Search results for query: lenire

Because it's worsened a significant portion of the people who have used it. 80% of who specifically? Doctors who provide Lenire are very selective in who they approve Lenire usage for, that's already introducing statistical bias. 80% of who specifically? How long did they use it? Chronic/fresh...

That's the difference between private medicine and government run health service. PROFIT MOTIVE. Prozac has been sold by the same people despite it not working. So why not Lenire?

I doubt that. As stated many times here before, the trial for Shore's device was double-blinded placebo controlled. Lenire did not feature a placebo group. That is one of the biggest things that sets them apart and why they should be more confident in their product. After all the hard work...

...FDA over TENT-A3, so perhaps a bit more than just marketing. I agree. There seems to have been an element of customer guinea-pigging where Lenire is concerned. I also don't like the way they've advertised it, especially the glossy videos from way back. I always had a problem with Neuromod's...

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...

Scam sells!

...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...

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.

...treatment regime [in your own words] and really need to pry any additional information out of them. You do you man, but don’t dare downplay the multiple Tinnitus Talk users that have had their suffering worsened by Lenire and feel you have the authority to ‘correct this thread once and for all’.

I don't know about that. At this point, that still doesn't seem to be happening with Lenire. I would attribute it to the device unless there were specifics provided to conclude otherwise, such as if the participant was using the dreaded Tinnitus Mix or attended a rock concert without hearing...

...seems like the first trial hasn’t been mentioned much, but it seems more successful. There's something I can’t quite wrap my head around. If Lenire had a success rate in the high 80s percentile but no placebo, and we assume a 20 percent improvement for the placebo, that still leaves Lenire...

A placebo effect can't cut your tinnitus in half for months. That's not how it works.

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.

...see. It is possible that the FDA could fast-track Dr. Shore's device as a "De Novo" or novel treatment (the only other approved treatment is Lenire, but that is a good sign that the FDA may also approve this device, IMO.) With Lenire, their "first trial" results were published in 2020, and...

No because apparently Lenire can make tinnitus worse.

I'm about to end week six of my Lenire treatment. This week, I went three consecutive days without tinnitus. However, I woke up with a spike yesterday morning, and my tinnitus returned to its uncomfortable worst. This has been the pattern since I started the treatment: good days and bad...

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.

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?

On the other hand, we don't know for sure that it wasn't submitted to the FDA a while ago, possibly even last year. But I agree that preparing for the worst-case scenario is not a bad idea.

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

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?

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.

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

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.

...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...

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...

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...

IMHO, your post comes across as victim-blaming.

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?

...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...

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!

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...

...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...

...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.

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

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

Has anyone been able to get Lenire in USA yet?

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

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"?

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...

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...

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.

...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...

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...

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.

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

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

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.

...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...

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...

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 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.