Lenire Tinnitus Review | New Tinnitus Treatment 2021 by Neuromod

one of the most interesting developments for tinnitus research in the past few years has been bimodal neural stimulation and there's a company based out of ireland called neuromod that has released a product called the linear device which simultaneously stimulates the trigeminal nerve by putting something on the tip of the tongue and at the same time wearing headphones to stimulate the auditory system with certain sounds so there's two modes of stimulation the tongue mode number one and then the ears the hearing system mode number two that creates what's called bimodal stimulation in this video i'm going to explain this linear device how much it costs what's its effectiveness what is the research going into it when will it be available in the u.s who's going to get it first which subgroups does it work for and the most up-to-date research information that i could find so welcome to pure tinnitus hello my name is dr ben thompson i'm an audiologist in california i created this youtube channel to help you with your tinnitus wherever you're at whatever resources you're looking for whether that be helping to manage tinnitus the psychology or sound therapy or you're looking to get the most up-to-date information on research for a cure and different kinds of treatment solutions out there i invite you to subscribe to my youtube channel unfortunately 75 of my viewers maybe you who's watching this watch my videos without subscribing so if you subscribe that really would mean a lot to me it keeps me motivated to make these videos to serve you so let's get into the linear device and what you need to know i recently watched a web class a webinar presentation from the ceo of neuromod the company that makes linear and their group of researchers who have been following the patients and the clinical trials so far over the past few years the company is based out of ireland and right now they have this linear device let's first talk about the setup so this device which i'm going to show pictures of right now has a headphones that you wear over your ears and also has a device that you put into your tongue so they both are routed through this handheld device that looks more or less like an old school ipod and at the same time there's stimulation delivered to your tongue and there's sounds being delivered to your ears the sounds in the ears are variable with some high-pitched tones and the stimulation on the tongue not exactly sure how that feels but it's not intense it's supposed to be very light someone described it as the type of candy that pops and crackles when you put it on your tongue some of the researchers were describing that people say it's that kind of sensation i'm interested in this device and i'm trying to analyze how effective it would be i know many people with tinnitus are looking for anything and they would almost try anything but i don't want you to try something if it's not actually effective or if it's not vetted through research and studies this specific device the it's designed to be used for six week increments where for one hour per day during those six weeks you are listening to the sounds and you have the device also connected to your tongue at the same time so they're suggesting you could do this for 30 minutes in the morning and 30 minutes in the evening or basically whatever hour you can find in your day to wear this device on lanier's website they advertise that linear is a breakthrough evidence-based tinnitus treatment from neuromod which is the company that has created linear and linear harnesses the science of neuromodulation you can see here they have options to visit the clinic in ireland or to find other european clinics so what is linear linear is a device that you can use in the comfort of your own home to help treat and manage tinnitus linear is a non-surgical device designed for use by patients in your home after being fitted and evaluated by a healthcare professional the device components linear is a medical device with three main parts first we have the controller so this white controller here is what you would hold in your hand to change the volume of the noise in your ears as well as to change the stimulus charge of the electrical piece on your tongue so this is the linear controller a lightweight handheld device that controls the timing and intensity of the treatment you can start pause and resume the treatment session adjust the volume of the sound and adjust the level of the tongue stimulation here's an example of someone holding the tongue stimulator with the headphones the treatment goes into some of the details uh one important point i wanted to show you that linear is recommended to be used for 30 to 60 minutes per day and use for a minimum of 12 weeks it's important that each session is completed in a place that is quiet and comfortable the more relaxed you are during the treatment the better linear is intended for prescription use only if linear is deemed suitable and thus prescribed for you by a healthcare professional the audio and tongue stimulation are configured and calibrated to your individual characteristics during the initial fitting that's typically the characteristics of your hearing test here's the timeline that linear recommends we have the initial assessment and then the device fitting that's all within the first month and then for six weeks you're using the device at your home every day for between 30 and 60 minutes after that six week period of usage there's a review assessment with your audiologist or other healthcare professional that's working with you on this device followed by another six weeks of using the device in your home and then reviewing the progress followed by potentially continued use depending on if you perceive benefit from it and if it's helping you right now the linear is only available in ireland and other european clinics let's check out where in europe you can get the linear right now there's four countries that are servicing linear ireland austria belgium and germany with the most clinics in germany commonly asked question is linear available in the united states linear is not currently available in the us the company neuromod is seeking fda approval through the government to make linear available as soon as possible you can subscribe to their newsletter for updates if linear isn't available in your country there is a chance that you can travel to one of the clinics in europe and have your services done in person and then follow up virtually that is possible you can reach out to linear if you're interested in that their main clinical trial which that the data was released at the end of 2020 is called the tent a1 trial and this is specifically for the linear device with 326 participants one of the main takeaways i took from listening to the web class with the researchers was that it's hard to control for tongue and ear stimulation because a classic control group let's lose let's use the example of a covid vaccine for the control group they would put in a fake serum a fake vaccine there's nothing in it whereas for the active group they would put in the real covid vaccine and then they would test the antibodies for both groups and for the coveted vaccine example if the group who was given the active vaccine has a large amount of antibodies and the control group had no change then that's a great example of how the participants were completely blinded they had no idea which one would be in their system and their their that controls for the placebo effect when you have something in your tongue you're gonna feel it when you have something in your ears you're gonna hear it so it's hard to play a dummy representation of that that's not actually stimulating the tongue the trigeminal nerve as well as the the actual hearing system and the auditory nerve as well in their clinical trials the linear group tried to control for some of these factors they had three different groups the first group had synchronized stimulation of the tongue and the sound at the same time the other group had asynchronous stimulation varying varying periods i believe the third group had a more delayed stimulation so they tried to control to see which was which um in those three arms those three groups in the study there were some minor differences but overall not anything dramatic at the time that they were reporting the research at least from that first group the outcome measures they used were two of the most common measures the tinnitus handicap inventory and the tinnitus functional index so notice here that they're not measuring directly the loudness of the tinnitus and that gets a little tricky it's very subjective to determine how well this device is working especially because there's no true placebo control group so it makes it a little complex to interpolate this data but we're certainly interested and we're not going to dismiss it because it's hard to control based on the specific research um in the 10 a1 clinical trials with 326 participants 86 percent 86 of them showed improvement in the tinnitus symptom severity after three months eighty percent of treatment compliant participants showed continued improvement one year later and eighty percent said that they would recommend the linear to others with tinnitus 65 said that they actually benefited from using the device so again here it seems like most people would recommend someone with tinnitus trying this and then most people reported some symptom improvement this is not a cure this is not going to eliminate most tinnitus however if it could reduce the if it could reduce the intensity of the symptom if it could reduce the tinnitus or at least how bad it affected your life then that might be something worth considering so in just a moment i'm going to get to these most common questions asked about when will it be available in the u.s where is it available now does insurance cover it does it work for hyperexcuses does it work for tinnitus does it work for synonymous without hearing loss i'm going to get to those in just a second i want to personally explain how i feel like this kind of device it has promise there's been a lot of research going into it it is the most promising type of tinnitus treatment i would say com i would say similar promise with the hair cell regeneration at this point but those kinds of drugs for hair cell regeneration those are way off like those are way out in the future you're not going to have them any time soon soon this device is currently available to some people in europe they're actually using it and reporting benefit so that has our interest in mind okay what i want to explain to you who's watching this who may have tinnitus and maybe considering the linear device is that this is something that will be used in my opinion this is something that will be used as a part of the therapy plan as a part of the treatment plan i don't think that the linear device will be used in isolation as the only tinnitus treatment i believe that sound therapy hearing aids when appropriate counseling working with a therapist also taking care of your health in a more holistic way that those should equally be valued in this process and those should not be forgotten thinking that this linear device is going to be the uh the end all solution to your tinnitus however that said this has a place in that treatment protocol this has the place to be complementary to the other kinds of treatments things that i recommend on this channel as we had just mentioned the psychological the relaxation techniques as well as the actual sound therapy through hearing aids or sound in your environment etc so now let's get to these common questions uh number one and this is all reported from the webinar that i just watched took notes so this is coming straight from the company itself through me number one when will it be available in the u.s um the linear device is currently in the fda approval process and they're hoping it'll be available sometime in 2021 personally i wouldn't be surprised if it's not available uh for 2021 and it gets extended i mean the fda right now with covid uh managing coronavirus working from home i'm sure that's complex but we're going to be monitoring that absolutely on this channel so make sure you're connected and subscribed to get the updates but i wouldn't be surprised if it isn't released in the us until 2022 but we'll see where is it available now where is the linear device for tinnitus available now it is available in select countries in europe i believe that's germany ireland austria and one other we're going to review that as well um but yeah it is available in europe if someone desperately wanted to try this they could in theory travel to europe travel to those countries to those clinics pay the money get the device and use it at home for a six week period and then figure out a way to return it or mon or continue to use it does insurance cover the linear device for tinnitus it may cover the right now it's too early that insurance doesn't cover it but there may be a time when insurance does cover this and it depends on the region depends on the country depends on the insurance you have but likely not at first another question asked in this webinar can the linear device be programmed remotely or is it in person only a recent audiogram a recent hearing test is needed to program the device then the adjustments can happen via telehealth i work in the telehealth space with tinnitus so i'm monitoring that closely but yes it makes sense that as long as someone has a recent hearing test i would recommend within the last six months potentially within the last year but within the last six months is best with that hearing test that audiogram the linear device can be programmed and then the adjustments could be made i don't think they adjust i don't think there's any adjustments to be made via telehealth but the follow-up the counseling the instruction the check-ins making sure it's going smooth making sure you're following the protocol that they recommend that can all happen via telehealth does the linear device work for hyperacusis the results suggest that it may work for hyperacusis as well in fact tinnitus hub did an internal study and they showed that those with hyperacusis and relatively good hearing so that's sound sensitivity and relatively good hearing that those patients had a high likelihood of success with the linear device not completely eliminating those symptoms in most cases but showing some improvements so that it would justify the cost which leads me to my next question how much does the linear device cost in europe right now it's about 2500 euros so in the u.s we can expect it to be around 3 000 to 3 500 u.s dollars and again insurance probably wouldn't cover that at first um another question here does the linear device improve unilateral tinnitus as well the results so far from the study from the researchers explaining it in this web class the results so far suggest that the linear device can be used for unilateral tinnitus as well you still use the tongue stimulation for the trigeminal nerve and you still wear the headphones for both ears but it can work for unilateral tinnitus as well so far that's what the results suggest now how about for tinnitus without hearing loss uh yes the linear can be used without a diagnosed hearing loss this is still worth trying the audiogram even has limitations so if you get a hearing test that shows it's in the normal range that doesn't mean there's that doesn't mean that your hearing hasn't changed since from earlier period in your life there's also something called hidden hearing loss where the small little cells in the cochlea are not transferring the sound to the auditory nerve and a classic hearing test doesn't always catch that so there are some changes to the structures of the hearing system that may be affected however a hearing test would show that your hearing's in the normal range so that's an important factor overall it's still early in the development we're still in the clinical trials but it is looking like this linear device is helping people and that many people who have tried it would recommend it more than 50 of people who tried it would recommend it to someone with tinnitus so something that i'm monitoring something that i think you may want to keep on in your back pocket make sure you're subscribed to my youtube channel here ben thompson aud speaking it's been a pleasure to host you uh explaining this linear tinnitus device and trying to answer the questions of will it apply to you and if so when my honest advice for you is it may be of benefit and we may be able to have that work for you and provide some relief but don't hold out as that that this is the all or nothing solution right try to take care of yourselves try to do everything you can for your overall health and wellness and sleep and manage anxiety manage stress right now because oftentimes that's the biggest opportunity we have to impact our lives right now with tinnitus that said these different technological solutions bimodal stimulation is going to be really popular in the next few years there's going to be a lot of devices coming out i know of three personally right now i know three different bimodal stimulation devices that are either in development or have already been released so those are something that i'm going to be monitoring closely hopefully we'll get to a stage where these different bimodal stimulation devices can have large-scale research studies that can compare them or that they each have individual studies that use similar metrics so that we can go through and pick the best kind of bimodal stimulation and friends with that that is my summary of the linear device so far i'm going to be updating this very closely whenever there's new research that comes out i'll be updating it i'm also going to use the linear device to compare it to the other bimodal stimulation devices and see how they all shake out in terms of improving your life with tinnitus so please stay subscribed to this youtube channel follow me if you have any questions you can comment on the video below thank you so much for watching this video check out these next videos to my side to learn more about tinnitus and different devices that can help you bye bye see you later

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