New University of Michigan Tinnitus Discovery — Signal Timing

Am I reading it right that she insists the peer review preceeds the FDA submission? This will waste a lot of time. Put the results in a bloody preprint, as many researchers do, especially those funded by grants coming from taxpayer money, and submit that to the FDA, and then in parallel submit to a journal for peer review.

 

Why do professionals talk such nonsense?

 

Has this research been part taxpayer funded?

 

That the previous end date was April until yesterday.

 

I'm sorry to say this but, at this point, if De Ridder came out earlier than Shore with a device that works and stole her market it would be poetic justice. I don't think he can be that fast, though, and to commercialize it in the US he would need to engage the FDA. However, if the device is almost ready and he doesn't care about a journal publication before the approval, he could beat Shore even in the US in terms of timing, as journal publications can take years in the worst cases.

I have nothing against Shore as a scientist, I think she is excellent and a true scholar, but her continued delays and especially her obsession with the journal publication preceeding the FDA approval could cost us dearly and there is really no need for it. Once you unblind the data you know if the trial was successful or not. Seriously, if a journal were to reject her work or criticized heavily her work, requiring a major revision, would she re-do the trial from scratch? You cannot do a major revision of the trial, only of the article. This journal thing is madness. Do a write-up for the FDA and deal with the journal separately, in parallel. There must be a way to do this. This happens in other areas of science all the time.

 

She has received government grants. Medicine is not my field, but I think you can see some of her grants here.

I believe this one should be specific to the science behind the device.

 

Our dear reputable scientists don’t seem to realize (or care) that people are taking their lives over tinnitus. F**k reputation, give us a cure.

 

Don't think he can beat her for an FDA approval but 100% he will be faster to start treatments in Europe than Auricle. Remember that in the EU, without any required approval, he can theoretically start tomorrow with compassionate use if he has a number of devices to use. No trials needed. Just like he provides/provided all kind of other experimental, non-"approved" treatments.

 

This is why YOU GUYS SHOULD HAVE STOPPED BOTHERING THEM. I knew this was going to happen. Trust me, if they wanted us to know they would have let us known.

I know it's hard, I know it's life and DEATH. Trust me I know my brothers and sisters, but this is just one of those things where we must charge it to the game. They got us all in the palm of their hands.

I mean how hard is it for her or her team to simply say "FOR SOME THIS WILL BE WORTH THE WAIT", that would mean the world, but it's her right to do what she wants. My anger isn't towards her but to our government, the ATA & Pawel Jastreboff. But that's for another topic. The point is we shouldn't have to solely rely on Susan Shore. She should be one of many researchers close to curing tinnitus with this particular method.

Sadly it's either their way or no way. So sit back, grab a hearing aid, masker, pills, etc and I guess we wait it out another 400 decades lol...

 

Not sure where this comes from. The FDA process and the academic process proceed in parallel, but the FDA process determines when information can be disclosed and published. I think this research has preceded remarkably on schedule considering the challenges COVID-19 presented for clinical trials. Of course, we all would've liked a treatment a long time ago. Dr. Shore is commenting on the scientific process and the Auricle CEO is talking about the commercialization process. They are working in tandem.

Please explain, otherwise it seems like just name calling.

 

That is not name calling. I did not call Dr. Shore a "name".

This is an empty statement. This states nothing about requirements to publish in a medical journal (or the constraints to which Dr. Shore refers). I strongly suspect that there is no such requirement. This is simply a statement of intention. It provides zero information of value to the public around delay in publishing results. It is a non-sequitur.

@Chinmoku has covered it all.

 

Tinnitus Talk members regarding Lenire: absolute BS, their studies are not based on real science and strong clinical trials, they just wanted to rush this to market!

Tinnitus Talk members regarding Auricle: it’s absolute BS that Michigan is doing proper clinical trials, they need to rush this to market.

 

I felt it was a sort of, enough inquiries already, shut up.

 

Do you mean the "first" and "second" in the statement are not meant as a temporal and/or priority order? Jointly with her previous emails and the CEO one (super-evasive) this was my impression.

Are you saying the FDA process and the journal submission will proceed in parallel?

I am fine with the clinical trial being rigorous. We don't want another Lenire. But once it's finished, there is no reason to delay the process. There are people who can't go on much longer.

To those who say they have no obligations, I say the research has been funded by government research grants (I provided the links above) which is basically taxpayer money. It would be nice of Dr. Shore to show that perhaps it's more urgent and relevant to make this treatment accessible to people as soon as technically possible, once the trial is over, rather than being primarily concerned ("First") with a prestigious journal publication.

The peer review cannot lead to an improved trial, so there is no reason to prioritize the journal publication ("First"), considering it more important than the rest.

 

But it really does not matter what you think. Or are you going to send an email to change her mind, when she just asked to STFU and let her work? Even if she could have done it your way (I'm not sure about that), she and Jon Pearson have decided on a different approach. Respect that and be grateful someone wants to research and treat this torture. Some of it being paid for by taxpayer money has zero relevance, it's not like she's doing anything untoward. I feel bad for her honestly. The self-righteousness...

 

Perhaps it does not matter to you, but it can make a life/death difference to other people. You are the one who started the VAD thread, of all people you should know the urgency of this.

I'm not bombarding Shore with emails. I didn't send her a single one. You know nothing of me, of my background and of what I know. And certainly you are not going to tell me what I can and cannot say. If you see self-righteousness here that says more about you than me.

And you may not care how the taxes one pays are prioritized. Fine. You are entitled to your opinion. It matters to me.

 

Perhaps this would be helpful. There is a big misunderstanding here of how this all works. TL;DR: it's a comprehensive and timely process. The FDA is very rigorous and statements like "but once it's finished, there is no reason to delay the process. There are people who can't go on much longer." are, unfortunately, not how the process works. Let's all try to stay positive and supportive here.

How Long Does the FDA Medical Device Approval Process Take?

How Long Does it Take the FDA to Approve a Medical Device?

 

Tell that to Lenire "disimprovers", assuming they are still alive.

 

Yeah, kind of like fusion where no matter what year it is, it's always going to roll out 20 years in the future.

 

I remember similar sentiments about team-Neuromod vs. team-Shore prior to Lenire's release with many jumping on the Neuromod bandwagon based on them seeming to move at lightspeed vs. Shore's snail's pace and we saw how that one turned out.

I understand the emotions involved in but just because one treatment is racing ahead of another doesn't mean it's going to work. Just as a working treatment that isn't released is useless, a non-working treatment that comes out is equally useless.

Poetic justice can be served only if something comes out first which actually works.

 

Thank you for this. Medicine is not my field, as I said. I will read this. However, I feel some points I made on the priority in their press release and on the vagueness of their emails and press release still stand. And if the FDA is so rigorous, how is it that they approved devices like DeSyncra? This is totally at odds with this great rigor you mention, unless they have strongly tightened their criteria since then. But I'll read the documents.

 

Yeah, my statement was subordinated on De Ridder having his own clinical trial in TU Delft and having made things rigorously. I don't think that will be fast enough to overtake Shore.

 

So I guess we are looking at a Class 3 device, so 7-8 months for approval.

 

I send my tax dollars in to a lot of things. Guess what, I hardly get what I want out of it. It doesn't make me happy, I complain, but I don't think I own the process, or am owed something to which I know nothing or very little about, namely medicine.

I would have like to have seen a cure for cancer, which we have spent zillions of taxpayer $$ on. We have some treatments, but we don't have an overall cure. I don't demand from anyone they need to speed that up, yet every second someone is dying of it.

Maybe the problem is you just think she is lazy, or milking it. I don't think so but that is my opinion. If anything, she didn't have enough resources. You can get all the government grants you want. Maybe if she had more money it would have happened quicker. I worked for a non-profit. If only we had enough money, we could have done more, quicker.

Talk to your state rep or senator and tell them to get on her case if you think she is lazy or doesn't care. Check that - please do not do that.

 

No one here is clearly paying attention to the new Alzheimer’s drug. The FDA approved the drug but apparently corners were cut. Now patients can’t even obtain the drug and insurance companies won’t cover it. It costs $56,000 without insurance.

This may explain why Dr. Shore and her lab want to be diligent.

 

@AfroSnowman, I agree it's most likely a Class III device but do we have any official confirmation of this?

This and the adjacent pages are the official pages of the FDA for premarket approval of Class III medical devices. They go into plenty of details but don't provide average time estimates as opposed to the more informal articles provided earlier.

For context, DeSyncra had a study showing efficacy over placebo and the FDA approved it as a Class II device but the company website is now dead (for sale), so it looks like it doesn't really work for many cases. Also, DeSyncra was a sound therapy device whereas Shore's device acts also on nerves, so it's most likely Class III.

Eight months then, or longer, depending on when they start the process and on how many clarifications requests the FDA will send. For these requests, if I understand correctly, Auricle has 180 days max to respond. Then the commercialization. It will take a while, let's hope that at least they start the process soon.

 

I assume you are talking to me (there is a quote button). Please don't put words in my mouth. I never said she is milking it. I take exception to the vagueness of their statements and to the priorities in those statements. And I brought up the government funding to point out they are not exempted from enquiries. Does this mean they have to satisfy every whim of every taxpayer? Of course not, but the opposite attitude of not caring at all because cancer etc would lead you to a slippery slope where any discussion on how public money is spent should be censored. I don't think that's a good idea. And I'm not saying, and never said, that they haven't worked hard or diligently. They have. Shore is a top scholar. It's just that their communications are poor, vague and not informative enough to the public who funded them. And finally, possibly, they could move faster to initiate the FDA process, although this is not completely clear due to the vagueness of their statements.

 

@Chinmoku, I believe all groups are pleased with results.

Certain compliance such as safety and effectiveness with 510(k) needs final legal documentation before FDA submission. So, with this, a quiet period (I hate this term) is not unusual.

Regulatory stakeholders will have all sorts of discussion and meetings just before FDA submission.

Hug.

 

Didn't De Ridder question Dr. Shore's approach for improving tinnitus? If Lenire got approved in the US, then De Ridder could piggy back off that to get faster approval. It is easier to get devices approved once another one has, that is "close" to an already approved device.

 

I was reading about 510(k), Greg. It looks like after the quiet phase there will be some back and forth on possible technical questions with a 180 days response limit. Who knows when this will hit the market, let's hope soon for all extreme sufferers. A big hug, my friend.