I know you're gonna think I'm full of it, but this new tinnitus treatment just reduced symptoms in 95% of individuals who did it.
One thing that really upsets individuals with tinnitus, including myself, is that there is no universal cure for this extremely common condition. Tinnitus, or tinnitus, however you wanna pronounce it, is fine with me, is otherwise known as a ringing in the ears. And approximately 10 to 15% of people worldwide have tinnitus, and a lot of these individuals also have hearing loss. One of the main theories why tinnitus is so common in individuals with hearing loss is that it's due to an absence of sound making it to the brain. So if you have a hearing loss, you're not getting access to the sound and then your brain creates its own phantom sound to replace it. Now, tinnitus can be perceived differently by everyone. Mine happens to be more of a high pitch ring. Yours might be more of a low pitch roaring sound. The important thing to note here is that tinnitus is not created by your ears.
It is created by your brain, even though you might perceive it in your ears. That being said, hearing aids have been one of the most effective treatment options for tinnitus because they're capable of replacing the missing sound due to a hearing loss. And if you can once again get this ambient sound up to the brain, oftentimes it can shut down the mechanism of tinnitus. However, hearing aids are only effective in reducing tinnitus symptoms and approximately 60% of individuals who use them. And while this is great, it's not a hundred percent. That's why the recent news of the Lenire tinnitus treatment device from Neuromod is so exciting. The Lenire system consists of a pair of headphones to provide auditory stimulus and a tongue tip to provide mild electrical impulses to the tongue that work to stimulate both the attention and emotion systems in the brain. This non-invasive approach to treating tinnitus is a form of bimodal.
Neuromodulation, according to Neuromod, neuromodulation is a therapeutic treatment which can be used for a wide variety of conditions, including pain and depression. It works by alternating nerve activity by delivering a stimulus such as low levels of electric energy, which then alters or adjusts the activity within the body or the brain to improve the specific health condition. By modal neuromodulation is when you stimulate two different systems, and in this case, stimulating the auditory system through the ears and the somato sensory system through the tongue. Neuromod recently received de novo approval from the FDA for their Lenire bimodal neuromodulation device designed to treat tinnitus. The clinical trials for the Lenire device have been truly impressive, starting with their 10 to a one clinical trial. The results for this clinical trial were published in 2020, which indicated an improvement in tin symptoms, an 86.2% of individuals who were compliant with treatment over a 12 week period.
This a one clinical trial had a rather large sample size of 326 participants across Ireland in Germany, and resulted in lasting tinnitus improvement in 80.1% of the treatment compliant participants 12 months later. That's right. Not only was this device effective in reducing tinnitus symptoms immediately following treatment, but people were still experiencing a significant amount of benefit 12 months out, but it gets even better. Their 10th a two clinical trial was even more impressive. Hey guys, I hope you're enjoying the video so far. If you could do me a huge favor, click that like button. It really helps out my channel. And while you're at it, if you have not yet hit that subscribe button with notification bell, go ahead and do that as well. So you do not miss any of my newly released videos. That being said, let's go ahead and get right back to it.
In this clinical trial, out of 191 individuals, 95% of treatment compliant participants demonstrated improvement in tinnitus symptom severity. After 12 weeks of treatment, 91% of these individuals experienced continued improvement. When evaluated 12 months post-treatment and 87.8% of participants said they would recommend Lenire treatment to others with tinnitus. Honestly, these results are so good. I almost don't even believe them, but they were able to repeat this again in their 10th, A three clinical trials with 79.4% of individuals getting an improvement in their tinnitus symptoms. This a three clinical trial met the FDA's requirements for comparing six weeks of bimodal neuromodulation to six weeks of sound therapy alone, which allowed them to gain this de novo approval. Not only has this form of bimodal neuromodulation proven to be effective at reducing tinnitus symptoms and study participants, but it has also been proven to be safe. The Lenire system from Neuromod has proven to the FDA that it is ready for primetime inside of the United States, but this has got me thinking that this could be the most effective tinnitus treatment option that we've seen since hearing aids.
So what does this news of the FDA de Novo approval mean to someone like yourself who has tinnitus or other people who have tinnitus? Well, honestly, you should be really excited because it has been a long time since we've seen anything come remotely close to being this effective at treating tinnitus, especially after all of these years of pills, eardrops and miracle cures being pushed by pretty much anyone that have shown zero efficacy in reducing tinnitus symptoms. After all of these years, we finally have something that has been proven by research to be effective in reducing tinnitus and could ultimately be the cure for tinnitus. As of right now, it is just a matter of time before audiology clinics inside of the United States start offering the Lenire system as a tinnitus treatment option in conjunction with hearing treatment, using hearing aids, or as a standalone treatment in and of itself. If I were you, I would call your local audiology clinic and ask them if they are going to be offering the Lenire tinnitus treatment device that you can use to reduce your perception of tinnitus. And if they are, make sure that you get on their waiting list. You're one of the first in line to get it. And I can tell you this, I am 100% going to use the Lenire system to treat the tinnitus in my right ear. And if it works, get ready, because things are gonna get crazy.