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2026 data FDA MAUDE openFDA FDA Class III

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.

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FDA MAUDE casebook

openFDA event book Implant LIGHT-BOOK · MAUDE

#595 of 1000 · 1,332 reports · 2001–2026

  • BOOK 1,332 reports
  • RANK #595 of 1000
  • DEATH 0 death-typed
  • INJ 792 injury-typed
  • MALF 514 malfunction
  • SPAN 2001–2026
  • PEAK 2013: 129
  • PHOTO Intrauterine Tamponad…

Nearest event-volume peer: Intrauterine Tamponade Balloon (4 report gap)

Implant, Hearing, Active, Middle Ear, Partially Implanted sits #595 of 1000 among tracked device types with 1,332 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 →

Injury-coded reports run above the device-type norm

Implant carries 59.5% INJURY-coded reports, 29.2pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.0% corpus 1.5% · below corpus mean (-1.5 pp)
  • INJ 59.5% corpus 30.3% · above corpus mean (+29.2 pp)
  • MALF 38.6% corpus 64.8% · below corpus mean (-26.2 pp)

Lead product-problem code Device Operates Differently Than Expected is 19% of coded problems · Lead manufacturer MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH accounts for 99% of manufacturer-tagged reports · Top event location is 73% 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 1,332 MAUDE reports, ranked #595 of 1000.

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

Event Types

Injury 792 (59.5%)
Malfunction 514 (38.6%)
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 998 (75.2%)
323 (24.3%)
R 2 (0.2%)
Hospitalization 2 (0.2%)
Other 2 (0.2%)
L 1 (0.1%)

Top Product Problems

Device Operates Differently Than Expected 295
No Device Output 217
Output Problem 191
Insufficient Device Problem Information 187
Adverse Event Without Identified Device or Use Problem 185
Migration 130
Device Appears to Trigger Rejection 91
Explanted 42
Extrusion 29
Replace 29
Appropriate Device Problem Term/Code Not Available 26
Improper or Incorrect Procedure or Method 25
Break 17
Malposition of Device 15
Device Dislodged or Dislocated 14
Device Inoperable 14
Migration or Expulsion of Device 13
Device Stops Intermittently 12
Cut In Material 11
Noise, Audible 11

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: 68
22
2022: 52
23
2023: 68
24
2024: 80
25
2025: 91
26
2026: 47

Reports in 2025 (91) held close to the prior two-year average of 74.

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

Top Manufacturers

MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH 743
MED-EL Elektromedizinische Geraete GmbH 3
MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH 1
ST. JUDE MEDICAL - NEUROMODULATION 1

Event Locations

966 (72.5%)
I 352 (26.4%)
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 a comparable report-volume footprint

Implant carries zero death-typed MAUDE reports, so the peer set below compares report volume only; both axes are floored at ≥100 reports so the neighborhood stays in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (1,332 here).

Intrauterine Tamponade Balloon 1,328 Agent, Occluding, Vascular, Permanent 1,325 Stent, Colonic, Metallic, Expandable 1,319 Peripheral Mechanical Thrombectomy With Asp… 1,318

Similar death-typed counts

Nearest other device types by death-typed report count (0 here), distinct from the volume row.

Aberrometer, Ophthalmic 0 Accessories, Arthroscopic 0 Accessories, Cleaning Brushes, For Endoscope 0 Accessories, Implant, Dental, Endosseous 0

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

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.