LONDON, UNITED KINGDOM — Combat Stress has announced a new clinical trial in partnership with British health tech company TinniSoothe to evaluate the use of a wearable tinnitus device among UK veterans. The waitlist-controlled study represents a significant step toward identifying accessible, non-invasive treatment options for tinnitus and its associated mental health challenges.
Tinnitus, the perception of sound without an external source, affects an estimated 30 percent of UK veterans, according to Tinnitus UK. The condition is known to impact daily functioning and is often linked with post-traumatic stress disorder (PTSD), anxiety, depression, and insomnia.
“Veterans often suffer with tinnitus, which can worsen existing mental health conditions,” said Professor Dominic Murphy, Head of the Combat Stress Centre for Applied Military Health Research.
“There’s an urgent need for practical, scalable and non-invasive alternatives. Wearable sound therapy shows promise but has rarely been studied in isolation or in veteran populations.”
A previous feasibility study using TinniSoothe devices, submitted by Combat Stress to the Journal of Hearing Science, found the technology to be both practical and well accepted by veterans. All participants completed the study with no dropouts or serious adverse events, and most reported they would recommend the device to others.
Trial to Measure Clinical and Quality-of-Life Outcomes
The new 12-month trial will assess whether the TinniSoothe device can improve tinnitus symptoms and mental wellbeing in veterans. It will measure outcomes using the Tinnitus Functional Index (TFI), General Health Questionnaire (GHQ-12), Insomnia Severity Index (ISI), and Satisfaction with Life Scale (SWLS).
“We’re proud to partner with Combat Stress, combining rigorous research with real-world impact for those who served in our Armed Forces,” said Jez Lawson, Co-founder of TinniSoothe. “TinniSoothe was designed to be discreet, user-friendly and practical for daily life.”
The study has received ethics approval from the King’s College London Ethics Committee and is registered at ClinicalTrials.gov (NCT06905158). The trial protocol is published in Exploration of Digital Health Technologies and supported by the Watson Trust (ref: CSGN5863). Recruitment is currently underway.
- The protocol is published in its entirety at https://www.explorationpub.com/Journals/edht/Article/101165
About Combat Stress
Combat Stress is the UK’s leading charity specialising in veterans’ mental health. The organisation provides expert clinical services, conducts research, and advocates for improved care for those affected by PTSD, anxiety, depression, and related conditions.
About TinniSoothe Ltd
TinniSoothe is a UK-based health technology company developing a wearable, non-invasive tinnitus relief device. Its patented technology uses adjustable sound therapy through a small neck-worn module designed to reduce the perception of tinnitus through distraction and habituation.
Source: TinniSoothe
