Lenire — Bimodal Stimulation Treatment by Neuromod

[Candy]

I have signed up but before I go ahead can someone explain why they haven't published the clinical trial results? Would they go ahead with the product launch if the trial results were only partially positive?

 

[Agrajag364]

I have signed up but before I go ahead can someone explain why they haven't published the clinical trial results? Would they go ahead with the product launch if the trial results were only partially positive?

If anything it will prove there is a strong interest in the US. Hopefully it gets them attacking the regulatory hurdles faster.

I would probably describe them as regulatory safeguards! They need published clinical trial data to stand a shot with the US's FDA.

At the moment we have to assume Neuromod trial data is still going through peer review. I think it was January or so that they first talked about submitting the papers for peer review. It's not so unusual for it to take that long, especially if the reviewers have asked for more analysis of the data.

 

[GlennS]

View attachment 30125

Is the teacup half empty or half full? I'd rather fire this up when thinking of the first-adopters of Lenire.



Be happy for them. Be patient.

 

[Piney]

I wonder if the device can be used with a cochlear implant? I know they mentioned they may look at that possibility.

 

[Ricardo1991]

Be patient.

I agree, I am lucky to have had life bring me to the UK. However, if I were in America I think I would hang on somehow, but I think once it's been proven here in Europe to work it should go fast forward in America.

 

[Don Tinny]

I hope that users who get real improvements don't disappear from the forums. Humans tend to leave ugly things in the past and hide them.

 

[Watasha]

The user experience group sign up form is ready

Check the top of the thread for the banner link.

Please only fill the form if you intend to get the treatment soon. Also, you need to be committed to responding to follow-up questionnaires with which we track your progress. The data you submit may be used for research purposes and shared with researchers, but it will be anonymized before doing so.

Other updates

Once the first batch of devices are out there in the wild, we are also considering cleaning up this thread to start fresh (seeing so many of the current posts are about "when will it come out"), editing the first post to include a more detailed update of the current state of things, possibly alongside a Q&A - maybe even an updated one with Neuromod if they're open to that. Also like stated before, besides the more science-y user experience group, we are planning to have a separate users' thread where only those who are currently using the device can post in (everyone can read).

I think it would be an interesting data point to know individuals perceived loudness per the Lenire scale 1-10 and maybe even THI scores. If there was ever a time to collect that data this might be a good time. I'd be willing to share if I tried Lenire in the States.

 

[Lilah]

Can someone post the questions from the questionnaire here?

 

[Watasha]

Can someone post the questions from the questionnaire here?

It's quite a lot, I think you could probably scroll through it without submitting, that's what I did.

 

[acute]

there's a PDF attached

Where's the PDF? I can't see it anymore.

In their data, 40% of people had a decrease in THI less than 15 points.

To be fair, Neuromod haven't exactly buried this info. They've been saying all along that a large percentage of trial participants experienced 'clinically significant' improvement / reduction / benefits from the device.

Where can I see the actual data of Neuromod's clinical trials about Lenire?

I suppose TENT-A1 and TENT-A2 are the names of the clinical trials they did? Sorry for my misunderstanding.

 

[Candy]

I Googled them but the results of the 2nd one (TENT-A2) had not been published yet.

Also is the NDA still in place now that it's out? Anyone here tried Lenire?

 

[Jack Straw]

I hope that users who get real improvements don't disappear from the forums. Humans tend to leave ugly things in the past and hide them.

I agree.

 

[Redknight]

Since this is a sizable amount of money, does anyone know if this purchase can be eligible for tax refund for non-EU residents?

No reason why it wouldn't be.

 

[Redknight]

Can anyone report when their first scheduled appointment is?

Will do.

 

[Redknight]

So do you actually keep the device?

Yes.

 

[Markku]

For those interested, @RCP1 responded, he's busy but will touch base here when he has the opportunity.

I hope that users who get real improvements don't disappear from the forums. Humans tend to leave ugly things in the past and hide them.

That's partly why we're eager to collect the details of those who are going to try the device (the user experience group). That way we can reach out to them and follow their progress even if they drop off from here.

And not specific to Lenire, it is indeed true that people who get better may never come back to share the news (but here we have @JurgenG, great to see your tinnitus improved so much!);

 

[Redknight]

Incidentally... for those aiming to travel from the UK... it is advisable to take your passport if you are going to Dublin.

So long as Brexit doesn't happen midway through your trip you don't need a passport to travel to Dublin from the UK. You do need government ID though, like a driver's licence.

 

[Redknight]

I hope that users who get real improvements don't disappear from the forums. Humans tend to leave ugly things in the past and hide them.

I agree.

Promise I won't.

 

[Phi]

Is the 15 point decrease in THI experienced by 40% of trial participants, mentioned in an earlier post, considered to be clinically significant?

 

[JohnAdams]

As soon as someone goes through the screening process then come here immediately and spill the beans please.

 

[Mike T]

I Googled them but the results of the 2nd one (TENT-A2) had not been published yet.

Also is the NDA still in place now that it's out? Anyone here tried Lenire?

https://www.tinnitustalk.com/threads/q-a-tinnitus-hub-meets-neuromod-lenire.32369/

 

[Don Tinny]

I wonder if the use of earplugs during the treatment period could be counterproductive.

 

[M.K.]

Do you have to have hearing loss?

 

[Heinrich_S7]

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I feel you, this is going to be me if Lenire works and I don't have one yet!

I seriously jealous of you guys that got appointments. I can't wait until you guys get in.

 

[Don Tinny]

Do you have to have hearing loss?

Apparently not.

What we do know is that they exclude people with severe hearing loss.

 

[acute]

I lost my job due to tinnitus, now I have all the time in the world to waste So I'm planning to go to Ireland and stay there the three months that the treatment lasts, mainly because I do not want to endanger my ears further and cause them to suffer more in this early tinnitus stage by flying too much. I do not want to compromise my ears more by flying again and again... Of course, the problem of my stay is the money...

It would be very fun to rent a house in Dublin for all of us who want to try the treatment and stay there all together while the journey lasts. Support, companionship and noise free ambient!

 

[JohnAdams]

Do you have to have hearing loss?

Tinnitus is almost always accompanied by hearing loss.

 

[Joeymeatballs]

Thanks jmasterj I hope so, but mine is more like trapped air that I can move about by moving my jaw. Unless this is just me doing something weird with my tubes?? I think it's either ETD or TMJ, and TMJ would exclude me entirely...

Keeping fingers crossed for all of us!

TMJ is for sure an exclusion criteria? That makes no sense since @kelpiemsp has it and has had great success with this treatment.

 

[undecided]

You had stem cells?

Yeap. I've posted in the relevant thread.

Beta testers? You do know Neuromod has 2 of the largest clinical trials for a tinnitus treatment ever, right? Over 700 participants...

700 huh? I don't know if that's a lot - or a drop in the ocean. But as I said, good luck to everyone, hope this thing works some sorcery.

 

[JohnAdams]

700 huh?

That's actually a good sample size.