Lenire Tinnitus Treatment

UPDATE: OCTOBER 2023

Silicon Valley is proud to announce that we are the first Lenire Tinnitus Treatment provider in Santa Clara County.

Tinnitus is a symptom that causes ringing, buzzing, hissing or other noises perceived in the ears or the head. According to the American Tinnitus Association an estimated 25 million American adults experience tinnitus and an estimated 1.9 million U.S. veterans who receive compensation for tinnitus. Simply put, tinnitus is a perception of sound when there is actually no noise present in the immediate environment. While many people eventually habituate to this non-threatening sound, for some, it becomes a chronic problem, and they seek medical attention to obtain relief. Sadly, tinnitus distress contributes to difficulties with sleep, concentration, anxiety, and/or depression. To date, there is no known cure for tinnitus, however, there are several treatment options that can provide relief and help you better manage the symptoms associate with it.

One of the most recent tinnitus treatments that has received De Novo Classification from the FDA is a device known as Lenire. Based in Europe, Neuromod Devices Ltd developed Lenire which has recently completed a series of clinical trials in Ireland and Germany, involving over 500 patients. Lenire is a non-invasive medica device that uses bimodal neuromodulation, stimulating both the auditory and trigeminal nerves to help provide tinnitus symptom relief.

How does Lenire® Work?

The Lenire uses wireless, Bluetooth headphones that stream sound therapy delivered through your ears and a tongue-tip stimulator (using 32 electrodes) that delivers gentle electrical stimulation to your tongue simultaneously, via use of the Lenire controller. The premise behind Lenire is that by stimulating the trigeminal and auditory nerves simultaneously, the tinnitus pathways within the brain can be altered or reduced over a period of time.

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.

Readers should be aware 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. The first step is to have a comprehensive tinnitus evaluation by an audiologist who specializes in tinnitus.

When will Lenire be available in the U.S.?

Lenire just received De Novo classification from the FDA and will roll out in the U.S. beginning in early April 2023. The research papers on Lenire can be found on the Lenire website. At Silicon Valley Hearing, Inc, we specialize in providing the latest treatment options for tinnitus patients. We are looking forward to having an opportunity to work with Lenire in the very new future. Neuromod Devices Ltd selected a small group of clinics for the introduction and expansion of Lenire into the U.S. market. We anticipate being able to offer Lenire to tinnitus patients within the next 6-12 months.