Search results for query: lenire

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...

...Really, the only way I can stay remotely interested in Auricle is to hear that they now understand where things went wrong, that they've deduced how to address that, and that they intend to re-run the trial. I'm afraid anything less, and we're in grave danger of sliding into Lenire territory.

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...

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"?

Has anyone been able to get Lenire in USA yet?

I bet you've never heard the expression 'cum hoc ergo propter hoc'. I am profoundly disgusted by this Jastreboff now.

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.

...you at such a young age. I was also offered masking with my hearing aids, but that just felt like adding more noise. Have you been following Lenire? It has gone through multiple trials, received FDA approval, and is now in use. From their website: "Dual Mode is a form of bimodal...

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...

I am wondering how Dr. Shore could conduct a placebo group and Neuromod couldn't. Both are bimodal stimulation approaches. So why Neuromod hasn't done that with Lenire? By the way, there is not much news about Lenire... I know why...

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

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

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?

...You're a rock star. I'm going to use some of your advice on my worst days (I have Lorazepam instead of Xanax). Also, I have never heard of Lenire! I'll have to look it up. Thanks for sharing everything. It's awesome to hear you are winning the battle. Even if it's taking longer than we...

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

I just had a follow-up audiogram after my ENT requested it. By the way, I’ve been using the Lenire system for four months now. At my second follow-up session, I requested to switch the track from #1 to #6. Why the FDA hasn’t approved all the tracks remains a mystery. Track #1 combines noise...

IMHO, your post comes across as victim-blaming.

...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...

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...

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

There was a lady called, @AliceW, who claimed to suffer trigeminal neuralgia following Lenire use, although to the best of my knowledge she didn't update her situation on Tinnitus Talk. @Kam75 was in touch with her for a while.

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...

Holy Smokes! Lenire is now available in increasing numbers throughout the USA!

Thanks for sharing! I'm so happy something like this works for you! Did you present with reactive tinnitus while using Lenire, or has your tinnitus been more constant and not sensitive to sounds in your environment?

I am an atheist but I might just start to believe in a God if Dr. Shore's device proves to be as effective as we all hope. If it's turns out to be a Lenire MkII - my atheism will be confirmed.

...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...

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.

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...

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

Well, bye bye Lenire! Next time, perhaps include a control group!

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.

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...

...used Notched Sound Therapy and Acoustic Coordinated Reset Neuromodulation (ACRN), do you think they really helped reduce the tinnitus sound, or was it just a placebo effect? I’m also thinking about trying Lenire. Does it actually help, or is it just a scam based on what I’ve read on this forum?

"on your road to recovery" is what they should be saying.

Well, that seems to be the first definitive report in favor of Lenire here?

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!

...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...

How loud is your tinnitus? Would you say more mild to moderate, or severe and can't be masked?

...three years my hearing has not changed, yet I still have intrusive, loud tinnitus. That’s because it is not in the ears or ear canals. Is Lenire approved? No. That is why you have to pay five to seven thousand dollars without any guarantee it will help. Tinnitus should be added to the list...

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...

I completely agree, @EDDTEKK. I am happy for the very few Lenire has helped, everyone deserves relief and improvement, but it has worsened more people than it has helped, and therefore should not be given any money. Thank God we have Susan Shore to provide something that will be much, much...

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.

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

...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...

Regardless of what the studies say, there is still a chance of worsening tinnitus, in a similar way that Lenire is a complete gamble.

Lenire is pretty much a SCAM. If you are new to Tinnitus Talk, read this whole thread.

...The wording is purposefully and deceitfully written in this precise way to make you think it lowers volume - and if it was ever questioned, they can clearly show it's never mentioned. MODERATOR NOTE: Further Lenire discussion belongs here: Lenire — Bimodal Stimulation Treatment by Neuromod

Neuromod had to be, it was the only way they could possibly make any money. If Lenire had come out after Dr. Shore's device, I doubt nowhere near as many people would take a chance on it.

Wasn't the University of Minnesota device similar to Lenire? Sound with the electrical impulses to the tongue? I would assume it would have similar results as Lenire.

Does Lenire cause you to feel sleepy? Why do you suspect that happens?

...took the De Novo route at FDA, things are unfortunately delayed as the device is no longer De Novo because Neuromod completed the route with Lenire. Auricle will be a Class II device: FDA: Product Classification - Combined acoustic and electrical external stimulation device for the relief of...

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.

I wrote to Dr. Lim to know more about whas seems to be another clinical trial on Lenire. I received this answer: