Lenire — Bimodal Stimulation Treatment by Neuromod

[Bartoli]

They didn't think about Bluetooth latency and they're now seriously stressing.
In a year, they will launch the improved Lenire V2 with wired headphones, tonguetip, vagus nerve electrode and lidocaine pump and we'll be good.

 

[ajc]

Results: This study protocol was approved by the Tallaght University Hospital/St. James's Hospital Joint Research Ethics Committee in Dublin, Ireland. The first participant was enrolled on March 20, 2018. The data collection and database lock are expected to be completed by February 2020, and the data analysis and manuscript submission are expected to be conducted in autumn of 2020.

So Neuromod will submit their manuscript to a journal in autumn of 2020 and we can expect to see it published in 2021.

That's a long wait. Makes me suspicious.

 

[alanisnotadj]

The German launch should happen very soon. I received an email from Prof. Dr. med. A. Lesinski-Schiedat who confirmed to me that they are working very hard to make Lenire available in Hannover before the end of 2019.

So maybe I could have waited instead of going to Dublin last Tuesday but I went anyway.

I can also confirm what everybody has said about the professionalism of the Neuromod team.
Everything went well and I will pick up my device on the 3rd of December.

Let's see how it goes.

 

[GlennS]

So Neuromod will submit their manuscript to a journal in autumn of 2020 and we can expect to see it published in 2021.
That's a long wait. Makes me suspicious.

How does this timeline correspond to the FDA approval?

 

[Manny]

Has anyone seen this? Apparently the FDA review of the TENT-A2 was estimated to be completed in September.

https://clinicaltrials.gov/ct2/show/NCT03530306

Possible US launch soon?

Where do you see mention of FDA review?

 

[ajc]

Where do you see mention of FDA review?

@Heinrich_S7 is confused.

He thinks ClinicalTrials.org is related to FDA.

It's not.

ClinicalTrials.gov Study Completion Date has nothing to do with FDA review.

How does this timeline correspond to the FDA approval?

You would think FDA wants to see peer reviewed evidence before giving the green light? So a US launch might be ways off...

 

[ChrisBoyMonkey]

@Heinrich_S7 is confused.

He thinks ClinicalTrials.org is related to FDA.

It's not.

ClinicalTrials.gov Study Completion Date has nothing to do with FDA review.

You would think FDA wants to see peer reviewed evidence before giving the green light? So a US launch might be ways off...

From what the users are reporting the FDA is already looking at Neuromod's data.

 

[GlennS]

You would think FDA wants to see peer reviewed evidence before giving the green light? So a US launch might be ways off...

Is that true? Does that mean the FDA is stricter than the EU?

 

[hans799]

Is that true? Does that mean the FDA is stricter than the EU?

I think Neuromod has a head start in the EU (with the MuteButton), that's all.

 

[Ruse]

So Neuromod will submit their manuscript to a journal in autumn of 2020 and we can expect to see it published in 2021.

That's a long wait. Makes me suspicious.

Remember this is for TENT-A2 and not TENT-A1.

This seems like a fairly typical timeline to me if you consider that this trial has only just finished.

 

[Bartoli]

Is that true? Does that mean the FDA is stricter than the EU?

They had already launched MuteButton in the EU. Maybe they didn't have to get clearance again for Lenire as it's some sort of improved device that goes by a different name? Or maybe it just went quicker because of this... Just thinking out loud.

 

[Bartoli]

You would think FDA wants to see peer reviewed evidence before giving the green light? So a US launch might be ways off...

I believe you don't have to prove effectiveness, just that it's safe. How would all the homeopathic remedies and supplements end up on the shelves otherwise?

 

[Agrajag364]

Is that true? Does that mean the FDA is stricter than the EU?

Yes, the FDA is stricter, this been discussed before on the thread. They are stricter than the European notified body system for approval of medical devices.

Here's the table comparing the two and an excerpt from an article. They are tightening up the European rules but not till 2020 and not very much. I'm not clear on whether Lenire would be classified as a class two or a class three device by the FDA. But even if class two it's likely it would need decent trial data as there aren't really prior devices that are like it. Also with regard to the requirement for trial data in the EU, sometimes it can be tiny very low quality trials. From what I've heard in the past, the FDA usually requires better quality trial data than the European NB system. So I would assume that Neuromod would at least need to get their TENT-A1 trial past peer review before gaining approval, although I guess it's not 100% certain.

Put it this way, Carl Heneghan, professor of evidence based medicine at Oxford university, once managed to get orange fruit netting approved as a device in Europe. He was trying to show how crap the European system was. Americans are better protected.

https://www.thetimes.co.uk/article/scandal-of-fruit-netting-approved-as-surgical-implant-dvcqd2rt9mr

 

[Ruse]

Is that true? Does that mean the FDA is stricter than the EU?

The device only requires a CE mark for the EU. These only take around 4-6 weeks to obtain I believe.

 

[Dizzyhead888]

Anyone experienced any side effects (apart from temporary worsening of tinnitus) while using Lenire?

Just asking to set my expectations.

 

[Chinmoku]

You would think FDA wants to see peer reviewed evidence before giving the green light? So a US launch might be ways off...

Hasn't the FDA approved things like Levo and Desyncra? Did they come with a peer review and a published paper?

 

[Mentos]

Has anyone seen this paper before?

https://www.researchprotocols.org/2019/9/e13176/pdf

Seems like they are planning another phase of clinical trial, narrowing participants to tonal tinnitus only?

 

[MattS]

Is that true? Does that mean the FDA is stricter than the EU?

Yes, the FDA tends to be stricter, with greater red-tape as well. Many drugs/devices get approved in the EU (and/or other countries) prior to FDA approval.

 

[Bartoli]

Hasn't the FDA approved things like Levo and Desyncra? Did they come with a peer review and a published paper?

From Desyncra's website:

It's tried and tested:
Over 4000 patients have been treated with amazing results, reducing symptoms like loudness and annoyance, and quite often making the tinnitus disappear completely. Many clinics and doctors all over the world are already using Desyncra™ for Tinnitus.

I mean, can they claim such a thing? From what I've heard, it hasn't worked for anyone on Tinnitus Talk. They claim actual loudness reduction and making it disappear completely quite often.

 

[GlennS]

I mean, can they claim such a thing? From what I've heard, it hasn't worked for anyone on Tinnitus Talk. They claim actual loudness reduction and making it disappear completely quite often.

Could someone give me a brief cliff-notes version of what happened with Desyncra? It doesn't look like it uses anything but audio input, but other than that, its ad copy feels very much like Neuromod, which is kinda scary and I can understand how anyone who used it or hung out in the forum when the whole thing played out would be fearful that Neuromod will wind up the same.

 

[Mike T]

The device only requires a CE mark for the EU. These only take around 4-6 weeks to obtain I believe.

We manufacture medical devices. You need to have it classified a medical device if it is intended to treat any condition (a CE mark does not classify a product to treat a medical condition). We make pressure reducing mattresses to try to reduce pressure sores occuring. We have to do a lot of trials and testing in order for it to become a class 2 non-intrusive medical device.

 

[EDDTEKK]

Another user reports a worsening of tinnitus after using Lenire:

Hello folks.

First time on Tinnitus Talk for me. I have been using the device since the 4th of August 19. I was really positive to start. I have tinnitus in my right ear which is a high pitched whistle. In the left ear I have hyperacusis and fluctuating tinnitus.

I used Lenire for 30 minutes a day. After 4 weeks I noticed that both the tinnitus and hyperacusis were getting worse.

I had my review appointment and they suggested that I make more of an effort to get up to 60 minutes a day.

This set both my tinnitus and hyperacusis through the roof. It has got so bad that I have had to stop using it. I need things to settle down as it is breaking me at the moment. I have had tinnitus for 4 years so I am used to the struggle.

I plan to start again but need to regroup.

I had hoped that I would be one of the 60% who benefit. Keep your fingers crossed.

I am now really scared guys...

Regarding Desyncra: I remember that it helped 20% of the patients who were using it in 2012 and reported regularly in a German Panel. For SOME it seems to work.

But 80% of the ENTs stopped offering the treatment after the company went bankrupt.
Currently there are 3-4 ENTs who still offer it.

 

[Dizzyhead888]

Hello folks.

First time on Tinnitus Talk for me. I have been using the device since the 4th of August 19. I was really positive to start. I have tinnitus in my right ear which is a high pitched whistle. In the left ear I have hyperacusis and fluctuating tinnitus.

I used Lenire for 30 minutes a day. After 4 weeks I noticed that both the tinnitus and hyperacusis were getting worse.

I had my review appointment and they suggested that I make more of an effort to get up to 60 minutes a day.

This set both my tinnitus and hyperacusis through the roof. It has got so bad that I have had to stop using it. I need things to settle down as it is breaking me at the moment. I have had tinnitus for 4 years so I am used to the struggle.

I plan to start again but need to regroup.

I had hoped that I would be one of the 60% who benefit. Keep your fingers crossed.

This is the first actual real/not temporary worsening reported on Tinnitus Talk. I hope you get better. Reading this put me down.

 

[Chriscom]

Another user reports a worsening of tinnitus after using Lenire:

I am now really scared guys...

In case anybody is wondering, that's posted in the User Experience thread. (No disrespect intended to EDDTEKK, I just get lost here sometimes when I'm chasing down various comments).

 

[Allan1967]

Hello folks.

First time on Tinnitus Talk for me. I have been using the device since the 4th of August 19. I was really positive to start. I have tinnitus in my right ear which is a high pitched whistle. In the left ear I have hyperacusis and fluctuating tinnitus.

I used Lenire for 30 minutes a day. After 4 weeks I noticed that both the tinnitus and hyperacusis were getting worse.

I had my review appointment and they suggested that I make more of an effort to get up to 60 minutes a day.

This set both my tinnitus and hyperacusis through the roof. It has got so bad that I have had to stop using it. I need things to settle down as it is breaking me at the moment. I have had tinnitus for 4 years so I am used to the struggle.

I plan to start again but need to regroup.

I had hoped that I would be one of the 60% who benefit. Keep your fingers crossed.

Are you on the hissy noise scape with piano tunes?

 

[Bartoli]

@Allan1967
I'm not sure. Are you still using Lenire at the moment without the white noise sound?

 

[Heinrich_S7]

Another user reports a worsening of tinnitus after using Lenire:

I am now really scared guys...

Regarding Desyncra: I remember that it helped 20% of the patients who were using it in 2012 and reported regularly in a German Panel. For SOME it seems to work.

But 80% of the ENTs stopped offering the treatment after the company went bankrupt.
Currently there are 3-4 ENTs who still offer it.

I'm becoming more and more skeptical as time goes on. If this thing worked we would have heard something by now. Instead we're getting more nightmare stories of people needing to quit. Not looking good at all.

Regardless of what happens, I still believe tinnitus will be cured in the next couple years. Lenire is looking more and more like Desyncra though, I'm not sure if I'm going to invest any more time into it.

 

[Jogger1]

I'm a bit baffled by all of the negativity on Lenire. I've only seen one negative comment from a Lenire user. The rest are very positive.

???????? Please tell me who else is having a negative effect!

 

[ajc]

I'm a bit baffled by all of the negativity on Lenire. I've only seen one negative comment from a Lenire user. The rest are very positive.

???????? Please tell me who else is having a negative effect!

Read the User Experience thread. @Ade posted earlier today about his negative experience.

 

[ChrisBoyMonkey]

I'm a bit baffled by all of the negativity on Lenire. I've only seen one negative comment from a Lenire user. The rest are very positive.

???????? Please tell me who else is having a negative effect!

It appears to be mixed so far. Some great results, some worsening. Nobody has finished the arbitrarily established 12 week treatment yet though.