Search results for query: lenire

Aside from wanting to cut the auditory nerve decades ago (when research was practically nonexistent), what other surgeries have been proposed (just curious)? Anyway, now that we've discussed more or less every doubt and have no new information since July, this "silence" is agonizing, haha.

Except this one has been through proper clinical trials and shown statistically significant improvements. Lenire and the Michigan device are not the same.

...and reading posts from @linearb about their experience with the device, I’m feeling a bit more hopeful. Based on my research, it appears that Lenire was submitted to the FDA on August 18, 2021, and wasn't approved until March 6, 2023, according to this FDA document. So, if that's any...

...and such. I called Neuromod out on LinkedIn for their continuous marketing of their product. Their response was that just a tiny number of Lenire users got adverse effects. Which evidently is not true. So my advice is the same - there is not one single credible instance of anyone gotten...

Scam sells!

FDA may have asked for additional information / corrective actions that took Lenire a long time. Nearly 2 years for approval from submission is laughable for implantable devices, never mind much ‘lower risk’ devices like these.

It will be interesting to see what Neuromod is up to with their Lenire in the meantime - revenue is rolling in, they have electrical, mechanical, bio-med and software engineers on staff who are presumably working on something - improvements to current device, next-gen device, etc?

As I quoted before: "The Brand New Treatment Lenire Was Supposed To Silence The Ear; It Was Great In Theory But Made Us Quite Leery When Failures Were Posted On Here." Very insightful comment about how FDA approval of Lenire should open every fast track for the same approval being granted for...

...a question? How do we remain optimistic about these middle-ear implants and Auricle (I have never heard about brain implants) when things like Lenire & OTO-313 were hyped up and both were failures? The only thing about the middle-ear implants I am going by is that this has been taken from the...

The delay for Lenire was because the FDA made them go do another clinical study before approval. Shore's study is way more robust, US based, and created with the idea of FDA approval process in mind. I know nothing about nothing, but I'd be pretty surprised if they made her go through another...

So looking at this and knowing a bit about my experience and others' reported here, I wonder if Lenire doesn't just act on the medial pathway. It would explain the sort of handwaving descriptions (it's not quieter, but maybe just not as bothersome) that positive responders have had.

I remember reading that hyperacusis patients have the most success with Lenire.

Having good and bad days is normal. With or without 'treatment'.

...of compression/decompression used. It's not so much the latency itself that matters (this can range from 30-200 ms), but how stable it is. A stable latency (which is possible with better codecs) can be compensated for and, in the case of Lenire, can be reliably synced with the electrical pulses.

You’re the funniest person I’ve seen on Tinnitus Talk. I’m glad you’re here with us, but at the same time, I wish you didn’t have to be here and go through this pain. Still, I want to thank you for the humor in your posts. Even when I’m feeling my worst, I stumble upon something you’ve written...

...three years, at 96. I am highly handicapped each day, and cannot even imagine what a lower THI would be like. What sort of actual change would Lenire bring me? There are 288 pages of discussion on here, and such a mix of opinions ranging from "apocalyptically life-shattering" to "total...

...the study and even more surprised that they were resolved during the trial. From my experience, I have come across just as many stories about Lenire causing a worsening as success stories. One positive takeaway from this is the relatively small sample size—only 112 participants. This should...

This thread worries me a great deal. There must be a balance on this unsubstantiated 'hype.' Agreed. Dr. Shore's device won't be the last 'device' or 'contraption' to claim to reduce tinnitus. I believe it may even be detrimental. I advise everyone on Tinnitus Talk not to be the first or...

Not surprised since Lenire doesn't f*cking work lol.

It saddens me to see so many unprincipled doctors taking advantage of the desperation of tinnitus sufferers just to make money. Lenire doesn’t work, yet clinics everywhere are advertising it with claims of 80% or even 90% effectiveness. It seems no one is concerned about the lack of regulation...

Sadly no - Lenire will do a booming trade in the USA. That is why we have to get the word out there to protect buyers who think it works because they got FDA approval.

Why? With Bluetooth you do not have to care about another wire (you already have one from the tongue tip to the device). I use Lenire and am happy with it!

No because apparently Lenire can make tinnitus worse.

Yes, a third of us! (That is, a third of us will be experiencing more peaceful moments in the next 5-10 years.) And this only applies to a relatively privileged group. Are you well-paid? Do you have a degree? Do you live in North America? Is your car new? Although I don't check any of these...

IMHO, your post comes across as victim-blaming.

I bought Lenire from a clinic in Minnesota beginning of May. I used it for one week. It has not been a good experience. It raised my tinnitus and gave me headaches. My audiologist recommended me to postpone the treatment.

OK, my Lenire is now on the way to Dublin. I somehow feel hopeful but naked without my Lenire. I got so used to doing the treatment in the past 3 years. @AfroSnowman, do you have a source for the TENT-A3 study and regarding PS6?

It's quiet in this thread. Are there so few Lenire users on Tinnitus Talk? I've been away from the forum for a while but came back to see if anyone had positive results from Lenire. I started Lenire on June 25, 2023, so not quite a month yet. I believe it is having a positive effect. My...

There are numerous entries in this thread where concerns about the DeNovo status after Lenire are being raised, as you can ascertain by google searching this thread. As to their merit, I'm not the expert on that. Some random examples: ---------- Regardless if it's a requirement or not...

Audiologists, Lenire headquarters, or other brain oriented medical practices I believe.

Do we know what pathway Dr. Shore's device is going through, 510(K) or De Novo, and if it changed after Lenire was approved? I saw the Lenire FDA approval document. They submitted for approval in August 2021, with it being granted in March 2023. 19 months seems very, very slow. Is CE approval...

Yeah, she said she's sleeping better and got her life back, but she didn't say Lenire actually reduced her tinnitus at all, probably because it didn't.

...it was 15 kHz) bilateral tinnitus level was measured at 40 dB, and she did a 50 dB inverse mask noise for 1 minute, which made my tinnitus drop out for 30-45 seconds. In the last year, my tinnitus level has doubled to the point of seeking treatment. I am looking into Lenire and Nuheara for...

Lenire turned out to be just another placebo that turned bad for most people who tried it. Some found relief, many did not.

Barely enough to feel it, huh? So, aside from the Lenire effectiveness, does the Ketamine seem to help with anxiety at that low dose?

I hope you get some relief from VSS. When you used Lenire the first time around, did that seem to help reduce the reactivity or did the reactivity go away before you used Lenire for the first time?

A bit of both. The science is more rigorous, and the targeting mechanism is more precise.

I think that if you don’t experience any relief within 6 months, it’s nonsense to proceed with the device. It’s the same with Lenire. This is also valid for Neurofeedback. The doctors have always told me about this 6 month period. It seems to be some standard neurological treatment limit.

After reading many disheartening responses about Lenire, I quit. Nothing helps my T except for benzodiazepines. Case closed.

That's the nightmare I am afraid of. They did this to Lenire (which of course was a sham). I guess there's a way to pay off FDA's buddies.

...started in 2010, there is definitely more research and awareness of this condition. It's been slow progress but increasing recently. Although Lenire doesn't appear to be 'The One,' it is the first treatment to get FDA approval. It's a huge milestone really. This will get others interested in...

Dear @HighlyTall and @Nick47, In Colon et al. (2022), figure 9 elaborates on the question "Overall, would you say you have benefited from using this device (i.e. Lenire)?" 70.3% says "Yes."' 29.7% says "No." This is less than the 80% I mentioned. Kind regards, Jan

...participant feedback. But as mentioned, real-world results may turn out to be far more disappointing than the study results, just like with Lenire. We can only hope that's not the case and keep our expectations in check. True. We need objective measures. And even then, the placebo effect...

...protocol is worth a try. He's experienced and sees real-world results. A new thread under treatments is apparently being started by a member here. Similar to Retigabine and Lenire, real-world data can be gathered. This thread is for electrical stimulation of the ear, though. Not that I know of.

Below is from the Brai3n clinic, one of the centers involved in the trial. So, 6% of the population will find this effective.

What Neuromod are claiming is that Lenire reduces TFI/THI. That's what they consider "tinnitus levels", however that is not measuring volume. What TFI/THI measures is your REACTION to tinnitus. That is why it is a habituation device. Because it only manages your reaction to your tinnitus, and...

Has anyone been able to get Lenire in USA yet?

I got an email peddling Lenire from an audiologist's office I recently visited: Tinnitus journey? WTF? Would an oncologist say this to a cancer patient? "Cancer journey"?

From your earlier comment about Neuromod, I thought maybe you had used and been burned by Lenire. So, I was not surprised to see your follow up and pessimism after wasting all that time and money. But, the study for the Shore/Auricle device looks more convincing, and that it could work. Results...

Recently I completed my treatment with Lenire using their device as prescribed. I will do my best to remain factual and refrain from subjective commentary. Here are the facts from my experience. I was drawn to Lenire largely because of its FDA approval here in the US. I also read their posted...

...as accomplished. I expect great things from them working together. Yes, UCI is a very respected institution. What you learned from using Lenire has absolutely nothing to do with the Shore device and whatever it is you made. Lenire is only superficially similar to the Shore device, the two...

Because Lenire is a habituation device. It does not lower tinnitus volume. Dr. Shore's device does. It reduced tinnitus volume by 50-75% in 12 weeks in her last human trial.

Do you deal with reactive/sound sensitive multi-sound tinnitus? Something tells me you do, but I cannot remember. I thought Lenire was best suited for non-reactive tinnitus, and could make reactivity worse? I may be wrong.

Isn't it strange that Lenire never explicitly required "somatic tinnitus", even though the University of Minnesota trials it was based on did require somatic tinnitus. Could that be why it doesn't work for so many people?

Have people with sound reactive tinnitus, with or without hyperacusis, had good results with Lenire?

...the numbers don't lie, regardless of the optimism or pessimism someone has for the device. And as you mentioned, real-world experiences with Lenire turned out much worse than people were expecting. So while Dr. Shore's device study may have shown that 30% of participants truly benefited when...