Lenire — Bimodal Stimulation Treatment by Neuromod

You may be absolutely right, I've noticed some things as well that aren't in the official Neuromod brochure.

 

The controller give the user the option to increase or decrease both the volume of the headphones and the intensity of the electrical stimulation through the tonguetip. They reckon it doesn't make any difference to the efficacy of the treatment, but that it's best to leave both in the default setting.

 

Is there a video I missed explaining how the sound works with the tongue thingy?

Or would a Lenire user be good enough to explain... thanks!

 

I'm not a Lenire user, but from what has been said in the thread it's white noise and bleeps with the bleeps being synced to the tongue pulses. The signal timing is important in inducing neuroplastic changes. They have other programs without the white noise. I believe @Drone Draper uploaded a sound file at some point.

 

Oh nice, is it relatively easy to swap appointments? Have people done this before?

That makes sense, because my hyperacusis has been getting better where whistles being blown and other loud higher pitch noises like that don’t affect me anymore, and I’ve also been experiencing less reactive tinnitus in conjunction with that improvement. Loud noises like air suspension from buses still hurts though, but doesn’t induce ringing.

 

Hi from Dublin...

I pick up my device tomorrow...

Hope it will give results!

 

If you want I can ask them.

My appointment would be the 5th of May.

When is yours?

 

Remember reading a few people saying the reactivity was greatly improved.

 

Did you find a cheap hotel?

I need to book something decent just for one night.

 

I would be more comfortable if I could read a peer review publication before my appointment.

Any idea when will the peer review be published?
One month? One year?

 

They said this in last month's Tinnitus Talk Podcast interview... once they've submitted the paper it will still take up to 6 months for the academic journal to process it.

Answer to your question I think is "one year"

 

They said in October 2018 that they were about to submit for peer review and then they said it again one year later. I don’t think anything is guaranteed.

 

I’m in Dublin Center, O’Connell street. Holiday Inn Express 110 euros/night. Very nice and comfortable room. Then I’ll take bus to the Hermitage Clinic (25 minutes from the center).

 

Thanks for your reply.

When they say:
The complete date set from all the Clinical Trials is absolutely enourmous

This seems honest justification? Or are they not confident on the peer review results and are just postponing?

 

Thing is when they set the masking level of the white noise, I still had a left ear tinnitus that could be heard quite loud so I turned up the volume 3 steps and it seemed to have some kind of a better effect on it. Just to clarify. The MML test with the white noise is truly just your subjective view when your tinnitus seems masked.

Also I did try to do it more times during the day but will refrain from this until my 12 weeks are done.

I got a call back today from Neuromod. Not from the clinic though and asked about the time you should use Lenire and they say you should use it the instructed 60 minutes per day, not more.

 

Neuromod said it's not possible to swap appointments.

I'm sorry!

 

It feels like stalling to me, or maybe that their resources are so limited that they don't want to spend the money to expedite it.

The thing is, the regulatory environment in the EU allows them to move ahead, so from a business standpoint, the urgency isn't there.

 

I'm am beyond sure that this has been discussed to death but I am not keen on going through 191 pages to find the answers.

What is the difference between this and the MuteButton? I was doing some news searches and found a bunch of old articles talking about the wonders of the clinically proven soon to be deployed everywhere MuteButton. Is there any real advancement between the old tech and new?

 

Ross talks about it in the video here:

 

Me too. I am not really happy with all this dragging on of the peer review. The size of the dataset should not be a reason not to publish the paper unless they are still analyzing the dataset itself. You publish a paper, not the data. You may need to make part of the data available to referees during the peer review, but that's it. Except the peer review has not even started, so why wait to submit? Is the paper finished or not? If it is finished put a preprint online, as is done in maths/physics (arXiv.org), biology (biorXiv), medicine (PubMed Central), social sciences (SSRN.com) etc. Then you may amend it later for publication but at least the research is out and people can read and check it even before the formal peer review is done. This would be the least they could do before charging 2500 EUR to clients.

All this dragging is bad, suppose a referee or an informed reader finds an important problem they have not thought about in the preprint, why should all the clients that bought the product earlier be exposed to that, like guinea pigs? The correct sequence should be

1) Post a preprint and allow for some preliminary feedback from the community.
2) Submit the paper to a journal with a formal peer review process
3) Get the referee reports and implement any recommendations they make
4) Publish the paper

I feel commercialization of something related to medical treatments should be done at the earliest after step 1, much better if after step 3, but anyway not before step 1. True, nobody is forcing us to buy the product but given the desperation of some tinnitus sufferers it would be more honest to wait for 3, to make sure something fully sound is being sold.

Am I being too demanding? I understand proprietary information, IP and all that, but if the intention is to publish anyway, why all this delay?

 

I had terrible spasms that have gone away now.

 

I just found this:
https://hoersys.de/tinnitus

They seem to be giving appointments for Hannover, Germany.

I will ask for price etc...

 

In a nutshell it's improved timings. Obviously this treatment is all about the underlying software rather than the hardware itself.

 

It’s the same thing, they probably perfected it a bit since 2011 is my guess...

Here at Tinnitus Talk we have witnessed the device’s initial conception in 2011 as “MuteButton,” building up to a launch in 2015. The device was on sale for a couple of months in Dublin, before Neuromod pulled it from the market to conduct more thorough clinical studies and pursue FDA approval. Since then, the company has conducted one large scale clinical trial (TENT-A1), with a second one in progress (TENT-A2). Based on our Q&A with the company back in December 2018, they seem to believe there is now enough substantiating evidence to bring the device to market.​

 

As far as I am concerned these trial results are invalid because one of the principal investigators WORKS FOR THE COMPANY MAKING THE DEVICE.

 

Do you mean you had them prior to starting Lenire, or that they were a temporary side effect of the treatment?

 

Lenire is now available in Germany (Hannover). First patients have had assessments already.

 

For people wanting to apply for Lenire in Germany:

"Eine Terminanfrage und das Reservieren eines Platzes in der Warteliste ist unter info@hoersys.de möglich."
("An appointment request and reserving a place on the waiting list is possible under info@hoersys.de.")

 

If this lenire treatment doesn’t make things worse...

Theoretically one could try Lenire... and then try Dr. Shore’s device in year 2030... or whenever.... without any negative effects.

In other words... using one timing methodology shouldn’t screw you up to try a different timing methodology... right?

 

Just a heads up, I've been in contact with a researcher doing a different trial but is well aware of Lenire. He says he was at the presentation Dr. Lim gave in February and it looked very promising.

For peer review in general, it's not a vicious scrutinization or anything like that. It's more of a "I would've done this differently" kind of thing.

I really don't think it's a huge deal they commercialized before peer review, honestly it benefits us for being able to be treated faster. It's a tiny company, they need money, and we need treatment.