Treatment compliance/adherence and protocol deviations
Compliance with treatment protocols is defined for each treatment arm separately. For combined treatments, failing to meet the criteria for one of the arms is sufficient to identify a patient as failing to comply with the protocol. Table The number and percentage of participants compliant with treatment will be presented per treatment group. Compliance is determined by App-use log files (SC, ST), hearing aid log files (HA), and participation in treatment sessions (CBT). Acceptable compliance will be defined as ≥ 50% of the recommended intervention (participation in ≥ 6 CBT sessions including the first two, using HA four or more hours per day, on average, according to data logging, having completed at least the first 6 chapters of SC and having played at least once each of the four ST stimuli categories). Withdrawal from/compliance with the randomized intervention will be summarized using the following variables:Number of treatment discontinuations;Number of patients who decided to continue with study visits even though they canceled their treatment;Discontinuation reasons (where available);Compliance with the intervention (in percent), as described in Table All cases of protocol deviations will lead to an exclusion of the respective participant from the per protocol analysis. A list of deviations will be presented in a table including the treatment arm and details of the deviation. Protocol deviations are defined as any deviations from the study protocol [