Lenire — Bimodal Stimulation Treatment by Neuromod

In my opinion - those with severe tinnitus + hyperacusis - may well be very dubious of Lenire.
What we are already suffering from is sheer “F*cking Hell!”

Just suppose for one moment that Lenire made it even worse.
Unlikely? - who knows?
Personally, I have read no Lenire user success stories that I consider to be convincing or credible.
Remember Allan1967.

Just my two bobs worth.

 

Hello everyone,

@Kam75 talks about me.

I had to stop Lenire after using it for 6 days. I am so sad. I really don't know what happened to me...

After 6 days of using Lenire in December, I triggered a sharp pain in the external pavilion of my left ear and gradually the pain spread throughout the left side of my head. I feel tingling, burning and unbearable pain like electric shocks in the hemiface and the skull on the left side. I really don't know what happened after using Lenire. I've never had this before. it seems to be a neuralgia of the left trigeminal nerve on the 3 branches... (like an electrical hyperexcitability of the nerve). It's lasted more than a month now... I worry a lot. of course I cannot use Lenire as long as these symptoms persist.

I have an MRI planned on February the 3th but I think nothing will be seen/found.

My doctor thinks I overreacted to Lenire's electric stimulation. I don't understand why because no one has this side effect in the clinical trials and the stimulation is low and safe. I am so disappointed to have to stop the treatment because I think it really can soothe my tinnitus.

I really hope to have these symptoms resolved ASAP and continue the treatment again...

 

@Rafa03: thanks a lot for the support! I feel so lonely with the condition...

@Autumnly, @El BUZZ: I know personally the girl who got trigeminal neuralgia. She developed that sickness just 6 days after using Lenire. She contacted Neuromod and they answered her that they had zero participants in the trials who developed trigeminal neuralgia using Lenire.

So she's also somehow lost. She wonders if this is a coincidence or is it Lenire that caused that sickness.

I was devastated when I learned that, as I was planning to try Lenire, but now I won't.

 

Neuromod seems to make it very clear to all their patients that temporary worsenings are not unusual. Also, I can not remember one patient story on here saying they experienced a permanent worsening.

Allan was exposed to his house alarm twice, developed an ear infection, had issues with his eardrum and changed his medication during the time he tried Lenire. He also didn't finish the treatment.

Nonetheless, we should be wary of any new treatment, Neuromod is no exception. It's also understandable if someone with tinnitus doesn't want risk experiencing any temporary worsenings.

 

‘WOW @threefirefour - it seems I am capable of humour without realising it.

Oh I do love a good audianT !!

 

I guess this is up to each person, ain´t it.

I took the risk. Since I figured that I have already been through hell and know what it feels like and if I could get an improvement with Lenire it would be worth the risk.

To each its own. In regards to Lenire success stories, I would consider myself one.
Since Lenire didn´t sell a cure. And I do consider myself soothed.

And if I count the number of calm days over the last 7 days, the count is up to 4.

 

Something to maybe ask your doctor about... Is it possible you had a latent virus in your trigeminal ganglion that activated with electrical stimulation (e.g. something in the herpes family like EBV, HHV-6, zoster)? It's one of the causes of Trigeminal Neuralgia (though uncommon) but that would be easily treatable at least.

 

Alice I really do sympathise - this is an awful turn of events and the correlation with Lenire use is evidently high.

It sounds like your doctor is giving good advice and the potential for some kind of over-excitement in that branch of the nerves seems plausible. With that in mind I'm sure they'll be able to calm things down soon.

 

When I returned to France after my stay in Dublin where I picked up Lenire, I got a very bad cold / sinusitis. I used Lenirefor 6 days while I started to catch this cold... I was so happy to begin Lenire!

Then my terrible symptoms of trigeminal neuralgia started. Caroline of Neuromod told me to stop using Lenire while I was sick. She reassured me that Lenire was not dangerous and that no one had developed trigeminal neuralgia among the trial participants.

The doctor treated my cold with antibiotics and cortisone, the cold is now gone. But the terrible trigeminal neuralgia remained... I refuse to take the prescribed anti-epileptics. I want to calm the electrical activity of my nerve by natural means. I clearly feel a nervous hyperexcitability of my 3 branches of the left trigeminal only. I clearly don't know what happened. I'm still going to have an MRI to rule out mechanical causes. Honestly I think the MRI won't show anything. It's like Lenire woke this up in me... the body is so mysterious.

 

Thank you for sticking up for me. I was honestly very angry after his reply and had to take a timeout in order not to shout at him.

I'm still very interested in the device, just not right now as it's still pretty much a shot in the dark. I want to see more concrete results and can then act on an informed basis.

 

It appears I got accepted on the 27th. When I submitted my application on November 13th (4 months in) I would’ve undoubtedly gone, fresh off the coattails of @Redknight‘s success, still deep in the suicidal throes of tinnitus. The last two and a half months have enabled me to at least mask the 13 kHz ‘eeee’. I’m also following @Drone Draper‘s experience with intrigue, as a cursory evaluation of his posts reveals personality characteristics & tinnitus comorbidities similar to mine.

Unfortunately, I’d say the trigeminal neuralgia was the nail in the coffin for me. I hope this works for everyone, but I’m going to wait and see about Dr. Shore and Frequency Therapeutics by the end of the year. Maybe Lenire will be made more available by then.

 

How many have reported worsenings that have since gone away? How long does worsening have to last before it's deemed permanent? The Lenire documentation suggests that temporary worsening is something that can happen really only during the first few weeks of treatment, so anyone still suffering worsening at or beyond the 12-week mark should classify it as effectively permanent, even if they are still continuing to use Lenire beyond that.

I am starting to question how honest Neuromod has been in their statements about this topic. It's obviously in their best interest to marginalize worsening as both rare and short-lived.

I think between now and the end of the year Neuromod is going to have to directly address the disconnect between its internal stats and Tinnitus Talk's report. I don't think they really addressed it effectively in the last interview but it was maybe too early to really press them on this point.

I mean, if they want to withhold their internal stats from actual patients, that's their prerogative, but they can't stop outside attempts to gather stats. They're going to have to deal with this one way or another.

 

I read a case report (from the 1950s so maybe take a grain of salt) of influenza causing trigeminal neuralgia. The timing with the upper respiratory virus is weird but maybe just a total coincidence.

 

Yeah, this is why I think this treatment is better suited to mild/moderate sufferers than severe. I think we’d all agree that the people on Tinnitus Talk are in a moderate-to-severe majority. I think it’s more likely that Lenire decreases MML on more of an absolute dB basis than a percentage basis. 6dB reduction of someone’s 14dB tinnitus is obviously more consequential than a 6dB reduction of someone’s 44dB tinnitus. But i don’t know, because @Krolo is happy with his results, and he is both a chronic & severe case.

I think they could be cherry-picking stats as well. Between the cost, travel, reception date, and complete uncertainty of response, I’m banking on gradual diminishment in the three months before my reception of Lenire, over Lenire.

 

@Jazzer, with all due respect but I find of tremendous bad taste and sensationalism to keep bringing up Allan's case. It has been discussed "ad nauseam" what he was going through and to pretend that Lenire was the cause of it all is way too awkward.

@AliceW I feel really sorry for you as I have a relative who is a trigeminal neuralgia sufferer as well, although he has his symptoms under control due to meds, in his bad days he could not smile, talk, drink, eat nor talk... Lots of things can trigger it, a hard impact against your face, a vein pushing against the nerve, an infection, etc... I really hope your case gets resolved asap and to see you determined to continue your treatment with Lenire makes me feel very confident about the device.

 

I would love Lenire to be straightforward but guess it’s not. As someone who’s more neutral (in my opinion, like I do have an appointment pending so not that impartial I guess…) I’d like to give my two cents on the matter in order for this to help maybe some of you.

The positive:

• First treatment for tinnitus, as in first with data from several clinical trials backing it up.

• Neuromod have been here long time, first with MuteButton that indeed failed. But it’s not like they came out of nowhere with the claim of a cure.

• The technology on which it’s based (i.e. bimodal neuromodulation) has shown some promise through at least one clinical trial by Dr. Susan Shore (second one ongoing) and one by the Minnesota team albeit for this one we only have anecdotal evidence.

• They do seem committed and appear to care about the tinnitus community. They’ve been willing to talk with Tinnitus Hub, they were part of the discussion in the House of Commons earlier this month advocating for the need of research, they heralded the dinner between several actors of the tinnitus world to increase the cooperation between them. To me, apart from scientific data and all that, that’s the reassurance I need. To have caring people in charge.

• "Negative" people seem to dismiss entirely the stories of remission we’ve had here were Lenire had a dramatic effect. From both the clinical trials and the final product. « When it doesn’t work Lenire is a scam and when it does the people would have had the same results without » Like c’mon it’s like you want it to fail.

Now for the negative:

Basically there is a counterpoint to every argument I bring.

• Efficacy for tinnitus treatments are not measured ideally to say the least. We’re in dire need of biomarkers; MML and THI are up to the patient and highly influenced by your state of mind. The efficacy endpoints are really questionable right now. But it’s not Neuromod’s fault, it’s the state we’re in. So first efficient treatment doesn’t mean elimination or reduction, just that overall your tinnitus is more manageable.

• I think that both the community and Neuromod are responsible for the « overhype » of Lenire. They never promised a suppression of tinnitus for everyone but at the same time you come around with the first treatment for tinnitus to a community that’s been expecting something for years, you just have to be careful. And boy, have they not been that. I understand they have a product to sell but start to compare what patients call a treatment for tinnitus to what Neuromod propose and the Venn diagram isn’t quite a perfect full circle.

• This treatment isn’t even a year old. You have to go by anecdotal testimonies and Neuromod claims to make up your mind. The second clinical trial’s data is a subject that’s brought up every now and then and I have to agree GIVE THE PEOPLE THE DATA. The time it has taken to publish a paper like that is just loooooong. And you can’t be blamed for asking yourself if the data aren’t as good as they’re saying, hence why they’re stalling. Or are they gathering more data thanks to this European release? Neuromod says they’re hard at work to get it published and I believe them. I also think that at the end of the day, even with the data published, I don’t see everyone’s mind changing.

• Dr. Susan Shore doesn’t target the same nerve and seems to get better results (on a 13 people trial though).

• While positive testimonies shouldn’t be dismissed, I can’t act like lukewarm ones don’t exist. They are the most open to interpretation. The user feels like Lenire did something but can’t quite pinpoint it. You also have the one where nothing happened and then the much feared worsenings. Neuromod states that all worsenings by Lenire are temporary, and no serious adverse events were reported.

But then again, as I write this, I read about your experience @AliceW and feels so sorry… This is a silly thought, but as a fellow frenchman I was really rooting for you (I mean I’m rooting for everyone here but French people gotta be French). I am praying so hard this is just a temporary awful worsening.

So what have we learned here? Well first don’t do a write-up about Lenire because there’s a strong chance you’ll make yourself depressed. I am hopeful for the device though someone other who would do a write-up like this might lean on the other side (maybe do not judge @GlennS that harsh). As always we lack clarity on what works and what may not work for tinnitus sufferers. The only thing that is different to me is that they at least seem to care and are tinnitus advocates. And that’s something? Anyway, it’s up to you to test what works for your tinnitus, this one just seems to have more chance of working than what has existed before, with relatively limited risks. Or so we think at the moment.

In the meantime be nice!

 

I’m so sorry to hear about your situation. Have you had any dental work done on that side?

The reason I’m asking is because two years ago I developed something like what you describe. I went to the dentist and had a filling replaced on a molar, two weeks later I started getting headaches that got worse and worse, a few weeks later I had excruciating pain in my lower jaw, cheek, ear and temple area that developed. I went to two different dentists thinking it was TMJ or tooth infection, they did X-rays and surprisingly found nothing. I went to the emergency room where they told me I probably had trigeminal neuralgia, a very rare condition that affects less than 5/100,000 people. I eventually started feeling pain in my molar, after pressing down on my teeth hard with my fingers (desperately searching for a cause), went to an endodontist who performed a special kind of X-ray (can’t remember what is was called) and needed a root canal.

That fixed the problem of course but I was fathomed that I had no pain or other symptom in the molar for two months!

Again this is a very rare and unlikely disease, perhaps a visit to an endodontist would be a good idea?

 

Loudness is measured by matching your tinnitus with the same sound. Loudness ranges from a few dBs to 20 dBs. I don't think it is possible to have a 44 dB tinnitus. You must be mistaking actual Loudness and MML which doesn't just depend on the loudness of your tinnitus, but also on its frequency. It's harder to mask a 12 kHz tinnitus pitch than 2 kHz.

MML is not relevant in my opinion. I have a very low pitched tinnitus that I hardly hear 99 % of the time, but I can hear my 8 kHz tinnitus all the time.
My opinion is, there are more parameters than just tinnitus loudness that may influence the results such as age, use of antidepressants/benzodiazepines, stress.
But we need the data from Neuromod to understand who may or may not benefit.

 

I think it's naive to think Neuromod is doing that because they care. I think they're doing that to push their product and sell it to various stakeholders. Or do you really think they're not doing all of that for their own benefit?

 

I actually almost said 6MML reduction of 14dB vs. 6MML reduction of 44dB. But I thought the verbiage didn’t make sense. I may be confused about MML but it is (apparently) possible to have +20dB tinnitus, ala Krolo:

Regarding this...

I think MML is relevant but I’m with you on the problems with pitch, for sure. I am the exact same case as you—don’t care about my low frequency whirring, absolutely hate my 13 kHz hissing. It’s possible that damage at the lower frequencies cranks up the gain to all frequencies which may lead to the high-pitched tinnitus.

 

Again you may see that in the light you want. It's not all black and all white. Of course they're a business, at the end of the day they have to make money. That doesn't mean they don't care about the people they're trying to help. They're open to dialogue and to tinnitus advocacy, I don't quite see that in other companies involved in the "tinnitus business". I'm cautiously optimistic about them, I think I made that clear in my post.

 

I hope you know how obvious it is that you are just trying to circle the wagons and protect Lenire. Don't for a moment think you come across as objective in assessing risk-factors.

 

I know what I know and I don't give a #@%* about what you think I know or not so you better punch out from the idea of falling on every one of my comments looking for some of that bad juju you seem to feed with. And just to cross my last words ever with you:

This is a forum. People come here to share their ideas, conjectures, opinions, experiences, etc... If I want to protect Lenire I am very free to do it, mate. Deal with it and move on. You seem to be fully incapable of discussing something without putting a huge amount of polemic in it. You take stuff too personal. Big ego there. Bye.

 

Medical science is not harmless. A Facebook user warned about the possibility of developing trigeminal neuralgia many months ago, so I'm not so surprised.

Is trigeminal neuralgia worse than tinnitus? I hope you get better soon.

 

This is hilarious coming from a guy who straight up admits he’s using “his own metrics” to grade its success, and it contradicts every other well run study on its effectiveness both professional and non.

 

Great write up here. I’ve been keeping track of dB standard candles from some reports and it seems that we as a community have overestimated how much a dB decrease actually is. I do disagree that MML is as variant as THI though, researchers like Dr. Lim have noted that Tinnitus Volume and Frequency very rarely deviate from their natural patterns. It would have been best if Neuromod used MML but they used THI, which is just a bad metric.

 

Just playing devil's advocate, Neuromod have told me that the 12 week period was only relevant in the clinical trials. They are saying this is not relevant to paying customers. You've come to the end of the consultations you've paid for and any further appointments will incur further fees, but they have told me they still consider me (and by extension, you) to be their client.
Aside from this, I'm getting really confused by MML stats. 10 dB is usually described as being as loud as someone breathing - ie almost inaudible. If your tinnitus is 10 dB or below, in what situations do you hear it?

 

In my experience, MML measurements are all over the place. Some use true sound comparisons, where 10 dB would be extremely quiet and borderline inaudiable. Susan Shore and Neuromod use this. Others use “subjective” measurements where it’s as if the sound itself is coming from your ear. In this framing 10 dB is average or above average.

 

No I didn't have any dental work on that side... What happened is a mystery...

I have the symptoms on the 3 branches of the trigeminal nerve. That means that it is the source of the ganglion that is overexcited... according to me, by the tongue stimulation (most people with trigeminal neuralgia have only one or two branches affected). I'm actually trying Chinese plants to calm excitability of the system and auricular therapy. The doctor said that he thinks my nerves are not damaged, just overexcited and perhaps have some inflammation. I'll do an MRI next week just to be sure there is no neurological reasons behind this. My doctor in auricular therapy said to me that by stimulating the tongue, several nerves are stimulated, not only the trigeminal one. So he tries to calm down the activity of my whole nerve system that Lenire could have excited...

I did my Lenire session on Saturday morning which went well (I felt slight stimuli of the nerves in the face at times during my sessions but nothing painful and a user with whom I am in contact tells me they feel the same during sessions) and on Saturday afternoon I suddenly felt a very sharp pain in the pavilion of the left ear which spread all over my left side in the hours that followed.

Above all, I don't want to worry anyone (I'm the only one it happens to, I wonder why...), just wanting to inform everyone, given that @Kam75 has spoken of what happened to me. I believe in Lenire a lot and I wholeheartedly hope to be able to continue my treatment to overcome my tinnitus ASAP and that everything goes back to normal.