A clinical analysis finds the device delivers significant symptom improvement, including for those with severe cases
Relief from tinnitus may be more achievable than ever, thanks to new research showing more than 90% of users experienced a measurable benefit from a novel treatment device.
More than 7 million adults in the UK live with tinnitus, a condition that causes ringing, buzzing or clicking in the ears. For around one in 10, the symptoms can be severe enough to affect sleep, concentration and mental health. Despite the prevalence of tinnitus, effective treatment has long proved elusive for most.
Real-World Effectiveness of Lenire for Tinnitus Relief
Now a large-scale real-world study from the Alaska Hearing and Tinnitus Center, published in Nature Communications Medicine, offers evidence that the Lenire device can deliver meaningful relief. The retrospective analysis followed 220 patients between May 2023 and June 2024. After 12 weeks of treatment, 91.5% reported a clinically significant reduction in symptoms.
How Bimodal Neuromodulation Therapy Works
Lenire, a form of bimodal neuromodulation therapy, works by combining audio stimulation with gentle electrical pulses delivered to the tongue. The use of two methods of brain stimulation reportedly stops the brain from processing tinnitus sounds, providing relief for the sufferer. The device is used under the guidance of a trained audiologist, with two 30-minute sessions per day forming the standard protocol.
The study builds on previous clinical trials, notably the TENT-A3 study that underpinned Lenire’s approval for use in America in March 2023. That trial found 89% of participants would recommend the treatment. In the new real-world analysis, patients saw an average improvement of 27.8 points on the Tinnitus Handicap Inventory (THI), a widely used measure of severity.
Expert Perspectives and Considerations
Dr Emily E McMahan, an audiologist involved in the study, said: “The publication of these data underscores the effectiveness of Lenire when patients are supported by experienced clinicians. It’s an encouraging step forward in how we manage tinnitus.”
Safety outcomes were also positive, with no serious adverse events reported. The device is now in use across Europe and the United States.
Professor Hubert Lim, one of the scientists behind the development of Lenire, said the results point to a broader shift: “Obtaining real-world outcomes that surpass even those from our controlled clinical trials marks a significant advancement. It suggests that with clinician support, we can move towards more reliable, evidence-based therapies for tinnitus.”
Micaela Stonestreet, a Clinical Audiologist at Hearology®, which provides support and diagnostic services for people with tinnitus in the UK, commented, “There is a long history of products claiming to help with tinnitus, so we approach each new solution with a healthy degree of scepticism. When considering new treatments, it’s essential to examine the supporting evidence critically.
“Lenire has undergone testing both in controlled research settings and also in everyday clinical practice. The most robust evidence comes from the TENT-A3 trial, a formal clinical study designed in consultation with the U.S. Food and Drug Administration (FDA). The study adhered to strict protocols, monitored device usage, and ultimately formed the basis for Lenire’s FDA approval in 2023.
“By contrast, a more recent real-world study conducted at a single private clinic in Alaska assessed how Lenire performs in routine care. However, unlike a clinical trial, this study lacked a control group, relied on self-reporting from the participants, and did not verify device usage. It’s also important to note that both authors of this study had financial ties to the device manufacturer.
“Taken together, these studies indicate that Lenire could be a promising option for people with moderate or severe tinnitus. However, whilst early results are definitely encouraging, further independent research and long-term data will be crucial to fully establish the effectiveness of this new device and procedure in treating tinnitus.”
References:
- What is tinnitus? – NHS explanation of the symptoms, causes and common treatments for tinnitus, along with guidance on when to seek help.
- Lenire – Official site of the makers of the device, including explanatory videos.
- Tinnitus Handicap Inventory – a useful overview of this standard tool for measuring how much tinnitus affects a person’s daily life.
- Harvard Health – exploring the latest thinking on tinnitus and its treatment.
