New University of Michigan Tinnitus Discovery — Signal Timing

[DaveFromChicago]

What occurred to me:
If this Bimodulation has such potential, then why is it being developed in only such relatively isolated sites as Dublin and a small city in Michigan?
Why aren't at least a dozen major University/Research Centers in the largest metropolitan areas competing for the first, best product?

 

[Josdela]

What occurred to me:
If this Bimodulation has such potential, then why is it being developed in only such relatively isolated sites as Dublin and a small city in Michigan?
Why aren't at least a dozen major University/Research Centers in the largest metropolitan areas competing for the first, best product?

It's simple, there are other health conditions that interest them more, tinnitus is not a nuisance to the medical, scientific and university community.

 

[GlennS]

I wonder why everybody is so hyped about this

I think you answered your own question. Hype is about wishful thinking about what something is rather than the reality. Now that the hype bubble is bursting for Lenire, hope is shifting here.

 

[thinlay]

hope is shifting here.

In the good or the bad sense?

 

[GlennS]

In the good or the bad sense?

I dunno. Both? I feel like the epitome of tinnitus coping mechanisms is to hold onto hope for treatments even if down deep you know it's a longshot. I know it helps me get through the day.

 

[thinlay]

I dunno. Both? I feel like the epitome of tinnitus coping mechanisms is to hold onto hope for treatments even if down deep you know it's a longshot. I know it helps me get through the day.

Science is moving very fast.

 

[MRItechssuck]

For people that have had tinnitus for 20 years, no... science is not moving very fast... not at all, in my opinion.

For an allegedly prolific issue... I see zero commercials or mentions of tinnitus, or the loudness of anything.

You would think with everyone wearing their little earpods, someone would caution against hearing damage, but sadly no.

I knew 20 years ago the damage that walkmans were doing to hearing... yet I still see new people with headphone hearing damage every week on this board (and I have been a member for 5 weeks!).

Industry is not on our side... when there are $3000 hearing aids, supplement manufacturers, dumb ENTs raking in the cash, rap stars blasting their music on tv... yeah... aside from a handful of researchers looking for gov handouts... we are left on our own.

We will never compete with the profits.

 

[ChrisBoyMonkey]

What occurred to me:
If this Bimodulation has such potential, then why is it being developed in only such relatively isolated sites as Dublin and a small city in Michigan?
Why aren't at least a dozen major University/Research Centers in the largest metropolitan areas competing for the first, best product?

Neuromodulation is still relatively new and is being tested for many kinds of diseases. We're lucky to have these people looking into tinnitus with it now.

 

[GlennS]

I think it's important to avoid bitterness. I mean, Pete Townshend had already raised the issue of tinnitus before I acquired mine in the early 90s. I knew what the risks were and I was just careless. There have been many awareness raising campaigns over the years. The recent Star is Born movie showed the high stakes. People (especially youngsters) are just too reckless and assume their bodies are sturdier than they actually are. You take that and add to it the biological fragility of the ear, more fragile than other animals like birds who can regenerate their hearing, and the inherent difficulty of devising a treatment... I really think it's not a matter of just throwing money at the problem and voila. Nobody really knows if this is truly treatable or not. It's right up there with trying to cure things like parkinson's or epilepsy.

 

[Stefaniie]

I think it's important to avoid bitterness. I mean, Pete Townshend had already raised the issue of tinnitus before I acquired mine in the early 90s. I knew what the risks were and I was just careless. There have been many awareness raising campaigns over the years. The recent Star is Born movie showed the high stakes. People (especially youngsters) are just too reckless and assume their bodies are sturdier than they actually are. You take that and add to it the biological fragility of the ear, more fragile than other animals like birds who can regenerate their hearing, and the inherent difficulty of devising a treatment... I really think it's not a matter of just throwing money at the problem and voila. Nobody really knows if this is truly treatable or not. It's right up there with trying to cure things like parkinson's or epilepsy.

I only remembered this after I got tinnitus but they taught us about the dangers of being exposed to too much loud noise back when I was in middle school, I think it was. (I am 22 now). I remember learning specifically about tinnitus. Talk about foreshadowing.

Anyway, I forgot about all of it pretty much as soon as the psa was over. And it was never brought up again. It's good to teach younger kids about this but they should target older kids as well. High school and college. Keep bringing it up until it gets through peoples heads... mentioning it once won't have any affect. Even then, they might have an "oh well if it happens it happens" attitude. People who don't have tinnitus just don't understand. They don't think it's that big of a deal. Even when they hear people complain about how tortuous it is, they think we're just being dramatic. People love to believe that there isn't anything they can't bounce back from.

 

[Tybs]

I only remembered this after I got tinnitus but they taught us about the dangers of being exposed to too much loud noise back when I was in middle school, I think it was. (I am 22 now). I remember learning specifically about tinnitus. Talk about foreshadowing.

Anyway, I forgot about all of it pretty much as soon as the psa was over. And it was never brought up again. It's good to teach younger kids about this but they should target older kids as well. High school and college. Keep bringing it up until it gets through peoples heads... mentioning it once won't have any affect. Even then, they might have an "oh well if it happens it happens" attitude. People who don't have tinnitus just don't understand. They don't think it's that big of a deal. Even when they hear people complain about how tortuous it is, they think we're just being dramatic. People love to believe that there isn't anything they can't bounce back from.

Demonstrating what tinnitus is would probably be more effective than just having campaigns. Set up a small audio set in front of the classroom and lock the door. "This lesson, we're gonna taste a bit of what living with tinnitus feels like", and turn on the sound. People would go crazy within five minutes. Not having the option to walk away from the sound would probably give a better impression than a bunch of old guys claiming loud sounds can make you deaf (which, to be fair, could actually be preferable above having tinnitus).

People need to experience, not to be told. But I guess we just never learn, being human and all... let's hope Shore eventually works her things out.

 

[Rb86]

For people that have had tinnitus for 20 years, no... science is not moving very fast... not at all, in my opinion.

For an allegedly prolific issue... I see zero commercials or mentions of tinnitus, or the loudness of anything.

You would think with everyone wearing their little earpods, someone would caution against hearing damage, but sadly no.

I knew 20 years ago the damage that walkmans were doing to hearing... yet I still see new people with headphone hearing damage every week on this board (and I have been a member for 5 weeks!).

Industry is not on our side... when there are $3000 hearing aids, supplement manufacturers, dumb ENTs raking in the cash, rap stars blasting their music on tv... yeah... aside from a handful of researchers looking for gov handouts... we are left on our own.

We will never compete with the profits.

I agree with all of that except the inability to compete with profits part. Whoever figures this shit out and cures it well... their children's children's children won't have to worry about money. The statistics of this are huge, and even with proper understanding of noise risk, damage will still happen. Hell, look at cigarette smoking and lung disease. A whole generation of idiots are vaping now.

 

[thinlay]

For people that have had tinnitus for 20 years, no... science is not moving very fast... not at all, in my opinion.

For an allegedly prolific issue... I see zero commercials or mentions of tinnitus, or the loudness of anything.

You would think with everyone wearing their little earpods, someone would caution against hearing damage, but sadly no.

I knew 20 years ago the damage that walkmans were doing to hearing... yet I still see new people with headphone hearing damage every week on this board (and I have been a member for 5 weeks!).

Industry is not on our side... when there are $3000 hearing aids, supplement manufacturers, dumb ENTs raking in the cash, rap stars blasting their music on tv... yeah... aside from a handful of researchers looking for gov handouts... we are left on our own.

We will never compete with the profits.

I agree with you.

But I was talking about science, not about prevention. The secondary purpose of science is to prevent it effectively.

But I think that the profit race is to our advantage, because the commercial potential of this kind of medicine far exceeds that of hearing aids or other current market of hearing.

Schumpeter said "creative destruction", the appearance of this new technology will lead to major economic change in the sector. Hence the interest that science is moving quickly for all these pharmaceutical companies, and therefore I do not think that the question of tinnitus is treated only by a handful of researchers and scientists.

 

[ChrisBoyMonkey]

I agree with you.

But I was talking about science, not about prevention. The secondary purpose of science is to prevent it effectively.

But I think that the profit race is to our advantage, because the commercial potential of this kind of medicine far exceeds that of hearing aids or other current market of hearing.

Schumpeter said "creative destruction", the appearance of this new technology will lead to major economic change in the sector. Hence the interest that science is moving quickly for all these pharmaceutical companies, and therefore I do not think that the question of tinnitus is treated only by a handful of researchers and scientists.

There are indeed motives for the companies in it for profit, but so far they have not been very successful. Neuromod is probably the first to successfully make something that actually helps.

More companies have tried or are trying, but with little success. The academics seem more promising, such as how this device seems more promising than Neuromod's Lenire, but sadly they are moving so much slower. Hopefully this device is actually out next year though. The U of Minnesota has been working on one too, but right now their lead researcher is splitting his time with Neuromod, so there's something of a mix of both private company and academia to them.

Still, this treatment might also be within reach. She's been saying she hopes for results of this second trial by mid 2020, and possible commercialization that same year...

 

[thinlay]

There are indeed motives for the companies in it for profit, but so far they have not been very successful. Neuromod is probably the first to successfully make something that actually helps.

More companies have tried or are trying, but with little success. The academics seem more promising, such as how this device seems more promising than Neuromod's Lenire, but sadly they are moving so much slower. Hopefully this device is actually out next year though. The U of Minnesota has been working on one too, but right now their lead researcher is splitting his time with Neuromod, so there's something of a mix of both private company and academia to them.

Still, this treatment might also be within reach. She's been saying she hopes for results of this second trial by mid 2020, and possible commercialization that same year...

Yes it is true.

I think you have summed up well the situation with regard to the development of aid in the area of bimodal stimulation.

 

[HootOwl]

It has been mentioned that she is seeing even better results with long term use correct? While I don't know if this will help with my hearing distortion, I would kill to have it knock out my reactive tinnitus like it did for RedKnight in the meantime. As it stands, I'm wary of Lenire and would prefer this as a "safer" alternative (although there is no way to know about worsening until the next trial concludes).

@linearb During your trial the longest period you used it for was only 2 weeks if I remember correctly? Or was it longer?

 

[Fightthearmy]

Still, this treatment might also be within reach. She's been saying she hopes for results of this second trial by mid 2020, and possible commercialization that same year...

As far as I know it takes three trials at minimum to get FDA approval. Aren't they still one trial short?

 

[ChrisBoyMonkey]

As far as I know it takes three trials at minimum to get FDA approval. Aren't they still one trial short?

Not necessary, medical devices are different.

 

[Hammers]

As far as I know it takes three trials at minimum to get FDA approval. Aren't they still one trial short?

Isn't that for drugs? Don't medical devices only need 2 trials?

 

[linearb]

Still, this treatment might also be within reach. She's been saying she hopes for results of this second trial by mid 2020, and possible commercialization that same year...

I am just going to reiterate again that this is the same timeline they have been tracking against since 2013: "Phase-II ongoing in 2020, commercialization hopefully that year, or within the following years".

I am only pointing that out because in the industry I am in (web software), having a project that's been going on for 6 years and is still tracking against its original timeline is beyond impossible, and I think it's Just Dandy that any large organization can do anything with that kind of procedural accuracy.

Even if they miss their date by a bit, the fact they've hit every milestone to date without having to slide three quarters is impressive.

 

[Fabrikat]

Even if they miss their date by a bit, the fact they've hit every milestone to date without having to slide three quarters is impressive.

You're very generous to Dr. Shore. That's fine, but really if your timeline for a two phase trials process is stretched out to nearly ten years, chances are very good that your going to hit all your timelines riding that tortoise as hard as you can.

You've got to admit, she's taken her own sweet time. Let alone if her device will actually do much for us here. I won't even go there.

 

[all to gain]

I think it's important to avoid bitterness. I mean, Pete Townshend had already raised the issue of tinnitus before I acquired mine in the early 90s. I knew what the risks were and I was just careless. There have been many awareness raising campaigns over the years. The recent Star is Born movie showed the high stakes. People (especially youngsters) are just too reckless and assume their bodies are sturdier than they actually are. You take that and add to it the biological fragility of the ear, more fragile than other animals like birds who can regenerate their hearing, and the inherent difficulty of devising a treatment... I really think it's not a matter of just throwing money at the problem and voila. Nobody really knows if this is truly treatable or not. It's right up there with trying to cure things like parkinson's or epilepsy.

It's hard not to be bitter. We didn't all get tinnitus from too much noise, but some of us got it from medication which we were told was to help us and that it was safe.

There is still little awareness even in regard to noise being too loud. I found myself in a tinnitus sufferer's nightmare a couple of weeks ago: we were bused out to the waiting 737, which had its engines already idling and we were surrounded by 2-3 other airplanes. Some idling, some taxiing and in the nearby distance one taking off. All very close. And there we were the unsuspecting passengers being subjected to massive levels of noise. And none of the passengers seemed to notice. I had my ear muffs on by this point. Didn't do much though.

 

[linearb]

You've got to admit, she's taken her own sweet time. Let alone if her device will actually do much for us here.

I'll admit no such thing ; in 2013 they were designing these protocols for humans based on animal models. Can you name other medical devices based on new bottom up models that have gone from hypothesis to FDA approved in a significantly faster way?

No idea if the device will help you ; fairly certain it will help me since I used one for a month. if I had to put money on it right now my prediction would be that this helps "a significant minority of people", based on the numbers published to date. so, I think you're correct to be skeptical, the proof is in the pudding

 

[GlennS]

I am just going to reiterate again that this is the same timeline they have been tracking against since 2013: "Phase-II ongoing in 2020, commercialization hopefully that year, or within the following years".
...
Even if they miss their date by a bit, the fact they've hit every milestone to date without having to slide three quarters is impressive.

IMHO, this is an R&D project that could be compressed down to a much shorter timeframe. So saying at onset it's gonna take 7 years when it could be done in, let's say, 3 and finishing it in 7 years is nothing to crow about. Given the small number of test subjects and limited number of trial phases I really do not think they've been working on this fulltime.

 

[linearb]

IMHO, this is an R&D project that could be compressed down to a much shorter timeframe. So saying at onset it's gonna take 7 years when it could be done in, let's say, 3 and finishing it in 7 years is nothing to crow about. Given the small number of test subjects and limited number of trial phases I really do not think they've been working on this fulltime.

okay, sure... what specific parts of their process do you think could have been compressed, and how? I've been tracking this effort fairly closely since 2013 and until a year or so ago was in regular contact with someone from the team. The biggest time sinks were chasing funding, which sucks but is pretty much the name of the game for stuff like this. Beyond that, I know that several people involved in this (not just Shore) have tinnitus and a strong empathetic desire to get something out.

I'm curious where you think they have dragged their feet or whatever.

 

[MRItechssuck]

Dr. Shore has tinnitus herself? I didn't know this.

 

[ChrisBoyMonkey]

I am just going to reiterate again that this is the same timeline they have been tracking against since 2013: "Phase-II ongoing in 2020, commercialization hopefully that year, or within the following years".

I am only pointing that out because in the industry I am in (web software), having a project that's been going on for 6 years and is still tracking against its original timeline is beyond impossible, and I think it's Just Dandy that any large organization can do anything with that kind of procedural accuracy.

Even if they miss their date by a bit, the fact they've hit every milestone to date without having to slide three quarters is impressive.

Yeah, its amazing

Have you heard anything from them recently?

I'll admit no such thing ; in 2013 they were designing these protocols for humans based on animal models. Can you name other medical devices based on new bottom up models that have gone from hypothesis to FDA approved in a significantly faster way?

No idea if the device will help you ; fairly certain it will help me since I used one for a month. if I had to put money on it right now my prediction would be that this helps "a significant minority of people", based on the numbers published to date. so, I think you're correct to be skeptical, the proof is in the pudding

When did she say "a significant minority of people"?

I've seen in interviews she says it's for somatic tinnitus and goes on to say that's 2/3rds of the tinnitus population, the majority.

And where did you find the results? All I ever could find is pretty much this:

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

Last I emailed her she said the results appear cumulative, so she's likely seeing even more success now.

 

[AfroSnowman]

Last I emailed her she said the results appear cumulative

Chris do you know what this means? Is it that the current round of testing supports the earlier trial results?

 

[AfroSnowman]

significant minority of people

If I remember her results correctly it came in at around 80% response rate right? So if she only treats somatic patients which is ~ 66% of the Tinnitus population at a 80% success about 53% of the total Tinnitus population would get relief through her tech.

That assumes of course that she isn't able to up her success rate and that it doesn't work on nonsomatic patients

 

[ChrisBoyMonkey]

Chris do you know what this means? Is it that the current round of testing supports the earlier trial results?

Better than that. It means the results she is seeing this time are better than first time. From what she is seeing, the more the people use her device, the greater the benefit. The first trial was only 4 weeks, since this one is more, she if confirming that further use drives further plasticity (fixing the hyperactive cells).

Neuromod imagines the same thing with their device, it's probably true of both devices. They might eventually hit an apex where tinnitus can only be diminished by so much, but no one really knows yet.