Lenire — Bimodal Stimulation Treatment by Neuromod

[ThomasW]

The public release is the biggest test for Lenire and could be seen as a public trial. This is the turning point in the research and development of devices for tinnitus but it will take time to get all the facts and info together.

Anyone with Lenire, are you fully aware of all the things that spike or relive your tinnitus?

 

[AfroSnowman]

I poked at the Neuromod folks for an update about appointments. Their response...

"The 2020 appointments will be set up late September/October and we will contact you then regarding and update on appointments."

 

[Sironketchup]

Has anyone who got the email saying 2019 appointments are filled up had any follow up contact from Lenire?

No I'm still waiting for an email. I had a dream tonight that I got an appointment in September lol.

Hopefully they will contact us soon.

Anyone who is on the waiting list got an appointment yet?

I don't get why the electrode would wear off after that time. I do believe the actual usable time would be far longer and in case the electrode wears off there might be ways to revive it.

Cheers.

 

[friend74]

I poked at the Neuromod folks for an update about appointments. Their response...

"The 2020 appointments will be set up late September/October and we will contact you then regarding and update on appointments."

Wow, that's more than a year from now on. F... this. It's more likely they release it in Germany before i guess.

 

[alanisnotadj]

Wow, that's more than a year from now on. F... this. It's more likely they release it in Germany before i guess.

I think they meant they will set up appointments for 2020 in September/October 2019
I am also on the waiting list.

 

[Sironketchup]

Wow, that's more than a year from now on. F... this. It's more likely they release it in Germany before i guess.

No, it's like 1-2 months.

Thanks for the info!

 

[Bob den Hartog]

Wow, that's more than a year from now on. F... this. It's more likely they release it in Germany before i guess.

It might be they'll taking the time in between as preparation to roll out the treatment across Europe, as they're currently swamped with helping people in Dublin.

 

[Phi]

Wow, that's more than a year from now on. F... this. It's more likely they release it in Germany before i guess.

I think they mean in September/October 2019 they will organize the appointments for 2020.

 

[Kam75]

Hello!

On the Neuromod website, they say that if we have various types of tinnitus, we need to ask our otolaryngologist if Lenire would work for us.

I'm kind of scared because I have at least 3 different types of sounds (one that sounds like a cricket in my left ear and a high-pitched noise and a dental drill-like sound all over my brain.

For people who already had their appointment with Neuromod, did you ask your doctor or did you ask a member of the Neuromod's staff if Lenire can work with various kind of tinnitus? My otolaryngologist which is supposed to be a tinnitus specialist don't know about the Lenire.

I'm very anxious and depressive, I'm just 28 and my tinnitus is getting worse even though I stopped living the way I used to live before (which means I stopped going to night clubs, I stopped drinking alcohol, I don't go to cinema...) but this sh*t is getting worse

I couldn't sleep tonight, I couldn't go to work, I'm tired of living with that, it's been 6 months already...

 

[Paulmanlike]

Imagine a new episode of Black Mirror that has an iPod on it with a tongue zapper that cured everybody's tinnitus in the world.

Now I'm being serious - where the hell is this "peer review" that they said would be made available to patients? The fact we are well past the time it takes to review raises concerns for me.

As time is going on, I'm losing hope in Lenire. Honestly, it's not looking good. If this turns out to be another ACRN I am already prepared to be disappointed.

€2500 and no peer review of their 'results' means nothing to me.

Until there is evidence that doesn't come from a private enterprise that this thing has a good chance of working I have to be realistic and question why.

 

[AliceW]

@Paulmanlike,

Please let's hope and think of the healed people who testified...

It's our only possible cure today.

 

[GlennS]

No it doesn't. I can tell you for a fact, that is not how it is viewed. Nor is it how neuroplasticity works. That doesn't even make sense.

So how long do you expect your results to last, then? Here are key quotes from the Q&A, not even factoring in whatever messaging is currently on their website:

to compare efficacy of the treatment we compared baseline to final...and then at the followup phase six week, six months, twelve months, we wanted to see of those beneficial effects persisted in the longer run. We saw statistically significant improvements in all outcome measures....what we saw in the longer term...over 12 months...they both had an initial positive effect...but where they diverged was in the longer run.​

questioner asks about future acoustic trauma that creates a spike, not so much the treatment wearing off on its own as an inherent limitation of the nature of neuromodulation itself. Then we get this:

all we can say is what we have clinical evidence for. What we know right now is that if patients undergo a treatment of 30-60 minutes of stimulation a day, the majority of patients experience a 12 month benefit from that treatment. Now what happens thereafter, we'll have to figure out later.​

Sure, they're not guaranteeing it will never wear off, but they say that the majority of those in the trial did not experience the benefits wearing off after 12 months. You can always slap an asterisk on but at what point would it be fair to classify the results as effectively permanent?

All I can glean from their website is this image:

The treatment is characterized by monitoring and tweaking by their clinic. What constitutes "continued use" leaves things open to a lot of interpretation. For those who took possession of the device, what did they say about it?

 

[Agrajag364]

Imagine a new episode of Black Mirror that has an iPod on it with a tongue zapper that cured everybody's tinnitus in the world.

Now I'm being serious - where the hell is this "peer review" that they said would be made available to patients? The fact we are well past the time it takes to review raises concerns for me.

If it was a Black Mirror episode the iPods would malfunction and everyone would end up with worse tinnitus.

Neuromod said in October they were about to submit for peer review, and then in December they said they would submit the TENT-A1 paper for publication in early 2019. I've mailed them to ask if it's still in peer review. It's not unusual for peer review to take a while if the reviewers want revisions to the data.

 

[JohnAdams]

Hello!

On the Neuromod website, they say that if we have various types of tinnitus, we need to ask our otolaryngologist if Lenire would work for us.

I'm kind of scared because I have at least 3 different types of sounds (one that sounds like a cricket in my left ear and a high-pitched noise and a dental drill-like sound all over my brain.

For people who already had their appointment with Neuromod, did you ask your doctor or did you ask a member of the Neuromod's staff if Lenire can work with various kind of tinnitus? My otolaryngologist which is supposed to be a tinnitus specialist don't know about the Lenire.

I'm very anxious and depressive, I'm just 28 and my tinnitus is getting worse even though I stopped living the way I used to live before (which means I stopped going to night clubs, I stopped drinking alcohol, I don't go to cinema...) but this sh*t is getting worse

I couldn't sleep tonight, I couldn't go to work, I'm tired of living with that, it's been 6 months already...

I know it is not easy and there is no easy answer, but you have to dig deep and keep pushing forward in life. Imagine my horror looking at my 2 year old sleeping on the couch, fresh into this, in absolute shock and horror about how this would affect my ability to be a good father. 1 + year later, and I have improved a lot and life is getting easier. Hang in there friend.

 

[TinMan2019]

I asked about the 'continued use' after the 12 weeks. Being that they had a 3 month trial and 12 month efficacy results. They were really not all that 100% sure themselves. They really only have the 'clinical trial' data to go on. Some may relapse, and then need to undergo more treatment.

I don't think we'll have all the answers until this has been out for some time, as in a few years. When there will be some proper historical data.

As long as I get a slight decrease, then I'm happy. I think once you experience tinnitus, you can never truly go back to full silence, as you'll always be on the listen for it...

Again as previously mentioned a 4 dB reduction is enough to take it from "argghhh stop this!!" to "ok you're there but you're not bothering me". If i have to sit there doing a repeat treatment every now and then, then I could live with that.

As I sit here just over 2 weeks into my treatment, I'm worried that I get ZERO improvement, and that I've just wasted a whole lot of money and hope!

It wasn't cheap to buy the unit outright, along with all the flights... They're also expecting me to return in the next few weeks, which I most probably won't be doing.

I also don't think there's all that much to it in terms of individually configured for the user... The volume of both headphones and tongue tip can be user set and I was told it was ok to make it louder. As long as the hissing masks out the tinnitus, and there's a slight feel of the tongue tip, then it's doing its job.

I personally don't think the beeps and waves are actually custom to the hearing profile.

All that being said, I could be wrong. I think they're probably more concerned about people reselling their units rather than buying new from the clinician.

Anyway just my 2 cents.

 

[GlennS]

They're also expecting me to return in the next few weeks, which I most probably won't be doing.

Be careful there.

I know it's an expense and an inconvenience but I would not want to look back and wonder whether any deviation from their guidelines during treatment made it less effective. Even if their visits do nothing besides gather information it would be useful for the evolution of this treatment to provide that to them. Everyone who uses this are effectively trial subjects still and the more data they gather the better.

 

[JayBowson]

It wasn't cheap to buy the unit outright, along with all the flights... They're also expecting me to return in the next few weeks, which I most probably won't be doing.

I would urge you to reconsider this. Yes, it may come to pass that the treatment won't give you the results you'd hoped for. But from the TENT-A2 results we've seen posted in the images here it seems that they're able to drive more improvement from re-tuning the device settings. Which is what they're doing at these follow up meetings if I'm not mistaken.

It may even be that the settings you're currently on won't do anything for you but the new ones will. Who knows? You've already risked the bulk of the cash coming this far. It would be a colossal waste of potential if you didn't follow through properly now over the cost of a Ryanair flight and a day's holiday booked.

I don't mean to be harsh either but if you don't follow their regimen strictly I'm not sure how we could take your results in the User Experience Group as indicative of anything. For me at least, that feedback (good or bad) is the most valuable and topical thing going in the tinnitus research world at the moment.

 

[Sytex75]

I asked about the 'continued use' after the 12 weeks. Being that they had a 3 month trial and 12 month efficacy results. They were really not all that 100% sure themselves. They really only have the 'clinical trial' data to go on. Some may relapse, and then need to undergo more treatment.

I don't think we'll have all the answers until this has been out for some time, as in a few years. When there will be some proper historical data.

As long as I get a slight decrease, then I'm happy. I think once you experience tinnitus, you can never truly go back to full silence, as you'll always be on the listen for it...

Again as previously mentioned a 4 dB reduction is enough to take it from "argghhh stop this!!" to "ok you're there but you're not bothering me". If i have to sit there doing a repeat treatment every now and then, then I could live with that.

As I sit here just over 2 weeks into my treatment, I'm worried that I get ZERO improvement, and that I've just wasted a whole lot of money and hope!

It wasn't cheap to buy the unit outright, along with all the flights... They're also expecting me to return in the next few weeks, which I most probably won't be doing.

I also don't think there's all that much to it in terms of individually configured for the user... The volume of both headphones and tongue tip can be user set and I was told it was ok to make it louder. As long as the hissing masks out the tinnitus, and there's a slight feel of the tongue tip, then it's doing its job.

I personally don't think the beeps and waves are actually custom to the hearing profile.

All that being said, I could be wrong. I think they're probably more concerned about people reselling their units rather than buying new from the clinician.

Anyway just my 2 cents.

Yep as tough as it is, hang in there man, @JayBowson I believe is right on...

 

[Rafalek73]

I know it is not easy and there is no easy answer, but you have to dig deep and keep pushing forward in life. Imagine my horror looking at my 2 year old sleeping on the couch, fresh into this, in absolute shock and horror about how this would affect my ability to be a good father. 1 + year later, and I have improved a lot and life is getting easier. Hang in there friend.

@JohnAdams how much hearing loss do you have? Is your tinnitus in your ears or head?

 

[JohnAdams]

@JohnAdams how much hearing loss do you have? Is your tinnitus in your ears or head?

Very little hearing loss. Almost none. I don't make a distinction between tinnitus in your head vs ears. I think that is dumb. All perception happens in the brain so it's all in your head.

 

[ruud1boy]

It wasn't cheap to buy the unit outright, along with all the flights... They're also expecting me to return in the next few weeks, which I most probably won't be doing.

With respect, this is precisely why they didn't want people travelling from overseas to get the device.

Now that you have laid out the cash, it would be extremely foolish IMO to not stick to their regimen to the letter. I appreciate you're based in the States and the trucking back and forth must cost a bit, but surely you considered this before going in the first place?

They claim they identified in the most recent trials that changing the stimulation halfway through the initial treatment process yielded the best results - not bothering with this bit is nonsensical. You may as well just have thrown your money out of the window and hoped that helped with your tinnitus.

Get on the plane dude.

 

[spedgas]

I asked about the 'continued use' after the 12 weeks. Being that they had a 3 month trial and 12 month efficacy results. They were really not all that 100% sure themselves. They really only have the 'clinical trial' data to go on. Some may relapse, and then need to undergo more treatment.

I don't think we'll have all the answers until this has been out for some time, as in a few years. When there will be some proper historical data.

As long as I get a slight decrease, then I'm happy. I think once you experience tinnitus, you can never truly go back to full silence, as you'll always be on the listen for it...

Again as previously mentioned a 4 dB reduction is enough to take it from "argghhh stop this!!" to "ok you're there but you're not bothering me". If i have to sit there doing a repeat treatment every now and then, then I could live with that.

As I sit here just over 2 weeks into my treatment, I'm worried that I get ZERO improvement, and that I've just wasted a whole lot of money and hope!

It wasn't cheap to buy the unit outright, along with all the flights... They're also expecting me to return in the next few weeks, which I most probably won't be doing.

I also don't think there's all that much to it in terms of individually configured for the user... The volume of both headphones and tongue tip can be user set and I was told it was ok to make it louder. As long as the hissing masks out the tinnitus, and there's a slight feel of the tongue tip, then it's doing its job.

I personally don't think the beeps and waves are actually custom to the hearing profile.

All that being said, I could be wrong. I think they're probably more concerned about people reselling their units rather than buying new from the clinician.

Anyway just my 2 cents.

Don't they change the timing parameters at six weeks? Their studies showed better results for those that changed half way through treatment. I wouldn't blow off that appointment.

 

[EDDTEKK]

It's so strange that there is still no media hype about this treatment, don't you think so?

I mean they have been developing Lenire for years and advertised over the years when it was still under development, perhaps to find funders.

Now it's finalized and available on the market but you hear and read almost nothing about it.

I can't understand this strategy and manner.

 

[Agrajag364]

It's so strange that there is still no media hype about this treatment, don't you think so?

I mean they have been developing Lenire for years and advertised over the years when it was still under development, perhaps to find funders.

Now it's finalized and available on the market but you hear and read almost nothing about it.

I can't understand this strategy and manner.

Again, they have no good published evidence yet for their device. It is really only the laxity of the EU device regulatory system that allows them to sell and market the device without the published trial data. I doubt they could get past America's FDA without trial data being published.

Maybe the media will write about it when they finally publish their big trials In a peer reviewed academic journal.

 

[AliceW]

Guys, remember what @Clare B said:

« It was near the end of the treatment I noticed the improvement. The tinnitus was quieter. It continued to improve until I had my first quiet day and then came and went for a few weeks. The quiet days became more frequent and then it was completely gone! The full treatment was for 12 weeks. We had check ups after that up to 12 months ».

 

[spedgas]

It's so strange that there is still no media hype about this treatment, don't you think so?

I mean they have been developing Lenire for years and advertised over the years when it was still under development, perhaps to find funders.

Now it's finalized and available on the market but you hear and read almost nothing about it.

I can't understand this strategy and manner.

Their one clinic is booked out past the end of the year. Once they can meet demand I'd expect more media hype.

 

[Ruse]

Very little hearing loss. Almost none. I don't make a distinction between tinnitus in your head vs ears. I think that is dumb. All perception happens in the brain so it's all in your head.

I have always wondered whether tinnitus which appears "in your head" is actually just both ears ringing at roughly the same pitch and volume making the sound appear centered.

Similar to how some sounds will appear centred in music through headphones for example - in which both channels (L & R) will be playing the same sound at the same volume.

 

[JohnAdams]

I have always wondered whether tinnitus which appears "in your head" is actually just both ears ringing at roughly the same pitch and volume making the sound appear centered.

Yes, I spent years and years learning audio engineering and I am also a former college level electronics engineering adjunct instructor. Centered audio without any spread sounds like it is in the middle of your head. Its also more than volume, there is a phase component that makes it sound spreaded out. That can make it sound like it is in the middle of your head or way out beyond your ears yet still at equal volume.

The way you do that is to flip the phase of one channel 180 degrees and then phase shift it just a little tiny bit.

 

[GoatSheep]

Yes, I spent years and years learning audio engineering and I am also a former college level electronics engineering adjunct instructor. Centered audio without any spread sounds like it is in the middle of your head. Its also more than volume, there is a phase component that makes it sound spreaded out. That can make it sound like it is in the middle of your head or way out beyond your ears yet still at equal volume.

The way you do that is to flip the phase of one channel 180 degrees and then phase shift it just a little tiny bit.

*Invert the polarity of one channel 180 degrees and then phase shift it...

 

[spedgas]

I have always wondered whether tinnitus which appears "in your head" is actually just both ears ringing at roughly the same pitch and volume making the sound appear centered.

Similar to how some sounds will appear centred in music through headphones for example - in which both channels (L & R) will be playing the same sound at the same volume.

I had an audiologist tell me this may be a possibility.