New University of Michigan Tinnitus Discovery — Signal Timing

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

  1. Watch Hazel share good news about tinnitus
    1. Mathew Gould

      Mathew Gould Member Benefactor

      Tinnitus Since:
      6/2017
      Cause of Tinnitus:
      Neck/Jaw misalignment
      I wonder if this device helps with eye floaters from neck and jaw issues.
       
    2. IntotheBlue03

      IntotheBlue03 Member

      Tinnitus Since:
      12/2021
      Cause of Tinnitus:
      Cervical/TBD
      @Survivor234, I believe @Harder Calm provided an update that the trials and FDA application are delayed but that we could expect an update by mid 2022?

      The commercialization process is being setup now I believe in the form of Susan's company Auricle.

      Please feel free to correct me anyone who is more in the loop. Hoping that commercialization and completion of the trials in mid 2022 are on parallel tracks.
       
    3. DebInAustralia
      No Mood

      DebInAustralia Member Benefactor Advocate

      Location:
      Geelong, Victoria
      Tinnitus Since:
      30/12/13
      Susan Shore said the trial will finish by the end of April 2022.
       
      • Like Like x 3
      • Agree Agree x 2
      • Winner Winner x 1
    4. AfroSnowman
      Balanced

      AfroSnowman Member Podcast Patron Benefactor

      Tinnitus Since:
      April 16 2019
      Cause of Tinnitus:
      Nonnatural energy source
      I wonder how long after we will get top line results.
       
      • Good Question Good Question x 1
    5. Survivor234
      Hurting

      Survivor234 Member

      Tinnitus Since:
      2021
      Cause of Tinnitus:
      Noise-induced/Headphones
      And, considering they have a mailing list for updates next summer, it's likely that commercialization is around that period as well.
       
    6. AfroSnowman
      Balanced

      AfroSnowman Member Podcast Patron Benefactor

      Tinnitus Since:
      April 16 2019
      Cause of Tinnitus:
      Nonnatural energy source
      I believe they need to wait for FDA approval first.
       
    7. Survivor234
      Hurting

      Survivor234 Member

      Tinnitus Since:
      2021
      Cause of Tinnitus:
      Noise-induced/Headphones
      How long does that take?
       
    8. DebInAustralia
      No Mood

      DebInAustralia Member Benefactor Advocate

      Location:
      Geelong, Victoria
      Tinnitus Since:
      30/12/13
      Would an FDA application have been submitted yet?
       
    9. IntotheBlue03

      IntotheBlue03 Member

      Tinnitus Since:
      12/2021
      Cause of Tinnitus:
      Cervical/TBD
      @Harder Calm, hoping you might be able to advise from the update you provided regarding the FDA application being delayed?
       
    10. AfroSnowman
      Balanced

      AfroSnowman Member Podcast Patron Benefactor

      Tinnitus Since:
      April 16 2019
      Cause of Tinnitus:
      Nonnatural energy source
      I reached out to the CEO of Auricle a couple months back and he said:

      “With regard to the commercialization schedule, the conclusion of Dr. Shore’s confirmatory study will determine next steps with regulatory bodies, so we will have a better idea of where we stand mid 2022. Given that there are no FDA-cleared devices or drugs for the treatment of tinnitus, regulatory bodies—appropriately—have higher hurdles for safety and efficacy that must be satisfactorily demonstrated before clearance is awarded. As such, we don’t make public comments concerning timing since it is premature to do so. But please know that Auricle was formed to gain clearance and commercialize Dr. Shore’s device, so we are bringing talent and resources to this critical project. You’ll certainly hear from us when we have relevant and public news to report!”​

      So to me it looks like they are waiting for the results before getting FDA approval.
       
      • Like Like x 2
    11. Mentos

      Mentos Member Benefactor

      Location:
      Cracow, Poland
      Tinnitus Since:
      03/2015
      Cause of Tinnitus:
      Noise induced, loud rock concert
      Perhaps mid 2022 for the estimate comes from the following timing:

      - April/May end of study
      - 3 months for FDA clearance which brings us to July/August
       
      • Like Like x 1
    12. mrbrightside614

      mrbrightside614 Member Benefactor

      Location:
      NE Ohio, USA
      Tinnitus Since:
      July 2019
      Cause of Tinnitus:
      Acoustic trauma
      @linearb, sorry to ask more about your personal experience with this device, but is the sound they play through the airbud tailored from your tone-matching, or do they play “factory settings” type tones? I’m a little worried because I have a hard time tone-matching.
       
      • Good Question Good Question x 1
    13. AfroSnowman
      Balanced

      AfroSnowman Member Podcast Patron Benefactor

      Tinnitus Since:
      April 16 2019
      Cause of Tinnitus:
      Nonnatural energy source
      Man would that be sweet. I have no idea if 3 months or 10 months is more realistic but the thought that there will be something that can help being available in 2022 brings me joy.

      All of this of course assumes that the clinical trial confirms the positive results and doesn’t show any worsenings. As unpleasant as it is to think about, there is a real chance (not a likelihood but a chance) that this larger clinical trial comes in with a negative outcome. I want to hope but I can’t allow myself to have unrestrained optimism after the disappointments of Lenire and FX-322. The latter of which really put me in a dark place for a week or two.
       
      • Like Like x 2
      • Informative Informative x 1
    14. Padraigh Griffin

      Padraigh Griffin Member Podcast Patron Benefactor

      Tinnitus Since:
      05/2020
      Cause of Tinnitus:
      Unknown/Stress
      Just received this from Dr. Shore. Nothing new really.

      "Our second human study will end next year, and ‘Auricle’ will pursue regulatory clearance and commercialization. The study is double-blind, so we will not know results until the conclusion. We will make news public as soon as we have anything to report."​
       
      • Like Like x 2
      • Informative Informative x 1
    15. Bruce NH USA

      Bruce NH USA Member Benefactor

      Location:
      New Hampshire, United States
      Tinnitus Since:
      1981; intolerable since 11/2021
      Cause of Tinnitus:
      Loud music, then ototoxic drug (Paxil)
      The FDA is a strange animal---they certainly have proven that with COVID-19. I just hope that they don't drag their feet if the results of this study are convincing. Dr. Shore has been working on this for a decade---if the device is finally ready for Prime Time, let's see it!
       
      • Like Like x 1
    16. Xys87

      Xys87 Member

      Tinnitus Since:
      2005
      Cause of Tinnitus:
      Acoustic trauma
      I find it very odd and dubious that those who wish to commercialize this device are also the ones evaluating its efficacy.... there is a conflict of interest.These people have a pressure of result because of the millions invested and also know that there will be a lot of money to earn (even if their device is not efficacious).

      Just look at Lenire...

      I find it hard to trust but I hope I'm wrong.
       
      • Agree Agree x 1
    17. Survivor234
      Hurting

      Survivor234 Member

      Tinnitus Since:
      2021
      Cause of Tinnitus:
      Noise-induced/Headphones
      They're interested in commercializing it precisely because it's effective. And commercialization hasn't even started yet (the company has just been founded).

      And, in regards to tinnitus treatment, I am pretty sure that efficacy is what tinnitus sufferers are interested in. Lenire has failed because it did not provide the adequate treatment that tinnitus sufferers were looking for.

      Combined with the prohibitively high cost, it's something most tinnitus sufferers don't really care for. As a result, Lenire isn't making much money, even in its home area of Europe, as a form of tinnitus treatment.

      I would say, in comparison to Lenire, Susan Shore's device is significantly more likely to actually do something in reducing or eliminating tinnitus. And I think it'll only get better at doing that in the future.
       
      • Agree Agree x 2
      • Like Like x 1
      • Optimistic Optimistic x 1
    18. Padraigh Griffin

      Padraigh Griffin Member Podcast Patron Benefactor

      Tinnitus Since:
      05/2020
      Cause of Tinnitus:
      Unknown/Stress
      Neuromod’s Lenire trial was a joke of a trial. No sham control. Basically if you told people eating an apple a day (and had ‘science’ papers/research) would improve their tinnitus by an average of 12 pts on the TFI it would improve their tinnitus by 12 pts. That is the average placebo result in other trials. Basically they are marketing a placebo effect device. They should be in court like Theranos Elizabeth Holmes. Bunch of jokers.

      Susan Shore’s device is compared to sham and is double blinded. It is a well designed clinical trial and her device actually targets a supposed physiological cause of tinnitus in the DCN.

      Ask Neuromod what physiological cause it targets. Zilch, zero, none. Just a habituation device that is no more effective than placebo.

      I do hope that Dr. Shore’s device works and works well. Not just a 12 pt plus reduction in TFI that is deemed clinically significant.

      For many of us a TFI reduction of 12 pts is minuscule.

      All will be revealed in 2022. I’m more ‘excited’ about potassium channel modulators like XEN1101 targeting the hyperexcitability in the DCN myself. Hopefully without the side effects of Trobalt.
       
      • Like Like x 7
      • Agree Agree x 1
    19. IntotheBlue03

      IntotheBlue03 Member

      Tinnitus Since:
      12/2021
      Cause of Tinnitus:
      Cervical/TBD
      Hey Folks,

      Once again calling on those who are better versed in the technical aspects of Dr. Shore’s work.

      Is it the case that the frequency of tinnitus or hearing loss will be irrelevant with how her device works? I had watched the Tinnitus Hub 2019 interview and if I understand correctly, the focus is on the DCN.

      Curious if that means that the device should still be effective for users who have high frequency hearing loss past 8 kHz or normal audiograms (as I do)? I believe we are termed the “hidden hearing loss” subgroup of tinnitus sufferers.
       
    20. DebInAustralia
      No Mood

      DebInAustralia Member Benefactor Advocate

      Location:
      Geelong, Victoria
      Tinnitus Since:
      30/12/13
      I don't think the frequency or your hearing loss is relevant.

      Dr. Shore is addressing the hyperactivity of fusiform cells in the DCN as a result of auditory damage; even if it is hidden as in your case.
       
      • Like Like x 2
    21. IntotheBlue03

      IntotheBlue03 Member

      Tinnitus Since:
      12/2021
      Cause of Tinnitus:
      Cervical/TBD
      Excellent question and my concern as well in case anyone has any details around this.
       
    22. DimLeb

      DimLeb Member

      Tinnitus Since:
      14/03/2021
      Cause of Tinnitus:
      Idiopathic Cochleopathy Or Maybe Loud Music
      @IntotheBlue03, that's a good question since a lot of people may have a hard time tone matching due to multi-tones or just straight up complex sounds in their tinnitus (like broadband hums, tones masking each other etc etc).

      Personally I, being a sound engineer/designer, can't fully replicate my sounds, so I imagine, people without sound-spectrum experience will face even more technical difficulty.
       
    23. prowlinacage

      prowlinacage Member Podcast Patron Benefactor

      Tinnitus Since:
      05/10/2020
      Cause of Tinnitus:
      Long-term noise exposure
      Specially timed signals ease tinnitus symptoms in test aimed at condition’s root cause

      "The U-M device delivers sounds matched to the loudness and pitch of the phantom sounds that each patient hears."
       
      • Like Like x 1
    24. mrbrightside614

      mrbrightside614 Member Benefactor

      Location:
      NE Ohio, USA
      Tinnitus Since:
      July 2019
      Cause of Tinnitus:
      Acoustic trauma
      Sorry but I’m doing this @linearb and also want to ask how long the relief lasted? I’m hoping it can reduce my tinnitus for at least 8 hours for a normal night’s rest.
       
      • Like Like x 1
    25. IntotheBlue03

      IntotheBlue03 Member

      Tinnitus Since:
      12/2021
      Cause of Tinnitus:
      Cervical/TBD
      So I’ve resorted to screenshotting since I’m not that familiar with all the areas of Tinnitus Talk but here is a poster referencing 50+ weeks after a course of 3 month treatment. Can anyone verify this?

      C7470073-CE7F-4242-8099-311E3C505085.png
       
      • Like Like x 1
      • Helpful Helpful x 1
    26. SB1981

      SB1981 Member Benefactor

      Tinnitus Since:
      06/2019
      Cause of Tinnitus:
      Multifactorial
      If you click on the number of replies for a thread on the right hand side on desktop (not sure about mobile, not on my phone currently) it breaks down the replies in a thread to the individual poster. You can then choose @linearb and browse through some of his early posts in the thread. Just letting you know in case you aren't aware.

       
      • Helpful Helpful x 1
    27. Survivor234
      Hurting

      Survivor234 Member

      Tinnitus Since:
      2021
      Cause of Tinnitus:
      Noise-induced/Headphones
      What if you don't know the exact frequency of your tinnitus so that you can signal time? How long does it take to reduce tinnitus?
       
    28. IntotheBlue03

      IntotheBlue03 Member

      Tinnitus Since:
      12/2021
      Cause of Tinnitus:
      Cervical/TBD
      @Survivor234, others can chime in but I can imagine once this comes to market that it will be pushed to audiologist clinics where there will be pitch matching but here’s to hoping they make it more self intuitive in the way of apps etc as well.
       
      • Like Like x 1
    29. mrbrightside614

      mrbrightside614 Member Benefactor

      Location:
      NE Ohio, USA
      Tinnitus Since:
      July 2019
      Cause of Tinnitus:
      Acoustic trauma
      Pretty highly speculative and mostly in regards to Lenire, not Shore unfortunately.
      Thanks, but I only use Tinnitus Talk on my phone so I have to resort to good ol’ stalking his recent posts that were in this thread lol.
       
      • Helpful Helpful x 1
    30. Watasha
      No Mood

      Watasha Member Podcast Patron Benefactor Ambassador Advocate

      Tinnitus Since:
      03/2018
      Cause of Tinnitus:
      Unknown
      Next year as in 2023?
       
Loading...

Share This Page