Lenire Tinnitus Review | New Tinnitus Treatment 2023 By Neuromod

**Update: As of March 7th, 2023, Lenire has been granted FDA approval and can now be used by tinnitus patients in the United States.

One of the most interesting developments in tinnitus research over the past few years is something called bimodal neural stimulation, which involves two modes of simultaneous stimulation of our nervous system. There’s a company based out of Ireland called Neuromod that has recently released a device called Lenire, which uses bimodal neural stimulation through the tongue and the ears. Thus, this device works to stimulate the trigeminal nerve by putting something on the tip of the tongue and simultaneously stimulates the auditory system with sound therapy via headphones.

This article will offer a deep dive into Lenire, discussing how much it costs, its effectiveness as a mode of treatment, and the research around bimodal neural stimulation.

Lenire General Overview

Neuromod’s Lenire features headphones that you wear over your ears and a device that you put onto your tongue. Both connections are routed through a handheld device that looks similar to an old-school iPod. The sounds delivered to the ears are variable, and include some high-pitched tones, while the stimulation delivered to the tongue is very light (similar to candy that crackles when put on the tongue). 

Lenire’s website advertises the device as a breakthrough evidence-based tinnitus treatment that harnesses the science of neuromodulation. The device can be used in the comfort of one’s own home to help treat and manage one’s tinnitus. It consists of three main components. First, is the controller, which can change the volume of the noise delivered to the ears as well as change the stimulus charge delivered to the tongue. The controller can also start, pause, and resume treatment at any time.

source: lenire.com

Lenire is recommended to be used for 30 to 60 minutes per day over a minimum of 12 weeks. It is recommended that each daily session is completed in a quiet and comfortable location, as relaxation helps support the effectiveness of the treatment. The device is intended for prescription use only, and thus is configured and calibrated during an initial fitting with a healthcare professional.

Lenire recommends a specific timeline where after the initial six week period of usage, a review assessment is conducted with an audiologist or other healthcare professional. The device is then used for another six weeks, after which progress is reviewed. This first 12 week period may then be followed by continued use, depending on perceived benefit and effectiveness. The device is designed to be used for one hour per day, and a typical protocol might involve 30 minutes in the morning and 30 minutes in the evening, or merely using the device whatever hour there’s time in the day.

At the moment, Lenire is only available in Ireland and other western European clinics in Austria, Belgium, and Germany. Lenire is not currently available in the United States, as it is still in the process of seeking FDA approval.

2022 German Hearing Center Study On Lenire

In March 2022, the German Hearing Center at Hanover Medical School conducted a study on 20 patients who were administered treatment via Lenire, finding that 85% of patients experienced a reduction in their tinnitus handicap inventory (THI) score. However, the important part to note is that only 50% of individuals had a clinically significant change in their THI score. The THI is an industry-standard questionnaire used to measure the effectiveness of tinnitus intervention. While 85% of patients may have experienced a reduction in their THI score, these reductions could have been as small as 1 or 2 points, whereas a clinically significant reduction is considered to be 7 points or more. Thus, the important metric to focus on is the 50% of patients who reported clinically significant reductions. Among the patients who participated, the mean duration of tinnitus was 9 years.

These results are consistent with what’s been reported by patients and audiologists in the community. Nonetheless, it’s important to appropriately adjust one’s expectations about how Lenire might be used in clinical settings and how effective it can be. Ultimately, Lenire is another alternative therapy that can be supplemented to a foundational tinnitus therapy regime and support long-term tinnitus habituation.

Most Common Questions About Lenire For Tinnitus

At the moment, Lenire appears to be one of the most promising types of tinnitus treatment. It promises results similar to those of hair cell regeneration at this point, although the widespread use of the latter treatment is still far off. 

Lenire will likely be deployed as part of a larger therapy or treatment plan. Lenire won’t likely be a be-all-end-all solution to tinnitus, and instead will probably occupy an important place in a treatment protocol that might include sound therapy, hearing aids, counseling, therapy, and holistic lifestyle changes. All of these methods—including Lenire—have the potential to complement one another in treatment.

Below are some common questions pertaining to Lenire:

1. When will Lenire be available in the US?

Lenire is currently in the FDA approval process.

2. Where is Lenire currently available?

Lenire is available in select countries in western Europe, including Germany, Ireland, Austria, Belgium, and most recently Denmark. If a patient desperately wanted to use Lenire as part of their treatment, they would thus have to travel to a participating clinic in Europe.

3. Does insurance cover Lenire for tinnitus?

At the moment, no. However, there may be a time when insurance does cover Lenire, depending on the patient’s country and type of insurance.

4. Can Lenire be programmed remotely, or can it only be used in person?

A recent audiogram (hearing test) is needed to initially program the device, with subsequent adjustments available via telehealth. Thus, any follow-up, counseling, instruction, or check-ins can be administered via telehealth.

5. Does Lenire work for hyperacusis?

While patients that suffer from both hyperacusis and tinnitus can use Lenire, (and have had success in the past), Lenire focuses on treating tinnitus and is not a treatment for hyperacusis.

6. How much does Lenire cost?

There is currently no set price as this is still in the trial phases, but the purchase of the Lenire treatment will include appointments with a qualified healthcare professional.

7. Does Lenire improve unilateral tinnitus?

Results so far suggest that Lenire is effective in treating unilateral tinnitus as well.

8. Does Lenire improve tinnitus in cases where one hasn’t suffered hearing loss?

Lenire can still be used without a diagnosed hearing loss. Even if your hearing test results are in normal range, you aren’t precluded from possible changes in hearing compared to earlier in life. Hidden hearing loss occurs when cells in the cochlea stop transferring sound to the auditory nerve, and classic hearing tests don’t always capture these changes. 

All in all, while Lenire is still in development, it appears to be helping patients with tinnitus. More than 50% of patients who tried the device would recommend it to someone with tinnitus. Nonetheless, it is not useful to hold out for an all-or-nothing solution. As Lenire continues to be rolled out—along with a swath of other bimodal stimulation devices—we can continue to practice good health and wellness and manage anxiety and stress, as oftentimes these offer the biggest opportunities to treat tinnitus while we wait for different technological solutions to become more widespread.