Table 2.

Inclusion criteria of UNITI-RCT as specified in the study protocol [1]

Inclusion criteria
Tinnitus as the primary complaint
Tinnitus lasting at least 6 months
Age 18–80 years
A score ≥ 18 in the Tinnitus Handicap Inventory at Screening
A score greater than 22 at the Montreal Cognitive Assessment (MoCa)
Ability and willingness to use the UNITI mobile applications [3] on their smartphones
Openness to using a hearing aid (if allocation to the hearing aid stratum)
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)
Negative pregnancy test at screening (only at the clinical site in Granada due to specific standards of the local ethics committee)
Existing drug therapy with psychoactive substances (e.g., antidepressants, anticonvulsants) must be stable for at least 30 days at the beginning of the therapeutic intervention. The drug therapy should remain constant during the duration of the study. Necessary changes do not constitute an exclusion criterion per se but need to be recorded

^aDue 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