New University of Michigan Tinnitus Discovery — Signal Timing

[Fabrikat]

Perhaps the people that could be prodded gently are the board running the University Of Michigan.

Do they realise that a department on their campus has a medical advance potentially worth hundreds of millions of dollars to their bank accounts?

Why aren't they prioritising it's commercialisation? Do they realise other labs are working diligently to bring potential therapies to market? That their window of opportunity may not be large?

Perhaps they do know and simply don't think these sorts of considerations are very important to a teaching institution.

 

[F-u-T]

Is there an actual explanation about why tinnitus happens and how and why this signal timing stuff is effective?

Have you read this Scientific Article on the Shore research/ device?

https://stm.sciencemag.org/content/10/422/eaal3175

 

[Stefaniie]

It looks like it's not as a big concern for her device to me.

I also think her device is probably being looked at by the FDA right now, or if not will be soon. Maybe if we all email them and blast their higher channels we can influence a faster approval? I've emailed them before, I can provide a rough template from what I've used before.

I assumed her device would have similar hearing requirements as Lenire since they're essentially (at least to my knowledge) the same device/concept.

Hoping I'm wrong, though. With as much time as she's spent on her research, maybe she's figured out a way for her device to work for more... difficult hearing losses.

Definitely post the template.

 

[JaysterT]

Hi Chris, can you let us know where to send the email for the FDA and also provide your template?

I'd be willinf to email with you.

 

[ChrisBoyMonkey]

Hi Chris, can you let us know where to send the email for the FDA and also provide your template?

So I modified what I used a bit, and yes this is open to suggestions:

Dear FDA and staff,

I'm a tinnitus sufferer and I urge you to please look into prioritizing evaluating possible treatment avenues for this disease. This disease has quickly significantly reduced my quality of life to the point of helplessness, and would like nothing more to have my life back. This is more than just an annoying sound in the sufferer's head. It is a mental torture that too often brings even more symptoms to further reduce quality of life. Most commonly, this is a lack of sleep, which is detrimental to our health and well-being.

Because of the lack of treatments, any and all potential treatments should be given priority, even special fast tracking, as there currently is no treatment available. Treatment for the symptoms is not a real treatment for the condition, and do not help everyone much.

Please look into new treatments for tinnitus with priority before it is too late for some of us who are just holding on. Though often neglected, suicide too often looks like the only form of relief from this unbearable condition, and lives are literally on the line.

Tinnitus treatment should have been achieved years ago, but it is not too late for the FDA to help put an end the suffering of us tinnitus patients the right way by giving special consideration for the new waves of sciences that are targeting treating the condition itself, not only the symptoms.

Sincerely,

****

This is the email regarding the FDA department that evaluates medical devices:

DICE@fda.hhs.gov

As a bonus here is the FDA drug department email, but I don't think we have any potential drug treatments applying for approval in the near future:

druginfo@fda.hhs.gov

 

[Simon Czt]

As a bonus here is the FDA drug department email, but I don't think we have any potential drug treatments applying for approval in the near future:

druginfo@fda.hhs.gov

There is OTO 313 as a drug that targets tinnitus.

We also have FX322 and OTO 413, but this mainly targets hearing loss and hidden hearing loss, so for these two drugs, knowing if it will reduce tinnitus or not is just speculation unfortunately.

 

[ChrisBoyMonkey]

There is OTO 313 as a drug that targets tinnitus.

We also have FX322 and OTO 413, but this mainly targets hearing loss and hidden hearing loss, so for these two drugs, knowing if it will reduce tinnitus or not is just speculation unfortunately.

Yes but FX-322 will be at least 2-3 years (though not sure if it helps tinnitus yet) and OTO-313 we don't even know if it works yet, it's barely in phase 1, so that will probably be even longer...

What I'm hinting at and am targeting FDA DICE is for bimodal neuromodulation, which might be right around the corner (maybe 1 year for the Michigan device, hopefully less for Neuromod).

 

[Fightthearmy]

Dear FDA and staff,

I'm a tinnitus sufferer and I urge you to please look into prioritizing evaluating possible treatment avenues for this disease. This disease has quickly significantly reduced my quality of life to the point of helplessness, and would like nothing more to have my life back. This is more than just an annoying sound in the sufferer's head. It is a mental torture that too often brings even more symptoms to further reduce quality of life. Most commonly, this is a lack of sleep, which is detrimental to our health and well-being.....

The FDA staff will throw your petition straight into the trash bin. The FDA is "the fastest and most efficient drug-review program in the world" said FDA chief David A. Kessler. His crew does not believe it needs to be sped up!

 

[Cal18]

The FDA staff will throw your petition straight into the trash bin. The FDA is "the fastest and most efficient drug-review program in the world" said FDA chief David A. Kessler. His crew does not believe it needs to be sped up!

Perhaps we should remind them of the billions of dollars that get paid out to military related disability for tinnitus each year that could potentially go towards their salary.

 

[Fightthearmy]

Perhaps we should remind them of the billions of dollars that get paid out to military related disability for tinnitus each year that could potentially go towards their salary.

David A. Kessler isn't interested in your arguments.

Their livelihood doesn't hinge on "petty little things" like that.

 

[ChrisBoyMonkey]

David A. Kessler isn't interested in your arguments.

Their livelihood doesn't hinge on "petty little things" like that.

It's better than not doing anything at all. I'm sure you've heard of the analogy about the squeaky wheel.

 

[Fightthearmy]

It's better than not doing anything at all. I'm sure you've heard of the analogy about the squeaky wheel.

The problem is people like D. Kessler. They need to be removed from positions of power by any means we can envision and propose.

 

[Bndsmheowqhe]

https://innovation.medicine.umich.edu/wp-content/uploads/2019/03/Shore-flyer-1.pdf

 

[Otana]

https://innovation.medicine.umich.edu/wp-content/uploads/2019/03/Shore-flyer-1.pdf

Saw that on Reddit too. Looks like it's from August 2018 though.

 

[Autumnly]

https://innovation.medicine.umich.edu/wp-content/uploads/2019/03/Shore-flyer-1.pdf

"Significant Need
Some tinnitus cases are severe—some 6 million people cannot work or perform daily tasks because of the tinnitus or distress from the problem. Current therapies in the clinic have not definitively been shown to reduce tinnitus loudness or treat the underlying cause."

Didn't the number use to be 2-5 million people in the US? It's insane how high the number of severe tinnitus sufferers is.

 

[EDDTEKK]

Susan Shore... when the hell is she going to commercialize her device.

 

[parsky]

Susan Shore... when the hell is she going to commercialize her device.

She won't. My bet is the University will likely look for someone to license the tech to that will commercialize it. Notice on the last page "Product Launch Strategy - To be determined by licensee". Commercializing and manufacturing a product requires a completely different skill set than getting something through trials.

 

[ChrisBoyMonkey]

She won't. My bet is the University will likely look for someone to license the tech to that will commercialize it. Notice on the last page "Product Launch Strategy - To be determined by licensee". Commercializing and manufacturing a product requires a completely different skill set than getting something through trials.

I think the point of the question is when her device commercialized, whether by her or a licensee.

If we're lucky it could be as soon as the 2nd half of 2020.

 

[Dizzyhead888]

Can someone who is following this thread well answer the following:
1. Do we have testimonials of people getting noteworthy reductions from this device and other evidences? and how much failed?
2. When would it be released to the market?

 

[Jim51042]

Please stop commenting on this thread. Whether or not timing is effective no device will ever be made from this "Work". We should all move our focus to groups who don't waste time and thus are more likely produce.

 

[linearb]

Good lord, what happened to this thread? How did UMich go from being seen as one of the bimodal pioneers to suddenly being treated with.... suspicion, and viewed as illegitimate?

I realize that cynicism and pessimism can go hand in hand with tinnitus, but where are some of these insane ideas even coming from?

Please stop commenting on this thread. Whether or not timing is effective no device will ever be made from this "Work". We should all move our focus to groups who don't waste time and thus are more likely produce.

what are you smoking, and where can I get some? This group has produced the research that bimodal stim is based on, as well as performing the first bimodal trials for tinnitus on humans in the US. This is one of the only groups in the world that are actually "doing something".

She won't. My bet is the University will likely look for someone to license the tech to that will commercialize it. Notice on the last page "Product Launch Strategy - To be determined by licensee". Commercializing and manufacturing a product requires a completely different skill set than getting something through trials.

this is true, but as has been said many, many times a medical device manufacturer has already had contracts executed and the same company which built the prototype devices used in the trial, will produce commercial units once FDA clearance happens. I don't remember the name of the company off hand, but it's not secret, and I'm pretty sure you'd find if if you mined my posts here.

Can someone who is following this thread well answer the following:
1. Do we have testimonials of people getting noteworthy reductions from this device and other evidences? and how much failed?
2. When would it be released to the market?

Read the thread, read the thread, read the thread. Yes to #1, I am one of them, and we've got at least one other person who was in a similar trial at the University of Minnisota who said the same, and last I heard we had a couple people who might be in the current UMich trial, but I haven't been following the thread. I just opened it today and it seems to be pages of people projecting doom-and-gloom for basically no reason that I'm aware of.

I have stayed loosely in touch with the lab since I was a lab rat 4 years ago, and they have given me the same story all along: Phase-II ongoing with potential market as early as 2020, but that involves a lot of things going very right and getting FDA clearance before all trials complete. As early as ~2014, they were telling me that a launch window was "probably 2020-2024", and I don't see anything that's materially changed that?

Susan Shore... when the hell is she going to commercialize her device.

Uh... do you have a general understanding of the path for getting a new medical device from "idea" to "prototype" to "FDA paperwork" to "commercial device" to "commercial device that insurers will pay for"? If anything this is moving very fast compared to how long it would take a drug to go from idea to market.

tl;dr UMich told me in 2014 they expected to have something on the market "between 2020 and 2024", they were up front at that time that 2020 was a stretch goal based on being able to clear FDA before all trials completed, and this is the same basic information they're projecting today. So, they seem to be very consistent to me, they've published more actual RCTs on this than Neuromod (and much more recently), and the only thing that seems inconsistent is whether this thread is treating Shore as the second coming of Jesus or a laughingstock, which seems to vary day to day for reasons I am very unclear on.

 

[all to gain]

@linearb

I haven't read the thread, but I read in another thread that you were part of the trials and that you had 18 days of calm tinnitus.

What do you mean by that exactly?

How did you get on the trials if you had had tinnitus for more than one year?

Sorry, you've probably covered this elsewhere, I'm a newbie really.

I wonder if Dr. Shore looks in on the forum from time to time.

 

[Autumnly]

I found this comment from a person who was in the clinical trial of the Susan Shore device. I can only say they are working slowly. I did not get any further response.

View attachment 32098

 

[MattS]

@linearb: you really obtained silence from the bimodal process? That's pretty amazing. Truthfully, I'm pretty skeptical of the technology, but if it worked for you, then it's impossible to deny that it's likely to work for some, at least. Which is fantastic.

I'm just speaking off the cuff here: but my guess is that neither the full optimism (@John Mahan), not the full pessimism (many) is warranted. Rather, the device seems most likely to work for some, and to fail miserably for others. This is because the vagus nerve is likely implemented in some, but not all, of our tinnitus experiences. This suggestion is even borne out in Dr. Shore's groundbreaking animal work, where on average animals showed a decrease in tinnitus-related metrics. The on average is critical to remember - it means some animals responded better than others.

That's not intended as a critical statement. As I said, it's the good (success for some) and the bad (not for others) all at once. The question is what proportion will see a clinically-significant improvement, and obviously that won't be known until it comes available. For now, I just wanted to accurately frame everyone's expectations of the treatment, to perhaps curb the pre-treatment optimism and post-treatment frustration. There's often a lot of confusion around the nature of Phase I/II/III trials, how to interpret the results, what a "successful" trial means, etc., etc. Having fair expectations going in is the best way to prevent surprise/confusion throughout the process.

 

[GoatSheep]

@linearb: you really obtained silence from the bimodal process? That's pretty amazing.

where did you see this stated? This is a long thread to dig through so I'm just curious.

 

[MattS]

where did you see this stated? This is a long thread to dig through so I'm just curious.

Somewhere somebody implied that @linearb had *previously* indicated that he experienced some silence. Can't remember who/where exactly, but doesn't matter really because it was pretty much 3rd-party hearsay. I'd want confirmation from linearb himself if possible ..?

 

[GoatSheep]

Somewhere somebody implied that @linearb had *previously* indicated that he experienced some silence. Can't remember who/where exactly, but doesn't matter really because it was pretty much 3rd-party hearsay. I'd want confirmation from linearb himself if possible ..?

He says significant here. He doesn't mention silence. Perhaps somewhere else.



Also of note he said the device is continuous use or period use in direct response to me.
Which is different than the perception of Lenire on here.

And around 48 hours after cessation of use he began having his tinnitus return to previous levels.

I don't know what this means for the final product.

 

[ChrisBoyMonkey]

@linearb: you really obtained silence from the bimodal process? That's pretty amazing. Truthfully, I'm pretty skeptical of the technology, but if it worked for you, then it's impossible to deny that it's likely to work for some, at least. Which is fantastic.

I'm just speaking off the cuff here: but my guess is that neither the full optimism (@John Mahan), not the full pessimism (many) is warranted. Rather, the device seems most likely to work for some, and to fail miserably for others. This is because the vagus nerve is likely implemented in some, but not all, of our tinnitus experiences. This suggestion is even borne out in Dr. Shore's groundbreaking animal work, where on average animals showed a decrease in tinnitus-related metrics. The on average is critical to remember - it means some animals responded better than others.

That's not intended as a critical statement. As I said, it's the good (success for some) and the bad (not for others) all at once. The question is what proportion will see a clinically-significant improvement, and obviously that won't be known until it comes available. For now, I just wanted to accurately frame everyone's expectations of the treatment, to perhaps curb the pre-treatment optimism and post-treatment frustration. There's often a lot of confusion around the nature of Phase I/II/III trials, how to interpret the results, what a "successful" trial means, etc., etc. Having fair expectations going in is the best way to prevent surprise/confusion throughout the process.

Her device is stimulating more than just the Vegas nerve, she also goes for trigeminal. Specifically, the device is supposed to stop unruly fusiform cell activity in the dorsal cochlear nucleus, which is where the over 15 years of research is pointing to be the cause of tinnitus. What she is more unsure of is if it helps those without somatic tinnitus. Thankfully, it seems post people's tinnitus is somatic.

 

[Heinrich_S7]

Her device is stimulating more than just the Vegas nerve, she also goes for trigeminal. Specifically, the device is supposed to stop unruly fusiform cell activity in the dorsal cochlear nucleus, which is where the over 15 years of research is pointing to be the cause of tinnitus. What she is more unsure of is if it helps those without somatic tinnitus. Thankfully, it seems post people's tinnitus is somatic.

It also appears that the Michigan Device's effects kick in much faster but dissipate after several days. I wonder why this is. Lenire seems to be aiming for long term treatment with long term reduction?

I can modulate my tinnitus and it fluctuates so I'm certain mine is somatic as well. I'll probably get Susan Shore's product over Lenire. Based on the reports so far, Michigan sounds superior at the moment.

Hopefully Dr. Shore runs a bit faster to get this thing in our hands!

 

[MattS]

He says significant here. He doesn't mention silence. Perhaps somewhere else.

Thanks.

Her device is stimulating more than just the Vegas nerve, she also goes for trigeminal. Specifically, the device is supposed to stop unruly fusiform cell activity in the dorsal cochlear nucleus, which is where the over 15 years of research is pointing to be the cause of tinnitus. What she is more unsure of is if it helps those without somatic tinnitus. Thankfully, it seems post people's tinnitus is somatic.

Thanks Chris. I just took some time and read a couple of Shore's recent papers - her 2018 pre-clinical trial of bimodal stimulation, and her 2019 Neuron review (which is a tougher read, to be sure). I now have a much better understanding of her work, theory, technique, etc. It's promising for sure. Though the fact that the tinnitus percept comes back almost immediately upon stopping bimodal stimulation is a bit of a bummer. Particularly since the long-term effects of the technique are unknown (meaning it may or may not be suitable for lifetime use).

So, she's promoting LTD in the cochlear nucleus. I think her Neuron review implies how this is done. Has no one tried to recreate her pipeline? Test it out?