Evaluation of a Non-invasive Tinnitus Device for the Management of Tinnitus Symptoms in Military Veterans

Launched by COMBAT STRESS · Mar 25, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at a new device designed to help military veterans who suffer from tinnitus, which is a condition that causes ringing or buzzing in the ears. Many veterans experience tinnitus, and it can make daily life challenging. The trial will evaluate a non-invasive wearable device that produces white noise to see if it can reduce these annoying symptoms over a month.

To participate, veterans must be fluent in English, have served in the UK Armed Forces, and have had tinnitus for at least three months. They should be able to receive the device at home and follow the study instructions. However, those with certain severe hearing issues, ongoing treatments for tinnitus, or significant mental health challenges may not be eligible. Participants will be randomly assigned to either receive the device or join a waitlist, and everyone will be monitored for changes in their tinnitus symptoms over the study period. This trial is not yet recruiting participants, but it's an important step towards finding new ways to help veterans manage their tinnitus.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Fluent in speaking and reading English.
• • United Kingdom Armed Forces veteran
• • Persistent tinnitus for at least three months (participants with tinnitus had to confirm experience of constant ringing or buzzing \[bilateral or unilateral\] lasting longer than three months).
• • Able to receive the TinniSoothe device to their registered address
• • Able to follow study instructions
• • Sign the written consent form prior to any study-related procedures being performed
• Exclusion Criteria:
• • Below 18 years of age
• • Significant severe hearing loss without hearing aids
• • Individuals who have already habituated to tinnitus
• • Veterans receiving concurrent treatment for tinnitus (e.g., other wearable devices or ongoing audiological therapies)
• • Active self-harm or suicidal ideation
• • Severe psychotic disorder, dissociative identity disorder or other severe mental health difficulty
• • Current alcohol or drug-use disorder or dependency requiring further support or treatment that would significantly impact treatment engagement, as assessed clinician
• • Unwilling and/or unable to provide informed consent