TABLE 1.
Baseline characteristics
| Five-year Follow-up Population (n = 57)a | Implant Survival Population (n = 77)a | |||
| Characteristics | Test Group (n = 40) | Control Group (n = 17) | Test Group (n = 52) | Control Group (n = 25) |
| Sex | ||||
| Male | 19 (47.5%) | 10 (58.8%) | 23 (44.2%) | 15 (60.0%) |
| Female | 21 (52.5%) | 7 (41.2%) | 29 (55.8%) | 10 (40.0%) |
| Age at baselineb | ||||
| Years | 55.4 (SD 12.8; range, 22.1–78.8) | 64.2 (SD 9.4; range. 43.2–83.3) | 55.5 (SD 13.8; range, 22.1–80.1) | 61.7 (SD 13.5; range, 25.4–84.2) |
| Smoking at baseline | ||||
| No | 36 (90.0%) | 16 (94.1%) | 46 (88.5%) | 22 (88.0%) |
| Yes | 4 (10.0%) | 1 (5.9%) | 6 (11.5%) | 3 (12.0%) |
| Indication | ||||
| Conductive | 12 (30.0%) | 5 (29.4%) | 14 (26.9%) | 7 (28.0%) |
| Mixed | 14 (35.0%) | 9 (52.9%) | 20 (38.5%) | 13 (52.0%) |
| SSD | 13 (32.5%) | 2 (11.8%) | 17 (32.7%) | 4 (16.0%) |
| Other | 1 (2.5%) | 1 (5.9%) | 1 (1.9%) | 1 (4.0%) |
| Study site | ||||
| Nijmegen | 26 (65.0%) | 11 (64.7%) | 28 (53.8%) | 14 (56.0%) |
| Salford | 7 (17.5%) | 4 (23.5%) | 12 (23.1%) | 6 (24.0%) |
| Göteborg | 7 (17.5%) | 2 (11.8%) | 9 (17.3%) | 4 (16.0%) |
| Manchester | – | – | 3 (5.8%) | 1 (4.0%) |
a“Five-year follow-up population” includes all patients who were able to visit the clinic 5 years after implantation. “Implant survival population” includes all patients from the original trial and was used to determine the implant survival/loss during the complete follow-up.
bThe age at baseline was significantly different between the two treatment groups within the 5-year follow-up population (p = 0.03). There were no other significant or important differences between groups.
SSD indicates single sided deafness.