Lenire — Bimodal Stimulation Treatment by Neuromod

After what seemed like a long wait for the tinnitus community, Neuromod Devices in June 2019 launched its tinnitus treatment device called Lenire™.

The device has a long history, so for you relatively new to the discussion, let us give you a recap of what has transpired so far.

MuteButton

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.

How Does the Lenire Treatment Work?

Lenire is based on “bimodal neuromodulation” technology. Neuromodulation is the use of electrical stimulation to modulate nervous system functionality for therapeutic benefit. Neuromodulation has been applied in different ways – and with some, but limited success – to treat tinnitus, for instance as repetitive transcranial magnetic stimulation (rTMS). With bimodal neuromodulation, two pathways are stimulated simultaneously. In the case of Lenire, this concerns auditory stimulation through sound, and somatosensory stimulation of the trigeminal nerve, through electrical pulses to the tongue.

Is It a Cure? Is There Evidence That It Works?

Neuromod has so far only published the results of its safety and feasibility study. Following that, the company has conducted two clinical trials – TENT-A1 and TENT-A2 – but has not yet released the results from these trials, only the trial protocols.

However, Neuromod has spoken publicly about some high-level outcomes of their trials. In our video Q&A with the company, CEO Ross O’Neill spoke of 80% of patients who reported some level of improvement of their tinnitus after 12 weeks of treatment, and more than two-thirds who experienced a “clinically significant” improvement. He also reported that hyperacoustic patients in particular responded well to the device, with significant improvements in their tinnitus (not per se their hyperacusis though).

In our Tinnitus Talk Podcast interview with Ross O’Neill, he speaks about Lenire’s effectiveness in some more detail, highlighting how they accounted for the placebo effect and how they defined “clinically significant improvement.”

Outcomes of Tinnitus Hub’s Lenire User Experience Group Study

We have collected our own data on Lenire’s effectiveness. Not as a clinical trial (we don’t have the resources for that), but as a patient-led study based on experiences from Tinnitus Talk members who have used Lenire. Just to be clear, this study was completely independent, we have no commercial ties to Neuromod.

We didn’t get as large a sample size as we had hoped, but we managed to collect data from 43 patients. They were asked to complete surveys before they commenced treatment, at 6-weeks, and after the completion of the 12-week program (some of them dropped out before then though).

Our results are not as favorable as what Neuromod has communicated, but we did find that nearly half of our group benefited from the treatment. Then again, our study did not have the rigor of a full-blown clinical trial and the sample size was small. Still, you may be interested to learn what we found:



Want to Know More?

• For those of you wanting more detail, check out the Report 2 Summary attached below, which provides more depth on the key outcomes of the study.
• If you’re really hardcore, check out the full Report 2, with all the methods, data, statistical analysis, etc.
• If you want to know more about the study participants and their characteristics, check out Report 1 or the summary thereof.

None of the above could have been achieved without our volunteer project manager and data analyst @PeterPan – thank you!

 

These are really exciting times. The only reason things like this are happening is because the community is vocal and challenging the status quo of what audiologists and the old guard are saying.

However only time will tell how this fares, fingers crossed.

 

Hey! They paid for the domain for 10 years upfront. Seems like tiny but a good sign for me.

 

I will move to Ireland to get this. Get us a launch date ASAP Neuromod!

 

Seems like it's not just Ireland though right? When they say Europe I am curious what their timing with England will be.

 

Great news! Neuromod might be taking things slower than we'd prefer, but this is a sign that they still 100% intend to go ahead and come to market. Also, this happened a bit earlier than expected (opposition period for the trademark was supposed to end early May).

Me (and my credit card ) can't wait for more news!

 

I remain optimistic that this device is going to make a difference. With the new trademark registration and a new name, I hope it’s close to being released.

 

I'm not too optimistic. Remember the testimonial videos from Neuromod, and Markku not getting a reply from them. I think this device is basically going to be a lottery machine. It either will or will not work for you. And if it does, let's see how much relief we will get...

 

Woah, times for tinnitus are changing fast. I don't even care, I will fly out to Europe to get treatment for this if it works.

 

All these devices won’t help EVERYONE. Even the flu shot and surgeries involve risk and aren’t 100% effective.

But if 2/3 of patients get significant reduction then that’s definitely worth trying to see what effect it might have for you.

I only got tinnitus 4 months ago and can’t imagine living the rest of my life with it. I’ll try any legitimate treatment.

 

What is wrong with the testimonials? To the second point we are not owed an answer. Third, yes it is a lottery, they have said as much. At the moment it works for 2/3 of people with tinnitus. As for the relief we just don't know, but if other bimodal neuromodulation tests are to be believed then it ranges from anywhere from 3 dB to 10 dB or more in some cases. Some even saying that their tinnitus is gone.

 

Surely the fact that Susan Shore's team are working on a similar concept, this can only be a good thing, right?

I also take some comfort from the fact that Neuromod employed some big names... I mean, would people like Hubert Lim put their professional reputations on the line for something that's a dud? The tours, the advertisement in the ATA, the €24 million investment.

Anyway... I've registered and I believe from what I've read is it doesn't matter how many noises you have; what the cause was or how intense it is... provided you have reasonable hearing you're in with a chance. Please correct me if that's wrong.

I intend to get this, for once in my sorry life this company isn't on the other side of the world (I'm an hour's flight time away) so however it gets released I'll do my best to get in there early on.

 

I'd flop my wedding tackle in the mouth of a Great White Shark for 20% relief.

 

This is great news! Here's to hope!

 

It seemed to me that the average Neuromod improvement was 10 dB, but now I'm not sure where it came from.

 

What does this 3 dB to 10 dB mean?

 

Reduction of how loud the tinnitus is.

 

Noise perception - loudness level(s).

 

If this is true, a 3 dB to 10 dB reduction might seem marginal but in terms of the actual tinnitus loudness it is huge.

 

10 dB does not seem much.



Can you explain why it is huge?

 

Because in this case, the needle drops directly in your ear.

 

It seem to me the dB level is only important as it relates to your particular tinnitus noise level. 10 dB could be enough to suppress many people's tinnitus discomfort. And even if your tinnitus is super bad, it can only help.

 

dB is exponential meaning that 40 dB is double the volume of 30 dB and 50 dB is double the volume of 40 dB and so on.

 

It is generally agreed that any 10 dB decrease represents a halving of perceived loudness. This is due to the logarithmic nature of the decibel scale.

See e.g. http://www.sengpielaudio.com/calculator-levelchange.htm

 

You can play with dB levels online if you want to understand the difference. It’s hard to explain the difference. It is best experienced.

 

Do we really know how to compare dB levels for external noise versus head ringing sound. I don't know the answer to this. But we may be trying to compare apples to oranges.

 

Yes, we do.

 

Thank you for the update. Neuromod device is very positive news.

 

Lenire... as in... "Oui, oui, mes amis... this device will be available in le nire future!"

 

I remember reading somewhere that the majority of tinnitus cases are under 10 dB when you account for tone and hearing threshold level (dB SL). I don't know if I believe it as my tinnitus was consistently measured (matched) at around 30 dB multiple times, but I do think people overestimate the decibel level of their tinnitus. Minimum masking level (if you can mask it) is not the same at all.