TENT-A3: Controlled Pivotal Clinical Trial: Combining Sound and Tongue Stimulation for the Treatment of Tinnitus

Background

Tinnitus is a phantom sound caused by abnormal brain activity in the auditory networks. For millions of people worldwide, it represents a serious and often disabling condition. Although there is no unequivocal cure, recent findings show that bimodal neuromodulation - the simultaneous stimulation of auditory and somatosensory pathways - can affect brain plasticity and reduce tinnitus symptoms.

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Following previous successful studies (TENT-A1 and TENT-A2), TENT-A3 was established as a pivotal, controlled clinical trial to confirm the efficacy and safety of this approach and obtain approval from the U.S. FDA.

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Research goal

The purpose of the TENT-A3 study was to demonstrate that adding tongue stimulation to sound therapy leads to additional, clinically significant improvements in tinnitus symptoms. The study was conducted in collaboration between BRAI3N (Belgium), the German Hearing Center Hannover (Germany) and St. James's Hospital (Ireland).

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Research design

Number of participants: 112 patients with chronic tinnitus

Studiedesign: multicenter, single-arm, gecontroleerde studie

Treatment duration: 12 weeks

Phase 1 (6 weeks): sound stimulation only

Phase 2 (6 weeks): combination of sound + tongue stimulation via the Lenire® device

Primary outcome measure: improvement of at least 7 points on the Tinnitus Handicap Inventory (THI)

Secondary measure: improvement of at least 13 points on the Tinnitus Functional Index (TFI)

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Results

Clinical effect:
In the group with moderate to severe tinnitus (THI ≥ 38), response was significantly greater with bimodal stimulation (58.6%) than with sound therapy alone (43.2%; p = 0.022). Similar results were found with the TFI (45.5% vs. 29.6%; p = 0.010).

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High ease of use:
88.6% of participants would recommend the treatment to others. 62.9% reported subjective improvement in their tinnitus.

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Safety:
No serious side effects were observed. Most reported symptoms were mild and temporary (such as slight increase in tinnitus or tingling on the tongue).

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Compliance:
Participants used the device for an average of 52 minutes per day with a high compliance rate of over 80%.

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Conclusion

The TENT-A3 study confirms that bimodal neuromodulation with sound and tongue stimulation represents a safe and effective treatment for patients with moderate to severe tinnitus. The results showed that this combined stimulation provides additional clinical benefit on top of classical sound therapy and that the effect is associated with high patient satisfaction and safety.

These positive findings led to FDA De Novo approval (March 2023) of the Lenire® device, making it the first non-invasive, FDA-approved neuromodulation treatment for tinnitus.