2026 data FDA MAUDE openFDA FDA Class II

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 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, Implanted LIGHT-BOOK · MAUDE

#276 of 1000 · 6,678 reports · 1996–2026

  • BOOK 6,678 reports
  • RANK #276 of 1000
  • DEATH 0 death-typed
  • INJ 6,411 injury-typed
  • MALF 31 malfunction
  • SPAN 1996–2026
  • PEAK 2023: 742
  • PHOTO Prosthesis

Nearest event-volume peer: Prosthesis, Hip, Femoral Component, Cemented, Metal (21 report gap)

Hearing Aid, Bone Conduction, Implanted sits #276 of 1000 among tracked device types with 6,678 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 →

Injury-coded reports run above the device-type norm

Hearing Aid, Bone Conduction, Implanted carries 96.0% INJURY-coded reports, 65.7pp 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 96.0% corpus 30.3% · above corpus mean (+65.7 pp)
  • MALF 0.5% corpus 64.8% · below corpus mean (-64.4 pp)

Lead product-problem code Appropriate Device Problem Term/Code Not Available is 36% of coded problems · Lead manufacturer COCHLEAR BONE ANCHORED SOLUTIONS AB accounts for 100% of manufacturer-tagged reports · Top event location I is 45% 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 6,678 MAUDE reports, ranked #276 of 1000.

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

Event Types

Injury 6,411 (96.0%)
141 (2.1%)
Other 95 (1.4%)
Malfunction 31 (0.5%)

Patient Outcomes

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

Required Intervention 6,505 (96.3%)
Other 91 (1.3%)
R 53 (0.8%)
Hospitalization 42 (0.6%)
31 (0.5%)
H 18 (0.3%)
O 7 (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 Device Problem Term/Code Not Available 2,449
Patient Device Interaction Problem 1,855
Loss of Osseointegration 912
Adverse Event Without Identified Device or Use Problem 565
Failure to Osseointegrate 559
Insufficient Device Problem Information 132
Loosening of Implant Not Related to Bone-Ingrowth 113
Osseointegration Problem 55
Inadequacy of Device Shape and/or Size 32
No Apparent Adverse Event 32
Detachment of Device or Device Component 31
Explanted 22
Therapeutic or Diagnostic Output Failure 21
Extrusion 19
Patient-Device Incompatibility 12
Unexpected Therapeutic Results 9
Unknown (for use when the device problem is not known) 9
Biocompatibility 8
Device remains implanted 7
Device Issue 6

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: 693
21
2021: 709
22
2022: 711
23
2023: 742
24
2024: 621
25
2025: 569
26
2026: 285

Reports in 2025 (569) held close to the prior two-year average of 682.

Related Entities for Hearing Aid, Bone Conduction, Implanted

Event Locations

I 3,035 (45.4%)
2,678 (40.1%)
HOSPITAL 652 (9.8%)
HOME 233 (3.5%)
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 a comparable report-volume footprint

Hearing Aid, Bone Conduction, Implanted carries zero death-typed MAUDE reports, so the peer set below compares report volume only; both axes are floored at ≥100 reports so the neighborhood stays in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (6,678 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.