Lenire — Bimodal Stimulation Treatment by Neuromod

To EDDTEKK:

I have mentioned several times that I tried Desyncra with no results. I stopped their program in 08/2017.
Their website is still up.

I am very curious about how you learned that they are bankrupt?

 

This is ground zero for those looking for signs of hope. It makes sense to keep up to date on it. It's making it hard for me because following this thread has been key to my ability to cope day to day. If I write off Lenire I have no other date on the calendar to use as a carrot. If we actually had another release around the corner, some concrete dates from Susan Shore or Minnesota, then I could shift focus. But it's all at some nebulous point in the future (like Frequency Therapeutics).

 

Thank you for digging this out. This does not look like peer review language to me. Do they have a paper published in a journal? What about Levo? I don't think they do and I don't think that is a requirement for FDA approval.

 

Has anyone compared the signal timing that Dr. Shore published to the signal timing shown on Neuromod's presentation?

 

@Ade So sorry to hear about your experience. Please let us know whether the worsening clears up in time, as Neuromod said such worsenings should clear up in their video.

 

For Susan Shore, it's maybe 2020 if we're lucky. Minnesota doesn't seem to be anytime soon.

If we count up the improvements with worsenings so far, I think we still have more improvements. Someone could double check through them though.

 

Sorry, I meant ANM Medical (Prof Peter Tass) - which was the company before Desyncra. They went bankrupt!

Of course it’s still available as I said - under the new name Desyncra.

 

I wonder if both @Allan1967 and @Ade have had this reaction due to the white noise or the timings themselves? It would be interesting if Neuromod could send out the different sound options to patients beforehand so they could sample if they do anything to their tinnitus or hyperacusis.

 

Don’t get me wrong, I understand the hope thing. But I wouldn’t put all your eggs in one basket. I want Lenire to work too. But faith is faith and reality is reality.

To be honest what puts me off the most is the worsenings. It seems like right now, this device almost has as much odds of making your tinnitus worse as it does better. I’m sorry but that’s too much of a risk for me to take, I’m going to wait till that’s fixed. Which could be a while...

I’m strapping in for the long-haul.

 

That is an excellent question.

I would think, that if the right timing is applied, tinnitus should only go in one direction and that is down.
This is why I'm puzzled with people experiencing a tinnitus increase (even if temporary), when using Lenire.

I personally suspect possible compatibility issues with Bluetooth headset and the resulting signal latency to play some part in this, but of course I cannot prove any of it.

Does anyone know, if some participants in the Susan Shore trials (or the Minnesota University trials) had also experienced increase in their tinnitus during the treatment as well?

 

You're right. But I'm feeling somewhat uneasy that it CAN make it worse. Sure, they mentioned it in the Q&A video, and it should resolve on its own but it's scary stuff nonetheless...

I wonder if it has anything to do with hyperacusis? Most people with hyperacusis don't tolerate white noise well. Then again, that group was amongst the super-responders.

It was also mentioned in this thread that they tested for loudness discomfort levels at the initial appointments, so that makes me wonder how bad one's hyperacusis could be?

I know from the Q&A video Neuromod defined hyperacusis as an LDL of 60 dB of lower. In headphones, I think you reach 60 dB easily, so wouldn't the treatment protocol automatically make it impossible for people with hyperacusis to complete the treatment? Even if you can somewhat adjust the volume (12 dB up and down I believe it was).

About the super-responders phenomenon: there are days when I can tolerate sound better than other days. On those better days my tinnitus seems to be easier to ignore. I wonder if anyone else has had this experience and if this is all linked?

 

To Bartoli:

Regarding Desyncra, what especially disturbed me was that midway though my 36 week "treatment" they announced that they were conducting major clinical trials at the Washington School of Medicine in St. Louis, Mo. and at the Veterans Administration Center in Portland, Oregon.

I wondered why they still felt the need to conduct these trials when they posted the allegedly very positive results of previous trials conducted in Germany, Hungary and the UK.

Interestingly, when they revamped their Web Site they never mentioned these two later clinical trials (and in fact eliminated the postings for these three earlier ones).
This does not actually indicate a real confidence in their data, does it.

Regarding FDA approval, a lady I know with a medical backround said that often the applicant will say "Look, there is virtually no other treatment available, so why don't you let us release this even if only 20% might benefit. After all, 20% is better than the current state of nothing."
Perhaps Dr. Shore's device may be speedily approved by this same argument.

All I know is that Desyncra did nothing for me.

As the Doors said, I will still "break on through to the other side" and try Dr. Shore's device when it is available.
I have got to do everything reasonably feasible to get myself back to a tinnitus-free condition.

 

It's not though. We can clearly see the results are spread out across the board, and they were in the trials, too. The device and all peripherals being the same, latency can't be the issue here I think.

That is, unless every patient would benefit from a different signal timing.

 

Did you have tonal tinnitus at a frequency of less than 10 kHz?

 

To Dizzyhead888:

My left ear starts to lose hearing at slightly over 8000 Hz. My tinnitus sound can be that of:
1) a dentist's drill,
2) a jazz percussionist's cymbals,
3) a large sheet of paper being torn,
4) a high pitched tea kettle.

 

They downplayed those who had worsening symptoms in the interview. Based on hearsay from the forum Neuromod seems to be suggesting the vast majority of "disimprovement" can be expected to be a passing stage and people should power through the entire treatment to reach Valhalla. That's a pretty tall order.

 

According to this article no worsening was experienced in the Shore trial.

https://news.umich.edu/specially-ti...toms-in-test-aimed-at-condition-s-root-cause/

“No patient experienced a worsening of symptoms or quality of life, or other adverse events. Some said their phantom sounds got less harsh or piercing, or became easier to ignore.”

 

My hopes about Lenire are not that high currently.

Two have worse tinnitus, even though I think this is related to tinnitus reacting to noise (in particular to white noise) - which is different to my tinnitus.

Some report tinnitus improvement, but this could also be placebo or could have happened without tinnitus. But there are also long-term sufferers who report improvement.

But it's still too early making any conclusion. Thanks to all Lenire users reporting about their experiences. This really helps.

And I hope that Neuromod can adjust the device for "non-responders" to help them, too.

 

Keeping expectations in check seems reasonable at this point, based on what those using the system are reporting here. Some good, some bad, some basically neutral.

But of the two starkly negative experiences that I'm aware of, keep in mind that @Allan1967 experienced exposure to other severe noises that, according to him, are also at least potential, if not outright likely, culprits.

 

That is definitely good news for those who decided to hold off and not jump on the Lenire train right away.

 

Either way, we will find out very soon I would think.
Once the real world testing is done, we will have much more data.

 

Yes, that is my experience as well. The severity of my tinnitus on any given day is linked to the severity of hyperacusis on that day. On some days I don’t have tinnitus, and on these days I have no hyperacusis.

 

This is probably a coincidence, but I've had the best day for quite a while today. I had more beers than I was planning to yesterday, which usually guarantees a pretty bad next day w/ Mr. T and I woke up this morning feeling extremely apprehensive. By mid-morning, I was literally jumping around with excitement as my tinnitus was barely noticeable and not bothering me at all. Let's see what tomorrow brings.

 

I hope it stays low like this.

Your previous posts indicated that you had neither improvements nor worsening. So if you really have improved as you felt today, then this is really promising. It also would indicate that sometimes the device first needs like 2 months for one to start feeling results.

Keep us updated please.

 

I reached out to one of the testimonial members of Desyncra (Tinnitus Clinic). He had a one tone 9/10 tinnitus because of a concussion (his description of it and experience was genuinely legit). Desyncra knocked it down to 3/10. He claims that his tinnitus is now the least of his concerns.

Maybe this Desyncra really only works on pure tonal tinnitus and that's why it didn't work for you.

It doesn't work me, my tinnitus is 14 kHz.

 

What week are you on with your treatment?

 

I'm also having my best day thus far.

 

To Dizzyhead888:

Thanks very much for this new information.
They should have counseled me that their treatment would not work on varying tones (and I mentioned this during the interview; I described the white noise sensation).
I see now how their entire methodology is in fact predicated on this single tone concept.

And how many respondents have one single tone that never varies?

What also interests me is that this reported reduction was greater than any of the averages (or even best cases) posted in the original three clinical trial's data.

Not that I am arguing the falsity of this individual's report (or that it's just a placeboized exaggeration).

I know of three persons whose long term tinnitus suddenly disappeared (very mysteriously, for no specific reason that could be cited).

This is the most exasperatingly elusive, groundless condition imaginable.

 

I found this comment from a person who was in the clinical trial of the Susan Shore device. I can only say they are working slowly. I did not get any further response.