Lenire — Bimodal Stimulation Treatment by Neuromod

[threefirefour]

In a few months we have gone from "Lenire is working" to "Lenire doesn't work"... It's an emotional rollercoaster, I really don't know what to think.

Not really. If anything, we have established that it does indeed work. 70% is still a very significant amount of responders. But we also established that it isn't a cure, but just something to take the edge off.

 

[Candy]

@Markku I have respect for all the above organisations, but let's face it, the BTA does little in its media opportunities to champion the severe sufferers, as per my post 5 minutes ago in Allan1967's memorial thread.

Does anyone at the BTA even have tinnitus?!

Action on Hearing Loss may prove to be a better partner, but why aren't they involved?

Surely such small organisations as the BTA and the ATA need all the help they can get.

 

[all to gain]

Surely such small organisations as the BTA and the ATA need all the help they can get.

Big fish in a small pond comes to mind...!!

 

[MRItechssuck]

@Markku do you have the ability to "sticky" threads on this forum?

It would be helpful IMO if there could be a running total of Lenire users and their improvement. If you could come up with a numerical rating system for people to assign to their experience so others could use the data to be compared, versus individual anecdotal reports, would be helpful.

Not that you aren't busy enough running the forum... ;-)

 

[Markku]

@Markku do you have the ability to "sticky" threads on this forum?

It would be helpful IMO if there could be a running total of Lenire users and their improvement. If you could come up with a numerical rating system for people to assign to their experience so others could use the data to be compared, versus individual anecdotal reports, would be helpful.

Not that you aren't busy enough running the forum... ;-)

The Lenire User Experience Group spearheaded by @PeterPan is our method of doing that. It's very structured, scientifically sound (we consulted a couple of tinnitus researchers before we launched it) and helps us generate a useful report at the end of it.

I realize it can be frustrating having to wait until April to get it released though.

With regards to the "live/realtime" User Experiences & Reviews thread, I'm not sure we have the means to start doing anything different with it ourselves, but if someone wants to volunteer to collect and analyze all the experiences into something more coherent, I can attach that into the first post of that thread or create a new tab for it.

 

[Ed209]

@Markku I have respect for all the above organisations, but let's face it, the BTA does little in its media opportunities to champion the severe sufferers, as per my post 5 minutes ago in Allan1967's memorial thread.

Does anyone at the BTA even have tinnitus?!

Action on Hearing Loss may prove to be a better partner, but why aren't they involved?

Surely such small organisations as the BTA and the ATA need all the help they can get.

I've said this before, but my experience with advocates, advocacy groups and charity collaborations have not been entirely great in the past. Some I have spoken to seem to have a very insular mindset. What I mean by that is that I get the distinct impression (in some cases) that only their objectives seem to matter when it comes to helping the cause they're supposed to be advocating for.

I saw this problem when I did a fundraiser for a Children's charity (which was not the fault of the charity itself but one of their supposed main supporters) and I saw it many times when trying to promote tinnitus awareness and the urgent need for a cure or treatment that works. Instead of receiving help, I found many put up roadblocks instead which became rather infuriating rather quickly. Does it really matter whose work fundamentally leads to a working treatment? Just so long as it's found by someone? Why can't tinnitus groups just work together towards this common goal?

Tinnitus Hub is a breath of fresh air in this regard.

 

[all to gain]

I've said this before, but my experience with advocates, advocacy groups and charity collaborations have not been entirely great in the past. Some I have spoken to seem to have a very insular mindset. What I mean by that is that I get the distinct impression (in some cases) that only their objectives seem to matter when it comes to helping the cause they're supposed to be advocating for.

I saw this problem when I did a fundraiser for a Children's charity (which was not the fault of the charity itself but one of their supposed main supporters) and I saw it many times when trying to promote tinnitus awareness and the urgent need for a cure or treatment that works. Instead of receiving help, I found many put up roadblocks instead which became rather infuriating rather quickly. Does it really matter whose work fundamentally leads to a working treatment? Just so long as it's found by someone? Why can't tinnitus groups just work together towards this common goal?

Tinnitus Hub is a breath of fresh air in this regard.

Because of people and their egos!! It all comes down to that.

 

[FGG]

Unfortunately Australia is still good decade behind the rest of the western world. Not much here is available or accepted as treatment despite being used in other developed countries.

They just love to brag about being the best in the world. Far from it unfortunately!

This is not only for tinnitus but other illnesses as well.

Anything that becomes treatment for tinnitus somewhere in the world will take at least 5 years to become available here.

I wouldn't hold my breath, we won't be helped in Australia.

Australia was the first in the world to develop Cochlear Implants. It seems to have a history of solid research otology. Is that level of research still going on? I can't seem to find out anywhere what researchers are currently doing there.

 

[MRItechssuck]

@Markku I have respect for all the above organisations, but let's face it, the BTA does little in its media opportunities to champion the severe sufferers, as per my post 5 minutes ago in Allan1967's memorial thread.

Does anyone at the BTA even have tinnitus?

Action on Hearing Loss may prove to be a better partner, but why aren't they involved?

Surely such small organisations as the BTA and the ATA need all the help they can get.

The BTA and ATA should merge or dissolve and get out of the way.

What makes the ATA or BTA so special? It's some people that started a charitable organization, most likely for their own personal benefit.

As far as I have seen, Tinnitus Talk should register as the new standard bearer for tinnitus advocacy.

 

[TibuJenkins]

Not really. If anything, we have established that it does indeed work. 70% is still a very significant amount of responders. But we also established that it isn't a cure, but just something to take the edge off.

Funny thing is, whoever thought/thinks it was/is a cure is delusional. I don't see what else the people at Neuromod could to drive the point home that it isn't a cure besides a 40pt font banner at the top of their website.

 

[GlennS]

It would be important that Neuromod publishes new data from real patients.

They won't be doing that, at least not in the foreseeable future. The trend-lines were already evident when they were interviewed by Tinnitus Talk recently. Neuromod still claims the results of actual patients are in sync with TENT-A2, and yet they constructed some rationalization for why they won't release any official metrics or new testimonials. This forces us to have to just take their word for it.

Since they've made it clear they will not release internal data then all we have to go by is their published (or unofficial in the case of the Vimeo video) trial data matched up against Tinnitus Talk user experiences. So if there is something mysterious skewing the results here on Tinnitus Talk, there's still no other option than to use the Tinnitus Talk data as if it's an accurate representation of all Lenire users.

Last time around people split off into camps while casually interpreting the user experience data based on what's been scrolling through the forums. We went around in circles and people just dug in their heels. I am really looking forward to that official crunch-down of Tinnitus Talk data in April as it should clear the air. Nevertheless, I've learned that people will ultimately believe what they want to believe.

As Lenire becomes more available and they work through their backlog I would like to see some of the strongest evangelists put their money where their mouths are and see if their own results match their rhetoric.

 

[jmasterj]

Funny thing is, whoever thought/thinks it was/is a cure is delusional. I don't see what else the people at Neuromod could to drive the point home that it isn't a cure besides a 40pt font banner at the top of their website.

They are very open about it at the appointments that this is not a cure. They are also very open that it may not work for everyone. This is still very young technology and maybe in the next several years after refinement it could be a cure, but for now I would call it a step in the right direction.

Ultimately, hearing regeneration is probably the permanent cure.

 

[GlennS]

whoever thought/thinks it was/is a cure is delusional. I don't see what else the people at Neuromod could to drive the point home that it isn't a cure besides a 40pt font banner at the top of their website.

Typical evangelist strawman-tactic: claim that anyone expecting results above placebo are expecting a cure.

70% sounds good, but how can that be if only one person has seen good improvement?

It can't be because it's an inaccurate percentage. I see we're going to dip right back into "is this dress black or blue" again.

 

[UKBloke]

hey constructed some rationalization for why they won't release any official metrics or new testimonials

GDPR if I remember rightly. A bit of a lame excuse quite frankly.

 

[all to gain]

They won't be doing that, at least not in the foreseeable future. The trend-lines were already evident when they were interviewed by Tinnitus Talk recently. Neuromod still claims the results of actual patients are in sync with TENT-A2, and yet they constructed some rationalization for why they won't release any official metrics or new testimonials. This forces us to have to just take their word for it.

Since they've made it clear they will not release internal data then all we have to go by is their published (or unofficial in the case of the Vimeo video) trial data matched up against Tinnitus Talk user experiences. So if there is something mysterious skewing the results here on Tinnitus Talk, there's still no other option than to use the Tinnitus Talk data as if it's an accurate representation of all Lenire users.

Last time around people split off into camps while casually interpreting the user experience data based on what's been scrolling through the forums. We went around in circles and people just dug in their heels. I am really looking forward to that official crunch-down of Tinnitus Talk data in April as it should clear the air. Nevertheless, I've learned that people will ultimately believe what they want to believe.

As Lenire becomes more available and they work through their backlog I would like to see some of the strongest evangelists put their money where their mouths are and see if their own results match their rhetoric.

People desperately want to believe it works and will define 'works' to fit that belief.

I desperately want to believe it works, too. Had enough of suffering. But I'm not going to delude myself by making up figures that aren't there or that are based on 'maybe it helped a little, not sure' reports.

This is nothing against Lenire, and I hope it is modified and made better over time. I so want it to work for real.

 

[MRItechssuck]

Lenire is a tool. Sound files are a tool. This is not a cure. Even when you scrape your knee there is scar tissue... it heals but it is never the same. IMO false hope is as damaging to the psyche as no hope.

I will try Lenire, and hope it improves things... but it is not permanent. Until one person has been 100% tinnitus free using Lenire and has exhausted their personal life span... then yes, I'll consider it permanent.

Obviously given the newness... "permanence " can't be proven, can it?

 

[Ruse]

They won't be doing that, at least not in the foreseeable future. The trend-lines were already evident when they were interviewed by Tinnitus Talk recently. Neuromod still claims the results of actual patients are in sync with TENT-A2, and yet they constructed some rationalization for why they won't release any official metrics or new testimonials. This forces us to have to just take their word for it.

I thought they were releasing new testimonials which were to be filmed around now?

In fairness I'm not sure what Neuromod releasing real world data adds to either argument? Those who trust the clinical trial data will trust the 'real world' data and vice versa.

 

[lapidus]

Australia was the first in the world to develop Cochlear Implants. It seems to have a history of solid research otology. Is that level of research still going on? I can't seem to find out anywhere what researchers are currently doing there.

FWIW, Myriam Westcott is Australian. Here's a thread on Tinnitus Talk about what shes's up to now:

https://www.tinnitustalk.com/threads/fix-for-sound-induced-pain-—-stellate-ganglion-block.33478/

 

[AfroSnowman]

Good luck. A long journey to make. I hope it helps.

Thanks. Me too.

 

[UKBloke]

@ruud1boy thanks for your recent post in the User Experiences thread.

It reminded me of @Liz Windsor's post where the stated improvement was kind of vague because the improvement itself was kind of vague, befuddling almost, and seemingly quite difficult to describe.

I wanted to ask you, have you been retested for MML, and has there been a change? Also, do you think the characteristic of the tinnitus sound has changed while using Lenire?

 

[PeterPan]

This is the response I got, dated 12/6/19. I didn't want to post this back than due to Lenire coming out and deep down hoping the audiologist would be wrong!

Hello Valeri,

I think this is very good advice from your audiologist.

Simon

 

[Ruse]

Hello Valeri,

I think this is very good advice from your audiologist.

Simon

Not sure about a "40% placebo effect" though.

What does that even mean? Has anyone ever seen a 40% reduction in THI from a placebo arm in a tinnitus trial before?

Serious question if anyone knows.

 

[PeterPan]

I am really looking forward to that official crunch-down of Tinnitus Talk data in April as it should clear the air. Nevertheless, I've learned that people will ultimately believe what they want to believe.

Hi GlennS,

I just wanted to point out that the official survey will still suffer from the lack of a control. That is, we will not be able to conclude that any changes in people's tinnitus are a consequence of the Lenire treatment and some or all of the changes could be a result of a placebo effect.

If you have access to the leaked Neuromod report, you can see that there were 3 x ARMS. ARM3 was quite a bit different than ARM1 and ARM2. The frequency of the auditory stimulus was much lower, and there was a much longer delay between the tongue and auditory stimulus. But the results were almost identical across all 3 ARMS after 12 weeks. I am speculating that ARM3 was supposed to be the control i.e. Neuromod did not expect patients in this ARM to respond to this treatment (but they did).

Neuromod did see a difference between the Arms at 18 weeks, 38 weeks and 64 weeks, which implies that the treatment does work in the long term. However, the "p" value corresponding to the 64 week difference between ARM1 and ARM3 is only just significant (.042) and the difference in improvement is only 8 THI points.

The other thing Neuromod found was that people with Hyperacusis had a much better response in ARM1 than ARM3 (again implying that ARM3 was supposed to be a control), with a p=0.01 and a THI difference of 13.6 points. There were 12 patients with Hyperacusis in ARM1 and 21 in ARM3. To me, this seems to be the most significant finding.

PeterPan

 

[brokensoul]

the BTA does little in its media opportunities to champion the severe sufferers

Off topic, but would like to react anyhow.

Can anyone point me to some article or video where they even acknowledge the existence of severe tinnitus and talk about the consequences on quality of life?

I'm honestly under the impression that they (almost) don't want to talk about how severe this condition can be, because they do not want to scare people who recently got tinnitus.

They honestly revealed their line of thinking during an interview in regards to that movie that recently came out (with Bradley Cooper?). Wasn't there some Twitter storm following those statements, which they handled in a very poor manner and ultimately decided to delete everything, because it was all too negative and sounded too disrespectful to them in their opinion.

At that time it became obvious that at least some of them seem clueless to what tinnitus really is.

They seem more focussed on creating on overall impression that tinnitus improves after some time for the majority and that the others can manage it well through a positive attitude or through CBT or TRT therapy. Positive vibes you know. Those who struggle bad are mostly negative people. It's all in the mind!

They should care most for those who suffer the most, but they seemingly see it the other way around.

Maybe I've got it wrong. Maybe the veterans here understand these organisations better than a tinnitus newbie like myself.

Does anyone at the BTA even have tinnitus?

I'd like to know as well. Does anyone know?

 

[brokensoul]

They are very open about it at the appointments that this is not a cure. They are also very open that it may not work for everyone.

I'm really not that delusional to expect a cure, I would be really happy to see an objective 20% improvement. A treatment that can objectively reduce the tinnitus volume to some extent is definitely a winner in my book. Today there is no treatment whatsoever that can even reduce volume by 1%. It would be major progress. It would mean that we're on the right track with neuromodulation and that we simply need to improve on the design to make it better.

 

[Autumnly]

They honestly revealed their line of thinking during an interview in regards to that movie that recently came out (with Bradley Cooper?). Wasn't there some Twitter storm following those statements, which they handled in a very poor manner and ultimately decided to delete everything, because it was all too negative and sounded too disrespectful to them in their opinion.

I think that was the ATA...

Here's a link to the thread.

 

[GlennS]

I'm not sure what Neuromod releasing real world data adds to either argument?

The more data the better. When they shut down that Vimeo video that had a lot of additional detail on TENT-A2, it was a bad look. The worst "look" for Neuromod is to hold back information. That doesn't mean we'll necessarily trust the data (or more accurately, their spin on the data) but they should release data periodically.

the official survey will still suffer from the lack of a control.

There is a lot of data being gathered for the user reports. It should be possible to account for all sorts of variables in the end. That's not to say there will be only one way to interpret the data, but try not to make it seem as though it will be impossible to draw some conclusions.

 

[EDDTEKK]

What I am asking myself is why Hannover Ear Institute in Germany and Brai3n Clinic in Belgium are offering Lenire, despite the fact that the clinical trial results have not been peer reviewed yet?

Do they believe it will help some people or do they just want to make money?

 

[brokensoul]

I think that was the ATA...

Here's a link to the thread.

Yeah you're right it was the ATA.

Is the BTA any better though?

 

[Liz Windsor]

Thank you Liz for answering me, I hope you will have some good results soon.

However. I am wondering what the Neuromod team is thinking about just the little improvement you had after 20 weeks of treatment. It has been a long time but it's a good thing you continue, patience is probably key to success.

Hi again Laura... well, Neuromod's view is to continue with the treatment. I can call or contact or visit them again in Dublin at any time in the future should I wish. They stressed I am still their 'patient' in that even though I haven't responded as quickly as some this doesn't mean I won't in the future. I can change my tinnitus tone slightly by moving my jaw. My hearing loss is mild and my tinnitus is in the high frequencies. Hearing loss upwards of 8 kHz and tinnitus about 12 kHz... like a dentist's drill...

Au revoir!
Liz (assuming you're French)...