Lenire — Bimodal Stimulation Treatment by Neuromod

[DaveFromChicago]

To GlennS:

Very insightful point.

However, if the survey to be posted here within the next few weeks indicates the cumulatively disappointing results I am anticipating (given the clear majority of the reports we have already received), I am not really interested in whatever spin or explanation they will concoct as a response.

This is all too reminiscent of my experience with Desyncra; since I derived virtually no improvement I was no longer the slightest bit interested in their data representations of tangible successes. Nor was I interested in debating any various points of contention; "winning" such a debate would not have altered my results.

 

[PeterPan]

@PeterPan, just wondering what date you are releasing the survey results? Thanks.

The last patient in the original 43 should have completed their survey on the 7th May. So, not longer after this.

 

[PeterPan]

Those that benefit from Lenire, do they mostly have subjective tinnitus or somatic tinnitus? Anybody that knows the answer to this question?

We have a question about somatic tinnitus in the survey, and we should have some information on the effectiveness of the Lenire with somatic tinnitus in the Lenire report (albeit with a small sample).

 

[GlennS]

I am not really interested in whatever spin or explanation they will concoct as a response.

For me, the disconnect between user experience data and Neuromod's stats feels like an itch I can't scratch. Maybe just for the sake of consumer advocacy I want to see Neuromod have to wrestle with this head-on.

I would also like to see the "is this dress black or blue?" subjective crunching of data to end. Once I saw the preview of Tinnitus Talk's report I was really impressed. It's going to be far more substantial than anything any of us could possibly build by gleaning through the thread.

I'm not really a stakeholder at the moment as I doubt I would even consider trying it until it gets FCC approval (assuming that ever happens). The testimonials aren't good enough to warrant multiple flights to Ireland after the COVID-19 restrictions are lifted. But (and it's a big but) I feel like I have to leave some hope in my head for Neuromod to improve the parameters between now and FCC approval (although I really feel it was reckless to have released it in its current experimental state--overhyping it and downplaying the risks). I've come to view Neuromod as a little shadier or at least sloppier than I did before. That negative perception could turn itself around if they navigate through a followup interview well enough. I just don't know how they're gonna 'splain it all away.

 

[Sevv]

Well, even if Lenire does disappoint, I still believe that the research of Neuromod can be used for future devices (Shore device, UMinn device). After all, if only 1 in 10 new medicines are approved for the market, I can't imagine that it is that different for medical devices.

 

[Agrajag364]

Time to revive this photo eight months on.

 

[Agrajag364]

Well, even if Lenire does disappoint, I still believe that the research of Neuromod can be used for future devices (Shore device, UMinn device). After all, if only 1 in 10 new medicines are approved for the market, I can't imagine that it is that different for medical devices.

The requirements are less stringent for medical devices in the US and the EU.

 

[Martin69]

https://www.lenire.com/

"can provide" - if you are within the lucky 5%.

Nevertheless, no sarcasm. I hope they will continue to improve the device. There is not much more we have.
Best would be a device with remote programming.

 

[PhoenixAcademy]

https://www.lenire.com/

View attachment 38018
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"can provide" - if you are within the lucky 5%.

Nevertheless, no sarcasm. I hope they will continue to improve the device. There is not much more we have.
Best would be a device with remote programming.

Where did you see 5%? Is it really that low?

 

[Sevv]

The requirements are less stringent for medical devices in the US and the EU.

Well, in that case it's maybe more like "1 in 10 devices works".

 

[GlennS]

Where did you see 5%? Is it really that low?

Wait for the Tinnitus Talk report. No need for everyone to weigh in with their interpretation of the user experiences yet again.

 

[PhoenixAcademy]

Wait for the Tinnitus Talk report. No need for everyone to weigh in with their interpretation of the user experiences yet again.

What is the report going to show that we already can't see here?

Pardon my ignorance I haven't read all of these posts but from my casual reading of them it doesn't seem that this machine really does anything.

I do not recall seeing anyone exclaiming that this thing has returned their life back to normal or anything. I took Ginkgo Biloba for a while and it seemed like it was giving me the same level of results that people are reporting here. Even me when I wake up with a little spike and then jump in the shower and let the water spray on my teeth it really seems to lower the high frequency noise by more than what I have seen reported with the Lenire. Maybe I am being a little too critical, ignorant or both.

 

[GlennS]

What is the report going to show that we already can't see here?

Did you look at the preview? They have a lot of data gathered privately that isn't in the thread that helps provide better context. Is it suddenly going to change people from optimist to pessimist or vice versa? Maybe not, but it will probably apply a forceful nudge to those who really aren't seeing things as they really are.

I would agree that if Lenire were living up to the hype then the reports would not sound the way they do, but if you scale back your expectations and just want to know whether it's actually doing anything above and beyond placebo or whether you might be part of a particular subgroup that might fare better or worse, it's worth waiting for the report.

 

[PhoenixAcademy]

Did you look at the preview? They have a lot of data gathered privately that isn't in the thread that helps provide better context. Is it suddenly going to change people from optimist to pessimist or vice versa? Maybe not, but it will probably apply a forceful nudge to those who really aren't seeing things as they really are.

I would agree that if Lenire were living up to the hype then the reports would not sound the way they do, but if you scale back your expectations and just want to know whether it's actually doing anything above and beyond placebo or whether you might be part of a particular subgroup that might fare better or worse, it's worth waiting for the report.

I'm sorry, what is the preview?

 

[Jorge1984]

Why isn't Lenire paired with drugs that enhance neuroplasticity like nootropics? Wouldn't that enhance its efficacy?

 

[FGG]

Why isn't Lenire paired with drugs that enhance neuroplasticity like nootropics? Wouldn't that enhance its efficacy?

Why do you think the problem is that the neuroplasticity isn't strong enough?

 

[Jorge1984]

Why do you think the problem is that the neuroplasticity isn't strong enough?

I know for a fact neuroplasticity is strong but wouldn't other drugs enhance it or make it worse?

 

[FGG]

I know for a fact neuroplasticity is strong but wouldn't other drugs enhance it or make it worse?

I don't at all think the problem with Lenire is the brain isn't responding. The problem seems to be that it is responding unpredictably. I don't think nootropics are the answer to that.

 

[Tybs]

I don't at all think the problem with Lenire is the brain isn't responding. The problem seems to be that it is responding unpredictably. I don't think nootropics are the answer to that.

With the notion that "unpredictably" simply means that we don't understand its patterns yet. But as complicated as the brain is, eventually it should be possible to figure out what parameters matter and in what way. This will require "some" time of course...

 

[Tanni]

Hi guys,

I see there are a lot of comments about users' tinnitus becoming worse after using Lenire. Not sure if this is already known/useful to know, but when I went for my appointment with Neuromod last year they advised that I should expect my tinnitus to get worse at first. Apparently over half of the people who have used the device so far have reported this to be the case. It then goes on to get better apparently.

Just thought I'd mention it, as Neuromod were quite upfront about the fact that this would very likely be the case at first.

My tinnitus was really quiet at the time so I decided against using it for that very reason. They were adamant that it would not remain permanently worse but I just didn't want to take the chance.

 

[Martin69]

Very quiet here. Coronavirus stopped everything?

No new experiences from Lenire users?

 

[Lurius]

I would have written something in the user reviews, but I'm in a very difficult situation right now as I'm looking at a very real possibility of being evicted from my home. This makes me very depressed and unable to express myself properly. I just don't have the strength to write a lengthy review right now. It's going to have to be later, probably at 12 weeks, when the treatment comes to an end.

 

[jmasterj]

Very quiet here. Coronavirus stopped everything?

No new experiences from Lenire users?

There just really isn't a lot to report. I have been on my same setting for over 12 weeks since I can't get back to Ireland. I think the most frustrating part is that Neuromod hasn't reached out at all during this time. Any communication with them has had to be initiated by me. I will keep trudging along with it, but I don't have a lot of hope in the device at this time. I do wish I could get a timing change to see if it makes a difference.

I feel pretty much the same way as @pinklights98 in her recent review.

 

[EDDTEKK]

Same for me Nothing negative but also nothing positive at all to report.

This kind of treatment does nothing for me. It's like just listening to white noise and some music elements with a little electric tongue stimulation.

I would be happy to read any positive feedback to keep my hope and motivation high to proceed.

 

[hans799]

My washout period of 6 weeks has completed yesterday. The spike caused by the 2nd timing is gone... I think. I still don't sleep as well as I did before Lenire, but I can't really tell whether that is because of the tinnitus or because of the coronavirus lockdown, which is causing me a lot of anxiety, which in turn affects tinnitus of course.

I've now restarted the treatment with the first timing. For the first 1 week I'll do only 1x30mins based on the recommendation of Neuromod's audiologist. If things proceed like they did the first time, I'll have a slight worsening in 2-3 weeks, then it'll improve beyond baseline. My plan is to give it 6 weeks at least. If I get a spike again, I'm discontinuing Lenire for good, until there's a significant new version. If I improve (or experience no changes) I'll continue indefinitely.

 

[Martin69]

@pinklights98
@EDDTEKK
@jmasterj

I am sorry that it did not help one bit.
But thanks for the reports.

It makes no sense to me starting this treatment in Hannover, Germany.
I see Lenire similar to MuteButton - trial & error.

Let's hope that Susan Shore has something better for us.

 

[UKBloke]

Let's hope that Susan Shore has something better for us.

Hey Martin, I'm treading very cautiously where Susan Shore's research is concerned and not getting my hopes up too high. I have a major problem with the constraint she placed on the eligibility criteria of trial subjects for her device because it states: Preferably onset of tinnitus less than one year ago
[my emphasis]

To date I've never been able to find a satisfactory explanation as to why the inclusion criteria prejudices in this way. Perhaps prejudice is too strong a word but I think given the fact we've all, myself included, been hanging on for years to these researchers' every word our community needs to be a bit stronger in the stand it takes; if for no other reason than our own sanity.

Susan Shore did acknowledge to me in an email that her trial includes participants who have suffered with tinnitus for greater than one year. That said, I believe that wording the inclusion criteria in the way she did will have already sub-typed her participants and created bias. It's a rather sad irony that if her device came out 13 months from today, every single person that uses this forum would fall outside of the "preferable" inclusion trial criteria for the Michigan unit.

I don't know about Lenire any more; waiting for PeterPan's results and will make a decision. I want to try and end on a positive note though. I have to say that 2 or so years on from my own tinnitus spike, which I believe is now at a volume that is probably the "new normal", my own life is returning to a more manageable state. I believe this has been helped by the fact that the stress I was under (moving house) is now over. I do think stress plays a huge role aggravating this condition.

 

[hans799]

I believe this has been helped by the fact that the stress I was under (moving house) is now over. I do think stress plays a huge role aggravating this condition.

I recognize most of the regular posters here and have a subconscious judgement about how severe a case they are... you were in my "doing bad" basket. I am overjoyed to hear you're doing better.

And yes, I believe stress and anxiety have a very real effect on tinnitus. I have a sound which comes on when I'm overworked for more than a few weeks then goes away with rest... it's like a warning light. And I'm pretty sure my baseline volume is modified by anxiety. Not my perception of it; the actual volume. I hope your life will be more peaceful from now on.

 

[PeterPan]

Very quiet here. Coronavirus stopped everything?

Well, I have been preparing the report on the Lenire and doing some background research by reading some of the bimodal stimulation papers.

One thing I noticed from the leaked Lenire report is that, in the short term (i.e. 12 weeks), the effectiveness of the treatment seems to be quite insensitive to the timings and frequencies (which is at odds with the University of Michigan animal studies BTW). i.e. Arm 3, which is quite a bit different than the other arms is just as effective, on average as Arm1.

I've also noticed that the only thing that I can definitely say that has an effect on my tinnitus is having a shower (I have mild intermittent tinnitus with mild hyperacusis). I can wake in the morning with tinnitus, have a shower, and (on some occasions) the tinnitus disappears for the day. If I don't have a shower, this never happens. It's the only thing that has an effect. This has also been observed by others (e.g. @Golly ). Playing shower noises has no effect.

Now the shower provides both auditory and electrical stimulus (in the form of the sensation of water drops on the face and neck). I think this is a crude form of bimodal stimulation and that's why it works. Which I guess is an encouraging as far as bimodal stimulation goes. Maybe if you had 2 x 30 minute showers everyday this might helpful!

 

[Sevv]

And yes, I believe stress and anxiety have a very real effect on tinnitus. I have a sound which comes on when I'm overworked for more than a few weeks then goes away with rest... it's like a warning light. And I'm pretty sure my baseline volume is modified by anxiety. Not my perception of it; the actual volume. I hope your life will be more peaceful from now on.

Same here, mine fluctuates readily with my stress level.
Stress + anxiety = moderate (hard to mask)
No stress + bit of anxiety = mild (masked by ambient noise)

I'm looking forward to the Lenire report. If the results aren't too bad, I might eventually give it a try. I wouldn't mind having my previous level back...

I've also noticed that the only thing that I can definitely say that has an effect on my tinnitus is having a shower (I have mild intermittent tinnitus with mild hyperacusis). I can wake in the morning with tinnitus, have a shower, and (on some occasions) the tinnitus disappears for the day. If I don't have a shower, this never happens. It's the only thing that has an effect. This has also been observed by others (e.g. @Golly ). Playing shower noises has no effect.

Now the shower provides both auditory and electrical stimulus (in the form of the sensation of water drops on the face and neck). I think this is a crude form of bimodal stimulation and that's why it works. Which I guess is an encouraging as far as bimodal stimulation goes. Maybe if you had 2 x 30 minute showers everyday this might helpful!

Interesting, I've also had the impression that showers do help me. But the duration of the effect varies. Ironically mine seems to be lowest after a bad night.