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].
5
Able to receive the device at their registered address.
6
Able to follow study instructions.
7
Sign the written consent form prior to any study-related procedures being performed.
Exclusion criteria
1
Below 18 years of age.
2
Significant, severe, or profound hearing loss.
3
Individuals who have already habituated to tinnitus.
4
Veterans receiving concurrent treatment for tinnitus (e.g., other wearable devices or ongoing audiological therapies).
5
Active self-harm or suicidal ideation.
6
Severe psychotic disorder, dissociative identity disorder, or other severe mental health difficulty.
7
Current alcohol or drug-use disorder or dependency requiring further support or treatment that would significantly impact treatment engagement, as assessed clinician.
8
Unwilling and/or unable to provide informed consent.
While no direct funding was provided for the makers of the TinniSoothe device to support this project, we would like to acknowledge their generous support in discounting the TinniSoothe devices to the study team. We extend our deepest gratitude to all the veterans who participated in this research.
Author contributions
PH: Conceptualization, Investigation, Writing—original draft, Writing—review & editing. DM: Conceptualization, Supervision, Writing—review & editing. Both authors read and approved the final submitted version.
Conflicts of interest
The authors declare that they have no conflicts of interest. The authors confirm that the makers of the TinniSoothe device mentioned in the Acknowledgments have no conflicts of interest with the authors, and had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
Ethical approval
The study in this protocol was reviewed and approved by the local ethics committee of King’s College London (LRS/RGO-24/25-48840) and was registered as a clinical trial (registration number: NCT06905158). This study complies with the 2024 Declaration of Helsinki.
Consent to participate
Informed consent to participate in the study will be obtained from all participants.
Consent to publication
Not applicable.
Availability of data and materials
The data that will support the findings of this study are not yet available as the study is ongoing. Upon completion, the data will be made available by the corresponding author upon reasonable request.
Funding
This study is funded by the Watson Trust (reference number: [CSGN5863]). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
Open Exploration maintains a neutral stance on jurisdictional claims in published institutional affiliations and maps. All opinions expressed in this article are the personal views of the author(s) and do not represent the stance of the editorial team or the publisher.
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