Lenire — Bimodal Stimulation Treatment by Neuromod

[ChrisBoyMonkey]

No one would be happier than me to see this come out by 2020. I'll be standing right behind you in the line to get into the clinic.

Susan Shore has been working on this for nigh on twenty years. People on Tinnitus Talk have participated in her earlier trials with successful results, years ago. Tinnitus Talk members have been reporting her achievements since 2013. No one can doubt her commitment to proper scientific process.

For whatever reason, she has taken her sweet time pushing this forward and had earlier suggested 2022 to 2024 as her expected timeline. I may be wrong, but I've only heard her speak of a commercial partner in the last 12 months.

But to bring this back to Lenire, whilst Susan Shore walks to the beat of her own drum, maybe Lenire's introduction onto the scene has inspired the will to bring the date forward to 2020. Who knows? I hope so.

Knowing how long these things take, if the trial ends next year and then we have to wait for the FDA to do its work, I somehow can't help thinking it's going to take longer than 2020.

Yes I've looked deep into this. I know @linearb is one of them, but Dr. Shore has been saying that she aims for 2020 since 2018 when she did a podcast interview with the ATA, and still says that it's the goal in recent email inquiries. Now of course she may not achieve the 2020 goal, but it is the goal nonetheless.

It is exactly because of all the years she has devoted to researching this that I believe she has it down more than Lenire has, she's been studying tinnitus more than double the years they have, and the results from her first trial, because they were only 4 weeks but had pretty darn good results, seem much more promising than Neuromod's.

Which is why my plan is to get Lenire in the meantime until her device is available. I'm hoping Lenire will make it so I don't hear it in most places, and her devices so that I only hear it in quiet places.

When the day comes that her device is out, I look forward to seeing you there.

 

[JayBowson]

"Lenire is not the same as our treatment, which has been rigorously tested in a basic science model"

Damn, shots fired.

I thought the science behind the two devices was effectively the same.

I'd be eager to know exactly what she means by this and what Hubert Lim would have to say in response.

 

[Ruse]

Because Susan Shore has invested far more time in rigorous scientific studies. That's a big difference for a start.

If Neuromod collect and use their data wisely (and continue to collaborate with Dr. Lim) I honestly think that by the time Susan Shore's device is commercialised it could already be redundant.

 

[Daniel Lion]

No one would be happier than me to see this come out by 2020. I'll be standing right behind you in the line to get into the clinic.

Susan Shore has been working on this for nigh on twenty years. People on Tinnitus Talk have participated in her earlier trials with successful results, years ago. Tinnitus Talk members have been reporting her achievements since 2013. No one can doubt her commitment to proper scientific process.

For whatever reason, she has taken her sweet time pushing this forward and had earlier suggested 2022 to 2024 as her expected timeline. I may be wrong, but I've only heard her speak of a commercial partner in the last 12 months.

But to bring this back to Lenire, whilst Susan Shore walks to the beat of her own drum, maybe Lenire's introduction onto the scene has inspired the will to bring the date forward to 2020. Who knows? I hope so.

Knowing how long these things take, if the trial ends next year and then we have to wait for the FDA to do its work, I somehow can't help thinking it's going to take longer than 2020.

Of course it's going to take longer than 2020. The woman is a scientist, not a businesswoman. She has taken her "sweet time" because she is a conscientious doctor and scientist. She is motivated by something greater than money and has devoted her life to it. She's a freaking saint in my book. And I think she couldn't care less if Neuromod came to the market first... this is a classy, morally sound scientist.

Best of luck to the Neuromod clan, everybody's pulling for you...

Let's give Dr. Shore a break. She doesn't deserve any shit from us.

 

[UKBloke]

Any idea why Susan Shore said her treatment is not the same as Lenire?

I've been wondering that too. And if her treatment is markedly different does that represent another avenue of opportunity for those using Lenire that don't get the desired outcome?

 

[JayBowson]

Let's give Dr. Shore a break. She doesn't deserve any shit from us.

Honestly though the same could be said of Neuromod and Ross O'Neill. Unless they do something demonstrably shady.
There seems to be a bit of a showdown on these pages in the past between Shore and Neuromod followers. But I've never understood why.

Ideally we want both of these treatments to succeed.

For a few reasons.

1. Shore's device is not going to have 100% response rate. So Lenire could be an option for non-responders and vice versa.
2. If tinnitus treatment is moving towards the paradigm of bimodal stimulation, the last thing we want is one big player dominating the market as then they'll never be incentivised to improve their products or lower their costs to stay competitive.
3. We need as many heads working on this as possible. Shore's device could lead to some trend or statistic that gives us some key insight to the nature of this confusing condition. And the same could be said of Lenire.

In summary any sane minded sufferer really should be rooting for both IMO.

 

[AliceW]

Everyone defends their own device... Dr. Shore wouldn't say that Lenire is the same as her device...

 

[jmasterj]

I don't think it needs to be a battle between the two. I have donated to Susan Shore's cause a few times and looked into taking part in her latest trial, but they wanted participants to be less than 100 miles away.

I am going to Neuromod in November for the assessment. I hope Susan Shore's device is able to wipe away tinnitus forever, but right now Lenire is the most promising treatment we have right now.

It doesn't matter who is able to suppress tinnitus. I just want it better for myself and every sufferer out there. It's not a competition from a sufferer's standpoint.

Also, I think Susan's device still uses the same premise as Neuromod. She uses sound for stimulation, but her electrical stimulation is via the neck or cheek depending on where you can modulate your tinnitus. Remember also that Susan Shore's device is for somatic tinnitus only at this time.

 

[Fabrikat]

She has taken her "sweet time" because she is a conscientious doctor and scientist.

Indeed she is. She's also a fully tenured academic. She gets paid whether her device goes to market or not.

All I'm suggesting is that had she sought a commercial partner earlier, she wouldn't have needed to wait for funding for her trials and this machine may have been released already. She was into this way before Neuromod.

 

[all to gain]

Is Susan Shore's device only for somatic tinnitus?

Sorry, haven't read the whole thread.

 

[Fabrikat]

Everyone defends their own device... Dr. Shore wouldn't say that Lenire is the same as her device...

There may be some truth to that. But it's an interesting comment she's made. I wonder exactly what she means.

All these devices are based on the same timing experiments conducted at the University of Minnesota. I would've thought timings would need to be the same for all the devices. Unless she means that the nerves her device targets are different.

 

[ajc]

All these devices are based on the same timing experiments conducted at the University of Minnesota. I would've thought timings would need to be the same for all the devices. Unless she means that the nerves her device targets are different.

Bullshit. Dr. Shore is the Grandmother of bimodal stimulation. She's invented the timings and the technology. University of Minnesota is just copying her stuff.

 

[Daniel Lion]

Honestly though the same could be said of Neuromod and Ross O'Neill. Unless they do something demonstrably shady.
There seems to be a bit of a showdown on these pages in the past between Shore and Neuromod followers. But I've never understood why.

Ideally we want both of these treatments to succeed.

For a few reasons.

1. Shore's device is not going to have 100% response rate. So Lenire could be an option for non-responders and vice versa.
2. If tinnitus treatment is moving towards the paradigm of bimodal stimulation, the last thing we want is one big player dominating the market as then they'll never be incentivised to improve their products or lower their costs to stay competitive.
3. We need as many heads working on this as possible. Shore's device could lead to some trend or statistic that gives us some key insight to the nature of this confusing condition. And the same could be said of Lenire.

In summary any sane minded sufferer really should be rooting for both IMO.

Agreed... absolutely.

We should all be rooting for success on all fronts.

Well said Maestro, aka, JayBowson.

 

[DaveFromChicago]

To JayBowson:

As I mentioned before, someone on this forum said that Dr. Shore's device operates on more nerve complexes than Lenire's does (although I cannot yet substantiate this to any degree).
I know that everyone (myself included) is terribly impatient in anticipating ASAP the release of these devices.

Given the length of time and degree that we have suffered, this is akin to the proverbial carrot dangled right in front of our faces.

Daniel Lion is also correct: Dr. Shore as a committed scientist is not going to hurry her research just so that we have access to this device before she has satisfied herself regarding the scientific legitimacy (and thereby the potential for success) of every component.

I say to myself, "Can it really be true that a device exists that will place me back into my pre-tinnitus mindworld"?

But as a scientist of integrity it is going to take Dr. Shore as long and she feels it takes before the fully vetted model is released.

Also, JayBowson is entirely correct that there is no justification for assuming a "showdown" between these two. I certainly do not know at this point if Dr. Shore's device is an improved version of Neuromod.

It is rash at this point to draw any such conclusions (and given the nature of a particular patient's condition one device may on just this purely individualized basis be more beneficial than the other).

Given the promising and lucrative nature of these devices, I cannot believe that various Venture Capital Consortiums are not as anxious as we are to have them released on the Market.

I know it's hard (and I'm just as guilty of being overanxious as everyone else), but we will just half to dig into our reserves of patience and wait perhaps several months for real answers.

 

[GoatSheep]

IMO, she appears to be differentiating the quality of their methodology from the quality of her methodology if you read the email as a contiguous response and don't try to parse the first sentence of the treatments not being the same immediately. I don't think she's differentiating between them both being based on bimodal stimulation.

Why else would she elaborate on investing time in learning about research methodology and detail what she sees as the gold standard in response to an email where the only other treatment mentioned was Lenire.

 

[GlennS]

Susan is a PhD, an acclaimed and successful doctor.

Don't put her on a pedestal. Everyone has their pros and cons. My point is that academics are thinkers, and entrepreneurs are doers. It would help if she had someone more business-minded to spur things along.

 

[Fabrikat]

Bullshit. Dr. Shore is the Grandmother of bimodal stimulation. She's invented the timings and the technology. University of Minnesota is just copying her stuff

Thanks for your correction. It's Michigan, not Minnesota.

 

[jmasterj]

Bullshit. Dr. Shore is the Grandmother of bimodal stimulation. She's invented the timings and the technology. University of Minnesota is just copying her stuff.

Sorry, but Lim's research was what this was all based on. Even Neuromod themselves admitted they used his research for their device. You could even look back as far as 1985 for research for electrical stimulation for tinnitus. For sure Shore has gotten more press for her research and that is probably why it appears that way. I'm sure Shore has created her own timings as well.

Again, I don't know why this continues to be a hot topic. Who really cares as long as there is a promising treatment on the horizon.

 

[JayBowson]

View attachment 32017

IMO, she appears to be differentiating the quality of their methodology from the quality of her methodology if you read the email as a contiguous response and don't try to parse the first sentence of the treatments not being the same immediately. I don't think she's differentiating between them both being based on bimodal stimulation.

And if I'm honest that would be another worry about Lenire that I've had. I reasoned to myself: Given that there were 3 ARMs and ones which I suspect Neuromod knew were not effective in TENT-A1 that perhaps these were being used as a placebo arm? But that's just pure speculation.

Also if you go to about 35 mins into the interview with Ross O'Neill you can see when asked about the TENT-A2 trial he hesitates and refuses to discuss the details in the name of preserving best practices and maintain double blinding etc... So unless he's bullshitting my impression would be that they are using placebos and blinding. Though I haven't a clue about the details.

All will be revealed in time I guess

 

[jmasterj]

Is Susan Shore's device only for somatic tinnitus?

Sorry, haven't read the whole thread.

Here is her inclusion criteria for one of latest trials. It is interesting about the hearing loss threshold. Granted this is just for trials. It has been stated in other threads that as of right now it only treats somatic tinnitus, but it may work for non-somatic as well.

• Must report constant, subjective, preferably unilateral tinnitus without any active external or middle ear pathology.
• No greater than a moderate hearing loss at the tinnitus frequencies (≤55 Decibels Hearing Level).
• Must be able to modulate their tinnitus with a somatic maneuver
• Preferably onset of tinnitus less than one year ago, but present for at least 6 months. Tinnitus should be bothersome.
• Absence of retrocochlear pathology/8th nerve lesion
• No participation in a tinnitus treatment regimen within the past six months or participation in the University of Michigan stage 1 clinical trial.

 

[Daniel Lion]

Don't put her on a pedestal. Everyone has their pros and cons. My point is that academics are thinkers, and entrepreneurs are doers. It would help if she had someone more business-minded to spur things along.

She is on a pedestal. I think she's one hot, intelligent, kick ass woman. Sorry bro, I am a sculptor, and she is definitely on a pedestal. James Brown was the Godfather of soul, and Dr. Shore may well be, according to @ajc, the Godmother of neuromodulation. It is not her obligation to spur things along, just as it's not Stephen Heller's, the Godfather of hearing regeneration, to spur things along.

As much as I hate profound hearing loss which I suffer from, with tinnitus as a bonus, I don't begrudge scientists.

Sorry bro, I am a huge fan of Dr. Shore and her contribution to our plight and potential cures to help us.

 

[all to gain]

Here is her inclusion criteria for one of latest trials. It is interesting about the hearing loss threshold. Granted this is just for trials. It has been stated in other threads that as of right now it only treats somatic tinnitus, but it may work for non-somatic as well.

• Must report constant, subjective, preferably unilateral tinnitus without any active external or middle ear pathology.
• No greater than a moderate hearing loss at the tinnitus frequencies (≤55 Decibels Hearing Level).
• Must be able to modulate their tinnitus with a somatic maneuver
• Preferably onset of tinnitus less than one year ago, but present for at least 6 months. Tinnitus should be bothersome.
• Absence of retrocochlear pathology/8th nerve lesion
• No participation in a tinnitus treatment regimen within the past six months or participation in the University of Michigan stage 1 clinical trial.

So very specific criteria.

 

[GoatSheep]

So very specific criteria.

I inquired about being a trial participant.

I'm positive no Klonopin use (which probably extends to other benzos) in the last six months and fairly certain living within 100 miles of Ann Arbor are also current requirements. Though I don't think the distance thing was a previous requirement because @linearb flew in from Vermont or something regularly.

 

[Lilah]

"Preferably onset of tinnitus less than one year ago, but present for at least 6 months. Tinnitus should be bothersome."

So Dr. Shore's treatment may not work on long term sufferers?

 

[Fabrikat]

IMO, she appears to be differentiating the quality of their methodology from the quality of her methodology

Yes she's certainly implying her methodology and process is superior. But the questions remain.

How is her device different to Lenire's? And is it better?

 

[all to gain]

I inquired about being a trial participant.

I'm positive no Klonopin use (which probably extends to other benzos) in the last six months and fairly certain living within 100 miles of Ann Arbor are also current requirements. Though I don't think the distance thing was a previous requirement because @linearb flew in from Vermont or something regularly.

I don't fit hardly any of the criteria.

 

[Ruse]

So very specific criteria.

So much for her "rigorously tested" device which only includes people who have had tinnitus for less than a year.

 

[GoatSheep]

So much for her "rigorously tested" device which only includes people who have had tinnitus for less than a year.

@linearb was a participant though and he's had it for years.

Somewhere @linearb also reported "having 18 calm days in a row while doing treatment" to paraphrase him I believe.

 

[GoatSheep]

I don't fit hardly any of the criteria.

tinn.trial@umich.edu

Never hurts to double check and make sure of current criteria. Email and ask.

 

[all to gain]

tinn.trial@umich.edu

Never hurts to double check and make sure of current criteria. Email and ask.

I live a million miles away, so wouldn't make much difference anyway.

I did talk to Dr. Shore a while back via email. She said the device may well work for others too.

Being honest, I'm very pessimistic about this device and all the other devices.

I feel we are many years from something that truly helps and even further from a cure. I hope I'm wrong though.