Digital thErapy For Improved tiNnitus carE Study (DEFINE)
Tinnitus is a common condition that causes you to hear sounds like ringing, hissing, or buzzing that do not come from the outside world. While there is no cure, cognitive behavioural therapy (CBT)—a type of talking therapy—can help people cope and feel much less distressed. However, getting CBT on the NHS often involves long waiting lists of a year or more. The DEFINE study is testing whether a smartphone app called Oto can offer the same relief as one-to-one sessions with a hearing specialist. The app combines talking therapy techniques with mindfulness and educational tools. Participants are randomly placed into one of two groups: one uses the app, while the other sees a therapist. The entire study happens remotely from home over 12 months, giving participants quick, free access to tinnitus support while helping researchers improve future care.
At a glance
What is this study about?
Around one in seven adults in the UK experience tinnitus, hearing persistent ringing, buzzing, or whistling sounds that have no external source. For many, tinnitus can disrupt sleep, concentration, and daily well-being. A proven way to help manage this distress is cognitive behavioural therapy (CBT), a talking therapy that helps retrain how the brain and emotions respond to the sounds. Unfortunately, high demand means people often wait more than a year to see a specialist on the NHS.
To help solve this delay, researchers have developed the Oto Tinnitus Programme. This is a self-paced smartphone app that delivers CBT exercises alongside mindfulness, physical stretches, and educational advice. The DEFINE study aims to discover whether using this digital programme on your own phone is just as helpful at reducing tinnitus distress as traditional, one-to-one therapy with an audiologist or hearing therapist.
If the app proves to be just as effective, it could offer a much faster, more convenient way for thousands of people across the UK to access high-quality tinnitus support from the comfort of their own homes, without needing to take time off work or travel to hospital clinics.
Key takeaways
- The DEFINE trial tests whether a smartphone app can manage tinnitus as effectively as one-to-one talking therapy.
- Participation is 100% remote, requiring no clinic visits or travel.
- Participants receive either free one-to-one therapy or free access to the Oto app.
- The study lasts 12 months, with online check-in surveys at months 1, 3, 6, and 12.
- Open to UK adults who have had bothersome tinnitus for at least three months and have not previously tried tinnitus therapy.
Who may be eligible?
You may be able to take part if you are aged 18 or older and have had tinnitus symptoms for at least three months that negatively affect your everyday quality of life. Because the study compares treatments for beginners, you must not have previously had structured tinnitus therapy, such as CBT or Tinnitus Retraining Therapy (TRT). You will also need a smartphone, good spoken and written English, and the ability to give informed consent.
This study is not suitable for everyone. People with certain ear symptoms need in-person medical evaluation first, so you cannot join if your tinnitus is only in one ear, or if it pulses in time with your heartbeat. You will also not be able to join if you are awaiting ear surgery, currently pregnant or breastfeeding, taking part in another hearing trial, or experiencing severe mental health conditions that require psychiatric hospital care or specialist medication.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- I am aged 18 or older.
- I have had tinnitus for at least 3 months and it affects my daily life.
- I have never received CBT or Tinnitus Retraining Therapy (TRT) before.
- My tinnitus is in both ears (not just one) and does not beat like a pulse.
- I own a smartphone and have reliable internet access.
- I am not pregnant, breastfeeding, or awaiting ear surgery.
What does participation involve?
Taking part in this study lasts for 12 months and is carried out entirely from your home using phone calls, video meetings, and online forms. After an initial screening chat to ensure the trial is safe for you, a computer system will randomly assign you to one of two groups with an equal chance of being in either.
If you are placed in the therapist group, you will receive one-to-one tinnitus therapy sessions with a qualified audiologist or hearing therapist. If you are placed in the app group, you will download the Oto app to your smartphone and work through its guided exercises at your own pace. You will not need to take any trial medication. To track your progress, researchers will ask you to fill out secure online questionnaires at 1 month, 3 months, 6 months, and 12 months.
Potential risks and benefits
Locations (1)
- Not provided at time of registrationCity only-, England
Common questions
Do I have to travel to a hospital or clinic?
No. The entire study is run remotely, meaning all consultations happen over the phone or video call, and questionnaires are completed online at home.
Will taking part cost me anything?
No. Both the Oto app and the one-to-one therapy sessions are provided completely free of charge to participants.
Can I choose whether I get the app or the one-to-one therapist?
No. To keep the comparison fair and scientifically sound, a computer programme randomly decides which group you join.
What happens if I find the technology difficult to use?
The study team at Lindus Health will guide you through downloading the app and will be on hand to answer technical questions and help you set up.
Can I leave the study if I feel it is not helping me?
Yes. You have the right to withdraw from the trial at any time, for any reason, without giving an explanation.
How to find out more
Jameel Muzaffar
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.