Search results for query: lenire

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

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...

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.

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.

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...

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.

That's shady.

...might look like, as there has not been any real improvement so far. I am also worried about the lack of promising treatments. Options like Lenire or medications feel like risky gambles, and I am holding on to a small bit of hope for the Susan Shore device. However, I do not know when it...

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.

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.

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.

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...

@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 :)

Wow.

...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...

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

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!

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...

Well, finally.

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.

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

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

As an occasional user, I do believe that Lenire works, just not in a way that is meaningful enough to justify the time and expense. For example, I’m about a week into a cycle (I’ve done 3 full treatment cycles over the years) where I am experimenting with dosage (just 30 minutes/day) with the...

"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.

...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...

TENT-A3 Publication: → Combining sound with tongue stimulation for the treatment of tinnitus: a multi-site single-arm controlled pivotal 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...

...videos from that channel (Dr. Cliff) some time ago. It’s a sales channel with zero useful information. Dr. Lim joined Neuromod only after Lenire device was finished. I’m not sure what his further contribution was. Marketing? Joining Neuromod made him financially attached to the product, and...

I have had pulsatile tinnitus for a little over three months. It began after I took Lexapro for six days. I stopped taking the medication, but the pulsatile tinnitus has never stopped. Since then, I have developed a tone in my left ear that comes and goes throughout the day. I also experience a...

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...

...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...

Brai3n is doing a clinical trial for Lenire now.

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

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!

I imagine Tinnitus Quest is something that has been in the works for a while. We know from the data that this device will not work for everyone. I look at this device as a step on the road to superior treatments.

I don't have anxiety or depression, just pain from piercing tinnitus so I can't speak to that personally, but that is the claim. I've been using Joyous service because they are cheap, they'll give you up to 120 mg per day for $120/month. At 120 mg I definitely feel it and wouldn't want to go for...

Though I am afraid to jinx it, I do have to report a notable improvement using Lenire while microdosing Ketamine. This is my third or fourth cycle over the course of 3 years with the device but for the first time it seems to be effective enough that it is making a positive impact on my QoL...

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...

...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)...

...and I am still glad they did that much, but I was hoping they would ultimately release a statement. The question now is if we should try Lenire. People are saying it could cause an increase in perceived tinnitus and/or hearing damage. I would welcome an explanation for why those same...

Why are they doing another clinical trial?

...how Susan and her team have perfected the exact tone/pulse needed to calm the auditory nerve. Many have tried before... Neosensory Duo, Lenire, magnetic pulses, TENS and haven't gotten the results promised. It feels like such a simple stimulation process, yet she seems to have gotten the...

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

...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...

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...

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.

...Netflix are completely irrelevant here. Why discuss the amount of work required to build a Facebook clone when a website on the level of, say, Lenire, can be created in a week? Or, if working at a more relaxed pace, in a month? This can be achieved either by writing the website’s code and CMS...

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

...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...

How dangerous is Lenire?

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

We certainly don't want a Lenire Mark 2.

...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...

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."

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.