TABLE 1.
Hearing Loss | |||
Mild to Moderate | Severe to Profound | Total | |
Age, years | |||
Mean (SD) | 39.6 (11.3) | 46.6 (10.9) | 42.8 (11.6) |
Range | 19–60 | 19–61 | 19–61 |
Time from onset, hours | |||
Mean (SD) | 25.9 (11.8) | 31.9 (12.1) | 28.6 (12.3) |
Range | 3–47 | 6–48 | 3–48 |
Presence of tinnitus, number (%) patients | 36 (100.0) | 29 (100.0) | 65 (100.0) |
Tinnitus present, concurrent onset | 25 (70.3) | 22 (75.9) | 47 (72.3) |
Tinnitus pre-existing | 4 (13.5) | 1 (3.4) | 5 (7.7) |
No tinnitus present | 7 (16.2) | 6 (20.7) | 13 (20.0) |
Novel-onset tinnitus only: | |||
Tinnitus loudness (0–10) | |||
Mean (SD) | 5.2 (1.7) | 6.4 (1.9) | 5.7 (1.9) |
Range | 2–8 | 3–10 | 2–10 |
Initial frequency range, number (%) patients | 25 (100.0) | 22 (100.0) | 47 (100.0) |
Low frequency hearing loss | 11 (44.0) | 5 (22.7) | 16 (34.0) |
Medium frequency hearing loss | 5 (20.0) | 4 (18.2) | 9 (19.1) |
High frequency hearing loss | 9 (36.0) | 13 (59.1) | 22 (46.8) |
Audiogram type, number (%) patients | 25 (100.0) | 22 (100.0) | 47 (100.0) |
Type A (ascending) | 4 (16.0) | 0 (0.0) | 4 (8.5) |
Type B (flat) | 5 (20.0) | 3 (13.6) | 8 (17.0) |
Type C (descending) | 9 (36.0) | 8 (36.4) | 17 (36.2) |
Type D (U or V shaped) | 6 (24.0) | 1 (4.5) | 7 (14.9) |
Type E (total or subtotal anacusis) | 0 (0.0) | 8 (36.4) | 8 (17.0) |
Not assignable | 1 (4.0) | 2 (9.1) | 3 (6.4) |
Hearing threshold (pure tone average), dB | |||
Mean (SD) | 47.7 (5.7) | 85.7 (21.0) | 65.5 (24.2) |
Range | 31.7–58.3 | 60.0–120.0 | 31.7–120.0 |
Hearing loss, dB | |||
Mean (SD) | 36.1 (6.2) | 72.0 (22.4) | 52.9 (24.0) |
Range | 20.0–48.3 | 41.0–116.7 | 20.0–116.7 |
PTA indicates pure tone average (mean hearing threshold at three most affected contiguous audiometric test frequencies); SD, standard deviation. Placebo-treated patients in clinical trial AM-111-CL-08-01 (Study A; n = 65).