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)

Table 1 Summary of assessments

	Trial period
	Baseline	12-week follow-up	Participant interviews (within 1 month of follow-up completion)
Enrolment
Eligibility screen	X
Informed consent	X
Randomisation	X
Assessments
Baseline characteristics	X
Audiometry	^aX
Hearing aid specification	^bX
Hearing aid fitting	^cX
TFI	X	X
HHIE	X	X
HUI3	X	X
HADS	X	X
MYMOP2	X	X
EQ-5D-5L	X	X
Healthcare resource use	X	X
Hearing aid adherence	X	X
Safety reporting		X
Global rating of change score		X
Experience of tinnitus management			X^de
Experience of research process			X^de

^aHearing thresholds measured no more than 6 months prior to baseline may be reused
^bFor those randomised to receive a hearing aid
^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
^dA subset of participants and audiologists only
^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

ISSN: 2055-5784