New University of Michigan Tinnitus Discovery — Signal Timing

[Chinmoku]

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'm still trying to read the FDA documentation. It's very hard with this scream from hell in my ears, sleep deprivation and 24/7 torture make it very hard. I think for all parts concerned De Ridder should complete a clinical trial first, especially for a Class III device. He has one going on in Delft, apparently. Then probably, as you say, the fact that similar bimodal neuromodulation devices would have been approved earlier could simplify some aspects of the FDA approval process, but if the clinical trial results weren't good enough it would be kind of pointless. So it all really boils down to how good the Delft trial results will be. Also, I don't know how long De Ridder has been working consistently on bimodal neuromodulation. Shore has been working consistently on it for a long time.

 

[kingsfan]

Simply hearing positive results is all I am concerned with at the moment. I feel that knowing it is effective may be enough to keep myself and others hanging on through the process of FDA approval. But this waiting for journal publication nonsense leaves a sour taste in my mouth when the results are right in front of them. If she really is in this to help suffering, and it isn't just some academic flex, why not throw us a bone?

 

[ploughna]

Simply hearing positive results is all I am concerned with at the moment. I feel that knowing it is effective may be enough to keep myself and others hanging on through the process of FDA approval. But this waiting for journal publication nonsense leaves a sour taste in my mouth when the results are right in front of them. If she really is in this to help suffering, and it isn't just some academic flex, why not throw us a bone?

Where are the 100s of people that took part I wonder - all sworn to secrecy I assume! But I agree, the waiting game can be tough to take. I just try not to think about it and deal with it myself as best I can.

 

[Gb3]

If she really is in this to help suffering, and it isn't just some academic flex, why not throw us a bone?

She responded to this in her email update. She can't. What is so hard to understand about that.

 

[kingsfan]

She responded to this in her email update. She can't. What is so hard to understand about that.

Many things are hard to understand when your head is screaming at you.

 

[Padraigh Griffin]

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.

De Ridder questioned to me what happens when the treatment ends with the Shore device? I was like thinking 'you just keep using it' but I didn't answer like that to the Professor. I have a Zoom with the Professor coming up and will discuss research the best I can.

 

[Tomas80]

Do you know what I think? If a person's tinnitus worsened during testing the device, their anger would be stronger than a non-disclosure agreement and they would complain under a pseudonym. No complaints yet, so at least I believe we will not risk aggravation of our tinnitus. Or?

 

[DebInAustralia]

Sorry if it is obvious, but is Dr. Shore's trial now due to end in July?

 

[UHPTS]

Sorry if it is obvious, but is Dr. Shore's trial now due to end in July?

July what year?

 

[Chinmoku]

Sorry if it is obvious, but is Dr. Shore's trial now due to end in July?

That's what I understood to be the new expected end date. Emphasis on expected.

 

[DaveFromChicago]

Should we all pitch in with donations so that I can retain a Private Investigator (and as an Insurance Adjuster I know of a really good one, like Jack Nicholson in "Chinatown") to visit Ann Arbor, MI and see if he can persuade some of these participants (were there actually 400?) to divulge their experiences with this?

This PI is one of those people who can chat up a person and within 10 minutes have him/her giving out phone numbers, physical and e-mail addresses, names of relatives, etc. Perhaps he could even work his methods on Dr. Shore to get real answers.

Just kidding; I dread the legal ramifications that could be cited against me if I really did this.

 

[TomBradyGOAT]

De Ridder questioned to me what happens when the treatment ends with the Shore device? I was like thinking 'you just keep using it' but I didn't answer like that to the Professor. I have a Zoom with the Professor coming up and will discuss research the best I can.

Who says the treatment ends? Diabetics will always take insulin.

 

[Chinmoku]

Should we all pitch in with donations so that I can retain a Private Investigator (and as an Insurance Adjuster I know of a really good one, like Jack Nicholson in "Chinatown") to visit Ann Arbor, MI and see if he can persuade some of these participants (were there actually 400?) to divulge their experiences with this?

Private Investigation
(refashioned after Dire Straits)

It's a mystery to me
The game commences
For the usual fee
Plus expenses
Confidential information
It's in a trial
This is my investigation
For the suicidal

I go checking out the reports
Digging up the dirt
You get to meet all sorts
In this line of work
Delay and procrastination
There's always an excuse for it
I read FDA documentation
And I still can't get used to it

And what have you got
At the end of the day?
What have you got
To take away?
A bottle of benzos
And a new set of fears
Blinds on a window
And a scream inside the ears

Scarred for life
No compensation
Private investigations

Original song (hyperacusis/noxacusis people be careful)

 

[Bruce NH USA]

Private Investigation
(refashioned after Dire Straits)

It's a mystery to me
The game commences
For the usual fee
Plus expenses
Confidential information
It's in a trial
This is my investigation
For the suicidal

I go checking out the reports
Digging up the dirt
You get to meet all sorts
In this line of work
Delay and procrastination
There's always an excuse for it
I read FDA documentation
And I still can't get used to it

And what have you got
At the end of the day?
What have you got
To take away?
A bottle of benzos
And a new set of fears
Blinds on a window
And a scream inside the ears

Scarred for life
No compensation
Private investigations

Original song (hyperacusis/noxacusis people be careful)

Brilliant!

 

[Padraigh Griffin]

Who says the treatment ends? Diabetics will always take insulin.

Yep. My point exactly but I am just saying what Professor De Ridder said to me. I have a Zoom again in 6 days. I will mention it again.

 

[InNeedOfHelp]

A new preprint from Dr. Susan Shore on synapse cells:

Inner hair cell synapse density influences auditory processing (PDF)

 

[IntotheBlue03]

Hi all,

Hate to bother everyone but very much struggling still between my severe visual issues and spiking tinnitus currently.

Can anyone advise where we are with Dr. Shore timeline wise?

 

[Uklawyer]

Can anyone advise where we are with Dr. Shore timeline wise?

@IntotheBlue03, not very far, unfortunately. The gist of it is: it will be done when it's done. Apparently, they want to take their time and not rush anything because they are professionals. They have to fully unblind and then present the results in a recognised medical journal. Until then, we are not permitted to know the results.

Hang on in there.

 

[DebInAustralia]

@IntotheBlue03, not very far, unfortunately. The gist of it is: it will be done when it's done. Apparently, they want to take their time and not rush anything because they are professionals. They have to fully unblind and then present the results in a recognised medical journal. Until then, we are not permitted to know the results.

Hang on in there.

A friend reached out to Dr. Shore about the trial ending in July. This is what she responded:

It is mostly concluded. We are just awaiting some final documents to be returned.

Best wishes,
Susan

 

[IntotheBlue03]

@IntotheBlue03, not very far, unfortunately. The gist of it is: it will be done when it's done. Apparently, they want to take their time and not rush anything because they are professionals. They have to fully unblind and then present the results in a recognised medical journal. Until then, we are not permitted to know the results.

Hang on in there.

Hey @Uklawyer,

Nice to hear from you. Are the rumors true that they won't be releasing the preliminary results until after the peer review? Guessing that could land us in 2023.

 

[InNeedOfHelp]

Decreasing dorsal cochlear nucleus activity ameliorates noise-induced tinnitus perception in mice

More fresh evidence targeting the DCN has effect.

They are actually using a chemical compound hM4Di-DREADDs without any other form of stimulating. Not sure if this is available in pill form.

Update:

The compound used is clozapine-N-oxide, not sure if this is more or less the same as Clozapine.

 

[Uklawyer]

Are the rumors true that they won't be releasing the preliminary results until after the peer review? Guessing that could land us in 2023.

Apparently, there will not be any "preliminary results" - just final results.

@ajc posted the following response from Dr. Shore:

"Sharing Results from the Second Human Trial

We understand the desire to know results as soon as possible, but the release of clinical-trial results is constrained. First, as reputable scientists, we will publish the findings in a relevant journal after proper peer review. Second, regulatory agencies (e.g., FDA, NIH) are careful in their reviews of novel therapies, as they should be, so all of us must be patient."​

I have no idea how long that could take, nor why this process must be followed

 

[IntotheBlue03]

Apparently, there will not be any "preliminary results" - just final results.

@ajc posted the following response from Dr. Shore:

"Sharing Results from the Second Human Trial

We understand the desire to know results as soon as possible, but the release of clinical-trial results is constrained. First, as reputable scientists, we will publish the findings in a relevant journal after proper peer review. Second, regulatory agencies (e.g., FDA, NIH) are careful in their reviews of novel therapies, as they should be, so all of us must be patient."​

I have no idea how long that could take, nor why this process must be followed

Thanks @Uklawyer. I am quite disappointed in this as I don't see why the two can't be decoupled on separate tracks (FDA and peer review). It seems more knowledgeable people than me have confirmed this as a possible avenue in the past. At this rate I don't even know if I will be alive to hear about the results. I really hope Dr. Shore isn't taking this route to save face because the results aren't good. I can't wrap my mind around the rush to commercialize and then this slow walking at the end of the study. As other people have said, it would be great to have confirmed good results to look forward to.

 

[InNeedOfHelp]

Apparently, there will not be any "preliminary results" - just final results.

@ajc posted the following response from Dr. Shore:

"Sharing Results from the Second Human Trial

We understand the desire to know results as soon as possible, but the release of clinical-trial results is constrained. First, as reputable scientists, we will publish the findings in a relevant journal after proper peer review. Second, regulatory agencies (e.g., FDA, NIH) are careful in their reviews of novel therapies, as they should be, so all of us must be patient."​

I have no idea how long that could take, nor why this process must be followed

Susan Shore co authored a report which is not peer reviewed yet but already available just a week ago, see a few posts above. Yes, it gets published in a journal but it does not say a pre-publication is not made available first.

 

[Ela Stefan]

Apparently, there will not be any "preliminary results" - just final results.

@ajc posted the following response from Dr. Shore:

"Sharing Results from the Second Human Trial

We understand the desire to know results as soon as possible, but the release of clinical-trial results is constrained. First, as reputable scientists, we will publish the findings in a relevant journal after proper peer review. Second, regulatory agencies (e.g., FDA, NIH) are careful in their reviews of novel therapies, as they should be, so all of us must be patient."​

I have no idea how long that could take, nor why this process must be followed

Do you want me to translate the above? 2028 and maybe not even then! Mark my words!

 

[Chinmoku]

Susan Shore co authored a report which is not peer reviewed yet but already available just a week ago, see a few posts above. Yes, it gets published in a journal but it does not say a pre-publication is not made available first.

This is what I was saying from the start, it's what is usually done and I'm glad this is happening here but is the pre-print about the trial? I haven't managed to read it yet under this 24/7 torture. Has anyone checked it?

Do you want me to translate the above? 2028 and maybe not even then! Mark my words!

I won't be here by then. I don't know whether to laugh at all the factors that are keeping this treatment from being made available soon and at the wording of priorities in their totally uninformative communications, including the CEO's, or to cry. I think I'll go for crying.

Depending on how long the quiet phase lasts (3-6 months?), the subsequent 180 days for technical clarifications, the industrialization and distribution, we are looking at a range of 1 year (unrealistically optimistic) - 3 years (moderately pessimistic). So July 2023 to July 2025, hoping for 2024, but it might take even longer than 2025 as you say. I won't make it that long, and with me a few others. It is what it is.

 

[Uklawyer]

This is what I was saying from the start, it's what is usually done and I'm glad this is happening here but is the pre-print about the trial? I haven't managed to read it yet under this 24/7 torture. Has anyone checked it?

No, it is not the pre-print for this trial. Dr. Shore's name is one of 7 on this paper, which studies whether inner hair cell (IHC) synaptopathy leads to hidden hearing loss in mice.

Confused? I certainly am.

 

[Bambam0]

Depending on how long the quiet phase lasts (3-6 months?), the subsequent 180 days for technical clarifications, the industrialization and distribution, we are looking at a range of 1 year (unrealistically optimistic) - 3 years (moderately pessimistic). So July 2023 to July 2025, hoping for 2024, but it might take even longer than 2025 as you say. I won't make it that long, and with me a few others. It is what it is.

At a risk of sounding naive, I have a lot of faith in this operation to quickly scale once results are published. The Auricle, Inc presentation late 2021 was a premature showing of their hand. They wouldn't have started to raise money otherwise.

Assuming they are positive, once results are published I will personally do everything in my power (and I think a lot of folks here will too) short of storming their offices/lab, to get my hands on relief. I will not idly sit by knowing there is an effective treatment to this disaster of a condition just sitting behind red tape. There's way too much on the line.

 

[Chinmoku]

No, it is not the pre-print for this trial. Dr. Shore's name is one of 7 on this paper, which studies whether inner hair cell (IHC) synaptopathy leads to hidden hearing loss in mice.

Confused? I certainly am.

It simply means that either the trial pre-print is not ready (trial ends technically in July) or that Dr. Shore has no intention of putting a trial pre-print out. So what I had hoped hasn't actually happened. Oh well, I kind of gave up on Dr. Shore by now. If something good and fungible comes out of her work, eventually, I'll take it as a pleasant surprise if I will still be around.

 

[TomBradyGOAT]

What is hard is my tinnitus is the ultimate case of somatic. I am getting neck cramps right now and, when it cramps, the tinnitus stops for a second. I can also turn my head so far to the right that it stops, but I am talking like exorcism, turning. Any med that ramps it up, returns to base once I remove the med, like SSRI. So my DCN be all jacked up.