New University of Michigan Tinnitus Discovery — Signal Timing

[Dkellz]

Is no one else concerned about their inability to launch this device?

POV: You're Susan Shore, and you have the first device in history to treat tinnitus. Your inbox is full of people begging for help for years. Every time you walk down the street, someone asks for an update. Desperate people are begging for help 24/7.

Your successful clinical trials began in 2015-2016 (is this accurate?).

It's nearly June 2024, and you haven't even submitted it to the FDA?

Overall, this is either incredible negligence or a sign that something isn't right.

 

[Higo]

Is no one else concerned about their inability to launch this device?

POV: You're Susan Shore, and you have the first device in history to treat tinnitus. Your inbox is full of people begging for help for years. Every time you walk down the street, someone asks for an update. Desperate people are begging for help 24/7.

Your successful clinical trials began in 2015-2016 (is this accurate?).

It's nearly June 2024, and you haven't even submitted it to the FDA?

Overall, this is either incredible negligence or a sign that something isn't right.

I thought it had already been submitted to the FDA, but just waiting on the FDA to accept it?

 

[BlueMoon86]

Yeah, I don't know what's going on with Dr. Shore's device. There has been complete radio silence when it should have been submitted to the FDA already. The clinical trials showed arguably the best results in improving tinnitus aside from Lidocaine and cochlear implants. I have no dog in this fight because I don't think it would help me anyway, but so many people are desperate for this.

 

[Zuben]

Quick question: How many of the trial subjects had had tinnitus for over two years? In short, did they test subjects with chronic tinnitus?

 

[AfroSnowman]

Quick question: How many of the trial subjects had had tinnitus for over two years? In short, did they test subjects with chronic tinnitus?

I don't know the numbers off the top of my head, but I know this was absolutely geared toward people with chronic tinnitus, and I haven't seen or heard of any negative correlation with the length of tinnitus.

 

[Anomalous]

Quick question: How many of the trial subjects had had tinnitus for over two years?

Pretty much all of them. See "tintime" (tinnitus duration), for which the y-axis measures the number of years since tinnitus onset (source).

 

[RunningMan]

I thought it had already been submitted to the FDA, but just waiting on the FDA to accept it?

They had planned to submit to the FDA by the end of the first quarter of 2024, but later, that line was removed from the webpage, as @gameover pointed out earlier in this thread. That could indicate it being delayed, as that was the only thing removed from the page. So, it's best to be patient with this product.

The same thing didn't work for my other tones, though, unfortunately. I am very reactive to residual inhibition. I can play any frequency, and my tinnitus will disappear completely for half a minute.

I get this as well. It works best on my mid-frequency tone, but it will even reduce my louder hissy tinnitus somewhat, but not completely. But once the external tone stops, it returns to baseline in about half a minute.

 

[Joeseph Stope]

I did this when my tinnitus first worsened. I got a new tone at 4.4 kHz, left it alone for nearly year to see if it would go away; it didn't. I started listening to the same tone with my phone under my pillow as I slept. For a month the 4.4 kHz tone kept reducing until it became masked by my usual 6 and 12 kHz tones. I don't notice it anymore at all.

The same thing didn't work for my other tones, though, unfortunately. I am very reactive to residual inhibition. I can play any frequency, and my tinnitus will disappear completely for half a minute.

Very curious or mysterious. I'm on a tinnitus spike once I get hit by a loud/intense noise of the right frequency collection. Hopefully, science will provide a way of viewing -- maybe in the visual sense, perhaps some other way with all the electronic and microscopic inventions -- either the interior of the cochlea if that's where it's at, or in the brain if that's where it's at... or likewise the nerve system. Of course, I know that this is something for the future.

 

[Dizzyhead888]

It appears that for over a decade, Dr. Shore has been leading this alone without any team or help (prior to its commercial partners), and everything is 10x slower.

It's a shame she is working at this pace.

It's a shame that she doesn't provide any timeline updates, whatever type.

I understand confidentiality is important to the process. However, she is well aware there are suicidal cases for whom a timeline alone gives hope and keeps them alive.

 

[Pixelito]

Is no one else concerned about their inability to launch this device?

POV: You're Susan Shore, and you have the first device in history to treat tinnitus. Your inbox is full of people begging for help for years. Every time you walk down the street, someone asks for an update. Desperate people are begging for help 24/7.

Your successful clinical trials began in 2015-2016 (is this accurate?).

It's nearly June 2024, and you haven't even submitted it to the FDA?

Overall, this is either incredible negligence or a sign that something isn't right.

It's possible it's under FDA review as we speak.

It's possible it isn't.

If we don't hear something by the end of this year, then it's probably time to worry.

 

[Fightthearmy]

They had planned to submit to the FDA by the end of the first quarter of 2024, but later, that line was removed from the webpage, as @gameover pointed out earlier in this thread. That could indicate it being delayed, as that was the only thing removed from the page. So, it's best to be patient with this product.

I get this as well. It works best on my mid-frequency tone, but it will even reduce my louder hissy tinnitus somewhat, but not completely. But once the external tone stops, it returns to baseline in about half a minute.

In the medical industry, there are very few reasons to link an actor's external communication with their commitments. At this point, it's equally reliable that Auricle will announce intent to run a new trial (which will last five years) or that they will "temporarily" suspend all activity.

It appears that for over a decade, Dr. Shore has been leading this alone without any team or help (prior to its commercial partners), and everything is 10x slower.

It's a shame she is working at this pace.

It's a shame that she doesn't provide any timeline updates, whatever type.

That's because the timelines aren't reliable. She communicates with Tinnitus Talk every month. If she has no team, who are the numerous authors of the June 2, 2023 publication? Who are Gerilyn R. Jones, AuD; David T. Martel, PhD; Travis L. Riffle, AuD, PhD; Josh Errickson, PhD; Jacqueline R. Souter, AuD; Gregory J. Basura, MD, PhD; Emily Stucken, MD; Kara C. Schvartz-Leyzac, AuD, PhD?

 

[DebInAustralia]

It's possible it's under FDA review as we speak.

It's possible it isn't.

If we don't hear something by the end of this year, then it's probably time to worry.

Either way, most of this thread is speculation. We have no choice but to sit tight and hope we hear something soon.

 

[RunningMan]

In the medical industry, there are very few reasons to link an actor's external communication with their commitments.

Yes, you mentioned earlier in the thread that it would not be submitted to the FDA in Q1. However, the later removal of that line in the article during Q1 confirmed that it wasn't likely to be submitted in Q1 as originally indicated.

I think this is the last we heard from Auricle (Jon Pearson):

https://www.tinnitustalk.com/posts/705315

 

[JimmyStrong]

most of this thread is speculation.

It reminds me of Frequency Therapeutics, lol.

 

[dipp]

That's because the timelines aren't reliable. She communicates with Tinnitus Talk every month.

Hi. Where do you get this from? I would like to know.

 

[Watasha]

Either way, most of this thread is speculation. We have no choice but to sit tight and hope we hear something soon.

I agree 100%, but we are not limited to sitting tight. I'd encourage everyone with the capabilities, time, and resources to find something they can do to advance the cause, whether it's donating to their favorite researcher, writing their political representative, praying for a cure, etc.

 

[Joeseph Stope]

It appears that for over a decade, Dr. Shore has been leading this alone without any team or help (prior to its commercial partners), and everything is 10x slower.

It's a shame she is working at this pace.

It's a shame that she doesn't provide any timeline updates, whatever type.

I understand confidentiality is important to the process. However, she is well aware there are suicidal cases for whom a timeline alone gives hope and keeps them alive.

One big hug to Dr. Shore. It makes things so much easier to bear when one learns of someone who took the care, time, and trouble to fight our corner all those years back. Even if it all doesn't work out, the thought counts—or counts for a lot.

I recall years back, this lady politician showed up to our tinnitus self-help group and made a little talk/speech. It made a big difference (to our little group).

 

[Fightthearmy]

Hi. Where do you get this from? I would like to know.

This thread. Dr. Shore has responded to a lot of emails from Tinnitus Talk members.

 

[Dkellz]

Either way, most of this thread is speculation. We have no choice but to sit tight and hope we hear something soon.

It's not speculation. What I see voiced in this thread are facts.

• Clinical trial results
• Lack of visibility about launch plan
• Lack of communication in general
• Inability to submit to FDA

These are facts.

 

[Bhaveen]

It's not speculation. What I see voiced in this thread are facts.

• Clinical trial results
• Lack of visibility about launch plan
• Lack of communication in general
• Inability to submit to FDA

These are facts.

Well, hold on. Her communication, although we think isn't a lot, is more than Hubert Lim or Lenire. We don't know if they have submitted or not, so it's not fair to say "inability". She also made it clear that she didn't want to share timelines. I think her reasoning for this is that mentioning it would add more speculation and also cause fear of it hampering the process with the FDA. I don't personally agree with this thought process. I think, if anything, it would alleviate fears of knowing things were progressing.

So, I think the time and date comment was removed simply because she didn't want it shared, not because they were running behind. Someone put that comment in the article by mistake. Obviously, we don't know if that comment ever had any credibility in the first place.

 

[UHPTS]

It's not speculation. What I see voiced in this thread are facts.

• Clinical trial results
• Lack of visibility about launch plan
• Lack of communication in general
• Inability to submit to FDA

These are facts.

Now they sit on a patent (I'm not sure, though, what part of that document is an actual patent), unable to move anything forward.

What a waste of time, money, and people's lives.

If they are not competent to move things forward, they should make their findings public. I'm sure there are companies that would make it into a product quickly. After all, the final thing is no rocket science. In fact, it is very simple.

Or there is that other possibility. The device doesn't really work, and they just keep prolonging the time. Susan Shore has managed this for 20 or so years.

 

[Bhaveen]

Or there is that other possibility. The device doesn't really work, and they just keep prolonging the time. Susan Shore has managed this for 20 or so years.

The device doesn't work? Seriously? Is it getting this silly now?

 

[Higo]

Now they sit on a patent (I'm not sure, though, what part of that document is an actual patent), unable to move anything forward.

What a waste of time, money, and people's lives.

If they are not competent to move things forward, they should make their findings public. I'm sure there are companies that would make it into a product quickly. After all, the final thing is no rocket science. In fact, it is very simple.

Or there is that other possibility. The device doesn't really work, and they just keep prolonging the time. Susan Shore has managed this for 20 or so years.

Regardless of how long they're taking, at least they're trying to create something to help us sufferers. Sometimes things take longer than expected; I know it can be frustrating, but at least we have something in sight. They're at the final steps now, so maybe a year or two of waiting to see how this goes. You can't expect them to waste their time and money to allow other companies to profit from their work.

 

[Dkellz]

Well, hold on. Her communication, although we think isn't a lot, is more than Hubert Lim or Lenire. We don't know if they have submitted or not, so it's not fair to say "inability". She also made it clear that she didn't want to share timelines. I think her reasoning for this is that mentioning it would add more speculation and also cause fear of it hampering the process with the FDA. I don't personally agree with this thought process. I think, if anything, it would alleviate fears of knowing things were progressing.

So, I think the time and date comment was removed simply because she didn't want it shared, not because they were running behind. Someone put that comment in the article by mistake. Obviously, we don't know if that comment ever had any credibility in the first place.

I'm not talking about her communication directly; after the clinical trial data release, I assumed she would have had to fulfill some PR.

I'm not impressed by her answers to Tinnitus Talk's questions. They all looked like they were answered by a PR bot.

All in all, it's been a shambles so far.

 

[Cmspgran]

@linearb was in the first clinical trial and stated how well the device worked for him. You can find his posts, and he wasn't the BS type. Two double-blinded clinical trials have proven it to work. What else could Dr. Shore actually do? It really is getting silly.

 

[UHPTS]

Let's not forget that at some point, Susan Shore knew the potential of the device to improve the quality of life for many quite a bit. That didn't matter to her. She first needed to have her article peer-reviewed before doing anything else. Over 20 years of work that solidified in beep, space, zap, larger space, and again... Mindblowing.

 

[Nick47]

Is there any point in continuing the debate here? The information is already available, and Dr. Shore has provided all the necessary details. New members can find answers to their questions by reading through the thread and reviewing the studies with integrity.

 

[slc]

Yes, you mentioned earlier in the thread that it would not be submitted to the FDA in Q1. However, the later removal of that line in the article during Q1 confirmed that it wasn't likely to be submitted in Q1 as originally indicated.

I think this is the last we heard from Auricle (Jon Pearson):

https://www.tinnitustalk.com/posts/705315

The response from Jon Pearson seems hopeful and indicates a clear intent to seek approval. It appears that progress is being made towards clinical availability. They are avoiding the release of partial information about the approval process, which could lead to widespread inaccurate speculation. It seems they are focused on obtaining approval and are likely trying to avoid undermining the FDA approval process by speaking prematurely, as it is not within their control.

 

[Anomalous]

Susan Shore knew the potential of the device to improve the quality of life for many quite a bit. That didn't matter to her. She first needed to have her article peer-reviewed before doing anything else.

 

[Dkellz]

@linearb was in the first clinical trial and stated how well the device worked for him. You can find his posts, and he wasn't the BS type. Two double-blinded clinical trials have proven it to work. What else could Dr. Shore actually do? It really is getting silly.

Wasn't that nearly a decade ago? The clinical trial was limited in numbers. We'll get much more valuable data after the rollout.

They are wasting an incredible amount of valuable time.