New University of Michigan Tinnitus Discovery — Signal Timing

He's probably making $500k a year too and had no clue what tinnitus was 2 years ago. That's why the rich should have the shit taxed out of them. Well maybe not if they are a business owner.

 

which requires the submission of "basic results" for certain clinical trials, generally no later than 1 year after their Completion Date

https://clinicaltrials.gov/ct2/about-site/results

 

Unblinding is being pushed back till next year?

 

Think that's a mistake, @AfroSnowman.

Thanks for asking @DebInAustralia. Sadly, it seems that asking too many questions prompts a generic response of "we cannot answer all these questions and rush things".

I think we simply need to ask (for all the difference it will make) why we cannot see preliminary results of the trial once all the data are in. If we could only see some data, we could then worry about compassionate use, FDA approval etc if those results are promising.

 

I guess I read this as publication in 2023. I would think, knowing nothing about it, that they would unblind as soon as the study is over, because what reason could she have not to?

 

I think the answer was posted previously...

 

Thanks very much for pursuing this as far as you can, @Uklawyer and @AfroSnowman.

Could it be that the reason for the data not being released is quite simply because so far it yields no more than what any placebo trial would produce?

And @Mentos is entirely correct about the content of that reply being utterly without any discernable content. This reminds me so much of the now-you-see-it-now-you-don't tactics employed by Neuromonics, SoundCure, Desyncra, Lenire, etc.

As Hamlet once said, something is quite obviously rotten in the State of Denmark.

 

Deal with it.

Nobody should expect any results before 2023. The sense of entitlement here is mind blowing. These people aren't on your payroll. Do you think they are going to risk regulatory filings (like Jon Pearson said) just to satisfy some of your curiosity? Noooooo.

They want to get the device out even if the results are lackluster. Two years from now we might all be witnessing another Lenire flop. I won't have my hopes up.

 

Tell that to the people who died for lack of a cure because they couldn't stand one more minute of torture. Tell that to those who are living in hell every second of their life and don't have the strength to carry on one more week or month. Sense of entitlement? What the hell are you talking about? What do you think these extreme cases are doing? Drinking beer and playing bridge while being moderately curious about the results? Some of these people have children they can't attend to anymore, families are destroyed. There are people living in hells you don't even imagine. Of course the Auricle and University of Michigan people can care zero about it, but why should we keep silent about it? Please. If that CEO email isn't a masterpiece of corporate @#@#%&-speak I don't know what is. It didn't explain anything. He doesn't owe us any explanation (well unless the research was partly funded with tax money) but then say it clearly you don't care, don't send that masterpiece email. "Deal with it". Sheees.

 

Super possible that will be the case, but that seems a pretty extreme take at this point. I imagine that maybe it has just been unblinded or maybe it is yet to be and will be in a week or two. I'd give her/them a month or two to analyze and understand a study that is likely the culmination of decades of research before making any kind of public comment.

I'll put on my tin foil hat if there is still radio silence through August.

 

Shore's device is not for me, but this is bullshit. Some people are literally on the verge.

 

I’m calling BS on that excuse. Why did Dr. Shore release data on the preliminary trial of 20 people if that would risk regulatory filing/FDA approval? Why did Lenire release papers with results of their multiple trials, but are now in the process of obtaining FDA approval? Lenire is going to be approved by FDA before Shore’s team can even create a spreadsheet to compile data. Entitlement. No. Just don’t believe their exceedingly excuses anymore.

 

I agree entirely with F-u-T.

Would there have been all these delays that have gone on for years if the device had completely eliminated, let's say, 90% of all of the participants' tinnitus?

Or, since I have Migraines, if it were as effective for tinnitus as Maxalt is for Migraines?

 

I propose we all assume that competent people are working diligently and as quickly as possible. It's a better assumption than some of the name calling and wild conjecture. I also think an expert on the FDA approval process would be enlightening for the forum, if one could be found.

In the meantime, let's support each other and stay positive while we wait.

 

Erm, sorry to state the obvious, but the results are the results. 400 people, quantitative feedback using a couple of scales. Essentially all unblinding has been done. Data would have been set out at various points of the study and double-checked. The final data point needed to be completed. Plus unblinding.

I don't see why it has to take until summer for a possible statement on results, nor what the risks are with regulatory filings.

 

To all the people who think this is going to be a cure; it’s not. It’s going to alleviate the symptoms. I think everyone needs to chill out. We aren’t even through April! Even if they had the results and told us they were impressive, it’s not like it would be out tomorrow.

 

Why not do some research into the regulatory process and the risks before assuming they don't exist? Why not assume it's proceeding and hope for the best?

 

Professor Dirk de Ridder doesn’t believe that bimodal stimulation will do anything to tinnitus loudness. Just distress. Maybe all of our hopes were too high. I just listened to the Tinnitus Talk Podcast again.

This shit will not help us at the end. If it comes out 2023 or 2024, it doesn’t matter.

 

We did have an expert on the FDA approval process.

On 01/23/2022 Jason Ranovik (who has a PhD and has published scientific papers) stated the
following as a conclusion to his post:

This is the standard timeline for trials of this type. Check out the very impressive commentary in the rest of his post. He sure seems to know what he is talking about.

There's unfortunately something very worrying that's causing such continual delays into more and more years.

 

Because I cannot be bothered and because, as a lawyer, it makes no sense to me.

 

I've come to expect regular attempts to tone-police from Tinnitus Talk threads such as this.

Critical posts are always followed by tone-policers and the cycle just swirls around endlessly.

 

Thanks @DaveFromChicago for posting @Jason Ranovik's informed and helpful post. I would point out, however, that Jason's expertise is publishing non-medical research. Here we are more concerned with the FDA approval process than peer review publishing. Regardless, it seems to be progressing reasonably on schedule, FDA willing.

 

It's like that on every forum and every social network... It's how humans evolved to communicate...

 

One can research unblinding for a medical device. Mentioned will be that 50% of medical device studies don't detail results. Also mentioned is once a trial is completed, a final electrical shock conclusion needs to be made. Patent use - theirs and others need review. Lots of fine print. Fine print includes exclusions of use. Some exclusions always include vein and artery conditions and hypertension.

One can review the legal processes of electroCore, Inc. which is a commercial stage bioelectronic medicine company, focused on developing non-invasive vagus nerve stimulation therapy (nVNS) platform. nVNS is a platform for bioelectronic medical therapy that modulates neurotransmitters and immune function through its effects on both the peripheral and central nervous systems. The Company is providing gammaCore device for the treatment of cluster headache, drug induced headache and migraine, the acute treatment of migraine and episodic cluster headache. They have FDA approval per headaches and device is on the market.

 

Hmmm... I've heard a different story from Dr. De Ridder in my exchange with him. Interesting.

Be that as it may, we need to take @linearb's word for it that Auricle did have a positive effect on his tinnitus. The results of the first double-blind clinical trial (at most 12 dB decrease in several cases) of this device also make a convincing case in that matter.

 

Wasn't it multimodal stimulation Dr. De Ridder was talking about?

 

Can this gammaCore device be bought and used, if you are in Europe?

 

The TU Delft device and Auricle are both bimodal stimulation devices.

And yeah, he mentioned that he aims to alter the fusiform cell activity in the DCN with the TU Delft device in the same way as Susan Shore's Auricle.

 

Yes.

https://craft.co/electrocore/locations

electroCore has many patents for modulation neurotransmitters and immune function through its effects on both the peripheral and central nervous systems.

gammaCore is similar to that of the University of Michigan device.