Search results for query: lenire

Please tell me: How in the world does a product such as Lenire get FDA approval if it doesn’t work?

I just heard on NPR Here & Now, they were promoting Lenire. A doctor out of Boston said his patients were having good rates of success. I was surprised considering how lackluster an experience everyone here seems to have.

Or even Clonazepam/Gabapentin to buy him some time.

...everyday noises and isn’t maskable anymore by environmental noises. This bugs me the most because before it was easily maskable. Is it possible that Lenire can reverse the threshold shift done by the SSRI? So that the tinnitus can be masked again? What exactly is the success Lenire achieves?

I was on the Lenire study like a hawk. However, I am a bit behind with the latest study with Dr. Shore. Apologies if this has been answered before. I have just been reading through the second trial results, which look ‘too good to be true. ' However, what was the percentage of responders out of...

...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...

Well, someone already did. It was Lenire, and even with much more sketchy science and trial design. I really don't know what to say. I'm 31 now, from Europe. I hoped I would have a few years of relative youth left when something emerges, just to "be there" if things get too bad. With this news...

...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.

...there are ups and downs, some sessions might even spike it. It's enough to get a taste of what bimodal stimulation could do, but not enough to not call myself disabled by tinnitus. But maybe now like 60% disabled instead of 80%. There was a lady who said she got trigeminal neuralgia from...

That's strange they would say that. I spoke to Sven yesterday at the TRI conference in Dublin and he specifically mentioned how his device is different from Lenire. I shot a short video in fact, which we'll publish soon in the TRI thread and on our video channels.

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...

If Dr. Shore's Device that, let's say, yields real improvement, is released next year, will it render Lenire as obsolete as a B & W TV Set?

I give Lenire 1 year before they go out of business from exorbinant costs vs. zero results. So far they only have two outlets in Indiana.

If money was no object, would you try Lenire as soon as possible or wait for Dr. Shore's device?

...as "Are you a tinnitus lover?", which I am most certainly not, haha. My tinnitus is a fluctuating mess but I have had some success with Lenire. It's not all bad. It has definitely helped me. But I've also had a lot of experiences where it made it worse. The insane worsening I had in spring...

That’s not true. I think you are under the assumption that Lenire is a cure. It’s not. It’s a treatment. There has been people on here saying it helps but, as always, the negative reviews are focused on!

To TomK: The most valuable feature of this Forum is that Lenire has already been reported by many to be no more effective than a placebo.

I am getting my Lenire in 2 weeks! Can't wait! The clinical trials appear to have tested this thing with thousands of patients. Are they lying about the results?

...submitted their research (funded and carried out by themselves), it ticked th FDA boxes, they paid their fee - and the FDA judged that Lenire is actually not a danger to use; nobody is going to blame the FDA for getting killed or brain damage by Lenire because it just has no capability to do...

What clinic is that?

I hope the brain doesn’t get used to the pattern in Dr. Shore’s device, so that the effect gets reduced in time. Like happens with Lenire. That was the reason why Neuromod changes the parameters in Lenire after 6 weeks of treatment. What do you think?

It won't flop like Lenire for thousands of reasons that have been widely described here many times.

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

...between a PROFIT driven company and a credit worthy researcher genuinely trying to help people by developing technology that works. Lenire have to be given credit for the way they have made their device commercially successful. I don't know who is backing Dr. Shore's device but clearly some...

How does Lenire help you?

https://www.medpagetoday.com/surgery/otolaryngology/103453 This is coming to the US soon. Is this the Lenire, is it worth the hype?

Does anyone know when Neuromod applied for FDA approval? Did it take a year or so for Lenire to be approved?

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.

That is really good news. We need an independent study on Lenire.

The similarities are VERY superficial. I wouldn't compare the two just because they are both bimodal stimulation.

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.

Also, don’t forget the sampling bias for one audiologist who will happily profit from selling it to you. Many people who are not on Tinnitus Talk will buy it, realize it doesn’t work for them, and put it in a cupboard forever. Sampling bias works both ways.

Aside from the rigorous basic research that went into Shore’s device as opposed to a throwing spaghetti at the wall approach with Lenire, the idea of Lenire is to make the fusiform cells all hyperactive so that the tinnitus area isn’t so distinct, while Shore’s device aim to lessen the...

Didn’t Lenire roll out super quickly in the US after they got FDA approval? I assume Auricle will be the same if not faster? (I’m referring to the comments above about how quickly audiologists are likely to embrace it). Do I understand correctly that once something has been submitted to the...

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

Lenire: Sorry you must pay $4,000 for our help or you can go live with loud hissing in your ears until the time comes for me to be gone.

...is available. These people do not seem serious or competent. Probably taking their sweet time to burn through investors' money as they pay their salaries. The device may be out eventually but perhaps it will be a similar flop to Lenire. Maybe a little better. Some people will be helped, most...

And the end of Neuroscam a.k.a. Lenire.

Bluetooth vs. Wired aside, you seem to have had tinnitus for a very long time. Do you feel it has helped you? Have you experienced a reduction in your tinnitus?

The reason that Lenire took so long is that the FDA asked them to do another trial. That won't be the case for Dr. Shore. And of course Neuromod used their trial as a marketing opportunity by conveniently deciding to not use a placebo for their trials!

...'breakthrough tinnitus treatment' of some silly fucking app? And Hearing Health Foundation and Healthy Hearing promoting Neosensory and Lenire? It is criminal. These organizations have a job to critique the studies. MSM has a job to do 'investigational journalism,' not just promote horseshit...

So many questions can be answered by just spending even a little bit of time searching the forum. And yes, Lenire is a scam. Susan Shore's device is the shining light in our lives at the moment.

...into a product with only a 10% success rate. If real-life experiences confirmed this, product sales would be dead within a year. Like with Lenire, very few are going to pay thousands of dollars for something that gives them almost no chance of working. They might initially, but over time...

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

And yet they approve something like Lenire, and not for it being safe alone. No corruption involved!

Wow.

Not really. What I noticed the first few times after using Lenire is that it would change an otherwise always stable set of ringing sounds, and would make it whoosh and variable. It was kind of gradual that the reactivity went down. Things might be a little different for me though because I was...

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.

...already habituated for many years to the milder garden variety. I was hoping my prior post in this thread would be the last but clearly the Lenire saga is continuing with negative experiences like yours. Your summary has raised some important questions, which I hope you won't mind me asking...

My friend said she saw a commercial on TV looking for candidates to try out SOMETHING for T but didn't get the #, USA. Could it be Lenire?

I think yes! Lenire has improved my condition, even though I've quit it for now after about 2 years.

Lenire is pretty much hot garbage. Neuroplasticity is something that humans lose with time but slightly, otherwise you would never be able to learn anything new at an older age which isn’t true. And, if Dr. Susan Shore is correct about us basically having misfiring neurons - all we need to do...

Well, finally.

None. They do not apply electrical stimulation to the cochlea nor count as electrical stimulation generally, because they are bimodal (electric and audio).

You and I have both been her for a while, but I forgot -- do you have hearing loss? I am under the impression that Lenire won't really help those with significant hearing loss, but maybe I'm wrong? Trying to decide if it's worth the $4,000 gamble.

Just like Lenire was going to be the saviour. Isn't there a forest where people can go to die like in the Matthew McConaughey movie? Cheaper than VAD...