Lenire — Bimodal Stimulation Treatment by Neuromod

This article is in Dutch but it says that Lenire is now available at the Brai3n clinic in Belgium.

Tongstimulatie voor de behandeling van tinnitus

 

This is a very long thread. I’m seeing that the consensus is moving away Lenire.

Are there any accessible and positive neuromodular methods out there?

 

Hello, I was born hard of hearing and have been fitted with hearing aids. With my hearing aids I can hear perfectly well!

I have just seen on Lenire's website, that the treatment is not feasible for people with severe hearing loss...



But is it not possible to put the headphones on top of my hearing aids????
I listen to my music like this and it works very well, I don't understand...

If the only treatment that could be effective is not available in my case, I will seriously consider suicide... because recently my tinnitus has gone up to 10 times louder, I have the sound of a lawnmower that I hear everywhere...

 

I went to Dublin last year but was refused treatment as I have high frequency hearing loss. Neuromod had not reported that this treatment would be unsuitable and only made it known post my trip.

There are other treatments on the way so don’t despair.

 

It's weird because here...



...he's speaking about people who are severely deaf and have to wear cochlear implants!

I have hearing aids and when I wear them I can hear perfectly well.



I don't understand why this treatment wouldn't work with their headphones + hearing aids...

 

Having used the UMich device and having a strong layman's understanding of how it works, I can think of no reason this wouldn't work if your aid-corrected thresholds were sufficient to hear the beeps.

This is just another thing in the long list of claims Lenire has made, along with their very dubious choice to use wireless headphones on a medical device where latency in the ms range matters, which makes me skeptical that their tech is as good as the more solidly research-backed devices which have yet to see market.

 

Thank you for your reply, it gives me some hope!

But I don't know what the UMich device is? Is it the same stuff as the Lenire device?

Have you had any improvement in your tinnitus?

 

I asked if I could use Lenire if I had hearing aids and the answer was in the negative.

I think they are still moving the goalposts a bit. They are very nice people but I spent a lot of money in airfare from the U.K. and hotel accommodation.

There seems to be a very mixed response in outcome success.

 

You have used the UMich device? Were you in a trial? How long did you use it for and what type of results did you have?

 

Yes -- I posted about it pretty extensively in the UMich thread in the Research News category. I believe you would want to look at that thread from the timeframe of 1/1/2016 - 6/1/2016 to see what I had to say about it at the time.

Sorry to redirect you to another thread, but the stuff I had to say about the treatment at the time is probably a lot more interesting than my memories from 5 years later.

The TL;DR is, I think it works, and if someone gave me an opportunity today to buy the experimental device I used for $10,000, I would do so.

But, I am not yet willing to spend even a fraction of that on Lenire, they got some splainin' to do as far as I am concerned.

 

Clinical trial data on efficacy, never mind side-effects and worsening, is not mandatory for device approval in the EU.

It’s very wrong.

 

Thanks, did not realize you had posted it elsewhere!

 

thanks to whatever kind moderator or admin turned my text into a link to the thread!

Yeah, this is why I'm not very interested in Lenire until they clear FDA process. Or not.

Also note - the approval they DO have in Ireland is from 2015 based on the previous version of the device. This also, likely, would not be acceptable to the FDA.

 

The next gen of this needs to come with a user-friendly EEG kit - you run the EEG and either via teleconference with a Lenire employee or a self-guided app, the device is configured with timings unique to your biometric data. My fear is this being a medical device and not a consumer electronic, iteration cycles will be looooooooooooooooooong.

 

Another article about Lenire and TENT-A1 trial (even if is is not mentioned, it can be recognized by the data "326 people taking part").

Note: In this study, worsening of tinnitus is not a serious advert event. Hum...

Tinnitus Symptoms Improve With Sound and Tongue Stimulation

A noninvasive device that delivers sound to the ears and electrical stimulation to the tongue improved tinnitus symptoms in a trial reported in Science Translational Medicine. No drugs or devices are approved for tinnitus, which affects 10% to 15% of people.

demonstrated in smaller studies. In the recent trial, researchers randomly divided 326 adults with chronic tinnitus into 3 groups that received different stimulation settings. They instructed participants to use the device for a minimum of 36 hours in 60-minute sessions over 12 weeks.

Overall, tinnitus symptom severity significantly improved, although about a fifth of participants experienced no change or a worsening of symptoms. Two groups that received neuromodulation using higher-frequency tones with synchronized or shorter delayed tongue stimulation had sustained improvements over 12 months.

No serious treatment-related adverse events (AEs) occurred with the device. Most participants adhered to the treatment and said they benefited from it. “These high compliance and satisfaction rates, when compared to the reported AEs, support a strong benefit-to-risk profile for this medical device treatment for tinnitus,” the authors wrote.

Source: https://jamanetwork.com/journals/jama/article-abstract/2772741

 

Another good find. The cited article lists the usual suspects:

It's the dissonance in this research that never ceases to confound me. Even in the above two paragraphs it's there: "No serious treatment-related adverse events occurred with the device" as an addendum to, "about a fifth of participants experienced no change or a worsening of symptoms". Do they really believe that using their device and experiencing a worsening of symptoms is not an adverse event?

Also, how is one supposed to usefully interpret the statement that "about a fifth experience no change or a worsening? By their own semantics it could be that 99% of that one-fifth experienced a worsening. While still making the original statement true, the consequences of this for most users would be much more dire than if the figures were the other way round.

These wordings remind me of a situation we had in the UK some years ago with an ISP called Virgin Media. Their advertising stated connection speeds "up to" 8 Mbps (or whatever it was). The reality was nowhere near that for the average user and eventually a case was brought to court. When the judge examined the evidence he made the point that using the words "up to" had allowed VM to provide any old crap as long as it was above zero. I'm often reminded of this scenario when reading stuff from Neuromod. Wording is so important, and there's has never sat quite right with me.

 

Neuromod's marketing, in a nutshell:

 

To UKBloke:

Very insightful regarding the use of such self-protective terms to camouflage the real minimal or deleterious effects.

In Lenire's case, there was even an incomprehensible, slipshod lack of awareness regarding the obvious contradiction you mentioned.

I noticed that Julian Cowan Hill employs such nonspecific language so that he cannot be cited when his treatments are ineffective. He will, for example, contend that it is "definitely possible" to completely cure tinnitus, or that he has "helped" hundreds of clients. Such calculated, nonspecific expressions ("helped" can mean virtually anything) are evasions about the real utility of his methods.

Let's see if Lenire actually receives FDA approval, and if so whether my rigorously science-based ENT Doctor recommends it.

 

"helped" people part with their cash probably.

 

I would think Lenire would face stricter scrutiny under Biden's tenure than Trump's hydroxychloroquine administration.

 

Got an eMail from Lenire® <info@lenire.com>:

For the Germans (I guess the presentation will be in German language), there is a Webinar planned by two tinnitus experts in Germany. They are talking about Lenire. They do some presentations about "promising results" with Lenire. They explain how Lenire works and patients report about their experiences. Also a Q&A is planned.
I have subscribed and will attend.


Die Tinnitus-Experten Professor Lenarz und Professor Langguth informieren in einem Live-Webinar am 08.12.2020 um 18:00 Uhr über vielversprechende Ergebnisse mit Lenire.

Hallo <Name>

Professor Lenarz ist Direktor der HNO-Klinik und des Deutschen Hörzentrums der Medizinischen Hochschule Hannover. Professor Langguth leitet das Tinnituszentrum der Universität Regensburg. Beide Mediziner berichten über vielversprechende Ergebnisse in der Tinnitus-Therapie mit Lenire. Der Wirkmechanismus der Therapie wird erklärt und Patienten berichten über ihre Anwendungserfahrungen. Die Mediziner stehen für Fragen zur Verfügung.


Hier finden Sie die Webinar-Anmeldung.

Hier finden Sie die Details zur Agenda:

18:00 Begrüßung und Einführung in das Thema
Prof. Prof. h.c. Dr.med. Thomas Lenarz, Direktor der HNO-Klinik und des Deutschen HörZentrums (DHZ) der MHH

18:08 Neuartige Tinnitus-Therapie mit Lenire
Florian Elsäßer, Geschäftsführer der Neuromod Deutschland GmbH

18:13 Lenire als Ergebnis wissenschaftlicher Forschung
Prof. Dr. med. Berthold Langguth, Leiter des Tinnituszentrums an der Universität Regensburg

18:28 Die PCMF Studie
Prof. Prof. h.c. Dr.med. Thomas Lenarz

18:33 Therapieablauf mit Lenire bei HörSys und an der MHH
Tamás Frank, HörSys GmbH

18:40 Das sagen unsere Patienten zu Lenire
Prof. Prof. h.c. Dr.med. Thomas Lenarz

18:45 Diskussion, Fragen und Antworten
Prof. Dr. Andreas Büchner

18:55 Schlusswort
Prof. Prof. h.c. Dr.med. Thomas Lenarz

Wir freuen uns auf Ihre Teilnahme und einen interessanten Austausch.

 

Please record your impressions and share with all of us what they said.

I fear it's a sales pitch.

If Berthold Langguth doesn't criticize Neuromod at all, he's a paid stooge.

 

Why do you think Berthold Langguth would criticize Neuromod?

He is there to promote it I think.

 

I guess honesty is a little too much to ask.