New University of Michigan Tinnitus Discovery — Signal Timing

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

    1. Fabrikat

      Fabrikat Member

      Tinnitus Since:
      1973
      Cause of Tinnitus:
      Otosclerosis then volume then viral infection
      Perhaps the people that could be prodded gently are the board running the University Of Michigan.

      Do they realise that a department on their campus has a medical advance potentially worth hundreds of millions of dollars to their bank accounts?

      Why aren't they prioritising it's commercialisation? Do they realise other labs are working diligently to bring potential therapies to market? That their window of opportunity may not be large?

      Perhaps they do know and simply don't think these sorts of considerations are very important to a teaching institution.
       
      • Agree Agree x 1
    2. F-u-T

      F-u-T Member

      Location:
      AZ USA
      Tinnitus Since:
      10/2018
      Cause of Tinnitus:
      Acoustic Trama
      Have you read this Scientific Article on the Shore research/ device?

      https://stm.sciencemag.org/content/10/422/eaal3175
       
    3. Stefaniie

      Stefaniie Member

      Tinnitus Since:
      2017
      Cause of Tinnitus:
      Hereditary hearing loss/noise exposure
      I assumed her device would have similar hearing requirements as Lenire since they're essentially (at least to my knowledge) the same device/concept.

      Hoping I'm wrong, though. With as much time as she's spent on her research, maybe she's figured out a way for her device to work for more... difficult hearing losses.

      Definitely post the template.
       
    4. JaysterT

      JaysterT Member

      Tinnitus Since:
      05/2019
      Cause of Tinnitus:
      Ototoxicty?
      I'd be willinf to email with you.
       
    5. ChrisBoyMonkey

      ChrisBoyMonkey Member Podcast Patron

      Location:
      US
      Tinnitus Since:
      2019
      Cause of Tinnitus:
      Noise
      So I modified what I used a bit, and yes this is open to suggestions:

      Dear FDA and staff,

      I'm a tinnitus sufferer and I urge you to please look into prioritizing evaluating possible treatment avenues for this disease. This disease has quickly significantly reduced my quality of life to the point of helplessness, and would like nothing more to have my life back. This is more than just an annoying sound in the sufferer's head. It is a mental torture that too often brings even more symptoms to further reduce quality of life. Most commonly, this is a lack of sleep, which is detrimental to our health and well-being.

      Because of the lack of treatments, any and all potential treatments should be given priority, even special fast tracking, as there currently is no treatment available. Treatment for the symptoms is not a real treatment for the condition, and do not help everyone much.

      Please look into new treatments for tinnitus with priority before it is too late for some of us who are just holding on. Though often neglected, suicide too often looks like the only form of relief from this unbearable condition, and lives are literally on the line.

      Tinnitus treatment should have been achieved years ago, but it is not too late for the FDA to help put an end the suffering of us tinnitus patients the right way by giving special consideration for the new waves of sciences that are targeting treating the condition itself, not only the symptoms.

      Sincerely,

      ****

      This is the email regarding the FDA department that evaluates medical devices:

      DICE@fda.hhs.gov

      As a bonus here is the FDA drug department email, but I don't think we have any potential drug treatments applying for approval in the near future:

      druginfo@fda.hhs.gov
       
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    6. Simon Czt

      Simon Czt Member

      Location:
      France
      Tinnitus Since:
      06/2018
      Cause of Tinnitus:
      Acoustic trauma
      There is OTO 313 as a drug that targets tinnitus.

      We also have FX322 and OTO 413, but this mainly targets hearing loss and hidden hearing loss, so for these two drugs, knowing if it will reduce tinnitus or not is just speculation unfortunately.
       
    7. ChrisBoyMonkey

      ChrisBoyMonkey Member Podcast Patron

      Location:
      US
      Tinnitus Since:
      2019
      Cause of Tinnitus:
      Noise
      Yes but FX-322 will be at least 2-3 years (though not sure if it helps tinnitus yet) and OTO-313 we don't even know if it works yet, it's barely in phase 1, so that will probably be even longer...

      What I'm hinting at and am targeting FDA DICE is for bimodal neuromodulation, which might be right around the corner (maybe 1 year for the Michigan device, hopefully less for Neuromod).
       
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    8. Fightthearmy

      Fightthearmy Member

      Tinnitus Since:
      2012
      Cause of Tinnitus:
      work-related
      The FDA staff will throw your petition straight into the trash bin. The FDA is "the fastest and most efficient drug-review program in the world" said FDA chief David A. Kessler. His crew does not believe it needs to be sped up!
       
    9. Cal18
      Nerdy

      Cal18 Member Benefactor Advocate

      Location:
      San Diego
      Tinnitus Since:
      12/2016
      Cause of Tinnitus:
      2010 / 2016 Both SSRI Withdrawal and Mild Hearing Loss
      Perhaps we should remind them of the billions of dollars that get paid out to military related disability for tinnitus each year that could potentially go towards their salary.
       
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    10. Fightthearmy

      Fightthearmy Member

      Tinnitus Since:
      2012
      Cause of Tinnitus:
      work-related
      David A. Kessler isn't interested in your arguments.

      Their livelihood doesn't hinge on "petty little things" like that.
       
    11. ChrisBoyMonkey

      ChrisBoyMonkey Member Podcast Patron

      Location:
      US
      Tinnitus Since:
      2019
      Cause of Tinnitus:
      Noise
      It's better than not doing anything at all. I'm sure you've heard of the analogy about the squeaky wheel.
       
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    12. Fightthearmy

      Fightthearmy Member

      Tinnitus Since:
      2012
      Cause of Tinnitus:
      work-related
      The problem is people like D. Kessler. They need to be removed from positions of power by any means we can envision and propose.
       
    13. Bndsmheowqhe

      Bndsmheowqhe Member

      Tinnitus Since:
      2016
      Cause of Tinnitus:
      Loud noise exposure
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    14. Otana
      No Mood

      Otana Member Benefactor

      Location:
      US
      Tinnitus Since:
      11/2017
      Cause of Tinnitus:
      Noise exposure
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    15. Autumnly
      Wishful

      Autumnly Member Podcast Patron Benefactor Ambassador Hall of Fame Advocate

      Location:
      Germany
      Tinnitus Since:
      July/August 2013
      Cause of Tinnitus:
      Noise induced
      "Significant Need
      Some tinnitus cases are severe—some 6 million people cannot work or perform daily tasks because of the tinnitus or distress from the problem. Current therapies in the clinic have not definitively been shown to reduce tinnitus loudness or treat the underlying cause."

      Didn't the number use to be 2-5 million people in the US? It's insane how high the number of severe tinnitus sufferers is.
       
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    16. EDDTEKK

      EDDTEKK Member

      Location:
      Belgium
      Tinnitus Since:
      1999
      Cause of Tinnitus:
      Infection
      Susan Shore... when the hell is she going to commercialize her device.
       
      • Good Question Good Question x 3
    17. parsky

      parsky Member

      Tinnitus Since:
      8/1/17
      Cause of Tinnitus:
      Unknown
      She won't. My bet is the University will likely look for someone to license the tech to that will commercialize it. Notice on the last page "Product Launch Strategy - To be determined by licensee". Commercializing and manufacturing a product requires a completely different skill set than getting something through trials.
       
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    18. ChrisBoyMonkey

      ChrisBoyMonkey Member Podcast Patron

      Location:
      US
      Tinnitus Since:
      2019
      Cause of Tinnitus:
      Noise
      I think the point of the question is when her device commercialized, whether by her or a licensee.

      If we're lucky it could be as soon as the 2nd half of 2020.
       
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    19. Dizzyhead888

      Dizzyhead888 Member Benefactor

      Tinnitus Since:
      2015
      Cause of Tinnitus:
      unknown
      Can someone who is following this thread well answer the following:
      1. Do we have testimonials of people getting noteworthy reductions from this device and other evidences? and how much failed?
      2. When would it be released to the market?
       
    20. Jim51042

      Jim51042 Member

      Tinnitus Since:
      3/28/16
      Cause of Tinnitus:
      Headphone use
      Please stop commenting on this thread. Whether or not timing is effective no device will ever be made from this "Work". We should all move our focus to groups who don't waste time and thus are more likely produce.
       
    21. linearb
      Psychedelic

      linearb Member Benefactor Hall of Fame

      Location:
      temporarily banished from this plane of existence.
      Tinnitus Since:
      1999
      Cause of Tinnitus:
      karma
      Good lord, what happened to this thread? How did UMich go from being seen as one of the bimodal pioneers to suddenly being treated with.... suspicion, and viewed as illegitimate?

      I realize that cynicism and pessimism can go hand in hand with tinnitus, but where are some of these insane ideas even coming from?

      what are you smoking, and where can I get some? This group has produced the research that bimodal stim is based on, as well as performing the first bimodal trials for tinnitus on humans in the US. This is one of the only groups in the world that are actually "doing something".

      this is true, but as has been said many, many times a medical device manufacturer has already had contracts executed and the same company which built the prototype devices used in the trial, will produce commercial units once FDA clearance happens. I don't remember the name of the company off hand, but it's not secret, and I'm pretty sure you'd find if if you mined my posts here.

      Read the thread, read the thread, read the thread. Yes to #1, I am one of them, and we've got at least one other person who was in a similar trial at the University of Minnisota who said the same, and last I heard we had a couple people who might be in the current UMich trial, but I haven't been following the thread. I just opened it today and it seems to be pages of people projecting doom-and-gloom for basically no reason that I'm aware of.

      I have stayed loosely in touch with the lab since I was a lab rat 4 years ago, and they have given me the same story all along: Phase-II ongoing with potential market as early as 2020, but that involves a lot of things going very right and getting FDA clearance before all trials complete. As early as ~2014, they were telling me that a launch window was "probably 2020-2024", and I don't see anything that's materially changed that?

      Uh... do you have a general understanding of the path for getting a new medical device from "idea" to "prototype" to "FDA paperwork" to "commercial device" to "commercial device that insurers will pay for"? If anything this is moving very fast compared to how long it would take a drug to go from idea to market.

      tl;dr UMich told me in 2014 they expected to have something on the market "between 2020 and 2024", they were up front at that time that 2020 was a stretch goal based on being able to clear FDA before all trials completed, and this is the same basic information they're projecting today. So, they seem to be very consistent to me, they've published more actual RCTs on this than Neuromod (and much more recently), and the only thing that seems inconsistent is whether this thread is treating Shore as the second coming of Jesus or a laughingstock, which seems to vary day to day for reasons I am very unclear on.
       
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    22. all to gain
      No Mood

      all to gain Member

      Tinnitus Since:
      June 2019
      Cause of Tinnitus:
      never trust a doctor
      @linearb

      I haven't read the thread, but I read in another thread that you were part of the trials and that you had 18 days of calm tinnitus.

      What do you mean by that exactly?

      How did you get on the trials if you had had tinnitus for more than one year?

      Sorry, you've probably covered this elsewhere, I'm a newbie really.

      I wonder if Dr. Shore looks in on the forum from time to time.
       
      • Good Question Good Question x 1
    23. Autumnly
      Wishful

      Autumnly Member Podcast Patron Benefactor Ambassador Hall of Fame Advocate

      Location:
      Germany
      Tinnitus Since:
      July/August 2013
      Cause of Tinnitus:
      Noise induced
       
    24. MattS
      Relaxed

      MattS Member

      Tinnitus Since:
      06/2019
      Cause of Tinnitus:
      Power Tools
      @linearb: you really obtained silence from the bimodal process? That's pretty amazing. Truthfully, I'm pretty skeptical of the technology, but if it worked for you, then it's impossible to deny that it's likely to work for some, at least. Which is fantastic.

      I'm just speaking off the cuff here: but my guess is that neither the full optimism (@John Mahan), not the full pessimism (many) is warranted. Rather, the device seems most likely to work for some, and to fail miserably for others. This is because the vagus nerve is likely implemented in some, but not all, of our tinnitus experiences. This suggestion is even borne out in Dr. Shore's groundbreaking animal work, where on average animals showed a decrease in tinnitus-related metrics. The on average is critical to remember - it means some animals responded better than others.

      That's not intended as a critical statement. As I said, it's the good (success for some) and the bad (not for others) all at once. The question is what proportion will see a clinically-significant improvement, and obviously that won't be known until it comes available. For now, I just wanted to accurately frame everyone's expectations of the treatment, to perhaps curb the pre-treatment optimism and post-treatment frustration. There's often a lot of confusion around the nature of Phase I/II/III trials, how to interpret the results, what a "successful" trial means, etc., etc. Having fair expectations going in is the best way to prevent surprise/confusion throughout the process.
       
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    25. Selah1281

      Selah1281 Member Benefactor

      Location:
      A Living Hell
      Tinnitus Since:
      06/2019
      Cause of Tinnitus:
      Unknown
      where did you see this stated? This is a long thread to dig through so I’m just curious.
       
    26. MattS
      Relaxed

      MattS Member

      Tinnitus Since:
      06/2019
      Cause of Tinnitus:
      Power Tools
      Somewhere somebody implied that @linearb had *previously* indicated that he experienced some silence. Can't remember who/where exactly, but doesn't matter really because it was pretty much 3rd-party hearsay. I'd want confirmation from linearb himself if possible ..?
       
    27. Selah1281

      Selah1281 Member Benefactor

      Location:
      A Living Hell
      Tinnitus Since:
      06/2019
      Cause of Tinnitus:
      Unknown
      He says significant here. He doesn’t mention silence. Perhaps somewhere else.

      A9B41F8B-E7EE-4B9C-AA9B-2DE84783B2A7.png

      Also of note he said the device is continuous use or period use in direct response to me.
      Which is different than the perception of Lenire on here.

      And around 48 hours after cessation of use he began having his tinnitus return to previous levels.

      I don't know what this means for the final product.

      0A211881-0A40-4CD1-BF52-5EAC07BEB36E.png

      06FEE537-BA16-4EB3-8349-C949C78364F9.png
       
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    28. ChrisBoyMonkey

      ChrisBoyMonkey Member Podcast Patron

      Location:
      US
      Tinnitus Since:
      2019
      Cause of Tinnitus:
      Noise
      Her device is stimulating more than just the Vegas nerve, she also goes for trigeminal. Specifically, the device is supposed to stop unruly fusiform cell activity in the dorsal cochlear nucleus, which is where the over 15 years of research is pointing to be the cause of tinnitus. What she is more unsure of is if it helps those without somatic tinnitus. Thankfully, it seems post people's tinnitus is somatic.
       
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    29. Heinrich_S7
      Psychedelic

      Heinrich_S7 Member

      Tinnitus Since:
      Uncertain
      Cause of Tinnitus:
      noise exposure
      It also appears that the Michigan Device’s effects kick in much faster but dissipate after several days. I wonder why this is. Lenire seems to be aiming for long term treatment with long term reduction?

      I can modulate my tinnitus and it fluctuates so I’m certain mine is somatic as well. I’ll probably get Susan Shore’s product over Lenire. Based on the reports so far, Michigan sounds superior at the moment.

      Hopefully Dr. Shore runs a bit faster to get this thing in our hands!
       
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    30. MattS
      Relaxed

      MattS Member

      Tinnitus Since:
      06/2019
      Cause of Tinnitus:
      Power Tools
      Thanks.
      Thanks Chris. I just took some time and read a couple of Shore's recent papers - her 2018 pre-clinical trial of bimodal stimulation, and her 2019 Neuron review (which is a tougher read, to be sure). I now have a much better understanding of her work, theory, technique, etc. It's promising for sure. Though the fact that the tinnitus percept comes back almost immediately upon stopping bimodal stimulation is a bit of a bummer. Particularly since the long-term effects of the technique are unknown (meaning it may or may not be suitable for lifetime use).

      So, she's promoting LTD in the cochlear nucleus. I think her Neuron review implies how this is done. Has no one tried to recreate her pipeline? Test it out?
       

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