Search results for query: lenire

No, they are trying to do opposite things, both using bimodal stimulation. Lenire is trying to broadly stimulate everything in an attempt to lower the perceived noise in the narrow band that you actually experience tinnitus. Dr. Shore's device uses specific timings to calm and desynchronize the...

I think a 510(k) submission will be likely but far as I know we have no confirmation of that. Superficially (very superficially) it could be considered similar enough to Lenire to get the 510(k) distinction.

Neuromod doesn’t claim Lenire lowers tinnitus loudness. Leave it alone.

Lenire didn't take long to get to US market after FDA approval; I think it was about a year? Auricle is seeming like mid-2025.

...(read: paid off) "well-respected" specialists/researchers affiliated with "top tier" schools in the U.S., I bet they will keep pushing Lenire snake oil device as long as they have more profit from it. It's funny, when I asked said specialist if he will offer Auricle once available, he said...

Wow.

...sample of tinnitus sufferers. If you included more people with greater hearing loss, for example, the numbers would likely look less favorable. Based on all the feedback from Lenire users, it was less effective than these numbers coming out of the Shore study. Lenire User Experiences and...

Are you planning on listening to Sedley while doing the Lenire tongue tip? If timings matter, that could be a bad idea.

I certainly hope you are right. I am not an expert but I agree choosing Bluetooth was idiotic, adding expense and complexity.

Well, finally.

I think your numbers aren't quite accurate.

...a second thought. Plus, it’s essentially the closest treatment option we have to look forward to right now, minus a few other ventures. Lenire was significantly less successful than anticipated. The Auricle device has the science and minds behind it. I understand the frustration - believe me...

I hope they surpass Lenire when it comes to commercialization and distribution in the USA. I get random emails from Lenire about singing up and such and at the bottom it always says “may take several months to be contacted”. I emailed my ENT office as an FYI of the current status of the Susan...

I don't really know much about FDA, but maybe (and hopefully) it will not take as much time to authorise the marketing of Susan Shore's device, as it is an American device? :dunno:

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've been using Lenire for about 3 years and I'm pretty sure it does something more than YouYube. It's just not constant, often after a session it spikes my tinnitus. But all in all it makes it lighter. Sometimes almost gone. But my tinnitus is still louder sometimes, so much that I doubt the...

Damn and half of it is venture debt too. It will be interesting to see how this plays out in terms of them pursuing US DoD contracts with the Auricle team on its heels. I would sure love to see the financials to see how they are justifying a $15M Series B (that probably puts them at a ~$100M...

I don't think money is an issue. However, I read on the thread that it "probably" won't be "DeNovo" because there has already been Lenire (which AT LEAST ON PAPER is a "similar" device).

...can be mitigated at all by devices which rely on neuroplasticity. I am 70 years old and my neurons have probably lost all plasticity. So Lenire and Susan Shore's device may not even have a chance to work on me unless some breakthrough occurs. I am 10 weeks into Lenire and not observing any...

Two clinics I know about, who offered Lenire in the past, were very disappointed with its efficacy. Neither is anymore offering this treatment to their patients. So the study results are absolutely not in line with the real world data.

...words like "prestigious" don't really mean anything. You can say that Hubert Lim is a prestigious researcher and use it as a sales point for Lenire, but only until the truth is revealed, and that what is happening right know. The truth needs to be postponed. Given Dr. Shore's skill...

How dangerous is Lenire?

It must be helping some people. I hope audiologists aren’t just recommending something that doesn’t work, though I completely appreciate it doesn’t work for all.

...more than living with it without being depressed or anxious) like the back of my hand. Experiencing this like I have, I think something like Lenire can be a good option for those with mild tinnitus who keep having to run into a quiet room to check to see if it's there - but equally white...

@ChrisBoyMonkey, I have had tinnitus since 2008 after a noise trauma. After that I got floaters and VSS. I live in Germany. If Lenire works for your VSS, maybe I will get the device too :)

In Dr. Shore's paper, timing is parameter #1. Lenire is based on a different theory I know, but where Dr. Shore's papers are well constructed, Lenire's are enigmatic. In my opinion, using a Bluetooth system in such sensitive device is an unnecessary source of complexity, to favor the...

And the worst part about it is that now the brain dead audiologists and doctors will push Lenire on us. Which I guess is better than the typical learn to live with it.

I'm more concerned with what works. If people were saying that Lenire made their tinnitus go away, I wouldn't care about the lack of placebo.

Brai3n is doing a clinical trial for Lenire now.

"Lenire is the first bimodal neuromodulation device to go through the rigours of the FDA’s De Novo process." Rigours? What, like the lack of a placebo control? Riiiiiiiight.

...the fact that there have been two successful well-designed studies, the device has been in development for what... 20 odd years (?), unlike Lenire, and so is very unlikely to be a cash grab, there is (admittedly limited) positive feedback from a Tinnitus Talk member, @linearb, who was part of...

There is no frequency matching with Lenire, just a fitting to your hearing profile.

Guys, wait for Dr. Shore’s device! Don’t spend your money on Lenire! It’s absolutely a scam. If you want feedback on Lenire’s efficacy, contact Bra3in clinic in Belgium and ask for their experience with their patients... You will be surprised!

Yes, it's certainly expensive, but at least some will experience an improvement using Lenire due to the placebo effect, so they will consider it money well spent. That might be worth it to some people, not me. So, hopefully Auricle pans out, which showed some real improvement vs. a placebo.

...hopefully released) might help members refine and learn the strengths and weaknesses of bimodal treatment using Auricle, something akin to the Lenire User Experiences thread. I won't argue our discussions here had an impact on Lenire research — I don't think it did — but it certainly alerted...

...not cynically. I will be watching Tinnitus Talk to see people's experience with the actual Auricle device; just as instructive as there aren't 100's of people flooding online forums saying Lenire helped them, I will gauge the responses here on whether the expense of this device is worth it...

This occurred to me when the first series of reports about Lenire were posted: "The brand new treatment Lenire, Was supposed to silence the Ear; It was great in Theory, But we became Leery, When failures were posted on Here."

...tinnitus is ramped up after having a relatively good day. Like another review I read said, I may have jumped the gun and moved too fast to try Lenire but that’s just my personality. I can be a bit too emotional and anxious. Anyhow, I have had short mild episodes of low level tinnitus that...

Lenire is surely helping 3 of my friends currently. I’m considering it myself due to the possibility of Dr. Shore’s device being delayed for many more years. My friends have reported going from their tinnitus bothering them 90% of the time to 30-40% of the time. One barely notices his tinnitus...

Thanks @Nick47 for looking this up. The pathsurveyor.com link to the Lenire FDA letter shows the application was submitted August 18, 2021 and the letter of approval was dated March 06, 2023. A search using Lenire's product code, "QVN - Combined Acoustic And Electrical External Stimulation...

Dreadful - and if you consider he was worth hundreds of millions - one assumes he had the best medical care. I wonder if he tried all options - Lenire etc etc. EDIT: Oh I just looked up the thread - so he tried Lenire.

I wouldn't put money down on it, but I'm pretty sure that 60% had statistically meaningful improvement.

I used Lenire for 6.5 weeks.

Shore’s device is also fundamentally different than Lenire. Shore’s device is based on calming the excited tinnitus causing neurons in an effort to reduce or eliminate tinnitus. Lenire is based on exciting different neurons than the tinnitus causing ones in an effort to cause habituation...

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!

That's shady.

Dr. Shore mentioned communicating with the FDA throughout the clinical trial process, so one would hope she followed the FDA's guidelines. In some articles, she has been quoted as saying her focus is now on commercialization, so ideally, another clinical trial won’t be necessary. However, based...

We certainly don't want a Lenire Mark 2.

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

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

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...

Hello Tinnitus Talk, I haven't been on here in a while. Last I posted I was doing much better, thanks to a little Lenire use plus a healthy lifestyle. And by doing much better I mean quiet tinnitus, not habituation. If you all recall, I was "brave" enough to go with Otonomy's OTO-313 trial...

Why are they doing another clinical trial?

Lenire made my tinnitus worse. It started a new noise that I still have 8 months after using the device which will likely never improve. This is my first post. I will try to keep it brief. I'm hopeful that @Lon_p sees my post because I'm highly certain we attended the same seminar at the...

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

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.

Is Lenire helping you currently?