Treatment Evaluation of Neuromodulation for Tinnitus - Stage A3

Summary

TENT-A3 is a single arm repeated measures prospective investigation evaluating the safety and efficacy of the Lenire device for tinnitus treatment. The Lenire device provides non-invasive bimodal (sound and tongue) stimulation to alleviate the symptoms of chronic, subjective tinnitus. Participants presenting to one of the several study sites with a diagnosis of chronic subjective tinnitus who meet the inclusion criteria are enrolled in the investigation while the study site is active. The objective of TENT-A3 is to determine whether the addition of tongue stimulation to sound-only stimulation provides additional clinically significant improvements in tinnitus symptoms beyond that of the sound-only stimulation component of the bimodal treatment.

Conditions

• Tinnitus

Interventions

DEVICE

Lenire

The sound stimulus of PS6 is comprised of sequences of tones and is spectrally modified according to the participant's hearing thresholds so that different components of the sound stimulus can be sufficiently heard by the participant irrespective of their hearing characteristics (audiological profile). The tongue stimulus of PS6 is delivered by an array of electrical signals via 32 transmucosal electrodes contacting the anterodorsal surface of the tongue. The sound and tongue stimulus parameters are presented with certain stimulus rates and timing relationships between modalities.

Sponsors & Collaborators

• BRAI3N (clinical site), Belgium

  collaborator UNKNOWN

• St James's Hospital (clinical site), Ireland

  collaborator UNKNOWN

• German Hearing Center Hannover (clinical site), Germany

  collaborator UNKNOWN

• Avania (CRO/project manager), Netherlands

  collaborator UNKNOWN

• Neuromod Devices Ltd.

  lead INDUSTRY

Principal Investigators

• Welmoed Gjaltema · Avania, Netherlands

• Michael Boedts · BRAI3N, Belgium

• Guan Khoo · St. James's Hospital, Ireland

• Thomas Lenarz · German Hearing Center Hannover, Germany

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-03-21

Primary Completion

2022-09-06

Completion

2022-10-25

Countries

• Belgium
• Germany
• Ireland

Study Locations