Lenire — Bimodal Stimulation Treatment by Neuromod

[Rafa03]

@PeterPan
First of all, thank you for the info, God bless you.

With *completed successfully* I understand it refers to patients that have completed the treatment with improvement?

 

[all to gain]

Hello El Buzz,

We only have 17 completed 12 week surveys to date, which is a pretty small sample and any results would not be very reliable.

However, we do have information on dropout rates, which might be of use at this stage.

We had 24 who signed-up and who should have completed by now. However, only 17 have got to the 12 week stage.

Here is the breakdown:

View attachment 35738

PeterPan

Interesting that one person bought the device but did not use it.

Only 17 completions out of 24 doesn't sound too good, although it's a very small sample.

 

[Sironketchup]

So how did your trip work out?

May I ask you what hotel did you choose? I'm thinking about taking a hotel near the clinic or near the airport? Recommendations in general are welcome (I forgot to bookmark the postings regarding this subject in this thread

It all worked out very well. I'm back in Germany now.

I stayed in an AirBnb room in Lucan, it is very easy to get there from the airport and only 15 minutes by bus from there to the clinic.

https://www.airbnb.com/rooms/15064868

I will post the first review soon.

 

[PeterPan]

With *completed successfully* I understand it refers to patients that have completed the treatment with improvement?

No, it means they have completed the 12 weeks and completed the survey at the conclusion of the 12 weeks.

 

[Paulmanlike]

Hi all,

Hope everybody is well.

It's been a while since I posted as I have been through some grief in my life.

Can anybody give me their thoughts on whether or not Lenire is working out?

I scrolled through the other thread and I am nowhere convinced it's working, at least not for the majority. I would add that I am in a position now where I am not so desperate, however it'll be good news if it has a good chance of helping people.

I was so hopeful Lenire would be a breakthrough. What are your thoughts?

Hope all members who remember me are well.

 

[GlennS]

With all due respect, Peter, I think you could give us a preview on how things are starting to look like about the data you are harvesting.

I don't think the report is going to show anything dramatically different from what can be gleaned by reading through the thread and sort of mentally crunching the numbers. I mean, are there really that many participants who are reporting privately and not in that thread? The broad strokes are pretty easy to discern.

 

[Jack V]

Hello El Buzz,

We only have 17 completed 12 week surveys to date, which is a pretty small sample and any results would not be very reliable.

However, we do have information on dropout rates, which might be of use at this stage.

We had 24 who signed-up and who should have completed by now. However, only 17 have got to the 12 week stage.

Here is the breakdown:

View attachment 35738

PeterPan

Hi Peter,

Just to clarify, did 4 people total drop out due to adverse reactions or 2 people total (could be interpreted either way)?

Thanks,

Jack

 

[Bartoli]

Hi Peter,

Just to clarify, did 4 people total drop out due to adverse reactions or 2 people total (could be interpreted either way)?

Thanks,

Jack

I don't think it's interpretable in 2 ways, although I get what you're trying to say. The sum has to be 24, so it would be 4 dropping out in total, of which 2 before the 6 week mark, and 2 after the 6 week but before the 12 week mark.

 

[Jack V]

I don't think it's interpretable in 2 ways, although I get what you're trying to say. The sum has to be 24, so it would be 4 dropping out in total, of which 2 before the 6 week mark, and 2 after the 6 week but before the 12 week mark.

I figured it's worth asking since adverse reactions is such an important consideration, but if the total numbers add up to 24 then I'm sure you're right.

 

[RCP1]

During the initial 12 weeks of treatment my tinnitus went up and introduced a new frequency, so now I have 2 tones in the left ear and 1 in the right ear.

Neuromod then reprogrammed the device and the resulting next 12 weeks is that my tinnitus is through the roof, to a point that it is waking me up during the night and totally disrupted my sleep.

I am now so desperate that I am on antidepressants and don't want to say where my thoughts have taken me to, but you can probably guess. And all for €2k plus cost of flights etc just to be used as a lab rat to further their data gathering.

They want me to come back for another reprogramming and as you can imagine the thought of it ramping up even further scares the life out of me.

My life is now ruined.

My tinnitus got a lot worse about 18 months ago. All I can say is you somehow adapt over time. Don't write yourself off yet.

May well be able to cope further along the road.

Lenire seems to be causing real harm to some. Are Neuromod getting any feedback on this?

 

[threefirefour]

My tinnitus got a lot worse about 18 months ago. All I can say is you somehow adapt over time. Don't write yourself off yet.

May well be able to cope further along the road.

Dude, not the time.

 

[LongWait]

@hans799 has mild tinnitus, MML 10 dB if I'm right. He's happy with Lenire.

Mine's 6x that MML. Lenire certainly looks good for mild/placebo level results.

The recent bad feedback makes me realize it may not be worth the risk if your tinnitus is catastrophic.

 

[MRItechssuck]

What needs to be known is if the Lenire treatment worsening will go away if the treatment is stopped and return to base level and how long that takes.

The sample set is much too small to say whether the severity of tinnitus has anything to do with whether Lenire helps or worsens the tinnitus.

More data is needed...

From the other thread, "There are 10 treatment programs at this moment in time. However many of these are not used as Neuromod focus on the programs that led to the best response rates during the trials."

Is is this all trial and error? Yikes.

 

[AfroSnowman]

@hans799 has mild tinnitus, MML 10 dB if I'm right. He's happy with Lenire.

Mine's 6x that MML. Lenire certainly looks good for mild/placebo level results.

The recent bad feedback makes me realize it may not be worth the risk if your tinnitus is catastrophic.

I'm in roughly the same MML ball park as you. I think one of the differences in reporting between severe and mild tinnitus with this treatment is that with mild tinnitus being a bit quieter you get silence. For me my tinnitus is a bit quieter but it is still there, just a bit easier to bear.

It is a lot easier to discern definitive improvement from the former than the latter.

 

[friend74]

Right now I'm pretty insecure. I might cancel my appointment. Although there are not many long time sufferers that have tried Lenire yet. At least two of them got worse (one of them for sure). I'm clueless what to do...

 

[ThomasC]

@hans799 has mild tinnitus, MML 10 dB if I'm right. He's happy with Lenire.

Mine's 6x that MML. Lenire certainly looks good for mild/placebo level results.

The recent bad feedback makes me realize it may not be worth the risk if your tinnitus is catastrophic.

I'm sure he meant above hearing threshold and not MML. A MML of 10 dB is very very low, I wouldn't even call that tinnitus. It means it would be masked everywhere, even in quiet rooms.
And 60 dB is quite bad but I wouldn't call that catastrophic.

 

[Bartoli]

I'm sure he meant above hearing threshold and not MML. A MML of 10 dB is very very low, I wouldn't even call that tinnitus. It means it would be masked everywhere, even in quiet rooms.
And 60 dB is quite bad but I wouldn't call that catastrophic.

Isn't MML also above hearing threshold? Mine was expressed in dB SL. And my tinnitus match also. Since, I've read up on it a bit and it seems the protocol is to establish a loudness match by presenting a tone at 1kHz.
Mine was done with a narrowband noise around 8000Hz... But because I don't have hearing loss at 8000Hz maybe it's as good? This was not at Neuromod but in my local hospital though.

What's the purpose of matching and masking if there's no standards to abide by?

 

[Ruse]

What's the purpose of matching and masking if there's no standards to abide by?

One of the main reasons why THI is usually the primary outcome in tinnitus trials.

 

[ThomasC]

Isn't MML also above hearing threshold? Mine was expressed in dB SL. And my tinnitus match also. Since, I've read up on it a bit and it seems the protocol is to establish a loudness match by presenting a tone at 1kHz.
Mine was done with a narrowband noise around 8000Hz... But because I don't have hearing loss at 8000Hz maybe it's as good? This was not at Neuromod but in my local hospital though.

What's the purpose of matching and masking if there's no standards to abide by?

I don't know how the MML is measured but I'm sure it is completely different than dB SL. I think that dB SL is measured by matching your tinnitus with the same frequency sound. Then you subtract the intensity of this sound from the hearing Threshold. db SL is in most cases below 15 dB.

 

[Bartoli]

I don't know how the MML is measured but I'm sure it is completely different than dB SL. I think that dB SL is measured by matching your tinnitus with the same frequency sound. Then you subtract the intensity of this sound from the hearing Threshold. db SL is in most cases below 15 dB.

As you can see on the picture it is both in dB SL in my case. Is that a mistake? I know I read somewhere that a loudness match at the tinnitus frequency will yield lower dB results because of the likely higher hearing threshold due to hearing loss in that region. It also falsely suggests that the sound the patients hears is a quiet sound. I read most people are below 15 or 10 dB SL, but using what method? Mine is 20dB SL, but measured from part of my hearing where my threshold is 0 or even -5dB.

My tinnitus is bad, but that bad?

 

[Bartoli]

One of the main reasons why THI is usually the primary outcome in tinnitus trials.

Which is arguably even worse. Have a loudness match at 1kHz or another part of the hearing which is unaffected by hearing loss. That would somehow level the playing field in my opinion.

 

[ThomasC]

As you can see on the picture it is both in dB SL in my case. Is that a mistake? I know I read somewhere that a loudness match at the tinnitus frequency will yield lower dB results because of the likely higher hearing threshold due to hearing loss in that region. It also falsely suggests that the sound the patients hears is a quiet sound. I read most people are below 15 or 10 dB SL, but using what method? Mine is 20dB SL, but measured from part of my hearing where my threshold is 0 or even -5dB.

My tinnitus is bad, but that bad?

View attachment 35786

Mine is 15 dB SL but it was once measured at 5 dB SL and it didn't seem much lower than usual.

For me, they just matched my tinnitus with the same sound (or at least the pitch that sounded the same).

20 dB SL is loud, can you mask it?

 

[Chinmoku]

Trying to decide what to do... I have an appointment in March, but the severe cases are dubious. Remembering the scatter plot on results in the trials posted some time ago, I seem to recall that the severe cases were the ones with the least relative improvement. We have a couple of cases here with worsening, and that is something someone with severe tinnitus can hardly afford. I am really uncertain on what to do, I don't even have the result of the Tinnitus Talk survey to help. There are only the preliminary stats run by @threefirefour that seem to say it helped 70% of people. That would be ok but it's a very small sample. I am desperate for relief, but I can't afford a worsening and I am really irritated to pay 2.5K without even a preprint detailing the methodology and the results. What to do...

 

[GlennS]

There are only the preliminary stats run by @threefirefour that seem to say it helped 70% of people.

I immediately debunked that.

 

[Bartoli]

Mine is 15 dB SL but it was once measured at 5 dB SL and it didn't seem much lower than usual.

For me, they just matched my tinnitus with the same sound (or at least the pitch that sounded the same).

20 dB SL is loud, can you mask it?

I think so. I tend not to hear it when there's running water or a shower or when cooking (frying) or when there's crickets. But I hear it in the car, over TV, conversation, outdoors.
Because of that I'm trying to rely more on distraction than actual masking.

Here's the thing. The audiologist used the same sound for masking as for loudness matching. She stopped at 25dB SL because I indicated that I had hyperacusis and I found the high frequency audiometry earlier unpleasant.

She simply noted MML >25dB SL. I kinda sorta could hear my tinnitus at that level, but it didn't stick out and I had to tune in and ask her to remove the masking sound and restart it. I feel that I could probably still have heard it when the masking level went up because my tinnitus is higher pitched than the masking sound, so I wonder if there even exists a level at which it would be masked?

Needless to say I was bummed with such a high number, but a number is just a number and I still need to move forward as well as I can.

The only thing to remember for this is that it's no cold hard science when Neuromod does these tests. Do you have big fluctuations? 5 and then 15 dB loudness is all over the place? And can you mask it?

 

[BBakkers]

@Chinmoku

I sat in the same situation. And have reflected upon it like you the same way. For myself I decided it's not worth the risk and the money. As you already say, we can somewhat cope with tinnitus now but a worsening would be devastating.

I'll follow Neuromod and Lenire with interest and hope they will make progress so that I can perhaps get a treatment in the near future.

I hope my reflection helps you.

 

[threefirefour]

I immediately debunked that.

Except you didn't. You posted bad stats and people immediately dunked on your poor methodology.

 

[Ruse]

I immediately debunked that.

Sure - if by debunked you mean rejected user reviews reporting improvements.

 

[GlennS]

Sure - if by debunked you mean rejected user reviews reporting improvements.

The way things have emerged since, I'd say my analysis is far closer to the truth.

 

[threefirefour]

The way things have emerged since, I'd say my analysis is far closer to the truth.

Everyone else's predictions have been keeping up with recent developments and yours still isn't even remotely close.