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Lenire — Bimodal Stimulation Treatment by Neuromod
- Thread starter Tinnitus Talk
- Start date
More negative reviews of Lenire now from people who have been using it for some time, with earlier improvements appearing to fade away. Crucially Lenire hasn't been tested in a trial with placebo and I suspect what is happening is the largely placebo effect in earlier stages is now disappearing for people who have been using it longest.
MemberThe discussion here has definitely passed an inflection point. It used to be people filing into camp optimist vs. skeptic and just arguing from a position of speculation and spin, almost like arguing over who is going to win next year's Superbowl. But now some of those same long-time participants have indeed put their money where their mouth is and have even reached the end of their 12-week period. Their testimony carries a lot of weight.
I know I'm repeating myself here but I think the most important facet of the Lenire story at present is the undeniable disconnect between the User Experience reports and Neuromod's claimed outcome stats (both from the trials and informal statements about how actual end-users are faring).
I am really looking forward to Tinnitus Talk taking the pending crunched data from April and getting Neuromod into a formal response. I know Tinnitus Talk wants to maintain a good channel of communication with them but this independent data-gathering is a necessary check and balance against the sort of exploitation that has been par for the course with tinnitus pseudo-treatments. Neuromod has been the benefit of a lot of renewed goodwill despite the failure of MuteButton. If the treatment works, then Neuromod has nothing to be afraid of by being placed under the microscope, but the more it squirms and evades and cries foul the more suspicious they'll look. So really the burden is on them and Tinnitus Talk has every right to put them under the hot-seat.
I know I'm repeating myself here but I think the most important facet of the Lenire story at present is the undeniable disconnect between the User Experience reports and Neuromod's claimed outcome stats (both from the trials and informal statements about how actual end-users are faring).
I am really looking forward to Tinnitus Talk taking the pending crunched data from April and getting Neuromod into a formal response. I know Tinnitus Talk wants to maintain a good channel of communication with them but this independent data-gathering is a necessary check and balance against the sort of exploitation that has been par for the course with tinnitus pseudo-treatments. Neuromod has been the benefit of a lot of renewed goodwill despite the failure of MuteButton. If the treatment works, then Neuromod has nothing to be afraid of by being placed under the microscope, but the more it squirms and evades and cries foul the more suspicious they'll look. So really the burden is on them and Tinnitus Talk has every right to put them under the hot-seat.
FounderYou keep speaking the truth, Glenn.
Maybe I can take this opportunity to express our relationship with Neuromod. You know how there's been one or two people who think that we're being paid off by Neuromod or are somehow in their pockets.
For transparency's sake:
- Neuromod has never paid us a cent. They didn't even cover @Steve's expenses to Ireland to do the first video Q&A. Furthermore, they stressed that financial compensation would never be part of the picture due to the conflict of interest it would create. (Don't ask me how they're sponsoring BTA and ATA at the same time... I don't know, but this is the case with us).
- At the time of kicking off our Lenire User Experience Group, they expressed some concerns with it, but we proceeded with the group due to what is at the core of Tinnitus Talk - we want to remain as impartial as possible. It's worth highlighting though that despite the expressed concerns which mostly seemed valid to us, we never got the impression they wanted to censor our patient experiences.
- I acknowledge that by having these interviews, groups and threads we've given Neuromod quite a lot of attention. I can only imagine how many of our unregistered readers have ended up learning about Lenire from here and buying a device. Sometimes I regret this because I really expected the peer review to be published at the time of the launch of the device, or soon thereafter. I don't want to direct people to spend money on things that may not work as well as they had hoped. Tinnitus sufferers have already been exploited too much. On the other hand, I feel like we were doing - and are doing - important work covering this new treatment that surely piques people's interest. At the very least we can provide people with a wider angle of coverage (like the interviews, our own in-house User Group and Experiences thread) than what is coming from Neuromod themselves. We hope we can help people make more informed decisions than what would be possible without us.
- We have appreciated the courteous and welcoming attitude from Neuromod in terms of being interviewed and contacted. And I believe @Hazel has said this well before, when we do our Tinnitus Talk Podcast etc, it's important we do these interviews cordially, otherwise we risk not being able to get interesting people on the program anymore. Just an example: a past active member hated our guts for not literally attacking Derek Hoare and Rilana Cima in our European Guidelines episode. They thought we should have been ruthless and rip them apart in the interview. No, we don't like that style. We prefer talking civilly but still bringing up the questions and concerns from our community. If that's then misinterpreted as us agreeing or liking something, we can't help it. We will never please everyone.
- Again: in a future interview with Neuromod (if such comes to fruition) we will ask the hard questions, we will survey our community what they want to know, and we will do our part. We will talk about our findings and let them answer. And at the same time, we'll approach the interview with the same open-mindedness and cordiality as we do our others.
I think there are a lot of people who come to Tinnitus Talk not so much to get informed but because they are desperate for hope or sense of solidarity. I understand how useful hope, even false hope, can be just to provide enough motivation to get by day to day. I have leaned on that sense of hope over much of the last year by camping out in this thread. But my analytical side simply can't maintain hope in the face of contrary data. I would be overjoyed if somehow Neuromod come up with a convincing explanation for why the end user experiences are worse than their stats suggest or they come up with some breakthrough tweak that improves outcomes (better late than never). I don't take pleasure in having become pessimistic and I'm not here just to be able to snicker and say "I told ya so". So I understand why people are the way they are but it's just one of my biggest pet-peeves when people double-down on denial and conjure up a lot of flimsy rationalizations. It's the whole Iraqi Information minister or Black Knight "just a flesh wound" phenomenon. People should avoid going down that road because it's super cringey.
- Jul 8, 2019
- 1,160
- Tinnitus Since
- 1991
- Cause of Tinnitus
- Loud Music / family history
There's two words that keep returning to my mind whenever I think about the state of Lenire thus far: "clinically significant". What a contentious pair of words they turned out to be.
You've nothing to be regretful about. Tinnitus Talk is fighting the good fight.
Yeah, clenching my jaw makes it louder, sometimes chewing does the same thing.
- May 22, 2019
- 257
- Tinnitus Since
- 01/2019
- Cause of Tinnitus
- NIHL & TMJ
Speak for yourself. Those who have been tracking the reviews online see it very differently.
- Feb 11, 2019
- 801
- Tinnitus Since
- 01/2014
- Cause of Tinnitus
- Headcold/Flu
Please recall that from the very onset of this I opined my serious suspicions for two reasons:
1) The best testimonial interviews they could come up with for You Tube were identical to and no better than the sorts of rhetorical comments we would have encountered from a purely placeboized trial;
2) This rhetoric was so similar to what I encountered from the results of the "Clinical Trials" conducted by Desyncra.
Although Desyncra did nothing for me, at least it did not worsen (at times critically) my pre-existing condition.
However, I recalled that great observation from "Macbeth":
"Who can look into the seeds of time
And tell which grains will grow and which will not."
We required this length of time to collect this hands-on real user data.
This prompted me to ask myself why Lenire has been so reluctant and alibi prone in not releasing this commonly cited independent Peer Review.
Given the results reported on this forum thus far, I wonder how receptive our FDA will be in granting approval.
Let's just hope that this is still nonetheless the start of a path to a truly effective treatment.
1) The best testimonial interviews they could come up with for You Tube were identical to and no better than the sorts of rhetorical comments we would have encountered from a purely placeboized trial;
2) This rhetoric was so similar to what I encountered from the results of the "Clinical Trials" conducted by Desyncra.
Although Desyncra did nothing for me, at least it did not worsen (at times critically) my pre-existing condition.
However, I recalled that great observation from "Macbeth":
"Who can look into the seeds of time
And tell which grains will grow and which will not."
We required this length of time to collect this hands-on real user data.
This prompted me to ask myself why Lenire has been so reluctant and alibi prone in not releasing this commonly cited independent Peer Review.
Given the results reported on this forum thus far, I wonder how receptive our FDA will be in granting approval.
Let's just hope that this is still nonetheless the start of a path to a truly effective treatment.
- Jun 13, 2019
- 1,108
- Tinnitus Since
- 10/2018
- Cause of Tinnitus
- Started with a cold, possibly worsened by medication/noise
Publish the bloody technical paper already! Now! Or with the current evidence and leaked scatterplot I'm going to cancel my appointment.
Very differently indeed. I was pretty sure anyone still waving the (militantly) optimist banner would check in here. Knock yourself out. I think you're in the distinct (and shrinking) minority. So I'm not sure who "those" represent besides yourself and maybe a couple others in my ignore filter. Anyway, thanks for baiting me back into snark mode.
Yeah it's true Glenn's stats weren't even close to accurate. But he's right that Lenire is underperforming with site-based improvements. I will release my final stats in late March but Lenire has underperformed here.
That being said as *the* person who tracked down each online review the most (maybe except for PeterPan), I don't see Lenire extremely over/underperforming in any major metric. Here's what I've noticed:
Neuromod official stats:
Including placebo: 86%
Excluding placebo: 70%
My stats:
Including placebo: 85%
Excluding placebo: 70%
Neuromod really needs to just release the technical paper, but they clearly haven't made it a priority. Very disappointed in them tbh.
Forgive me - can you explain what these numbers mean for dummies (i.e. me)?
Thanks,
Jack
- Jul 8, 2019
- 1,160
- Tinnitus Since
- 1991
- Cause of Tinnitus
- Loud Music / family history
Hasn't the main problem here been the meaning of the phrase "clinically significant"? I mean, 86% of treatment completed users saying, "Erm, well, yeah, hmmm, there could be a bit of difference in my tinnitus now, and that might be down to Lenire", is just not the same as 86% saying, "Hell yeah, my tinnitus is much lower in general now since treatment; Lenire has done the job and I'm feeling much better."
I've been looking at Tinnitus Talk for a little over a year now, and am not familiar with the arc of optimism for other technologies mentioned by longer term posters. Would it not be fair to say with Lenire, though, that whilst the results are underwhelming, there *are* results. With many of these other products the common element seems to be zero effect. Lenire appears to make some marginally better, and perhaps some worse. But that does at least present some empirical evidence in favor of the theorized treatment mechanism. This seems to be a step forward, regardless of Lenire's particular performance. Or am I mischaracterizing things?
- Jul 8, 2019
- 1,160
- Tinnitus Since
- 1991
- Cause of Tinnitus
- Loud Music / family history
I don't think you're mischaracterising the situation at all although I do feel the statement that Lenire has perhaps made some patients worse is understated.
I'm a huge proponent of this kind of technology, and even if ultimately the research leads us down a cul-de-sac, today I believe we're going in the right direction. That said, it's the vagueness of what it actually is that Lenire can or is supposed to do in clinical terms both in testing and in the field coupled with the lack of peer review that poses a gaping disconnect. I don't think we'll see any letup in the contention here until Neuromod squares that circle.
It definitely works for me and for a couple other folks. So it's not a dummy. But individual reactions vary greatly.
Yes exactly. If I said both groups fit under improved, then it would be an 86% reduction. If I only said the latter group improved, it would be only 70% improved.
- Jul 8, 2019
- 1,160
- Tinnitus Since
- 1991
- Cause of Tinnitus
- Loud Music / family history
Sorry to keep pressing this point but how are you making the distinction? I mean, if a patient "feels" they improved, that's down to stuff like THI, right? Therefore what criteria does a patient's outcome need to satisfy in order that you can say they "actually" improved? Is it stuff like MML? Haven't we had situations where MML has increased and yet the patient "feels" marginally better? It doesn't make sense.
Yes I feel that's where the disconnect lies. My methodology is to try to record dB reduction as much as possible using reported dB reductions (compared to Lenire's 6 dB) and comparing improvement language to known "standard candles". People have been wondering why the official improvement rate that Neuromod and I share is 70%, but the Tinnitus Talk exclusive observed real improvement rate is 55%.
I honed in on the problem: dB reduction doesn't make as much of an impact as we thought unless it goes into the single digits. You could have people like Mike T who have huge dB improvement but little "real" improvement because their tinnitus is so loud it hardly makes a difference. And on the other hand you could have people like Hans799 have very good improvement with little because their tinnitus is so mild.
In other words; why Tinnitus Talk results are underwhelming is because people with loud tinnitus are less likely to have an impact, and people who linger on tinnitus forums are more likely to have loud tinnitus. Therefore people on Tinnitus Talk are less likely to have a reduction in perceived tinnitus volume.
- Jul 8, 2019
- 1,160
- Tinnitus Since
- 1991
- Cause of Tinnitus
- Loud Music / family history
This point has been made quite a few times but I think now we're seeing Tinnitus Talk results come in it does give us something more tangible to work with so thanks for going through it again.
Based on the data you're collecting do you feel confident that we can establish a new metric going forward - one that provides some kind of statistical probability for the treatment's efficacy based on one's own MML, which a person could of course measure prior to engaging Neuromod at much less cost and strife?
Well I was hoping that perhaps Neuromod could release subtype information that could help certain sufferers figure out if they're prone to improvement or not. It would be hard to really come up with an actual new method to help sufferers if they'll benefit a lot from treatment. And I'm not an actual tinnitus researcher so I probably wouldn't be able to propose a good method. But if I had to, I'd say we should focus on comparing before-after MMLs or mild and severe sufferers, and compare them to their own before-after THIs.
70% still sounds pretty good, but would you say that out of that 70% maybe only 25% experience very good results and the rest is average? Or how would you break it down?
Wow you're almost exactly spot on. 26% seem to have a "Great" rating in terms of reduction. And yeah the remaining 44% improved is meh.
Yes, but it seems like the odds of your tinnitus getting worse are just as high as them getting better--with the majority never seeing change exceeding placebo. That tells me that while yes, neuromodulation is a thing, Neuromod has really oversold its ability to harness and control it. I mean, it's like they have their fingers on a tinnitus volume knob but they don't know which direction to turn it to make it go down. It's a risky proposition to jump in this early.
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