2026 data FDA MAUDE openFDA

Hearing Aid, Bone Conduction

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 LIGHT-BOOK · MAUDE

#258 of 1000 · 6,973 reports · 2003–2026

  • BOOK 6,973 reports
  • RANK #258 of 1000
  • DEATH 3 death-typed
  • INJ 6,855 injury-typed
  • MALF 39 malfunction
  • SPAN 2003–2026
  • PEAK 2015: 824
  • PHOTO Warmer

Nearest event-volume peer: Warmer, Thermal, Infusion Fluid (16 report gap)

Hearing Aid, Bone Conduction sits #258 of 1000 among tracked device types with 6,973 MAUDE reports spanning 2003–2026. 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 98.3% corpus 30.4% · above corpus mean (+67.9 pp)
  • MALF 0.6% corpus 64.5% · below corpus mean (-63.9 pp)

Lead product-problem code Appropriate Term/Code Not Available is 53% of coded problems · Lead manufacturer COCHLEAR BONE ANCHORED SOLUTIONS AB accounts for 98% of manufacturer-tagged reports · Top event location is 48% of location-tagged rows .

Hearing Aid, Bone Conduction 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 carries 6,973 MAUDE reports, ranked #258 of 1000.

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

Event Types

Injury 6,855 (98.3%)
Other 62 (0.9%)
Malfunction 39 (0.6%)
14 (0.2%)
Death 3 (0.0%)

Patient Outcomes

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

Required Intervention 6,823 (96.4%)
R 93 (1.3%)
Hospitalization 84 (1.2%)
Other 30 (0.4%)
20 (0.3%)
L 5 (0.1%)
O 5 (0.1%)
S 4 (0.1%)
H 3 (0.0%)
Death 3 (0.0%)
Life Threatening 3 (0.0%)
Congenital Anomaly 1 (0.0%)
Disability 1 (0.0%)

Top Product Problems

Appropriate Term/Code Not Available 2,268
Loss of Osseointegration 587
Patient Device Interaction Problem 557
Adverse Event Without Identified Device or Use Problem 515
Insufficient Information 107
Expulsion 55
Patient-Device Incompatibility 25
Failure to Osseointegrate 22
Inadequacy of Device Shape and/or Size 22
Biocompatibility 20
Signal Artifact/Noise 19
Extrusion 17
No Apparent Adverse Event 16
Therapeutic or Diagnostic Output Failure 13
Output Problem 12
Loosening of Implant Not Related to Bone-Ingrowth 8
Detachment of Device or Device Component 7
Device Appears to Trigger Rejection 7
Osseointegration Problem 7
Unexpected Therapeutic Results 7

Yearly Trend

03
2003: 1
05
2005: 1
06
2006: 2
07
2007: 4
08
2008: 110
09
2009: 76
10
2010: 91
11
2011: 123
12
2012: 346
13
2013: 640
14
2014: 545
15
2015: 824
16
2016: 692
17
2017: 379
18
2018: 336
19
2019: 497
20
2020: 547
21
2021: 490
22
2022: 387
23
2023: 348
24
2024: 232
25
2025: 258
26
2026: 44

Related Entities for Hearing Aid, Bone Conduction

Event Locations

3,335 (47.8%)
I 3,062 (43.9%)
HOSPITAL 466 (6.7%)
HOME 58 (0.8%)
OUTPATIENT TREATMENT FACILITY 18 (0.3%)
OTHER 15 (0.2%)
NO INFORMATION 13 (0.2%)
OUTPATIENT DIAGNOSTIC FACILITY 5 (0.1%)
UNKNOWN 1 (0.0%)

Compare COCHLEAR BONE ANCHORED SOLUTIONS AB vs COCHLEAR BONE ANCHORED SOLUTIONS, AB →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Hearing Aid, Bone Conduction, 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 (6,973 here).

Similar death-typed counts

Nearest other device types by death-typed report count (3 here), distinct from the volume row.

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