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2026 data FDA MAUDE openFDA

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.

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FDA MAUDE casebook

openFDA event book Implant, Cochlear MID-BOOK · MAUDE

#50 of 1000 · 72,793 reports · 1993–2026

  • BOOK 72,793 reports
  • RANK #50 of 1000
  • DEATH 68 death-typed
  • INJ 40,649 injury-typed
  • MALF 31,606 malfunction
  • SPAN 1993–2026
  • PEAK 2023: 5,727
  • PHOTO Aortic Valve

Nearest event-volume peer: Aortic Valve, Prosthesis, Percutaneously Delivered (243 report gap)

Implant, Cochlear sits #50 of 1000 among tracked device types with 72,793 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 →

Event-type mix vs corpus

Shares of FDA event_type codes on this device type, compared with the mean across 1,000 device types that have ≥100 MAUDE reports. Codes are report labels, not adjudicated causation.

  • DEATH 0.1% corpus 1.5% · below corpus mean (-1.4 pp)
  • INJ 55.8% corpus 30.4% · above corpus mean (+25.4 pp)
  • MALF 43.4% corpus 64.5% · below corpus mean (-21.1 pp)

Lead product-problem code Appropriate Term/Code Not Available is 20% 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 72,793 MAUDE reports, ranked #50 of 1000.

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

Event Types

Injury 40,649 (55.8%)
Malfunction 31,606 (43.4%)
Other 407 (0.6%)
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 48,502 (64.8%)
20,405 (27.3%)
R 1,933 (2.6%)
Hospitalization 1,458 (1.9%)
Other 1,174 (1.6%)
O 419 (0.6%)
H 409 (0.5%)
L 222 (0.3%)
Life Threatening 134 (0.2%)
Death 71 (0.1%)
S 64 (0.1%)
Congenital Anomaly 26 (0.0%)
Disability 17 (0.0%)
D 3 (0.0%)
C 2 (0.0%)

Top Product Problems

Appropriate Term/Code Not Available 10,355
Mechanical Problem 6,889
Adverse Event Without Identified Device or Use Problem 6,449
Impedance Problem 5,324
Output Problem 5,162
Device Operates Differently Than Expected 2,620
Expulsion 2,509
Migration 2,372
Insufficient Information 2,206
Circuit Failure 1,350
Therapeutic or Diagnostic Output Failure 1,344
No Device Output 1,139
Migration or Expulsion of Device 804
Device Dislodged or Dislocated 739
Positioning Failure 658
Device Appears to Trigger Rejection 528
Intermittent Communication Failure 454
Unexpected Therapeutic Results 451
Extrusion 419
Material Protrusion/Extrusion 311

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: 1,774
11
2011: 2,296
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: 4,403
21
2021: 5,260
22
2022: 5,502
23
2023: 5,727
24
2024: 5,603
25
2025: 5,511
26
2026: 839

Related Entities for Implant, Cochlear

Top Manufacturers

ADVANCED BIONICS, LLC 15,874
COCHLEAR LTD 15,808
MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH 12,529
COCHLEAR LTD. 10,563
COCHLEAR LIMITED 5,690
MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH 3,542
ADVANCED BIONICS LLC 3,375
COCHLEAR LTD . 948

Event Locations

48,575 (66.7%)
I 20,447 (28.1%)
HOSPITAL 2,609 (3.6%)
OUTPATIENT DIAGNOSTIC FACILITY 348 (0.5%)
OTHER 228 (0.3%)
NO INFORMATION 207 (0.3%)
UNKNOWN 129 (0.2%)
HOME 121 (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 similar MAUDE profiles

Two openFDA-derived peer sets for Implant, Cochlear, both floored at ≥100 reports so the neighborhoods stay in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (72,793 here).

Aortic Valve 72,550 Cabinet, Table And Tray, Anesthesia 71,750 Glucose Dehydrogenase, Glucose 73,910 Set 71,401

Similar death-typed counts

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

Laryngoscope, Rigid 68 Pulmonary Valve Prosthesis Percutaneously D… 69 Stylet, Catheter 69 Iliac Covered Stent, Arterial 70

Read our methodology - how this data is sourced, computed, and verified.

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.