2026 data FDA MAUDE openFDA

Hearing Aid, Bone Conduction, 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 Hearing Aid, Bone Conduction, Implanted LIGHT-BOOK · MAUDE

#275 of 1000 · 6,463 reports · 1996–2026

  • BOOK 6,463 reports
  • RANK #275 of 1000
  • DEATH 0 death-typed
  • INJ 6,197 injury-typed
  • MALF 30 malfunction
  • SPAN 1996–2026
  • PEAK 2023: 742
  • PHOTO Tube, Tracheostomy

Nearest event-volume peer: Tube, Tracheostomy (W/Wo Connector) (21 report gap)

Hearing Aid, Bone Conduction, Implanted sits #275 of 1000 among tracked device types with 6,463 MAUDE reports spanning 1996–2026. 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 95.9% corpus 30.4% · above corpus mean (+65.4 pp)
  • MALF 0.5% corpus 64.5% · below corpus mean (-64.0 pp)

Lead product-problem code Appropriate Term/Code Not Available is 37% of coded problems · Lead manufacturer COCHLEAR BONE ANCHORED SOLUTIONS AB accounts for 100% of manufacturer-tagged reports · Top event location I is 47% of location-tagged rows .

Hearing Aid, Bone Conduction, Implanted in the event-volume neighbourhood

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

reports

What this shows Hearing Aid, Bone Conduction, Implanted carries 6,463 MAUDE reports, ranked #275 of 1000.

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

Event Types

Injury 6,197 (95.9%)
141 (2.2%)
Other 95 (1.5%)
Malfunction 30 (0.5%)

Patient Outcomes

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

Required Intervention 6,316 (96.6%)
Other 69 (1.1%)
R 51 (0.8%)
Hospitalization 39 (0.6%)
31 (0.5%)
H 17 (0.3%)
O 6 (0.1%)
S 2 (0.0%)
Life Threatening 2 (0.0%)
L 1 (0.0%)
Congenital Anomaly 1 (0.0%)
Death 1 (0.0%)

Top Product Problems

Appropriate Term/Code Not Available 2,419
Patient Device Interaction Problem 1,697
Loss of Osseointegration 872
Adverse Event Without Identified Device or Use Problem 559
Failure to Osseointegrate 502
Insufficient Information 128
Loosening of Implant Not Related to Bone-Ingrowth 101
Osseointegration Problem 55
No Apparent Adverse Event 28
Detachment of Device or Device Component 26
Inadequacy of Device Shape and/or Size 26
Therapeutic or Diagnostic Output Failure 13
Patient-Device Incompatibility 12
Biocompatibility 8
Extrusion 8
Expulsion 6
Device Appears to Trigger Rejection 5
Output Problem 5
Unexpected Therapeutic Results 5
Signal Artifact/Noise 4

Yearly Trend

96
1996: 1
00
2000: 1
02
2002: 1
03
2003: 1
05
2005: 5
06
2006: 18
07
2007: 9
08
2008: 2
12
2012: 4
13
2013: 21
14
2014: 46
15
2015: 52
16
2016: 309
17
2017: 614
18
2018: 629
19
2019: 635
20
2020: 692
21
2021: 709
22
2022: 711
23
2023: 742
24
2024: 621
25
2025: 572
26
2026: 68

Related Entities for Hearing Aid, Bone Conduction, Implanted

Event Locations

I 3,035 (47.0%)
2,510 (38.8%)
HOSPITAL 605 (9.4%)
HOME 233 (3.6%)
OUTPATIENT TREATMENT FACILITY 48 (0.7%)
OTHER 26 (0.4%)
AMBULATORY SURGICAL FACILITY 2 (0.0%)
NO INFORMATION 1 (0.0%)
NURSING HOME 1 (0.0%)
OUTPATIENT DIAGNOSTIC FACILITY 1 (0.0%)
UNKNOWN 1 (0.0%)

Compare COCHLEAR BONE ANCHORED SOLUTIONS AB vs COCHLEAR LTD →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Hearing Aid, Bone Conduction, Implanted, 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 (6,463 here).

Similar death-typed counts

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

Disclaimer: MAUDE figures for Hearing Aid, Bone Conduction, Implanted 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 Hearing Aid, Bone Conduction, Implanted; 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.