New University of Michigan Tinnitus Discovery — Signal Timing

[UHPTS]

Where is this chart from? It is quite incomprehensible. What does active first mean? Control first? Why do columns start at zero? Anyone had zero tinnitus years? Can someone explain in detail what data this chart shows?

 

[Jonno02]

Where is this chart from? It is quite incomprehensible. What does active first mean? Control first? Why do columns start at zero? Anyone had zero tinnitus years? Can someone explain in detail what data this chart shows?

I don't understand why everyone still has such high hopes for this device. After 10 years of development, we still have no relevant data. Only guesses, assumptions, hope. Nothing more.

• Active = treatment
• Control = baseline / no treatment / placebo

A stipulation was chronic tinnitus (6 months) - so this would be zero years.

Why wouldn't we have high hopes? It's a well planned study and from what we've seen, it absolutely works. Of course the devil is in the detail, but compared to anything else, it's definitely the most promising route.

We're far from an injection or tablet to cure tinnitus, but the first real treatment that shows it is possible to reduce, or maybe even in some cases, eliminate tinnitus is groundbreaking. One, we have a treatment. Two, it might get other companies on the wagon.

With the setback regarding Frequency Therapeutics we've all recently read about, let's not take the wind out of people's sails any further until we see the data from the study.

 

[awake 44]

• Active = treatment
• Control = baseline / no treatment / placebo

A stipulation was chronic tinnitus (6 months) - so this would be zero years.

Why wouldn't we have high hopes? It's a well planned study and from what we've seen, it absolutely works. Of course the devil is in the detail, but compared to anything else, it's definitely the most promising route.

We're far from an injection or tablet to cure tinnitus, but the first real treatment that shows it is possible to reduce, or maybe even in some cases, eliminate tinnitus is groundbreaking. One, we have a treatment. Two, it might get other companies on the wagon.

With the setback regarding Frequency Therapeutics we've all recently read about, let's not take the wind out of people's sails any further until we see the data from the study.

Great response for negative attitude.

 

[Nick47]

3) I am skeptical to the fact that patients kept improving during washout (?)

@Markku, I'm not sceptical about this actually! In her literature she talks about long-term plasticity. I think it's likely a delayed effect of cellular changes that take place during active treatment. If it's a whole brain network, then it may take time for other areas to reconfigure after treatment.

All other points seem valid though.

@Tomas80, relax. There is a scale that starts at 0. You can see mean chronicity is around 10 months. Mean TFI 40 etc etc.

Go back through the thread to read the preliminary results. The image is from the Palm Springs Hearing Seminar and supplied to this site by @Markku and @Hazel. I reposted as it seemed to have slipped under the radar, because people keep going on about the starting TFI scores. Well, here are the mean scores. The graph has nothing to do with the results and everything to do with mean baseline characteristics of the participants, based on which group (active/sham) they were originally assigned to.

The preliminary results were good.

There are still plenty of questions in the queue though.

 

[AnthonyMcDonald]

We're far from an injection or tablet

Potassium channel openers already exist. All that has to be done is a trial for tinnitus sufferers.

 

[KoolKat]

Please Susan, don't pull a fast one on us.

 

[Jonno02]

Potassium channel openers already exist. All that has to be done is a trial for tinnitus sufferers.

I'm not clued up about Potassium channel openers. But surely if they were already out there and worked, people would be taking them without a trial?

 

[Markku]

I'm not clued up about Potassium channel openers. But surely if they were already out there and worked, people would be taking them without a trial?

I imagine @AnthonyMcDonald is probably refering to how Trobalt (Retigabine) seemed to help some people's tinnitus but the side effects were too heavy and the drug was withdrawn from market. Now Xenon Pharmaceuticals have a drug called XEN1101 in clinical trials which is touted to have fewer side effects and better efficacy than Trobalt. But it is an epilepsy drug first and foremost, not trialed for tinnitus (even as secondary outcome measure), and would be prescribed off-label for tinnitus. If it reaches the market, I'm sure some people will have it prescribed off-label and we'll have another interesting round of anecdotes to follow.

There's also Prof. Tzounopoulos who is working on his own version, aimed at treating tinnitus (and who we actually have an update to post about soon when @Hazel's reports from the ARO 2023 conference start coming out), but he is not in human trials yet.

This can be continued in here:

• Xenon Pharmaceuticals' XEN1101 — Kv7 Potassium Channel Modulator
• Prof. Thanos Tzounopoulos Receives $2 Million Grant

Let's keep this thread focused on Dr. Shore.

UPDATE: The progress report on Prof. Tzounopoulos' work has been published, → read more.

 

[Roh Jos]

1. When do we expect Dr. Shore to release the Phase 2 clinical trial paper? Does anyone have any expertise on how long publishing a paper and the peer review process takes in this field? What is the best case and worst case scenario for the time it may take?

2. Why haven't any news sites released any articles about the tremendous success that Dr. Shore's device seems to provide? The chart demonstrating a 75% decrease in tinnitus loudness has been out for a while, but I don't see anything online regarding this. It seems like nobody is talking about it outside of this thread.

 

[Nick47]

When do we expect Dr. Shore to release the Phase 2 clinical trial paper? Does anyone have any expertise on how long publishing a paper and the peer review process takes in this field? What is the best case and worst case scenario for the time it may take?

@Roh Jos, max 6 months. It was sent for peer review in the middle of December.

 

[Jonno02]

1. When do we expect Dr. Shore to release the Phase 2 clinical trial paper? Does anyone have any expertise on how long publishing a paper and the peer review process takes in this field? What is the best case and worst case scenario for the time it may take?

2. Why haven't any news sites released any articles about the tremendous success that Dr. Shore's device seems to provide? The chart demonstrating a 75% decrease in tinnitus loudness has been out for a while, but I don't see anything online regarding this. It seems like nobody is talking about it outside of this thread.

1. It depends. each journal is different, but for my publications the peer review was completed between 4-8 weeks. Now it depends if amendments or changes are requested and the extent of these changes. I'd be surprised if it takes longer than 12 weeks for all of the peer reviews to be complete. So we may be seeing results in the next 6-8 weeks.

2. Because there is no 'news' yet, so to speak. I could release a series of graphs on the internet claiming I have achieved "this and that" but without the actual data, nobody can verify it. There's also no product yet. If the device was hitting the shelves next week, there would be a lot of media attention on it. I'd bet that when it comes out, if people on here and the general population are reporting "IT DOES WORK!" it'll gain a huge amount of traction.

Unfortunately right now, it's just a thing we've been told works, but they haven't released the data, publication or device.

 

[dj_newark]

@Roh Jos, max 6 months. It was sent for peer review in the middle of December.

It's not max 6 months. Her saying that it will take 6 months to publish is only an estimate. No one knows for sure how long it will take, not even her! It could take longer, it could be less time.

I asked an academic I know how long he thought it could take to publish a scientific paper and he said "anywhere from one month to one year!"

However, let's hope Dr. Shore is right and that it will only be 6 months since she submitted in early December. I'm personally hoping it will be even less time, however I am trying to manage expectations.

 

[Ryan Scott]

1. It depends. each journal is different, but for my publications the peer review was completed between 4-8 weeks. Now it depends if amendments or changes are requested and the extent of these changes. I'd be surprised if it takes longer than 12 weeks for all of the peer reviews to be complete. So we may be seeing results in the next 6-8 weeks.

2. Because there is no 'news' yet, so to speak. I could release a series of graphs on the internet claiming I have achieved "this and that" but without the actual data, nobody can verify it. There's also no product yet. If the device was hitting the shelves next week, there would be a lot of media attention on it. I'd bet that when it comes out, if people on here and the general population are reporting "IT DOES WORK!" it'll gain a huge amount of traction.

Unfortunately right now, it's just a thing we've been told works, but they haven't released the data, publication or device.

In my opinion, if the device truly does work, then the research publications explaining the correlations to the mechanisms of why it works will be just as important as the device itself. Once you get that breakthrough when developing something novel, it really just starts opening new doors for the future.

 

[PeterPan]

I am skeptical to the fact that patients kept improving during washout (?)

The cynic in me suggests that the closer a product gets to commercialisation, the more untethered the claims become...

 

[Josh59]

Based on reading the most recent messages and, if I understand correctly, the results of Dr Shore's Phase 2 trial will be published around September?

As for the launch of the device, it would happen sometime in 2025-2026?

All of Dr. Shore's work was accompanied by public investment in the United States, am I correct? So when it comes out in the US and Europe, do you think the device will be offered free of charge by the public health services?

Or do you think it will be in the line of Neuromod's Lenire and totally private, so the device needs to be 100% paid for by the patient?

 

[Jonno02]

Based on reading the most recent messages and, if I understand correctly, the results of Dr Shore's Phase 2 trial will be published around September?

As for the launch of the device, it would happen sometime in 2025-2026?

All of Dr. Shore's work was accompanied by public investment in the United States, am I correct? So when it comes out in the US and Europe, do you think the device will be offered free of charge by the public health services?

Or do you think it will be in the line of Neuromod's Lenire and totally private, so the device needs to be 100% paid for by the patient?

I think we'll see the publication before September.

Not a chance it'll take 2-3 years after publication for device launch. Someone else could potentially beat them to market with a copycat of their own device in that timeframe.

Aside from spreading knowledge, a publication means absolutely nothing compared to regulatory approval. I'd seriously hope that the data crunching behind the scenes is going full tilt to get it submission-ready prior to the publication going live. Getting your submission in is 9/10th's of the battle. Optimistically, 6 months later you may have approval.

This would be regarded as a Class 1 medical device by the FDA I think. That's the lowest risk category. Unfortunately it's the first of its kind, so a 510k route isn't possible, it'll be a full-on submission.

For Europe, as this is a medical device in the loosest possible sense, it won't be governed by all of the strict Medical Device Regulations (MDR) implantable devices are, which very much helps us.

If it works, the device should be at a state of immediate manufacturing after approval.

 

[Nick47]

I think we'll see the publication before September.

Not a chance it'll take 2-3 years after publication for device launch. Someone else could potentially beat them to market with a copycat of their own device in that timeframe.

Aside from spreading knowledge, a publication means absolutely nothing compared to regulatory approval. I'd seriously hope that the data crunching behind the scenes is going full tilt to get it submission-ready prior to the publication going live. Getting your submission in is 9/10th's of the battle. Optimistically, 6 months later you may have approval.

This would be regarded as a Class 1 medical device by the FDA I think. That's the lowest risk category. Unfortunately it's the first of its kind, so a 510k route isn't possible, it'll be a full-on submission.

For Europe, as this is a medical device in the loosest possible sense, it won't be governed by all of the strict Medical Device Regulations (MDR) implantable devices are, which very much helps us.

If it works, the device should be at a state of immediate manufacturing after approval.

I think you've nailed it and it's a post worthy of being 'pinned' as it answers a lot of questions frequently asked in a pretty realistic way.

6 months would take us to early June 2023. Depending on what work is being done behind the scenes with the FDA approval, 6 months later would be December 2023. 2024 would be phased rollout across the year to various areas. EU and UK may be easier as we already have the Sono Silentium thing approved and that's Class 2A.

Of course we don't know what is going on behind the scenes and a lot of the approval process may be well advanced already with everything in place to start manufacturing once the final box is ticked. Maybe they know it will be approved in Europe and have already started manufacturing...

 

[Tomas80]

I think you've nailed it and it's a post worthy of being 'pinned' as it answers a lot of questions frequently asked in a pretty realistic way.

6 months would take us to early June 2023. Depending on what work is being done behind the scenes with the FDA approval, 6 months later would be December 2023. 2024 would be phased rollout across the year to various areas. EU and UK may be easier as we already have the Sono Silentium thing approved and that's Class 2A.

Of course we don't know what is going on behind the scenes and a lot of the approval process may be well advanced already with everything in place to start manufacturing once the final box is ticked. Maybe they know it will be approved in Europe and have already started manufacturing...

This is exactly what raises my doubts. Such a serious and significant matter and Auricle is unable to provide the public with an anticipated timetable. Only conjectures, hopes, desires... Incomprehensible.

 

[AnthonyMcDonald]

Auricle is unable to provide the public with an anticipated timetable.

Because they don't want to spread false information, that won't make them look good as a company. Publishing scientific literature, manufacturing, training specialists, etc etc. isn't a fixed process with a certain predictable timetable. There are too many factors to take into account.

They absolutely without a doubt want to get the massive payout from this device hitting the market as soon as possible, just as we want a treatment as soon as possible. It's not like they are purposefully delaying its release.

 

[ajc]

Because they don't want to spread false information, that won't make them look good as a company. Publishing scientific literature, manufacturing, training specialists, etc etc. isn't a fixed process with a certain predictable timetable. There are too many factors to take into account.

They absolutely without a doubt want to get the massive payout from this device hitting the market as soon as possible, just as we want a treatment as soon as possible. It's not like they are purposefully delaying its release.

That's exactly it. Can you imagine if they gave any estimates and they were not met? And God forbid if they gave wrong estimates more than once, @Tomas80 would not be happy about it!

They are doing this the professional way, not like your usual charlatans providing ETAs and hyping things up all the way there with fancy-ass marketing but no substance.

 

[awake 44]

They absolutely without a doubt want to get the massive payout from this device hitting the market as soon as possible, just as we want a treatment as soon as possible. It's not like they are purposefully delaying its release.

They deserve every single dollar that the device will bring, plus I hope they will live long and happily surronded by hookers and tons of crack.

 

[awake 44]

Unfortunately right now, it's just a thing we've been told works, but they haven't released the data, publication or device.

Not true. The outcomes of the 1st trial are already published. So it is not only told, but it has already (at least to some degree) been proven it works.

 

[Champ]

All of Dr. Shore's work was accompanied by public investment in the United States, am I correct? So when it comes out in the US and Europe, do you think the device will be offered free of charge by the public health services?

Or do you think it will be in the line of Neuromod's Lenire and totally private, so the device needs to be 100% paid for by the patient?

I love the optimism but I'd bet a lot of money patients are gonna pay for this.

 

[Nick47]

I have no problem with it being a device that needs paying for, as long as costs are reasonable.

 

[awake 44]

I have no problem with it being a device that needs paying for, as long as costs are reasonable.

I know Polish healthcare system very well. I'm assuming that patients will have to pay for the device for 10 years. After that, our Ministry of Health will make the decision to cover the costs by national healthcare system.

 

[Jonno02]

As an early adopter, I'd be happy to pay a few thousand £. A drop in the ocean compared to the potential relief.

 

[SarahMLFlemmer]

I have no problem with it being a device that needs paying for, as long as costs are reasonable.

I don't mind paying a fortune for it, as long as it works. Do you have great expectations for this device?

 

[Nick47]

Do you have great expectations for this device?

@SarahMLFlemmer, not so much personally due to my unilateral hearing loss but for a chunk of people yes, I do.

 

[Sironketchup]

I'm happy to fly to the US and A if needed to get some proper brain zaps.

If this thing really works, which I only believe if I can feel it myself, let's have a nice party at a very nice location.

A tinnitus-free-party...

 

[Pat Bolton]

@SarahMLFlemmer, not so much personally due to my unilateral hearing loss but for a chunk of people yes, I do.

Why should unilateral hearing loss matter?