Table 2.

Schedule of visits, tasks, and assessments for TENT-A2 study.

TENT-A2a timeline		Screening	Enrollment and fitting	Post-allocation					Follow-up
				Telephone call	Interim visit	Telephone call	Endpoint visit
		t – 8 wk	t = 0 wk	t + 3 wk	t + 6 wk	t + 9 wk	t + 12 wk	t + 18 wk		t + 38 wk	t + 64 wk
Task
	Eligibility screen	✓
	Informed consent	✓
	Allocation		✓
	Training on using the device		✓
	Review of device usage data				✓
	Encourage subject compliance		✓	✓	✓	✓
	Return device						✓
Intervention
	Arm 1		✓	✓	✓	✓	✓
	Arm 2		✓	✓	✓	✓	✓
	Arm 3		✓	✓	✓	✓	✓
	Arm 4		✓	✓	✓	✓	✓
Assessment
	Medical history	✓					✓
	Medications or illnesses	✓	✓		✓		✓	✓		✓	✓
	Audiometric test of hearing	✓					✓
	Tinnitus location and tonality	✓	✓		✓		✓	✓		✓	✓
	Tinnitus loudness matching	✓
	Loudness discomfort level	✓	✓		✓		✓	✓		✓	✓
	Mini-Mental State Examination	✓
	State-Trait Anxiety Inventory	✓
	Somatic assessment		✓
	Oral assessment		✓				✓
	Minimum masking level	✓	✓		✓		✓	✓		✓	✓
	Pittsburgh Sleep Quality Index	✓	✓		✓		✓	✓		✓	✓
	Tinnitus Handicap Inventory	✓	✓		✓		✓	✓		✓	✓
	Tinnitus Functional Index	✓	✓		✓		✓	✓		✓	✓
	Visual analogue scales	✓	✓		✓		✓	✓		✓	✓
	Hyperacusis questionnaire		✓		✓		✓	✓		✓	✓
	Clinical Global Impression				✓		✓	✓		✓	✓
	Adverse Events	✓	✓		✓		✓	✓		✓	✓
	Device usability questionnaire						✓
	Demographic data							✓

^aTENT-A2: Treatment Evaluation of Neuromodulation for Tinnitus - Stage A2.

^bt: timepoint from enrollment and fitting.