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!
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