Lenire — Bimodal Stimulation Treatment by Neuromod

[Annpann]

Happy New Year guys! May this year will be a year of silence (also a reduced tinnitus volume will be a bless ) !

I got my tinnitus almost five years ago in my left ear (infection), it's not reactive. Last time I checked my THI was around 30.

I have my first appointment with Neuromod in March and I started thinking if it's worth the flights, hotels and other expenses .

I was wondering if anyone from the Lenire users that got tinnitus from ear infection can share some insights about the treatment?

P.S.
The only one that I know of are Allan1967 who I pray recovers and the Italian dude (luca?) who is not posting that much .

I promise to share my insights when the time arrives.

Hi, I am at the start of using Lenire and I got tinnitus from an ear infection. I will post when I have used it a few more times. The treatment is the same no matter what the cause.

 

[Lucky97]

Happy New Year guys! May this year will be a year of silence (also a reduced tinnitus volume will be a bless ) !

I got my tinnitus almost five years ago in my left ear (infection), it's not reactive. Last time I checked my THI was around 30.

I have my first appointment with Neuromod in March and I started thinking if it's worth the flights, hotels and other expenses .

I was wondering if anyone from the Lenire users that got tinnitus from ear infection can share some insights about the treatment?

P.S.
The only one that I know of are Allan1967 who I pray recovers and the Italian dude (luca?) who is not posting that much .

I promise to share my insights when the time arrives.

Yes. Lenire works very well on me and my tinnitus Is almost gone.

 

[JohnAdams]

Why would this need FDA approval when many other sound devices that claim to treat tinnitus as well as supplements do not?

 

[GlennS]

you were expecting the stats to mean more (lifechanging events) than they actually do.

I have my own idea of what constitutes "statistically significant" improvement. If it doesn't meet that threshold then it may as well be placebo. I know a lot of those you probably lump in as an improver are for all intents and purposes a no-change and of those who say they've improved it looks like we've only seen two that improved above and beyond placebo. Just 2 out of how many in total? A dozen? More? Not great.

 

[Phi]

Yes. Lenire works very well on me and my tinnitus Is almost gone.

Hi Lucky,

Glad to hear the treatment is going well.
How long have you had tinnitus?
How many weeks have you been using Lenire?

Thanks.

 

[Meiro]

Hi, I am at the start of using Lenire and I got tinnitus from an ear infection. I will post when I have used it a few more times. The treatment is the same no matter what the cause.

Good to know! Thank you and good luck!

Yes. Lenire works very well on me and my tinnitus Is almost gone.

Fantastico! Grazie mille and good luck!

 

[JayBowson]

I have my own idea of what constitutes "statistically significant" improvement. If it doesn't meet that threshold then it may as well be placebo. I know a lot of those you probably lump in as an improver are for all intents and purposes a no-change and of those who say they've improved it looks like we've only seen two that improved above and beyond placebo. Just 2 out of how many in total? A dozen? More? Not great.

Yeah so as I've said before. Neither I, nor anyone else, is obliged to use Glenn's non placebo certification. Thankfully. (That includes Neuromod). So your entire point is moot. I've already corrected you on this but you chose to ignore it.

 

[alex1975]

Why would this need FDA approval when many other sound devices that claim to treat tinnitus as well as supplements do not?

I think they want to get FDA approval so they can just use that title as a selling point and to show it's safe. Levo has FDA approval and from what I've heard, does nothing (at least I couldn't find any reliable user reviews).

 

[GlennS]

I've already corrected you on this but you chose to ignore it.

Heaven's to betsy! A crime has been committed!

The reason I'm ignoring it is that it's a subjective judgment on the part of anyone evaluating Lenire. Your attempt to say it's objective rather than subjective is what needs correcting. I mean, you can go to any one of many threads here that have the same exact sort of wishy washy testimonials. Lenire is supposed to be different. So far we have about 3 unambiguous improvers by my count. Better than nothing but not matching their statistical breakdown unless you classify even the mildest wishy washy "I sort of felt better today but then I had a spike" reports as "improvement". But hey, live in your reality-distortion-field all you like as long as you stop being so condescending. I know exactly what I'm reading in those user reports and I know what it amounts to in the aggregate.

By far the largest class of reports are those who claim it did nothing that they can detect but they are continuing to use it after 12 weeks, which is not that encouraging. So from my vantage point you're attempting to claim that a glass that's 1/4 full is actually half-full and being optimistic about it and I'm closer to calling things as they are. But we'll keep going around in circles with you strawmanning me by falsely claiming that I expect everyone to be completely and miraculously cured. It sure seems like you're spinning this into more of a positive and being trigger-happy over anyone who doesn't tow your line because you need the hopium.

 

[Sironketchup]

Hey guys,

I have managed to get an appointment for the February 6th.
I will be in Dublin between February 4-8. Anyone there then?

Cheers!

 

[alex1975]

Hey guys,

I have managed to get an appointment for the February 6th.
I will be in Dublin between February 4-8. Anyone there then?

Cheers!

That's great! When did you initially sign up? Still waiting for my appointment :-/

 

[ChrisBoyMonkey]

Why would this need FDA approval when many other sound devices that claim to treat tinnitus as well as supplements do not?

It's likely considered class 2 medical device so it has to go through approval. They also really want to hit the US market because there's nothing else really available.

That other junk doesn't have to but that's why they have to add "not evaluated by the FDA" on the packaging. It is still bull that they let those kind of things ride but take so long letting things that work in. It's almost like they want to see us suffer.

 

[JohnAdams]

It's almost like they want to see us suffer.

Which "they"?

Serious Question.

 

[JayBowson]

The reason I'm ignoring it is that it's a subjective judgment on the part of anyone evaluating Lenire. Your attempt to say it's objective rather than subjective is what needs correcting. I mean, you can go to any one of many threads here that have the same exact sort of wishy washy testimonials.

This is all just you holding Lenire to your own personal standard and nothing more. None of the rest of this forum are obliged to follow this to avoid "comitting crimes" or "being wrong on the internet". And neither are Neuromod in order for their figures to be accurate.

By far the largest class of reports are those who claim it did nothing that they can detect but they are continuing to use it after 12 weeks, which is not that encouraging.

This may have been true 2 months ago but isn't any longer. It may again be true in another 20 reports time. But at the moment, yeah, no.

But we'll keep going around in circles with you strawmanning me by falsely claiming that I expect everyone to be completely and miraculously cured.

I wonder these days if you know what strawmanning means? I have the direct quote of you saying what I'm claiming you are right here?

So we had every reason to believe a positive result should be more dramatic than what you and other optimists file as a "success" checkbox. But no, some people here are clinging to anything even remotely positive in the hopes of making the math work (which it still doesn't).
Excuse me for setting the bar higher.

See?

It sure seems like you're spinning this into more of a positive and being trigger-happy over anyone who doesn't tow your line because you need the hopium.

The irony in you claiming I'm being condescending but then posting this nonsense and just deciding I'm wrong with no more additional effort than linking an image? Oh there's reality distortion going on alright Glenn. But I'm not the purveyor.

 

[Cojackb]

@Cojackb,

I'm in Australia and wanted to ask how did you cope with such a long flight between the UK and New Zealand?

Any bad effect on your tinnitus?

Thanks!

Apologies for the delayed reply, I don't log on here much these days.

Honestly... I suspect the flights to and from the UK and NZ I've been doing recently have been partly to do with my tinnitus getting worse.

It only became problematic around two weeks after landing back in the UK and also seemed to be louder again after returning to my job in New Zealand late last year. But I've also been diagnosed with ETD which can contribute to tinnitus and am due to see an ENT consultant in February to investigate further.

Don't be put off from flying though, nearly everybody I spoke to and all the research I did, suggest flying doesn't make your tinnitus worse.

 

[ChrisBoyMonkey]

Which "they"?

Serious Question.

The FDA. I remember last I emailed them they just responded with a big generic signature type email with a bunch of gibberish about things having to be proven safe for people and what not. Yes I agree with the what, but if it seems safe and it might help people they shouldn't make it so hard for us to try it.

But it really just annoys me that they won't even let people try some things at this point because it's not FFA approved, like we don't have the options to at least try things that other countries have. Just like how you had to fly to South Korea to try the PRP.

And here we are with a promising treatment that has applied for approval and no news of it moving forward with them whatsoever. Instead those of us who really want it have to fly over there for at least the chance to try it.

 

[Agrajag364]

I thought it was a good question. I looked it up in the Q&A with Dr. Ross O'Neill. The most important arguments are that the improvements they've seen in the trials go beyond the improvement seen in a typical placebo, and that the improvements lasted over at least 12 months, which also doesn't tend to happen in the placebo effect.

As to why they didn't include placebo in the trials (Ross said Neuromod got that question a lot, and it sounds like he's sick of it), apparently, it's hard to design a placebo arm for a medical device without unblinding the trial and have the patients notice that they're not getting any electrical stimulation for instance, voiding the whole double blinded placebo protocol.

It all seems very credible to me.

Ross O'Neill's answer on the placebo arm sounds feasible to me, but didn't Susan Shore disagree? I can't remember where she said that, if anybody else can, please link, I think it was discussed earlier in the thread.

 

[Bartoli]

Why would this need FDA approval when many other sound devices that claim to treat tinnitus as well as supplements do not?

My guess is because it's the first in it's category "bimodal stimulation".

 

[Sironketchup]

That's great! When did you initially sign up? Still waiting for my appointment :-/

I signed up end of June, 2018.

I hope you get your appointment soon, but be prepared to wait until Summer 2020.

 

[Ruse]

Ross O'Neill's answer on the placebo arm sounds feasible to me, but didn't Susan Shore disagree? I can't remember where she said that, if anybody else can, please link, I think it was discussed earlier in the thread.

Are you referring to this? Circa 3.20 onwards?

What's interesting to me in this video is that Shore mentions each patient will receive both the sham treatment and the real treatment.

I wonder whether patients can actually feel the electrical stimulation in her device, otherwise it would be obvious which was real and which was the sham? This would perhaps explain why Shore is able to create a convincing sham treatment whereas Neuromod cannot.

 

[ChrisBoyMonkey]

Ross O'Neill's answer on the placebo arm sounds feasible to me, but didn't Susan Shore disagree? I can't remember where she said that, if anybody else can, please link, I think it was discussed earlier in the thread.

She pretty much just said clinical trials should be blinded, randomly controlled and have placebo.

 

[Bartoli]

She pretty much just said clinical trials should be blinded, randomly controlled and have placebo.

I'm interested to see if she has found a way to do a placebo test for a medical device. From the sound of her answer one would assume yes.

Might also be her affiliation to the university that leaves her unable to deviate from the academical good practice of placebo testing. We'll have to wait and see.

I have been wondering if her peer reviewing work for Lenire might delay UMich Device. Let's hope not!

 

[JJ4211]

Are you referring to this? Circa 3.20 onwards?

What's interesting to me in this video is that Shore mentions each patient will receive both the sham treatment and the real treatment.

I wonder whether patients can actually feel the electrical stimulation in her device, otherwise it would be obvious which was real and which was the sham? This would perhaps explain why Shore is able to create a convincing sham treatment whereas Neuromod cannot.

You can feel the electrical stimulation in both devices, however it is so light of a sensation, by design, that you'd never be able to tell if the signal timing was drastically different in each device, rendering one a placebo and one a treatment, but which is which, is left undetectable to the trial participant.

I know this as fact because I am in the current trial.

 

[threefirefour]

You can feel the electrical stimulation in both devices, however it is so light of a sensation, by design, that you'd never be able to tell if the signal timing was drastically different in each device, rendering one a placebo and one a treatment, but which is which, is left undetectable to the trial participant.

I know this as fact because I am in the current trial.

That's so cool. Thank you for being on the front lines of tinnitus research.

 

[GlennS]

I know this as fact because I am in the current trial.

Are you at liberty to share details of your experience while it's ongoing?

 

[ChrisBoyMonkey]

You can feel the electrical stimulation in both devices, however it is so light of a sensation, by design, that you'd never be able to tell if the signal timing was drastically different in each device, rendering one a placebo and one a treatment, but which is which, is left undetectable to the trial participant.

I know this as fact because I am in the current trial.

I'm not going to ask too much to help keep you anonymous but have you seen any reduction in your tinnitus?

You don't have to answer if you don't want to either.

 

[RaZaH]

Yes. Lenire works very well on me and my tinnitus Is almost gone.

For how long have you had tinnitus?

 

[threefirefour]

For how long have you had tinnitus?

October 2018. Says in his profile.

 

[JJ4211]

That's so cool. Thank you for being on the front lines of tinnitus research.

Very happy to donate my time and ears / brain to the cause.

 

[JJ4211]

Are you at liberty to share details of your experience while it's ongoing?

Believe me, I want to, because as someone who has this junky tinnitus condition, I know how much I thirsted for info, signs of progress, etc. That said, I don't want to screw over the trial or say anything that would compromise their scientific approach, or influence perception by the scientific community. I've been lurking for a while on this board, refraining from discussing it, but the question about the placebo vs. true treatment was something that I felt like I could comment on. Their experiment design, from my non-scientific view, is very strong.