MuteButton

[GamesB2]

Anyone care to give the dumbed down one-liner summary?

Tinnitus can be 'seen' in brain activity, tested bimodal stimulation on guinea pigs, saw lowered activity and lowered signs of them 'hearing' their tinnitus.

Obviously there's a bit more to it and they tried a few different stimulation techniques but that's the gist I got from it.

 

[Jack Straw]

Tinnitus can be 'seen' in brain activity, tested bimodal stimulation on guinea pigs, saw lowered activity and lowered signs of them 'hearing' their tinnitus.

Obviously there's a bit more to it and they tried a few different stimulation techniques but that's the gist I got from it.

It also uses a different nerve to do this than Neuromod.

 

[_Patrick_]

Can't wait for trimodal neuromodulation that uses both nerves!

 

[Eric N]

Tinnitus can be 'seen' in brain activity, tested bimodal stimulation on guinea pigs, saw lowered activity and lowered signs of them 'hearing' their tinnitus.

Obviously there's a bit more to it and they tried a few different stimulation techniques but that's the gist I got from it.

What are they testing on pigs or humans?

 

[grate_biff]

I can't help but think that the holdup for the launch might be from them having found something through one of the "arms" in the last (TENT-A2??) trial and they want to tweak the machine before putting it out there.

In that case, it will be worth waiting for, even though it is really hard. I'm desperate for relief over here!

 

[F-u-T]

Anyone care to give the dumbed down one-liner summary?

Susan Shores Device:
20 Human Participants Clinical Trial for 4 weeks:

"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."

Basically their results showing Bimodal Stimulation has real promise. I know Neuromod stimulates a different nerve. Doesn't mean the results can't be similar.

 

[Jack Straw]

Susan Shores Device:
20 Human Participants Clinical Trial for 4 weeks:

"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."

Basically their results showing Bimodal Stimulation has real promise. I know Neuromod stimulates a different nerve. Doesn't mean the results can't be similar.

@david c this is why it isn't a habituation device. I know it is a different device but they both use bimodal stimulation.

 

[GamesB2]

What are they testing on pigs or humans?

That study is on Guinea Pigs.

 

[Paulmanlike]

I can't help but think that the holdup for the launch might be from them having found something through one of the "arms" in the last (TENT-A2??) trial and they want to tweak the machine before putting it out there.

In that case, it will be worth waiting for, even though it is really hard. I'm desperate for relief over here!

Well in TENT-A1 they had 3 different arms.

In TENT-A2 they have 9 different arms.

They will be testing each arm amongst the different groups for six weeks, then move onto the next arm. A limitation to the study is that they won't know if effects noted during the 6-12 week arm are because of that arm, or if it's a carry over effect from the previous 0-6 week arm.

What will also be interesting is to why they've designed the trial that way and what are in these new arms.

The objectives were to confirm the efficacy of the previous TENT-A1 AND to also adjust parameters to see if it can achieve better outcomes.

 

[Paulmanlike]

A while back I was concerned why part of the inclusion criteria for the TENT-A2 study was to have had tonal tinnitus. I contacted Neuromod to ask them why this was. I got a reply today as follows:

Dear Paul,

Thank you for your interest in Neuromod and for your enquiry. Clinical trials are designed to ask and inform specific research questions. The evidence to answer these research questions is gathered by enrolling patients according to pre-defined inclusion and exclusion criteria. The evidence is then used to support regulatory applications, where the recommended use is published in the approved labelling. Specific inclusion and exclusion criteria will vary from trial to trial, as the research questions for each trial may vary. Evidence from multiple trials may be considered when determining the appropriate use of a treatment. The inclusion and exclusion criteria for TENT-A1 and TENT-A2 differ in a number of respects; the reasons for the differences are related to the underlying goals and objectives of the clinical trials.

To date we have not seen evidence that the tonal or atonal nature of tinnitus experienced influences an individual's suitability for the treatment.

Once the device is approved and available in your region, your healthcare professional will be trained on the recommended use and the evidence that supported the regulatory approval. Your healthcare professional will determine on an individual patient basis whether the treatment should be recommended taking into account many factors including tonality/atonality.

We thank you for your question

With best wishes

Neuromod

 

[OnceUponaTime]

but a new born baby girl doesn't help

Awww congratulations kelpie. I'm sure the baby screams are heavenly. Lol.

 

[Bndsmheowqhe]

Maybe that's why they took in Dr. Lim, to help make it work better.

That's what I've been thinking. The device itself isn't that important, it's the timing/programming. They obviously brought him onboard for credibility but I don't see why he wouldn't also spill the beans on the Minnesota tech especially if he now has a financial interest in seeing Neuromod succeed.

I want to believe this is part of the reason for the delay and that they've made improvements with the programming since the trials but just can't come out and say it.

That would explain why investors were willing to pump $25,000,000 into the company.

In the meantime they're stuck trying to promote it with old information and studies knowing full well that it's better now.

 

[kelpiemsp]

That's what I've been thinking. The device itself isn't that important, it's the timing/programming. They obviously brought him onboard for credibility but I don't see why he wouldn't also spill the beans on the Minnesota tech especially if he now has a financial interest in seeing Neuromod succeed.

I want to believe this is part of the reason for the delay and that they've made improvements with the programming since the trials but just can't come out and say it.

That would explain why investors were willing to pump $25,000,000 into the company.

In the meantime they're stuck trying to promote it with old information and studies knowing full well that it's better now.

Because the Minnesota tech is very different in *how* it functions. It's also much more wearable.

 

[F-u-T]

That study is on Guinea Pigs.

Yes "Guinea Pigs". Both the Cavia Porcellus and Homo Sapien species.

 

[Bndsmheowqhe]

Because the Minnesota tech is very different in *how* it functions. It's also much more wearable.

Since you were there perhaps you could shed some more light on this. I'm trying to decide if Lim brought anything to table for Neuromod other than being a name. He must have had some useful information for them regarding timing.

 

[annV]

Since you were there perhaps you could shed some more light on this. I'm trying to decide if Lim brought anything to table for Neuromod other than being a name. He must have had some useful information for them regarding timing.

Hubert Lim very likely had a non-competing clause in his contract where he can't share such details with Neuromod.

 

[Tanni]

Once the device is approved and available in your region, your healthcare professional will be trained on the recommended use and the evidence that supported the regulatory approval. Your healthcare professional will determine on an individual patient basis whether the treatment should be recommended taking into account many factors including tonality/atonality.

Thanks for this, very interesting.

Above seems to contradict where they say tonality and atonality doesn't make a difference, but never mind. I guess we will see when we try it.

I'm sure this won't be picked up on the NHS for a long time, and if it's private they'll put you in for anything as long as you're prepared to pay. My 70-year-old Grandad came out once with a circumcision booked And that's not what he went in for!

 

[dayma]

Since you were there perhaps you could shed some more light on this. I'm trying to decide if Lim brought anything to table for Neuromod other than being a name. He must have had some useful information for them regarding timing.

I am sure he did. It would be weird if he didn't.

You can't take the direct IP but you can sure take your personal experiences to another company.

 

[Bndsmheowqhe]

Hubert Lim very likely had a non-competing clause in his contract where he can't share such details with Neuromod.

He has a financial interest in making this a success. I'm sure there are ways that he could have directed Neuromod in the right direction without directly violating any previous agreements.

 

[Paulmanlike]

Thanks for this, very interesting.

Above seems to contradict where they say tonality and atonality doesn't make a difference, but never mind. I guess we will see when we try it.

I'm sure this won't be picked up on the NHS for a long time, and if it's private they'll put you in for anything as long as you're prepared to pay. My 70-year-old Grandad came out once with a circumcision booked And that's not what he went in for!

I didn't get onto that, but yes quite contradicting.

I wonder what other factors they will take into account before recommending the treatment.

They must have worked out what patient "subtypes" (whatever that means under subjective tinnitus) are more likely to respond to treatment if they are going to ask about the "many factors".

As far as we all know what has been provided so far to us, is that 80% have responded somewhat in trials and those tinnitus sufferers with hyperacusis are super responders. And one arm (high frequency synchronisation) has better sustained effects.

So what are the "many factors" that they will take into account?

I'm half tempted to ask them about this but don't want to push my luck. I guess it could be worth a try...

 

[dayma]

He has a financial interest in making this a success. I'm sure there are ways that he could have directed Neuromod in the right direction without directly violating any previous agreements.

Non-competes don't work like that anyhow. If he had an employee agreement w/ a non-compete clause he would not be working with them. That's the whole point of a non-compete. You give people an incentive to sign a non-compete which limits what jobs you can take post-employment. Basically you have knowledge so important to the company that they will limit you working in the industry at all for a set amount of years. Yes, there are term limits normally.

Example; an exec at Pfizer would receive cash, stock, options or some other asset up front to sign an employee agreement. If that is breached at any time they can legally go after the money, stocks, options, etc...

 

[kelpiemsp]

Hubert Lim very likely had a non-competing clause in his contract where he can't share such details with Neuromod.

I've never seen this in an academic setting. Can you provide some reason for this? Usually there is just a standard percent the university receives from work he does.

 

[kelpiemsp]

Since you were there perhaps you could shed some more light on this. I'm trying to decide if Lim brought anything to table for Neuromod other than being a name. He must have had some useful information for them regarding timing.

Funny story... my best friend has a fairly prestigious PhD in EE and was asked if he would consider developing micro controllers for a neurostimulation device in Minnesota. Things are still happening there. He also suffers from tinnitus. But would rather live in California than join the fight lol.

 

[Bndsmheowqhe]

Money talks and I think lim jumping ship to Neuromod tells us a lot. He obviously thinks this device is good enough or has enough potential to warrant stabbing his colleagues in the back over it. He probably saw the writing on the wall and knew that by the time the University of Minnesota device is available it will be late to the party. As a tinnitus sufferer I salute his treachery.

 

[kelpiemsp]

Money talks and I think lim jumping ship to Neuromod tells us a lot. He obviously thinks this device is good enough or has enough potential to warrant stabbing his colleagues in the back over it. He probably saw the writing on the wall and knew that by the time the University of Minnesota device is available it will be late to the party. As a tinnitus sufferer I salute his treachery.

He is still working at the University of Minnesota. This is really the most effective way to pipeline deep research into the main stream. University of Minnesota will likely get a portion of all proceeds the MuteButton device creates and probably has licenses on the signal timing.

 

[Paulmanlike]

On a link posted previously, Hubert Lim's name is not under the inventors for the Neuromod. Rather, Dr. Ross O'Neill and a few others are. That's weird. If he contributed to the device - shouldn't he be one of the inventors?

 

[Bndsmheowqhe]

He is still working at the University of Minnesota. This is really the most effective way to pipeline deep research into the main stream. University of Minnesota will likely get a portion of all proceeds the MuteButton device creates and probably has licenses on the signal timing.

Very interesting. Do you know if they're still planning on marketing their own device. It sounds like the one you tried was very effective.

 

[MarkLud]

Just read the highlights of that latest Susan Shore report... damn, 12.2 dB down in just four weeks? To think of the possibilities with these bimodal treatments to compound and continue to improve over time... 8 weeks... 12 weeks... 6 months... 3 years...

 

[GlennS]

They obviously brought him onboard for credibility but I don't see why he wouldn't also spill the beans on the Minnesota tech especially if he now has a financial interest in seeing Neuromod succeed.

The proper term for what Neuromod did was "poaching". One can hope they did it for more reasons than just name-dropping. I also don't see why (other than greed) he would jump ship just to associate his name with a less effective treatment. At the same time, if Minnesota's results are better, it's baffling why it seems to be permanently stuck in the lab whereas Neuromod is gunning for release. You've got two companies with their own issues. They're just different issues.

However, if, and I say IF, the Neuromod is deliberately spinning the efficacy of the treatment in the interests of rushing it to market then it raises all the old specters of MuteButton. They have to realize the minimum threshold this treatment has to reach in order to convince people to gamble their money on it.

 

[spedgas]

The only level of disappointment I have left for this device is when it works for 80% of those who use it and I find myself in the 20% percent it doesn't help. That would be rock bottom for me. I've already lost the 10-15 percent of the population with tinnitus lottery. That would be adding insult to injury.