Excuse me, I want to keep the temperature down here, but if @linearb was cured, as I seem to remember reading, why would he want to go and get cured again?
@linearb felt good effects from the Susan Shore Device, while he was using it. Those good effects didn't last after the trial.
Because all of the armchair researchers here do not think it will work and come out, it is safe to say that there is no hope of anything ever coming out in our lifetime.
I knew Mr. Doom and Gloom would chime in. It doesn't work! We get it.
Also to note, @linearb was a participant in the very first trial where he was only using the device for 4 weeks, instead of the 6 weeks, which showed a more lasting effect.
I mean, you can look up @linearb and read his posts yourself. If I remember correctly, he said that he did receive benefits from the machine while using it, but it went away after his 4 weeks were over. He was also sure to point out that he was in the first original trial, in which there were only 20 participants, and that they only tested for 4 weeks which didn't show any lasting effects after the trial was over. It was the second, larger trial that had 99 participants using the device over 6 weeks that showed lasting effects.
It's difficult reading that because of the fact that maybe 2+ months could have extremely promising effects. Yet Auricle isn't experienced enough to launch it.
Perhaps it's because I have mild rather than severe tinnitus symptoms today, but I'm positively framing this. Auricle is serious about the FDA submission. The Susan Shore et al. studies show promise, albeit with questions folks have raised about the placebo treatment/washout period affecting the actual treatment efficacy. (Maybe that will open some new research avenues.) We have no control over the timeline. I get the desperation of folks at their wits' end suffering. I've been there at various points.
In the same way that insulin doesn't work because diabetics need to keep injecting it?
The answer to every question you asked is in this thread. Use the search and select "Posted by Member." Years ago, @linearb documented his experience on this thread. There is also a discussion on Lenire's timeline.
I've been guilty of being pessimistic myself, but I hope you're correct and that it's just a matter of time.
That's very kind of you.
You're misunderstanding my post, but it DOES work. Please, I implore you to read his experience with it. As I already mentioned, he was enrolled in the first trial of 4 weeks, which showed benefits while using the device. The benefits went away after his 4 weeks.
Dr. Shore mentioned in her recent webinar that the trend of decreasing volume continued even at the 6-week mark. She suggested that this could imply further reductions if usage extends beyond 6 weeks. My thinking is that, like with many treatments—from antidepressants to acupuncture to everyday painkillers—some take longer to show results. I'm hoping that those who showed less of a decrease in volume after 6 weeks might experience further improvement, ultimately leading to better overall results. For some, it might even be a case where nothing happens at first, and then suddenly, at around 8 weeks, things change. I've seen reports from Lenire users where they experienced no progress for weeks, and then, all of a sudden, there was a significant improvement.
Very true. I believe the recent lack of communication from Auricle has unnecessarily soured my perspective. This might be due to my recent transition from a mild to severe case of tinnitus. However, after re-reading the positive results of the Phase 2 trial and reading posts from @linearb about their experience with the device, I'm feeling a bit more hopeful.
It's the other way around. Lenire was available in parts of Europe around 2019-2020, so years before America.
On the other hand, we don't know for sure that it wasn't submitted to the FDA a while ago, possibly even last year.
In Dr. Shore's clinical trial(s), the patient population was kind of small compared to Lenire.
Yes, a third of us! (That is, a third of us will be experiencing more peaceful moments in the next 5-10 years.) And this only applies to a relatively privileged group. Are you well-paid? Do you have a degree? Do you live in North America? Is your car new? Although I don't check any of these boxes, I should probably still consider myself 'privileged'—being from the West, holding two noisy jobs despite having tinnitus (both low-wage, of course), and currently not having any significant medical expenses.
Dr. Shore mentioned communicating with the FDA throughout the clinical trial process, so one would hope she followed the FDA's guidelines. In some articles, she has been quoted as saying her focus is now on commercialization, so ideally, another clinical trial won't be necessary.
The clinical trial device looked like this:
You are not getting this confused with the Bionics Institute technology, are you? They are looking at several more portable prototypes. I've heard nothing of new prototypes for Auricle.
If I remember correctly, the active arm received electrical impulses so faintly that the participant soon habituated to them and did not feel them. In essence, they were blinded to whether or not they had active or placebo treatment. That's how Dr. Shore explained her blinding.
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