Tinnitus Lenire The First Non-Invasive Bimodal Neuromodulation Tinnitus Treatment Device
Tinnitus Lenire. Contrary to other forms of treatment for tinnitus such as hearing aids, sound maskers and retraining therapy, Lenire offers noninvasive bimodal neuromodulation with both sound and electrical stimulation to stimulate both parts of the brain simultaneously – the first such non-invasive bimodal device ever approved by FDA de novo for treating tinnitus.
Lenire’s FDA clinical trial resulted in 8 out of 10 compliant participants experiencing a decrease in their Tinnitus Handicap Inventory score, as well as saying they would recommend it to others.
What is Lenire?
Lenire is an innovative non-invasive tinnitus treatment device which utilizes an innovative bimodal neuromodulation approach. Available at select clinics after having successfully soothed and relieved tinnitus during two large scale clinical trials, this groundbreaking therapy device developed by Ireland-based neuromodulation manufacturer Neuromod Devices provides both acoustic stimulation via headphones along with electrical pulses targeted towards the tongue for treatment of tinnitus.
Lenire Tinnitus Relief Treatment has been independently clinically evaluated and has shown significant results with over 85% of compliant patients experiencing significant improvements to their severity scores after 12 weeks of using Lenire. This was measured with industry standard evaluation tools such as Tinnitus Handicap Inventory (THI) scores and Tinnitus Functional Index (TFI), both widely used to assess effectiveness in managing tinnitus symptoms.
Traditional treatments for tinnitus – hearing aids, sound masking and retraining therapy – have focused on one or two components alone; however, this approach often has limited success rate with patients and may not work for all forms of tinnitus. Therefore, it is wise to seek an evaluation by an audiologist or healthcare provider specializing in this condition for an in-depth evaluation.
At times, the best solutions to managing tinnitus may include multiple approaches – general wellness practices, counseling sessions, cognitive behavioral therapy sessions and lifestyle modifications can be combined for maximum efficacy in alleviating its intensity and perceived volume. These solutions may also reduce stress and anxiety levels which often leads to decreased levels of tinnitus intensity or perceived volume.
Other effective tinnitus treatments include acoustic noise generators, maskers and behavioral strategies. If these approaches fail to bring relief then more invasive procedures like deep brain stimulation or spinal cord stimulation should be explored further.
Lenire may provide those in search of more advanced solutions with an effective tinnitus treatment option. Available by prescription only in the US from an audiologist or qualified health care professional, this device combines acoustic stimulation of ears with electrical tongue stimulation in order to retrain your brain so as to lower attention and sensitivity levels associated with your tinnitus – known as bimodal neuromodulation and shown to be successful through Tent-A2 clinical trial published in 2020.
How does Lenire work?
Lenire is the world’s first noninvasive bimodal neuromodulation tinnitus treatment device to demonstrate soothing and relieving effectiveness during clinical trials, and has received CE marking for treatment by appropriately qualified healthcare providers in Europe as well as De Novo approval by US FDA.
Therapy using sound and gentle electrical pulses to stimulate the trigeminal and auditory nerves in your brain will produce positive changes that alter tinnitus signal pathways and lessen symptoms.
Lenire treatments involve wearing wireless Bluetooth headphones equipped with custom sounds designed to activate the auditory nerve. At the same time, a small device that resembles an old iPod will be placed on your tongue containing 32 electrodes to safely deliver electrical pulses to your trigeminal nerve – all controlled using a handheld controller used by patients to start and stop sessions.
It has been demonstrated that this device rewires neural activity in patients, leading them to report decreased or eliminated tinnitus symptoms. These results are in line with studies using neuromodulation therapies like transcranial magnetic stimulation to treat tinnitus – using powerful magnets to stimulate cells within the brain.
Though results of this new technology appear encouraging, it should be remembered that further studies will shed more light on its effectiveness at relieving tinnitus symptoms as compared with traditional therapies such as masking.
Lenire has proven its worth as an effective treatment for relieving tinnitus symptoms while simultaneously improving concentration and sleep. A study reported that 90% of sufferers reported an improvement in their ability to focus and concentrate while using Lenire devices – something scientists attribute to neuroplasticity effects in the brain.
Peter Byrom is proud to be an authorized Lenire partner, offering this revolutionary non-invasive at-home medical device for treating tinnitus. To see if Lenire could benefit you, get in touch and book an initial assessment session with our specialist tinnitus team today.
Can Lenire help me?
Lenire is a non-invasive, at-home tinnitus treatment device developed by Irish medical technology company Neuromod and uses sound and tongue stimulation to retrain the brain to reduce tinnitus symptoms. Three large clinical trials have confirmed its efficacy.
De Novo approval by the FDA has granted this device European availability. It consists of an intra-oral device which sits comfortably in your mouth and features tiny electrodes on its tip which deliver mild yet safe energy pulses to activate auditory nerves. Customised sounds played via wireless headphones also work alongside tongue stimulation to retrain brain pathways and relieve tinnitus symptoms.
Bimodal approach has been shown to produce greater reductions in tinnitus severity than sound therapy alone. The TENT-A3 trial, designed to meet FDA De Novo requirements and running from March to October 2022 at three independent sites, reported 70.5 percent of patients experienced clinically significant decreases in their tinnitus severity with Lenire. Results of this groundbreaking trial were recently published by Science Translational Medicine as leading peer-reviewed academic journal.
Chronic subjective tinnitus sufferers will find this development immensely encouraging. Tinnitus symptoms are difficult to define precisely; often described as an audible buzz or ringing sound in the ears that distracts and impairs quality of life. With its potential to significantly enhance quality of life for these patients, this new therapy could play an invaluable role in their care.
At Lenire, the first step to discovering whether or not you qualify as a candidate for our treatment services is scheduling an initial assessment at one of our partner clinics. This assessment will include an audiological and tinnitus examination as well as recommendations for an optimal treatment plan with Lenire.
Once approved for Lenire use, an audiologist will create and tailor an individual treatment plan specifically to you. A typical daily schedule may involve using Lenire for one hour prior to bedtime but this can be tailored according to individual needs.
How much does Lenire cost?
Neuromod Devices Ltd of Ireland have designed Lenire as an innovative new tinnitus treatment device using neuromodulation technology. Bimodal neuromodulation – stimulating two pathways simultaneously with sound through headphones and electric stimulation of the trigeminal nerve on the tongue to drive long-term changes to brain pathways to treat tinnitus – offers an exciting treatment option to millions worldwide suffering from this condition that significantly impairs quality of life.
Lenire recently completed a clinical trial which demonstrated that 95 percent of participants reported improved tinnitus symptoms and that these improvements had sustained over time. The results were published earlier this month in Science Translational Medicine, an established and peer-reviewed academic journal. Although these results are encouraging, it should be remembered that every person’s case can vary and different treatments work better for certain individuals – so for optimal results when considering Lenire therapy it would be prudent to have an in-depth evaluation by an audiologist specializing in tinnitus before making up your mind on whether to use Lenire or not.
Once a tinnitus assessment has been conducted, patients will be provided with a treatment plan including Lenire as well as cognitive-behavioral therapy and tinnitus retraining therapies – which both serve to alleviate their condition while simultaneously managing anxiety and stress, which often exacerbate it further.
The Lenire device is an intra-oral appliance designed to fit comfortably within the mouth. It contains a small electrode which delivers safe, gentle, and comfortable electrical stimulation directly onto the surface of the tongue while customized sounds from wireless headphones activate auditory nerves in the brain – proven effective against tinnitus symptoms in three large clinical trials.
Your healthcare provider will create a treatment plan tailored specifically to your tinnitus symptoms, and provide you with a controller containing custom sounds and tongue stimulators specifically configured for you. They will also instruct you in administering it at home while monitoring progress.
At The Tinnitus Clinic, our audiologist will assess your tinnitus to see if Lenire therapy may be suitable. If it is, we’ll arrange an appointment and guide you through integrating this innovative treatment into daily life.
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