New University of Michigan Tinnitus Discovery — Signal Timing

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

    1. SR88

      SR88 Member

      Tinnitus Since:
      09/2021
      Cause of Tinnitus:
      Unknown
      Not at all "BS." It's driven by the FDA approval process as clearly stated in previous posts by the Auricle CEO and other informed forum members. There is every incentive to go as fast as possible.
       
    2. ajc

      ajc Member

      Tinnitus Since:
      11/2002; spike 2009; worse 2017-18
      Cause of Tinnitus:
      Loud music - noise damage
      Got this email JUST NOW! HOT OFF THE PRESS!

      Greetings to everyone who has requested updates on the tinnitus clinical trial at the University of Michigan.

      Given the high volume of inquiries that we receive and our desire to provide a timely and consistent response, we are sending this message to all whom have contacted us.

      Clinical Trial Update

      After publishing our first human pilot study in 2018, we commenced a second, larger clinical trial. Despite COVID-19 pandemic impacts, the study participants and our staff worked diligently so that the clinical trial could continue. Although our second human trial will conclude shortly, we cannot make those study results public until it is appropriate to do so.

      Sharing Results from the Second Human Trial

      We understand the desire to know results as soon as possible, but the release of clinical-trial results is constrained. First, as reputable scientists, we will publish the findings in a relevant journal after proper peer review. Second, regulatory agencies (e.g., FDA, NIH) are careful in their reviews of novel therapies, as they should be, so all of us must be patient.

      We are dedicated to bringing this novel therapy to the millions of global sufferers of this terrible affliction. As such, we have established a private company (Auricle, Inc.) with the goal of obtaining regulatory clearance to commercialize the treatment.

      Please understand that we cannot provide any additional information at this time, so we will not be responding to additional queries for results.

      Our very best wishes,
      Susan E. Shore, PhD, and The Shore Lab
       
      • Informative Informative x 7
    3. Chinmoku

      Chinmoku Member Benefactor Hall of Fame

      Tinnitus Since:
      10/2018
      Cause of Tinnitus:
      Started with a cold, possibly worsened by medication/noise
      Am I reading it right that she insists the peer review preceeds the FDA submission? This will waste a lot of time. Put the results in a bloody preprint, as many researchers do, especially those funded by grants coming from taxpayer money, and submit that to the FDA, and then in parallel submit to a journal for peer review.
       
      • Agree Agree x 3
    4. Uklawyer

      Uklawyer Member

      Tinnitus Since:
      03/2020
      Cause of Tinnitus:
      Medication - antidepressants
      Why do professionals talk such nonsense?
       
      • Agree Agree x 5
    5. UKBloke
      Caffeine

      UKBloke Member Benefactor

      Tinnitus Since:
      1991
      Cause of Tinnitus:
      Loud Music / family history
      Has this research been part taxpayer funded?
       
    6. InNeedOfHelp

      InNeedOfHelp Member

      Tinnitus Since:
      08/2021
      Cause of Tinnitus:
      MRI Scan
      That the previous end date was April until yesterday.
       
      • Agree Agree x 1
    7. Chinmoku

      Chinmoku Member Benefactor Hall of Fame

      Tinnitus Since:
      10/2018
      Cause of Tinnitus:
      Started with a cold, possibly worsened by medication/noise
      I'm sorry to say this but, at this point, if De Ridder came out earlier than Shore with a device that works and stole her market it would be poetic justice. I don't think he can be that fast, though, and to commercialize it in the US he would need to engage the FDA. However, if the device is almost ready and he doesn't care about a journal publication before the approval, he could beat Shore even in the US in terms of timing, as journal publications can take years in the worst cases.

      I have nothing against Shore as a scientist, I think she is excellent and a true scholar, but her continued delays and especially her obsession with the journal publication preceeding the FDA approval could cost us dearly and there is really no need for it. Once you unblind the data you know if the trial was successful or not. Seriously, if a journal were to reject her work or criticized heavily her work, requiring a major revision, would she re-do the trial from scratch? You cannot do a major revision of the trial, only of the article. This journal thing is madness. Do a write-up for the FDA and deal with the journal separately, in parallel. There must be a way to do this. This happens in other areas of science all the time.
       
      • Agree Agree x 5
    8. Chinmoku

      Chinmoku Member Benefactor Hall of Fame

      Tinnitus Since:
      10/2018
      Cause of Tinnitus:
      Started with a cold, possibly worsened by medication/noise
      She has received government grants. Medicine is not my field, but I think you can see some of her grants here.

      I believe this one should be specific to the science behind the device.
       
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    9. Gee82

      Gee82 Member

      Tinnitus Since:
      12/2018
      Cause of Tinnitus:
      Noise
      Our dear reputable scientists don’t seem to realize (or care) that people are taking their lives over tinnitus. F**k reputation, give us a cure.
       
      • Agree Agree x 6
    10. InNeedOfHelp

      InNeedOfHelp Member

      Tinnitus Since:
      08/2021
      Cause of Tinnitus:
      MRI Scan
      Don't think he can beat her for an FDA approval but 100% he will be faster to start treatments in Europe than Auricle. Remember that in the EU, without any required approval, he can theoretically start tomorrow with compassionate use if he has a number of devices to use. No trials needed. Just like he provides/provided all kind of other experimental, non-"approved" treatments.
       
      • Informative Informative x 1
    11. KoolKat

      KoolKat Member

      Location:
      USA
      Tinnitus Since:
      2013
      Cause of Tinnitus:
      HeadPhones/ Noise induced
      This is why YOU GUYS SHOULD HAVE STOPPED BOTHERING THEM. I knew this was going to happen. Trust me, if they wanted us to know they would have let us known.

      I know it's hard, I know it's life and DEATH. Trust me I know my brothers and sisters, but this is just one of those things where we must charge it to the game. They got us all in the palm of their hands.

      I mean how hard is it for her or her team to simply say "FOR SOME THIS WILL BE WORTH THE WAIT", that would mean the world, but it's her right to do what she wants. My anger isn't towards her but to our government, the ATA & Pawel Jastreboff. But that's for another topic. The point is we shouldn't have to solely rely on Susan Shore. She should be one of many researchers close to curing tinnitus with this particular method.

      Sadly it's either their way or no way. So sit back, grab a hearing aid, masker, pills, etc and I guess we wait it out another 400 decades lol...
       
    12. SR88

      SR88 Member

      Tinnitus Since:
      09/2021
      Cause of Tinnitus:
      Unknown
      Not sure where this comes from. The FDA process and the academic process proceed in parallel, but the FDA process determines when information can be disclosed and published. I think this research has preceded remarkably on schedule considering the challenges COVID-19 presented for clinical trials. Of course, we all would've liked a treatment a long time ago. Dr. Shore is commenting on the scientific process and the Auricle CEO is talking about the commercialization process. They are working in tandem.
      Please explain, otherwise it seems like just name calling.
       
    13. Uklawyer

      Uklawyer Member

      Tinnitus Since:
      03/2020
      Cause of Tinnitus:
      Medication - antidepressants
      That is not name calling. I did not call Dr. Shore a "name".
      This is an empty statement. This states nothing about requirements to publish in a medical journal (or the constraints to which Dr. Shore refers). I strongly suspect that there is no such requirement. This is simply a statement of intention. It provides zero information of value to the public around delay in publishing results. It is a non-sequitur.

      @Chinmoku has covered it all.
       
      • Agree Agree x 3
    14. Gb3

      Gb3 Member

      Tinnitus Since:
      12/19
      Cause of Tinnitus:
      Sshl
      Tinnitus Talk members regarding Lenire: absolute BS, their studies are not based on real science and strong clinical trials, they just wanted to rush this to market!

      Tinnitus Talk members regarding Auricle: it’s absolute BS that Michigan is doing proper clinical trials, they need to rush this to market.
       
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    15. TomBradyGOAT

      TomBradyGOAT Member

      Tinnitus Since:
      2016
      Cause of Tinnitus:
      Who knows
      I felt it was a sort of, enough inquiries already, shut up.
       
    16. Chinmoku

      Chinmoku Member Benefactor Hall of Fame

      Tinnitus Since:
      10/2018
      Cause of Tinnitus:
      Started with a cold, possibly worsened by medication/noise
      Do you mean the "first" and "second" in the statement are not meant as a temporal and/or priority order? Jointly with her previous emails and the CEO one (super-evasive) this was my impression.

      Are you saying the FDA process and the journal submission will proceed in parallel?

      I am fine with the clinical trial being rigorous. We don't want another Lenire. But once it's finished, there is no reason to delay the process. There are people who can't go on much longer.

      To those who say they have no obligations, I say the research has been funded by government research grants (I provided the links above) which is basically taxpayer money. It would be nice of Dr. Shore to show that perhaps it's more urgent and relevant to make this treatment accessible to people as soon as technically possible, once the trial is over, rather than being primarily concerned ("First") with a prestigious journal publication.

      The peer review cannot lead to an improved trial, so there is no reason to prioritize the journal publication ("First"), considering it more important than the rest.
       
      • Agree Agree x 4
    17. ajc

      ajc Member

      Tinnitus Since:
      11/2002; spike 2009; worse 2017-18
      Cause of Tinnitus:
      Loud music - noise damage
      But it really does not matter what you think. Or are you going to send an email to change her mind, when she just asked to STFU and let her work? :ROFL: Even if she could have done it your way (I'm not sure about that), she and Jon Pearson have decided on a different approach. Respect that and be grateful someone wants to research and treat this torture. Some of it being paid for by taxpayer money has zero relevance, it's not like she's doing anything untoward. I feel bad for her honestly. The self-righteousness... :facepalm:
       
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    18. Chinmoku

      Chinmoku Member Benefactor Hall of Fame

      Tinnitus Since:
      10/2018
      Cause of Tinnitus:
      Started with a cold, possibly worsened by medication/noise
      Perhaps it does not matter to you, but it can make a life/death difference to other people. You are the one who started the VAD thread, of all people you should know the urgency of this.

      I'm not bombarding Shore with emails. I didn't send her a single one. You know nothing of me, of my background and of what I know. And certainly you are not going to tell me what I can and cannot say. If you see self-righteousness here that says more about you than me.

      And you may not care how the taxes one pays are prioritized. Fine. You are entitled to your opinion. It matters to me.
       
      • Agree Agree x 5
    19. SR88

      SR88 Member

      Tinnitus Since:
      09/2021
      Cause of Tinnitus:
      Unknown
      Perhaps this would be helpful. There is a big misunderstanding here of how this all works. TL;DR: it's a comprehensive and timely process. The FDA is very rigorous and statements like "but once it's finished, there is no reason to delay the process. There are people who can't go on much longer." are, unfortunately, not how the process works. Let's all try to stay positive and supportive here.

      How Long Does the FDA Medical Device Approval Process Take?

      How Long Does it Take the FDA to Approve a Medical Device?
       
    20. GlennS

      GlennS Member Podcast Patron Hall of Fame

      Tinnitus Since:
      1992
      Cause of Tinnitus:
      Loud music
      Tell that to Lenire "disimprovers", assuming they are still alive.
       
      • Agree Agree x 1
    21. GlennS

      GlennS Member Podcast Patron Hall of Fame

      Tinnitus Since:
      1992
      Cause of Tinnitus:
      Loud music
      Yeah, kind of like fusion where no matter what year it is, it's always going to roll out 20 years in the future.
       
    22. GlennS

      GlennS Member Podcast Patron Hall of Fame

      Tinnitus Since:
      1992
      Cause of Tinnitus:
      Loud music
      I remember similar sentiments about team-Neuromod vs. team-Shore prior to Lenire's release with many jumping on the Neuromod bandwagon based on them seeming to move at lightspeed vs. Shore's snail's pace and we saw how that one turned out.

      I understand the emotions involved in but just because one treatment is racing ahead of another doesn't mean it's going to work. Just as a working treatment that isn't released is useless, a non-working treatment that comes out is equally useless.

      Poetic justice can be served only if something comes out first which actually works.
       
      • Agree Agree x 4
    23. Chinmoku

      Chinmoku Member Benefactor Hall of Fame

      Tinnitus Since:
      10/2018
      Cause of Tinnitus:
      Started with a cold, possibly worsened by medication/noise
      Thank you for this. Medicine is not my field, as I said. I will read this. However, I feel some points I made on the priority in their press release and on the vagueness of their emails and press release still stand. And if the FDA is so rigorous, how is it that they approved devices like DeSyncra? This is totally at odds with this great rigor you mention, unless they have strongly tightened their criteria since then. But I'll read the documents.
       
      • Good Question Good Question x 1
    24. Chinmoku

      Chinmoku Member Benefactor Hall of Fame

      Tinnitus Since:
      10/2018
      Cause of Tinnitus:
      Started with a cold, possibly worsened by medication/noise
      Yeah, my statement was subordinated on De Ridder having his own clinical trial in TU Delft and having made things rigorously. I don't think that will be fast enough to overtake Shore.
       
    25. AfroSnowman
      Balanced

      AfroSnowman Member Podcast Patron Benefactor Hall of Fame

      Tinnitus Since:
      04/2019
      Cause of Tinnitus:
      Nonnatural energy source
      So I guess we are looking at a Class 3 device, so 7-8 months for approval.
       
    26. Paul1980

      Paul1980 Member

      Tinnitus Since:
      2010
      Cause of Tinnitus:
      Music, prescription drugs
      I send my tax dollars in to a lot of things. Guess what, I hardly get what I want out of it. It doesn't make me happy, I complain, but I don't think I own the process, or am owed something to which I know nothing or very little about, namely medicine.

      I would have like to have seen a cure for cancer, which we have spent zillions of taxpayer $$ on. We have some treatments, but we don't have an overall cure. I don't demand from anyone they need to speed that up, yet every second someone is dying of it.

      Maybe the problem is you just think she is lazy, or milking it. I don't think so but that is my opinion. If anything, she didn't have enough resources. You can get all the government grants you want. Maybe if she had more money it would have happened quicker. I worked for a non-profit. If only we had enough money, we could have done more, quicker.

      Talk to your state rep or senator and tell them to get on her case if you think she is lazy or doesn't care. Check that - please do not do that.
       
      • Winner Winner x 1
    27. Gb3

      Gb3 Member

      Tinnitus Since:
      12/19
      Cause of Tinnitus:
      Sshl
      No one here is clearly paying attention to the new Alzheimer’s drug. The FDA approved the drug but apparently corners were cut. Now patients can’t even obtain the drug and insurance companies won’t cover it. It costs $56,000 without insurance.

      This may explain why Dr. Shore and her lab want to be diligent.
       
      • Agree Agree x 1
      • Informative Informative x 1
    28. Chinmoku

      Chinmoku Member Benefactor Hall of Fame

      Tinnitus Since:
      10/2018
      Cause of Tinnitus:
      Started with a cold, possibly worsened by medication/noise
      @AfroSnowman, I agree it's most likely a Class III device but do we have any official confirmation of this?

      This and the adjacent pages are the official pages of the FDA for premarket approval of Class III medical devices. They go into plenty of details but don't provide average time estimates as opposed to the more informal articles provided earlier.

      For context, DeSyncra had a study showing efficacy over placebo and the FDA approved it as a Class II device but the company website is now dead (for sale), so it looks like it doesn't really work for many cases. Also, DeSyncra was a sound therapy device whereas Shore's device acts also on nerves, so it's most likely Class III.

      Eight months then, or longer, depending on when they start the process and on how many clarifications requests the FDA will send. For these requests, if I understand correctly, Auricle has 180 days max to respond. Then the commercialization. It will take a while, let's hope that at least they start the process soon.
       
    29. Chinmoku

      Chinmoku Member Benefactor Hall of Fame

      Tinnitus Since:
      10/2018
      Cause of Tinnitus:
      Started with a cold, possibly worsened by medication/noise
      I assume you are talking to me (there is a quote button). Please don't put words in my mouth. I never said she is milking it. I take exception to the vagueness of their statements and to the priorities in those statements. And I brought up the government funding to point out they are not exempted from enquiries. Does this mean they have to satisfy every whim of every taxpayer? Of course not, but the opposite attitude of not caring at all because cancer etc would lead you to a slippery slope where any discussion on how public money is spent should be censored. I don't think that's a good idea. And I'm not saying, and never said, that they haven't worked hard or diligently. They have. Shore is a top scholar. It's just that their communications are poor, vague and not informative enough to the public who funded them. And finally, possibly, they could move faster to initiate the FDA process, although this is not completely clear due to the vagueness of their statements.
       
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    30. Greg Sacramento

      Greg Sacramento Member Benefactor Ambassador Hall of Fame Advocate

      Tinnitus Since:
      04/2011
      Cause of Tinnitus:
      Syringing + Somatic tinnitus from dental work
      @Chinmoku, I believe all groups are pleased with results.

      Certain compliance such as safety and effectiveness with 510(k) needs final legal documentation before FDA submission. So, with this, a quiet period (I hate this term) is not unusual.

      Regulatory stakeholders will have all sorts of discussion and meetings just before FDA submission.

      Hug.
       
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