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  1. Jim Vasilakis

    New University of Michigan Tinnitus Discovery — Signal Timing

    If Lenire could be approved with just two clinical trials, Auricle could also be approved. It's non-invasive, meaning the clinical trial requirements are less stringent.
  2. Jim Vasilakis

    New University of Michigan Tinnitus Discovery — Signal Timing

    Yes, the science behind the device is solid. The marketing and rollout are problematic. Those are two different things; they don't correlate.
  3. Jim Vasilakis

    New University of Michigan Tinnitus Discovery — Signal Timing

    I'm not talking about a loud bar; I'm talking 70-80 dB, which is fine.
  4. Jim Vasilakis

    New University of Michigan Tinnitus Discovery — Signal Timing

    From my understanding, it works similarly to residual inhibition. For residual inhibition to work, you don't have to match your tinnitus sound exactly. You can go to a bar and listen to music, and your tinnitus can disappear for a while.
  5. Jim Vasilakis

    New University of Michigan Tinnitus Discovery — Signal Timing

    Saying that Dr. Shore's device doesn't work, when not only have there been two clinical trials with great results but other studies using bimodal electrical stimulation have also yielded good results, is bad faith. It might not work for everyone, but it does work. Reductions above 11 dB aren't...
  6. Jim Vasilakis

    New University of Michigan Tinnitus Discovery — Signal Timing

    We don't know if the participants in the second trial returned to baseline, but they kept improving without using the device, which didn't happen in the first trial. All in all, the common pattern is that the device improvement is NOT a placebo. In both studies, there were reductions in the...
  7. Jim Vasilakis

    New University of Michigan Tinnitus Discovery — Signal Timing

    It was more fine-tuned since the results remained after the six-week period, whereas in the first clinical trial, tinnitus returned to baseline after four weeks. The results of the second clinical trial were permanent.
  8. Jim Vasilakis

    New University of Michigan Tinnitus Discovery — Signal Timing

    Placebo doesn't reduce tinnitus volume by 10 dB, especially since most people's tinnitus loudness is below 20 dB. That kind of decrease is more than just a psychological effect. Also, a placebo doesn't last for months; it can last for some days, but it returns to baseline. That's why placebo is...
  9. Jim Vasilakis

    New University of Michigan Tinnitus Discovery — Signal Timing

    There is no evidence that you habituate to the device. There is evidence that increasing the treatment duration causes more benefits, as shown in Study 2. That's a fact.
  10. Jim Vasilakis

    New University of Michigan Tinnitus Discovery — Signal Timing

    The placebo effect doesn't cut your tinnitus by 75% and 11 dB for almost two months. I'm not a tinnitus expert, but that I know. A decrease like that is physiological, not psychological. I don't think there has been a tinnitus sufferer who had the placebo effect for more than some days.
  11. Jim Vasilakis

    New University of Michigan Tinnitus Discovery — Signal Timing

    A placebo effect can't cut your tinnitus in half for months. That's not how it works.
  12. Jim Vasilakis

    New University of Michigan Tinnitus Discovery — Signal Timing

    So, I see we have circled back to the skepticism era. I understand it; tinnitus can make everyone pessimistic and bitter. I just want to remind you most bimodal stimulation studies with electrical signals have reduced the tinnitus volume and annoyance in most participants. So, it's not just Dr...
  13. Jim Vasilakis

    New University of Michigan Tinnitus Discovery — Signal Timing

    Why would EU approval be years away? The FDA is stricter than the EU usually.
  14. Jim Vasilakis

    New University of Michigan Tinnitus Discovery — Signal Timing

    Anyone who thinks that a device created by an esteemed Michigan Professor who has been in the field for 30 years is a scam needs to get off these forums. And this is coming from an inherently cynical person who became even more so after tinnitus. You are not thinking straight. It might not be...
  15. Jim Vasilakis

    New University of Michigan Tinnitus Discovery — Signal Timing

    It's clear to me that the device will help the majority of patients with somatic tinnitus which again is the majority of tinnitus patients overall. I'm not throwing headlines like 90% of tinnitus patients will have 70% reduction but it seems to me the majority will have SOME reduction.
  16. Jim Vasilakis

    New University of Michigan Tinnitus Discovery — Signal Timing

    65% had a clinically significant reduction and the rest had a reduction as well.
  17. Jim Vasilakis

    New University of Michigan Tinnitus Discovery — Signal Timing

    I don't think it needs to be the exact tinnitus frequencies, just approximating.
  18. Jim Vasilakis

    New University of Michigan Tinnitus Discovery — Signal Timing

    Only a 24-year-old can hear 17000 Hz so I think it's natural. There is a reason ENTs don't do extended audiograms. Unless you are a kid, every adult is going to have some loss in those frequencies.
  19. Jim Vasilakis

    New University of Michigan Tinnitus Discovery — Signal Timing

    Extended audiograms aren't going to be very useful since everyone has damage to the higher frequencies due to age. A person in his 30s who doesn't hear 17000 Hz, there is no way to know if it's due to age or noise damage.
  20. Jim Vasilakis

    New University of Michigan Tinnitus Discovery — Signal Timing

    You didn't understand what I wrote. I never said she doesn't care about tinnitus patients. Of course she does. But the lack of urgency is mainly IMO because she isn't personally bothered by it so there is a dissonance between her care about tinnitus patients and and an intimate feeling of...
  21. Jim Vasilakis

    New University of Michigan Tinnitus Discovery — Signal Timing

    The delay pattern is quite simple. Dr. Shore isn't bothered by her tinnitus. It's hard to feel urgency when the condition you have doesn't affect you. If a cancer researcher has someone in his family with cancer, won't he push the research even faster from his end. Dr. Shore is meticulous but...
  22. Jim Vasilakis

    New University of Michigan Tinnitus Discovery — Signal Timing

    I will repeat it once more for the people downplaying the reduction from the device. If you are lucky and you are among the 70% that this device helps, then there is a VERY GOOD chance that the more you use it, the more it reduces tinnitus. Don't get too stuck on the whole "only 6 dB...
  23. Jim Vasilakis

    New University of Michigan Tinnitus Discovery — Signal Timing

    It depends on the level of hearing loss you have. The device calms down cells, it doesn't repair hearing loss. I guess a bar is safe but a club or a concert wouldn't be advised even if your tinnitus went away. At least until a hearing regenerative drug comes up.
  24. Jim Vasilakis

    New University of Michigan Tinnitus Discovery — Signal Timing

    There is no guarantee that it needs to be used constantly. People in the trials kept improving weeks after they stopped using it and changes remained months after washout.
  25. Jim Vasilakis

    New University of Michigan Tinnitus Discovery — Signal Timing

    I was never worried about the FDA approval. To me, the real question is the rollout and funding. The FDA won't take more than 6 months to approve it, it's a non invasive device and it hasn't shown any adverse effects. The real question is, when it will become available after the approval?
  26. Jim Vasilakis

    New University of Michigan Tinnitus Discovery — Signal Timing

    They didn't rush anything regarding vaccines. The technology had already been available for years. And there aren't any actual studies that link hearing loss with the vaccines with actual association. It's best to not spread fear against the vaccines.
  27. Jim Vasilakis

    New University of Michigan Tinnitus Discovery — Signal Timing

    I'm not worried about the second group so much as for the 65% success rate. In my mind if the criteria was somatosensory modulation, the success should have been a bit higher. It's not a bad percentage considering most people have a somatosensory component but I expected the reduction to be in...
  28. Jim Vasilakis

    New University of Michigan Tinnitus Discovery — Signal Timing

    I seriously doubt a placebo can reduce the loudness of tinnitus by 2x. That's a very noticeable difference and the improvement lasted for several weeks.
  29. Jim Vasilakis

    New University of Michigan Tinnitus Discovery — Signal Timing

    The word disabling was wrong. I meant more like bothering tinnitus. The kind you still want to get rid of but it's not debilitating. I meant no offense to Dr. Shore, she is my best hope so far but the fact that she has very mild tinnitus and she has probably been habituated for years if not...
  30. Jim Vasilakis

    New University of Michigan Tinnitus Discovery — Signal Timing

    No one is doubting Dr. Shore's integrity. What many people have noted is that she has continuously taken her sweet time on many occasions, such as insisting on publishing her Phase 2 study first instead of proceeding with the regulatory process. That probably stems from the fact that her...
  31. Jim Vasilakis

    New University of Michigan Tinnitus Discovery — Signal Timing

    Lenire doesn't work. Period. If Dr. Shore's device is slightly better than Lenire, then it means it won't help the majority of people significantly. I'm sorry but I really don't get how we have gone from a 75% loudness reduction to just "slightly better than Lenire".
  32. Jim Vasilakis

    New University of Michigan Tinnitus Discovery — Signal Timing

    Is there a guarantee that the only reduction will be that of 12 dB? The trial participants only used the device for a month and then stopped. What if we use it for two months straight?
  33. Jim Vasilakis

    New University of Michigan Tinnitus Discovery — Signal Timing

    If the device becomes available in the US, then it's a matter of time till it's available abroad. It's a non-invasive treatment.
  34. Jim Vasilakis

    New University of Michigan Tinnitus Discovery — Signal Timing

    Sorry, I assumed the DCN is in the cochlear area, I'm not well versed with ear as I tend not to look at too many details for my peace of mind lol. But loudness hyperacusis does happen in the cochlear area most of the time, right? That's the area that gets damaged and produces the condition...
  35. Jim Vasilakis

    New University of Michigan Tinnitus Discovery — Signal Timing

    Does that mean that loudness hyperacusis happens exclusively at the cochlea? Because if that's the case, the device will almost certainly help.
  36. Jim Vasilakis

    New University of Michigan Tinnitus Discovery — Signal Timing

    Sorry to digress, I just wanted to ask a quick question regarding this. So loudness hyperacusis is caused by noise damage? Also, a question regarding the device. Does anyone know if the loudness reduction remained permanently? We know subjects kept improving but do we know if anyone returned to...
  37. Jim Vasilakis

    New University of Michigan Tinnitus Discovery — Signal Timing

    Actually, most people with tinnitus don't have hyperacusis. Close to 40% of tinnitus patients have hyperacusis, so just not the majority. Most people with hyperacusis also have tinnitus but that is a different equation.
  38. Jim Vasilakis

    Can Intermittent Laser Sound (85-95 dB) Cause Hearing Loss or Worsen Tinnitus?

    Hello everyone. I have a surgery next week for a coccyx (tailbone) cyst removal through laser. My doctor told me the procedure runs an hour and the laser will be used from the 20th minute onward intermittently, for 5-6 seconds at a time with a 15-20 second break in between, possibly with even...
  39. Jim Vasilakis

    Can Anxiety on Its Own Cause Tinnitus or Hearing Loss?

    The thing is that a low hum can't be masked as easily as my other sound, that's why it scares me. I don't know what to do.
  40. Jim Vasilakis

    If a Tinnitus Sound Goes Away When You Plug Your Ears, Is It Actually Tinnitus?

    I have that as well. The best way to describe it is low level fridge noise in my left ear. My ENT says that it's because my brain has been in high alert mode for months so that's why he hears that new sound. It goes away when I plug my ears!!! Is there any chance that it's hyperacusis?
  41. Jim Vasilakis

    Can Anxiety on Its Own Cause Tinnitus or Hearing Loss?

    Hi everyone. A little background for me. I have had tinnitus for over a year and in last January it changed. That caused me immense anxiety and i developed generalized anxiety disorder with dizziness and some breathing problems. With sound therapy I managed to soften the sound until last week...
  42. Jim Vasilakis

    White Noise Makes Tinnitus Worse?

    OK, thanks Michael.
  43. Jim Vasilakis

    White Noise Makes Tinnitus Worse?

    Hi, I wanted to ask whether running water and streams are considered white noise?
  44. Jim Vasilakis

    What Is the Benefit of Sound Enrichment?

    Thanks for the response Michael. I was asking about the type of sound that running water is. I think it's categorised as white noise but someone told me it's broadband noise really.
  45. Jim Vasilakis

    What Is the Benefit of Sound Enrichment?

    Hi, I have a last couple of questions regarding sun enrichment for anyone who can answer them. I'm using this video at low frequency (15%) during night and I wanted to ask if it's a good sound for sound enrichment: Also, is it really white noise? Because someone in those threads told me...
  46. Jim Vasilakis

    Listening to Music Is My Dying Passion: Do I Risk Making My Mild Tinnitus Worse?

    I want to hop in and ask if movies in the 45-55 dB range are OK for a couple of hours? Thanks for anyone willing to answer this.
  47. Jim Vasilakis

    Frequency Therapeutics — Hearing Loss Regeneration

    How do you suspect you have a dip at 5 kHz? Is there any way to gauge that? Regarding FX-322, when we will have a clearer picture? Summer?
  48. Jim Vasilakis

    Frequency Therapeutics — Hearing Loss Regeneration

    Huh interesting. My ENT can't do an extended audiogram but he doesn't believe it's necessary since the trajectory from 6 kHz to 8 kHz is going up instead of down. I have debated long and hard whether that 5 dB drop is the cause of my tinnitus. I wish i knew. Anyway, what is the current...
  49. Jim Vasilakis

    Frequency Therapeutics — Hearing Loss Regeneration

    In my case my ENT thinks my 5 dB hearing loss is the cause of my tinnitus but I don't know how likely that is.
  50. Jim Vasilakis

    Frequency Therapeutics — Hearing Loss Regeneration

    Can you elaborate on that please? My latest audiogram shows a 5 dB drop on the 4 kHz range in my left ear. Is this normal? Do all humans have a drop on some frequency?
  51. Jim Vasilakis

    What Is the Benefit of Sound Enrichment?

    I understand that Michael, however the slight sharpening of the tinnitus is enough to throw me off. Based on your experience even with daily frustration because of tinnitus is there a chance that the threshold will be lowered with sound enrichment? I know you are not an ENT but you are...
  52. Jim Vasilakis

    What Is the Benefit of Sound Enrichment?

    So, if I got it right, someone still bothered by their tinnitus won't have the threshold lowered by sound enrichment? It still bothers me to be honest. I still try to find ways not to hear it during the day and run from it.
  53. Jim Vasilakis

    What Is the Benefit of Sound Enrichment?

    Thanks for the clarification Michael. I was wondering what were the 6-8 weeks you were saying. Is this the amount of time one can see an improvement with sound enrichment?
  54. Jim Vasilakis

    What Is the Benefit of Sound Enrichment?

    What I'm trying to say is that if sound enrichment does work, can it permanently reduce the volume of my tinnitus? And if that happens and then I stop it, will the tinnitus then return to its previous levels? Sorry if that wasn't clear, I'm just trying to understand how sound enrichment...
  55. Jim Vasilakis

    What Is the Benefit of Sound Enrichment?

    I have seen a lot of people say their tinnitus stabilized after a year or two? That doesn't apply?
  56. Jim Vasilakis

    What Is the Benefit of Sound Enrichment?

    Cool. That sounds promising. What happens if it does work and then I stop it? Does it reverse to its previous state? Will I need to use sound enrichment for the rest of my life?
  57. Jim Vasilakis

    What Is the Benefit of Sound Enrichment?

    Sorry to come back to this but can sound enrichment be done with a phone? I don't have the financial capacity to buy an Oasis device, I have already put my parents through a lot of expense. Can the phone next to my bed playing low level nature sounds provide sound enrichment?
  58. Jim Vasilakis

    Audiogram and Other Hearing Test Results

    Hello everyone. I just got my latest audiogram and it showed a -5 dB drop in the 4 kHz in the left ear. The thing that troubles me is that I did an audiogram at a different doctor two months ago and it showed no hearing loss in the 4 kHz range. My latest doctor believes my tinnitus is due to...
  59. Jim Vasilakis

    What Is the Benefit of Sound Enrichment?

    Thanks Michael. I do leave some quiet time during sleeping. I use nature sounds for 4 hours per night. I assume they also can't cause hyperacusis in the long run, right?
  60. Jim Vasilakis

    Is There Such Thing as *Too Much* Masking / Sound Enrichment?

    Can sound enrichment with nature sounds aka crickets and waterfalls cause hyperacusis? I'm worrying since I'm playing masking sounds a lot during the day and night to help me sleep that I might be causing fatigue to my auditory system. I play the sounds at very low volume and for about 4 hours...