Lenire — Bimodal Stimulation Treatment by Neuromod

[Agrajag364]

Strange. Unless the European regulator is happy to receive anecdotal feedback this doesn't concur with what Ross O'Neill said during his second Tinnitus Talk interview:

View attachment 40297

Yeah well they also said in 2018 that they were about to publish their trial data.

August 2020... crickets chirping.

 

[GlennS]

What happened? (I haven't been following this thread.)

The website is up for me. That doesn't indicate that Lenire should be a "thing", though.

As for Minnesota, hasn't it been established that there are no plans to commercialize now?

And as for Lenire 2.0, we already had MuteButton which failed. How many strikes does Neuromod get before one comes to the conclusion they don't know what they're doing? I might be able to tolerate it versioning up as the price of progress if at least they had at least first verified that it wouldn't make people's condition worse, but it HAS and it's hard for me to let that go or reward that. This also raises questions about the regulatory process over in the EU that it was approved and there is, as of now, no move on regulators to review or reassess said approval.

 

[Tanni]

This also raises questions about the regulatory process over in the EU that it was approved and there is, as of now, no move on regulators to review or reassess said approval.

Totally agree with everything in your post. I think the above is because tinnitus is a subjective condition, so they can't definitively say/prove that Lenire has made anyone's tinnitus worse, therefore they view it as a harmless device.

 

[KotaDomowa]

As for Minnesota, hasn't it been established that there are no plans to commercialize now?

If I understood correctly, no plans for commercialization of the Minnesota device But I hope that maybe in the future...

For 6 weeks I didn't use Lenire. Today, I started trying again. Previously it worked great, then it got ugly. Even though I took a short break, it still either didn't help or even made the tinnitus worse. So I stopped the treatment for the past 6 weeks.

I don't believe it will work again.

 

[friend74]

Despite everything, has anybody been to Hannover as of yet?

 

[PauloZ]

Despite everything, has anybody been to Hannover as of yet?

I have been to Hannover.

 

[Lucifer]

I have been to Hannover.

Did you end up getting the Lenire device?

 

[ruud1boy]

Doing my faithful weekly check in for my second time around this merry-go-round.

Week 3 is in the books. My first half of the week was pretty rough, meaning a normal top of my range hard tinnitus day prior to doing Lenire. My immediate first thought/hope is that it is the predicted worsening that precedes improvement, alternatively it could be I was just having a few bad days.

Anyways I'm back to my Lenire normal which is quite concretely a better normal, one that is far less destructive to my day to day life. I still hear the tinnitus 24/7 over everything 99% of the time, but more bearable.

I plan to continue out to about 6 weeks then go onto a maintenance type program.

Again I put the shout out to the universe of Tinnitus Talk users. I'm looking for a European based angel to receive and then forward me a replacement tip from Neuromod as they can't ship directly to the US. I only have a couple months left on this tongue tip.

Please DM me if you are interested in helping.

Thanks.

Why can you not get Neuromod to send you a new tongue tip in the United States? Customs?

If need be, I'd be happy to receive one for you and send it on. Whether Neuromod will play ball with this remains to be seen though.

 

[AfroSnowman]

Why can you not get Neuromod to send you a new tongue tip in the United States? Customs?

If need be, I'd be happy to receive one for you and send it on. Whether Neuromod will play ball with this remains to be seen though.

Thanks. I have had a couple other people offer to help me out. If those fall through I'll be sure to reach out.

Neuromod won't/can't legally send their medical devices to countries where it isn't approved. I imagine that they would open themselves up to fine or the like. It's a royal pain that I can't just order it directly.

Same deal with the reprogramming. I understand that if you are in the EU you can ship it to them they will reprogram and send it back to you. No luck doing that across the pond.

 

[PauloZ]

Did you end up getting the Lenire device?

Yes I did. See my post in the Lenire User Experiences thread.

 

[DaveFromChicago]

Hi, I think it is time to write my 6 months update.

Just a quick info about my history:
I'm now 29 years old.
I got severe tinnitus in November 2018 possible due to cold/virus/stress induced sudden hearing loss.
But nobody can really tell me the exact reason.
I have no hearing loss from 0-8 kHz.
My tinnitus sounds like an aggressive buzzing electric wave in my whole head. I think my tinnitus is about 12-13 kHz.
The tinnitus gets louder and changes in pitch when I clench my jaw. I often hear that while eating chewy stuff like baguette or gummy bears.
It's also reactive to noise.
Right after getting tinnitus I fell into deep depression (major depression diagnosed). I could not sleep, stayed awake for 3 days in a row. Cried all day. Lost my job (I'm a pharmacist), still living on benefits.

I started the Lenire treatment at the beginning of February, luckily just before COVID-19 hit.

In the first months of using the device there was almost no positive progress, the treatment spiked my tinnitus for some time after each session. Sleep improved a bit, I was still using Mirtazapine.

After about 2 months my head started to feel a bit lighter, clearer, and i started to taper off the Mirtazapine.

The tinnitus started to feel less intrusive, but still severe.

The progress was very very slow, so slow that it's sometimes hard to tell if it is placebo or not.

After 6 months I felt like I had plateaued, during daytime I often was less aware of the tinnitus, it was just easier to tune it out, it was less piercing.

I had to stop for about 3 weeks waiting for the new tongue tip.

The next time was very interesting. My tinnitus started to be much more fluctuating, sometimes it was almost gone when I was in bed.

Anyway, after 2 weeks I felt like it's getting worse again so I was happy to go on the the treatment.

Now this time the effect was instant. After my first session my mood got better and the tinnitus became somehow lighter.

I'm now 10 days into my second 6 months of treatment and it's still fluctuating, but better.

Conclusion:
- this treatment takes time, improvement can be very slow.
- this treatment WORKS, at least for some, but it's most probably not a cure
- this is NOT a scam

If you have the money and are not afraid of a worsening, I highly recommend going for Lenire.

It will hopefully keep me going until Frequency Therapeutics' FX-322 and the University of Michigan (Susan Shore) device come out.

Note: I'm still on PS1 and will keep the program change as a joker for later.

Lenire gives me hope.

At present there is nothing in the World I fear more than a tinnitus worsening (not even contracting COVID-19), especially when you consider that such a horrendous, suicide ideation producing outcome will cost in excess of $3,000.00 and could be to whatever degree long term or permanent.

Am I to understand that you have already used this for six months and are now starting on your seventh? Didn't Lenire stipulate that results should be observable after 12 weeks? Are we now supposed to use this for a whole year?

Isn't this a classic demonstration of the Law of Diminishing Returns?

Nonetheless, thanks very much for your report; it has, however, decided me against trying it all the more. I described Lenire in a cursory fashion to my ENT Doctor (who had never heard of it) and he gravely warned against any device that could possibly overstimulate the Trigeminal Nerve. If you research online, this far more agonizing than tinnitus; it is actually called "The Suicide Disease".

 

[ajc]

Are we now supposed to use this for a whole year?

Don't make a mistake Dave. Such a long treatment duration is laughable and can't be contributed to Lenire.

For all we know @Sironketchup is experiencing placebo or natural improvement.

Lenire has been a bust. It joins the likes of Desyncra. It's the sad truth.

 

[Tanni]

Are we now supposed to use this for a whole year?

I believe you're supposed to use it indefinitely? That's what I was told by Lenire anyway.

I described Lenire in a cursory fashion to my ENT Doctor (who had never heard of it) and he gravely warned against any device that could possibly overstimulate the Trigeminal Nerve.

That's interesting, as one user has claimed this has happened to her. Does it stimulate the Trigeminal Nerve?

 

[UKBloke]

Does it stimulate the Trigeminal Nerve?

That's exactly what it's doing.

 

[Tanni]

That's exactly what it's doing.

Oh dear. That doesn't sound good then. I hope the user in question has recovered since stopping using the device.

 

[DaveFromChicago]

Very insightful, ajc, in pointing out the similarities to Desyncra (which I was credulous enough to spend $5,269.00 on and wear for 5 hours per day for 36 weeks, yielding an outcome as insubstantial as shining a flashlight on my head would have had).

My wife, as we say in the US, read me "The Riot Act" and said, "After the total dud that Desyncra was don't you dare think of withdrawing any more from your 401k to finance another a so-called treatment that has not been fully substantiated by a recommendation from our ENT Doctor with hundreds of proven real outcomes."

 

[Kam75]

Oh dear. That doesn't sound good then. I hope the user in question has recovered since stopping using the device.

Are you talking about the girl who developed trigeminal neuralgia after using Lenire?

If so, I know this person. Unfortunately she hasn't given me any news for many months.

She was already very affected by her tinnitus, I don't know if this new disease has led her to an even deeper depression.

It is very sad, and personally I will not test any device that stimulates the trigeminal nerve.

 

[GlennS]

I believe you're supposed to use it indefinitely?

The original hype was that you would only have to use it for as long as those in the trials did and the positive results would stick--like it was rewiring your brain. A one-time thing.

 

[Fred185]

A lot of shortcoming between facts and advertising.

I got tinnitus over four years ago from an explosion in a drum I was burning trash in. Seriously affected my life. When the average person watches television, they are being brainwashed unwillingly.

Two years ago my 43-year-old daughter told me she had breast cancer. Well going to the doctors with her, and moving in her home to help, was the least we could do. Everyone sees the amazing breakthroughs with cancer today. I was shocked when, surgery, chemotherapy, and radiation was the only course of action available , along with the advertised new drugs. These drugs could add 60 days to your life at over 10K a month. Money was never the issue, life was. She died February 22, despite taking her to the best doctors in the country. But they told her she was cancer free in November 2019 and to return to work. I asked the doctor to do a PET scan to prove she was cancer free. He said the FDA Standard of Care does not allow for another scan unless you develop symptoms. That scan then happened eventually, and the news at that point was it was stage IV and very serious.

So, today, when I see those cancer commercials I want to vomit. We are now raising our five year old granddaughter in her home, so her father can work. Stress does make tinnitus worse, so from time to time I check this forum to see if anything real is happening to help tinnitus sufferers.

So far, the best advice, is to mask the sound when it gets too bad. My cell phone is my best friend at night in bed. I play background sounds of running water. I can put the phone under my pillow and it stays on all night. I cannot put anything in or over my ears with sound. In a matter of minutes it overwhelms me and my tinnitus spikes.

 

[Sironketchup]

My plan is to use Lenire for at least 1.5 years. That's about the time I had tinnitus before I started using Lenire.

Bimodal stimulation / neuroplasticity seems something that (often) needs a lot of time.

@Lurius, glad to hear from you man. Do you think the program change gave you some kind of "boost" or would PS1 have had the same effect?

 

[Lurius]

My plan is to use Lenire for at least 1.5 years. That's about the time I had tinnitus before I started using Lenire.

Bimodal stimulation / neuroplasticity seems something that (often) needs a lot of time.

@Lurius, glad to hear from you man. Do you think the program change gave you some kind of "boost" or would PS1 have had the same effect?

What I think is happening is simply that the second setting is working better for me than the first. Not more complicated than that

 

[StubbyJ]

Hello my friends. I want to keep this brief.

I've now been using Lenire for 6 months. 4 months on the first setting and 2 months on the 2nd setting.

After switching to the 2nd setting, I had some quiet days at first. Then it went back to baseline and there was a little improvement for a while. During almost the full month of August I had very little improvement at all. But I kept using the machine, because I'm a soldier and I feel like I need to use it for the full duration before I can really say if it has worked or not.

Today, the 31st of August, is the 2 year "anniversary" for my tinnitus. And for some reason, my tinnitus is almost completely gone today. I don't know if it's a coincidence, placebo or just lucky, but it's never been this quiet in a really long time. Can't remember last time it was like this. So this gives me hope that it could actually go away completely if I keep using the machine for another 2 months. I know I may be setting myself up for failure by hoping, but I think I need something to look forward to because my life is pretty horrible as it is.

I'll make another review in 2 months time and will tell you the final result of my experience with Lenire. Let's hope I'm free of tinnitus by then.

Congrats! What an awesome feeling it must be.

 

[TealD]

Hello everyone. It's been a while since I last was here on Tinnitus Talk. I am now starting TMS treatments for my depression and hoping the best for my mental health.

I'm curious to know how Lenire has been for everyone. I don't want to look through 258 pages of text.

I hope it has worked for all of you and this is the revolutionary treatment we all hoped for.

 

[Tanni]

The original hype was that you would only have to use it for as long as those in the trials did and the positive results would stick--like it was rewiring your brain. A one-time thing.

Yes, I remember now -- they followed up with the trial participants and the results had stuck.

When I went to see them, they said that that was just the length of the trial -- apparently some people were needing to use it for a lot longer, and some people may need to use it indefinitely.

Perhaps it's different for everyone, who knows.

 

[pieternel]

I have been to Hannover.

I was also in Hannover. I had a very bad experience there. I had to pay a lot of money and never received Lenire.

They also do not respond to emails.

 

[MadsWithT]

I was also in Hannover. I had a very bad experience there. I had to pay a lot of money and never received Lenire.

They also do not respond to emails.

I decided to go for the downpayment plan. So I paid around 700-800 euros. With 2 more downpayments to make. When I decided to return the device, Neuromod told me that they would not give a refund.

They would also harass me for the outstanding money. I haven't heard from them since I returned the device.

To me, the whole Lenire arrangement is looking more and more like a money grabbing scheme. And a mistreatment.

 

[MadsWithT]

Hello everyone. It's been a while since I last was here on Tinnitus Talk. I am now starting TMS treatments for my depression and hoping the best for my mental health.

I'm curious to know how Lenire has been for everyone. I don't want to look through 258 pages of text.

I hope it has worked for all of you and this is the revolutionary treatment we all hoped for.

It is not. This is however exactly what Neuromod is banking on. Tinnitus Talk members not willing to read through the thread and applying a great deal of confirmation bias in their choice making.

 

[Martin69]

I was also in Hannover. I had a very bad experience there. I had to pay a lot of money and never received Lenire.

They also do not respond to emails.

Unbelievable.

 

[PauloZ]

I was also in Hannover. I had a very bad experience there. I had to pay a lot of money and never received Lenire.

They also do not respond to emails.

Well, I had a decent experience. Only complaint I have is that their ENT department is a bit chaotic. In Hannover you have to deal with the ENT department and the German Hearing Center (audiologists).

And a lot of waiting on all the ENT exams. I also would advice to bring someone who can speak German, or that you can speak it yourself. The doctors and professor speak good English, but the ladies behind all the desks don't.

But the correspondence up front with the audiologist Dr. Frank was really good. After I sent him an e-mail, he called me the next morning to explain everything. He always answers his phone and e-mails. He also speaks good English. All the costs were clear as well, so don't know what went wrong with your visit.

Because we came from The Netherlands (long drive), he even worked overtime, so that I could get the Lenire system right away.

 

[Michael01]

I just wish more experienced tinnitus ENT doctors were available and knew more about it here in Australia. Getting a referral to see an ENT is hard enough in my case but knowing that now who you are going to see knows what they are taking about, would be good as well.

Going overseas to get something that may work doesn't sound like a very good option, at lest for me, as what happens if something goes wrong?