Lenire Device for Tinnitus

This trial aims to determine if the Lenire Device can help people with tinnitus (ringing in the ears) through bimodal stimulation, which combines sound and gentle electrical pulses. Researchers will measure changes in brain activity to assess the device's impact after six weeks of use. Participants will either use the device daily or join a control group that does not use it. Ideal candidates have experienced non-pulsing tinnitus for over three months but less than 20 years and can hear the device's sounds. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could lead to new treatments for tinnitus.

If you've started, stopped, or changed the dosage of certain medications like antidepressants, anticonvulsants, neuroleptics, or opioid painkillers in the last 3 months, you might not be eligible for the trial. Also, if you use benzodiazepines or sedative hypnotics, you cannot participate.

Research has shown that the Lenire device, which combines sound with gentle tongue stimulation, is safe for people with tinnitus. Studies have found no serious side effects related to the device. This strong safety record contributed to its FDA approval for treating tinnitus. More than 500 people have used the device in large trials, experiencing benefits with minimal risk. Overall, these results suggest the treatment is well-tolerated.¹²³⁴⁵

Researchers are excited about the Lenire device for tinnitus because it offers a novel approach called bimodal stimulation, which combines sound with mild electrical pulses to the tongue. Unlike traditional treatments like sound therapy alone or medication, this dual-action method aims to retrain the brain’s response to tinnitus more effectively. This innovative delivery method has the potential to provide relief in a non-invasive and drug-free way, making it a promising option for those who haven't found success with existing treatments.

Research has shown that the Lenire device, which uses a special type of stimulation, significantly reduces tinnitus symptoms. In this trial, participants in the treatment group will use the Lenire device for 1 hour daily. After six weeks of treatment, 78% of users in previous studies reported a noticeable decrease in their tinnitus. This improvement increased to 91.5% after 12 weeks of use. Another study found that 80.1% of participants who continued the treatment experienced ongoing improvement even a year later. These findings suggest that the Lenire device effectively reduces the ringing or buzzing in the ears for many people.¹²⁶⁷⁸