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 Class II (moderate risk, special controls required), regulated under 21 CFR §874.3340 (Ear, Nose, Throat panel).
FDA MAUDE casebook
openFDA event book Active Implantable Bone Conduction Hearing… LIGHT-BOOK · MAUDE
#377 of 1000 · 3,437 reports · 2018–2026
- BOOK 3,437 reports
- RANK #377 of 1000
- DEATH 1 death-typed
- INJ 3,067 injury-typed
- MALF 369 malfunction
- SPAN 2018–2026
- PEAK 2025: 1,008
- PHOTO Gauge, Depth
Nearest event-volume peer: Gauge, Depth (2 report gap)
Active Implantable Bone Conduction Hearing System sits #377 of 1000 among tracked device types with 3,437 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 →
Injury-coded reports run above the device-type norm
Active Implantable Bone Conduction Hearing… carries 89.2% INJURY-coded reports, 58.9pp 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 89.2% corpus 30.3% · above corpus mean (+58.9 pp)
- MALF 10.7% corpus 64.8% · below corpus mean (-54.1 pp)
Lead product-problem code Appropriate Device Problem Term/Code Not Available is 42% of coded problems · Lead manufacturer COCHLEAR LTD accounts for 52% 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
- Control
Control, Pump Speed, Cardiopulmonary Bypass
3,469 reports
- Catheters
Catheters, Suction, Tracheobronchial
3,457 reports
- Gauge, Depth
Gauge, Depth
3,439 reports
- Active Implan… (this)
Active Implantable Bone Conduction Hearing System
3,437 reports
- Adaptor
Adaptor, Hygiene
3,426 reports
- Driver
Driver, Wire, And Bone Drill, Manual
3,399 reports
What this shows Active Implantable Bone Conduction Hearing System carries 3,437 MAUDE reports, ranked #377 of 1000.
Event Types
Patient Outcomes
FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.
Top Product Problems
Yearly Trend
Reports rose to 1,008 in 2025, up from an average of 593 in the two years before - a recent-year increase, not a lifetime pattern.
Related Entities for Active Implantable Bone Conduction Hearing System
Top Manufacturers
Event Locations
Nationwide devices with a comparable volume-and-death footprint
Two openFDA-derived peer sets for Active Implantable Bone Conduction Hearing…: 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 (3,437 here).
Similar death-typed counts
Nearest other device types by death-typed report count (1 here), distinct from the volume row.
Read our methodology - how this data is sourced, computed, and verified.
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.