Lenire — Bimodal Stimulation Treatment by Neuromod

I read that you have had a negative experience with Lenire. I am sorry to hear that.

How are you doing now?

Would you mind reiterating your rationale why Lenire is not helpful?

 

First and foremost, Lenire is not helpful because the treatment is not tailored to each user, i.e. the reference to settings numbered 1 and 2 such. Neuromod is not being truthful on this.

Secondly, there is no signal timing. With the latency induced by the Bluetooth headphones and the cascade of sounds and electric stimuli the device provides, signal timing simply cannot happen.

I still experience a massive hiss from using Lenire, which means that an increase in tinnitus can be permanent. Opposed to what Neuromod claims.

 

I just thought I'd share this video from my local TV station here in the Minneapolis/St. Paul market. As most of you know Dr. Hubert Lim is an Associate Professor at the University of Minnesota as well as the Chief Scientific Officer at Neuromod.

He makes it sound more like a habituation device and not necessarily an improvement device, but I will let you give your own take.

New research from U of M could help tinnitus patients

 

Thanks very much, jmasterj.

Precisely what did he mean when he said:

1) "The brain can detach itself or focus away from the tinnitus";
2) "It doesn't necessarily mean the loudness has been reduced";
3) "It's more about how they're feeling; the stress, the reaction, the symptom severity of the tinnitus"?

How can the "symptom severity" be reduced without the loudness as well?
This is just the sort of evasive, insubstantial rhetoric that we encountered when Lenire initially promoted this (especially regarding those testimonials on YouTube).

If this is eventually allowed for sale in the US, what will my audiologist say?

"It will not reduce your loudness but placeboize you into being in a better frame of mind by going through the motions of the application of an authentic-seeming simulacrum of a medical device"?

 

I guess this device can trigger habituation. There are different neural connections between the prefrontal cortex and the limbic brain, between those who have habituated and those who have not.

 

I’d rather waste €2500 on lottery scratch tickets. The information we've received about Lenire makes me think it's simply sketchy. Furthermore, I am more interested in waiting to get other treatments like regenerative hearing medicine.

It is clear now that Lenire has been released to make a quick buck in sales predominately.

 

Any chance one of you guys can mirror the video? Seems they don't want us pesky English watching...

 

It's here on YouTube:

New research from U of M could help tinnitus...

 

Sounds like grounds for a lawsuit, if they continue that up. There is such a thing as false advertising, among other things.

 

Yes, after someone invents a method to objectively measure tinnitus.

 

Just received this from Neuromod:

[News] Lenire's TENT A1 trial results published by STM

Hi,

In 2016 we set out on the largest and longest followed-up clinical trial of a medical device for tinnitus sufferers. It's been quite a journey.

Over 3 years our TENT A1 trial investigated if Lenire's non-invasive bimodal neuromodulation treatment (Lenire uses wireless headphones which deliver specific audio tones and background noise while our Tonguetip® delivers mild electrical stimulation to your tongue) could reduce the severity of tinnitus symptoms.

326 participants took part and we measured their symptoms up to 12 months post treatment.

Fast forward to today and we are proud to say the results of our trial show that Lenire is a clinical success at reducing the symptoms of tinnitus.

What were the results?

• 86.2% of treatment compliant participants reported an improvement in tinnitus symptom severity after 12 weeks of treatment;
• 80.1% of treatment compliant participants experienced continued improvement in tinnitus symptom severity when evaluated 12-months post-treatment;
• 77.8% of participants said they'd recommend Lenire to others.

See the results for yourself, here's a list of our resources about the results of the study:

• Get our easily digestible infographic
• Read our press release about the results
• View our TENT A1 paper and supplemental materials

Why are these results significant?
For tinnitus sufferers without an effective treatment option available to them there's now a clinically proven alternative providing sustained improvement of symptoms.

Our results were published in last week’s edition of the highly regarded medical journal Science Translational Medicine in a paper titled: ‘Bimodal neuromodulation combining sound and tongue stimulation reduces tinnitus symptoms in a large randomized clinical study’.

The peer-reviewed publication in a top scientific and clinical journal supports the credibility and acceptance of Lenire's results by the medical and research communities for meeting the needs of tinnitus sufferers.

Interested in starting your journey with Lenire? Find a clinic today.

 

Cheers.

 

That would be my take on what Lim says in this interview too. Very disappointing because it seems to contradict the whole soothing thing and raises further questions by also opening up the door to the, "Perhaps you're not quite allowing yourself to enjoy the benefits" chat with Neuromod when things don't work out; i.e. any lack of improvement can be attributed to a flaw in the patient's psychology rather than the efficacy of the device.

The only way round this situation I can think of is to wait until there is some kind of empirical means of measuring tinnitus - scanning for errant neuronal activity or whatever. Then patients can not only focus on treatments that robustly claim to actually lower tinnitus but also hold the provider to account by generating proper test results.

 

To UKBloke:

You are entirely correct.

This is reminiscent of my experience with migraines.

Although I know with entirely subjective clarity when the drug Maxalt eliminates the pain, in order to have it approved there had to be diagnostic, externally measurable proof that it narrowed the blood vessels surrounding the brain.

Various charlatans (such as Julian Cowan Hill) have no more of a basis for defending the efficacy of their methods than such solely anecdotal, empirically unverifiable comments about how many clients "felt better."

 

I feel so sad for you.

Are you planning on using Dr. Shore's device when/if available in future?

 

@DebInAustralia,

Thanks, at least I didn't contract trigeminal neuralgia.

In regards to Susan Shore's device, I don't think I would use it. I am highly skeptical. Anyhow, it looks like that device will never see the light of day.

I perceive the bimodal neurostimulatien treatment to be fraudulent and dangerous. Reading the latest statements from Hubert Lim tells me something really fishy has been going on.

 

Interesting to have Neuromod's own research on Lenire's efficacy. Perhaps unsurprisingly they appear to deliver some impressive looking figures eg:

"86.2% of treatment compliant participants reported an improvement in tinnitus symptom severity after 12 weeks of treatment;"

These figures stand in contrast with the data collected in Tinnitus Talk's own Lenire participant survey where - from what I remember - somewhat less than half reported Lenire having a positive long-term impact on their tinnitus.

What can explain such contradictory results? Well, I think we need to look at Neuromod's own findings with some degree of scepticism, they have an obvious vested interest in trying to make Lenire look good. I haven't been able to get access to the whole article but even looking at the abstract and the supplementary materials there is evidence that Neuromod have been "massaging" their data.

Take a look at this extract from their supplementary materials:

"Fig. S12. Changes in tinnitus symptoms based on responses to first satisfaction question. Participant were asked at the end of treatment (fig. S1), “overall, would you say you have benefitted from using this device?” Out of 272 responses, 66.5% indicated “Yes"

So 66.5% of participants indicated that the device had been beneficial after the 12 week treatment period. Still a high figure but a lot less than the headline figure of 86.2% reporting improvement after 12-week treatment period Neuromod are quoting in their headline figures. What can explain the discrepancy?

I think the keywords are "86.2% of treatment compliant participants". My guess is that Neuromod looked hard at those participants not reporting improvement and tried to find ways in which they had been "Non-treatment compliant", so that they could disqualify them. Those participants who had reported improvement - Neuromod probably didn't worry so much about finding out whether they had been "treatment compliant" or not.

 

Thanks very much, david c:

Yesterday Lenire e-mailed me this report, and I had exactly the same reservations.
I recall one reporter stating that, when the Police in various locales want to report that their Inner City murder rate has declined, they have standard methods known as "juking the stats" (like reclassifying a murder as a suicide).

Let's hope that the FDA is perspicacious enough to recognize this.

 

Hubert Lim talks with David Stockdale from British Tinnitus Association:

Can bimodal stimulation reduce the severity of...

 

My takeaway from the video is that they are throwing darts still, despite selling the product commercially. It's experimental and hence risky.

I also felt that Hubert Lim was sort of huffing and puffing his way around the disimprovers. I was not really satisfied with his response. For instance, he talked about how some who dropped out lost contact with them, and I perceive those people as having lost confidence to the point where they didn't want to allow themselves to keep being a guinea pig. That is how some of the people here wound up after disimprovement. The number was like 60 something out of 300 something, a much too high a ratio (1 in 5) and that's not factoring in any creative numbers on their part.

 

At about 10:45:

David Stockdale: "I think it's important to make it clear as well that we are not talking about the eradication of tinnitus."

Dr. Lim: "Correct: (it's about) the tinnitus symptoms severity and their reaction to it."
He then says that there actually were "a handful" of participants whose tinnitus did actually go away.

That's news to me in following all of the reported users on this site.

David Stockdale only threw softballs.

I got burned once with Desyncra for $5,269.00, and I'll be damned if I will invest another $3,000.00 in this now-you-see-it-now-you-don't evasiveness...

Let's see if the FDA really green lights this given the ever-varying commentary about its true effectiveness.

 

Important information about your Desyncra® for Tinnitus therapy

Dear Sir/Madam, In the event that your Desyncra® for Tinnitus iPod is no longer functional, we regret to inform you that Desyncra® for Tinnitus therapy can no longer be taken advantage of. Due to bureaucratic obstacles on the part of the licensor, it was not possible to maintain current connections. Unfortunately, all efforts made in this regard were in vain. For this reason, the app is no longer available and will be withdrawn from the market. Unfortunately, no further information about this is available. We ask that you please take note of this, and we wish you all the best!​

This was just posted on Desyncra's website.

Pardon my Internet illiteracy, but precisely what does this mean? That they are no longer in business?

 

So, TRT basically.

 

I was one of the earlier users (July 2018).
I used to have 8 sounds, now I have 2.

There were two forum members who reported elimination of tinnitus via Lenire. Andrew and Clare (don't recall usernames?). And @kelpiemsp who was in Hubert Lim's trial.

In my case I had 7 or 8 tinnitus sounds, now I have 2. I couldn't sleep prior to Lenire, now I sleep pretty much normally.

As I've said before I have mixed feelings about Lenire as I'm still left with what can be severe tinnitus on some days but what I've stated above are matters of fact.

I'm still a tinnitus sufferer but I have good days and before my tinnitus felt like it was splitting my skull in half, which it hasn't done that since August 2019 when I started Lenire.

Of the two sounds I'm left with only one is bothersome, I'm hoping Will Sedley can help with it.

This is the first incarnation of this technique I wouldn't throw the towel in on it just yet.

 

I'm 8 months into Lenire therapy I really think it helps in some way.
It teaches the brain to ignore the tinnitus (somehow by spiking it and then giving it a lot of audio input).

Probably due to sudden hearing loss.

I think it was like 2 weeks. Then it came back.

Lenire is most probably not a cure, but for me it somehow soothes the tinnitus. To the point I'm lying in the bed with my girlfriend, it's almost silent and I'm hardly aware of the tinnitus. Vaping weed and noises like fans still spike the tinnitus, it's reactive, and on some days it's still harder to cope. But all in all I'm better better.

 

@kelpiemsp wasn't using Lenire so his experience is only relevant for evaluating neuromodulation in general, not Lenire.

I do have a problem with a company barreling forward with releasing a product without peer review and with this high of a "disimprovement" rate. It's reckless and it turns me off regardless of whether it's considered legal in the EU.

This is not to invalidate those who feel it's helped them, but just as they're pausing some of the COVID-19 vaccines due to what are often a scant number of negative side effects I don't see how it is a device like this can win EU approval with a 20% chance of having your tinnitus symptoms worsen.

I don't know the rationale but it may be that regulators feel that having your tinnitus worsen is no big deal even though we have at least one suicide on record potentially as a result of it.

 

This is probably why pharmaceutical companies like Otonomy are seemingly attempting to get their treatments approved in America first because it is I think much more difficult to gain approval there and as a result you potentially are going to get superior products.

 

@Hazel just wrote an independent assessment outlining all the pros and cons of Lenire.

Please take a moment to read, comment, and share it where you can.

 

Hmm.... 6%? How does this reconcile with Lim's interview which amounted to roughly 20% disimprovement?