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Table 1 Eligibility criteria

From: Unification of Treatments and Interventions for Tinnitus Patients (UNITI): a study protocol for a multi-center randomized clinical trial

Inclusion criteria Exclusion criteria
- Primary complaint tinnitus
- Chronic tinnitus (≥ 6 months)
- Age between 18 and 80 years
- A score of ≥ 18 in the Tinnitus Handicap Inventory (THI; [41] - at least mild tinnitus distress
- A score of > 22 in the Montreal Cognitive Assessment (MoCa; [52])-absence of mild cognitive impairment
- Ability and willingness to use the UNITI mobile applications on smartphones
- Openness to use a HA (if indication and allocation to HA group)
- Ability to understand and consent to the research (hearing ability, intellectual capacity)
- Ability to participate in all relevant visits (no plans for, e.g., long-term holidays or pregnancya)
- Existing drug therapies with psychoactive substances (e.g., antidepressants or anticonvulsants) must be stable for at least 30 days at the beginning of the therapeutic intervention. The drug therapy should remain constant during the course of the study. Necessary changes do not constitute an exclusion criterion per se, but need to be recorded.
- Objective tinnitus or heartbeat-synchronous tinnitus as primary complaint
- Otosclerosis/ acoustic neuroma or other relevant ear disorders with fluctuation hearing
- Present acute infections (acute otitis media, otitis externa, acute sinusitis)
- Meniere’s disease or similar syndromes (but not vestibular migraine)
- Serious internal, neurological or psychiatric conditions
- Epilepsy or other disorders of the central nervous system (e.g., brain tumor or encephalitis)
- Clinically relevant drug, medication or alcohol abuse up to 12 weeks before study start
- Severe hearing loss-inability to communicate properly in the course of the study
- One deaf ear
- Missing written informed consent
- Start of any other tinnitus-related treatments, especially hearing aids, structured counseling, sound therapy (with special devices; expecting long-term effects) or cognitive behavioral therapy in the last 3 months before the start of the studyb
  1. a Due to specific standards of the local ethics committee at the clinical site in Granada, Spain , with respect to the conduction of RCTs, all female participants will be tested with regard to an existing pregnancy
  2. b If a HA has already been worn 3 months before screening, eligible candidates are allowed to participate, but are automatically assigned to the group with no HA indication