Lenire — Bimodal Stimulation Treatment by Neuromod

Yes, that's what I think, too. My appointment is on Monday. They have not confirmed yet that it's possible to change to PS6.

All in all, it makes my tinnitus lighter. But there are ups and downs, some sessions might even spike it.

It's enough to get a taste of what bimodal stimulation could do, but not enough to not call myself disabled by tinnitus. But maybe now like 60% disabled instead of 80%.

There was a lady who said she got trigeminal neuralgia from Lenire.

 

Especially since the FDA approval takes Neuromod's word for it that it won't make tinnitus worse. Very disappointed in the FDA. I never thought we'd rubber stamp this. I'd like to believe that even if this barely works above placebo that it's been improved enough not to worsen your tinnitus but I am going to wait and see what US users think.

And of course that is absent from Neuromod's press release.

 

Let's get to the bottom of this claim.

The only indication of any effectiveness I found on FDA.gov is this:

"FDA believes that class II (special) controls provide reasonable assurance of the safety and effectiveness of the device type." (source)

The press releases include several mentions of it being effective, but the source for such statements appears to be exclusively Neuromod themselves. I could not trace any of these statements of effectiveness to an impartial source such as the FDA. The trialing methodology in the press release appears entirely dissociated from all of the claims of concrete effectiveness found therein, possibly with the intent to be misleading:

TENT-A3: Controlled Clinical Trial
TENT-A3 was a controlled clinical trial, designed by Neuromod to meet the FDA’s requirements, that compared the effects of 6 weeks of bimodal neuromodulation with 6 weeks of sound therapy alone. The trial was conducted at three independent sites from March to October 2022 with 112 enrolled participants8.

 

Thanks - I have not done the research you have done, but none of this surprises me. I feel sad that sufferers will be misled by the information provided.

 

So bimodal stimulation does DO SOMETHING, meaning they are on the right track, correct?

Basically if Neuromod tweaked Lenire, made a few improvements, it for sure would do something, right?

 

That has not been independently demonstrated.

You have heard of the placebo effect I hope.

There are also random fluctuations in tinnitus which users may be mistakenly connecting with their usage of the device.

This is why we need science to confirm that something actually works better than placebo.

 

There was a lady called, @AliceW, who claimed to suffer trigeminal neuralgia following Lenire use, although to the best of my knowledge she didn't update her situation on Tinnitus Talk. @Kam75 was in touch with her for a while.

 

In the same way that shooting a target range with a wide-spread shotgun does something. But it doesn't hit the target accurately.

There are success stories, but also a hell of a lot of failure stories including me.

Ultimately, if you want to take the 50/50 gamble, that's your choice. If I had my time again, I wouldn't. The risk of it getting worse outweighs the benefit of it getting better.

Just wait it out, take precautions, and don't do anything daft. These things take time.

 

Does Lenire cause you to feel sleepy? Why do you suspect that happens?

 

So what’s the good word?

 

I've had the appointment and it will be changed to PS6. It's supposed to be without white noise, just tones.

We'll see. At least this will keep my hope running until Dr. Shore's device.

 

Where are you located? I'm in the US and I wonder if they will do this for me.

EDIT: I just reached out, I'll see what they say. They really owe me the update they could never do during COVID-19.

 

So you have not changed to PS4 yet?

I'm in Germany so it's easy for me, they will pick it up by UPS.

In case they deny you, I could offer to play the middleman.

By the way, they told me that it's now possible to put in two programs and to change it with some kind of key combination. They will tell me at a free appointment. So I can change to PS3 if I want.

 

Thanks for the offer. I’ve got a couple friends in the UK I will try hitting up first.

Lenire said they could do the remote consult but that I’d need a UK/EU address to have it shipped to and from. It costs a lot of money to ship that from the US.

I asked if they were getting better responses from the PS6 because honestly the PS1 didn’t do enough to justify the time, effort and money.

 

Does anyone have an appointment at one of the US clinics yet? The Lenire website says availability will begin in April.

 

I wrote to Dr. Lim to know more about whas seems to be another clinical trial on Lenire. I received this answer:

 

I just did an appointment with the Irish team. They suggest updating my device to PS4 and PS6. Though this programming change will be "free" under my original contract, it will cost me at least $200 in shipping plus, if they tell me the tongue tip is close to expiration, another $250.

So $200-450 bucks to try this thing under different parameters, plus the investment in time (12 weeks of one hour a day treatment all for a habituation device that was underwhelming my first time around), I am on the fence on whether this is worth it.

It did do a little something for me and she said that these new timings had modestly better outcomes than the first. I'll probably do it... I guess... I don't know.

 

OK, my Lenire is now on the way to Dublin.

I somehow feel hopeful but naked without my Lenire. I got so used to doing the treatment in the past 3 years.

@AfroSnowman, do you have a source for the TENT-A3 study and regarding PS6?

 

No, she said it was unpublished. It wasn't very clear how much hand waving she was doing with the data. I don't think she was proposing that PS6 was a big improvement over PS4. She did describe the PS1 setting as not having as much long lasting impact. She said that in PS1, the stimulation was synchronized with the sound, that in PS4 it was only partially synchronized and in the PS6, it targeted a lower and narrower frequency range while being partially synchronized.

When I asked her about the targeting of lower frequencies, as my tinnitus is very high pitched, she said it didn't matter and described the mode of action as a habituation process - pushing the tinnitus awareness to the back of the mind.

 

@AfroSnowman, do you think the matching of the tinnitus frequencies is less important than we think? I have high frequency hearing loss, but low frequencies like bubbling water and electric toothbrushes seem to give me momentary residual inhibition.

I see on the University of Michigan/Dr. Shore thread people talking a lot about tinnitus matching and I have seen some mentions in the literature, but not much. And in the animal studies they wouldn't have been able to do this.

 

There's a wide error band allowed on the frequency matching, can't find the source though.

 

I now think of Lenire as a sound therapy habituation device with a bit of a speed boost from additional stimulation. What I see in general is modest results which plateau during the first couple months of use. I think this would be consistent with how most severe tinnitus people experience habituation. It's very much still there but a bit less bothersome.

This is a long way around to say that I don't think residual inhibition comes into it. When I use sound therapies in my hearing aids, I often find that lower tones farther away from my high-pitched unmaskable tinnitus work better to focus my attention away from my nasty sounds than trying to blend noises closer to the screaming in my head.

I think the mode of action for this is entirely different than Shore's device, habituation vs. suppression.

 

Thanks pal.

I agree. The lower frequency sounds do much more for me. High frequencies just send my tinnitus higher. White noise is tortuous.

 

There is no frequency matching with Lenire, just a fitting to your hearing profile.

 

Same.

"Habituation vs. suppression," that makes sense!

I hate the flash bang noise in my forehead, that's the worst. It's only in my head when it's super quiet though.

 

Do you deal with reactive/sound sensitive multi-sound tinnitus? Something tells me you do, but I cannot remember. I thought Lenire was best suited for non-reactive tinnitus, and could make reactivity worse? I may be wrong.

 

I do on both counts. I’m sure it sometimes left things louder after a treatment but as it basically sucks all the time, I don’t give much worry about measuring bad and worse. It is what it is. Under the same rubric I don't give much thought to reactivity; the tinnitus changes in response to sound but for me that is a bit of a shrug.

Overall I probably complain about my tinnitus slightly less when I am doing Lenire but it isn’t a very meaningful difference to my quality of life.

 

Do not do it. Do not give any more money to Lenire. $100 each way in shipping is a con = it should be half that.

There is no evidence that the tongue tip does anything useful. Give that a miss. Of course they will tell you - since it is coming to them - might as well replace ahead of time.

Sigh sigh - money down the drain.

 

They aren’t charging me for shipping, that’s just the cost for me to ship it across the pond to friends in the UK.

 

I got an email peddling Lenire from an audiologist's office I recently visited:

Tinnitus journey? WTF? Would an oncologist say this to a cancer patient? "Cancer journey"?