New University of Michigan Tinnitus Discovery — Signal Timing

[ccm302]

Were there any interviews of the participants other than one sentence responses that it helped them or did not? If it's in this thread, just tell me and I'll go hunting.

 

[AfroSnowman]

Were there any interviews of the participants other than one sentence responses that it helped them or did not? If it's in this thread, just tell me and I'll go hunting.

Do a search for @linearb. He wrote extensively about his experience with the first trial.

 

[Nick47]

She and her colleagues are also working to develop pharmacological manipulations that could enhance stimulus timed plasticity by changing specific molecular targets.

Just read the above from 2013. It seems the pharmacological approach was dropped.

 

[Joeseph Stope]

Just read the above from 2013. It seems the pharmacological approach was dropped.

It's interesting to note that the "tools" or approaches available can be classified as 1) sound therapy, e.g., Lenire, Auricle, Jastreboff, Tomatis, 2) stimulation, e.g., Lenire, Auricle, and 3) pharmaceuticals, e.g., Alprazolam, Lidocaine, Retigabine.

Surgery seems to be dropped -- maybe with good reason.

We're gettin' there... or at least ruling out the stuff that doesn't work

 

[Anuar Lukios]

It's interesting to note that the "tools" or approaches available can be classified as 1) sound therapy, e.g., Lenire, Auricle, Jastreboff, Tomatis, 2) stimulation, e.g., Lenire, Auricle, and 3) pharmaceuticals, e.g., Alprazolam, Lidocaine, Retigabine.

Surgery seems to be dropped -- maybe with good reason.

We're gettin' there... or at least ruling out the stuff that doesn't work

Aside from wanting to cut the auditory nerve decades ago (when research was practically nonexistent), what other surgeries have been proposed (just curious)?

Anyway, now that we've discussed more or less every doubt and have no new information since July, this "silence" is agonizing, haha.

 

[Nick47]

Aside from wanting to cut the auditory nerve decades ago (when research was practically nonexistent), what other surgeries have been proposed (just curious)?

Look under Research News. This thread is for the Michigan device only.

 

[Anuar Lukios]

Look under Research News. This thread is for the Michigan device only.

Thank you, very kind of you but mine was a rhetorical question, no desire to discuss it here in this thread. I know that surgery has been used (or at least considered) for "specific" cases and not as a "definitive" solution for everyone or the majority.

Regarding the Shore device, do you think it could be effective for someone like me who has a "mixed" tinnitus? I have some modulable tones (thus somatic) and others not... I've heard it said that tinnitus is one sound and that's it, so even if only some tones are modulable, it means that my entire tinnitus is somatic, but I don't know if that's true. Please explain

 

[Philip83]

Regarding the Shore device, do you think it could be effective for someone like me who has a "mixed" tinnitus? I have some modulable tones (thus somatic) and others not... I've heard it said that tinnitus is one sound and that's it, so even if only some tones are modulable, it means that my entire tinnitus is somatic, but I don't know if that's true. Please explain

There are quotes further back in this thread where Dr. Shore mentions this and says something in the ballpark of tinnitus being a spectrum and you don't have to hit every single different tone with the device to combat it.

 

[Jonno02]

There are quotes further back in this thread where Dr. Shore mentions this and says something in the ballpark of tinnitus being a spectrum and you don't have to hit every single different tone with the device to combat it.

I SO agree with this. One day I match my main tone at 4910 Hz and the the next day I'm like 'wtf that's way too low, it's 5500 Hz' today. Yet in my head is sounds like the same frequency day to day before I actually check... if that makes sense. I just think it's different frequencies being dominant in my tinnitus spectrum.

Man I can't wait to try this thing. If only to stop myself from going mad, I actually need to laugh at how absurd a condition this is. Why in the name of fuck does our brain create phantom frequencies in our heads.

 

[Philip83]

I SO agree with this. One day I match my main tone at 4910 Hz and the the next day I'm like 'wtf that's way too low, it's 5500 Hz' today. Yet in my head is sounds like the same frequency day to day before I actually check... if that makes sense. I just think it's different frequencies being dominant in my tinnitus spectrum.

Man I can't wait to try this thing. If only to stop myself from going mad, I actually need to laugh at how absurd a condition this is. Why in the name of fuck does our brain create phantom frequencies in our heads.

Yeah, my left ear one goes between a static 3500 Hz to 4500 Hz, while the right ear oscillates constantly between like 900 Hz to 1000 Hz like a police siren. And then of course the main and loudest cicadas-sound covering my head like a cloud. Good times.

 

[gameover]

Why in the name of fuck does our brain create phantom frequencies in our heads.

That's a good question. A much better one, why the f*** nobody talks and warns about it? Why the f*** I know about some stupid cancers, Parkinson's, MS and other awful diseases I can't anything about to protect myself from, but I had no clue about tinnitus and I could do a whole lot about to protect myself from? That's the f***ing good question. But then this is not the right thread to be asking it.

 

[Philip83]

That's a good question. A much better one, why the f*** nobody talks and warns about it? Why the f*** I know about some stupid cancers, Parkinson's, MS and other awful diseases I can't anything about to protect myself from, but I had no clue about tinnitus and I could do a whole lot about to protect myself from? That's the f***ing good question. But then this is not the right thread to be asking it.

Yeah, this is insane actually. I remember seeing a guy on the news with tinnitus before I had it (when I was like 15 or something. I got it at 17) and I was like "fuck, that's the worst condition you could ever get". But as far as I remember, NOTHING was said in the show about that it's 100% PREVENTABLE. It didn't even really convey that it was caused by noise trauma. Truly baffling. And hence my complete lack of ear protection in my teens.

 

[SarahMLFlemmer]

Yeah, this is insane actually. I remember seeing a guy on the news with tinnitus before I had it (when I was like 15 or something. I got it at 17) and I was like "fuck, that's the worst condition you could ever get". But as far as I remember, NOTHING was said in the show about that it's 100% PREVENTABLE. It didn't even really convey that it was caused by noise trauma. Truly baffling. And hence my complete lack of ear protection in my teens.

Truly baffling

 

[DimLeb]

Yeah, this is insane actually. I remember seeing a guy on the news with tinnitus before I had it (when I was like 15 or something. I got it at 17) and I was like "fuck, that's the worst condition you could ever get". But as far as I remember, NOTHING was said in the show about that it's 100% PREVENTABLE. It didn't even really convey that it was caused by noise trauma. Truly baffling. And hence my complete lack of ear protection in my teens.

Yeah well, it's not 100% preventable. I don't want to be that guy, but I think more than 50% of the people with tinnitus, got it suddenly for seemingly no reason (or ear diseases that develop unknowningly). And that's way worse because with a specific noise trauma, at least you know the reason.

But yeah, there should be way way more information and awareness about the consequences of excessive noise and ear health.

 

[Philip83]

Yeah well, it's not 100% preventable. I don't want to be that guy, but I think more than 50% of the people with tinnitus, got it suddenly for seemingly no reason (or ear diseases that develop unknowningly). And that's way worse because with a specific noise trauma, at least you know the reason.

But yeah, there should be way way more information and awareness about the consequences of excessive noise and ear health.

Indeed. I ment to state that I was talking about noise-induced tinnitus specifically.

 

[Dkellz]

While I don't mean to sound pessimistic, my concern centers on the stories I've read about Dr. Shore being inundated with requests for access to her equipment after the trial. It seems that countless individuals afflicted with tinnitus have reached out to her over the years, pleading for relief. Additionally, considering she likely follows Tinnitus Talk, she is more than aware of the global struggle against tinnitus during her extensive research and development phase, yet FDA approval is still pending?

If I were in Dr. Shore's shoes, having had such extensive interaction with those in need, I would be doing everything in my power to expedite the release of this device.

However, there's a thought that perhaps the device's efficacy isn't quite as positive as we think. Could it be possible that delaying its launch to align with another treatment could be strategically more advantageous for Dr. Shore's reputation? Something about this situation seems off to me. Perhaps the device is effective, but it might achieve greater results when combined with another upcoming treatment that's on the cusp of a major breakthrough?

I just can't work out how and why this is taking so long given what Dr. Shore knows about the tinnitus community.

It feels like this is a long way off. I hope I'm wrong and I know we all thank Dr. Shore for her immeasurable contribution to tinnitus research, but I feel that maybe we'll see another treatment released before we get to experience this one which is a major downer in reality.

 

[dj_newark]

There's been an update regarding Dr. Shore's device submission to the FDA. Apparently they're planning a Q1/2024 submission:

→ Medical Device Startup Auricle Celebrates Licensing with Bell-Ringing Celebration

 

[Joshyboy]

While I don't mean to sound pessimistic, my concern centers on the stories I've read about Dr. Shore being inundated with requests for access to her equipment after the trial. It seems that countless individuals afflicted with tinnitus have reached out to her over the years, pleading for relief. Additionally, considering she likely follows Tinnitus Talk, she is more than aware of the global struggle against tinnitus during her extensive research and development phase, yet FDA approval is still pending?

If I were in Dr. Shore's shoes, having had such extensive interaction with those in need, I would be doing everything in my power to expedite the release of this device.

However, there's a thought that perhaps the device's efficacy isn't quite as positive as we think. Could it be possible that delaying its launch to align with another treatment could be strategically more advantageous for Dr. Shore's reputation? Something about this situation seems off to me. Perhaps the device is effective, but it might achieve greater results when combined with another upcoming treatment that's on the cusp of a major breakthrough?

I just can't work out how and why this is taking so long given what Dr. Shore knows about the tinnitus community.

It feels like this is a long way off. I hope I'm wrong and I know we all thank Dr. Shore for her immeasurable contribution to tinnitus research, but I feel that maybe we'll see another treatment released before we get to experience this one which is a major downer in reality.

I couldn't agree more. I also chatted with the CEO & Co-Founder of Auricle and he seemed to have a "not anytime soon" tone. I'm confident in Dr. Shore but the people chosen to move this forward seem to lack a successful track record.

 

[Jonno02]

While I don't mean to sound pessimistic, my concern centers on the stories I've read about Dr. Shore being inundated with requests for access to her equipment after the trial. It seems that countless individuals afflicted with tinnitus have reached out to her over the years, pleading for relief. Additionally, considering she likely follows Tinnitus Talk, she is more than aware of the global struggle against tinnitus during her extensive research and development phase, yet FDA approval is still pending?

If I were in Dr. Shore's shoes, having had such extensive interaction with those in need, I would be doing everything in my power to expedite the release of this device.

However, there's a thought that perhaps the device's efficacy isn't quite as positive as we think. Could it be possible that delaying its launch to align with another treatment could be strategically more advantageous for Dr. Shore's reputation? Something about this situation seems off to me. Perhaps the device is effective, but it might achieve greater results when combined with another upcoming treatment that's on the cusp of a major breakthrough?

I just can't work out how and why this is taking so long given what Dr. Shore knows about the tinnitus community.

It feels like this is a long way off. I hope I'm wrong and I know we all thank Dr. Shore for her immeasurable contribution to tinnitus research, but I feel that maybe we'll see another treatment released before we get to experience this one which is a major downer in reality.

• It does not matter how many people are suffering with this condition, approval takes as long as it takes.
  
  
• It does not matter that people get in contact with her, she cannot circulate unapproved medical devices.
  
  
• It doesn't matter how much she wants approval, the FDA will decide the timeline and if her documentation and data meet regulatory standards to progress.
  
  
• It's not purposefully taking long - from outsiders perspectives yes it may appear that way. It's not a case of "study done, SUBMIT." It can take months and months to get your documentation and data into a submission ready format. And from my experience, Universities do not meet the quality standards of private companies, so this will add to the time. For example, it might take Auricle 4 months to get a compliant QMS under the QSR requirements.

This. Is. Completely. Normal.

Please, please, please understand that the journey from proving your device to submitting isn't a straight line. It's more like a tree. There are loads of little branches coming off of large trunks.

21 CFR 820 for medical devices doesn't just allow you to conduct a trial, submit and then sell.

You need:

• A QMS (HUGE task) - ISO9001 and 134985 certification
  
  
• Training procedures (manufacturing, use, supplier approval documentation, complaint procedures etc)
  
  
• Quality records of all your design and requirement documentation
  
  
• FMEA documentation
  
  
• DMEA documentation
  
  
• PFMEA documentation
  
  
• Post market surveillance strategies

And this is just the tip of the iceberg of what you need outside the scope of clinical trials. Essentially you need to PROVE to the FDA that you're a competent medical device manufacturer, not just that you have a device that works.

Do not stress yourself out with what ifs and maybes, there will be a lot going on behind the scenes.

 

[ajc]

There's been an update regarding Dr. Shore's device submission to the FDA. Apparently they're planning a Q1/2024 submission:

Dated September.

I told ya all along that it wasn't submitted to the FDA yet. Feels good to be proven right.

 

[dj_newark]

Dated September.

I told ya all along that it wasn't submitted to the FDA yet. Feels good to be proven right.

Yes I know it was dated September. This is the first I've seen it.

I was less sure it'd been submitted as time went on. The truth is no one has any idea of the work that's happening behind the scenes. It's good that there's evidence of this moving forward!

Congrats! Enjoy your victory.

 

[Kleiner]

I guess it will take another year after the FDA decision to think about what to do, and waiting another year to start thinking about production after.

I respect Dr. Shore's work but I come to think that the best way for her technology to come out, is to have it stolen by the Chinese who don't care about patents.

 

[RunningMan]

However, there's a thought that perhaps the device's efficacy isn't quite as positive as we think. Could it be possible that delaying its launch to align with another treatment could be strategically more advantageous for Dr. Shore's reputation? Something about this situation seems off to me. Perhaps the device is effective, but it might achieve greater results when combined with another upcoming treatment that's on the cusp of a major breakthrough?

I can't see Dr. Shore delaying it just to wait for another treatment to come along that may or may not work well.

We should have a pretty good idea of the efficacy based on the study. Of 99 study participants, 53% of those receiving the active treatment had clinically significant improvement at week 6 vs. 20% of those in the control group. That's a 33 percentage point difference between active and control.

 

[InNeedOfHelp]

• It does not matter how many people are suffering with this condition, approval takes as long as it takes.
  
  
• It does not matter that people get in contact with her, she cannot circulate unapproved medical devices.
  
  
• It doesn't matter how much she wants approval, the FDA will decide the timeline and if her documentation and data meet regulatory standards to progress.
  
  
• It's not purposefully taking long - from outsiders perspectives yes it may appear that way. It's not a case of "study done, SUBMIT." It can take months and months to get your documentation and data into a submission ready format. And from my experience, Universities do not meet the quality standards of private companies, so this will add to the time. For example, it might take Auricle 4 months to get a compliant QMS under the QSR requirements.

This. Is. Completely. Normal.

Please, please, please understand that the journey from proving your device to submitting isn't a straight line. It's more like a tree. There are loads of little branches coming off of large trunks.

21 CFR 820 for medical devices doesn't just allow you to conduct a trial, submit and then sell.

You need:

• A QMS (HUGE task) - ISO9001 and 134985 certification
  
  
• Training procedures (manufacturing, use, supplier approval documentation, complaint procedures etc)
  
  
• Quality records of all your design and requirement documentation
  
  
• FMEA documentation
  
  
• DMEA documentation
  
  
• PFMEA documentation
  
  
• Post market surveillance strategies

And this is just the tip of the iceberg of what you need outside the scope of clinical trials. Essentially you need to PROVE to the FDA that you're a competent medical device manufacturer, not just that you have a device that works.

Do not stress yourself out with what ifs and maybes, there will be a lot going on behind the scenes.

It is completely normal to submit almost 2 years after completing your final trial to the FDA for a class II device which has an equivalent substitute? Biggest BS in this thread so far. They had plenty of time to make pre-arrangements. They had plenty of time to fundraise through corporations and not private equity. If you have pre-FDA alignment, you know what to submit and you can be prepared for this.

She even had plenty of time to tell us or during the Tinnitus Talk Q&A that she would submit in Q1/2024 as this was apparently public information. Instead she chose to give us silence (pun intended) and not manage expectations. This information was available online and yet she decided to 'not harm any FDA discussions'. Total BS.

What a way to manage almost 20 years of research. Researchers should stay in the lab. Let corporations take care of product launches.

Can you imagine the FDA requesting an additional trial during their submission because of the lack of data and small trial size and crossover model not working? Will we be looking at 2027? And in the meantime NOT launching in Europe, where only a CE approval is required which is hardly an approval at all, at least to get some funds going and start capturing market share?

I sincerely hope the TU Delft device or Xenon Pharmaceuticals beats the crap out of this. Poor management and a poor project as far as I'm concerned. Sorry for the rant but I feel we have the right to rant here.

It's all about managing expectations and patient involvement. And these topics clearly are not under control. If we had been properly informed, I'd be just fine with the wait.

 

[Cernuto]

If you have pre-FDA alignment, you know what to submit and you can be prepared for this.

There's no pre-alignment. The FDA will delay for any reason they can find. They can and will demand more information. The more information given to them, the more they want. They will thoroughly exhaust everything within their sight before approving anything. This is why people have to be careful with what they say publicly. The FDA's focus is about benefiting their interests, not approving products that may potentially help tinnitus patients.

 

[SilverFox]

We should have a pretty good idea of the efficacy based on the study. Of 99 study participants, 53% of those receiving the active treatment had clinically significant improvement

Only participants with somatic tinnitus were tested. Thus the efficacy for the general case is unknown.

 

[Jonno02]

It is completely normal to submit almost 2 years after completing your final trial to the FDA for a class II device which has an equivalent substitute?

Please cite an FDA source that agrees this (and I assume Lenire?) are equivalent substitutes.

They had plenty of time to make pre-arrangements. They had plenty of time to fundraise through corporations and not private equity. If you have pre-FDA alignment, you know what to submit and you can be prepared for this.

You don't make 'pre-arrangements'. It's one thing being in a development/design-phase of a project, moving to market-ready is a completely separate thing. You don't get everything I spoke about ready only for your development phase to fail and show no clinical improvement. For a multi-national established company, they can have things like suppliers ready for the go-ahead and the funding to inject into a huge launch. For a novel technology and a start-up company, that's just not possible.

She even had plenty of time to tell us or during the Tinnitus Talk Q&A that she would submit in Q1/2024 as this was apparently public information. Instead she chose to give us silence (pun intended) and not manage expectations. This information was available online and yet she decided to 'not harm any FDA discussions'. Total BS.

She does not owe you, me or anybody else here a thing. She is not our friend. She is a researcher creating a product. I think people here forget that sometimes. This is a for-profit venture.

She is entirely right, you do not speculate on FDA (or any other regulator) approval. If she said "we're going to submit on X month" and it then turned out to be "X+3 months" because of additional work, people would be going mad with speculation as to why there was a delay. Best not to say anything.

What a way to manage almost 20 years of research. Researchers should stay in the lab. Let corporations take care of product launches.

It's her research and she's entitled to handle it any way she sees fit, regardless if that harms you or I by delaying the launch. What happens if a corporation buys the rights and then decides not to launch?

Can you imagine the FDA requesting an additional trial during their submission because of the lack of data and small trial size and crossover model not working? Will we be looking at 2027? And in the meantime NOT launching in Europe, where only a CE approval is required which is hardly an approval at all, at least to get some funds going and start capturing market share?

Think you've won your own trophy for "biggest BS in this thread." You state "CE approval" like you're conforming to electrical standards for a plug. You understand that the EU (and specific country entities within) have regulators/notified bodies exactly like the FDA? And you must confirm to strict regulations (EUMDR). Gaining EU approval has exactly the same hurdles as US approval. For a company with such limited resources, it makes sense to target one region right now. As much as I'd like them to launch in Europe at the same time, it's not gonna happen.

You can tell me I'm talking utter shite if you like. I understand the mental anguish of being in the unknown about a device that may greatly improve our lives. I'm not saying this device will work as hoped, but as somebody with years of experience dealing with regulators in the USA, Europe, South America and Asia, I completely understand why this isn't on the shelves yet.

I'm not saying this has been well managed or has the right people working on it, I have zero information on their project management. I'm just saying that for a new company with a novel treatment, gaining regulatory approval from the FDA is a tremendous feat.

 

[JRC1]

• It does not matter how many people are suffering with this condition, approval takes as long as it takes.
  
  
• It does not matter that people get in contact with her, she cannot circulate unapproved medical devices.
  
  
• It doesn't matter how much she wants approval, the FDA will decide the timeline and if her documentation and data meet regulatory standards to progress.
  
  
• It's not purposefully taking long - from outsiders perspectives yes it may appear that way. It's not a case of "study done, SUBMIT." It can take months and months to get your documentation and data into a submission ready format. And from my experience, Universities do not meet the quality standards of private companies, so this will add to the time. For example, it might take Auricle 4 months to get a compliant QMS under the QSR requirements.

This. Is. Completely. Normal.

Please, please, please understand that the journey from proving your device to submitting isn't a straight line. It's more like a tree. There are loads of little branches coming off of large trunks.

21 CFR 820 for medical devices doesn't just allow you to conduct a trial, submit and then sell.

You need:

• A QMS (HUGE task) - ISO9001 and 134985 certification
  
  
• Training procedures (manufacturing, use, supplier approval documentation, complaint procedures etc)
  
  
• Quality records of all your design and requirement documentation
  
  
• FMEA documentation
  
  
• DMEA documentation
  
  
• PFMEA documentation
  
  
• Post market surveillance strategies

And this is just the tip of the iceberg of what you need outside the scope of clinical trials. Essentially you need to PROVE to the FDA that you're a competent medical device manufacturer, not just that you have a device that works.

Do not stress yourself out with what ifs and maybes, there will be a lot going on behind the scenes.

How long should it take for a non-invasive device?

 

[gameover]

I respect Dr. Shore's work but I come to think that the best way for her technology to come out, is to have it stolen by the Chinese who don't care about patents.

They probably would not care about making sure it works at all / is copied correctly, either...

 

[Jonno02]

How long should it take for a non-invasive device?

If you can predict that, play the lottery. Unfortunately, it's an impossible question to answer.