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Science of Lenire

Lenire is a dual mode stimulation device that is proven to soothe tinnitus.

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Science of Lenire

Lenire Clinical Trial Takeaways

Safety and Effectiveness Trialed with 600+ People 4

Landmark Results

91% of those who used Lenire as advised had sustained relief from tinnitus for at least 12-months after treatment. 2

Lenire Outperforms Sound [3]
Lenire vs Sound-Only

Lenire was shown to be more effective than sound alone for those with moderate or worse tinnitus in its third clinical trial. 3

Lenire is Highly Recommended
Highly Recommended

83% of clinical trial participants would recommend Lenire to treat tinnitus. 4

How Lenire Soothes Tinnitus

Lenire pairs tongue and sound stimulation to help you pay less attention to tinnitus. This is a type of dual mode stimulation we call bimodal neuromodulation.


TENT-A2 Results: Sustained Relief for 91% of Patients 2

91% of patients in Lenire’s 2nd large trial averaged a 20.3 point reduction (THI) in tinnitus that lasted for at least a year after the trial. 2

Reducing tinnitus from 51.2 (moderate) to 30.9 (mild) on average, for example, is a huge quality of life improvement.

What is Tinnitus Handicap Inventory (THI)?

Tinnitus Handicap Inventory is a clinical standard for measuring tinnitus. Measured on a scale of 1 – 100, higher scores means worse tinnitus. Decreasing THI leads to an improved quality of life for tinnitus patients.

Understand the Science Behind Lenire

  • What is neuromodulation?

    Neuromodulation is a therapeutic treatment which can be used for a wide variety of conditions including pain and depression. It works by alternating nerve activity by delivering a stimulus (such as low levels of electric energy) which then alters or adjusts the activity within the body or the brain to improve the specific health condition. Most recently, neuromodulation has emerged as a potential and promising treatment for the management of tinnitus.

  • What is bimodal neuromodulation?

    Bimodal neuromodulation is the stimulation of not one but two nerves at the same time. With Lenire, for example, you have the combination of electrical stimulation via the tongue as well as auditory stimulation via the ear. Research has suggested that the combined stimulation of these two nerves drives stronger adaptive neuroplasticity, which in turn can reduce the brain’s attention and sensitivity to the tinnitus sound to a greater extent than when stimulating only a single nerve at a time.

  • What is the advantage of bimodal neuromodulation?

    Various research and clinical studies have shown that the combined stimulation of auditory (via the ear) and somatosensory nerves (via the tongue, for example), such as achieved using the non-invasive Lenire device, is more effective when it comes to inducing the positive neuroplasticity important to ease the tinnitus symptoms than stimulating one input at a time. This serves to counter the unhelpful neuroplasticity that gives rise to tinnitus in the first place.

  • How effective is Lenire?

    Lenire has been proven as a safe and effective tinnitus treatment in clinical trials with more than 600 participants.

    • TENT-A1 (Trial 1): This study showed that 86.2% of treatment compliant participants reported an improvement in their THI score after 12 weeks of treatment. 80.1% reporting improvement that sustained for 12 months after treatment.
    • TENT-A2 (Trial 2): 91%of compliant patients had sustained relief from tinnitus that lasted 12-months. The average reduction in tinnitus was 20.3 THI points, equal to a full THI grade.
    • TENT-A3 (Trial 3): Lenire has been proven to be more effective than sound-alone for the majority of people with moderate or worse tinnitus.
    • All Trials: Across all clinical trials, 83% would recommend Lenire to treat tinnitus.

    Lenire also conducted real world trials with more than 200 people. The results of Lenire’s real world trials closely matched clinical trial results.

  • Is Lenire better suited for certain types of tinnitus?

    Lenire is recommended for patients with subjective tinnitus (where the sound or ringing sensation is only audible to the person experiencing it, regardless of the type of sound they are hearing).

  • What grade is my tinnitus?

    Tinnitus is measured on a scale of 1 – 100 on the Tinnitus Handicap Inventory. The higher your THI score, the more impactful tinnitus is on your life. These are classed in the following categories.

    • 00 – 16: Grade 1 (Slight)
    • 18 – 36: Grade 2 (Mild)
    • 38 – 56: Grade 3 (Moderate)
    • 58 – 76: Grade 4 (Severe)
    • 78 – 100: Grade 5 (Catastrophic)

    Lenire’s second clinical trial demonstrated that our dual mode approach could reduce tinnitus impact by a full grade. For example, reducing tinnitus from Severe to Moderate.

Lenire Scientific Advisory Board

Scientific Advisory Board

Lenire collaborates with opinion-leading scientists and clinicians to conduct large exploratory trials at internationally recognised sites.

Webinar: How Lenire Soothes Tinnitus 2

Experts from the team behind Lenire discussed the exceptional results of Lenire’s TENT-A2 clinical trial. Watch to see how Lenire was proven safe and effective in a second large scale clinical trial.

Published Papers

TENT-A1 Research Paper:

Bimodal neuromodulation combining sound and tongue stimulation reduces tinnitus symptoms in a large randomized clinical study (2020)

Published on: 07/10/2020 Corresponding author: Hubert Lim Download.pdf (1.68 MB)

TENT-A1 Supplementary Materials:

Supplementary Materials for Bimodal neuromodulation combining sound and tongue stimulation reduces tinnitus symptoms in a large randomized clinical study

Published on: 07/10/2020 Corresponding author: Hubert Lim Download.pdf (3.06 MB)
tinnitus-paper-cover

TENT-A2 Protocol Paper:

Noninvasive Bimodal Neuromodulation for the Treatment of Tinnitus: Protocol for a Second Large-Scale Double-Blind Randomized Clinical Trial to Optimize Stimulation Parameters

Published on: 01/09/2019 Corresponding author: Hubert Lim Download.pdf (556.43 KB)
TENT-A2 Cover Page

TENT-A2 Research Paper:

Different bimodal neuromodulation settings reduce tinnitus symptoms in a large randomized trial

Published on: 30/06/2022 Corresponding author: Hubert Lim Download.pdf (3.97 MB)
safety and feasibility research cover

TAVSS Research Paper:

An Investigation of Feasibility and Safety of Bi-Modal Stimulation for the Treatment of Tinnitus: An Open-Label Pilot Study

Published on: 04/02/2016 Corresponding author: Caroline Hamilton Download.pdf (117.62 KB)

Retrospective Analysis of Real-World Patients:

Real-world clinical experience with bimodal neuromodulation for the
treatment of tinnitus.

Published on: 02/02/2022 Corresponding author: Drs. Thomas Lenarz, Anke Lesinski-Schiedat, and Andreas Buechner Download.pdf (310.03 KB)

Find a Clinic Near You

Lenire has expert Partner Clinics across America, Europe, and the United Kingdom. Use the Lenire Clinic Map to start your Lenire treatment.

Find a Clinic

1. TENT-A1 Conlon et al., Sci. Transl. Med. 12, eabb2830 (2020)
2. TENT-A2: Conlon et al., Different bimodal neuromodulation settings reduce tinnitus symptoms in a large randomized trial, Sci Rep.
3. TENT-A3: Clinical trial data in preparation for independent publication: clinicaltrials.gov/ct2/show/NCT05227365.
4. Aggregate: TENT-A1, TENT-A2, TENT-A3 aggregate clinical trial results.
Note 1: All statistics based on compliant patients. Patient compliance criteria is detailed in Lenire’s clinical trial design.
Note 2: TENT-A1/TENT-A2 were not considered by the United States of America FDA as part of Lenire’s FDA Grant and, as such, applies solely to outside the US.