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Regardless of the circumstances, you don't have the science to back up your claims. All you have are anecdotes. There is no evidence, only claims...
No, I am not referring to the current generation of Lenire at all, or even a slightly updated version of it. I do not have any insight into what...
Insults were hurled by both sides, and neither side took the high road. I apologize for my behavior, but I don't apologize for relating my...
Yeah, yeah. Denial ain't just a river in Egypt! Some of us value anonymity (to the extent possible) on sites like this. It's a choice. There's...
The reason you defend @R. David Case is because you are @R. David Case. This is obvious. I respectfully disagree with @Markku on that. How anyone...
Sure, my man! It's my pleasure and civic duty to warn others about this dangerous "treatment". I think it's highly likely that @Smork is a sock...
Haha! Very mature. I call you a 'nutcase,' and you respond by calling me one! What are you? Five years old? And that study you sent me was about...
Testimonials mean nothing. Where's your scientific study? Where's your placebo control? Even if it was "3500" people you say you've "helped," this...
Oh! Another natural remission that a tinnitus scammer takes credit for. Well done! Congratulations. Warning: @R. David Case is a nutcase quack...
Thanks man. Yeah, this has been a challenge to live with all these years. I have a LOT of faith in the Susan Shore device, which is in review...
Dr. Shore addresses this in the Q&A when the Polish Tinnitus Association asked if they could help commercializing the device in Poland: Remember...
It was implied when you said:
No, I'm not blaming my tinnitus on this one thing. I've had it for 34 years! Look at my profile. I'm saying that I believe (strongly) that his...
Everyone always thinks that jobs they don't do are easy.
I used this "treatment" on low volume for well over a year, and it did indeed make my (already severe) tinnitus worse!
Your claims that your system is more advanced than Dr. Shore's tinnitus device are laughable! This is a completely absurd and "God Complex" type...
I wrote Dr. Shore asking that question back when she was still replying to me and all that she would say was that "That statement was taken out of...
That's why I said "IF they're submitting as a 510(k)." Yes it's speculation. Welcome to Tinnitus Talk! You must be new here. Almost everything...
If they're submitting as a 510(k), the FDA tries to have a decision in 90 days, give or take. That can be affected by staffing levels, and if the...
That would be ideal! It's been far too long without an update, leading to much speculation and pre-mature disappointment. @Hazel, if you could...
Jon Pearson has claimed in an email that Auricle is fully funded at this point.
Thanks, I appreciate that. I was not aware of the fact that there was no requirement to avoid other tinnitus treatments during the washout period....
Dr. Shore addresses this in the Q&A. I hope this helps!
No, the crossover was invalidated, basically, because the device worked too well. And the effects of the treatment lasted through the washout...
Cool, I think/hope I am. However, I think if it gets approved soon, we may see it be available THIS year. No one knows for sure of course. Yes,...
You mean 20 years of research that crystalized into two double-blinded, placebo-controlled trials with proven results. The device worked so well...
Okay, but what are you basing that on? Do you have some inside knowledge? Dr. Shore has been working on this for over 20 years and she's just...
She doesn't know any more than you or I do. She's speculating. That's practically all this thread is, just speculation. Some are more informed...
We have an update from Auricle CEO Jon Pearson: I found this email every encouraging and reassuring!
Not sure where that's coming from? It comes from the FDA itself! In this context an AI request would mean an 'additional info request' or in...
You'll have to visit a clinic to set the device, but I think it's designed for home use.
I think a 510(k) submission will be likely but far as I know we have no confirmation of that. Superficially (very superficially) it could be...
At the Palm Springs Hearing Seminar from last year I believe. The reason for the tinnitus starting (acoustic trauma in your case) shouldn't...
That was probably the easiest group for her to test. That doesn't mean it won't work for other kinds. More testing will be needed after it's been...
Yes I know it was dated September. This is the first I've seen it. I was less sure it'd been submitted as time went on. The truth is no one has...
There's been an update regarding Dr. Shore's device submission to the FDA. Apparently they're planning a Q1/2024 submission: → Medical Device...
I think that Dr. Shore's trials were really well run especially when we compare them to the Lenire trials. I think there's almost no chance of FDA...
The reason that Lenire took so long is that the FDA asked them to do another trial. That won't be the case for Dr. Shore. And of course Neuromod...
I've heard that it can take anywhere from 6 months to 2 years to prepare a submission to the FDA for a Class 2 medical device! So it appears that...
I have more information now than when I made those allusions you quote above. I now know that FDA approval does not depend on publishing, at the...
Yes, they certainly may have waited until they were published before submitting the device to the FDA. All that I am pointing out is that it's not...
What's the matter with me? What's the matter with you? DeNovo is not compassionate use. It is for a 'first of its kind' device. As I've stated...
December 2022 wasn't even a year ago. It's too soon to give up hope. I looked at Dr. Shore's progress update from June and that reminded me that...
The FDA doesn't care if you're published or not. They examine your evidence directly. Although it is probably 'good form' and expected to be...
My doctor said she would help me investigate if the Kv7 modulators BHV-7000 and XEN1101 were available through FDA compassionate use. I think Dr....
Great! Thanks for confirming that, @Markku!
Dr. Djalilian has one of the most promising lines of research besides Dr. Shore. I hadn't heard of the work being done at Mayo Clinic in...
Not that I am aware of. I do know that it is the reason so many (including myself) found some relief from Retigabine, because it activated the...
The MAIN DIFFERENCE is that Lenire is a habituation device, and the Shore device is not. The Shore device that was developed at the University of...
I don't really think that TFI/THI or MML are great ways of determining how someone is doing with their tinnitus. All you can really do is rely on...
If you came up with all those alternate interpretations of a simple, straightforward sentence, it's not. It's abundantly clear what he meant....
That's a completely normal use of the English language. Where are you from?
Through masking levels. Yes, most tinnitus is subjective, but to determine volume they use MML - or Minimum Masking Level. They play a masking...
There is something about the placement of the electrodes on the different devices that targets different parts of the brain. The MAJOR difference...
The similarities are VERY superficial. I wouldn't compare the two just because they are both bimodal stimulation.
Further studies will be needed, but I think it's highly unlikely that it would make you worse. I could be wrong of course, almost everything in...
Yeah, but I think with continued use of the device we'll see further improvement in symptoms. They had to cap the use of the device timewise for...
I don't know what it seems like, but she is researching hyperacusis. She has confirmed that for me in an email.
Nah, she's researching hyperacusis too. I just don't think she's focusing on that as much as she is tinnitus right now.
I think what she means is that all silence is relative. Our bodies make noise and there are few places on earth that are truly quiet. At least...
