Evaluating the Effectiveness of a Non-invasive Tinnitus Device in Reducing Symptoms of Tinnitus and Mental Health Difficulties in Military Veterans: Waitlist-Controlled Trial

Given the profound impact of tinnitus on the lives of military personnel and veterans, along with substantial economic costs and barriers to treatment, it is crucial to explore the feasibility of novel approaches. We have conducted a Feasibility and Acceptability trial which supported the feasibility, acceptability, and safety of a non-invasive tinnitus device (i.e., TinniSoothe) in a sample of 20 military veterans. TinniSoothe is a non-invasive, small, wearable white noise device, designed to provide comfortable and discreet relief of tinnitus symptoms. TinniSoothe produces highly configurable white noise and can be used for 24 hours without the need for anything in one’s ear. Though we have supported the feasibility and acceptability of this wearable device, further research is needed to explore whether this device is effective in reducing tinnitus symptoms and mental health difficulties. 

This study aims to assess whether the device will reduce tinnitus symptoms and associated mental health difficulties such as symptoms of post-traumatic stress disorder (PTSD), anxiety, depression, and sleep disturbances.  

This is a waitlist-controlled trial exploring the effectiveness of a new non-invasive tinnitus device (i.e., TinniSoothe) in military veterans experiencing tinnitus. Veterans who are eligible and appropriate will be randomised to one of the two conditions: the immediate intervention group using the tinnitus device (i.e., TinniSoothe) or the WL control group (i.e., delayed access to TinniSoothe after one-month post-randomisation). Both groups, once they receive the device will be asked to use the TinniSoothe device for a one-month period. The TinniSoothe device involves wearing a small non-invasive device around the participants neck during the daytime and docking the device to a stand at night. Both groups will be given questionnaires at baseline, one-month post-randomisation, and at the two-month post-randomisation point.  

Is this non-invasive device effective in reducing tinnitus symptoms and associated mental health difficutlies? 

We aim to recruit a sample of 20 veterans who have self-reported tinnitus for more than three months.