Lenire — Bimodal Stimulation Treatment by Neuromod

As regards to TENT-2A results, Dr. Conlon just mentioned 'very soon'. They have been 'signed off on'.

I asked him if the TENT-3A study was for FDA approval.

I got no response.

 

Just a few extra tidbits from my 30 minutes with Dr. Brendan Conlon of Lenire.

He was not aware of Potassium Channel modulators but when I pushed him harder, he recalled attending a conference that Prof. Thanos spoke at. He feels a cure for tinnitus will be pharmacological. He would not prescribe XEN1101 without a tinnitus study. He had never heard of Retigabine.

He was not aware at all of the South Korean study.

He was not aware to my best knowledge of Otonomy's work.

When he said about possibly trying Lenire, I said I was waiting on TENT-2A and also the outcome of the Michigan device. I asked him was he aware of this, yes he was familiar with Dr. Shore but not familiar with the device. I also mentioned that user reviews on Tinnitus Talk were not great at present and we were eagerly awaiting TENT-2A results.

Also, notably I mentioned I had volatile tinnitus and that Lenire was better with tonal tinnitus. He said that in the data, it worked just as well for both tonal and non tonal tinnitus.

I also asked him about Hubert Lim and his success at 'curing' tinnitus with specially timed signals whilst hooked up to an EEG at University of Minnesota. I asked would Neuromod not consider launching a premium service where customers could pay to have this individualised treatment. He brushed off the suggestion.

He was eagerly awaiting the end of our appointment as to be honest there was nothing he could offer me (I have the two most common tinnitus triggers, hearing loss in high frequency and a history of severe stress).

He acknowledged his connection with Prof. De Ridder but was totally against implantables.

He eagerly awaited the next patient as he could probably help them, but also he felt uncomfortable as I was a 'keyboard warrior' who probably has done more generalised tinnitus research in the last two years by multiples.

I thanked him sincerely for trying to treat tinnitus. His focus is on being a performing ENT. His research into tinnitus is now done and Lenire is something of an aside now. I feel Hubert Lim is the technology officer there now.

A nice man, but he was glad to see the back of me. Medical professionals understandably don't like patients who are 'know it alls' like me

Can't blame them.

 

How are you doing? Did you go back to Lenire and did it help if so?

 

Thanks for the question. The post you are quoting is quite old, from last year. It was the prelude to my insane worsening that lasted 6 months. That period was the worst time of my life, I think. A cacophony of sound flooding my entire brain every single day for 6 months. I'm not doing any keto diets anymore, to put it like that and I'm also not touching any drugs that isn't 100% necessary for my survival.

But about Lenire. I'm going to talk about something here now that I've been extremely reluctant to mention in any way, shape or form. For reasons. Personal reasons. This is all pretty personal to me but I've decided to finally bring it up. I've been using Lenire since 2020. The first year I used it for 1 hour every day, with a small break in the summer to change the mouthpiece. I took a break around Christmas and started it again in March after I got a severe worsening. This coincided somewhat with me going off Olanzapine which I had taken for 2 years and I had also just put on something called Alimemazine, which another user also reported gave him insane setbacks, new sounds, increased loudness etc.

After experimenting and talking with the audiologist from Neuromod on the phone at least 3 times every week for quite some time, I landed on the "sweet spot" for me, 20 minutes. I stopped using Lenire again when the worsening started, because they advised me to do so. We didn't know what the culprit was back then and they said it was unlikely to be Lenire but they wanted to be sure. They told me to wait until it settles down. I started using it again in the fall of 2021. I also started working out in the gym around that time. My crazy worsening also settled around that time. I had e-mail correspondence with the audiologist at this time and I had developed something I would call "trust" with her. This person knows I have autism and I found her advice and friendly demeanour to be very helpful in calming me down, reassuring me and not losing hope. I guess you could say I was becoming a little dependent on her.

Around Christmas time I was completely lost and the tinnitus had started to become extremely bad again on a regular basis despite using Lenire. She would often send me emails every now and then to check on me. On one occasion my nihilism got the better of me and I admitted my suicidal ideation to her. I even said I was going to kill myself on Christmas eve. I was very much at the "what's the point?" here so I didn't see much light in any tunnel. Unfortunately, this caused her to alert someone much higher up in the system and the whole ordeal was handed over to them. Some kind of protocol they have at Neuromod, when the suicide flag goes off they apparently have a system for that. So I got a call from an Irish woman who was very, very concerned about my health. She inquired about this, offered psychiatric assistance through Zoom and so on. That's all fine, but I was caught completely unaware that someone else was going to be addressing this. The fact that my personal email had been handed over to someone else made me feel very uncomfortable. I asked why I wasn't speaking to the audiologist, and I was told that it was because "this wasn't her table". I later asked her directly about this in an e-mail and I got some kind of lame, methodical answer about how they have a protocol for that kind of thing.

I felt betrayed and I wasn't sure if I could trust this person anymore. I lost all interest in corresponding with Neuromod and when I saw that they had actually changed their whole company's profile, name and so on, the betrayal felt even worse. I realize that she was just trying to help me but what we feel individually about stuff like this is our own personal issue and we all have our reasons for feeling that way. I don't think anyone is wrong to feel a certain way about something like this. That's why I've been so reluctant to mention this.

I started using Lenire again in April, 20 minutes every day for 2 months. Today is actually the day I take a break again. So I'm off Lenire now until August 1 and then I'm back on it for another 2 months. If I combine it with more than 3 hours of sleep, it helps. If something is missing from the equation, it does nothing and it can even get a lot worse. But sleeping somewhat well, Lenire helps me long term.

But I don't think I want to talk to them anymore. Not unless I absolutely have to.

 

I bought Lenire 2 years ago. I want to use it again now.

I forgot how its charger looks like.

Anyone can share a picture of the charger?

 

How does Lenire help you?

 

I mean this with all due sympathy but this is the very sort of thing that questions the legitimacy of Lenire as a treatment. What I see here is no clear cause and effect and a see-saw that could very well be driven by rather than mediated by the use of Lenire.

Eliminating variables seems to be the best way to avoid risk, especially with something advertised to essentially reprogram your brain.

The fact Neuromod has a standard protocol to deal with suicide risk tells me not so much that people are entering into treatment suicidal (they are supposed to prescreen out those) but that the treatment protocol itself may be pushing people to the brink (as some here feel was the case with a Tinnitus Talk member who chose to be an early adopter).

I mean, one datapoint can be a coincidence, but a lot is a pattern.

 

Different bimodal neuromodulation settings reduce tinnitus symptoms in a large randomized trial

TENT-2A study results are published.

 

I got the email too. Out of 191 participants;

• 95% of treatment compliant participants achieved an improvement in their tinnitus symptoms after 12 weeks of treatment with a greater average improvement in symptoms than reported in TENT-A1
• 91% of treatment-compliant participants experienced improvement in tinnitus symptoms that sustained 12 months after treatment
• 87.8% said they would recommend treatment to others with tinnitus

So my question is - Have the TENT-A2 settings been used in the general population or only on these 191 participants?

 

I'm sure this will generate a ton of discussion but this is the table I am most interested in:

https://www.nature.com/articles/s41598-022-13875-x/tables/3

Around a quarter to a third of trial participants report worsening within the first half of the treatment. This then somehow drops to 5-10% by the end.

I find it frustrating that no Tinnitus Talk members seem to have described improvements that are as unambiguously positive as this study suggests.

 

Keep in mind this is a worst-to-treat population. Like with all sickness, the ones who are the sickest are the most difficult to treat.

 

A tinnitus study without a placebo group is the most pointless thing there is.

If the device didn't work, you end up choosing a bit better values because you feel guilty towards the person who wants to help you.

Then it's an incredibly expensive device, so you choose better values because otherwise it looks like you used it wrong, etc.

Tinnitus sufferers are susceptible to placebo effects.

I remember a video showing a participant in the first study in Regensburg during the final survey. Very old, didn't look like the brightest candle on the cake and, when asked if it's gotten any better, he just said yes but didn't explain anything. When asked if the tinnitus had gotten quieter, he said yes. I could see that he felt compelled to give positive answers. It looked like he certainly didn't understand anything about neuromodulation etc.

Unfortunately, I can no longer find the video, or it has been deleted.

So you are welcome to buy the device overseas if available, but I advise you against it (I tested it myself, completely ineffective.)

 

So you’re saying a person who has heart surgery can’t be better if they don’t understand cardiovascular surgery.

 

Not exactly.

Rather: if your study doctor explains to you after waking up from the new heart surgery procedure that has just been carried out - which, according to studies, has helped 95% of all participants so far - and is very complex and, above all, more expensive (which you get for free as a study participant), you say as a less self-confident person, yes I think I'm doing better, tick that.

What the doctor doesn't tell you: He just cut you open, didn't really do anything to your heart and sewed it up again. (Sorry I have to compliment myself, this is my best comparison with Neuromod's Lenire so far.)

 

How can you have such a difference between their numbers (~90% people that recommend Lenire) and the overall feeling on this forum (very bad reviews from most who have tried it)?

I know that people who had bad experiences are more likely to share it but the difference is really too big here.

And I'm not saying they (Neuromod) are cheating with numbers either. I just have no clue what is happening when I read their results...

 

No placebo group explains the difference.

 

Spot on! No placebo, no blinding means money stays in pocket.

 

Does anyone know if there has been anyone from the USA that has gone over to the UK, Ireland, or Europe to get the Lenire treatment? Are there any clinics that have it that will treat someone from the USA who travels over to the clinic for treatment?

I called one of the clinics in the UK to inquire about this, but they basically turned me away saying they can not treat Americans because it is not approved by the FDA yet, even if we fly over to be at the clinic in person.

Any help on this issue would be much appreciated. Thank you!

 

@Lurius, @GlennS,

I mean this with as much respect as humanly possible, but guys, we're talking about medical professionals here. Any time a person in their care so much as mentions suicide or the possibility of no longer continuing life, the programming kicks in. They can't exactly ignore a patient saying they want to die - any place that deals with sick or emotionally hurt people has such protocols. You must, at all times, present yourself as a character who would be normal and content as anyone else, if only your condition improved. I know it is unfair. It's a symptom of the world we live in.

 

Seriously I’ve been meaning to write this. They are mandated to report anyone that is threatening to harm themselves.

 

All of what I say here below is subject to change, because it is quite an endeavor to go overseas and I don't guarantee this will work, not to mention the treatment. I would also study this thread and the other thread about user reports. I would also take everything with a grain of salt. I believe the treatment can work. I haven't done it because of going overseas, and my understanding is you needed to stay there for a few weeks to go to 3 appointments, and I go between being able to deal with tinnitus, to having "bad days."

I contacted 3 German clinics, at Lenire's suggestion, from their "Clinics" page, and they all said they could treat me. I almost made an appt with Germany Hearing Clinic, aka Deutsches Hörzentrum Hannover. If you contact them, make sure you understand what is involved time and expense-wise.

Also, you need to have decent hearing. I have moderate, but normal hearing loss, confirmed with a test. I would get a test if you don't have one, and send that to them before setting anything up, to make sure you don't get there and they say you can't use the treatment, along with checking with them on anything that could deny you treatment, such as past drug use, hearing aid use, what kind of tinnitus you have (I don't think it works unless you have somatic).

Email:

Dear Paul,

...I got some dates for examination at Prof. Lenarz’s clinic. For Lenire-Treatment at least 3 fitting-events are necessary for optimal results (including the event following the examination).

The costs for Lenire-Treatment:

250€ - 600€ clinical examination
1900€ Lenire-device
350€ first fitting
Each 250€ every follow-up appointment

The Tonguetip has to be replaced after 180 hours of use. When you use Lenire two times 30 minutes a day, the Tonguetip will last a half year. You can replace it by yourself, the replacement costs 250€ (you can order the replacement directly at Neuromod‘s online store - we will create an account here). For Payment please bring a credit card.

Best regards,
Philipp Becker
Hörakustik-Meister
HörSys GmbH
Deutsches Hörzentrum Hannover
Karl-Wiechert-Allee 3
30625 Hannover
lenire@hoersys.de
Tel. +49 511 554 769 78​

 

I went to Max Bauer, Neues Hoeren Munich and bought the device. I gave it back after 6 weeks, it helped zero. I got a 66% refund.

He once had a video with a guest from the US who flew over and bought the device directly from him. So you don't need a clinic, etc. I think the individual attitude is nonsense anyway.

Neuromod acts as if you could configure the device in a special way, which is also nonsense. The tinnitus frequency is not even queried and the device is not set accordingly.

In principle, Max Bauer seemed serious to me. When I returned, he said it was a pity, 50% of the patients had experienced an improvement. Well, the question is how much you can believe that.

In any case, you can ask him whether he can send the device to the USA.

Max Bauer had advertised Lenire in many videos a year ago, and you don't hear anything from him anymore in this regard.

My opinion: Better buy an EMS device and play sounds from your smartphone, that costs 2% of the Lenire.

 

The New Yorker Magazine reporter Patrick Radden Keefe has just published "Rogues: True Stories Of Grifters, Killers, Rebels, And Crooks."

He gives extensive reportage to the now famous case of that allegedly breakthrough drug for Alzheimer's which turned out to be a complete fraud.

The stock from the issuing company plummeted.

The reason: One market analyst said, "The market does not like a drug that helps only half the people who receive it."

Why do these purveyors of Lenire assume that such a poor showing of only a "50% improvement" (and to what degree is this only placebo-based?) is nonetheless very satisfactory?

Are they serious about convincing clients to make a financial outlay of over (where I live) $3,000.00 for what appears to be no more than a pure gamble, especially when they are suspiciously vague about the extent of these supposed "50% improvements"?

 

I'm American and I got in touch with Neuromod/Lenire in Ireland before COVI-19. It seemed like I was eligible for treatment but I would have to fly over to Ireland. I believe others on Tinnitus Talk have done the same.

Instead I went to India and did 6 weeks of panchakarma (bodily cleansing based upon Ayurveda in which treatment includes a daily oil massage with medicinal oils, a lighter primarily vegetarian diet, oil flowing onto the forehead or third eye, steambath, and yoga if one chooses). My tinnitus went from severe to easy going moderate and remained that way for about 2 months after I returned to the United States. Alas, I had to deal with COVID-19 and other stressors and the tinnitus gradually got worse. I'm looking forward to going back to India when I deem travel there reasonably safe.

In any case, I got a few follow up letters from Lenire. I vaguely recall I even had a tentative date scheduled to fly over to Ireland. I'm not sure what their present policy is.

 

A new clinical trial for Lenire is being conducted at University of Minnesota.

Assessment of Bimodal Stimulation Device Compliance and Satisfaction in Individuals With Tinnitus

 

If it worked, it would be available via the NHS.

 

That is really good news. We need an independent study on Lenire.

 

I wish they invested their money in some more promising research instead of wasting it into a device that already showed inconsistent results.

 

Lenire just sent me a USA focused marketing email. They must think they are getting closer.

 

Lenire seems to be on the retreat here in German-speaking countries, and they want to sell the remaining devices to you. I drove from Zurich to Munich in 2020, he can no longer be found on the Lenire card, he probably had too many returns of the device.

https://www.lenire.com/de/arzt-akustiker-find/

I can only repeat myself, it is a smart looking mp3 player that delivers an unscientific sound mix with a few ems tongue shocks. Production costs under 50 euros, sales price 3,000 euros.