Lenire
FDA approved Tinnitus Treatment Device
We’ve partnered with Neuromod Devices Ltd to bring you this amazing, new, clinically proven tinnitus treatment device. Our clinic was one of first 15 healthcare providers trained and qualified in the United States to offer this new revolutionary tinnitus treatment device. We were the first and only clinic in Colorado to provide this new tinnitus treatment. Lenire® is one of the newest tinnitus treatments that has received De Novo Classification from the FDA.
Lenire is a non-invasive, evidence-based treatment device proven to soothe tinnitus. Lenire® is a medical device that uses bimodal neuromodulation to drive long-term relief from tinnitus. The treatment is designed to use it from the comfort of your home to manage your tinnitus with the help of our qualified Doctor of Audiology.
Our Audiologist, Dr. Patty Kalmbach, Au.D. traveled to Dublin, Ireland to be trained in providing this new tinnitus treatment device. We now have three Doctors of Audiology (Dr. Kalmbach, Dr. Grabowski and Dr. Jenkins) who are all trained in providing tinnitus treatment using Lenire. Your Doctor will evaluate your tinnitus and determine if Lenire is right for you. If Lenire is recommended, your Doctor will prescribe a treatment plan that typically includes two daily 30-minute sessions over a 12 week period. We will continue to provide both telehealth and in office visits throughout treatment. During these follow up visits, your Doctor may adjust device settings or treatment protocols to optimize the potential for relief.
How does it work?
The Lenire uses wireless, Bluetooth headphones that stream soothing sound therapy delivered through your ears and a tongue-tip stimulator (using 32 electrodes) that delivers mild gentle electrical stimulation to your tongue simultaneously, via use of the Lenire controller. The premise behind Lenire is that by stimulating the trigeminal nerve (in your tongue) and auditory nerves (in your ear) simultaneously, the tinnitus pathways within the brain can be altered or reduced over a period of time. Bimodal neuromodulation induces positive changes (Neuroplasticity) in the brain to ease the bothersome symptoms of tinnitus. The sounds and pulses work together to retrain your brain. You pay less attention to your tinnitus reducing its impact on your day-to-day life.
Clinical Trials and Success Rates
Based on the TENT-A2 clinical trial involving 191 patients, 95% of compliant TENT-A2 participants reported a clinically significant improvement their tinnitus symptom severity after 12 weeks of treatment. When evaluated at 12-months post-treatment, 91% of compliant TENT-A2 participants reported continued improvement in their tinnitus symptom severity. To date, there have been three clinical trials completed, involving more than 500 participants, and the research has demonstrated that the Lenire device has clinically shown a reduction in the symptoms of tinnitus. The research papers on Lenire can be found on the Lenire website.
Clinical Trial Takeaways
- 83% of 500+ participants across three successful clinical trials would recommend Lenire for the treatment of tinnitus.
- 71% of those with moderate or worse tinnitus had a meaningful reduction in tinnitus severity with Lenire after 6-weeks when 6-weeks of audio-only therapy had minimal impact.
- Zero serious adverse side effects related to Lenire were reported, validating the safety of the device.
- 204 real world patient results closely match clinical trial data.
- One bimodal neuromodulation tinnitus treatment device granted approval by the FDA following a controlled clinical trial – Lenire.
Lenire: Extensively Clinically Trialed
Lenire has the largest body of evidence for any tinnitus treatment device, having been subject to three large scale clinical trials involving more than 600 tinnitus patients. Lenire’s clinical trials – TENT-A1, TENT-A2, and TENT-A3 have been published in prestigious scientific journals such as Nature, and Science – Translational Medicine. Takeaways include:
- TENT-A1 (2020) was one of the largest and longest followed up tinnitus device trials. 86.2% had an improvement in their tinnitus after 12-weeks, 80.1% had an improvement that sustained for at least 12-months after treatment ended.1,2,5
- TENT-A2 (2022), optimised treatment with Lenire and showed better results. 95% reported an improvement after 12 weeks of treatment.1,3,5 91% reported that their improvement sustained for at least 12-months.1,3,5
- TENT-A3 (2024), was a controlled clinical trial that compared Lenire to sound-alone. Lenire was found to be more effective at treating tinnitus than sound-alone for patients with moderate or worse tinnitus. As well as this, the majority who benefited from sound-alone gained additional benefit from Lenire.1,4,5
- 83% of 500+ all trial participants would recommend Lenire to treat tinnitus.
How can I get started?
Our Audiologists are trained in the treatment of tinnitus. It should be noted that tinnitus is a complex condition and no one same treatment method works consistently for all patients. Different treatments may work better for different individuals based on their medical history, hearing profile, severity of their tinnitus symptoms and tinnitus impact on their emotional and mental well-being. We offer various treatments for tinnitus which are based on your tinnitus profile.
The first step is to fill out the form below or give our office a call at 303-534-0163 and talk with Rebecca our Office Manager, to schedule a complete hearing evaluation and tinnitus assessment to determine if Lenire is right for you.
