Results
tinnitus loudness
Of 337 individuals screened for eligibility, 99 (mean [SD] age, 47 [12.7] years; 59 males [60%], 40 females [40%]; 85 with non-Hispanic White [86%] and 14 with other [14%] race and ethnicity) were enrolled and randomized to treatment group 1 (n = 49) or group 2 (n = 50) (Six weeks of active treatment (phase 1) resulted in a cumulative decrease in both overall TFI scores and tinnitus loudness levels. Unexpectedly, during the period 1 washout phase, there was a continued decline in TFI scores (ITT population: from –12.0 to –14.1 points; PP population: from –13.2 to –17.0 points) and tinnitus loudness levels (ITT population: from –5.8 to –9.2 dB SL; PP population: from –7.2 to –10.9 dB SL) (eFigures 4 and 5 in 