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Table 1 Summary of assessments

From: Protocol for a multi-centre randomised controlled stand-alone feasibility trial to assess potential effectiveness and cost-effectiveness of digital hearing aids in patients with tinnitus and hearing loss (the HUSH trial)

 Trial period
Baseline12-week follow-upParticipant interviews (within 1 month of follow-up completion)
Enrolment 
Eligibility screenX  
Informed consentX  
RandomisationX  
Assessments
Baseline characteristicsX  
AudiometryaX  
Hearing aid specificationbX  
Hearing aid fittingcX  
TFIXX 
HHIEXX 
HUI3XX 
HADSXX 
MYMOP2XX 
EQ-5D-5LXX 
Healthcare resource useXX 
Hearing aid adherenceXX 
Safety reporting X 
Global rating of change score X 
Experience of tinnitus management  Xde
Experience of research process  Xde
  1. aHearing thresholds measured no more than 6 months prior to baseline may be reused
  2. bFor those randomised to receive a hearing aid
  3. cMay take place at baseline or at a second fitting appointment. Fitting should take place ideally within 2 weeks up to a maximum of four from the time of the first visit
  4. dA subset of participants and audiologists only
  5. eFor patients who consent to taking part in the interviews only, interviews for those selected will take place within 1 month of consent. Audiologist interviews will take place towards the end of the recruitment period of the trial