Search results for query: lenire

...that's the case, then it does make sense that her device isn't approved yet. She likely submitted it to the FDA as a De Novo device, but when Lenire got that classification and was approved, then she likely had to re-submit as a 510(k) which goes a lot quicker. So I'm hoping it will be...

This can be answered with a quick search on the forum. But basically Lenire is Bluetooth controlled preprogrammed crap with no precise timing tailored for different people and 0 placebo-controlled research.

I used the pathsurveyor.com that they mentioned in the video. Here is the timeline for Lenire. Couldn't find Dr. Shore's. De Novo approvals seem to take 18-24 months. 510k (if that's the route) can take as little as a month, with an average of 121 days. Thing is, has it been submitted...

Sad goddamn day. Ross O'Neill and his piece of shit junk walkman didn't deserve the approval.

Why are they doing another clinical trial?

Sure, if I had money to throw away. I never went for Lenire. But I followed them from the start when it was called MuteButton. It was exciting but it wasn’t the great success it was speculated to be. Personally, it makes much more sense to wait for Dr Shore’s device but, even then, I will be...

But tinnitus volume is somewhat subjective. Right? I can have very low level tinnitus and it can be extremely bothersome and intrusive and therefore, I think it’s very high in volume. Somebody could have tinnitus that they estimate to be 60 dB high and it doesn’t bother them. I guess my...

Anyone know why the University of Minnesota is recruiting for a clinical trial on Lenire, despite it being FDA approved? I was considering joining the trial, just to be able to try it sooner.

Neuromod got approval for Lenire in the US market: Irish firm’s tinnitus treatment approved for US market

Dear @HighleyTall, According to research, it works for about 80% of the people... Maybe that percentage is too high, so let's assume it works for 50%. If you have one million dollars, why not just try it? I saw you live in Belgium, you can get it in Ekeren, near Antwerp, Dr. Andrea Kleine Punte...

...from Otologie or whatever the fuck they're calling themselves these days. Apparently they have merged the part of their company that handles Lenire with a business partner called The Audiology Clinic. Which means that the on-site office in Dublin is changing location. They insist there will...

...Brain Circuits Using Targeted Auditory-Somatosensory Stimulation to Treat Phantom Percepts A Randomized Clinical Trial," key differences between Dr. Shore's work and previous studies. I would imagine that would include Lenire. In terms of Lenire,, here is a portion of one of my previous posts:

How scary would that be. Spend all this money on a device and make your tinnitus worse lol.

So bimodal stimulation does DO SOMETHING, meaning they are on the right track, correct? Basically if Neuromod tweaked Lenire, made a few improvements, it for sure would do something, right?

How does Lenire help you?

Make sure you spread the word to warn others.

The arsehole has a financial relationship with Lenire too. What's his next job? Offering milk thistle extract and CBT to people suffering from pancreatic cancer? He has a few good videos to pump up the viewing numbers but at the core he has nothing to offer that a high street audiologist doesn't.

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.

If some Tinnitus Talk members are or have been in the clinical trials for Dr. Shore's device, are they required to not post any information? I think I remember some member who was participating in clinical trials for Lenire and provided some information here prior to the launch, am I right?

So true. I just think there is no comparison between Dr. Shore's device and Lenire. Lenire does not target a physiological cause of tinnitus. In fact the evidence we have from Phase 1 tentatively suggests that Dr. Shore's device will calm those fusiform cells more with continued usage.

There's new firmware available for the Lenire device. My device is dated 2023-04-13, so not terribly old. But it has always had this annoying glitch where, twice during every session, a "scratchy" noise lasting about one second would occur. It was annoying but not really terrible. But I found...

...meetings occur prior to you being able to submit) meeting until then. It is highly likely it has not been submitted. This has nothing to do with the company. It has everything to do with the FDA. Hard as it may be, stay strong. Everything happens very slowly, then (like with Lenire) all at...

No but I am certainly looking forward to that sense of optimism and possibility on these boards when we were all waiting to try Lenire.

How is Lenire controlled? I actually hope it’s just a straight up purchase. The majority of audiologists, and ENTs especially, don’t give a hoot about tinnitus.

As of yesterday I counted only 17 clinics in the entire US that were carrying Lenire (and none were in Illinois). This bears all of the characteristics of going the way of every one of those other now defunct "treatments" (SoundCure, Neuromonics, The Levo System, Desyncra). How do they expect...

I agree with positivity. However, many on these forums have seen good looking research and treatments fail. Given the nonsense from Lenire and Frequency Therapeutics, it is our job to critically evaluate what is before us. No one has criticised Dr. Shore's science, however we may critique her...

Neuromod, the company who claims over 90% success rate for Lenire based on studies that are not placebo-controlled? I would rather wait an extra year than let those scammers take any advantage from Dr. Shore's work!

...as I understand it, Hubert Lim knocked up some specialist machine that @kelpiemsp was miraculously cured by, went on to work with Neuromod’s Lenire instead, and we heard no more about his invention? The whole thing sounds like fan fiction to me. I don’t mean to offend anyone, but there’s no...

What clinic is that?

...published or not, because they examine your evidence directly. Theoretically she could have resubmitted to the FDA as a 510(k) device once Lenire was approved in March. But knowing her, I don't think she would do that, because Lenire is only superficially similar to the Michigan device. If...

Awesome!!! That was the dream of how this was going to work for us all. Congrats at finally finding something to offer real relief.

...‘real world’ cases. It always seems to be around 60% of respondents and slightly higher than placebo (I know it’s more than double). Just like Lenire, ACRN, LLLT. Sadly, I don’t feel excited about it, although I will wait to see ‘real world’ testimonies on this site if it happens. I would be...

...mean they are claiming they reduce tinnitus volume or severity. That's a big difference! Tinnitus is such a variable condition. Again, if Lenire helps with anything, it helps with the perception of the condition. It does not reduce tinnitus volume. If people are experiencing relief, good for...

Seems to be the case. The success rate is not looking too impressive though. But I think there are some people earlier in this thread who had benefits too.

So much for FDA and safety...

I'd like to think it's because Lenire is: FDA probably has intelligent enough brains to see through Lenire's horseshit studies with no placebo control. Dr. Shore comes from an acclaimed institution and her research is much more robust.

...at my wits’ end. I’m barely able to work, the electrical hiss is making me so afraid. I have better days and really bad days. When I found Lenire to be available in my city yesterday, there was a glimpse of hope I can do something. Every bit of relief is better than no relief. My tinnitus is...

In which category does Lenire and Dr. Shore's device lie?

It is good that you can return this device for a refund. Lenire should do that offer too - it might attract to them more buyers.

They don't have to lie, the trial results were not controlled for placebo. You'll need to make your own judgment call on that.

Ah, yes. I saw another snake oil salesman, a local one, Brian Fligor. After spending good time discussing options, i.e. Lenire, hearing aids, and TRT, steering me towards the last (probably most profitable - he could always try to sell me Lenire later), he innocently slipped "I have tinnitus...

"Like the shirt on your back" —Hubert Lim

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

...is. Under the same rubric I don't give much thought to reactivity; the tinnitus changes in response to sound but for me that is a bit of a shrug. Overall I probably complain about my tinnitus slightly less when I am doing Lenire but it isn’t a very meaningful difference to my quality of life.

I think there was one user on this thread that reported issues along those lines, but I forget who.

...right to the state-of-the-art "Western" techniques/treatments. You name it and I've been there/done it (tried it). That includes Neuromo's Lenire device in Dublin. I gave that a good go (of course years before it became FDA approved in the US), but apparently I'm in the 30% of nope, didn't do...

Not doubting at all, because I’m eagerly awaiting Dr. Shore’s device as opposed to trying Lenire. However, what would you say the major differences are (besides the double blind study)? Is there a different mechanism of action in the stimulation (i.e. cheek and neck vs. tongue) that makes a...

Wow.

...@JayJay1, where did you come from? The fact that the USA have lousy food regs, and poor FDA regs for medical treatments meaning the rubbish Lenire has been approved, and a minimum wage of $7.25 in many states (in the UK it is 11 GBP), plus frankly a ton of issues - and I talk about these -...

This is the kind of post adding just smoke to the thread plus it seems to me it would belong more to the Lenire discussion. It's obvious you only have not gone through this thread to elaborate a decent and solid opinion but also you are talking as if Auricle device were decades from being released.

Brai3n is doing a clinical trial for Lenire now.

Well, finally.

Is it actually true that Lenire can make the tones you hear softer? Since my reintroduction of Paxil, my tone is so much higher than before. I'd love to have it softened.

I read that Neuromod is currently training audiologists in the U.S. for Lenire, and they have a waiting list you can join. They will let you know when it becomes available near you. After hearing that it made tinnitus worse for some, I think I’ll pass.

The Lenire is such a major rip off - at £3000 or so it looks like a contrived device to separate suffering people from their money. Plus trips to Ireland which can be very costly. The problem with measuring tinnitus is that subjects are being asked to give a score on their reduction - this is...

I think the Michigan device and potentially one of those potassium channel openers offer a lot of hope for the future.

No, are you not familiar with Dr. Lim's work at the University of Minnesota? The current Lenire is a joke. The next version based on his work will be game changing.