Lenire — Bimodal Stimulation Treatment by Neuromod

[UKBloke]

Keep it simple. Neuromod have never controlled for placebo. Susan Shore has.

Whether or not to try any new treatment is down to the individual patient and their own risk profile, which is their responsibility.

 

[Nick47]

It became my opinion that bimodal stimulation for tinnitus is a failure, after reading the important parts of the results of the study released not long ago. There were a lot of dropouts from the study, the improvements were meagre and highly prone to bias. Same problems as with the Lenire study. I have experience with that particular treatment and know how dangerous it is.

Some big statements there. Yes, there were a lot of participants that did not follow the full protocol, I agree.

I disagree that the results were meagre. Mean reductions of 6-10 dB are clinically significant.

Yes, despite the integrity of the scientist, there may have been bias due to enormous pressure to succeed.

In the real world it will obviously benefit more than Lenire, no ifs or buts. However it may be 25-30% who get clinical benefit. That's higher than Lenire's sub 10% by a long way.

It would be handy if you were a little more specific, having read the whole report.

1) Where do you expect evidence of bias occurred?
2) What would amount to clinically significant outcome measures as opposed to meagre?

 

[MadsWithT]

1) Where do you expect evidence of bias occurred?
2) What would amount to clinically significant outcome measures as opposed to meagre?

1. The same problem as with all tinnitus studies - the self-report levels, what they call TFI. This relies on too many factors, including psychological. The metrics are hard to define "how do you feel with your tinnitus now?" or "on a scale of 1 to 10, how much does the tinnitus bother you?". This is all subjective statements. No one as yet made an objective way of measuring tinnitus, even though it should be possible.

2. Yes, those outcomes are meagre. Clinical significance is impossible for me to give since all the reports are subjective. Can you trust that people got 5 dB reduction? Or did they learn to live with the sound during the course of the trials and got better that way? Accounting for all the quitters there are also disimprovement going on.

 

[Nick47]

1. The same problem as with all tinnitus studies - the self-report levels, what they call TFI. This relies on too many factors, including psychological. The metrics are hard to define "how do you feel with your tinnitus now?" or "on a scale of 1 to 10, how much does the tinnitus bother you?". This is all subjective statements. No one as yet made an objective way of measuring tinnitus, even though it should be possible.

2. Yes, those outcomes are meagre. Clinical significance is impossible for me to give since all the reports are subjective. Can you trust that people got 5 dB reduction? Or did they learn to live with the sound during the course of the trials and got better that way? Accounting for all the quitters there are also disimprovement going on.

They used TinnTester to measure dB.

Also, a 6 dB reduction is a 50% reduction in volume - that's not clinically significant to you?

Yes, people failing to follow protocol and dropouts are always a cause for discernment.

 

[MadsWithT]

They used TinnTester to measure dB.

Also, a 6 dB reduction is a 50% reduction in volume - that's not clinically significant to you?

Yes, people failing to follow protocol and dropouts are always a cause for discernment.

I have no faith in this TinnTester. Never heard about it, it sounds like another marketing buzzword.

The average reduction in tinnitus was as much as 50%? Then we have read different papers.

Anyhow, in regards to the efficacy of the Susan Shore device, I believe in it when I see it.

This thread is derailing now. Anyone reading this should understand that Lenire is something to stay away from.

 

[Jonno02]

They used TinnTester to measure dB.

Also, a 6 dB reduction is a 50% reduction in volume - that's not clinically significant to you?

Yes, people failing to follow protocol and dropouts are always a cause for discernment.

He's made his mind up that Dr. Shore's device doesn't work, without any evidence for his point of view. You're wasting your time, Nick.

 

[MadsWithT]

He's made his mind up that Dr. Shore's device doesn't work, without any evidence for his point of view. You're wasting your time, Nick.

Yes, you're right. What I, or anyone frequenting this forum, thinks about Dr. Shore's device however, has no effect on the outcome anyhow.

 

[EDDTEKK]

I checked how many clinics in Germany still offer Lenire. Actually, I found that only 3 clinics are left! Frankfurt, Hannover and Munich.

As far as I remember, there were many more clinics in the beginning offering Lenire. Why did they stop offering it?

For me this means the final failure for Neuromod.

 

[Stuart-T]

For me this means the final failure for Neuromod.

No, because they got into the real big money market - USA.

But once suppliers realise this is a dud, they will hopefully stop offering it - or will they?

 

[RocketJSquirrel]

To my fellow Lenire users, I have a few questions. They're not terribly important, but would satisfy my curiosity as a newby.

1. Is the "i" in "Lenire" long or short? I initially assumed "eer" but then started to suspect it was as in "Ireland".
   
   
2. Two or three times during each half-hour session, the sounds gets distorted, kind of "scratchy" like a needle across a vinyl record, for about one second. Then the sound returns to normal until the next time it happens. Do they all do this, is it Bluetooth interference, or do I maybe have a defect in my device? My house is full of Bluetooth and WiFi devices and it would be impractical to turn them all off during my sessions.
   
   
3. About half the time when I power on the headphones, I hear two beeps after the "power on" voice. Half the time, no beeps. I wonder what the beeps are trying to tell me?

Thanks for any insight.

 

[Sironketchup]

Two or three times during each half-hour session, the sounds gets distorted, kind of "scratchy" like a needle across a vinyl record, for about one second. Then the sound returns to normal until the next time it happens. Do they all do this, is it Bluetooth interference, or do I maybe have a defect in my device? My house is full of Bluetooth and WiFi devices and it would be impractical to turn them all off during my sessions.

Yea, Wi-Fi (2.4 GHz) and Bluetooth devices can interfere. I had the problem with Wi-Fi and my phone.

 

[Stuart-T]

To my fellow Lenire users, I have a few questions. They're not terribly important, but would satisfy my curiosity as a newby.

1. Is the "i" in "Lenire" long or short? I initially assumed "eer" but then started to suspect it was as in "Ireland"

I hear it pronounced eer on YouTube etc and assume this was the sound from the first time I saw the word.

But it contradicts the open vowel sound in ire which is found in the word fire. I could find no example of words ending in ire which produce an eer sound.

I just looked on Neuromod's website and played a video and it was pronounced with the eer sound.

 

[RocketJSquirrel]

Is the "i" in "Lenire" long or short? I initially assumed "eer" but then started to suspect it was as in "Ireland".

OK, I stumbled across the podcast and learned it indeed sounds like "Ireland".

EDIT:

Oh, never mind. They pronounce it both ways in the podcast. I should listen more and post less.

 

[UKBloke]

OK, I stumbled across the podcast and learned it indeed sounds like "Ireland".

EDIT:

Oh, never mind. They pronounce it both ways in the podcast. I should listen more and post less.

It's pronounced Le-Dire.

 

[Nick47]

Le - Snire.

 

[dd314]

Keep it simple. Neuromod have never controlled for placebo. Susan Shore has.

I'm more concerned with what works. If people were saying that Lenire made their tinnitus go away, I wouldn't care about the lack of placebo.

 

[UKBloke]

I'm more concerned with what works. If people were saying that Lenire made their tinnitus go away, I wouldn't care about the lack of placebo.

I don't know what you're trying to say here. I don't believe even Neuromod have ever stated that Lenire will make tinnitus go away. The effect is supposedly one of calming, no? Hence the Latin name.

There are plenty of people that have already stated that Lenire did something positive for them - Neuromod released a slew of user review videos a couple of years ago to that effect. And of course their much hyped TENT-A2 graphs will tell you of the positive effects (Hubert Lim discussed this during their Webinar a year ago).

On that basis anyone not caring about a lack of placebo might just go straight ahead and purchase the treatment. But we here have benefitted from the not-inconsiderable number of independent user reviews and tepid results that have raised serious questions about the veracity of the positive results. And this is where a placebo arm would absolutely have given us an additional dimension to work with. Frankly, it would have bolstered Neuromod's position too.

 

[Stuart-T]

Just went through some pages of the Lenire User Experiences thread. I have not done an actual count after 3-4 pages but my impression is 50% or so have had no impact. There are some spectacular successes like @Red Knight - and there are many who say it has lowered their tinnitus.

Having used neuromodulation sounds myself (Art of Zen on YouTube), when my levels get a bit high, I believe in this approach. If I listened to Art of Zen for 30 minutes a day every day, perhaps my levels would also decrease like many who have used Lenire? Maybe I will try.

So yes, for some people Lenire may well work - but then so might other methods whereby sounds are played which cost nothing at all.

It should be pointed out though that Lenire at 30 minutes a day has the potential for a HUGE placebo effect. It's beyond being in a controlled study where you take a pill twice a day. That level of commitment may well have some psychological impact in many users, convincing them they have lower tinnitus.

But anyway - it does make me smile when I read "Neuromod assured me that most user are experiencing long term benefits."

What do you expect them to say!

I would like to see a study of people who first used Lenire 5 years ago.

I understand Lenire is a word of Latin origin - which means it would bee pronounced with a eer sound.

 

[UKBloke]

It should be pointed out though that Lenire at 30 minutes a day has the potential for a HUGE placebo effect. It's beyond being in a controlled study where you take a pill twice a day. That level of commitment may well have some psychological impact in many users, convincing them they have lower tinnitus.

The huge potential for placebo effect was a key concern very early on. I remember back in 2019 or whenever it was that Ross O'Neill explained to Tinnitus Talk it was nigh on impossible with this mode of treatment to test for placebo.

At the time even though Susan Shore had managed to do it, I was prepared to give Neuromod the benefit of the doubt based on a couple of things:

• The tongue is likely much more sensitive to stimulation (or lack thereof) than the skin of the neck and cheek à la the UMich device
• Neuromod's trial entry criteria allowed for people with time since tinnitus onset <5 years whereas UMich was "preferably" less than 12 months

Really it was that second point that was key for me. Although I make this comment with no scientific basis, just gut instinct, I have a sense that someone with tinnitus for 5 years knows the condition much better than a person with early onset and may therefore be more realistic in their assessment of any treatment and less likely to fall foul of the placebo effect.

I had quite an open mind about Neuromod and was prepared to take a helicopter view and play the long game but as soon as the Tinnitus Talk user reviews started coming in, something just didn't sit right.

 

[Tryn2BHopeful]

The way I see it, people have tried less effective ways to try to rid themselves of tinnitus (as I have seen on Tinnitus Talk).

If you have the money and will to try it, go for it. It doesn't seem to me that there are any definite answers as to how to help individuals with tinnitus that are available up to this point. Apparently everything is a try at your own risk.

Hopefully something pans out for tinnitus sufferers sooner rather than later.

 

[Stuart-T]

Really it was that second point that was key for me. Although I make this comment with no scientific basis, just gut instinct, I have a sense that someone with tinnitus for 5 years knows the condition much better than a person with early onset and may therefore be more realistic in their assessment of any treatment and less likely to fall foul of the placebo effect.

Not necessarily as those who have had tinnitus for 5 years may have grown indifferent to varying levels - as I have done just over 1 year on. And the longer one has had it, the more one may be in a wishful thinking state that something finally works.

Do you know what the control group were given in Dr. Shore's trial? I mean real pill vs. sugar pill is easy to have a control group for. Dummy sounds vs. real treatment sounds?

 

[RunningMan]

Do you know what the control group were given in Dr. Shore's trial? I mean real pill vs. sugar pill is easy to have a control group for. Dummy sounds vs. real treatment sounds?

The control group had auditory but no electrical stimulus, but they still wore the electrodes in the same position as the active treatment group. And the results were about 5 dB better (lowering tinnitus volume) in the active treatment group. 6 dB to 10 dB drop would be considered half as loud.

Placebo positive results can be pretty high even with a pill.

 

[Gb3]

Do you know what the control group were given in Dr. Shore's trial? I mean real pill vs. sugar pill is easy to have a control group for. Dummy sounds vs. real treatment sounds?

They didn't receive the electrical stimulation.

 

[UKBloke]

Not necessarily as those who have had tinnitus for 5 years may have grown indifferent to varying levels - as I have done just over 1 year on. And the longer one has had it, the more one may be in a wishful thinking state that something finally works.

Are you indifferent to varying levels or indifferent to your tinnitus overall? If you're indifferent overall, then reaching that point after one year since onset I'd consider you essentially cured (as much as the garden variety definition of habituation is concerned).

On the 5 year question though, why would somebody who'd grown indifferent to varying levels over that period of time also be in a wishful state that something finally works? That seems a contradictory statement.

 

[Stuart-T]

They didn't receive the electrical stimulation.

Fair enough - did the researchers who applied the electrodes know if they were placebo or active?

 

[ajc]

Fair enough - did the researchers who applied the electrodes know if they were placebo or active?

Can you maybe ask these questions in the right thread?

New University of Michigan Tinnitus Discovery — Signal Timing

And before asking questions, maybe you can read the study (or are you one of those people who can't do any research themselves and need things spoon fed?):

Reversing Synchronized Brain Circuits Using Targeted Auditory-Somatosensory Stimulation to Treat Phantom Percepts

Answer is right there...

The treatment device was programmed to deliver either active or control stimulation based on the date of enrollment in the study and randomization number to maintain double-blinding. To facilitate blinding during the control treatment (auditory only), participants were instructed to place the electrodes in the same position during both treatment phases and for both phases of the study. These 2 factors effectively blinded participants and study teams to the treatment phase (control vs active). In the pilot and the present studies, all participants reported quickly habituating to the electrical stimulus, which was close to threshold, making the stimulus difficult to detect. Participants stated that they could not tell whether they were receiving the control or active treatment.

 

[Stuart-T]

Can you maybe ask these questions in the right thread?

New University of Michigan Tinnitus Discovery — Signal Timing

And before asking questions, maybe you can read the study (or are you one of those people who can't do any research themselves and need things spoon fed?):

Reversing Synchronized Brain Circuits Using Targeted Auditory-Somatosensory Stimulation to Treat Phantom Percepts

Answer is right there...

Thanks.

Are you indifferent to varying levels or indifferent to your tinnitus overall? If you're indifferent overall, then reaching that point after one year since onset I'd consider you essentially cured (as much as the garden variety definition of habituation is concerned).

On the 5 year question though, why would somebody who'd grown indifferent to varying levels over that period of time also be in a wishful state that something finally works? That seems a contradictory statement.

Indifferent is probably the wrong word - resigned is the right word.

Many people 1 year in may still be hoping it will go away - I lost hope at the 6 month point and gave up hope entirely at the 1 year mark. Yes - resigned is what I mean.

It is an issue, otherwise I would not be on here. I manage to live with it in a way that it does not significantly affect my life. It seems strange that a noise that made me almost suicidal in month 1 should have become a tolerable nuisance at month 12.

 

[DeanD]

It's quiet in this thread. Are there so few Lenire users on Tinnitus Talk? I've been away from the forum for a while but came back to see if anyone had positive results from Lenire.

I started Lenire on June 25, 2023, so not quite a month yet. I believe it is having a positive effect. My tinnitus is usually louder immediately after a 30 minute session, but that's temporary. I feel like the overall volume of my tinnitus is slightly reduced.

Last Thursday I went to bed and realized I was hearing silence for the first time in decades. It was very strange not to hear my usual constant ringing. That, too, was temporary and the tinnitus is back. But I'm hoping that's an indication that further improvement will occur.

How loud is your tinnitus?

Would you say more mild to moderate, or severe and can't be masked?

 

[RocketJSquirrel]

How loud is your tinnitus?

Would you say more mild to moderate, or severe and can't be masked?

It varies, usually mild to moderate. Every once in a while it gets to screaming loud and at that point I'm likely to slap on the Lenire 'phones and run another 30 minute session at +1 volume just to drown out the tinnitus.

I've had tinnitus for 25 years, so I'm accustomed to hearing it all the time. Masking is OK as a distraction, but doesn't really drown out the tinnitus.

 

[Rb86]

I just heard on NPR Here & Now, they were promoting Lenire. A doctor out of Boston said his patients were having good rates of success. I was surprised considering how lackluster an experience everyone here seems to have.