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New University of Michigan Tinnitus Discovery — Signal Timing

#5,581
2noist said:
Stop the nonsense. You are asking people to drop critical thinking and become blind sheep.

In the world of science, there have been more promising developments (than this device) that ended up being relatively ineffective in the real world.
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Dr. Shore's extensive research is commendable. I think her trial design shows her creativity and innovative thinking, so I give her big ups there. But ultimately it still hinges on subjective and unreliable self-reports and rating scores (TFI) to evaluate her device's effectiveness. This, in my view, raises concerns. If there's one thing I despise in the field of tinnitus research, it's the absence of dependable methods of objectively detecting and quantifying tinnitus. It's the number one roadblock that has halted any sort of progress in finding effective solutions.

No tinnitus treatment initiative, including Dr. Shore's device, has managed to overcome that hurdle. So there's always going to be a possibility that this device will be yet another disappointment for a substantial portion of the population.

But I like Dr. Shore (she's one of my 'celebrity' crushes after all!) and I root for her success. Because if she triumphs, it means a lot of sufferers also benefit. That is a good thing.
 
#5,582
ZFire said:
Dr. Shore's extensive research is commendable. I think her trial design shows her creativity and innovative thinking, so I give her big ups there. But ultimately it still hinges on subjective and unreliable self-reports and rating scores (TFI) to evaluate her device's effectiveness. This, in my view, raises concerns. If there's one thing I despise in the field of tinnitus research, it's the absence of dependable methods of objectively detecting and quantifying tinnitus. It's the number one roadblock that has halted any sort of progress in finding effective solutions.

No tinnitus treatment initiative, including Dr. Shore's device, has managed to overcome that hurdle. So there's always going to be a possibility that this device will be yet another disappointment for a substantial portion of the population.

But I like Dr. Shore (she's one of my 'celebrity' crushes after all!) and I root for her success. Because if she triumphs, it means a lot of sufferers also benefit. That is a good thing.
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I feel that's because an objective measurement and a cure are intrinsically linked.

A lot of conditions are discovered through analysis. For example, a blood test that finds low white cell count or a vitamin deficiency. If this same thing is found in all patients suffering from the same condition, researchers can link this back to being a potential root cause and objective test.

For tinnitus there is no such 'marker.' A whole range of neurological conditions rely on patient feedback to determine if the treatment is working, i.e depression.

If there was a marker, a cure would be easy. 'Your magnesium is low, if you take a supplement, your tinnitus will disappear.' It's not that researchers aren't focussed on finding an objective measure, it's that it's incredibly difficult.

Unfortunately, I don't see that situation changing any time soon. All we can do is cross everything possible and hope this device works. If Susan Shore's device works, perhaps there will be some sort of imaging technique built off her research that can show hyperactivity of the DCN.

Sucks. But what doesn't suck with tinnitus!
 
#5,583
ZFire said:
Dr. Shore's extensive research is commendable. I think her trial design shows her creativity and innovative thinking, so I give her big ups there. But ultimately it still hinges on subjective and unreliable self-reports and rating scores (TFI) to evaluate her device's effectiveness. This, in my view, raises concerns. If there's one thing I despise in the field of tinnitus research, it's the absence of dependable methods of objectively detecting and quantifying tinnitus. It's the number one roadblock that has halted any sort of progress in finding effective solutions.

No tinnitus treatment initiative, including Dr. Shore's device, has managed to overcome that hurdle. So there's always going to be a possibility that this device will be yet another disappointment for a substantial portion of the population.

But I like Dr. Shore (she's one of my 'celebrity' crushes after all!) and I root for her success. Because if she triumphs, it means a lot of sufferers also benefit. That is a good thing.
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Dr. Shore did objectively measure tinnitus.
 
#5,584
Does anyone recall how tinnitus loudness level was measured by Dr. Shore et al? They used TFI scores (indeed subjective) and "tinnitus loudness level." Did they attempt to match frequency and decibel level to make that determination as to loudness level?

It's not stated in the Reversing Synchronized Brain Circuits Using Auditory-Somatosensory Stimulation article.
 
#5,586
slc said:
Does anyone recall how tinnitus loudness level was measured by Dr. Shore et al? They used TFI scores (indeed subjective) and "tinnitus loudness level." Did they attempt to match frequency and decibel level to make that determination as to loudness level?

It's not stated in the Reversing Synchronized Brain Circuits Using Auditory-Somatosensory Stimulation article.
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If I recall correctly, she used a piece of software called TinnTester (or something like that). I tried to find out more information about that at the time but there was little out there.
 
#5,587
Jonno02 said:
I feel that's because an objective measurement and a cure are intrinsically linked.

A lot of conditions are discovered through analysis. For example, a blood test that finds low white cell count or a vitamin deficiency. If this same thing is found in all patients suffering from the same condition, researchers can link this back to being a potential root cause and objective test.

If there was a marker, a cure would be easy. 'Your magnesium is low, if you take a supplement, your tinnitus will disappear.' It's not that researchers aren't focussed on finding an objective measure, it's that it's incredibly difficult.

For tinnitus there is no such 'marker.' A whole range of neurological conditions rely on patient feedback to determine if the treatment is working, i.e depression.

Unfortunately, I don't see that situation changing any time soon. All we can do is cross everything possible and hope this device works. If Susan Shore's device works, perhaps there will be some sort of imaging technique built off her research that can show hyperactivity of the DCN.

Sucks. But what doesn't suck with tinnitus!
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I pretty much agree with most of what you're saying here.

Although, tinnitus is not just a neurological condition, but also physiological one. Patient feedback can be valuable, but we need objective outcome measures alongside it, rather than relying solely on patient input. It's proven to be unreliable by itself. Something needs to change.
Nick47 said:
Dr. Shore did objectively measure tinnitus.
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I presume you're referring to one of those psychoacoustic tests (TinnTester I believe) where they play a range of tones/sounds to the individual and then ask them to indicate the presence and characteristics (pitch, loudness, frequency) of their tinnitus in relation to those test tones? Sorry, but that's still subjective.
 
#5,588
ZFire said:
Dr. Shore's extensive research is commendable. I think her trial design shows her creativity and innovative thinking, so I give her big ups there. But ultimately it still hinges on subjective and unreliable self-reports and rating scores (TFI) to evaluate her device's effectiveness. This, in my view, raises concerns. If there's one thing I despise in the field of tinnitus research, it's the absence of dependable methods of objectively detecting and quantifying tinnitus. It's the number one roadblock that has halted any sort of progress in finding effective solutions.

No tinnitus treatment initiative, including Dr. Shore's device, has managed to overcome that hurdle. So there's always going to be a possibility that this device will be yet another disappointment for a substantial portion of the population.

But I like Dr. Shore (she's one of my 'celebrity' crushes after all!) and I root for her success. Because if she triumphs, it means a lot of sufferers also benefit. That is a good thing.
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I don't want to say something stupid but didn't the doctor use TinnTester (by Larry Roberts)?
TinnTester is a software suite designed by Larry Roberts to measure psychophysical attributes of tinnitus including loudness and likeness at several frequencies. The TinnTester reports loudness measurements in dB SPL which can also be expressed as sensation level (SL) by comparing to the audiogram. There have been a number of studies showing test-retest reliability.
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It doesn't seem like just a simple "subjective evaluation." It seems rather reductive as a description, but I could obviously be wrong too.
 
#5,589
#5,590
Long time lurker, first time poster. Trying to stay on the positivity train with everybody else that this device works.

I've searched extensively, but haven't seen it - are there any follow-up dates or timelines (beyond guesstimates) for anything with this device other than a potential release next year or the year after, pending all the approvals and everything else goes well?
 
#5,592
ccm302 said:
are there any follow-up dates or timelines (beyond guesstimates) for anything with this device other than a potential release next year or the year after, pending all the approvals and everything else goes well?
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There is no official news about it.

The more positive among us think a release between 1 and 2 years.

According to the pessimists, 3 to 5 years.

According to those catastrophists, it will never come out.

The study is now finished. Dr. Shore said she is co-founder and chief scientific officer of Auricle Inc (the company that will sell the device). She also said that Jonathan Pearson (the CEO) is working to obtain approval of the FDA. In short, we just have to wait.

These statements simply make me think that things are too developed to see a device abandonment or release in 5 years or more.
 
#5,593
Anuar Lukios said:
These statements simply make me think that things are too developed to see a device abandonment or release in 5 years or more.
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In other words, you have confidence and you have an instinct that it's less than 5 years away?

I'm with you (if that's what you're saying). I mean, people will be lined up around the block 10 times over. Can't wait for the day!
 
#5,595
Yeah, a release within 2 years sounds reasonable. But wide scale availability could be considerably longer, depending on where you live, even in the U.S. Hopefully most of us who are interested will be able to get it in our home states within 3 years.
 
#5,600
Dr. Shore has been working on this potential treatment for 25 years and during that time there have been many articles online and in medical journals about her efforts. She sent out an email to her subscribers on her progress approximately 6 months ago.

Auricle Inc knows there are thousands of tinnitus sufferers around the world anxiously and patiently waiting to try the device.

The time has come for Auricle Inc to hire a media spokesperson and put out monthly or at least quarterly updates on the progress of the device and potential ETA instead of being stealthy and keeping everyone in the dark. Transparency is the professional and right thing to do.
 
#5,601
Karl Tallman said:
Dr. Shore has been working on this potential treatment for 25 years and during that time there have been many articles online and in medical journals about her efforts. She sent out an email to her subscribers on her progress approximately 6 months ago.

Auricle Inc knows there are thousands of tinnitus sufferers around the world anxiously and patiently waiting to try the device.

The time has come for Auricle Inc to hire a media spokesperson and put out monthly or at least quarterly updates on the progress of the device and potential ETA instead of being stealthy and keeping everyone in the dark. Transparency is the professional and right thing to do.
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Cool story bro. They have already stated that they prefer and choose to be quiet and opaque while they are preparing for FDA submission. You ain't getting any updates anytime soon.

Last I checked you ain't the one making decisions on their behalf :) They are professional. They don't want to fuck up the FDA submission by having a loud mouth.
 
#5,603
Tweaker said:
I've read it can take 250 days from initial submission for FDA to approve DeNovo applications and that it is also a very costly process.
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I don't think money is an issue. However, I read on the thread that it "probably" won't be "DeNovo" because there has already been Lenire (which AT LEAST ON PAPER is a "similar" device).
 
#5,604
Someone may have already done this, so I'll delete it if someone comes along and says as much. I've got the below ranges of time for approval for each process type that they may try:

Clearance Type
  • 510k - Min[days] 50 // Max[days] 175
  • De Novo - Min[days] 150 // Max[days] 394
  • Expedited - Min[days] 15 // Max[days] 60
Feel free to check my math and I'll adjust. So, as soon as we have a filing date and type, I can put it in my spreadsheet and have a date range for approval given the above averages.

And if anybody has date ranges for other processes, I can plug those in too and get a pure guesstimate on time until release, pending all things are equal.
 
#5,605
ccm302 said:
Someone may have already done this, so I'll delete it if someone comes along and says as much. I've got the below ranges of time for approval for each process type that they may try:

Clearance Type
  • 510k - Min[days] 50 // Max[days] 175
  • De Novo - Min[days] 150 // Max[days] 394
  • Expedited - Min[days] 15 // Max[days] 60
Feel free to check my math and I'll adjust. So, as soon as we have a filing date and type, I can put it in my spreadsheet and have a date range for approval given the above averages.

And if anybody has date ranges for other processes, I can plug those in too and get a pure guesstimate on time until release, pending all things are equal.
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Well done.

Just to add:

If the FDA require additional information (AI request) or have a list of questions (very common, I think the average number of questions per submission at my work is approximately ~40 of varying levels of complexity), the time stops. Sometimes you'll only have 2-4 weeks to respond, or they may give longer depending on what you're asked.

During this time, the approval 'clock' stops. When you respond, it starts again. These are called cycles. Depending on the severity of the AI request from the FDA and the data provided, the clock may even be restarted.
 
#5,608
ccm302 said:
Someone may have already done this, so I'll delete it if someone comes along and says as much. I've got the below ranges of time for approval for each process type that they may try:

Clearance Type
  • 510k - Min[days] 50 // Max[days] 175
  • De Novo - Min[days] 150 // Max[days] 394
  • Expedited - Min[days] 15 // Max[days] 60
Feel free to check my math and I'll adjust. So, as soon as we have a filing date and type, I can put it in my spreadsheet and have a date range for approval given the above averages.

And if anybody has date ranges for other processes, I can plug those in too and get a pure guesstimate on time until release, pending all things are equal.
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I think I've been following this thread closely.

Are you saying it has been submitted to FDA for approval?

How do we know for sure this process has even begun?

I hope it has, but I'm not sure the clock is ticking yet.
 
#5,609
BTaylor12 said:
I think I've been following this thread closely.

Are you saying it has been submitted to FDA for approval?

How do we know for sure this process has even begun?

I hope it has, but I'm not sure the clock is ticking yet.
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@ccm302 clearly said this timeline was based "as soon as we have a filing date".

It could have been last summer or last month. Or, not at all yet.
 

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