COCHLEAR LTD

Manufacturer adverse-event records for COCHLEAR LTD 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 · 1996–2026 · mid-book · quiet Death-code · injury-heavy

Injury-mix signature

COCHLEAR LTD leans injury-heavy in event_type mix

Injury-coded event_type share is 83.7% (injury-heavy tercile) beside 0.07% Death-coded (quiet). Volume band: mid.

What the Injury-mix reading shows for COCHLEAR LTD

The standout signal for COCHLEAR LTD is Injury-mix: 83.7% Injury-coded (injury-heavy) beside 0.07% Death-coded, on a mid-book footprint.

Mid-pack volume still shows a clear device fingerprint; the table below is the actionable layer for COCHLEAR LTD. Event_type Death/Injury codes differ from patient-outcome rows - see methodology.

Reports span 9 device types, led in this extract by Injury at 14,792 (83.7% of event_type total). Peak single-year volume reaches 2,047 reports across 25 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.

17,680
Total Reports
12
Event-type Death
14,792
Injury Reports
9
Device Types

Event Types

Injury 14,792 (83.7%)
Malfunction 2,868 (16.2%)
Death 12 (0.1%)
6 (0.0%)
Other 2 (0.0%)

Patient Outcomes

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

Required Intervention 16,221 (88.5%)
Other 630 (3.4%)
R 605 (3.3%)
Hospitalization 434 (2.4%)
H 161 (0.9%)
76 (0.4%)
O 63 (0.3%)
Life Threatening 46 (0.3%)
L 43 (0.2%)
S 23 (0.1%)
Death 14 (0.1%)
Congenital Anomaly 9 (0.0%)

Yearly Trend

96
1996: 21
97
1997: 4
98
1998: 2
04
2004: 1
06
2006: 2
07
2007: 1
08
2008: 14
09
2009: 531
10
2010: 124
11
2011: 136
12
2012: 453
13
2013: 491
14
2014: 97
15
2015: 240
16
2016: 409
17
2017: 1,379
18
2018: 1,429
19
2019: 1,685
20
2020: 1,974
21
2021: 1,531
22
2022: 1,239
23
2023: 1,414
24
2024: 1,907
25
2025: 2,047
26
2026: 549