2026 data FDA MAUDE openFDA

Active Implantable Bone Conduction Hearing System

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 Active Implantable Bone Conduction Hearing… LIGHT-BOOK · MAUDE

#390 of 1000 · 3,021 reports · 2018–2026

  • BOOK 3,021 reports
  • RANK #390 of 1000
  • DEATH 1 death-typed
  • INJ 2,692 injury-typed
  • MALF 328 malfunction
  • SPAN 2018–2026
  • PEAK 2025: 1,008
  • PHOTO Dressing, Wound, Drug

Nearest event-volume peer: Dressing, Wound, Drug (0 report gap)

Active Implantable Bone Conduction Hearing System sits #390 of 1000 among tracked device types with 3,021 MAUDE reports spanning 2018–2026. 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 89.1% corpus 30.4% · above corpus mean (+58.7 pp)
  • MALF 10.9% corpus 64.5% · below corpus mean (-53.6 pp)

Lead product-problem code Appropriate Term/Code Not Available is 44% of coded problems · Lead manufacturer COCHLEAR LTD accounts for 54% of manufacturer-tagged reports · Top event location is 73% of location-tagged rows .

Active Implantable Bone Conduction Hearing… in the event-volume neighbourhood

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

reports

What this shows Active Implantable Bone Conduction Hearing System carries 3,021 MAUDE reports, ranked #390 of 1000.

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

Event Types

Injury 2,692 (89.1%)
Malfunction 328 (10.9%)
Death 1 (0.0%)

Patient Outcomes

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

Required Intervention 2,804 (88.4%)
100 (3.2%)
R 82 (2.6%)
Other 57 (1.8%)
Hospitalization 55 (1.7%)
H 43 (1.4%)
O 28 (0.9%)
Life Threatening 2 (0.1%)
Death 1 (0.0%)

Top Product Problems

Appropriate Term/Code Not Available 1,420
Expulsion 673
Adverse Event Without Identified Device or Use Problem 293
No Device Output 185
Insufficient Information 151
Output Problem 85
Device Dislodged or Dislocated 83
Device Appears to Trigger Rejection 78
Unexpected Therapeutic Results 45
Patient Device Interaction Problem 42
No Apparent Adverse Event 32
Inadequacy of Device Shape and/or Size 30
Loss of Osseointegration 29
Signal Artifact/Noise 24
Therapeutic or Diagnostic Output Failure 22
Failure to Read Input Signal 16
Improper or Incorrect Procedure or Method 15
Loose or Intermittent Connection 14
Migration 13
Device Handling Problem 12

Yearly Trend

18
2018: 2
19
2019: 25
20
2020: 70
21
2021: 238
22
2022: 306
23
2023: 473
24
2024: 712
25
2025: 1,008
26
2026: 187

Related Entities for Active Implantable Bone Conduction Hearing System

Event Locations

2,203 (72.9%)
HOSPITAL 606 (20.1%)
I 205 (6.8%)
OTHER 4 (0.1%)
HOME 2 (0.1%)
OUTPATIENT TREATMENT FACILITY 1 (0.0%)

Compare COCHLEAR LTD vs COCHLEAR LIMITED →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Active Implantable Bone Conduction Hearing…, 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 (3,021 here).

Similar death-typed counts

Nearest other device types by death-typed report count (1 here), distinct from the volume row.

Disclaimer: MAUDE figures for Active Implantable Bone Conduction Hearing… 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 Active Implantable Bone Conduction Hearing…; 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.