Tinnitus is a symptom that causes ringing, buzzing, or other noises perceived in the ears or head. While there is no known cure for tinnitus, there are several treatment options that can provide relief and help manage the symptoms associated with it. In this post, we will review the Lenire Tinnitus Treatment product.
One of the newest tinnitus treatments that has received De Novo Classification from the FDA is a device called Lenire®. The Lenire is designed to deliver electrical stimulation to the tongue and to the ear simultaneously. The device was developed by a company called Neuromod Devices, and it has been approved and used in Europe.
How Is Lenire® Supposed to Help Tinnitus?
The Lenire® device incorporates bimodal stimulation to treat tinnitus, as it stimulates the auditory system with headphones and the somatosensory pathways with electrical stimulation via a tongue stimulator.
The headphones play a series of tones that are customized by a trained provider to the individual’s specific tinnitus frequency. At the same time, 32 electrodes on the tongue deliver a mild electrical pulse that is designed to stimulate the trigeminal nerve.
The theory behind the Lenire® device is that by stimulating the trigeminal and auditory nerves simultaneously, the tinnitus pathways in the brain can be altered resulting in reduced tinnitus.
Neuromod’s Clinical Studies
In Neuromod’s latest study, participants with clinically significant tinnitus used the Lenire® device daily for 12 weeks. Out of 191 subjects, 95 percent reported improvement in symptom severity. Furthermore, 91 percent of participants in this latest study reported sustained benefit at 12 months post-treatment.
Why is the jury still out on the Lenire® device for tinnitus treatment?
Although bimodal stimulation for tinnitus treatment using two different modes of sensory stimulation has several studies to support it, the research conducted by Neuromod for their bimodal device, Lenire®, does have the following limitations:
- Lack of animal studies to defend that the tongue stimulators are effective at changing neural activity along the auditory pathway
- Lack of a placebo group
- Lack of an objective measurement of benefit other than surveys completed by patients.
Lack of animal studies
There have been animal studies to show that tongue stimulation can have drastic effects on the neural activity in the central nervous system; however, Neuromod did not test their 32 tongue-stimulating electrodes in an animal study of themselves before using it in human clinical trials. In contrast, Dr. Susan Shore, a researcher at the University of Michigan, has extensively studied animal models for bimodal stimulation related to tinnitus. Her research shows that bimodal stimulation using electrodes on the face and/or neck and a precisely timed auditory stimulus reduces the neural activity of damaged nerve cells. Her device, the Michigan Tinnitus Device, is currently being evaluated in a clinical trial.
No placebo group
Neuromod did not incorporate a placebo group in their studies. This presents itself with limitations because all patients with tinnitus want to experience benefits, which makes it difficult to rule out the placebo effect. It is known that some patients will report natural improvements in their symptoms when they have hope that something new might help them. Without a placebo group to identify how many patients would experience this as compared to the study group, it is impossible to identify whether a placebo effect exists or not with the Lenire® studies.
In contrast, Dr. Shore’s work with the Michigan Tinnitus Device does incorporate a placebo version of the treatment to reduce the probability of the placebo effect.
Lack of objective measurement
Surveys completed by patients are not always reliable outcome measures. The studies on Lenire® used reductions in the scores on the Tinnitus Handicap Inventory and the Tinnitus Functional Index as evidence of treatment efficacy. In my opinion, these surveys can produce overly positive results. This is because a reduction of 14 points on the TFI, for instance, has been recommended as the minimum number to indicate patients demonstrating a true change in their tinnitus. Neuromod used this number as their gauge of success. My 20 years of experience is that patients will not admit to a meaningful reduction in their tinnitus severity with such a small change in this score. A more realistic number would be closer to a 40-point reduction on the TFI for patients to report significant benefit from any type of tinnitus treatment.
Lastly, my biggest concern regarding Lenire® is that they do not address the permanent damage to the auditory pathways that are likely responsible for the neuronal hyperactivity of tinnitus in most cases. For someone with normal hearing and no underlying damage to the auditory system, the science behind bimodal stimulation makes total sense. However, if there is damage or changes to the auditory pathways and that is untreated, the Lenire® may temporarily reset the nerve cells back to normal activity, but the underlying missing input to the brain is likely to cause relapse.
It is my opinion from decades of working with tinnitus patients that we cannot ignore untreated hearing loss as it relates to tinnitus or overall brain health in general. This critical component is not addressed by Lenire® or mentioned by Neuromod as a contributing factor to the potential benefit or lack thereof with their approach. Without first-hand knowledge of how the Lenire® works and is received by patients, I will not recommend this device for tinnitus treatment.
It is also important to note that tinnitus is complex, and different treatments may work better for different individuals based on their medical case history, audiologic profile, and severity of symptoms.
The first step is to have a comprehensive tinnitus evaluation by an audiologist specializing in tinnitus to determine appropriate candidacy options.