New University of Michigan Tinnitus Discovery — Signal Timing

[RunningMan]

I have seen the "6 month" comment a few times. But that is 6 months once they have applied for FDA approval.

Have they actually applied? I haven't seen a definitive yes to that question.

I'm not sure the 6 month clock is ticking yet.

That question would not be answered, as per the Q&A response. There's a lot of speculation in this thread. No one posting here really knows. But, I think 6 months is highly optimistic and unlikely for getting this treatment in your hands. This is a long process, and I think you should be prepared that it's going to take much longer to be widely available. I think some posters up thread mentioned 2025 or 2026 after some previous discussion on what's involved.

Also remember, the effectiveness isn't looking that great, averaging just 5 dB to 6 dB better reduction than the control group (placebo) and clinically significant for only 65% of people (not sure how much that percentage is over the control group that had clinically significant reduction). So keep your expectations in check.

 

[Tristan23]

Hello, I've been following this thread for a couple of months and came across something interesting that hasn't been shared yet on this forum.

Some people were disappointed that Susan Shore didn't give any clear answers about hyperacusis, but it is definitely on her radar. A dissertation called Role of the Cochlear Nucleus Circuitry in Tinnitus and Hyperacusis was written by David T. Martel, who happens to be Vice President of R&D at Auricle, according to his LinkedIn. And as you can see on the first page, Susan Shore herself was in the Doctoral Comittee.

I don't have a lot of experience with science myself, but I scanned through it and the identification of hyperacusis subtypes seems quite interesting for finding proper treatments. Check it out:

PDF: Role of the Cochlear Nucleus Circuitry in Tinnitus and Hyperacusis

Further, we predict that these subtypes of hyperacusis would respond to different therapies. Excitatory hyperacusis could be treated with drugs that dampen excitatory activity, while disinhibition hyperacusis is more likely to respond to drugs that enhance inhibitory activity. We also predict that the hyperacusis-subtypes will be accompanied by different disorders. H1 (reflecting increases in bushy-cell ANF coupling) and H2 (reflecting increased non-auditory excitatory input) predict that bushy cells will show increases in sound-evoked activity and SFR, which may result in more or worse tinnitus. Indeed, other studies have shown that subjects with hyperacusis-and-tinnitus report worse tinnitus than subjects with only tinnitus (Hebert et al., 2013; Schecklmann et al., 2014)

 

[Watasha]

That question would not be answered, as per the Q&A response. There's a lot of speculation in this thread. No one posting here really knows. But, I think 6 months is highly optimistic and unlikely for getting this treatment in your hands. This is a long process, and I think you should be prepared that it's going to take much longer to be widely available. I think some posters up thread mentioned 2025 or 2026 after some previous discussion on what's involved.

Also remember, the effectiveness isn't looking that great, averaging just 5 dB to 6 dB better reduction than the control group (placebo) and clinically significant for only 65% of people (not sure how much that percentage is over the control group that had clinically significant reduction). So keep your expectations in check.

Agree. Dr. Shore's device is not the end for tinnitus. There are several other promising treatments in development, including electrical stimulation of the cochlea.

 

[ErikaS]

When I talked to someone from the FDA over the phone about 3 months ago, he told me it is confidential knowledge when someone submits for FDA approval. They cannot confirm or deny if something has been submitted, and the search engine options on the FDA site only show devices that have been approved. You can search both 510(k) and De Novo separately.

 

[BTaylor12]

If you search for devices, there has been no device submitted for FDA approval. A few people have looked at it. I have not.

That's what I'm thinking. There seems to be a lot of comments that's we're now just waiting for 6 months to go by before being approved.

I'm not convinced at all the process has even begun.

That question would not be answered, as per the Q&A response. There's a lot of speculation in this thread. No one posting here really knows. But, I think 6 months is highly optimistic and unlikely for getting this treatment in your hands. This is a long process, and I think you should be prepared that it's going to take much longer to be widely available. I think some posters up thread mentioned 2025 or 2026 after some previous discussion on what's involved.

Also remember, the effectiveness isn't looking that great, averaging just 5 dB to 6 dB better reduction than the control group (placebo) and clinically significant for only 65% of people (not sure how much that percentage is over the control group that had clinically significant reduction). So keep your expectations in check.

Yup, well a reduction of anything is good. Heck something that prevents it from getting worse is good too!

 

[Utdmad89]

Also remember, the effectiveness isn't looking that great, averaging just 5 dB to 6 dB better reduction than the control group (placebo) and clinically significant for only 65% of people (not sure how much that percentage is over the control group that had clinically significant reduction). So keep your expectations in check.

It was explained in the Q&A that a 6 dB reduction equals 50% less tinnitus. Are you saying that isn't great?

At this time, nothing can reduce tinnitus. But something that has been proven to work isn't that great... WTF?

 

[Binnen-dahlia]

I know the wait for Dr. Shore's tinnitus device can feel like forever, especially when it's something that could change our lives.

The FDA process is no joke, but that's a good thing – it means they're making sure it's the real deal. Hang tight, keep those fingers crossed, and let's remember we're all in this together.

There's a light at the end of this tunnel, and I'm hopeful it's going to be worth the wait. Sending everyone good vibes!

I like your vibe!

 

[RunningMan]

It was explained in the Q&A that a 6 dB reduction equals 50% less tinnitus. Are you saying that isn't great?

At this time, nothing can reduce tinnitus. But something that has been proven to work isn't that great... WTF?

No, definitely not great, 6 dB to 10 dB equates to a perceived 50% reduction in volume with a test tone. It takes 3 dB to even be noticeable. My tinnitus varies on its own a lot more than that and is still way too loud even at its lowest.

If your tinnitus is lower to begin with, you might be ok with the limited reduction.

There are some audio samples posted earlier in this thread if you really want to listen to what that differences are at those dB reductions. With more variable and dynamic sounds, the differences are less noticeable.

I'll take 50% reduction, but it's certainly not that great. Of course, it's going to be more for some people, less for others, and apparently clinically ineffective for possibly 30% to 40% of people.

Hope for the best, you might be one of the lucky ones, but keep expectations in check.

There are a host of things that people have reported reducing their tinnitus, including things tested through studies, and that even includes a placebo. But that's beyond the scope of this thread to list all of those things as they are covered elsewhere.

 

[AmePerdue]

It was explained in the Q&A that a 6 dB reduction equals 50% less tinnitus. Are you saying that isn't great?

At this time, nothing can reduce tinnitus. But something that has been proven to work isn't that great... WTF?

I agree that a potential 6 dB reduction provides hope. But in my book, it will be "proven to work" only when I see the cascade of enthusiastic user reviews on Tinnitus Talk joyfully announcing that their tinnitus was halved and it doesn't bother them anymore.

 

[Pixelito]

That question would not be answered, as per the Q&A response. There's a lot of speculation in this thread. No one posting here really knows. But, I think 6 months is highly optimistic and unlikely for getting this treatment in your hands. This is a long process, and I think you should be prepared that it's going to take much longer to be widely available. I think some posters up thread mentioned 2025 or 2026 after some previous discussion on what's involved.

Also remember, the effectiveness isn't looking that great, averaging just 5 dB to 6 dB better reduction than the control group (placebo) and clinically significant for only 65% of people (not sure how much that percentage is over the control group that had clinically significant reduction). So keep your expectations in check.

My comments about the 6 months were only speculation on how long it would take for FDA approval, not when the device would be available. FDA lists 6-10 months for any approvals, so 6 months is certainly a realistic possibility.

As to whether the device has been submitted for approval yet, that is only speculation as well. Looking at the timeline of product development and comments by Dr. Shore concerning discussions with the FDA, it would seem logical that it has been submitted. I can't think of a reason why it wouldn't have by now.

But again, that is just hopeful guessing.

 

[El BUZZ]

Fueled by a massive spike and the scary feeling about this volume turning into my new normal, I've read A LOT of online scientific magazines and newspapers which have covered Dr. Shore's research, trials and device. Absolutely all them say this (or something similar) regarding the approval journey:

"Dr. Shore now wants to move the device quickly through the approval process and then onto the market."

 

[David Baime]

I have been following the Dr. Shore/UMich/Auricle stuff. All sounds great since it's the first I read that attempts to go past the "habituation" (or fancy word for getting used to as if you won't notice it any more), which has never worked for me with the scores of modalities and treatments I've tried. It's incredibly nice to hear it's actually going after the aberrant erratic, mis-firing activity or neurons in absence of outside sound and to stop or at least decrease the activity. It's a physical thing going on in there related to [dorsal] cochlear nucleus, so something that seems to be aimed at actually impacting and snuffing down that physical activity, to reduce the VOLUME/LOUDNESS of the damn thing, has my interest. You don't hear of much if any of that objective, which seems to me to be the real deal (if it can work).

My big question, if anyone out there knows is this. As you can tell (and I've posted before), I've tried probably 50+ different things, ranging all the way from many "Eastern" techniques, right to the state-of-the-art "Western" techniques/treatments. You name it and I've been there/done it (tried it). That includes Neuromo's Lenire device in Dublin. I gave that a good go (of course years before it became FDA approved in the US), but apparently I'm in the 30% of nope, didn't do anything.

Dr. Shore's device appears very "bimodally" similar to Lenire which did not work, which of course obviously discourages me a bit. The technology and application sound similar, so WHAT'S THE MAIN DIFFERENCE? As noted, this one claims to target lowering the aberrant neural mis-firing which sounds like the way to go, whereas it's not clear that is the case with Lenire, but they seem "eerily" similar in nature.

Any thoughts appreciated.

Thanks,
David

 

[Jonno02]

I have been following the Dr. Shore/UMich/Auricle stuff. All sounds great since it's the first I read that attempts to go past the "habituation" (or fancy word for getting used to as if you won't notice it any more), which has never worked for me with the scores of modalities and treatments I've tried. It's incredibly nice to hear it's actually going after the aberrant erratic, mis-firing activity or neurons in absence of outside sound and to stop or at least decrease the activity. It's a physical thing going on in there related to [dorsal] cochlear nucleus, so something that seems to be aimed at actually impacting and snuffing down that physical activity, to reduce the VOLUME/LOUDNESS of the damn thing, has my interest. You don't hear of much if any of that objective, which seems to me to be the real deal (if it can work).

My big question, if anyone out there knows is this. As you can tell (and I've posted before), I've tried probably 50+ different things, ranging all the way from many "Eastern" techniques, right to the state-of-the-art "Western" techniques/treatments. You name it and I've been there/done it (tried it). That includes Neuromo's Lenire device in Dublin. I gave that a good go (of course years before it became FDA approved in the US), but apparently I'm in the 30% of nope, didn't do anything.

Dr. Shore's device appears very "bimodally" similar to Lenire which did not work, which of course obviously discourages me a bit. The technology and application sound similar, so WHAT'S THE MAIN DIFFERENCE? As noted, this one claims to target lowering the aberrant neural mis-firing which sounds like the way to go, whereas it's not clear that is the case with Lenire, but they seem "eerily" similar in nature.

Any thoughts appreciated.

Thanks,
David

They both use bimodal stimulation, but work on entirely different areas of the body/nerves. It's like breaking your arm but putting a cast on your leg. Unless the cast goes on the right area, it's not going to work.

I do agree we need to keep expectations in check, but twice now, Dr. Shore's device has been proven to work in a clinical setting. The extent of that effectiveness can only be realised once it's on the market, of course.

But...

After the first flight of mankind, just 66 years later we went to the moon.

Marie Curie isolated radium in 1902. The nuclear bomb was created 43 years later.

The transistor was invented in 1947. The Intel 8080 was released just 27 years later.

Point is, once a technology is created, no matter how juvenile or basic it may seem, it can evolve and progress at an insane rate. Dr. Shore's device has been proven to work in a setting far beyond Lenire.

Version 1 of the device might be a bit like the Wright brothers' plane. But someday someone will come along and turn it into a space shuttle.

 

[AfroSnowman]

I have been following the Dr. Shore/UMich/Auricle stuff. All sounds great since it's the first I read that attempts to go past the "habituation" (or fancy word for getting used to as if you won't notice it any more), which has never worked for me with the scores of modalities and treatments I've tried. It's incredibly nice to hear it's actually going after the aberrant erratic, mis-firing activity or neurons in absence of outside sound and to stop or at least decrease the activity. It's a physical thing going on in there related to [dorsal] cochlear nucleus, so something that seems to be aimed at actually impacting and snuffing down that physical activity, to reduce the VOLUME/LOUDNESS of the damn thing, has my interest. You don't hear of much if any of that objective, which seems to me to be the real deal (if it can work).

My big question, if anyone out there knows is this. As you can tell (and I've posted before), I've tried probably 50+ different things, ranging all the way from many "Eastern" techniques, right to the state-of-the-art "Western" techniques/treatments. You name it and I've been there/done it (tried it). That includes Neuromo's Lenire device in Dublin. I gave that a good go (of course years before it became FDA approved in the US), but apparently I'm in the 30% of nope, didn't do anything.

Dr. Shore's device appears very "bimodally" similar to Lenire which did not work, which of course obviously discourages me a bit. The technology and application sound similar, so WHAT'S THE MAIN DIFFERENCE? As noted, this one claims to target lowering the aberrant neural mis-firing which sounds like the way to go, whereas it's not clear that is the case with Lenire, but they seem "eerily" similar in nature.

Any thoughts appreciated.

Thanks,
David

Aside from the rigorous basic research that went into Shore's device as opposed to a throwing spaghetti at the wall approach with Lenire, the idea of Lenire is to make the fusiform cells all hyperactive so that the tinnitus area isn't so distinct, while Shore's device aim to lessen the hyperactivity and thereby lessen the actual tinnitus. So it is kind of the opposite approach even though they are both bimodal.

 

[gameover]

Aside from the rigorous basic research that went into Shore's device as opposed to a throwing spaghetti at the wall approach with Lenire, the idea of Lenire is to make the fusiform cells all hyperactive so that the tinnitus area isn't so distinct, while Shore's device aim to lessen the hyperactivity and thereby lessen the actual tinnitus. So it is kind of the opposite approach even though they are both bimodal.

I still do not get the premise behind Lenire. It sounds like a bunch of nonsense. Is it supposed to make everything louder so tinnitus is "drowned" better? That sounds like inducing hyperacusis and makes no sense whatsoever. At least the premise behind Dr. Shore's device makes sense.

 

[UKBloke]

WHAT'S THE MAIN DIFFERENCE?

• Lenire supposedly raises the overall level of auditory excitability to that of the tinnitus so that the patient apparently notices it less. A bit baffling but hey ho. On the other hand, Susan Shore's device aims to lower the excitability of the tinnitus creating neurons, so seems more targeted; a bit more elegant.
• Lenire's point of access for the electrical stimulation is via the tongue. Susan Shore's system attaches to the neck and/or cheek area.
• Neuromod didn't control for placebo while Susan Shore did*

As has already been stated, management of expectations right now is essential.

(* there's been some controversy on this point. You'll need to go back in the thread to read about that.)

 

[AfroSnowman]

I still do not get the premise behind Lenire. It sounds like a bunch of nonsense. Is it supposed to make everything louder so tinnitus is "drowned" better? That sounds like inducing hyperacusis and makes no sense whatsoever. At least the premise behind Dr. Shore's device makes sense.

Yes, that is my understanding. I think that is why Lenire is a habituation device and not a real treatment. Also maybe it explains some of its claims of success that differ so radically from the experiences reported here. I could imagine how a mild tinnitus sufferer might just need a bit of neural distraction to ignore it while it would would make no difference to a severe tinnitus sufferer.

I hold out some hope for the Shore device, it makes sense, it has been well and legitimately researched, it comes out of a big research university, no real red flags, but all we can do is wait for the next milestone in the FDA process and see. It sure would be nice to be able to do anything to positively impact tinnitus and if this doesn't do it, we are all going to be waiting a good long time for the next realistic hope.

 

[slc]

Key points from Dr. Shore's work:

• control group
• double-blind
• testing for results of treatment included psychoacoustic tinnitus loudness measurement (not just Tinnitus Handicap Inventory, THI, or one of the similar surveys)

I have been following the Dr. Shore/UMich/Auricle stuff. All sounds great since it's the first I read that attempts to go past the "habituation" (or fancy word for getting used to as if you won't notice it any more), which has never worked for me with the scores of modalities and treatments I've tried. It's incredibly nice to hear it's actually going after the aberrant erratic, mis-firing activity or neurons in absence of outside sound and to stop or at least decrease the activity. It's a physical thing going on in there related to [dorsal] cochlear nucleus, so something that seems to be aimed at actually impacting and snuffing down that physical activity, to reduce the VOLUME/LOUDNESS of the damn thing, has my interest. You don't hear of much if any of that objective, which seems to me to be the real deal (if it can work).

My big question, if anyone out there knows is this. As you can tell (and I've posted before), I've tried probably 50+ different things, ranging all the way from many "Eastern" techniques, right to the state-of-the-art "Western" techniques/treatments. You name it and I've been there/done it (tried it). That includes Neuromo's Lenire device in Dublin. I gave that a good go (of course years before it became FDA approved in the US), but apparently I'm in the 30% of nope, didn't do anything.

Dr. Shore's device appears very "bimodally" similar to Lenire which did not work, which of course obviously discourages me a bit. The technology and application sound similar, so WHAT'S THE MAIN DIFFERENCE? As noted, this one claims to target lowering the aberrant neural mis-firing which sounds like the way to go, whereas it's not clear that is the case with Lenire, but they seem "eerily" similar in nature.

Any thoughts appreciated.

Thanks,
David

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; Susan E. Shore, PhD tate in their article, "Reversing Synchronized Brain Circuits Using Targeted Auditory-Somatosensory Stimulation to Treat Phantom Percepts A Randomized Clinical Trial," key differences between Dr. Shore's work and previous studies. I would imagine that would include Lenire.

None of these studies used a control or sham group or nontreatment group; thus, all participants were aware that they were receiving an active treatment, increasing the risk for placebo effects. In contrast, the current trial had a control or sham group that received auditory-only stimulation. In addition, the current study used a psychoacoustic tinnitus loudness measurement as a primary outcome measure in addition to the TFI and THI surveys. While the TFI and THI questionnaires are both validated and widely used in tinnitus research and are important measures of tinnitus distress, the addition of a robust psychoacoustic tinnitus loudness measurement further validated the perceived reductions in tinnitus distress surveys.

In terms of Lenire,, here is a portion of one of my previous posts:

As opposed to the Neuromod site (which is super misleading), the Lenire.com website states, "A recent clinical trial showed that 95% of participants who used Lenire as directed demonstrated an improvement in tinnitus symptom severity (as measured by THI score) when evaluated after 12 weeks of treatment."

The term "tinnitus symptom severity" is not clear UNTIL they state, "as measured by THI score." Of course, THI does not measure decibel level. It is an attempt to measure how bothered the person is by tinnitus. Thus an improvement in emotional outlook, or achievement of "habituation" (a term that I find way too loose and overused), or even placebo effect, belief that something happened because at least a person was treated and someone listened... so many factors might influence the THI score.

Basically Lenire -- at least on lenire.com -- is claiming that THI scores will improve. The chart displayed on their page indicates an improvement from 51.2 to 33.5, so in the "moderate" to "high mild" range. In my view, folks with relatively moderate symptoms have a way better shot at "habituating" and addressing emotional distress.

 

[dj_newark]

I have been following the Dr. Shore/UMich/Auricle stuff. All sounds great since it's the first I read that attempts to go past the "habituation" (or fancy word for getting used to as if you won't notice it any more), which has never worked for me with the scores of modalities and treatments I've tried. It's incredibly nice to hear it's actually going after the aberrant erratic, mis-firing activity or neurons in absence of outside sound and to stop or at least decrease the activity. It's a physical thing going on in there related to [dorsal] cochlear nucleus, so something that seems to be aimed at actually impacting and snuffing down that physical activity, to reduce the VOLUME/LOUDNESS of the damn thing, has my interest. You don't hear of much if any of that objective, which seems to me to be the real deal (if it can work).

My big question, if anyone out there knows is this. As you can tell (and I've posted before), I've tried probably 50+ different things, ranging all the way from many "Eastern" techniques, right to the state-of-the-art "Western" techniques/treatments. You name it and I've been there/done it (tried it). That includes Neuromo's Lenire device in Dublin. I gave that a good go (of course years before it became FDA approved in the US), but apparently I'm in the 30% of nope, didn't do anything.

Dr. Shore's device appears very "bimodally" similar to Lenire which did not work, which of course obviously discourages me a bit. The technology and application sound similar, so WHAT'S THE MAIN DIFFERENCE? As noted, this one claims to target lowering the aberrant neural mis-firing which sounds like the way to go, whereas it's not clear that is the case with Lenire, but they seem "eerily" similar in nature.

Any thoughts appreciated.

Thanks,
David

The MAIN DIFFERENCE is that Lenire is a habituation device, and the Shore device is not. The Shore device that was developed at the University of Michigan over the past 20 years addresses the neuronal hyperactivity of the brainstem causing tinnitus by reducing that hyperactivity. Dr. Shore posits and I think proves that this is the 'root cause' of tinnitus.

All of this hyperactivity occurs in a structure of the brain known as the cochlear nucleus, having both a left and a right part known as the dorsal cochlear nucleus (DCN). The cochlear nucleus is located in a structure of the brain known as the "pons" which sits between the medulla oblongata and the midbrain. The hyperactive cells causing tinnitus are known as fusiform cells. The voltage gated (Kv7) potassium channels in this part of the brain are supposed to calm overexcited brain cells, but they are in a weakened state and unable to do so in people with severe tinnitus. So the Shore device is essentially taking over that duty, hopefully allowing them to recover and carry on their work of calming down the brain.

Reason I'm explaining all this is because Lenire does not increase the hyperactivity of the fusiform cells in the cochlear nucleus, according to my understanding. If what I believe is correct increasing the excitability of fusiform cells of the cochlear nucleus would increase tinnitus volume. Instead what it does is increase the excitability of the brain cells in other parts of the brain around the cochlear in an attempt to get the user to notice their tinnitus less. Thereby making habituation more likely.

I don't think what Lenire is doing is very good or successful. It's yet another in the parade of expensive, useless devices targeting the tinnitus community. I strongly believe that the Shore device will not be like the others in this category.

People are making an apples and oranges comparison between the Shore device and Lenire, because they see they are both "bimodal stimulation devices to address tinnitus". But in truth they are trying to do two completely different things and going about it in a completely different way. They are not the same! Also I am not a brain scientist and not a scientist of any kind, so I may not have gotten all of that right. Feel free to correct anything I got wrong.

 

[UKBloke]

The voltage gated (Kv7) potassium channels in this part of the brain are supposed to calm overexcited brain cells, but they are in a weakened state and unable to do so in people with severe tinnitus. So the Shore device is essentially taking over that duty, hopefully allowing them to recover and carry on their work of calming down the brain.

Are there are any interviews you're aware of with Dr. Shore that you can point us to where she talks about the influence of the Kv7 channels? I think these voltage gates are the most intriguing part of the puzzle.

 

[dj_newark]

Are there are any interviews you're aware of with Dr. Shore that you can point us to where she talks about the influence of the Kv7 channels? I think these voltage gates are the most intriguing part of the puzzle.

Not that I am aware of. I do know that it is the reason so many (including myself) found some relief from Retigabine, because it activated the potassium channels in the affected region of the brain for tinnitus. And for that reason we look forward to XEN1101/BHV-7000.

I'm not saying that those interviews with Dr. Shore talking about voltage gated potassium channels and their role in tinnitus aren't out there, I'm just saying I'm not aware of any. And that part I wrote in the last post about the Shore device allowing the potassium channels to recover and start doing their job for the tinnitus sufferer was speculation on my part. It may well be that it doesn't happen. But it could be that the Shore device in combination with potassium channel openers could be the one-two punch we need to completely solve this problem!

It's also possible that the potassium channel openers can be the one solution we need. Only time will tell! But a combination of both will be a powerful combination if that's what it comes to!

 

[Nick47]

Are there are any interviews you're aware of with Dr. Shore that you can point us to where she talks about the influence of the Kv7 channels? I think these voltage gates are the most intriguing part of the puzzle.

@UKBloke:

Potassium channels and HCN channels have been shown to be important for tinnitus generation and resilience (Li et al., 2013; Li et al., 2015; Pilati et al., 2012a; Pilati et al., 2012b). In studies on mice, Li et al. (2015) demonstrated that noise-induced tinnitus developed in mice that did not compensate for a reduction in KCNQ2/3, while those that did not develop behavioral evidence of tinnitus (using GPIAS) showed a re-emergence of KCNQ2/3 channel activity as well as a reduction in HCN channel activity. In addition to KCNQ2/3 (also termed Kv7), Pilati et al. (2012b) showed that reduction in Kv3 current underlies increased fusiform-cell bursting. Together with increased excitatory neurotransmission and decreased inhibitory neurotransmission, changes in intrinsic membrane excitability in DCN are associated with the development of tinnitus.

Mechanisms of noise-induced tinnitus: Insights from cellular studies

 

[UKBloke]

@UKBloke:

Mechanisms of noise-induced tinnitus: Insights from cellular studies

Cheers for that, mate. I especially like the sentence within the section titled, "Not everyone with hearing loss develops tinnitus" that states:

suggesting that intrinsic membrane properties are altered in animals developing tinnitus, but not in those that do not develop tinnitus after noise exposure

Understanding why the above occurs is I think the Holy Grail.

 

[lolkas]

I have seen the "6 month" comment a few times. But that is 6 months once they have applied for FDA approval.

Have they actually applied? I haven't seen a definitive yes to that question.

I'm not sure the 6 month clock is ticking yet.

My understanding is that you won't see/can't search submissions, but only approvals? Basically I thought stuff gets listed after approval.

 

[BTaylor12]

My understanding is that you won't see/can't search submissions, but only approvals? Basically I thought stuff gets listed after approval.

You can search for premarket notifications for devices. There's nothing listed for this as far as I can tell.

 

[UKBloke]

My only real question left regarding this device is, are we finally going to get to see @annV's boobs?

 

[El BUZZ]

OK guys, I'll be off Tinnitus Talk until all the dust around this is settled.

I was here back when AM101 was going to be the ultimate tinnitus terminator. I even participated in the clinical trials. It failed and the frustration was a hard pill to swallow.

Same with Lenire.

All this speculation is like walking in circles and it takes its toll on my anxiety, which is already off the charts due to the noise packed in my head.

It's really awesome how a lot of you have a genuine scientific insight about all this and it is wonderful that you take your valuable time to guide us through the fog surrounding this subject. You've genuinely saved my sanity dozens of times.

My hopes are high this time. I think that, thanks to Dr. Shore, most of us will be able to say in the near future: Hey, I was there when tinnitus was finally hacked.

I wish you all the best, you truly deserve it. Be patient and strong. Tight hugs!

 

[Nick47]

I can see from the Q & A that for many in Europe this will be a longer wait. I thought EU clearance would be quicker.

 

[Utdmad89]

I can see from the Q & A that for many in Europe this will be a longer wait. I thought EU clearance would be quicker.

That is what I was worried about.

 

[Jonno02]

I can see from the Q & A that for many in Europe this will be a longer wait. I thought EU clearance would be quicker.

That's a result of Auricle's commercial approach / launch.

For example, if you submit at the same time, normally BSI will approve before the FDA. But unfortunately they're not submitting to the BSI right now.