Search results for query: lenire

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.

...possibly a few others) Dr. Shulman's Clonazepam + Gabapentin Hearing aids, if there is hearing loss Cochlear implants for severe hearing loss Lenire Options 5 and 6 are not suitable for you. Lenire is approved but rarely effective, can exacerbate the condition, and is expensive. The study...

What clinic is that?

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:

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.

There's a very good chance it's already been submitted and is under FDA review as we speak. It just makes too much sense when considering the timeline of events. Which would give us an announcement anytime over the second half of 2024. Wouldn't that be nice?

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.

...affect your life, that goes from 0 to 100 points and a reduction of 13 points is considered clinically significant and that's just about what Lenire achieved in its trials. Problem with that? Give someone a bowl of ice cream and ask them to report their TFI, you'll find those 13 points...

I'm wondering if Neuromod operates on a basis similar to smartphone producers: only introduce incremental upgrades every 1 or 2 years so that people will continue to buy (minor) upgrades for slightly better results. Somehow, Dr. Lim and his fellow researchers managed to cure @kelpiemsp, so they...

The MAIN DIFFERENCE is that Lenire is a habituation device, and the Shore device is not. The Shore device that was developed at the University of Michigan over the past 20 years addresses the neuronal hyperactivity of the brainstem causing tinnitus by reducing that hyperactivity. Dr. Shore...

"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.

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.

...about the placement of the electrodes on the different devices that targets different parts of the brain. The MAJOR difference is that Lenire is meant to be a habituation device. It's not even trying to reduce the level of sound one experiences. I'm not sure how successful it is in that, but...

...likely that they started as De Novo and had to reapply as I said earlier. There are different criteria for 510(K) and De Novo pathways. And Lenire created the De Novo for bimodal stimulation. Every Monday around 11:00 CET the new batch of 510(K) approvals is published here: FDA: 501(K)...

...sharing your experience. I am so so sorry this was the outcome. It is honestly becoming a crime with how many sufferers have worsened due to Lenire. I just wanted to share with you that there are practitioners out there that have studied long haul COVID-19 in-depth and have come up with...

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...

Thanks so much @Hazel. Were there any interesting/compelling presentations on hyperacusis?

Does anyone with any FDA knowledge know if Neuromod announced it publicly when they submitted documents regarding Lenire for FDA approval? Is it common practice for companies to publicly announce when they have submitted for FDA approval? I just can’t understand why Dr. Shore couldn’t give...

...effectiveness. Likely, you would see NIH/VFA in the U.S. subsidize the device for military service members, sort of how they are/have with Lenire. Eventually, insurance will not be able to deny its effectiveness, and it will work its way into major insurance carriers, etc. Even then, there...

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

...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...

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...

Why are they doing another clinical trial?

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.

I'm going to ignore @Jonno02's extremely nonconstructive and toxic feedback. Occasionally it leads to single or multiple days with lowered volume and intensity. The most important aspect though is the increased ability to withstand the noise; a kind of mental fortitude is brought about.

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

Having been in medical device development for 30 years in startups, most often the R&D, project and development engineers are laid off and the marketing group is staffed up once the product is released, especially when it's a one product company like Neuromod.

Yes, their statement is problematic. As opposed to the Neuromod site (which is super misleading), the Lenire.com website states, "A recent clinical trial showed that 95% of participants who used Lenire as directed demonstrated an improvement in tinnitus symptom severity (as measured by THI...

Wow.

...a trial. In tinnitus, a large placebo response is often seen. Due to this, a crossover design is often better, where the participant is their own placebo. My biggest concern is seeing misleading scams in academia (Lenire & Neosensory) promoted by reputable charities, companies, and media...

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!

Well, finally.

Please don't compare Susan Shore to Lenire. Susan has been studying tinnitus for 20 years and she is really trying to helps us. Lenire only cares about making money, they didn't even do a real clinical trial like Susan Shore is doing.

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

To my fellow Lenire users, I have a few questions. They're not terribly important, but would satisfy my curiosity as a newby. Is the "i" in "Lenire" long or short? I initially assumed "eer" but then started to suspect it was as in "Ireland". Two or three times during each half-hour session...

You must absolutely forgive yourself! You tried a supposedly ‘proven treatment’ for tinnitus. Unfortunately Lenire is anything but. It’s a poorly researched, appallingly trialled joke of a device marketed by snake oil salesmen preying on the desperation of people looking for some peace from...

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?

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

Brai3n is doing a clinical trial for Lenire now.

...If she was curious about tinnitus research and wanted to stay up to date, she would know about Susan Shore. The fact that your audiologist compares the ScumScamLenire with Susan Shore's device is enough evidence to consider your audiologist irrelevant, and hopefully eventually AI will...

...My audiologist asked me to link her to Susan Shore's research. She was not convinced about this "groundbreaking science." She talked about Lenire, which took a similar approach and was a complete failure. The same is true for brain stimulation: There are many expectations but very little to...

German Tinnitus Association has issued a warning against Lenire. It’s in German. Sorry. Use Google translator. https://tinnitusheilen.de/lenire/

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.

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.

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

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.

...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...

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.

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?

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.

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...

Make sure you spread the word to warn others.

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...

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.

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...

Here is the answer I got from the FDA:

...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:

We certainly don't want a Lenire Mark 2.