2026 data FDA MAUDE openFDA FDA Class II

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 Class II (moderate risk, special controls required), regulated under 21 CFR §874.3302 (Ear, Nose, Throat panel).

FDA MAUDE casebook

openFDA event book Hearing Aid, Bone Conduction LIGHT-BOOK · MAUDE

#263 of 1000 · 7,116 reports · 2003–2026

  • BOOK 7,116 reports
  • RANK #263 of 1000
  • DEATH 3 death-typed
  • INJ 6,994 injury-typed
  • MALF 43 malfunction
  • SPAN 2003–2026
  • PEAK 2015: 824
  • PHOTO Hemostatic Metal Clip…

Nearest event-volume peer: Hemostatic Metal Clip For The Gi Tract (30 report gap)

Hearing Aid, Bone Conduction sits #263 of 1000 among tracked device types with 7,116 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 →

Injury-coded reports run above the device-type norm

Hearing Aid, Bone Conduction carries 98.3% INJURY-coded reports, 68.0pp 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 98.3% corpus 30.3% · above corpus mean (+68.0 pp)
  • MALF 0.6% corpus 64.8% · below corpus mean (-64.2 pp)

Lead product-problem code Appropriate Device Problem Term/Code Not Available is 54% 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 7,116 MAUDE reports, ranked #263 of 1000.

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

Event Types

Injury 6,994 (98.3%)
Other 62 (0.9%)
Malfunction 43 (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 6,933 (96.4%)
R 96 (1.3%)
Hospitalization 87 (1.2%)
Other 32 (0.4%)
20 (0.3%)
H 5 (0.1%)
L 5 (0.1%)
O 5 (0.1%)
S 4 (0.1%)
Death 3 (0.0%)
Life Threatening 3 (0.0%)
Congenital Anomaly 1 (0.0%)
Disability 1 (0.0%)

Top Product Problems

Appropriate Device Problem Term/Code Not Available 3,870
Loss of Osseointegration 1,206
Patient Device Interaction Problem 618
Adverse Event Without Identified Device or Use Problem 557
Insufficient Device Problem Information 263
Failure to Osseointegrate 261
Expulsion 66
Device Dislodged or Dislocated 40
Component Falling 35
Inadequacy of Device Shape and/or Size 30
Therapeutic or Diagnostic Output Failure 30
Device remains implanted 29
Patient-Device Incompatibility 27
Extrusion 25
Explanted 24
Signal Artifact/Noise 23
Biocompatibility 20
Detachment Of Device Component 17
No Apparent Adverse Event 16
Device Slipped 13

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: 261
26
2026: 184

Reports in 2025 (261) held close to the prior two-year average of 290.

Related Entities for Hearing Aid, Bone Conduction

Event Locations

3,444 (48.4%)
I 3,058 (43.0%)
HOSPITAL 504 (7.1%)
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 a comparable volume-and-death footprint

Two openFDA-derived peer sets for Hearing Aid, Bone Conduction: 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 (7,116 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.