times. I'm curious about this myself. I have a Zoom meeting with Prof. Dirk De Ridder in October, I will ask him his opinion about it. Although the only one who really knows the answer to this is probably Dr. Shore. But the way I see it, it's all in the brain so I don't see why it shouldn't help everyone.
       
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    17. InNeedOfHelp

      InNeedOfHelp Member

      Tinnitus Since:
      08/2021
      Cause of Tinnitus:
      MRI Scan
      It would be good to have an updated opening post with all the information currently available because many of these questions come by every few pages. Please take your time to read through the last 10-15 pages. But since you are new and I don't want to scare you away:

      - Most of Dr. Shore's research is exclusively around noise induced tinnitus, including this device. It was tested on noise exposed guinea pigs.

      - This specific device is not tested on people without somatic tinnitus. But we don't know if the guinea pigs that this was tested on had somatic tinnitus either. Guinea pigs don't talk :) Still worked for them. I wouldn't worry about this.

      - A different bimodal device tested on a Belgian university showed that their device worked the same of somatic or non-somatic tinnitus.

      - It would (my theory, not scientifically studied) make sense if it might work slightly better on people with somatic tinnitus - these people might be more senstive to the electroshock stimuli applied since they can already modulate on their own without help.

      Regarding the earlier discussion on Phase 2/3. Phase 3 is not required by law but I really wouldn't be surprised if a third study would follow. Perhaps in parallel to the launch.
       
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    18. AfroSnowman
      Balanced

      AfroSnowman Member Podcast Patron Benefactor Hall of Fame

      Tinnitus Since:
      04/2019
      Cause of Tinnitus:
      Nonnatural energy source
      One additional point, I don't believe that the source of the tinnitus (as long as there wasn't a tumor, etc) was one of the qualifying or disqualifying criteria for taking part in this study. I don't believe anything in her papers suggests that her tech is more geared towards noising induced damage as opposed to ototoxic, or anything else. The targeting of somatic tinnitus sufferers was based upon the assumption that those who can already impact their tinnitus by physically pulling of nerves on the face and neck would be promising candidates for the stimulation of those same nerves. The selection of somatic tinnitus sufferers in the study does not exclude that it may be equally impactful on non-somatic tinnitus. It just wasn't tested.
       
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    19. JLH

      JLH Member

      Tinnitus Since:
      February 2022
      Cause of Tinnitus:
      Unknown
      Thanks, this is helpful. Do you know if the device could be helpful for low frequency / humming tinnitus or is this more targeted towards the traditional higher pitched ringing tinnitus?
       
    20. OptimusPrimed
      Spaced

      OptimusPrimed Member Benefactor

      Tinnitus Since:
      10/2007
      Cause of Tinnitus:
      Acoustic trauma - Repeated gun blasts
      Will Susan Shore’s device assist with reactive tinnitus? Or somatosensory pulsatile tinnitus?
       
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    21. dj_newark

      dj_newark Member Benefactor

      Tinnitus Since:
      1990
      Noise induced tinnitus IS somatic tinnitus in a lot of cases. All you need to do is see if your tinnitus changes when you clench your jaw, press on your face or make movements with your head. If that's the case then you have somatic tinnitus, whether it was noise induced or not!

      However, somatic tinnitus is the only kind of tinnitus that will be helped by the Michigan device AT FIRST. She says they will work on addressing other kinds of tinnitus once the device is out on the market.
       
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    22. EDDTEKK

      EDDTEKK Member

      Location:
      Germany
      Tinnitus Since:
      1999
      Cause of Tinnitus:
      Acoustic Trauma
      Dr. De Ridder told me that if you don't respond to Lenire, you might also not respond to Dr. Shore's device since it's the same concept.

      Do you guys agree on that? I had hopes but this statement is destroying it...
       
    23. Nick47

      Nick47 Member

      Tinnitus Since:
      2015
      Cause of Tinnitus:
      Viral/noise
      Err, 20 years research from a university will trump some jumped up entrepreneur. I think it will be a decimate improvement on Lenire, no doubts.

      Let's say Dr. Shore's trial will show 50% get meaningful improvements, I reckon that will translate to 25-30% getting success on Tinnitus Talk. Before you say I'm negative etc., there is no treatment now, so that's 25-30% more than we've ever had. BIG success and step forward!

      I've read threads on Tinnitus Talk from 2013 onwards that look foolish now, as predictions were made that were simply fantasist wishful thinking.

      Although Tinnitus Talk stands up better than any social media group I've been in for being realistic.
       
    24. DimLeb

      DimLeb Member

      Tinnitus Since:
      03/2021
      Cause of Tinnitus:
      Idiopathic Cochleopathy or Maybe Loud Music
      That's the stupidest thing I've ever read about these devices and I've read a lot. Shows once again how clueless even the most "knowledgeable" doctors/researchers/etc are about tinnitus.

      The devices' concepts are almost the opposite of each other. Dr. Shore's device targets only the region that is generating the tinnitus sound and tries to calm it down, while Lenire "supposedly" targets all regions and tries to simulate all those to make the tinnitus one "weaker".

      Lenire has no solid proof it even works, as nearly all reviews on the internet are mixed. Its studies were flawed and usually without a placebo group. I don't know if Dr. Shore's device really works or not, but so far the evidence is far more positive and solid. Of course, we must wait till these Phase 2 results.
       
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    25. dj_newark

      dj_newark Member Benefactor

      Tinnitus Since:
      1990
      No. It's not the same concept. I suspect a lot of what Dr. De Ridder says because he is frequently wrong!

      In Lenire they stimulate all the areas of the brain around the DCN to make it more active so the brain notices tinnitus less. Dr. Shore's device makes the fusiform cells of the DCN less active so that your brain doesn't produce the sound.

      Lenire is meant as a habituation device because the thinking is that if you make areas of the brain more active, it notices tinnitus less. Whereas the Dr. Shore device actually makes the noise in your head less loud. The two concepts are POLAR opposites, and completely different approaches.
      I am not sure about reactive tinnitus. But it will not treat pulsatile tinnitus.

      I am also not sure about somatosensory tinnitus, but if by that you mean somatic tinnitus then yes it will! It's designed only for somatic tinnitus now. But it may treat pulsatile, non-somatic and other forms of tinnitus later after the initial release of the device. Dr. Shore said that she will work on addressing other forms of tinnitus after the device is released.
       
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    26. Gb3

      Gb3 Member

      Tinnitus Since:
      12/19
      Cause of Tinnitus:
      Sshl
      Pulsatile tinnitus has to do with veins or arteries. It’s an actual real sound your veins are making because of an impingement or blockage. From what I understand, they can fix pulsatile tinnitus if they can locate the problem area.
       
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    27. dj_newark

      dj_newark Member Benefactor

      Tinnitus Since:
      1990
      I am less familiar with pulsatile tinnitus. You are right. So, Dr. Shore's device won't be able to treat that, but there are at least existing avenues for treatment.
      What device was this? Could you elaborate or, if you have any more information, could you provide it?
       
    28. Gb3

      Gb3 Member

      Tinnitus Since:
      12/19
      Cause of Tinnitus:
      Sshl
      • Agree Agree x 1
    29. Faff

      Faff Member

      Location:
      New Zealand
      Tinnitus Since:
      03/2022
      Cause of Tinnitus:
      Noise
      Though there are a few bimodal stimulation approaches and they tend to get all lumped together, Dr. Shore's device sticks out to me as slightly more rigorous for a few reasons; their animal model is designed to induce tinnitus through 'hidden' hearing loss rather than heavier noise exposure, the somatosensory spike timing plasticity targeting makes a lot of sense, and the trials so far have used a sham/active/washout approach that makes it easy to see accumulative effects. I also personally lend a little more weight to their use of TFI measurement over THI.

      Of course none of that means that they've got a reliable effect for certain, but those factors differentiate it enough from previous bimodal approaches that I'm paying very close attention to this despite the responder rate so far being little better than others.
       
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    30. OptimusPrimed
      Spaced

      OptimusPrimed Member Benefactor

      Tinnitus Since:
      10/2007
      Cause of Tinnitus:
      Acoustic trauma - Repeated gun blasts
      there is a subset of somatic tinnitus called somatosensory pulsatile tinnitus whereby the DCN no longer cancels somatosensory sounds hence modulation of sounds through muscle or joint movements. The other theory is that the auditory pathway/brain taps into existing somatic pathways to maintain neural pathways.

      So I’m not referring to pure pulsatile tinnitus like most are used to hearing about.
       
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