Table 2. Statistical Analyses of Revision Reasons and Device Survival Rates by Devicea.
| Device Model | Mean (SD) Follow-up Duration, y | No. | No. of Revisions | No. of CIs | Rate, No./Total No. (%) | Survival, % | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Device Failure | Flap-Associated Problem | Migration | Hematoma | CSF Leakage | Misinsertion | Revision | Device Failure | Cumulative | Device | ||||||
| 5-y | 10-y | 5-y | 10-y | ||||||||||||
| Cochlear | |||||||||||||||
| CI 24R | 15.1 (1.1) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 49 | 0 | 0 | 100 | 100 | 100 | 100 |
| CI 24RE | 10.2 (1.7) | 4 | 1 | 2 | 1 | 0 | 1 | 9 | 159 | 9/159 (5.7) | 4/159 (2.5) | 94.34 | 94.34 | 97.42 | 97.42 |
| CI 422 | 4.6 (1.9) | 4 | 0 | 0 | 0 | 0 | 0 | 4 | 185 | 4/185 (2.2) | 4/185 (2.2) | NA | NA | NA | NA |
| CI 512 | 7.9 (1.4) | 8 | 0 | 2 | 2 | 0 | 1 | 13 | 66 | 13/66 (19.7) | 8/66 (12.1) | 83.33 | NA | 90.24 | NA |
| CI 522 | 1 (0.4) | 1 | 0 | 0 | 0 | 0 | 0 | 1 | 30 | 1/30 (3.3) | 1/30 (3.3) | NA | NA | NA | NA |
| CI 532 | 0.5 (0.2) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 17 | 0 | 0 | NA | NA | NA | NA |
| Total, No. (%) | 7.5 (4.2) | 17 (63.0) | 1 (3.7) | 4 (14.8) | 3 (11.1) | 0 (0.0) | 2 (7.4) | 27 | 506 | 27/506 (5.3) | 17/506 (3.4) | 94.95 | NA | 96.97 | NA |
| Advanced Bionics | |||||||||||||||
| Clarion CII | 15.5 (0.4 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 4 | 0 | 0 | 100 | 100 | 100 | 100 |
| HiRes 90K | 11.4 (2.2) | 7 | 2 | 0 | 0 | 0 | 0 | 9 | 142 | 9/143 (6.3) | 7/143 (4.9) | 94.32 | 93.60 | 95.67 | 94.94 |
| Total, No. (%) | 11.5 (2.2) | 7 (77.8) | 2 (22.2) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 9 | 146 | 9/146 (6.2) | 7/146 (4.8) | 94.48 | NA | 95.79 | NA |
| Med-El | |||||||||||||||
| SONATAti100 | 6.8 (0.7) | 1 | 0 | 0 | 0 | 1 | 0 | 2 | 60 | 2/60 (3.3) | 1/60 (1.7) | 96.67 | NA | 98.31 | NA |
| CONCERTO | 3.8 (1.3) | 2 | 1 | 0 | 0 | 1 | 0 | 4 | 178 | 4/178 (2.2) | 2/178 (1.1) | 97.55 | NA | 98.77 | NA |
| PULSAR CI 100 | 6.5 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 100 | NA | 100 | NA |
| Synchrony | 0.6 (0.2) | 1 | 0 | 0 | 0 | 0 | 0 | 1 | 31 | 1/31 (3.2) | 1/31 (3.2) | NA | NA | NA | NA |
| Total, No. (%) | 4.1 (2.1) | 4 (57.1) | 1 (14.3) | 0 (0.0) | 0 (0.0) | 2 (28.6) | 0 (0.0) | 7 | 270 | 7/270 (2.6) | 4/270 (1.5) | 96.93 | NA | 98.15 | NA |
| Oticon | |||||||||||||||
| Neuro Zti/Total | 0.5 (0.3) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 | 3 | 0 | 0 | NA | NA | NA | NA |
| Total patients who had CIs, No. (%) | 7.1 (4.2) | 28 (65.1) | 4 (9.3) | 4 (9.3) | 3 (7.0) | 2 (4.7) | 2 (4.7) | 43 | 925 | 43/925 (4.6) | 28/925 (3.0) | NA | NA | NA | NA |
| Reason for revision rates, % | NA | 3 | 0.4 | 0.4 | 0.3 | 0.2 | 0.2 | NA | NA | NA | NA | NA | NA | NA | NA |
Abbreviations: CI, cochlear implant; CSF, cerebrospinal fluid; NA, not applicable.
a
Device failure was the most common reason for revision surgery. Among devices, the revision rate and device failure rate were highest with the CI 512. Among manufacturers, they were highest with Advanced Bionics devices.