Lenire — Bimodal Stimulation Treatment by Neuromod

Ohhh you want to rhyme,
I got some time.
You always enforce the negative posts,
But ignore the positive comments and begin to roast.
You are so dug in,
All you want to do is win!
Even when someone improves you’re quick to chime in and rule the roost,
It’s like your ego needs a boost!

 

To Gb3:

The reported stastics speak for themselves. That is all that limerick is based on.

Please check out my previous posts about how the reported results had no more of a success rate than what a pure placebo clinical trial would have produced. There are also too-many-to-list reports of failure on this Forum, which dwarf the reports of any success whatsoever.

And why would you think that this has anything to do with the bolstering of my ego? Why criticise the messenger? Don't you realize that it would also have been in my best, personal interest as well to have had this result in a resounding success?

Don't take out your indignation about these disappointing outcomes on me.

 

Initially, I actually only used it for about a month. After every session, my high pitched steady ring would become wooshy, it's hard to explain but it would definitely be different but not exactly quieter. This way alone it, wouldn't change long term for me.

About 2 months after that, shortly after my first Lenire review, I decided to experiment. I used the Lenire again for a few days, and once I got the wooshy sound going on I did the Reddit head tap thing but hard, almost painfully hard, but I wanted to see if I could get a permanent change, and I did. Yes this sounds risky but risk is a requirement for anything of real progress. At first it was just slightly better, but I kept this process up for a while, using just the head tapping without the Lenire, it stayed susceptible to change for quite a while after that.

It fluctuated as in sometimes a reset (which I would induce by doing the rough head tapping) would be slightly worse, and then sometimes way better. I don't do it anymore as it has been good like this for about 8 months, so I feel fine like this until something better is out. I wouldn't recommend the rough head tapping thing alone, I don't think that would induce a positive change without something like the Lenire disrupting it first.

 

Wild, I love it! Hope you're enjoying the increase in peace!

 

I am. Thank you so much, and good luck to you finding an increase in peace for yourself too.

 

https://tinnitusstudie.org/regions

Above is a link to a Lenire trial to be held by Neuromod in St. James, Dublin and also in Belgium by Brai3n + maybe other locations in Europe.

You can apply for the trial via the link above.

I believe it is 120 participants (or 140). You will get to trial Lenire for free. It must be related to TENT-3A.

There is a survey to be completed to assess eligibility. I am not eligible, probably because I have had middle ear surgery.

Maybe Lim's input can be seen more directly in the parameters in this trial.

 

Do they really think a third study will prove effectiveness? Is there a placebo group included? Once again, the study organizer is Neuromod. Not independent in my eyes.

 

I was ruled out of the initial study before it came to market. They never gave me a reason why I wasn't accepted. I wonder would I be eligible for it this time?

When it was released I did go to the clinic to buy it but didn't go through in the end.

Edit: Just did the questionnaire, not eligible. I wonder if that is due to TMJ or length of tinnitus. Who knows.

 

No placebo ONCE again. How will it get FDA approval with no placebo???

 

Yea, I think their selection criteria is very narrow so they can get the best results possible for their company. Maybe not the best results possible for tinnitus sufferers.

I am meeting Dr. Brendan Conlon as a patient in mid May.

I will ask him about TENT-2A and TENT-3A plus why are there no placebo in trials.

 

Regarding placebo, or lack thereof, I remember Ross O'Neill making the statement (which I won't post verbatim because I don't want to listen to the interview he gave Tinnitus Talk for the umpteenth time) that due to the nature of the device, in particular the tongue tip, it's difficult to control for placebo in a clinical trial.

I've got to give him credit for being honest, but how the company have gotten away with this is beyond me. I get a sense it will be "in the smallprint" somewhere.

 

Apologies if this isn't the place to do it. I haven't monitored this thread in close to two and a half years. Can anyone point me to the post(s) that give some of the more current information, what we know, about Lenire? It seems like they are continuing to do trials but are not seeking FDA approval.

 

They are definitely on the path to seeking FDA approval at some point. I follow them closely on LinkedIn and they have recently made a number of senior appointments in America, I think even established an office there.

In Ireland, Neuromod have somewhat rebranded their tinnitus service and are now called Otologie (can't remember the spelling) and offer hearing aids, CBT / counseling and Lenire

FWIW, when I went to buy it years ago, there was no pushy sales tactics and the head audiologist was pretty honest with me. I was at a particularly anxious point in my life at that time. I admire them for that. No one else takes tinnitus seriously here in my experience.

 

This was just posted yesterday on YouTube:

Episode#8: 2/2: "From Pavlov's dog...

He is back with a glowing report about the effectiveness of Lenire that frankly contradicts the information from users that we have received.

For example, check out the charts and graphs reporting on the amazing percentage of "satisfaction rates" at 21.00 (the total time is 25.32).

Interestingly, he said that his Clinical Trial started with 326 participants and ended up with 266 (was that because these 60 participants derived so little benefit that they couldn't be bothered to continue, and were therefore not included in the final tally?)

I can't believe how much of his presentation in nearly all of its aspects (even in the actual character of his rhetoric) resembles the pitches I received in being induced to try Desyncra.

He kept referring to this nebulous "Tinnitus Handicap Index" with no mention of anyone's tinnitus actually being eliminated.

There have thus far been only 72 views.

No one has yet commented. Who wants to be the first?

 

I actually wonder whether some patients experienced a worsening and dropped out.

Does he say it in the video? I can't listen, I have an extremely bad day.

To think he was doing such good work with the Minnesota trial. Sigh.

 

Very good point (which I had not considered and should have) about those 60 dropping out not just because it did nothing but because it got worse (I recall @Allan1967 having reported a worsening from such usage.)

Lim only gave the beginning and ending participant numbers; I had to do the subtraction. No explanation was given for the discrepancy.

I had considered blasting him in the Comments Section, especially given the very contrary reports we have received.

But I decided not to be invidious (which just means that a lot of people may get pissed at me) and leave this to each person's own discretion; they are all adults and they can draw conclusions from their own Internet Research.

However, from his insubstantial, vacillating, obfuscating commentary I will unequivocally not buy this.

 

Yea, and not just Allan, may he rest in peace, but also other members here like @MadsWithT. But Neuromod's real damage here is having convinced Lim to drop the much more nuanced Minnesota device for Lenire. Of course Lim made his own choice there, but had he continued with Minnesota he could be there with Susan Shore, maybe even better, as he was also doing brain scans for calibration. We will never know.

 

The first audiological clinic near my hometown stopped selling Lenire. I asked for a new tongue tip and they told me it was too ineffective and they don’t offer Lenire anymore.

I guess the next clinic will follow soon!

P.S. Neuromod has increased the price of a new tongue tip for Lenire from €250 to €300. It’s unbelievable...

 

Wow.

 

Well, finally.

 

IMHO, I think maybe the time has come for Tinnitus Talk to conduct a follow-up interview with Neuromod and be a bit bolder in confronting them with the disconnect between the results gathered here and their marketing spin/hype. I don't think much would be lost if bridges are burned over it.

 

What clinic is that?

 

I guess it comes with an "Apple" logo now.

 

This is why I am giving Dr. Shore the benefit of the doubt. Her device will work or not but I am quite sure it won't be bullshit.

 

@EDDTEKK, I asked you to provide the name of the clinic you said has discontinued offering Lenire, but you didn't, so far. You also said they are increasing the price of the tongue tip. Why would they do that if the device failed? Price increases normally follow demand.

I also don't understand why you are asking about this unless you just want to confirm your suspicions. Most of your old posts on Lenire indicate you were a skeptic from the get go, and then you tried it and it didn't work. Someone mentioned to me when I was considering trying a drug that I didn't think would work, so why would I try it. It is an interesting question, though those who don't have tinnitus, they don't get how we think about things. But it is an interesting question: Why did you try the device if you were such as skeptic of it?

But honestly I don't expect a serious answer, based on you past statements:

"Lenire changed their name to Otologie." No, that is false.

"It appears using Lenire is like Russian Roulette. Try or Die."

"Lenire will fade away in time. I am pretty sure."

"It has a 20/80 success rate?" I grant you that was a question but it is designed for a purpose.

These are just four, there are many more like this. People can read for themselves:
https://www.tinnitustalk.com/search/6882981/?q=lenire&o=date&c[user][0]=28263

I will admit I have been railing about the supposed Elon Musk device and am skeptical. But that device isn't on the market, and I try to correct things that are pointed out to me.

The way you want to suffer through this condition is your prerogative. It is kind of a shame because I won't put up with people doing this, no matter how constructive you think you are being. And I suggest others do the same.

Of course you didn't ask for my opinion and this is just a forum, people can say whatever the hell it is they feel like saying...

 

I met Dr. Brendan Conlon today and he was a nice man. I asked him if he would do a Tinnitus Talk interview but he said Ross O’Neill was the man for that. He assured me that Ross was just as familiar with the science as he was.

 

My report from Dr. Conlon is brief.

The TENT-2A results are due very soon. He was positive they would be an improvement over TENT-1A.

Also, the TENT-3A would not have much parameter changes from TENT-2A but TENT-2A did have significant parameter changes.

News very soon from TENT-2A.

He was a nice man. Admits it is not a cure but a treatment.

Hopefully the TENT-2A results show this improvement he alluded to.

Just one more little bit: he mentioned that TENT-A2 results were signed off on. I asked him were the results better than an average result of a TFI reduction of 13 points. He said he could not answer but there was a general indication that the results were very pleasing. That was my interpretation of his body language and tone.

 

Nice - did he mention US release or specifically when TENT-A2 results will be available?

 

Thanks for reporting back on this.

A treatment is good enough for me as long it provides some relief and sense of management over the condition.

Regarding the ongoing trials, the obvious question is, did he mention controlling for placebo?

 

No placebo. I did not want to push him or aggravate him. I respect the fact he is trying to treat the condition.

I did mention the South Korean publication and if he was aware of it. He was not. I also mentioned that the South Korean results were similar to Lenire in that there was no placebo.