Table 3.

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

Exclusion criteria
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 with the exception of vestibular migraine
Serious internal, neurological or psychiatric conditions
Epilepsy or other central nervous system disorders (brain tumor, encephalitis)
Clinically relevant drug, medication or alcohol abuse up to 12 weeks before study start
Severe hearing loss as defined by the inability to communicate properly in the course of the study
At least 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 studya

^aIf 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