2026 data FDA MAUDE openFDA FDA Class III

Implant, Cochlear

Adverse-event figures are drawn from the U.S. Food & Drug Administration (FDA) MAUDE database, refreshed March 2026, see our methodology.

OpenFDA device adverse-event casebook.

FDA MAUDE casebook

openFDA event book Implant, Cochlear MID-BOOK · MAUDE

#51 of 1000 · 75,024 reports · 1993–2026

  • BOOK 75,024 reports
  • RANK #51 of 1000
  • DEATH 68 death-typed
  • INJ 42,079 injury-typed
  • MALF 32,407 malfunction
  • SPAN 1993–2026
  • PEAK 2023: 5,727
  • PHOTO Transcervical Contrac…

Nearest event-volume peer: Transcervical Contraceptive Tubal Occlusion Device (522 report gap)

Implant, Cochlear sits #51 of 1000 among tracked device types with 75,024 MAUDE reports spanning 1993–2026. Rank counts report volume, not confirmed device fault. Event_type Death / Injury / Malfunction are one code per report — not the same population as patient-outcome rows ( methodology). Read with this device → · Lead manufacturer → · Similar-volume device →

Injury-coded reports run above the device-type norm

Implant, Cochlear carries 56.1% INJURY-coded reports, 25.8pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.1% corpus 1.5% · below corpus mean (-1.4 pp)
  • INJ 56.1% corpus 30.3% · above corpus mean (+25.8 pp)
  • MALF 43.2% corpus 64.8% · below corpus mean (-21.6 pp)

Lead product-problem code Appropriate Device Problem Term/Code Not Available is 19% of coded problems · Lead manufacturer ADVANCED BIONICS, LLC accounts for 23% of manufacturer-tagged reports · Top event location is 67% of location-tagged rows .

Implant, Cochlear in the event-volume neighbourhood

FDA MAUDE report totals among this device type and nearest nationwide peers

reports

What this shows Implant, Cochlear carries 75,024 MAUDE reports, ranked #51 of 1000.

Source FDA MAUDE via openFDA, aggregated by PlainHospital As of August 2026

Event Types

Injury 42,079 (56.1%)
Malfunction 32,407 (43.2%)
Other 407 (0.5%)
Death 68 (0.1%)
63 (0.1%)

Patient Outcomes

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

Required Intervention 50,581 (65.0%)
20,947 (26.9%)
R 2,044 (2.6%)
Hospitalization 1,527 (2.0%)
Other 1,328 (1.7%)
H 452 (0.6%)
O 445 (0.6%)
L 227 (0.3%)
Life Threatening 138 (0.2%)
Death 71 (0.1%)
S 66 (0.1%)
Congenital Anomaly 26 (0.0%)
Disability 17 (0.0%)
C 3 (0.0%)
D 3 (0.0%)

Top Product Problems

Appropriate Device Problem Term/Code Not Available 14,962
Adverse Event Without Identified Device or Use Problem 7,284
Mechanical Problem 7,225
Device Operates Differently Than Expected 6,112
Impedance Problem 5,702
Output Problem 5,237
Insufficient Device Problem Information 4,526
Explanted 4,198
Device remains implanted 3,851
No Device Output 3,796
Expulsion 2,704
Migration 2,563
Device Issue 2,363
Replace 2,094
Migration or Expulsion of Device 1,768
Circuit Failure 1,664
Therapeutic or Diagnostic Output Failure 1,631
High impedance 1,185
Device Stops Intermittently 941
Device Dislodged or Dislocated 890

Yearly Trend

93
1993: 1
94
1994: 4
95
1995: 2
96
1996: 45
97
1997: 123
98
1998: 149
99
1999: 182
00
2000: 247
01
2001: 344
02
2002: 845
03
2003: 940
04
2004: 1,069
05
2005: 1,143
06
2006: 1,540
07
2007: 1,639
08
2008: 1,793
09
2009: 1,897
10
2010: 1,773
11
2011: 2,294
12
2012: 3,078
13
2013: 2,689
14
2014: 2,676
15
2015: 3,105
16
2016: 2,786
17
2017: 3,122
18
2018: 3,054
19
2019: 3,405
20
2020: 4,402
21
2021: 5,260
22
2022: 5,502
23
2023: 5,727
24
2024: 5,603
25
2025: 5,511
26
2026: 3,074

Reports in 2025 (5,511) held close to the prior two-year average of 5,665.

Related Entities for Implant, Cochlear

Event Locations

50,559 (67.4%)
I 20,438 (27.2%)
HOSPITAL 2,860 (3.8%)
OUTPATIENT DIAGNOSTIC FACILITY 349 (0.5%)
OTHER 228 (0.3%)
NO INFORMATION 207 (0.3%)
UNKNOWN 129 (0.2%)
HOME 125 (0.2%)
INVALID DATA 82 (0.1%)
OUTPATIENT TREATMENT FACILITY 26 (0.0%)
AMBULATORY SURGICAL FACILITY 14 (0.0%)
NOT APPLICABLE 5 (0.0%)
PATIENT'S HOME 1 (0.0%)
SCHOOL 1 (0.0%)

Compare ADVANCED BIONICS, LLC vs COCHLEAR LTD →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Implant, Cochlear: nearest by total report volume and nearest by death-typed count, each floored at ≥100 reports so the neighborhoods stay in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (75,024 here).

Similar death-typed counts

Nearest other device types by death-typed report count (68 here), distinct from the volume row.

Disclaimer: MAUDE figures for Implant, Cochlear are informational only and are not clinical advice. Report codes do not prove device causation. Consult a qualified clinician before acting on this data.

Every figure on PlainHospital is rendered directly from federal source data, no number is typed in by an editor. Event-type mix on this page is computed from FDA MAUDE codes for Implant, Cochlear; corpus means use device types with ≥100 reports. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of August 2026.