Having read through the website and the background study for Lenire, I remain highly unconvinced.
Lenire is based on “bimodal stimulation” - which is two forms of sensory stimulation at the same time, a current on the tongue and noise in the ears. This is delivered through a “medical device” and the device/levels are “prescribed”. Medical terminology is used liberally on the Lenire website.
The study behind this device is claimed to be a large scale trial, and it was indeed a good number of patients, but there are things that would make many scientists wary.
1) Lack of a control group means there is no way to show any results aren’t simply a placebo effect. This is really important with any study, but even more so with a subjective condition like tinnitus which improves or worsens based on your own state of mind and is affected by stress. Since Lenire is directed to be used when a patient is relaxed and comfortable, for instance, it’s so important to have controls. I suspect anyone with tinnitus would benefit from taking 30-60 minutes to relax comfortably!
2) Approximately half the original group were not followed up - we need to know why they abandoned this trial in such large numbers. A successful cure for tinnitus where so many people leave the trial?
3) The participants in the trial were new to tinnitus, having had it for six months or less. This in itself is not an issue, in fact I think people who are new to tinnitus can be the toughest nuts to crack! But it means that the results cannot really be said to apply to people most likely to want to pay good money for help, the people who have suffered for years and tried other methods.
4) The improvement. The way tinnitus is measured is with a questionnaire showing the effects it is having on your life, how much you are thinking about it, whether your sleep is suffering etc. It’s highly subjective. An improvement of several points in this score might indicate a lifelong improvement in your relationship with your tinnitus, it might just be a good week in your life. The improvement most people seek is “no more tinnitus sounds ever”. If you go in thinking that, and come out with a reduction in your score of 14 points, your life may not really be changed in the way you’d hoped.
5) The cases where the tinnitus worsened. 16% recorded worsened symptoms, and again you have that large number of dropouts which we don’t have data for.
Certainly, based on the work done so far, it is not possible for me to recommend Lenire to any of my patients.