Table 2.

Schedule of assessment,

Time point	Screening	Enrolment and fitting	Postallocation				Follow-up	Follow-up	Follow-up
	Screening	Enrolment	Telephone call	Interim visit	Telephone call	Endpoint visit
	t - 10wks	t = 0	t + 3wks	t + 6wks	t + 9wks	t + 12wks	t + 18wks	t + 38wks	t + 64wks
Enrolment
Eligibility screen	X
Informed consent	X
Allocation		X
Training on device usage.		X
Review of device usage data log with participant.				X
Encourage patient compliance.		X	X	X	X
Return device.						X
Interventions
Arm 1		X	X	X	X	X
Arm 2		X	X	X	X	X
Arm 3		X	X	X	X	X
Assessments
Medical history	X
Previous or concomitant medications/illnesses		X		X		X	X	X	X
Tinnitus location & tonality	X	X		X		X	X	X	X
Audiometric tests of hearing	X					X
Loudness Discomfort Level (LDL)	X					X
Mini-Mental State Examination (MMSE)	X
Somatic assessment		X
Oral assessment		X				X
Regensburg Insomnia Scale		X				X
State-Trait Anxiety Inventory (STAI)	X			X		X
Tinnitus Functional Index (TFI)	X	X		X		X	X		X
Minimum Masking Level (MML)	X	X		X		X	X	X	X
Tinnitus Loudness Matching (TLM)	X	X		X		X	X	X	X
Tinnitus Handicap Inventory (THI)	X	X		X		X	X	X	X
Visual Analogue Scale (VAS) (loudness and intrusiveness)	X					X	X	X	X
Adverse events		X		X		X	X	X	X
Clinical Global Impression (CGI) (loudness and intrusiveness)				X		X	X	X	X
Device usability questionnaire						X
Hyperacusis questionnaire								X1	X2

wk, week.

¹Dublin, ²Germany.