New University of Michigan Tinnitus Discovery — Signal Timing

We have not one new piece of information. Trial is still "active" according to ClinicalTrials.gov.

 

I didn't think the trial was due to conclude till the end of this month?

I have reached out to a contact I've maintained over the years, who is putting her feelers out.

 

A friend emailed Dr. Shore.

They responded stating they are unblinding this month.

And will report findings in the summer.

Probably nothing new but hopefully drawing closer to a treatment.

 

Imagine if a member of the team was suffering from severe chronic tinnitus and was away sick and close to losing everything. I wonder what they would be saying to their colleagues about timelines for presenting results.

 

First day of summer June 21. Let the countdown begin.

 

Are you insinuating they are not already doing it as fast as possible?

Dr. Shore has been working on this for so long that she isn't going to start cutting corners now, she sees the forest for the trees, and wants her study to be as sound as possible so that it can be published in top tier journal. She doesn't want it to be another Lenire which was nothing but a big sham.

In your example, I think the colleague would know that they are working as fast as they can.

 

More like September 20

Honestly, results this summer isn't bad!

 

Which one is it? Which one are you going for? And what would be "cutting corners"?

How long do you think it would take to populate a database of responses to 400 people to limited questions on improvement to their tinnitus and to provide preliminary feedback?

What does publication in a medical journal have to do with that feedback?

 

Did they say which summer? hehe

 

Well, it is kinda bad considering all those "almost market ready" posts back in October. That "almost" turns out to be 1 or 2 years' time lol.

 

To DimLeb: Thanks very much for the updates.

The actual posting date for Auricle's "Almost Ready For Commercial Release" Announcement was September 7, 2021.

Since more than 7 months have already elapsed, who jumped the gun (and why) regarding this obviously premature release? Is this a classic organizational snafu where the left hand does not know what the right hand is doing?

Since our Chicago Tribune's Article about this on 01/2018, I have had mounting concerns about whether these people actually know what they are doing at all.

 

Results in summer is new.

Well, publication is one thing, yes that takes time. But data analysis/early results is another!

 

Any idea why they have to unblind at a later date (i.e. any later than the next day)? I do find it disappointing how cagey she is.

Can the quant analysts here offer to help the team with compiling the data before 2023?

 

How disappointing. The reasons for all of these delays she presents could well push this into 2024 (or who knows for how long? After all, so much of this is "out of her control").

What do we know about how effective this has been? How many have had their tinnitus completely eliminated
because of this treatment?

Is it time to give up on her the way we did on Lenire?

Who would like to bet me that when we have a new President this will still be unavailable?

 

Hey, before I get any hopes up in Germany, with a possible game changer coming out to those of you in the USA.

How much later will the device be available in Europe (as long as we are not conquered by Putin haha)? Can I buy it from someone here (for triple the price)?

I will try and pay for everything. Until then, I will continue to sleep about 3-4 hours a night, be unable to work and have headphones with masking sounds on all day long.

 

I guess I see a bit of a disconnect, here. There almost seem to be two paths: academia and commerce.

On the one hand, I know that Dr. Shore needs to build credibility for her product in the academic circles, hence the research and rigorous review via journals and publications.

On the other hand, she is part of a new company, Auricle, which reportedly has some $14 million in funding, and is looking to get this product FDA-approved and into the hands of audiologists, who would then cascade the device to tinnitus sufferers, like us. They make money, we have less tinnitus.

Does the FDA need the write-ups from journals and publications to fast-track this product and get it approved? They moved heaven and earth to get COVID-19 vaccines approved (obviously a different magnitude), so why the long process?

 

I can't believe she is now talking about 2023.

Publish a preprint as soon as you have done the unblinding, bloody hell. This should take a couple months, maybe three. Then submit and the peer review and the journal paper can come much later. Start approval application and commercialization yesterday, based on the preprint.

There are people suicidal. Some died recently. How long have you been working on this? Ok, you want to be thorough, ok, you don't want to do a Lenire, but in a few weeks you will know if it worked or not. Dr. Shore... everything has been so slow... people are dying... so sad...

Zzzzzzzz

 

I guess we shoulda known that even the results would take a long time since the whole project started like a decade ago, right? So each step of this moves ultra, ultra slow. Hopefully after 10 years of hard work and all that money, it’s a success.

 

Let’s face it. We aren’t going to know anything until at least the end of next year. Results must not be that spectacular or she would be pushing a little faster to cash in. I have been a big believer in Dr. Shore’s work, but at this point she is turning into a joke...

 

Let me provide some optimism to those feeling weary. I wouldn’t bank on the results being bad just yet. There’s just as much chance in them being good or even great. I don’t think her speed is being influenced by the results.

This taking a long time is totally consistent and in character with Dr. Shore’s performance thus far. The project has been in development for almost a decade now, I believe.

I think she’s taking her time to make sure this will have the best chance of being successful. She’s put 10 years of work into this, so there’s a lot of time and money invested in it. She’s not about to hurry the process now, when it’s entering the most critical stages of its being. Especially with all the money—past, present, and future—that’s on-the-line with this. This is perhaps her life’s work at this point; her magnum opus or mark she hopes to make in the medical community. If the results were great, she’s especially not about to start rushing things.

And she’s also in no hurry because she’s not the one suffering. There’s not that sense of urgency to get this thing up-and-running. If she had debilitating tinnitus herself, this thing might’ve been on the market years ago.

Only the true sufferers feel desperate and count the minutes. We’re at the mercy of those who are healthy (the docs and specialists). And so often, they can’t totally empathize or relate to us. That’s why so many people have bad experiences with doctors when it comes to this condition. They have no idea what true hell is and the absolute despair that accompanies it, and they just don’t realize how much their invention is a lifeboat to someone going down with the ship. Suicide is not on their minds.

 

Totally, F-u-T.

I wish I had made that comment about this becoming a joke, especially given that carrot-in-front-of-a-stick 09/07/21 notice about how this was nearly ready for release.

A question from a non-scientific prole: How is it that in spite of disappointing results Lenire is now available throughout Europe and in their preparation for upcoming USA release has established a headquarters in Oakbrook, IL? (Which, BTW, is not far from me). How have Neuromod been able to move this so much faster and not be hampered by what Dr. Shore cites as various difficulties?

 

I think Neuromod is grasping at straws. I spoke with an audiologist in Boston who was going to do a trial of Lenire with 10 patients, this winter, and right before the trial was supposed to start, Neuromod canceled it.

I got the vibe from him that the device is "not ready for prime time," so to speak... will it ever be?

 

The project has been in development for almost a decade but I do remember statements made around the original press/research paper release (although I can't find those right now) that said their current work was building on 15 years of research. So we're probably looking at more like a quarter of a century of research in this particular field of specialty.

@DaveFromChicago, regarding Lenire and Neuromod I think it's just a simple case of venture capital pushing for a ROI. Neuromod has also quietly shifted the goalpost regarding Lenire's clinical end use it would seem in as much as I understand they're now offering it up to be used in conjunction with TRT/CBT (one way of getting round not controlling for placebo I suppose).

A general observation I would make: from what I can see, a tenured professor like Susan Shore (Thanos Tzounopoulos is another one) has no real obligation to the clinical end user in this situation. I'd suggest their obligation is to the university and various co-financers whose real currency is data. Someone like Susan Shore has undoubtedly generated a vast amount of data for her university etc on this DCN subject over the years so in that respect I'd suggest she's already given them back more than enough value. Where that leaves us is moot, however.

Personally I'm still holding out for Susan Shore (maybe another year), FX-322 (although Frequency Therapeutics have recently reduced the size of their workforce by about 30% I believe, which doesn't bode well), and XEN1101 off-label use. If none of these interventions become available or work, I've resigned myself to throwing in the towel. In fact I've already started looking into alternative treatments, which actually don't sound that alernative given that other big players in the mainstream field like Dirk de Ridder think it's OK to munch on handfulls of horse tranquiliser whilst he shoots his ray gun at our heads.

 

Dave, you keep on referring to this article, who was quoted saying that it was about to be ready for release? Dr. Shore, or someone associated with her? It doesn't seem her style or anything like what I've heard her say.

Are you sure it wasn't just a "reporter" trying to make their article more click bait worthy? I'm just wondering if your frustration should be placed with the journalist, not with Dr. Shore et al.

I do a lot of work with the press and I can tell you it is a PITA because they frequently get the information wrong or take a different angle than what you are actually saying,

 

Thanks very much, UKBloke: What exactly do you mean by "horse tranquilisers and ray guns?"

And also, thanks very much, Bruce NH USA for that revealing report. Copping out of any sort of Clinical Trial can only mean one thing.

Look, all of this is so unfortunately reminiscent of my terribly frustrating, ill-fated experience with that useless Desyncra.

Regarding the effectiveness of these external treatments, I recall Saul Bellow quoting an old Jewish proverb:

"Call me Ikey, call me Moe,
What's it to Me,
Where's the Dough?"

Should I check back on 04/13/2024 to see if there has been any increment of forward movement? I'm going to be 68 next month, and I no longer have a vast storage of time.

This is also very similar to my experience with Migraines; all of the external treatments (such as Acupuncture, Massage, Heating Pads, etc.) were all too topical and superficial to penetrate into and shrink the dilated blood vessels that put pressure on the nerves. The drug Maxalt did exactly that; you know how when a drug really works you can just feel it's impact without all the second guessing and self-imposed gaslighting that goes with placebos.

I still believe that it will have to be a drug that remedies this.

 

Dirk De Ridder Explores Ketamine and HD Transcranial Infraslow Pink Noise Stimulation (HD-tIPNS)

 

Let's face it. Dr. Susan Shore is 103 years old. Does she even know what is going on? She should run in the next Presidential election.

She started with her tinnitus research way before Elon Musk started building rockets. There is a video on YouTube where she presents her research. It's from 2010. 12 years for f*** sake!

She is the face of the research so the anger goes at her. Though certainly it is mostly the corrupted academia environment that is behind all those delays.

@DaveFromChicago - you may come back to have a look at the progress when you are 70. I assure you there will only be new reasons for delays.

Susan E. Shore - Saturday Morning Physics -...

 

Dave is probably referring to the news from last fall. Auricle CEO said the device is nearly market ready in this video:

Auricle 2 min 2021 Rosenman Innovator Demo Day...

Nearly can be up for interpretation. It can mean a few years.