Table 1.

Inclusion and exclusion criteria assessed during the telephone screening and eligibility assessment (visit 1).

Inclusion Criteria

Men and women ≥ 18 years of age

Pure-tone average (PTA) hearing thresholds < 60 dB HL (0.5, 1, 2, 4 kHz)

Must be able to hear stimulation tones presented by the device at all frequencies

Chronic subjective tinnitus for more than 3 months

Dominant tinnitus pitch corresponding to a frequency between 0.2 and 10 kHz (practical lower boundary was 0.5 kHz due to test limitations with the Tinnitus Tester)

At least mild tinnitus, score ≥ 18 measured on Tinnitus Handicap Inventory (THI)

Willing to wear the device for 4 to 6 h daily during the trial

Sufficient command of English language to read, understand and complete the questionnaires

Able and willing to give informed consent

Exclusion criteria

Objective tinnitus, Ménière’s disease, temporomandibular joint disorder

Acoustic Neuroma

Pulsatile tinnitus

Intermittent tinnitus

Severe anxiety, >25 score measured on the Beck Anxiety Inventory (BAI)

Severe depression, >29 score measured on the Beck Depression Inventory (BDI-II)

Catastrophic tinnitus, score ≥ 78 measured on the Tinnitus Handicap Inventory (THI)

Hearing aid wearer for less than 9 months, or long-term hearing aid wearer has had a prescription adjustment within the last 3 months

Pure-tone absolute hearing thresholds > 70 dB on individual frequencies up to 11.2 kHz (unable to sufficiently hear the stimulus)

Taking part in another trial during the 30 days before study start

The individually tailored training stimulus is uncomfortable or not acceptable to the participantCurrently receiving another form of treatment for tinnitus