2026 data FDA MAUDE openFDA

Implant, Hearing, Active, Middle Ear, Partially Implanted

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 LIGHT-BOOK · MAUDE

#585 of 1000 · 1,298 reports · 2001–2026

  • BOOK 1,298 reports
  • RANK #585 of 1000
  • DEATH 0 death-typed
  • INJ 781 injury-typed
  • MALF 491 malfunction
  • SPAN 2001–2026
  • PEAK 2013: 129
  • PHOTO Catheter For Crossing…

Nearest event-volume peer: Catheter For Crossing Total Occlusions (5 report gap)

Implant, Hearing, Active, Middle Ear, Partially Implanted sits #585 of 1000 among tracked device types with 1,298 MAUDE reports spanning 2001–2026. 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 0.0% corpus 1.5% · below corpus mean (-1.5 pp)
  • INJ 60.2% corpus 30.4% · above corpus mean (+29.7 pp)
  • MALF 37.8% corpus 64.5% · below corpus mean (-26.7 pp)

Lead product-problem code Output Problem is 22% of coded problems · Lead manufacturer MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH accounts for 100% of manufacturer-tagged reports · Top event location is 72% of location-tagged rows .

Implant in the event-volume neighbourhood

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

reports

What this shows Implant, Hearing, Active, Middle Ear, Partially Implanted carries 1,298 MAUDE reports, ranked #585 of 1000.

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

Event Types

Injury 781 (60.2%)
Malfunction 491 (37.8%)
Other 25 (1.9%)
1 (0.1%)

Patient Outcomes

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

Required Intervention 980 (75.3%)
314 (24.1%)
R 2 (0.2%)
Hospitalization 2 (0.2%)
Other 2 (0.2%)
L 1 (0.1%)

Top Product Problems

Output Problem 182
Migration 121
Device Operates Differently Than Expected 117
Adverse Event Without Identified Device or Use Problem 113
No Device Output 109
Device Appears to Trigger Rejection 83
Insufficient Information 61
Improper or Incorrect Procedure or Method 7
Lack of Effect 7
Noise, Audible 6
Device Handling Problem 2
Malposition of Device 2
Positioning Problem 2
Circuit Failure 1
Fracture 1
Incomplete or Inadequate Connection 1
Intermittent Continuity 1
Intermittent Energy Output 1
Microbial Contamination of Device 1
No Apparent Adverse Event 1

Yearly Trend

01
2001: 1
03
2003: 1
04
2004: 1
05
2005: 8
06
2006: 3
07
2007: 8
08
2008: 34
09
2009: 64
10
2010: 57
11
2011: 87
12
2012: 84
13
2013: 129
14
2014: 112
15
2015: 80
16
2016: 65
17
2017: 44
18
2018: 53
19
2019: 41
20
2020: 54
21
2021: 67
22
2022: 52
23
2023: 68
24
2024: 80
25
2025: 91
26
2026: 14

Related Entities for Implant, Hearing, Active, Middle Ear, Partially Implanted

Event Locations

932 (71.8%)
I 352 (27.1%)
NO INFORMATION 11 (0.8%)
HOME 1 (0.1%)
OTHER 1 (0.1%)
UNKNOWN 1 (0.1%)

Compare MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH vs MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH →

Nationwide devices with similar MAUDE profiles

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

Disclaimer: MAUDE figures for Implant 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; 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.