New University of Michigan Tinnitus Discovery — Signal Timing

[Jerad]

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.

I don't want to be too overly presumptuous or negative because, like all things with tinnitus, nobody really knows for sure. But my gut feelings have never been super enthused with this device. It may help mild or moderate cases, but I think it's going to take a lot more than just a sound and electrical zapper to help the severe ones; something oral perhaps, like XEN1101, implanted electrodes, or DBS. But maybe I'm wrong. We have to remember that @linearb was helped by Susan Shore's device. So that's a big plus.

The waiting game is torture, especially for those who are suffering severely. When they feel a treatment is their lifeboat on a ship that's sinking, we can certainly understand why. And it's sad because they just want to know if the thing works for most. They don't want to wait another year and find out it doesn't. If they knew it was promising right now, waiting and patience would be easier feats. They'd be uplifted and motivated to endure because they'd finally believe we have something that works. Waiting and not knowing, though, feeds into that hopelessness and doubtfulness that often plagues us. We've seen treatments come and go that promised eternity, but ultimately sucked, like Lenire. We don't want to be burned again.

 

[DebInAustralia]

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.

No. But, it would give people who are really struggling, hope to hang on.

 

[Gb3]

No. But, it would give people who are really struggling, hope to hang on.

Of course but unfortunately they have to be a little patient. People are already on here predicting that the results are bad.

 

[TrevorSanders]

No. But, it would give people who are really struggling, hope to hang on.

Yea. I don't think these companies understand that what they say (or don't say) directly influences whether some people off themselves or not.

 

[Gb3]

Yea. I don't think these companies understand that what they say (or don't say) directly influences whether some people off themselves or not.

Didn't you back out of the OTO-313 trial?

 

[Blix M. Paraglot]

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.

Not just @linearb. Also @kelpiemsp. He was in the Minnesota trial under Dr. Lim (who, granted, hurt his own credibility with some here by later working for Neuromod*).

@kelpiemsp had very loud tinnitus and debilitating hyperacusis. He experienced a big decrease and his hyperacusis improved to the point where his big dog barking indoors didn't bother him. (!)

"Hi all just an update. I received the -15 timing, and I have to say I had the quietest weekend since this spike started. I even took a nap without masking. Anyways, it's slowly coming back, but it's not as loud as before. Plus I have done a few things that should have aggravated it (long bike ride, mowed lawn, saw a concert) This reduction has been 7-10 dB. I am very much looking forward to the next study where I can wear it every day. It might just be my evening peak (it tends to be a bit louder at night) I had my doubts immediately after the trial, but in my experience this plasticity takes time. For what its worth I experienced a couple firsts (since my new spike started) this weekend: sleep without masking, sleep with my ear against a pillow, and got like 3 hours with silence. That was pleasant."​

This was during one of the trials in which @kelpiemsp participated. His tinnitus dropped ~10 dB during the Minnesota clinical trial.

One conclusion from his experiences is that bimodal stimulation must be used regularly to manage tinnitus volume. Tinnitus will come back after being off the treatment, so it must be thought of as a daily part of a routine, like taking insulin. I'm okay with that.

I don't know why Dr. De Ridder has changed his tune (if he has) about bimodal stimulation actually attenuating tinnitus. That is why the technology is being considered in the first place.

*Keep in mind that the Minnesota trial had nothing to do with Lenire. Different device, different protocols.

 

[DebInAustralia]

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.

But he also said Naltrexone (in his paper) would treat distress only... we now know this isn't true (e.g., @Johnny Karate).

 

[DaveFromChicago]

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.

Thanks ever so much for responding to the rank insensitivity contained in that "Deal With It" remark.

"The sense of entitlement is mindblowing?"

Aussie Lea should be reminded that, regarding our 800,000 plus Armed Service people who are on disability because of this, yes in fact the American Government has a real obligation to do everything it can to find an effective treatment.

These kids volunteered to go to two wars in the Middle East and be subjected to the myriad amounts of massive noise that necessarily accompanies a modern wartime situation. (One Example: A Vietnam Vet told me that, even if you were 100 feet away from a 155mm howitzer, when it was fired the sound waves were powerful enough to penetrate your body such that you were completely lifted off your feet).

After what they sacrificed for their Country, they can have a quite legitimate sense of entitlement for finding an effective treatment for a condition that is admittedly invisible but nonetheless a very real wartime injury.

 

[kingsfan]

Not just @linearb. Also @kelpiemsp. He was in the Minnesota trial under Dr. Lim (who, granted, hurt his own credibility with some here by later working for Neuromod*).

@kelpiemsp had very loud tinnitus and debilitating hyperacusis. He experienced a big decrease and his hyperacusis improved to the point where his big dog barking indoors didn't bother him. (!)

"Hi all just an update. I received the -15 timing, and I have to say I had the quietest weekend since this spike started. I even took a nap without masking. Anyways, it's slowly coming back, but it's not as loud as before. Plus I have done a few things that should have aggravated it (long bike ride, mowed lawn, saw a concert) This reduction has been 7-10 dB. I am very much looking forward to the next study where I can wear it every day. It might just be my evening peak (it tends to be a bit louder at night) I had my doubts immediately after the trial, but in my experience this plasticity takes time. For what its worth I experienced a couple firsts (since my new spike started) this weekend: sleep without masking, sleep with my ear against a pillow, and got like 3 hours with silence. That was pleasant."​

This was during one of the trials in which @kelpiemsp participated. His tinnitus dropped ~10 dB during the Minnesota clinical trial.

One conclusion from his experiences is that bimodal stimulation must be used regularly to manage tinnitus volume. Tinnitus will come back after being off the treatment, so it must be thought of as a daily part of a routine, like taking insulin. I'm okay with that.

I don't know why Dr. De Ridder has changed his tune (if he has) about bimodal stimulation actually attenuating tinnitus. That is why the technology is being considered in the first place.

*Keep in mind that the Minnesota trial had nothing to do with Lenire. Different device, different protocols.

What a serious tease to have been in those studies, seen dramatic improvement, only to be left waiting years to have the opportunity to use it again. It doesn't seem right.

 

[Blix M. Paraglot]

What a serious tease to have been in those studies, seen dramatic improvement, only to be left waiting years to have the opportunity to use it again. It doesn't seem right.

And the thing is, the Minnesota clinical trial was getting fantastic results, possibly even better than Dr. Shore's device. But it seems to have gone nowhere after the conclusion of the trial. And Auricle is taking an eternity, in spite of being "almost ready for commercial release" a year ago. Some of us don't have any more eternities left.

 

[Joey72]

Aussie Lea should be reminded that, regarding our 800,000 plus Armed Service people who are on disability because of this, yes in fact the American Government has a real obligation to do everything it can to find an effective treatment.

These kids volunteered to go to two wars in the Middle East and be subjected to the myriad amounts of massive noise that necessarily accompanies a modern wartime situation. (One Example: A Vietnam Vet told me that, even if you were 100 feet away from a 155mm howitzer, when it was fired the sound waves were powerful enough to penetrate your body such that you were completely lifted off your feet).

After what they sacrificed for their Country, they can have a quite legitimate sense of entitlement for finding an effective treatment for a condition that is admittedly invisible but nonetheless a very real wartime injury.

Thanks for reminding people of us vets. Too often we are forgotten.

 

[Greg Sacramento]

I don't know why Dr. De Ridder has changed his tune (if he has) about bimodal stimulation actually attenuating tinnitus. That is why the technology is being considered in the first place.

In the link below, I placed a Dirk De Ridder patent with discussion at the top of page. Notice patent date. You could contact company indicated for research progress. Patent is also listed at bottom of page.

One can view all simulation patents that would be needed for tinnitus and hyperacusis towards bottom of link. Seen will be that electroCore owns most of the patents needed for tinnitus and hyperacusis including trigeminal and vagus nerve therapy.

You can contact electroCore for discussion per the University of Michigan and their accompanied partnerships and a lot will be expressed as confidential. Any comment by me on this would be hearsay. Not sure what is going on - cooperation, legal, either or more. We will know soon. Since electroCore is a public company, public statements are needed. So far, electroCore has FDA approvals for headaches and some other therapies. They have stated that they plan to undertake other therapies, some of which has been specifically noted.

US20060100671A1 - Stimulation of the amygdalohippocampal complex to treat neurological conditions - Google Patents

 

[DebInAustralia]

This is some correspondence I have received from one of Dr. Shore's PhD students (who worked with her during the earlier trials) regarding the situation:

I don't have an inside view, so I can't really say. I also don't know what they meant by market ready or who they said it to: market ready could mean one thing to an investor, another to a regulator, and to a patient something different. I do know that, for example, when we have a blinded study at my current lab, we don't want the people scoring to try to get a sense for which condition is which, that would defeat the purpose of the blinding. So we wouldn't want to have a sense of how things were going until we unblinded.

Not a big deal for hearing aid processing strategies (although we're always antsy), but I can understand how frustrating that is for patients when it's a treatment. We also control all of our data in house, so when we unblind it's a short process. But some larger clinical trials may use a data management company, and I have no idea how that would change the process (or even if that's relevant here). And I really don't know how having a company and something marketable could affect how things are done.

They may need to be especially cautious in what they say to avoid the appearance of impropriety. I read one article that noted there are risks to releasing preliminary results, as it could look like you're trying to manipulate investors or regulators. Again, I don't know if that would be relevant yet or not. So there may be some things going on that make perfect sense with the full picture. I don't know if they're getting questions a bit sooner than expected, the trial is due to wrap up this month (so may not be finished yet), and they may have thought questions would come after. When I looked yesterday, clinical trials still had the study as wrapping up this month, which is a good sign (they ping investigators whenever a deadline approaches, so you have to provide an update).

 

[DebInAustralia]

A friend wrote to Dr. Shore recently. Here is her response:

I am sorry if I mis communicated - yes we are finishing the trial on time but we do have to wait to unblind. We are crafting an email update to send to everyone so that they will understand the publication process and the regulatory process. This will go out soon. Best wishes, Susan Shore

 

[Paul1980]

This is some correspondence I have received from one of Dr. Shore's PhD students (who worked with her during the earlier trials) regarding the situation:

By "market ready" I think he was saying there is a large market of several million users that is out there, and once the product is ready, and proven, there won't be a need to convince people to try it. In other words, it could be a gold mine for an investor.

I don't think he meant anything beyond that, especially that the device is ready to go to market, which it clearly isn't until it goes through the FDA process, which could take who knows how long.

 

[TrevorSanders]

Didn't you back out of the OTO-313 trial?

Yea. I got nervous and decided not to follow through with it. I regret my decision though.

 

[Jason Ranovik]

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.

Thank you for the kind words, but please note that I am not an expert on the FDA approval process, only on the scientific method and publishing in journals. I can guesstimate at dates for results, and I can understand and help interpret those results for everyone else, but I have no idea how long the FDA will take to approve something like this.

I am a scientist, but not of the medical kind

Regarding the delays: I wouldn't worry too much about that. If there were any real problems, or if they had strong reason to believe that the device is not / would not be successful, they would just cancel the trial without completing it and spend the saved money on some other research. More realistically, it's entirely COVID-19-related. The study is 36 weeks long for each participant, and they likely don't have the resources (staff, equipment) to do all 300 participants at once, so they probably staggered them out. What I imagine happened is something like this:

• Originally targeted to finish the study some time in 2020?
• Any of many different issues caused a delay for at least 8 months, pushing to end of 2020 / early 2021
• In early 2020, they were recruiting their final batch of participants
• COVID-19 happened, participants can't travel, clinic shuts down for a year or so?
• Mid-2021, they restart the study, recruit and start their final batch of participants
• 36 weeks for that batch to finish brings us to early 2022

In summary, I must reiterate my main point from the original post: don't take the Phase I results too seriously, don't read too much into the delay of Phase II, and just wait for the Phase II results before deciding to keep or give up hope for this treatment.

As soon as the Phase II results are released or formally published, I will review them and write a comprehensive post going into all the details in a way that is easy for everyone to understand.

 

[Rb86]

The thing is, it's a device. Not sure if it's really crucial to have FDA approval. If it's as good as they claim, many would buy it, and word will travel fast of its efficacy.

 

[AfroSnowman]

The thing is, it's a device. Not sure if it's really crucial to have FDA approval. If it's as good as they claim, many would buy it, and word will travel fast of its efficacy.

FDA approval is only crucial if you want to sell it in the US. Joking aside my understanding is that they still need FDA approval but process is less rigorous than it would be for a drug or an implant.

 

[GlennS]

it's a device. Not sure if it's really crucial to have FDA approval.

 

[Rb86]

View attachment 50086

I'm serious. There are all kinds of supplements being sold - things that are ingested and made to help "_______". They just have to say on the label not approved by the FDA.

Here we have a device. Sure, FDA approval is a large bolstering to their attractiveness but the bottom line is, it either works or it doesn't. As desperate as we the tinnitus community are, we'd buy anything targeted at us, and the first hundred or two people would say this is amazing it's really helping me or this thing isn't doing anything. Make it available and we, the community, will shoot that thing to the stars if it's as good as they claim.

20 years is bullshit now. Shit or get off the pot.

 

[Hottopic29]

I'm serious. There are all kinds of supplements being sold - things that are ingested and made to help "_______". They just have to say on the label not approved by the FDA.

Here we have a device. Sure, FDA approval is a large bolstering to their attractiveness but the bottom line is, it either works or it doesn't. As desperate as we the tinnitus community are, we'd buy anything targeted at us, and the first hundred or two people would say this is amazing it's really helping me or this thing isn't doing anything. Make it available and we, the community, will shoot that thing to the stars if it's as good as they claim.

20 years is bullshit now. Shit or get off the pot.

I think Dr. Shore's device can be approved by the FDA in 6 months once they submit it since it falls under a certain category like a TENS device. It's not a medicine or implantable device that can cause major harm.

 

[prowlinacage]

20 years is bullshit now. Shit or get off the pot.

That's just not how real-deal science works or should work. And Dr. Shore is the real deal. It's been disappointing to read some of the negative speculative comments here regarding the completion of her study and the potential roll-out of the device. I'm as anxious as anyone here to learn whether or not this thing pans out, but the last thing I want is for her and her team to rush anything.

 

[DebInAustralia]

That's just not how real-deal science works or should work. And Dr. Shore is the real deal. It's been disappointing to read some of the negative speculative comments here regarding the completion of her study and the potential roll-out of the device. I'm as anxious as anyone here to learn whether or not this thing pans out, but the last thing I want is for her and her team to rush anything.

I am curious to understand why you would be disappointed to read some of the 'negative speculative comments' regarding the completion of her study and roll out...?

The way I see it is many of us are dangling by a thread. I totally get why people are distressed by the uncertainty.

I think for many here, there is a sense of urgency to getting access to the results and potential roll out because of the level of suffering that is evident here.

I doubt speculation from the tinnitus community is going to influence Dr. Shore's scientific timeline.

 

[SR88]

I am curious to understand why you would be disappointed to read some of the 'negative speculative comments' regarding the completion of her study and roll out...?

Because it just amplifies the frustration and provides no value. For example, the post saying FDA approval is not necessary where just a page or two back the CEO clearly said that FDA approval is driving the process.

There are people that are trying to offer informed guidance or predictions, like Jason, and there are those that are just venting. I would prefer to hear from the former.

 

[Uklawyer]

I doubt speculation from the tinnitus community is going to influence Dr. Shore's scientific timeline.

Indeed. If the results were really positive and a working schedule for approval and availability were provided, we would be massively uplifted.

 

[InNeedOfHelp]

Reversing Synchronized Brain Circuits With Targeted Auditory-Somatosensory Stimulation to Treat Phantom Percepts

Updated April 27

Estimated Primary Completion Date:
July 2022
Estimated Study Completion Date:
July 2022

Bunch of BS. I guess that is the unblinding date if the last patient has already been closed? I guess unblinding is done by a external notary as formality but waiting three bloody months for that is a waste of time. I was in the "good research takes time camp" but this is wasting time and has nothing to do with research.

You bet the TU Delft/Dirk de Ridder will be available much earlier then Auricle. Since EU does not have EMA approval required on this, if there are positive results Dirk de Ridder can start using the device instantly. He is agile and flexible in that sense.

 

[Uklawyer]

Estimated Primary Completion Date:
July 2022
Estimated Study Completion Date:
July 2022

What's the difference?

 

[SR88]

Bunch of BS. I guess that is the unblinding date if the last patient has already been closed? I guess unblinding is done by a external notary as formality but waiting three bloody months for that is a waste of time. I was in the "good research takes time camp" but this is wasting time and has nothing to do with research.

Not at all "BS." It's driven by the FDA approval process as clearly stated in previous posts by the Auricle CEO and other informed forum members. There is every incentive to go as fast as possible.

 

[ajc]

Got this email JUST NOW! HOT OFF THE PRESS!

Greetings to everyone who has requested updates on the tinnitus clinical trial at the University of Michigan.

Given the high volume of inquiries that we receive and our desire to provide a timely and consistent response, we are sending this message to all whom have contacted us.

Clinical Trial Update

After publishing our first human pilot study in 2018, we commenced a second, larger clinical trial. Despite COVID-19 pandemic impacts, the study participants and our staff worked diligently so that the clinical trial could continue. Although our second human trial will conclude shortly, we cannot make those study results public until it is appropriate to do so.

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.

We are dedicated to bringing this novel therapy to the millions of global sufferers of this terrible affliction. As such, we have established a private company (Auricle, Inc.) with the goal of obtaining regulatory clearance to commercialize the treatment.

Please understand that we cannot provide any additional information at this time, so we will not be responding to additional queries for results.

Our very best wishes,
Susan E. Shore, PhD, and The Shore Lab