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2026 data FDA MAUDE openFDA FDA Class I

Hearing Aid, Air-Conduction, Prescription

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 I (lowest regulatory risk tier, general controls), regulated under 21 CFR §874.3300 (Ear, Nose, Throat panel).

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FDA MAUDE casebook

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

#787 of 1000 · 673 reports · 1994–2026

  • BOOK 673 reports
  • RANK #787 of 1000
  • DEATH 2 death-typed
  • INJ 343 injury-typed
  • MALF 290 malfunction
  • SPAN 1994–2026
  • PEAK 2001: 198
  • PHOTO Forceps

Nearest event-volume peer: Forceps, General & Plastic Surgery (0 report gap)

Hearing Aid, Air-Conduction, Prescription sits #787 of 1000 among tracked device types with 673 MAUDE reports spanning 1994–2026. 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 → · Similar-volume device →

Malfunction reports sit below the device-type norm

Hearing Aid, Air-Conduction, Prescription carries 43.1% MALFUNCTION-coded reports, 21.7pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.3% corpus 1.5% · below corpus mean (-1.2 pp)
  • INJ 51.0% corpus 30.3% · above corpus mean (+20.7 pp)
  • MALF 43.1% corpus 64.8% · below corpus mean (-21.7 pp)

Lead product-problem code Unknown (for use when the device problem is not known) is 23% of coded problems · Top event location is 82% of location-tagged rows .

Hearing Aid, Air-Conduction, Prescription in the event-volume neighbourhood

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

reports

What this shows Hearing Aid, Air-Conduction, Prescription carries 673 MAUDE reports, ranked #787 of 1000.

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

Event Types

Injury 343 (51.0%)
Malfunction 290 (43.1%)
21 (3.1%)
Other 17 (2.5%)
Death 2 (0.3%)

Patient Outcomes

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

Required Intervention 306 (44.8%)
196 (28.7%)
Other 126 (18.4%)
Life Threatening 28 (4.1%)
Disability 8 (1.2%)
Hospitalization 6 (0.9%)
S 5 (0.7%)
R 4 (0.6%)
Death 3 (0.4%)
O 1 (0.1%)

Top Product Problems

Unknown (for use when the device problem is not known) 148
Detachment Of Device Component 99
Adverse Event Without Identified Device or Use Problem 72
Material Separation 71
Component Falling 36
Device, removal of (non-implant) 32
Break 18
Fitting Problem 18
Noise, Audible 17
Noise 14
Source, detachment from 14
Insufficient Device Problem Information 13
Other (for use when an appropriate device code cannot be identified) 13
Repair 13
Replace 11
Defective Device 10
Device, or device fragments remain in patient 10
Difficult to Remove 10
Device Operates Differently Than Expected 9
Reaction 9

Yearly Trend

94
1994: 9
95
1995: 2
96
1996: 1
97
1997: 42
98
1998: 85
99
1999: 57
00
2000: 18
01
2001: 198
02
2002: 8
03
2003: 9
04
2004: 6
05
2005: 3
06
2006: 5
07
2007: 13
08
2008: 13
09
2009: 3
10
2010: 1
11
2011: 3
12
2012: 6
13
2013: 37
14
2014: 4
15
2015: 6
16
2016: 7
17
2017: 4
18
2018: 12
19
2019: 9
20
2020: 5
21
2021: 4
22
2022: 4
23
2023: 8
24
2024: 16
25
2025: 53
26
2026: 22

Reports rose to 53 in 2025, up from an average of 12 in the two years before - a recent-year increase, not a lifetime pattern.

Related Entities for Hearing Aid, Air-Conduction, Prescription

Event Locations

555 (82.5%)
HOME 40 (5.9%)
NO INFORMATION 35 (5.2%)
UNKNOWN 14 (2.1%)
I 11 (1.6%)
INVALID DATA 6 (0.9%)
OTHER 5 (0.7%)
HOSPITAL 4 (0.6%)
NOT APPLICABLE 1 (0.1%)
OUTPATIENT DIAGNOSTIC FACILITY 1 (0.1%)
OUTPATIENT TREATMENT FACILITY 1 (0.1%)

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Hearing Aid, Air-Conduction, Prescription: 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 (673 here).

Forceps, General & Plastic Surgery 673 Hearing Aid 673 Hip Prosthesis 673 Camera, Surgical And Accessories 672

Similar death-typed counts

Nearest other device types by death-typed report count (2 here), distinct from the volume row.

Accessories, Catheter, G-U 2 Accessories, Soft Lens Products 2 Bed, Pediatric Open Hospital 2 Blade 2

Read our methodology - how this data is sourced, computed, and verified.

Disclaimer: MAUDE figures for Hearing Aid, Air-Conduction, Prescription 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, Air-Conduction, Prescription; 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.