Lenire — Bimodal Stimulation Treatment by Neuromod

One woman in my personal life had tinnitus for a year and it went away. I collected online stories as well. I don’t think it looks so good after a year or two.

 

I'm roughly one year in, and my tinnitus decreased from 9 to 1. It's still dropping (albeit slowly now), but I hardly care anymore at this point. I must add that mine is not sound-induced though.

 

It can get better, but not always. My first bout of moderate tinnitus lasted more than 2 years. Then it suddenly got better (I ruined it 2 years later).

I thought that Lenire could make me return to my previous state, but I see that it is nearly impossible.

 

To Agrajag364:

1) A saleslady at Whole Foods said that she had this for 5 years and it actually went away. She has no idea why.

2) A massage therapist told me that he learned to fly a private plane with no hearing protection;
you would assume that tinnitus from such continuous high pitched engine sounds would be permanent.
However, his went away after 7 years (and he was in his late 40's.)

3) My Naprapath (another massage therapist) said one of his clients had this for several years,
and it quite mysteriously disappeared suddenly (within seconds.) It took her several weeks to readjust to a return to silence and have confidence that this was the new permanence.

I have now had this for over 6 years and 2 months.
I don't know whether to be optimistic about such reports (wondering if this could really happen to me as well) or in a pit of black despair and/or jealousy that they were miraculously "liberated" and I may never be.

 

On the Neuromod website, Dr. Lim explains that bimodal stimulation uses two different inputs to stimulate nerves along the auditory channel. One of these is the electrical input to your tongue. That is, you ARE processing sound the electrical inputs as you would process sound.

You probably need to watch the video “The Brain that changes itself” to understand it better. The most analogous example is the case of Cheryl Schiltz who learned to process balance through the tongue. It bypassed the defective areas of her brain, just as Lenire is using the tongue to bypass the defective parts of the auditory channel.

And don’t underestimate the brain. With the right system, you could undoubtedly learn to hear with the tongue, just as the blind guy in the video learned to see with his tongue.

Lenire is painting sound on your tongue. And I’m sure the success of the treatment partly depends on how well you listen.

 

I don’t say that you have to consciously process sound with your tongue, but if your brain cannot recognize the tongue stimulation as sound input it won’t stimulate the nerves on the auditory pathway and the treatment will fail.

 

You are comparing two different technologies. I have seen the videos you referenced and Lenire is a different method. Lenire is not painting sound to your tongue. The electrical impulses to your tongue are stimulating the somatosensory side and not the auditory side.
Lenire is based on targeted bimodal auditory-somatosensory stimulation, involves two senses. The device plays a sound into the ears, alternating it with precisely timed, mild electrical pulses delivered to the tongue.

This sets off a process called stimulus-timing dependent plasticity, or STDP, which was first explored in animals and led to long-term changes in the rate at which the nerves fire. The approach aims to reset the activity of fusiform cells, which normally help our brains receive and process both sounds and sensations such as touch or vibration—what scientists call somatosensory inputs.

 

I've been abstaining from Lenire for 12 days now. I still have the spike. I think it might be fading - I notice long periods during the day when it's not present, and I've only had 2 nights of bad sleep since stopping which is 1 out of 6 instead of 1 out of 3. But it's still present and causes me significant distress.

I've looked up my journal. When I smoked weed for the last time this exact same noise was spiked in this exact same way. Then, it took 3 weeks for the spike to die down.

I'm very disappointed. The initial 6 weeks were so promising... then the second timing screwed the pooch. Right now, my quality of life is significantly worse than it was before I started Lenire; sleep is an issue again.

I really hope that the spike will go away. The thought that I spent a significant amount of money and time to make my nonissue tinnitus into an issue again tortures me.

 

If the spike is indeed subsiding, no matter how slow, then you will likely end up better than before Lenire: at least it is confirmed for you that there ís a timing set which helps you improve. Draw hope from that, and sit the spike through for now until it is gone.

I wouldn't use the device anymore before the first set is restored though.

 

Re: hans799 (and others):

It now appears in troublingly numerous instances that this Lenire is an unqualified fiasco.

Given the level of stress this condition induces, it would be utterly outrageous to be charged in excess of $3,000.00 for the apparently real probability of having this worsened (and I don't accept the fallback assurance that it will only be temporary; for several this has extended far longer.)

After all, let's not lose sight of the original raison d'etre for Lenire. Given these (to me, at least, especially if I was the recipient) catastrophic reports, I have almost forgotten that it was supposed to substantially reduce this.

Is Lenire aware of all of these "reversal of intended outcome" reports being compiled from this Tinnitus Talk?

Did they encounter (and to what degree) such woefully negative results during their own Clinical Trials?

If not, then why is there such a discrepancy between their results and what reports we are receiving?

Given the number of negative outcomes, will our FDA be reluctant to approve this?

 

This was presented... gingerly... in the last interview Tinnitus Talk gave them. Neuromod sort of brushed concerns under the rug.

That's the big question. This is what Tinnitus Talk says they will figure out next time they speak with Neuromod.

I would think so unless we're all missing something.

 

It does not make sense to me that Lenire produces lasting positive results, but temporary negative results. If neuroplasticity is at play and Lenire is capable of inducing that, either way should be permanent. (Susan Shore said as much about the timings).

I was eagerly awaiting Lenire when it launched but decided to wait for results. Now I wouldn't dare to poke it with a stick. All you early adopters are really brave and I really hope the worsenings turn out to be temporary and I'm wrong.

 

I understand the concerns there are about Lenire's positive effects being somewhat permanent (12 months) and negative effects like worsening of tinnitus not.

I get the impression that Neuromod simply does not know. Tinnitus is a very inexact science and we can all agree on that.

The good news is that they are potentially onto something that can again at least modulate the noise level/intensity on some patients with this method.

I feel they have a long way to go to get it to as close as perfect as possible.

It was reported that some patients got worse in their trials and recovered, however the trials were ONLY on 500+ patients. Compare that to actual drugs that go through trials and see their uncommon/rare side effects. They simply don't have robust evidence to guarantee anything, or even if worsening is possible or if it's a risk tinnitus may get worse.

They'll be sitting on a cash cow if they succeed in advancing this technology before the cure comes out (possibly by hearing regeneration).

On the other side, it's always possible these effects are patients' imagination. My tinnitus has been a little worse lately, because I've been stressed. If I was using Lenire I would attribute it to that.

 

Seems like all Hannover dates are postponed because of the coronavirus.

 

I hope all you guys who signed up for Lenire in Germany get an appointment asap.

 

I would have my appointment next week but I'm wondering whether I should cancel and postpone. Anyone else scheduled for next week and flying from London? What do you think? Will there be buses and taxis at the airport? Will Ryanair hold the flights? School are already closed and people work from home in Ireland, and now also in London for a good part.
If someone is scheduled for next week and still plans to go perhaps we can go together? Not sure what to do.

EDIT If anyone is flying from London next week please PM me, thank you

 

Just had a call from Neuromod. They said that during the trials they did have adverse events, but 100% of those has resolved after pausing treatment, and remained resolved (they followed them up for months). Timeframes varied, but were generally in the few days/few weeks range.

I've been off Lenire for exactly 2 weeks now. As I said the spike is trending downwards. I have experience with spikes to this noise - I once spiked it with weed and that took 3 weeks to resolve. So I'm very optimistic that this, too, will cease.

Now it's an interesting question that improvements can be permanent while spikes are temporary. @Paulmanlike's correct, tinnitus is very much an inexact science. However, medicine is full of such asymmetries. The body strives for homeostasis. Torn skin, broken bones, grief, or hangover, are all temporary states, and the body eventually returns to baseline. Why couldn't a tinnitus treatment have an asymmetry just like this, where healthy, beneficial states are permanent, while adverse states are usually temporary? I don't think anyone in the world knows - but there's a LOT of precedent for it in other fields.

EDIT: I got another call from Neuromod, this time from their audiologist. I asked her about their experiences with adverse events in the real world (as opposed to the trials). She says that most adverse events appear to have another cause; in addition, they have no reports of permanent spikes of any origin. She reiterated previous advice to abstain from Lenire, and they'll call me in 7 days.

 

I actually disagree there. I don't consider tinnitus to be an inexact phenomenon: in a universe following the rules of cause and effect, tinnitus behaves no differently.

The ways in which research is investigating tinnitus however: I guess that can often be called "inexact".

 

And how many of these were reflected in their success ratio? Were they counted as "non-compliant"? Non-compliance sounds like people who weren't disciplined enough to use the device, not those who were forced to drop out because of worsenings.

That sounds like their lawyers talking.

 

To GlennS:

You are entirely correct - does that ever sound like their lawyers talking. It is curious that they would rely on such an alibi when the worsening occurred immediately after Lenire usage with no other discernible changes or alterations in these affected patients routines, habits, experiences, medications, etc.

Also, they are begging a very apparent question - even if you agree for the sake of argument that these "adverse events appeared to have another cause", why wasn't Lenire effective enough to substantially reduce these as well as the pre-existent sounds?

 

I beg to differ, Hans. All of these things leave your body in a (slightly) altered state. The cut skin would leave you with a scar, broken bones have some calcification at the area where they broke, making them stronger in that point but weaker just next to that area. Grief leaves mental scars, hangovers permanent damage to the brain at best (although it would probably be so minor one wouldn't notice until after years of alcohol abuse).

You are right in that the body looks for a way to return to some sort of balance, but sometimes that's exactly what goes wrong. The central gain theory is an example, autoimmune diseases are another.

It could well be that Lenire's worsenings are not permanent (I hope not). The user reviews tend to show that it mostly temporary, but it could be permanent for some.

Why could it not? I'm not taking Neuromod's word for it.

 

I was on a medication called Accutane for acne when I was a teen.

It made everything temporarily significantly worse before making everything permanently better (as is a common effect of the treatment).

 

Well, I remember when I was literally addicted to exercise and I spent an inordinate amount of time at the gym. I began to associate the pain afterwards as a normal side effect along the lines of no pain, no gain. I didn't take a break from my gym regimen until I took a vacation and realized after a few days that the joint pain was permanent. I had effectively destroyed the cartilage in my knees. Point being that it's risky to shrug things off. How many of us have tinnitus in the first place after having had temporary tinnitus after concerts and mistakenly thought any sensation of tinnitus would go away?

 

It's always a balancing act, though. If you never tolerate any sort of temporary pain because it might actually be permanent, you achieve... nothing. No exercise, no diet change, no job change, no leaving or entering relationships, no moving cities... just stagnation. That's no way to live.

People cannot be faulted for taking reasonable risks. Do these backfire sometimes? Yes. Do we have to keep taking them, regardless? Yes, or we get nowhere.

 

Anyone flying to Dublin next week?

 

It's disheartening to see people with worsening. I hope that nothing is permanent in that regard.

It does at least prove a point that bimodal stimulation does actually do something, for what it's worth?

 

If I had prebooked an appointment AND prepaid for a Leneire, you still could not get me to visit an airport right now.

Maybe in 3 weeks. Maybe not.

 

Do you think it is that risky? Is contagion that likely? I have a carbon-filter mask, I realize it won't do much though. I have children and have been wondering what to do. If I let this go it will be months until the next appointment and I desperately need relief.

 

Neuromod is open during all this coronavirus pandemic?

 

For now.