Lenire — Bimodal Stimulation Treatment by Neuromod

[Tanni]

So does anyone know when the peer review is due to come out? Would be really interesting to see what is says.

Did any of the other tinnitus 'treatments' even have a peer review? I'm assuming the fact that Lenire is having one is the primary reason for most people having more hope in this device than previous treatments. As well as the 500 clinical trial participants of course.

 

[DaveFromChicago]

To GSC:
Very insightful observations regarding the release of Lenire.

After the unqualified failure of ACRN Sound Modulation therapies (see my prior comments regarding the expensive uselessness of Desyncra), as the WHO said, "we won't get fooled again."

At some point they will have to end the procrastination and offer this to us.
They will have to fess up to the blunt determination, i.e. does this really do anything to reduce the sound?

The propaganda that enticed me into buying Desyncra has been exhausted and used up and has no persuasive credibility for any new treatment.

I cannot believe that they are not aware that this applies to nearly everyone on this forum; let's just hope that the reason they will release this is because for once it is actually effective.

 

[Boni]

It all makes sense now. I have a coworker of mine who got his tinnitus from medication. He says that he alleviates his tone by bitting the tip of his tongue repeatedly. Hmm... wish it was that easy for me.

 

[Jazzer]

I have read @kelpiemsp's approval of the Neuromod device.
Is that all we currently have to go on?

Where are the affidavits from all of the other guinea pigs??

Is the evidence slim - or is it just my skepticism?

 

[ringinghours]

I kept fantasizing how when they finally release this thing my tinnitus will have already been cured after such a long delay.

I know, wishful thinking...

Wishful thinking that your tinnitus will be cured after a long time, or wishful thinking that Neuromod will release ever release this thing. LOL.

 

[Jazzer]

Wishful thinking that your tinnitus will be cured after a long time, or wishful thinking that Neuromod will release ever release this thing. LOL.

'Wishful thinking?'

Not something I've ever indulged in....x

 

[ruud1boy]

I have read @kelpiemsp's approval of the Neuromod device.
Is that all we currently have to go on?

Where are the affidavits from all of the other guinea pigs??

Is the evidence slim - or is it just my skepticism?

@kelpiemsp was on a different trial so he hasn't used the Neuromod device / tech - AFAIK. Still the device he has used works on a similar principle, so there's some encouragement that there is promise in this treatment modality.

As for other testimonials, we've had @Clare B as well. Independent, positive feedback from a Neuromod trial participant. Maybe the rest of them have never heard of Tinnitus Talk.

 

[Agrajag364]

Trademark on the name is confirmed on 6th May or something isn't it, so maybe we'll hear around then...

Or maybe when the peer review is out, although not sure when that is.

Is the release dependent on the findings of the peer review? In other words, if the peer review is unfavourable will they still go ahead and release the device? Or are they waiting on the peer review in order to convince audiologists to use it?

It was said that one reason Neuromod pulled the device after the prior release was they wanted to focus their resources on these trials, because decent trial results are necessary for device release in the United States. The United States have more stringent requirements of devices before they are released onto the market that the EU. So it is possible that the delay has something to do with meeting requirements for release in the US as well as EU.

But even if the US release would still be some way off after the trials are published, it is still quite likely that it's the wait for peer reviewed publication that is delaying the Irish/EU release. It was months ago now Neuromod said they had submitted the data for publication, and the peer review process can vary in length. Sometimes those peer reviewing the data will ask for very minor changes that can be done quickly, and sometimes they will ask for extensive changes and further experiments (in this case I guess analysis of the data) which can take months.

 

[Agrajag364]

I have read @kelpiemsp's approval of the Neuromod device.
Is that all we currently have to go on?

Where are the affidavits from all of the other guinea pigs??

Is the evidence slim - or is it just my skepticism?

There's @Clare B, and then further back on this thread @annV posted a link to a conference presentation of Neuromod's trial data.

 

[Clint Azzopardi]

So @ringinghours do you think that Neuromod will never release this? What leads you to think so?

 

[GlennS]

I have read @kelpiemsp's approval of the Neuromod device.
Is that all we currently have to go on?

Why is there this constant amnesia on the forum? Or is nobody even really paying attention despite camping out on this thread? Watch the Hubert Lim PowerPoint... in its entirety. There are scatter plot graphs that give you hard evidence.

Is the evidence slim - or is it just my skepticism?

Your skepticism.

Now that will be 5c.

 

[Jazzer]

 

[Paulmanlike]

Only listened to the presentation last night and glanced at the PowerPoint just now.

Things I have learned or found:

- A study in 2012 in CBT to treat tinnitus achieved the same results compared to Neuromod therapy. The benefit to Neuromod therapy is that this is achieved quicker in a matter of weeks/months compared to CBT that can take around 9 months to get those results. I am a little bit disappointed that it hasn't achieved better results to CBT therapy as CBT doesn't claim to reduce the noise but the THI/TFI scores are similar.

- They have only presented THI/TFI scores that are basically psychological measures of distress. No mention of reduction in minimum masking levels or Tinnitus Loudness Matching levels. Why is this?

- Around 30 people noticed an increase in their tinnitus. Most of these resolved as mentioned by Ross O'Neill.

- The trend appears to show that your baseline score of TFI/THI follows around the same amount of reduction you can expect after treatment. So if you are a severe tinnitus sufferer with a score of 76 you may go down to a score of 50 and if you are a 50 you go down to 25.

- There were a few (but not lots) where their score was next to nothing post treatment. These didn't particularly have high scores to begin with. This may mean that those with mild tinnitus may possibly achieve full remission of tinnitus. Or it could mean that time went on they've habituated to noticing it less (speculation).

- As I speculated in the past, TENT-A2 is about driving further benefits to tinnitus. Crossing over post 6 week appears to show further benefit on tinnitus symptoms (TFI, THI).

Now my own speculation/opinion:

While by nowhere near a cure, the results are encouraging. A few concerns is that only the THI/TFI scores were in the presentation. My own experience is that these would change by the days or weeks for myself personally even though my tinnitus level would stay the same give or take. I wasn't bothered by tinnitus one day this week and today it is irritating me. A subjective condition like this calls for more accurate measures of tinnitus to measure any actual reductions rather than perceived reductions.

The results are also similar to a complete course of CBT therapy that would do nothing directly to reduce the volume of your tinnitus, the only benefit here is that it is showing the same results faster.

I'm also curious as to why they never presented the MML/TLM levels - could it be there were none or very little improvement in these measures? This would after all correspond to the certain questionable testimonials.

Regardless, people have improved in their psychological measurements of tinnitus and they have already explored another way to increase that benefit (changing arms after 6 weeks in TENT-A2).

There is also the speculation that prolonged use/more different parameters not explored in TENT-A2 could induce further changes. They did not measure this so they can't comment on it for fact as of yet. Only what they have results for.

Also, as I have mentioned previously this isn't the full paper or peer review. I would just remind people that there have been papers put by private companies claiming to help 90% of the people with a sound therapy. This would correspond with improvement in TFI/THI scores.

 

[Bndsmheowqhe]

It was said that one reason Neuromod pulled the device after the prior release was they wanted to focus their resources on these trials, because decent trial results are necessary for device release in the United States. The United States have more stringent requirements of devices before they are released onto the market that the EU. So it is possible that the delay has something to do with meeting requirements for release in the US as well as EU.

But even if the US release would still be some way off after the trials are published, it is still quite likely that it's the wait for peer reviewed publication that is delaying the Irish/EU release. It was months ago now Neuromod said they had submitted the data for publication, and the peer review process can vary in length. Sometimes those peer reviewing the data will ask for very minor changes that can be done quickly, and sometimes they will ask for extensive changes and further experiments (in this case I guess analysis of the data) which can take months.

"It was said that one reason Neuromod pulled the device after the prior release was they wanted to focus their resources on these trials"

This is what concerns me about this company. They didn't spend years and millions of dollars just to remove it from market 2 months after it's initial release in 2015. It clearly wasn't working the way they had hoped it would and were forced to withdraw it. The fact that they can't own up to that and offer us this cock and bull story instead doesn't inspire confidence.

 

[Agrajag364]

Why is there this constant amnesia on the forum? Or is nobody even really paying attention despite camping out on this thread? Watch the Hubert Lim PowerPoint... in its entirety. There are scatter plot graphs that give you hard evidence.

Your skepticism.

Now that will be 5c.

View attachment 29291

Can you provide some comments on the data, as @Paulmanlike has done? I'm surprised that so few people on the thread have done this. You don't need to have a science background to provide comment on the data. I would be interested to here people's comments - how skeptical or positive they were - based on analysis of the data.

 

[Tanni]

- They have only presented THI/TFI scores that are basically psychological measures of distress. No mention of reduction in minimum masking levels or Tinnitus Loudness Matching levels. Why is this?

I'm also curious as to why they never presented the MML/TLM levels - could it be there were none or very little improvement in these measures? This would after all correspond to the certain questionable testimonials.

Oh no, good point!

Maybe they felt that the THI is the most accurate way of judging this subjective condition? If your tinnitus is louder or quieter each day due to your perception, the actual volume wouldn't make for very accurate data I suppose?

Overall, do you feel more positive after these results, or less positive?

 

[Ed209]

Only listened to the presentation last night and glanced at the PowerPoint just now.

Things I have learned or found:

- A study in 2012 in CBT to treat tinnitus achieved the same results compared to Neuromod therapy. The benefit to Neuromod therapy is that this is achieved quicker in a matter of weeks/months compared to CBT that can take around 9 months to get those results. I am a little bit disappointed that it hasn't achieved better results to CBT therapy as CBT doesn't claim to reduce the noise but the THI/TFI scores are similar.

- They have only presented THI/TFI scores that are basically psychological measures of distress. No mention of reduction in minimum masking levels or Tinnitus Loudness Matching levels. Why is this?

- Around 30 people noticed an increase in their tinnitus. Most of these resolved as mentioned by Ross O'Neill.

- The trend appears to show that your baseline score of TFI/THI follows around the same amount of reduction you can expect after treatment. So if you are a severe tinnitus sufferer with a score of 76 you may go down to a score of 50 and if you are a 50 you go down to 25.

- There were a few (but not lots) where their score was next to nothing post treatment. These didn't particularly have high scores to begin with. This may mean that those with mild tinnitus may possibly achieve full remission of tinnitus. Or it could mean that time went on they've habituated to noticing it less (speculation).

- As I speculated in the past, TENT-A2 is about driving further benefits to tinnitus. Crossing over post 6 week appears to show further benefit on tinnitus symptoms (TFI, THI).

Now my own speculation/opinion:

While by nowhere near a cure, the results are encouraging. A few concerns is that only the THI/TFI scores were in the presentation. My own experience is that these would change by the days or weeks for myself personally even though my tinnitus level would stay the same give or take. I wasn't bothered by tinnitus one day this week and today it is irritating me. A subjective condition like this calls for more accurate measures of tinnitus to measure any actual reductions rather than perceived reductions.

The results are also similar to a complete course of CBT therapy that would do nothing directly to reduce the volume of your tinnitus, the only benefit here is that it is showing the same results faster.

I'm also curious as to why they never presented the MML/TLM levels - could it be there were none or very little improvement in these measures? This would after all correspond to the certain questionable testimonials.

Regardless, people have improved in their psychological measurements of tinnitus and they have already explored another way to increase that benefit (changing arms after 6 weeks in TENT-A2).

There is also the speculation that prolonged use/more different parameters not explored in TENT-A2 could induce further changes. They did not measure this so they can't comment on it for fact as of yet. Only what they have results for.

Also, as I have mentioned previously this isn't the full paper or peer review. I would just remind people that there have been papers put by private companies claiming to help 90% of the people with a sound therapy. This would correspond with improvement in TFI/THI scores.

I haven't looked into the data on CBT, but if this is true, and they are marketing Lenire as a device that can objectively lower the level of tinnitus, then I'd really like to have seen how a placebo would have performed because it was recently shown that 74% of studies show that patients improve after having sham surgeries, and that 51% of trials show it was as effective as the real thing. This device could well be walking the line between these statistics until proven otherwise. This is why I was disappointed that there wasn't an effective placebo control being used in the trials, but I understand that implementing one was obviously a problem for them.

Sometimes the belief that something will work is all we need to see a positive change in a given condition.

We will learn a hell of a lot more from the real-world data once this device is out.

 

[KotaDomowa]

The persistent use of psychological measures instead of MLM is the only factor that destroys my optimism.

 

[lcho]

Can you provide some comments on the data, as @Paulmanlike has done? I'm surprised that so few people on the thread have done this. You don't need to have a science background to provide comment on the data. I would be interested to here people's comments - how skeptical or positive they were - based on analysis of the data.

While I agree with @Paulmanlike on questioning why they didn't present the MML/TLM scores, there are also positive highlights to take from the data analysis which I believe show that while this isn't a cure, it's an effective treatment - building upon his comments.

1. For hyperacusis sufferers, Arm 1 of their TENT-A1 study resulted in mean THI scores dropping 26.8 basis points, to 22.5 from an original 49.2. The particular stimulation method in Arm 1 is significantly more effective than Arm 3, showing that there is a significant factor in reducing the person's suffering beyond just habituation - and given the number of participants, this factor is very likely to be Neuromod's device.

2. The fact that the best bimodal stimulation settings resulted in almost identical lowering of THI scores in TENT-A2 that were observed in TENT-A1, again shows that this device, and this particular stimulation setting, is having an effect on tinnitus beyond habituation.

3. The finding in TENT-A2 that changing the stimulation settings in the second 6-week period drives further lowering of THI scores again shows that this device is having some sort of an effect, again beyond just habituation.

4. The graph on slide 14 shows that while Arm 1 and Arm 2 did slow down in their therapeutic effects towards the 12-week mark, it's possible that further reductions in THI could be achieved over time given that neuroplasticity isn't temporary, and also due to the fact that there is probably a well-established neural network resulting in tinnitus, which may require more than 12 weeks of disruption to significantly change.

So, hyperacusis sufferers seem to be able to gain a particularly large reduction from using this therapy compared to those without hyperacusis. The data also shows that this device is very, very likely to be driving reductions in THI scores beyond just habituation. On a third note, it's quite possible that using this device for more than just 12 weeks could drive further reductions in THI.

 

[F-u-T]

The new Lenire website says the device will be available soon in select clinics in Europe. Did the website always say Europe?

 

[Jazzer]

Despite @GlennS's dig about amnesia,
what I am looking for is actual personal accounts of what the part-takers own experiences were.

I am much less interested in what some technician's analysis of the treatment results is.

Horse's mouth will do me....x

 

[dayma]

The new Lenire website says the device will be available soon in select clinics in Europe. Did the website always say Europe?

Yup.

 

[GlennS]

Can you provide some comments on the data, as @Paulmanlike has done? I'm surprised that so few people on the thread have done this. You don't need to have a science background to provide comment on the data. I would be interested to here people's comments - how skeptical or positive they were - based on analysis of the data.

I'd have to go back through the data again but (from memory) a key distinction is that animal tests were conducted first and these allowed invasive low-level scans of brain activity demonstrating that the source of the T was diminishing (since there's no way to ask animals how they are feeling). This is why I don't see this as equivalent to CBT. It's attacking the problem at the source, not merely habituating. And if I had to choose between a 20% decrease in tinnitus due to habituating or due to the actual volume going down, I'd choose the latter. The latter is more of a real world empirical improvement whereas the CBT is more of a "mental discipine" akin to that guy in Doctor Strange who willed himself into walking again after becoming wheelchair-bound. Mind over matter is hard to achieve and hard to maintain.

 

[spedgas]

I'd have to go back through the data again but (from memory) a key distinction is that animal tests were conducted first and these allowed invasive low-level scans of brain activity demonstrating that the source of the T was diminishing (since there's no way to ask animals how they are feeling). This is why I don't see this as equivalent to CBT. It's attacking the problem at the source, not merely habituating.

Thanks for clearing this up. I was fearing that we were going down the "this is merely another habituation device" banter. I thought comparing scores to CBT was going to open that up again for debate. This is obviously not a sound habituation device. I couldn't agree with you more.

 

[GlennS]

Sometimes the belief that something will work is all we need to see a positive change in a given condition.

This is veering off-topic but I've had two anxiety attacks that led me to the ER.

Anyone has had an anxiety attack suddenly becomes a BELIEVER in the potency of the mind-body link.

The brain works on the basis of reinforcement. The more you obsess on an idea the more it strengthens synaptic connections to that idea (or sensation). This is why after a breakup it's best to get rid of reminders of the person and get busy on other things. Over time if you distract yourself with other activities it gives time for the memories and associations to weaken. But if you dwell on things it sucks you into a black-hole.

I doubt I'd still be alive had I not learned on my own how to play mental games like this to keep the tinnitus from completely taking over. When I joined this forum I was sort of being sucked in but I now feel I'm fairly stable (knock on wood) and hanging on even though I sense that my objective tinnitus is now permanently worsened and getting enough sleep is a constant challenge. I am in no way satisfied by having to rely on these survival tactics but if they had no value I'd be dead long ago. So I wish people wouldn't mock and belittle them.

 

[annV]

I have it on good authority from a person who was enrolled in the trial and knows people at Neuromod that they are launching it in Ireland in June!

Just a month to go!!!

 

[Heinrich_S7]

The radio silence from Neuromod has been rather frustrating. Even if they can't release the device, that's fine, just give us some kind of heads up. But it's May, Ross, come on, let us know what's up.

I'm hoping this thing gets to Canada/US soon. Really don't want to have to wait another year, I recall Ross told Steve in the interview 2019 for US release.

Other than that I'm still optimistic, @kelpiemsp and @Clare B's testimonials are what makes me enthusiastic. Mine is mild enough I think it'll knock it out completely. We just need to actually get it in our hands =P

 

[spedgas]

The graphs from the PowerPoint slides show that even after the treatment was over people still continued to improve their THI scores. @kelpiemsp has stated before that his THI score also improved at the end of the trial. He once said that if he was to take the THI again now that he thinks it would be even lower. Sure he is just one person who wasn't even part of this particular trial, but long before we found this test data he was telling us what he experienced and it matches up with these study results. I can't help but feel positive about that.

 

[Jazzer]

This is veering off-topic but I've had two anxiety attacks that led me to the ER.

Anyone has had an anxiety attack suddenly becomes a BELIEVER in the potency of the mind-body link.

The brain works on the basis of reinforcement. The more you obsess on an idea the more it strengthens synaptic connections to that idea (or sensation). This is why after a breakup it's best to get rid of reminders of the person and get busy on other things. Over time if you distract yourself with other activities it gives time for the memories and associations to weaken. But if you dwell on things it sucks you into a black-hole.

I doubt I'd still be alive had I not learned on my own how to play mental games like this to keep the tinnitus from completely taking over. When I joined this forum I was sort of being sucked in but I now feel I'm fairly stable (knock on wood) and hanging on even though I sense that my objective tinnitus is now permanently worsened and getting enough sleep is a constant challenge. I am in no way satisfied by having to rely on these survival tactics but if they had no value I'd be dead long ago. So I wish people wouldn't mock and belittle them.

I agree with every word.
We do not have a cure (yet.)
Mocking positive attitudes and coping methods is not only ridiculous but highly dangerous to our own psyche, let alone the reader's.
Anything that helps - relaxation, meditation, hypnotherapy, autosuggestion etc... has to be in, and not ruled out.
They are helping many of us to survive and maintain our optimism.

 

[Allan1967]

I have it on good authority from a person who was enrolled in the trial and knows people at Neuromod that they are launching it in Ireland in June!

Just a month to go!!!

Wow... you were right about the new name @annV so I have faith in you!