COCHLEAR LIMITED

Manufacturer adverse-event records for COCHLEAR LIMITED come from the U.S. Food & Drug Administration (FDA) MAUDE database via openFDA, refreshed March 2026 - see our methodology. Not medical advice.

FDA MAUDE device safety record · 2013–2026 · thin-book · quiet Death-code · injury-heavy

Injury-mix signature

COCHLEAR LIMITED leans injury-heavy in event_type mix

Injury-coded event_type share is 83.7% (injury-heavy tercile) beside 0.04% Death-coded (quiet). Volume band: thin.

What the Injury-mix reading shows for COCHLEAR LIMITED

The standout signal for COCHLEAR LIMITED is Injury-mix: 83.7% Injury-coded (injury-heavy) beside 0.04% Death-coded, on a thin-book footprint.

As a thinner-book manufacturer, a handful of device families can swing the totals; open the device table rather than reading the company headline alone. Event_type counts are not the same population as Patient Outcomes.

Reports span 7 device types, led in this extract by Injury at 5,638 (83.7% of event_type total). Peak single-year volume reaches 1,511 reports across 14 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.

6,733
Total Reports
3
Event-type Death
5,638
Injury Reports
7
Device Types

Event Types

Injury 5,638 (83.7%)
Malfunction 1,092 (16.2%)
Death 3 (0.0%)

Patient Outcomes

FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.

Required Intervention 5,941 (76.8%)
R 581 (7.5%)
Other 417 (5.4%)
O 356 (4.6%)
Hospitalization 198 (2.6%)
H 191 (2.5%)
15 (0.2%)
L 15 (0.2%)
Life Threatening 10 (0.1%)
Death 3 (0.0%)
C 2 (0.0%)
Congenital Anomaly 2 (0.0%)
D 1 (0.0%)
S 1 (0.0%)

Yearly Trend

13
2013: 4
14
2014: 1
15
2015: 3
16
2016: 7
17
2017: 18
18
2018: 20
19
2019: 50
20
2020: 97
21
2021: 871
22
2022: 1,343
23
2023: 1,343
24
2024: 1,390
25
2025: 1,511
26
2026: 75