New University of Michigan Tinnitus Discovery — Signal Timing

Sorry, man, but that ain't chump change. Not to say she's a grifter but to suggest she's somehow slumming it at that salary is a bit much, especially considering we don't know how many hours she really "works" in a given day (and based on how long this has been in development, I'd guess nowhere near 8).

 

For once I agree with you.

 

Why UMich will not start selling its equipment in Europe without a permit, just as Lenire did? Any opinions?

 

I didn't say it's chump change, what I said was:

This project is not the only thing she has going on at UMich. Professors in general work at least 40 hour weeks. I know lots of software bros making a lot more money and working a lot less, because capitalism is kind of stupid in terms of how markets value one thing over another, but what does that have to do with tinnitus?

My point is $160K is not very much money if one is pursuing maximizing money as a goal, and additionally that someone with Shore's background could make more in industry. That's just a fact, and a reason it's very common for retired academics to take consultancy positions.

What are we arguing about, exactly? None of Shore's comp is based on the outcome of this research, per se, and the actual degree of funding the research has gotten, while much more than Shore's salary, is a tiny tiny slice of UMich research.

I'm unclear where your disagreement is. I understand people being skeptical of tech they haven't used, that's normal and seems correct, and also, as I have long said in this thread, these devices will not help everyone with tinnitus.

@GlennS, what are you upset about (if you are upset)? Do you think Susan Shore should make less money? Do you think you should be making more money?

I'm just not sure what we're even talking about at this point. $160K would have sounded like a shitton of money to me when I was working at a nonprofit for $27K a year; now I know people who make twice that and smoke pot all day touching computers and managing computer touchers, so, you could say my perspective is blown on that, but I also don't see what Shore's comp has to do with any of this unless someone is seriously suggesting she's a grifter which would be hilarious to me because going into academia to be a grifter would be like going into prostitution to practice celibacy.

As far as Shore getting rich -- she probably will if the device works and makes it to market, because she is the co-founder of the company that's going to be selling it (Auricle), as far as I can tell.

Does this upset anyone? That is, if this tech works for some percentage of tinnitus patients and substantially improves their lives, and that is built on the back of 20 years of research and fundraising efforts that Shore has driven, in a capitalist society isn't it correct that there be a financial reward for that kind of behavior?

I'm far enough left that I think all of this stuff (all medical research) should be publicly funded with the results publicly owned, but, we're nowhere near that world and we're not going to get there, so this capitalist dystopia is what we're working with. You don't wanna hear my real, deep opinions on any of this because I'll start screaming about universal base income and seizing the means of production away from the capitalist gang bosses.

Contrast what Shore has done (2 decades of published, peer reviewed research, animal models used to build new neurophysical model of tinnitus, which is then tested in animals, treatment devised, tested in humans, refined, tested in more humans, probably eventually marketed based on substantial body of evidence that clears FDA) to what Leneire has done (barely gotten approval for a device in the UK, then used that to market a basically different device that has almost no published research behind it, no peer review, and definitely won't pass FDA scrutiny in current state, also a bunch of questionable tech decisions like using Bluetooth).

In this light, the UMich effort looks like a completely normal research endeavor to me, like any number of other academic tech research endeavors I have followed over the years, and Leneire looks suspiciously scammy.

I understand people being upset with the generally slow pace these things move at, but I am at a loss about actual animosity towards Dr. Shore. I've spoken with her, she was a nice lady, she was willing to continue a dialog even when I made it clear I was attempting to replicate her work using DIY stuff, she has a full slate of responsibilities for UMich, her salary at UMich is $10K over the average for all UMich tenured professors, and she's done more to advance tinnitus understanding than all those other professors combined, even if Auricle never delivers a device.

I think so, it was only a 20 person trial -- 19 people within driving distance of UMich, and my dumb ass getting on and off an airplane every week all spring long I got to find out some cool stuff about Ann Arbor and even considered moving there, though.

COVID-19 slowed everything down (not just this effort, academic research across the board) but it does look like stuff is moving forward; one doesn't start forming named companies and naming other existing companies as tech partners until things are approaching some kind of market ready state.

https://innovation.medicine.umich.edu/portfolio_post/shore/

https://rosenmaninstitute.org/portfolio/auricle/

The second link has a video which contains a graphic of what the current generation of device looks like. It looks more like a finished piece of tech than the prototype device I used in the Phase-II, but it's the same basic thing, it does not have wirelessness, it doesn't look like an iPad like leneire, and I would spend twenty thousand dollars instantly (the limit on my highest limit credit card ) to have one in my hands right now.

 

Aaahhhh.

@GlennS I realize I just did my typical thing of writing a fricking book in response to something someone said, and also probably made an ass of myself and maybe didn't even explain myself clearly.

To cut the meat off and get to the bones of this -- I don't think you're wrong about anything, we're just looking at this from very different perspectives, and I have a very obvious bias because I've used this thing and think it works, and I know enough about the implications of that to understand that my own thinking here is suspect. Because I dislike my tinnitus a lot and I used this thing and I am convinced it worked, so, hey, my perspective as an objective observer is completely blown.

I am mostly curious what your objections here are, if there are actions you think Shore or the University should be taking which they are not, etc.

I'd like to see that 14mil, at this point, just get blown up into 50mil funding to fast track the shit out of all this. I also, in a former lifetime, worked in a tech incubator attached to a research institution, so I know how profoundly unlikely that is to happen, because for every dollar in the pot there are always 2-3 hands reaching for it, all with their own stack of peer reviewed data showing Their Project Is Important.

Fortunately, I am pretty sure that the Capital forces behind UMich have their eyes on this as a moneyball in the air, and therefore even if shore got vaporized in a random solar flare tomorrow, the march towards Product would go on It's not like she has secret knowledge, excactly because all of this has been run as a completely normal research product. Unlike secret corporate shit where the death of a couple deep-knowledge engineers could potentially derail a product, academia is fanatical about documenting results fully in a way that would let someone else repeat them. That's more or less the basis of the whole machine.

Conversely, if my entire development team were hit with a space laser today, my company would likely go "shit, those people knew a bunch of random shit, we should have been a lot more aggressive about documenting it. Oh well, better start over"

 

You make it sound as if I'm the only one on this board who is questioning her level of commitment to this project. Obviously you're biased because you directly benefitted from it, but meanwhile, the rest of us haven't, because it's been in limbo for years. I don't buy the idea that she has invested as much time in it as she should considering how compassionate and concerned she is supposed to be on this issue.

Apples and oranges but we got multiple COVID-19 vaccines in less than a year. I do not think the timeline of Shore's device reflects normalcy. It's been moving in slow-motion. The trial sizes have also been comically small. Lenire's trials, flawed as they may have been, were so much larger. Why? I don't like being a backseat driver but despite being a layman, this project doesn't seem to have been well run.

Doesn't mean it will be a failure, but if it is a success then its release date will have come many years after it theoretically could have due to how it was run. Maybe it's an entitlement mentality or my desperation talking but I can't pin a medal on Susan Shore if I feel that things have been moving needlessly slow for so long, effective or not.

Also, nobody has yet really gotten a suitable explanation from Shore as to why it's taken so long. She is hit mostly by softball questions without any followup, which bothers me. Not that she should be burned at the stake but there has been something fishy going on here for a long time and a bit of braver journalism, someone willing to burn some bridges, would probably have been able to get to the bottom of it by now. Instead we can only speculate. It's the itch that can't be scratched.

 

You can't compare a highly contagious and deadly virus with tinnitus, for starters. Those vaccines got the highest priority everywhere and lots of funding. Second, this isn't a vaccine.

Clinical trials simply take ages, I agree that the whole process should be assessed to understand how we can speed up trials in general. A promising drug for another disorder I have passed phase 1 trials a decade ago. Today they still haven't started a phase 3 trial despite generally positive results in their trials.

And we all know tinnitus (and hyperacusis & tensor tympani syndrome even more so) research is chronically underfunded. I fully agree that treatments like this or Otonomy's drug should have been released years ago. Unlike hearing restoration, the technology behind it doesn't seem that cutting edge. But they make do with what they have.

 

Apples and oranges indeed, but I'd agree that we'd probably have much better tinnitus treatments if the entire global medical apparatus dropped most other things for a year and spent untold amounts of money nailing it down. This is likely true for a number of conditions.

What "normalcy" are you basing this on? Does anyone have other examples of novel medical devices which have had a faster evolution?

Here's the timeframe I see:
Mid 2000s: animal research begins; DCN identified as target, treatments devised, animal testing.
2013: First major academic discussions in front of large groups I am aware of going over results.
2015: Human trials designed with an intended market window of 2020-2024 and UMich staff at the time telling me 2024 might be more likely but try to be patient and optimistic.
2016: Phase II
2018-present: Ongoing larger studies; formation of business entities; manufacturing pipeline exploration.

We're 2.25 years out from the end of the market window they had projected in 2015, before COVID-19 threw a monkey wrench into everything from resources to people's willingness or ability to travel for indoor studies to chip shortages impacting manufacturing.

Again, compared to what? Doing a 20 person phase 2 on people already afflicted with something is a cheaper way (and easier to get past the ethics boards) than a larger phase 2, and the resounding differences in the data provided the necessary hook to get funding for the larger trials necessary for FDA. This all seems very normal to me.

These are non-FDA sanctioned trials run by venture capitalists, who are deliberately operating outside of the US because they are exploiting prior device approval from a UK regulatory body. They have been so far unwilling to publish full data sets, and as far as I can tell are further behind in the FDA process than UMich. Additionally the anecdotal data we have from here isn't very inspiring, and as someone who has worked in venture backed situations there's a lot of things that look wrong to me; I'll change my tune if they deliver results after clearing FDA hurdles. Apples and oranges again, though.

I don't know where the perception that it's "taking long" is coming from, or such interviews. Can you cite some examples? As I said above, they appear to be on the same timeline they originally laid out in my first conversation with them in late 2015, and may even hit that despite the COVID-19 bumpiness.

If anything, I am even more desperately anxious to get my hands on the thing because I'm very sure I am a good candidate for this particular tech; I just also don't think anything here is being particularly slow-walked. EUA pandemic vaccines aside, it generally takes 10 years to get a drug to market from the first human trials; devices often move faster, especially if no surgery is required, but on the other hand our whole government is operating as slowly as anything else at the moment. 2024 would be amazing to me.

 

@linearb, during your trial, did the device stimulate both the neck and cheek or just one of them? If I remember correctly, a lot of the coverage stated it functioned using one or the other. But in the video the device has just one earbud and two electrodes.

Was that the same setup you used?

 

While I do have plenty of bullet points to offer to back up my frustration with this project--they aren't new arguments and I'm reluctant to run over old ground. I just think you haven't been keeping up on this thread. If you want to just ignore those points and simply say "this all seems normal to me" then there's nothing left to do but agree to disagree as we're just sharing our outsider opinions.

It's coming from just about everyone active in this thread.

Are you? If it already helped you, I take it the effect was only temporary? Why would you need to be treated again if this really rewires the brain as advertised?

Technology is changing and old timeframes don't necessarily predict the future anymore.

 

I didn't think this was supposed to to rewire the brain, I thought this was supposed to suppress the tinnitus precept, therefore when you stop using it the tinnitus precept comes back.

 

I am both sympathetic to, and vastly share frustration at knowing this technology exists, would be generally helpful probably, and helpful to me personally definitely. I'm just not actively upset by it, because it's tilting at windmills. There are reasons, good and bad, that these things generally and in this specific case don't move at a fast pace, but I don't think there's anything unusual or untoward happening here compared to any other normal research project, and a lot of the controls built in ultimately arise from concerns about safety and snake oil.

Er, who is "advertising" it as a permanent fix? I was explicitly told by the UMich staff to expect effects to be temporary if noticed at all; this is consistent with everything I've read.

It's certainly possible that longer term treatment could have a longer term effect. It's also possible that a plateau could be reached, or a tolerance could build to the effect. There's no way to know without trialing it in larger numbers of humans for longer periods of time. I am unclear if that's part of the ongoing phase-IIIs, or if it's just testing variations on the timing protocols, or something else; I kept up on this a lot for the year or two after the trial I was in, then got sort of swept up in other parts of life.

I think the general sketchiness of Leneire is a pretty good example of why this particular space should not be disrupted. To the extent that FDA regulations aren't already written by the industry and lobbyists, they exist to protect people from either being maimed by unsafe treatments, or wasting money/time on stuff that doesn't work.

The idea is that (some?) tinnitus arises from a miswiring at the level of the dorsal cochlear nucleus, where several cranial nerves are integrated, and that precisely timed audio and somatosensory stimulation tricks this region of the brain into unwiring these maladaptive changes.

This isn't actually restoring hearing, so if the trickery isn't used on a regular basis the maladaptive wiring reestablishes itself.

 

Neuromod certainly did in its initial trial hype, talking about how the effects were indefinitely long-lasting.

 

To GlennS:

To get me to sign on, Desyncra gave me the exact same assurances that "improvements" would be permanent.

 

To me this is even more reason to be skeptical of Neuromod and I wouldn't really conflate them with UMich for all the reasons mentioned. Even if the tech is similar, having it emerge from the VC landscape vs a research institution is a significant difference that leads to silliness like Neuromod using Bluetooth, a protocol designed to transfer audio data among consumer entertainment devices, to try to synchronize timing. It's not that it couldn't work, it's just needlessly ramping the difficulty in the interests of advertising a "cool" feature. Wires are fine, timing is very very precise when a signal is traversing a known length of metal wire with known conductive properties.

 

@linearb, I appreciate all the commentary you provide to the discussion, especially given you prior experience. I just wanted you to know that.

 

Having tragically been here long enough to know how the spirit of these threads tend to swing from optimistic to pessimistic, and I just wanted to repost the link of the 2018 paper to remind everyone what we are talking about. It is hard to read this and not feel hope that we are on the cusp of a real and effective treatment, not a handwavy subtitle change in THI habituation effect in a noncontrol group study, but something that will substantially decrease the noise in a lot of our heads.

Auditory-somatosensory bimodal stimulation desynchronizes brain circuitry to reduce tinnitus in guinea pigs and humans

 

I can attest to that.

 

How long did the results last for? How big was the improvement?

 

And what was it like when the tinnitus came back? I like a glass of wine in the evening or a beer now and again. It doesn't seem to spike my tinnitus the following morning. But they say now that alcohol destroys your REM sleep --- not good if you are reduced to four -- four and a half hours a night. Another of life's pleasures destined for the back-burner?

 

The average improvement as measured objectively was a 6-10 dB reduction which means cutting the noise in half. That's probably consistent with my experience, but the more dramatic thing really was that it moved the sound from the forefront of my consciousness to the background (a thing which the Klonopin I now take also does, just not as well).

The effect wore off within days of cessation of using the device, and IIRC there were some spikes as tinnitus came "back online".

 

How much time per day did you have to commit to the the therapy?

 

30 minutes, but you can read or play video games or whatever.

 

Sounds completely doable.

 

Wonder what happened to the Republic campaign + website launch...

 

Can't you ask the CEO of Auricle like you did before? I wonder if Republic rejected their application?

 

I did. Got nothing back :/

 

Is there any thought that Dr. Shore's device might provide relief for hyperacusis?

 

I have been working in IT for 17 years. Everything from server administration to now security engineering. I guess I have never thought of myself as a computer toucher. It kinda sounds like the computer isn't consenting to what I am doing and I should be jailed. To be fair the operating system told me it was over 18. It just had a bunch of unpatched holes. Couldn't contain myself.

 

According to the patent filings it can help hyperacusis. Some of the DIY people who have created similar devices have reported a drop in hyperacusis along with tinnitus.