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Tinnitus since 2023??? You’re new to the game, so you can’t understand my frustration. Mine started in 1990 and has been severe since 1996. Judge all you want, but three decades of this hasn’t been easy.

OK, that's good of you to clarify, but you are still attributing behavior to me that wasn't mine. I did not ask them for daily, weekly, or monthly updates. No reasonable person would ask that. However, in the 4 years of Pearson being CEO, we have one Q&A with Dr. Shore, which we appreciate...

Who is harassing Auricle and its members? All of my interactions with Dr. Shore have been positive and infrequent. I haven't had email contact with her for years at this point. I don't even post to Tinnitus Talk much anymore, mostly due to vitriolic reactions like yours. Your accusations of me...

The 1st trial lasted 4 weeks and the second one lasted 6 weeks. Given that in the second trial, the second half of the study was invalidated because the participants didn't return to baseline, one would surmise that 4 weeks of usage was not enough to achieve LTD. They're not sharing any...

Auricle is literally killing us by remaining so silent. This astounding level of apathy that they are showing is simply appalling.

I believe you're wrong. Each person's case is as unique as a fingerprint. Sound, intensity, and every other factor vary from individual to individual. The only thing common to all is the source - the DCN, and the cause - hyperactive fusiform cells.

The Shore device is the only treatment that will reduce tinnitus volume. That's the treatment everyone needs. It's never been possible before until this device becomes available.

Four years as CEO of Auricle Inc., and what has Pearson actually accomplished? Nothing, as far as anyone can tell. That's why more and more people are turning to their "personal projects" to treat their tinnitus!

I heard an explanation that made sense to me. Dr. Shore couldn't get her device picked up by 'big pharma,' who could get this through FDA approval quickly, because the patent isn't strong enough to stand up to a patent challenge. It seems that synchronized signal timing may not be proprietary...

Well, thank you for the doom and gloom for severe tinnitus sufferers. The improvements were measured in TFI, but also loudness reductions were measured. So, I remain hopeful. We will have to wait and see if it can help a severe case. Still, I think that Auricle's policy of almost no...

I honestly don't think they'll hear back from Jon Pearson. Given the flippant response we got from the one communication we had with him, it seems he just doesn't care.

Everyone in the trial should have been somatic. It was an inclusion criterion for the trial.

It's completely standard for medical and medical device companies not to discuss FDA approval or device availability before release. Stop being paranoid.

Thanks for the update, @Markku! Maybe she plans to join the faculty at UCI in the fall. I guess we'll see!

Dr. Shore's role in the device is mostly over (for now). I imagine she might work on refining it after release (or whatever team she puts together will). Since she retired from the University of Michigan, she joined UCI (University of California Irvine) and is apparently still working. She's in...

No, she wasn't exactly alone. She led a lab at the University of Michigan, and she had a team helping her. She is not the sole inventor of the device; she shares credit for that with David Martel and Seth Koelher. There was an NDA with all the trial participants in place that asked them to keep...

Thank you but I highly doubt that. The tones the device plays are very quiet; about 5-10 decibels. By comparison a whisper is 30 decibels. In other words, the sounds that the device uses are about as loud as your own breathing. So I'm finding it hard to believe something like that alone could...

What do you attribute the worsening to? The device or to external events? I know at least one person from the study who had their tinnitus worsen attended a rock concert during the trial.

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 of it helping.

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 Neuromod may be up to. I am referring to the device Dr. Lim used to cure @kelpiemsp in the University of Minnesota thread. It's a completely...

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 experience that Tinnitus Mix made my tinnitus worse and for questioning the approach for Tinnitus Mix. I believe this method is really just residual...

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 nothing inherently good or bad about using a pseudonym. It's just something some of us wish to do.

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 could read that and not believe it was written by that guy is beyond me. For the record, I never said @R. David Case is a bad person or "scum of the...

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 account for @R. David Case! Good catch!

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 as good as the Lenire study. No placebo. I think you are proving my point. As others have pointed out, your method is nothing more than residual...

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 is all 100% unscientific and anecdotal without the science to back it up! I played it for two minutes and said it doesn't work? How about doing it...

Oh! Another natural remission that a tinnitus scammer takes credit for. Well done! Congratulations. Warning: @R. David Case is a nutcase quack who believes natural remissions are the result of his "treatment."

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 right now with the FDA (I believe they're not saying anything publicly), and it will probably be out in the next couple of years. Saying exactly when is...

Dr. Shore addresses this in the Q&A when the Polish Tinnitus Association asked if they could help commercializing the device in Poland: Remember that Auricle has a small staff, and each submission is a lot of work!

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 "treatment" took my already severe tinnitus and made it worse than it was before.

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 of thinking. You are a delusional quack! I tried your method with the recommended headphones for well over a year never missing a day. And it made my...

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 context", but she wouldn't elaborate any further, sadly.

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 here is speculation. I present nothing I say here as fact, but what I'm saying is generally correct that the FDA tries to decide 510(k) submissions in...

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 FDA has questions called "AI requests" or additional info requests back to the submitter. That can add time and is not a sign of anything wrong; it's...

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 please reach out to Dr. Shore for another update, that would be outstanding!

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. I wasn't aware of that, so thanks for bringing that to my attention. It seems common sense that no one would seek other tinnitus treatment during the...

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 phase and into Phase 2 where the first group was meant to have the placebo. The subjects going into Phase 2 would be prone to the effects of Phase 1 only...

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, the electrical signal is so faint that it can't really be felt. So it was easy for her to create a placebo group since no one knew really what they...

You mean 20 years of research that crystalized into two double-blinded, placebo-controlled trials with proven results. The device worked so well that the crossover was invalidated because the improvements continued through the washout phase. Dr. Shore is one of the most respected researchers...

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 joined another prestigious university to continue her work with another prominent researcher. You have a very interesting definition of what a scam is...

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 than others however!

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 other words the FDA is asking questions of the requestors. This is a normal part of the process and not an indication that anything is wrong. AI requests...

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 considered similar enough to Lenire to get the 510(k) distinction.

At the Palm Springs Hearing Seminar from last year I believe. The reason for the tinnitus starting (acoustic trauma in your case) shouldn't matter because as Dr. Shore states: All signals must be processed by the cochlear nucleus (including the dorsal cochlear nucleus) before ascending to the...

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 released!

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 any idea of the work that's happening behind the scenes. It's good that there's evidence of this moving forward! Congrats! Enjoy your victory.

There's been an update regarding Dr. Shore's device submission to the FDA. Apparently they're planning a Q1/2024 submission: → Medical Device Startup Auricle Celebrates Licensing with Bell-Ringing Celebration

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 asking for another trial, because she was really meticulous. But you're right, who knows? No one has a crystal ball to predict the future.

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 used their trial as a marketing opportunity by conveniently deciding to not use a placebo for their trials!

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 those saying that she has not submitted to the FDA are probably correct! But that's because the bulk of the post scientific work is preparing the FDA...

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 time I wrote those I was not clear on that. Dr. Shore said: Which may mean that they will wait for publication to submit to the FDA, but the meaning...

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 a requirement, and none of us knows whether she waited for publishing before submitting to the FDA. The only one with complete clarity on the subject...

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 previously, the FDA does not care if you're published or not, because they examine your evidence directly. Theoretically she could have resubmitted to...