New University of Michigan Tinnitus Discovery — Signal Timing

[AfroSnowman]

Does anyone know if they are performing different tests to try to optimize the treatment in this study (longer sessions, more weeks) or are they just performing a repeat of the earlier study with a bunch more people?

 

[Padraigh Griffin]

They are using the device for 6 weeks as opposed to 4 weeks in the original trial. Not sure if other parameters are changed.

 

[Oceanick]

Grrrr. I had it in my mind that the study end date was end of 2021.

Quite often results will be released prior to a published study end date.

 

[Gb3]

Quite often results will be released prior to a published study end date.

Why doesn't someone just email the guy? Why is everyone so scared?

 

[AfroSnowman]

Well, I don't think we are going to get this in 2022.

Here is the answer to my question for when this might come out from the CEO:

"With regard to the commercialization schedule, the conclusion of Dr. Shore's confirmatory study will determine next steps with regulatory bodies, so we will have a better idea of where we stand mid 2022. Given that there are no FDA-cleared devices or drugs for the treatment of tinnitus, regulatory bodies—appropriately—have higher hurdles for safety and efficacy that must be satisfactorily demonstrated before clearance is awarded. As such, we don't make public comments concerning timing since it is premature to do so. But please know that Auricle was formed to gain clearance and commercialize Dr. Shore's device, so we are bringing talent and resources to this critical project. You'll certainly hear from us when we have relevant and public news to report!"

 

[F-u-T]

Well, I don't think we are going to get this in 2022.

Here is the answer to my question for when this might come out from the CEO:

"With regard to the commercialization schedule, the conclusion of Dr. Shore's confirmatory study will determine next steps with regulatory bodies, so we will have a better idea of where we stand mid 2022. Given that there are no FDA-cleared devices or drugs for the treatment of tinnitus, regulatory bodies—appropriately—have higher hurdles for safety and efficacy that must be satisfactorily demonstrated before clearance is awarded. As such, we don't make public comments concerning timing since it is premature to do so. But please know that Auricle was formed to gain clearance and commercialize Dr. Shore's device, so we are bringing talent and resources to this critical project. You'll certainly hear from us when we have relevant and public news to report!"

Hopefully Lenire has already applied for FDA clearance and is approved by mid 2022.

Maybe that would significantly speed up the approval of Auricle.

 

[Gee82]

Well, I don't think we are going to get this in 2022.

Here is the answer to my question for when this might come out from the CEO:

"With regard to the commercialization schedule, the conclusion of Dr. Shore's confirmatory study will determine next steps with regulatory bodies, so we will have a better idea of where we stand mid 2022. Given that there are no FDA-cleared devices or drugs for the treatment of tinnitus, regulatory bodies—appropriately—have higher hurdles for safety and efficacy that must be satisfactorily demonstrated before clearance is awarded. As such, we don't make public comments concerning timing since it is premature to do so. But please know that Auricle was formed to gain clearance and commercialize Dr. Shore's device, so we are bringing talent and resources to this critical project. You'll certainly hear from us when we have relevant and public news to report!"

It looks like 2022 will be another year of waiting and no treatment coming up. Great.

 

[Amv]

I cheer for neuromodulation and Susan Shore, I really think today the only way to treat tinnitus will be through devices. I also am thankful for Lenire to have launched the device, learn and probably launch a new version in the upcoming years with all the learnings.

But I am also disappointed in how long Susan Shore's device is taking, it is really too long a time!

 

[Harder Calm]

So I did have communication with the CEO, this is what he told me:

- The majority (anywhere between 60-80%) of tinnitus sufferers have somatic tinnitus and actually a lot of people don't realize they have somatic tinnitus until they are shown or instructed how to do the proper somatic maneuvers.
- He stated that this device should be safe and effective for a wide range of tinnitus sufferers.

Thanks for sharing with us! 60 to 80 % seems quite a lot, didn't expect that. But maybe there are different degrees of "somatic", and to that degree it may help?

Another interesting point to compare Lenire and Shore/Auricle is of course where the electric stimulation is applied, i.e. tongue vs. jaw/neck. I'm clearly no medical expert, but read the tongue's nerves are somehow connected with the auditory system, but it still could be seen as simply a way to find an "entry point". I guess with jaw and neck it's better to differentiate left and right side. And apparently many people (including myself) are able to influence it by jaw/neck movements, so it seems logical at least to apply the stimulus there.

So my hopes are more on Auricle's side, I'd say. But of course it's good to have two companies getting more serious, and having to compete and improve that way, hopefully!

 

[AfroSnowman]

Thanks for sharing with us! 60 to 80 % seems quite a lot, didn't expect that. But maybe there are different degrees of "somatic", and to that degree it may help?

Another interesting point to compare Lenire and Shore/Auricle is of course where the electric stimulation is applied, i.e. tongue vs. jaw/neck. I'm clearly no medical expert, but read the tongue's nerves are somehow connected with the auditory system, but it still could be seen as simply a way to find an "entry point". I guess with jaw and neck it's better to differentiate left and right side. And apparently many people (including myself) are able to influence it by jaw/neck movements, so it seems logical at least to apply the stimulus there.

So my hopes are more on Auricle's side, I'd say. But of course it's good to have two companies getting more serious, and having to compete and improve that way, hopefully!

The other thing to remember is that they are trying to basically do opposite things.

Lenire is trying to excite everything to diminish the differences so that you habituate.

Dr. Shore's device is trying to decrease the actual mechanism of tinnitus.

 

[Mathew Gould]

The other thing to remember is that they are trying to basically do opposite things.

Lenire is trying to excite everything to diminish the differences so that you habituate.

Dr. Shore's device is trying to decrease the actual mechanism of tinnitus.

If you had to guess, would either device work better for someone who has annoying tinnitus 50% of the time and low tinnitus 50% of the time?

 

[AfroSnowman]

If you had to guess, would either device work better for someone who has annoying tinnitus 50% of the time and low tinnitus 50% of the time?

Having been an underwhelmed user of Lenire, I'm hoping and somewhat optimistic that Dr. Shore's device will be the winner.

 

[F-u-T]

If you had to guess, would either device work better for someone who has annoying tinnitus 50% of the time and low tinnitus 50% of the time?

I think we will see better results across the board from Auricle's device.

 

[Suaimhneach]

Having been an underwhelmed user of Lenire, I'm hoping and somewhat optimistic that Dr. Shore's device will be the winner.

Do you reckon, having used Lenire, that it might rule out being able to use Auricle?

Probably a stupid question but due to some change in pathways or something. I'm tempted to try Lenire but don't want to rule myself out of Auricle.

 

[UHPTS]

Do you reckon, having used Lenire, that it might rule out being able to use Auricle?

Probably a stupid question but due to some change in pathways or something. I'm tempted to try Lenire but don't want to rule myself out of Auricle.

That sounds like you think that people at Neuromod know what their device does to the brain.

To answer your question: I do believe it does not matter as Lenire is just an overpriced audio player with tongue tinkler. The visionary guy that financed the "development" made the device more appealing to the crowds by using Bluetooth erphones (that have tendency to make horrible loud interruptive noises, really) and giving the device a look of menstrual pad (he probably thought of himself as Steve Jobs of tinnitus). They also drew nice pics of how it zaps the brain...

 

[Spiral]

Well, I don't think we are going to get this in 2022.

Here is the answer to my question for when this might come out from the CEO:

"With regard to the commercialization schedule, the conclusion of Dr. Shore's confirmatory study will determine next steps with regulatory bodies, so we will have a better idea of where we stand mid 2022. Given that there are no FDA-cleared devices or drugs for the treatment of tinnitus, regulatory bodies—appropriately—have higher hurdles for safety and efficacy that must be satisfactorily demonstrated before clearance is awarded. As such, we don't make public comments concerning timing since it is premature to do so. But please know that Auricle was formed to gain clearance and commercialize Dr. Shore's device, so we are bringing talent and resources to this critical project. You'll certainly hear from us when we have relevant and public news to report!"

This probably just means that they are still figuring it out, it doesn't sound like they have something to commercialize at this point.

 

[Gb3]

This probably just means that they are still figuring it out, it doesn't sound like they have something to commercialize at this point.

Umm no. Exact opposite.

 

[tommyd87]

This probably just means that they are still figuring it out, it doesn't sound like they have something to commercialize at this point.

I don't think that this necessarily means that they have nothing to commercialise at this time. Rather it sounds like they need to work out or be told by the FDA what they need to do in terms of making the safety trial component satisfy their requirements.

Right now I think that the device is done in terms of design etc as there has been samples put up of what it looked like.

 

[T Toledo OH]

I volunteered a few weeks ago. I got a reply confirmation but no other communication since. I am 18 months into my tinnitus and it seems like not a damn thing has changed in the progression of the device. The Shore device is dragging ass, and I feel bad for everyone who is going to flush their money on Lenire in the USA once it gets approved.

 

[T Toledo OH]

Once again a new breakthrough is coming... "The Susan Shore device."

Read the fine print on this one. It only works on those with early onset unilateral tinnitus and those with mild to no hearing loss and those that can modulate their tinnitus by a jaw movement or head movement etc. Wow!

20 years on this?! Anyone on this forum speak up if this is you. What a joke.

Exactly. And 14 million to develop. Somebody must have kept a little of that pocket change.

 

[Bambam0]

I believe the Republic.co campaign is supposed to launch any day. Should have a lot more clarity around everything then!

 

[linearb]

Once again a new breakthrough is coming... "The Susan Shore device."

Read the fine print on this one. It only works on those with early onset unilateral tinnitus and those with mild to no hearing loss and those that can modulate their tinnitus by a jaw movement or head movement etc. Wow!

20 years on this?! Anyone on this forum speak up if this is you. What a joke.

You're way out of line and out of your depth on this, sorry.

I have moderate to severe bilateral tinnitus and have since 1999, significant worsening in 2010; I take 2 medications to make it somewhat tolerable.

I was a test subject in one of these trials, I think the UMich device works, and you are massively misunderstanding a crucial difference between "inclusion criteria for one of several devices" vs "number of people the device is likely to work for".

In Phase II (granted, there were only 20 of us), which included long-timers and hard-luck cases like me, a majority of people experienced some relief and the average was an objectively-measured reduction equal to rougly cutting the intensity of tinnitus in half (6-10 dB reduction; remember, decibels are logarithmic, so 30 dB is more or less half of 40 dB is more or less half of 50 dB, etc).

The tech works.

Exactly. And 14 million to develop. Somebody must have kept a little of that pocket change.

Haha do you have any idea how expensive it is to clear FDA hurdles and try out new technology in humans? Just for Phase II they had to have me evaluated by multiple physicians, plus ~20 visits to the lab attended by humans, plus the costs of partnership with a MI device manufacturer. "Pocket change" is exactly correct, the University of Michigan spent $1.6 billion on research in 2020.

If anything I'd expect people here to be annoyed Shore's project isn't getting more of that money, not raging about graft. Grifters don't, generally, go into clinical research science, the hours and pay are miserable compared to what you'd get working as a contractor in a related industry.

Case in point, I just looked it up. Susan Shore has worked at the university of Michigan since 2005 and has a current salary of $169047.45 annually.

Amazon is throwing that much money at college graduates right now and they can't fill seats fast enough. Someone with Shore's background who wanted to just go consult for megacorps or be a concierge medical consultant for some billionaire with hearing issues would rake in 10x what you make busting your ass in academia for 20 years.

 

[Suaimhneach]

You're way out of line and out of your depth on this, sorry.

I have moderate to severe bilateral tinnitus and have since 1999, significant worsening in 2010; I take 2 medications to make it somewhat tolerable.

I was a test subject in one of these trials, I think the UMich device works, and you are massively misunderstanding a crucial difference between "inclusion criteria for one of several devices" vs "number of people the device is likely to work for".

In Phase II (granted, there were only 20 of us), which included long-timers and hard-luck cases like me, a majority of people experienced some relief and the average was an objectively-measured reduction equal to rougly cutting the intensity of tinnitus in half (6-10 dB reduction; remember, decibels are logarithmic, so 30 dB is more or less half of 40 dB is more or less half of 50 dB, etc).

The tech works.

Haha do you have any idea how expensive it is to clear FDA hurdles and try out new technology in humans? Just for Phase II they had to have me evaluated by multiple physicians, plus ~20 visits to the lab attended by humans, plus the costs of partnership with a MI device manufacturer. "Pocket change" is exactly correct, the University of Michigan spent $1.6 billion on research in 2020.

If anything I'd expect people here to be annoyed Shore's project isn't getting more of that money, not raging about graft. Grifters don't, generally, go into clinical research science, the hours and pay are miserable compared to what you'd get working as a contractor in a related industry.

Case in point, I just looked it up. Susan Shore has worked at the university of Michigan since 2005 and has a current salary of $169047.45 annually.

Amazon is throwing that much money at college graduates right now and they can't fill seats fast enough. Someone with Shore's background who wanted to just go consult for megacorps or be a concierge medical consultant for some billionaire with hearing issues would rake in 10x what you make busting your ass in academia for 20 years.

This is a great write up, thanks! Just as a matter of interest, what two medications do you take to make it somewhat tolerable?

Thanks.

 

[Nobody19]

I really do hope this will also help with hyperacusis!

Mid 2022 will be exciting - results for this, OTO-313 and OTO-413!

 

[linearb]

This is a great write up, thanks! Just as a matter of interest, what two medications do you take to make it somewhat tolerable?

Thanks.

Clonazepam 2 mg + Gabapentin 600 mg.

I have a history with benzos, I wouldn't expect this to work for anyone else per se and it's relatively dangerous, YMMV.

 

[ColinUK]

Mid 2022 will be exciting - results for this, OTO-313 and OTO-413!

Well I really hope it is better than 2021. In 2020 were were waiting in anticipation about the results of FX-322.

I really thought this time last year that some treatment was going to be on the horizon in a short time frame and there were a bunch of people going around that had got relief from tinnitus... ooh being so excited about the anecdotes of people who had a complete suppression of their tinnitus after being in the trials then the results came out and we all know how that went.

Fingers crossed that 2022 is the year we get some good news

 

[AfroSnowman]

@linearb, were you the only one from Tinnitus Talk that took part in the first trial?

 

[PortugalTheMan]

Does Dr. Shore's device affect tinnitus that is a hissing tone? Or is it only suitable for pure tone tinnitus?

 

[EDDTEKK]

Will the device be launched in 2023? Man, Susan Shore is already so old!

 

[tommyd87]

Will the device be launched in 2023? Man, Susan Shore is already so old!

I think it will get released right after it is given approval. At this stage it seems that the biggest barrier's been getting it past that.