New University of Michigan Tinnitus Discovery — Signal Timing

@ChrisBoyMonkey First of all thanks, just hearing that put a bounce in my step.
Did she communicate this directly to you? When did you get that missive?

 

You're very welcome. It's what I aim to do, spread science-backed and realistic positivity. Right now, all of us sufferers need this.

Yes I emailed her. Anyone can email her, here is her info:
https://medicine.umich.edu/dept/khri/susan-e-shore-phd

 

If you feel you're armed with more info then you should share it first before I answer that. You know, maybe draft out a timeline of major events, things like that. But I'm hardly the only TT member who feels she's moving too slowly.

 

I finally found the actual results of her first trial. It's real great stuff. I've quoted the best part for you guys. I think Neuromod's average reduction was 7dB or so after 12 weeks. Keep in mind her current trial is now doing the treatment up to 10 weeks and she has said the effects appear to be cumulative.

"Tinnitus reduction reached an average of 12.2 dB in the fourth week of active treatment. Of the 20 participants tested, 2 reported complete elimination of their tinnitus toward the end of the active treatment period."

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

 

Everything I said in that post, I have said in this thread several times. I posted a complete timeline of my experiences shortly after completing the study, and I have also posted summaries or copy/paste of whatever significant interactions I've had with them along with my understandings at those times of their timelines communicated out... which has basically been a static, unmoving target.

I was under the assumption that you had read most of the thread, and had some specific fact-based grievance. Many TT members may feel she's moving too slowly, just as most of these people think the moon landings were faked and all of them believe the earth is flat. "A bunch of people believe a thing" is rarely a good reason to do so.

I get that you might not have time to read every page of a long thread that goes back 4 years; I'm sure you can understand that I also am not very interested in reposting in detail stuff that I had a better memory of ~2-3 years ago when I posted it. But, it's here in this thread and should be pretty easy to find. I believe I did the study in the spring of 2016, and was pretty quiet about it while I was in it and then posted some meatier takes on my experience immediately after. Info about subsequent contacts is just going to be peppered in here.

If peoople want to be mad at her, or think she's dragging her feet or whatever, by all means. I do not think it's a reality based view, and I am fishing for some kind of informational basis for that viewpoint.

 

I am glad someone shares my happiness

I was driving my ongoing communication with them; as an ex-test subject they were happy to continue the dialog and keep me in the loop as much as was allowed, but as I got increasingly wrapped up in my own life over the past couple years I let those lines go dead.

Shore never used those words. A lab clinician told me (paraphrasing now, 4 years ex post facto) that "if we end up helping a sizeable minority of people we will take that as a huge success. We don't expect this to work for 100% of people. We do think that there may be people who will eventually be candidates, based on stimulation of deeper or other nerves, but we're starting with people who are face/neck/jaw somatic because pragmatically that is a large percentage of the tinnitus population and also those nerves are easy for our tech to access".

80% of people have somatic involvement, per Dr. Salvi's studies at UB in the late 80s. But, there are just so many unknowns here -- I am basically trying to take the most cautious, cynical, pessimistic view that I possibly can as someone who is high on the tech because I used it and thought it made my head significantly quieter (and their objective volume matching agreed, which is more interesting to me than THI scores by a lot). I am heavily biased by my own experience, and I also think that there are definitely going to be some people left out to dry by this even if it works really well, some of those people will be the sort of end-of-the-road worst case scenario suicidal ideation types we see here -- and so we should all be pretty up front about that. My own gut is, if we could put a properly calibrated one of these things into the hands of every poster here tomorrow, I bet in a year there would be a lot less active posters here, but there would still be a lot.

I see you found the study itself; I thought it was really hopeful but limited by smaller sample size. Leneire claims their dataset is huge, comparatively, but in that case we're limited by VC backed for-profit co which so far is just releasing cherry picked stats and pretty graphs, and not complete data sets and protocols for peer review AFAIK. So, I trust the integrity of the UMich data a lot more, and they have tons of it on the animal side... but so far, just this one published report of 20, with a larger study ongoing.

 

it means that the longer the device is used, the stronger the effect is

this is a significant finding in the Phase-II, if true, because the Phase-I was limited by only being 30 days in length

 

I really do!

I think she's doing the best she can as someone who has it herself and empathizes with the sufferers. Fortunately, if she is saying the effects are cumulative, I'm thinking some of those who were none responders before would start seeing some benefit. Overall, this looks like it will help at least the majority of the somatic sufferers.

I agree that UMich seems much more reliable than Neuromod in terms of effectiveness, but Neuromod has also been pretty transparent that their device is nowhere close to a cure for most cases, but is rather a treatment to reduce it. You are right about their data taking so long for release, but that might be why they have Dr. Lim working for them, they might just be having trouble putting the data together, not exactly that they are trying to cherry pick it. I think it's still awesome that most people are still seeing improvements from their device, and at least some lucky people are seeing cure level results.

 

Can anyone comment on whether I am correct in understanding that Susan Shore's concept is fundamentally different than Lenire's in that she focuses on desynchronizing brain circuitry to reduce tinnitus while Lenire seems to focus on disrupting the neural networks to encourage neural plasticity.

From my 3 mile high reading of this she focuses on calming the actual activity that causes tinnitus (at least in some people) and Lenire focuses on giving the mind the opportunity to form new pathways.

Are these the same idea but using different vocabulary or is the approach fundamentally different?

 

Fair enough. When I have enough time on my hands I'll read through the entire thread.

 

She should have sought a commercial partner after her successful results following the trial you were involved in. There'd have been a few takers considering the positive results she achieved. She's only just announced one recently. She's dawdled alright. No rush.

Compare Frequency Tx to Dr. Shore's efficiency. They've already signed up international investors and distributors. And they haven't even published any formal empirical evidence of tangible success yet. And they've applied for and been granted fast track status, before phase two has even commenced. That's what I'd call a motivated organisation trying to get their product into the market as soon as possible. With greater risk of failure than Dr. Shore's device too.

Yes I do feel comfortable being mad at her. Ten years is unnecessarily long for trialling a non drug mechanical machine. Being mad at her won't do me any good of course, but this thread is an excellent place to vent.

 

She certainly had one, and afaik the commercial partner that she has now is the same one she had prior to that trial. Afterall, someone had to make the trial devices. It is the same company that made the Phase II devices. You think UMich is set up to fabricate their own medical devices? Nerp, they've had an FDA approved partner since day 1.

Cool, so you think a company which you straight up admit is vaporware at the moment, is doing better than a company in phase-IIs with published RCTs? I am very comfortable saying that some form of bimodal stim will beat Freq to FDA approval in US.



People who are willing to take tons of VC dollars without any published whitepapers arise deep suspicion on my part. Now they have a huge impetus to hit market and profitability without having actually demonstrated any efficiency or safety. Spider sense tingles, bat signal is flown over Gotham, etc. This is sort of the same state Leniere is in except they're actually at market and also say they have the data and published a bunch of pretty pictures from it, but no RCTs I am aware of.

You do you; I find that holding on to anger across the board is a harmful thing for me to experience, but I'm hardly trying to stop anyone from venting. Like I said, I was fishing for a rational or factual basis for that anger here, and I'm not finding any, yet.

By all means, continue directing your anger against the handful of people actually trying to help us, instead of the thousands of companies that are actively making the world louder and more full of ototoxic pollutants and otherwise more dangerous for us. Makes sense to me!

I am going to ask you the same things I asked the other person who made this comment:
* how many device trials have you followed closely?
* how many device trials have you been involved in or administered?
* how long does it usually take for an entirely new medical device to go from whitepaper -> product in the US?
* can you name some examples of other entirely new medical technologies requiring FDA approval which went from a whitepaper animal model to a human-use technology in a faster timeframe?

If there were some evidence that, you know, "medical devices in general go to market 50% faster than UMich's timeline", we could have that conversation, but it's not.

It takes 3-7 years to clear the FDA process here. To begin the FDA process you have to have a candidate device. To have a candidate device you have to have done a bunch of "other work".

Believe me, no one wants this thing faster than I do, because like I said I used it and I know it substantially suppresses my tinnitus. If I thought the UMich people were doing anything less than everything in their power to bring me relief, I would also be quick to throw them under the bus.

 

One what does it matter if Freq is not yet approved by FDA but approved in Euro or Asia. It would be available somewhere where a person could travel to. And why do you think Freq which has gone from Stage 1 to 2a in less then 3 years would take longer to get to Stage 4 then a group that has been working over a decade and is still at Stage 2. Regardless of whether it works if the device is not available in then its worthless. And based on their history we should not have confidence it going to be available in the next 5-7 years.

 

@linearb you said before that you were the best or one of the best responders to the treatment.

https://news.umich.edu/specially-ti...toms-in-test-aimed-at-condition-s-root-cause/

This article says 2 participants said their tinnitus completely disappeared. You didn’t seem to indicate yours went away completely during treatment.

Also, do you know if those who reported their tinnitus went away had it return after treatment cessation?

 

Could someone explain “why,” why it takes so long to test a non-invasive device? How is this any different than a muscle massager, or stimulation device?

Why can’t they waive any liability and let people have access? “Right to try” legislation for terminal patients allows any drug to be used to save a life, and I think many I here with severe tinnitus consider themselves terminal.

 

I don't think bi-modal stimulation is a harmless treatment, as it's easy to go wrong with this stuff and the device could worsen your Tinnitus, if it's not working well. This device is being tested as a medical device that is meant to help with Tinnitus, and it probably wouldn't be allowed to be commercialized, untill it is proven effective. In The US, the device will need FDA approval to get permission for commercialization. To get FDA approval, you need to have done a few phases of clinical trials.

Linearb participated in the early phases of the clinical study. I think that linearb already asked them, if he could continue using the device after his trial phase ended, but he was refused. He couldn't participate in the next trial phase, because his home was apparently too far from Michigan. So, I guess that you either have to participate in the on-going trials, or you will have to wait for the product to be commercialized, if you want to use the device. This is probably due to safety reasons or something.

It's also been mentioned, that University Of Michigan has been looking for a Tinnitus cure for like 20 years now, and obviously, they are not in a big hurry to get their device out, as soon as possible. It seems that the device will be as effective as it can be, when it will be commercialized, and this is like the main objective.

Everything else is mentioned by linearb himself, like 3 posts above.

 

Does this treatment have known side effects? Could our brain lose some ability if we use the device for years?
Just wondering.

 

No adverse events at all so far, not even temporary worsening of ringing. It's all safe so far.

 

That's my argument here. Dr. Shore has taken the seven year (and probably will be longer) route, rather than the three year one.

I don't believe the earth is flat or that the moon landing was fake. Just that she's taken a long and not particularly efficient road to get to the point she's at today.

Whatever commercial partnerships you say she's created, don't seem to have any money. In the end, she applied for and had to wait for cash to conduct the current trial from the NIH Brain Initiative, not primarily private investment houses, as Neuromod and Frequency have.

I'm not throwing her or her work under the bus, just expressing that she's not displaying the urgency or fundraising initiative that other setups show.

Neuromod managed to raise $6 million in capital, with less convincing results than Dr. Shore. Frequency raised $80 million or more. They're who I compare her to.

Maybe it's just a reflection of a teaching academy's approach to research. It's cumbersome and slow. There's classes to teach, academic obligations to fulfill, funding grants to apply for, Phd's to supervise. Who knows?

I just see the difference in her approach compared to Neuromod or Frequency. Frequency, if it doesn't bomb, will come out way later than Dr. Shore's machine, but look at them go.

Frequency began Phase 1 in December 2017/January 2018 and will be finished Phase 2a in 2020. Three years. For a drug. Dr. Shore says she will be finishing her Phase 2 in 2020, which she brought forward after scaring everyone with an original 2023 end date. Both outfits reaching the same end point, but just look at how long it took her to get there. And I'm nervous it'll go longer.

That's all I'm pointing out here. I'm not going to count peer review, FDA approvals, setup and distribution to commercial outlets etc. I've still got my spot in the cheer squad though, along with everyone else. I just wish she'd hurry the f#%* up!

 

In a past life I worked as an academic researcher in a large state university in ecology. I don't know how much of my experience crosses over into the mental frame work of folks working in the medical field, but when I was developing studies, doing research, and getting papers published the metric wasn't how fast I could get it done but how comprehensive and bullet proof my studies were. That's what mattered. That is what would get me my next job.

What I mean to say, and I say this as someone who is really not enjoying his Tinnitus at all, is that if her academic perspective is similar to what I had as an academic researcher then her top priority, job, and career is to develop and execute studies that furthers science's understanding and can stand up to rigorous challenges from all comers, not get a product to market ASAP.

That being said and having just reread her really impressive results section, for the love of God get a product to market soon please!

 

One last thought. It might also be taking so long because of the safety piece of this. Perhaps it is a matter of paying the devil now or paying him later. I don't know really anything about FDA approval of medical devices relative to safety, but maybe she is required to have people in her current protocol under observation for a year or more to establish the safety of the device. Perhaps if she doesn't do that now the government would require it later?

Even though this is an external device, it is playing with how the brain works. It would be a shame to find out that there is a neurological side effect from long term use only after tens of thousands of people had used this in the wild.

 

i dont think i really understand this. i dont see the connection between somatic and noise induced.

 

I don't think anyone truly grasps that yet, but we do know that the body has more input than just the ears where it comes to sound processing (e.g. bone conduction), and it also has been known for some time now that input from the neck is processed in the DCN as well. So the "how" is still vague, but the relation is definitely there.

 

@linearb

When you were in the Michigan study, were you testing two devices - conceivably a “real” device and a “placebo” device?

Having a hard time understanding how they designed this to get a scientifically reputable result? Feels like it would be fairly easy to tell which device is which as one likely didn’t have electrical Stimulation.

In the Lenire interviews, they said they did not test a placebo in their trial because it would be extremely difficult to mask which one was placebo and thus, only tested their actual device and protocol.

Curious on your take.

Thanks!

 

https://news.umich.edu/specially-ti...toms-in-test-aimed-at-condition-s-root-cause/

“After patients had the device calibrated to their own tinnitus symptoms, they learned to apply its earphones and electrodes for a 30-minute session each day. Half the group received the bimodal sound-and-electricity treatment for the first four weeks, while the other half received just sounds. Then, they all took a four-week break, and started the next four weeks receiving the opposite of what they’d received before. None of them knew which option they got first.”

 

"To their own tinnitus symptoms", does this mean that the machine must be adjusted according to the frequency of our tinnitus at each session?

 

No. The device sound can be updated like once every 4 weeks or even less frequently. That's also the case with Lenire device.

But, your tinnitus loudness could be significantly decreasing during those 4 weeks.

Also, in the safety tests of this device, the researchers obviously didn't know what kind of tinnitus frequency did the guinea pigs have, but the guinea pigs still showed signs of improved tinnitus, after using the device.

 

Quite the remark, that's actually an easily overlooked fact. I'm trying not to get my hopes up too much, but assuming the human trials are indeed as positive as we're hearing so far, the Michigan device could really end up being a big thing.

 

One callout on that; every one of these guinea pigs got tinnitus the same way. Us humans have a large variety of root causes for tinnitus, which adds variability into potential efficacy. But I fully agree - this is a really great remark and I’m excited to see this device launch! Feels like the strong science on this one is a real tailwind.

 

The physician wants me to get an MRI before I start the trial. I never had an MRI done before. Should I get it done?