New University of Michigan Tinnitus Discovery — Signal Timing

[Gb3]

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.

Their second clinical trial was pushed back due to the pandemic. You may have heard about it. It was called the COVID-19 pandemic.

 

[Jim Vasilakis]

Saying that Dr. Shore's device doesn't work, when not only have there been two clinical trials with great results but other studies using bimodal electrical stimulation have also yielded good results, is bad faith.

It might not work for everyone, but it does work. Reductions above 11 dB aren't placebo. I don't know how many times this needs to be said.

 

[Bhaveen]

Saying that Dr. Shore's device doesn't work, when not only have there been two clinical trials with great results but other studies using bimodal electrical stimulation have also yielded good results, is bad faith.

It might not work for everyone, but it does work. Reductions above 11 dB aren't placebo. I don't know how many times this needs to be said.

Dr. Shore mentioned that data will be collected once the device is on the market. This is encouraging because it suggests that they will seek to modify and improve the device based on the results they obtain.

 

[Dkellz]

Their second clinical trial was pushed back due to the pandemic. You may have heard about it. It was called the COVID-19 pandemic.

Interesting. Is that the same COVID-19 pandemic where Lenire managed to get to market and be rolled out?

 

[UHPTS]

Executing a clinical trial with 400 participants is a huge task. They managed it. How come they are unable now to proceed with getting the device to the market?

Also, how is it that in the first clinical trial with few participants, at least one person reported on Tinnitus Talk, yet with 400 participants, nobody came forward to share their experiences—not here, not in any other group.

 

[2noist]

Executing a clinical trial with 400 participants is a huge task.

They never had a clinical trial with 400 participants. The second trial had only 99 participants. The plan was to have more, but due to COVID-19 they reduced the number.

 

[AfroSnowman]

Also, how is it that in the first clinical trial with few participants, at least one person reported on Tinnitus Talk, yet with 400 participants, nobody came forward to share their experiences—not here, not in any other group.

Maybe there is an NDA.

 

[RunningMan]

Saying that Dr. Shore's device doesn't work, when not only have there been two clinical trials with great results but other studies using bimodal electrical stimulation have also yielded good results, is bad faith.

It might not work for everyone, but it does work. Reductions above 11 dB aren't placebo. I don't know how many times this needs to be said.

It won't be for everyone. The study showed 40% efficacy when factoring in the placebo, and real-world results could be considerably lower, as we've seen with Lenire. So keep your expectations in check. But no one ever said the placebo accounted for an 11 dB reduction on average. I have referred to this graph a couple of times before when you posted similar comments. The placebo group is indicated as the control on the graph.

As can be clearly seen, the placebo only accounted for about 5 dB average reduction through the period shown, NOT 11 dB.

However, while the average 5 dB reduction was 5 dB, there were a number of results among the placebo group that had 12 dB or greater reduction. Many bimodal users didn't do so well, but the super responder readings helped bring the average reduction up.

 

[Utdmad89]

real-world results could be considerably lower

Real-world results could be considerably higher.

 

[Karl Tallman]

Apparently Susan Shore is hosting a Zoom Webinar on June 11 titled "Harnessing brain plasticity to treat tinnitus research." I'm registered to attend. It will be interesting to see if she discusses Auricle and the current status of seeking FDA approval.

→ https://hearinghealthfoundation.org/webinar

 

[Markku]

I wanted to make some things clear with Dr. Shore regarding the Hearing Health Foundation webinar, and:

• The webinar will focus on the basic science to give an understanding of how the basic science first led to an understanding of how tinnitus develops in a brain circuit and then how this circuit can be modified to reduce tinnitus.
• There will be no comments about FDA process or market availability.
• There will be no comments about any competitive treatments.
• The talk will not be recorded so is only available to people who register.

 

[Kam75]

• There will be no comments about FDA process or market availability.
• There will be no comments about any competitive treatments.

This is, unfortunately, not surprising...

 

[UKBloke]

an understanding of how the basic science first led to an understanding of how tinnitus develops in a brain circuit

Is this aspect of tinnitus science actually settled? I'm not so sure, and I don't believe I've ever heard a convincing argument yet about what tinnitus really is (on a biological level) and why it occurs. In fact, this has been my main bugbear over the years. We have prominent tinnitus researchers and "experts" attempting to cure/treat something they can't even define on a causal level or even measure. Hence my oft used, "We're the wall they're throwing sh*t at" simile.

 

[dj_newark]

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.

No, she wasn't exactly alone. She led a lab at the University of Michigan, and she had a team helping her. She is not the sole inventor of the device; she shares credit for that with David Martel and Seth Koelher.

Executing a clinical trial with 400 participants is a huge task. They managed it. How come they are unable now to proceed with getting the device to the market?

Also, how is it that in the first clinical trial with few participants, at least one person reported on Tinnitus Talk, yet with 400 participants, nobody came forward to share their experiences—not here, not in any other group.

There was an NDA with all the trial participants in place that asked them to keep quiet during the trial, or they would be kicked out. It also politely asked them to continue being silent about the trial after it was over. It looks like most of them agreed. That's why no one who was in the trials has talked about their experience except for @linearb, who was in the trial back in 2017.

 

[IYIiKe]

Is this aspect of tinnitus science actually settled? I'm not so sure, and I don't believe I've ever heard a convincing argument yet about what tinnitus really is (on a biological level) and why it occurs. In fact, this has been my main bugbear over the years. We have prominent tinnitus researchers and "experts" attempting to cure/treat something they can't even define on a causal level or even measure. Hence my oft used, "We're the wall they're throwing sh*t at" simile.

Because no one knows, but the research Dr. Shore built has at the very least identified one of the first pathways that tinnitus is reproduced/sustained in the brain. That is progress.

The brain is an incredibly complex organ that we do not understand as a species.

I know that can be hard to fathom when you have nanobots literally being shoved up peoples asses to fix other conditions, but there are reasons for that. If you take a wrong turn with the wrong drug in the brain, you can permanently or terminally disable someone. Even worse, everyone's brain is unique. It's also an invisible disability. A small amount of the population (concentrated on these boards) has tinnitus AND is bothered significantly by it.

Also, think about it -- you're not going to have the Gee Whiz Nobel Prize winners in the field of tinnitus. Why would you focus an entire career on that when there are so many more lucrative specialties and opportunities for research? Dr. Shore should be respected for her successful body of work -- even if this device falls completely flat on its face, she has an inarguably advanced understanding of how tinnitus originates. The same question you ask, and that likely has to be answered before you can ask how to fix it.

Are you going to trust someone throwing shit at a wall, or someone who at least has decades of scientific research with reproducible results indicating they know the velocity/angle to throw the shit to have a shot of making it stick?

Don't get me wrong -- I'm as pessimistic as people come. I am under no illusion that there will be a cure or even meaningful treatment in my lifetime, as I think that would drive me mad(der). The field of tinnitus is sorely under-researched, and otology is in the dark ages. But I would rather cheerlead the .01% chance of success backed by solid evidence, no matter how long it takes, if it's produced by research.

Shore isn't the only scientist to have targeted the DCN, and even if the blueprint of her decades-long research fails, it's still a blueprint that someone doesn't have to change much to improve next time.

Perhaps when one of the other sexier conditions progresses, some dots will start to connect with the precept of tinnitus/retention, and it won't take decades of research to progress this field further from Jastreblowhard.

I understand how debilitating this condition is and the urgency for some people to stop the pain. But honestly, look around Tinnitus Talk in treatments. This is at least genuine hope for progress (including the device's failure) and not some failed drug trial withering in East Nowheresville with some venture capitalist.

 

[Nick47]

Is this aspect of tinnitus science actually settled? I'm not so sure, and I don't believe I've ever heard a convincing argument yet about what tinnitus really is (on a biological level) and why it occur

The Shore Lab has confidently said that the root cause of tinnitus is aberrant firing in the cochlear nucleus. The exact pathway to consciousness is not solved. If you ask Professor McNaughton, he would say his hypothesis and animal studies show the root cause is increased activity of cells in the spiral ganglion due to overactive pain-sensing HCN2 channels. He told me that his findings support the findings of the Shore Lab, but the real root is peripheral nerves, changing firing rates in the cochlear nucleus.

We aren't getting any more information on this until it's approved. Lips are sealed.

I'm just looking forward to this month's Tinnitus Talk Podcast and then the one with Professor McNaughton, conducted a few weeks ago.

 

[UKBloke]

Dr. Shore should be respected for her successful body of work -- even if this device falls completely flat on its face, she has an inarguably advanced understanding of how tinnitus originates.

I should preface by repeating my comment a few months back that I believe Dr. Shore has done good science. I also think this device will help people. If you remove the control, washout, and crossover of the last trial, the treatment's performance looks very promising. Of course, the fact that we have to do those things is a bit of an issue, but that's another conversation!

I know it's a bit of a crap analogy but if we say a squeak is originating from a car wheel housing are we correct to chuck oil over the entire thing? Sure, doing that may stop the squeak for a while, but eventually, the noise starts up again. When we can break into the housing and identify the incorrectly manufactured bearing, and replace it to stop the squeak altogether... Well, I'm sure you get the idea.

I understand I'm asking a lot of the science with the above example but I'm a bit of a pedantic sod. The main thing for me (as I'm sure it is for most of us here) is that the momentum is definitely now building to provide a proper scientific/engineering solution for tinnitus—anything to get us away from Justaboff and his talking workshops.

If you ask Professor McNaughton, he would say his hypothesis and animal studies show the root cause is increased activity of cells in the spiral ganglion due to overactive pain-sensing HCN2 channels. He told me that his findings support the findings of the Shore Lab, but the real root is peripheral nerves, changing firing rates in the cochlear nucleus.

I actually had a conversation (albeit brief) with Professor McNaughton a few months back. He (like many researchers) acknowledged tinnitus originating in the periphery but questioned migration into the CNS as "unnecessary" and cited current research discrediting migration of pain into the CNS. I'm looking forward to the podcast and to these things being fleshed out in a bit more detail.

 

[IYIiKe]

I know it's a bit of a crap analogy but if we say a squeak is originating from a car wheel housing are we correct to chuck oil over the entire thing? Sure, doing that may stop the squeak for a while, but eventually, the noise starts up again. When we can break into the housing and identify the incorrectly manufactured bearing, and replace it to stop the squeak altogether... Well, I'm sure you get the idea.

Science is the art of writing detailed reports of how wrong you were. How do you know chucking oil won't work if it's a car no one's ever figured out the damn squeak AND has never tried?

Besides, some of the oil might leak somewhere near the real problem area.

 

[Dkellz]

I wanted to make some things clear with Dr. Shore regarding the Hearing Health Foundation webinar, and:

• The webinar will focus on the basic science to give an understanding of how the basic science first led to an understanding of how tinnitus develops in a brain circuit and then how this circuit can be modified to reduce tinnitus.
• There will be no comments about FDA process or market availability.
• There will be no comments about any competitive treatments.
• The talk will not be recorded so is only available to people who register.

There are absolutely zero surprises here.

 

[dd314]

@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.

Don't forget, we also have @kelpiemsp here who says Hubert Lim's method worked for and it actually eliminated his tinnitus, not just improved it.

 

[Cmspgran]

Don't forget, we also have @kelpiemsp here who says Hubert Lim's method worked for and it actually eliminated his tinnitus, not just improved it.

I've read this story, and with respect as I understand it, Hubert Lim knocked up some specialist machine that @kelpiemsp was miraculously cured by, went on to work with Neuromod's Lenire instead, and we heard no more about his invention? The whole thing sounds like fan fiction to me. I don't mean to offend anyone, but there's no hope in that. There is, however, hope that Dr. Shore's device will come to market and help many people. As far as I can see, and I stay pretty abreast of updates on Tinnitus Talk and elsewhere, it is the only possible genuine treatment anywhere on the near horizon.

As far as I can see, everything else is fairytales, unicorns, or a decade away.

 

[Muggumbo]

Don't forget, we also have @kelpiemsp here who says Hubert Lim's method worked for and it actually eliminated his tinnitus, not just improved it.

It's insane that no further information has been released about that study. It would be great if they could collaborate with Dr. Shore and her device. From my understanding, they customized the timing per patient in that study.

 

[999]

Quick question: Is there no way to know if Dr. Shore's device is being looked at by the FDA as we speak? I feel like I've seen conflicting information about what is public knowledge regarding the FDA approval process.

 

[Dkellz]

It's insane that no further information has been released about that study. It would be great if they could collaborate with Dr. Shore and her device. From my understanding, they customized the timing per patient in that study.

At the risk of sounding constantly negative, Hubert Lim/University of Minnesota collaborating with Dr. Susan Shore could be a disaster. It would likely delay the launch of Dr. Shore's device by years (on top of the years we are waiting now). Hopefully, collaboration can happen after we have a lot of real-world data after the device's launch.

 

[dj_newark]

At the risk of sounding constantly negative, Hubert Lim/University of Minnesota collaborating with Dr. Susan Shore could be a disaster. It would likely delay the launch of Dr. Shore's device by years (on top of the years we are waiting now). Hopefully, collaboration can happen after we have a lot of real-world data after the device's launch.

Dr. Shore's role in the device is mostly over (for now). I imagine she might work on refining it after release (or whatever team she puts together will). Since she retired from the University of Michigan, she joined UCI (University of California Irvine) and is apparently still working. She's in the same dept as Dr. Hamid Djalilian. The thought of those two working together is exciting!

 

[Markku]

Since she retired from the University of Michigan, she joined UCI (University of California Irvine) and is apparently still working. She's in the same dept as Dr. Hamid Djalilian. The thought of those two working together is exciting!

I was curious about this. What Dr. Djalilian told me today when I told him I'd like to update the community:

From what I understand, Dr. Shore has retired from the University of Michigan and is living in our area. She is affiliated with the UC Irvine Center for Hearing Research but is not on our faculty technically. I will be meeting with her soon hopefully but we haven't started working together yet.

 

[WilRic]

I was curious about this. What Dr. Djalilian told me today when I told him I'd like to update the community:

That is good news. It may indicate that she is focusing exclusively on Auricle in some capacity. She also might have just retired. In either case, I think people should still be hopeful. Most commercialisation of research projects fails at junctures that already look good for Auricle. They've secured funding and business guidance from that UMich programme. That is huge. Academics are terrible at business. It's really quite shocking given how smart they are. Very often research-driven products fail to launch because the academics suffer from a crippling case of "the perfect is the enemy of the good." They struggle to let go of the scientific method, and let the engineering method take over. Those sort of "startup" programmes inside Universities help with that. They're not powerhouses of commerce, so things go slower. But they avoid the risk of some dodgy private equity firm swooping in and ruining everything.

The radio silence is frustrating, but I'd be much more worried about ongoing media releases at this very early stage. That usually indicates that you're dealing with vaporware and the business is trying to get more capital by promoting interest.

 

[dj_newark]

I was curious about this. What Dr. Djalilian told me today when I told him I'd like to update the community:

Thanks for the update, @Markku! Maybe she plans to join the faculty at UCI in the fall. I guess we'll see!

 

[GlennS]

Susan Shore has managed this for 20 or so years.

The Moller Skycar approach.

 

[Bhaveen]

I've read this story, and with respect as I understand it, Hubert Lim knocked up some specialist machine that @kelpiemsp was miraculously cured by, went on to work with Neuromod's Lenire instead, and we heard no more about his invention? The whole thing sounds like fan fiction to me. I don't mean to offend anyone, but there's no hope in that. There is, however, hope that Dr. Shore's device will come to market and help many people. As far as I can see, and I stay pretty abreast of updates on Tinnitus Talk and elsewhere, it is the only possible genuine treatment anywhere on the near horizon.

As far as I can see, everything else is fairytales, unicorns, or a decade away.

The Moller Skycar approach.

Well, Dr. Shore could have decided to give up after a few years and looked at a research topic other than tinnitus. Where would we then be?