Mean Change from Baseline to End of Study (baseline to Day 29 [4 weeks after dosing](Part A) or baseline to Day 57 [8 weeks after dosing] (Part B)). in Pure Tone Average Hearing Thresholds; a negative change indicates improvement.

Ear examinations were done at every visit. One of the important safety endpoints was an observation of a perforation in the ear drum that did not heal properly after the injection.

Validated, 25-item questionnaire; index score from 0 to 100; a negative change indicates improvement. The 25 items of the TFI represent 8 subscales covering multiple domains of tinnitus severity: 1) Intrusive, 2) Sense of Control, 3) Cognitive, 4) Sleep, 5) Auditory, 6) Relaxation, 7) Quality of Life, and 8) Emotional. Subjects answer each TFI question by rating their experience over the past week. Each subscale has 3 questions with a response ranging from 0 (best response) to 10 (worst response) in regard to the impact of tinnitus in these different aspects of the subject's life. The highest raw score would be 250 and the lowest would be 0. The raw score is then divided by the total number of valid answers and that in turn is multiplied by 10 to give an overall score range from 0-100, with 0 representing no impact of tinnitus on their daily life and 100 representing complete impact of tinnitus on their daily life.

Change in overall tinnitus status as perceived by the subject; this was a subject-reported outcome that evaluated the change in overall "global" tinnitus status as perceived by the subject. The subject was asked: "Since the beginning of the clinical study, how would you rate your tinnitus?".

The beginning of the clinical study in this context was the time prior to investigational product administration. The 7 response categories (and point scores) for the PGIC are:

• Very much improved = 3
• Much improved = 2
• Minimally improved = 1
• Unchanged = 0
• Minimally worse = -1
• Much worse = -2
• Very much worse = -3