GN ReSound 19397402Recalls & reported problems
Gn Hearing A/S · HI,LS761-DRW,MBL · Class 2
All models of GN ReSound (106)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05704819266781), received between May 29, 2017 and May 29, 2017 — classified as 1 injury.
The most frequently reported specific device problem is “Off-Label Use” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Off-Label Use1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 29, 2017Off-Label Use; Off-Label Use
AID HAS BEEN SWALLOWED. AN END USER HAS SWALLOWED THEIR HEARING AID WITH THE RECEIVER AND DOME ATTACHED. THEY ARE IN THE HOSPITAL AT THE MOMENT. THEY HAVE HAD AN XRAY AND IT IS LOCATED IN THE STOMACH.
Patient problems: Foreign Body In Patient
MAUDE report 6596459 ↗
Other Hearing aid, air conduction with wireless technology devices
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- GN ReSound 21625000Gn Hearing A/S · Hearing aid, air conduction with wireless technology20 reports
- Phonak Brand 050-0889-P5Sonova AG · Hearing Aid, Air Conduction With Wireless Technology8 reports
- GN Hearing 21655200Gn Hearing A/S · Hearing aid, air conduction with wireless technology8 reports
- Beltone 20623200Gn Hearing A/S · Hearing aid, air conduction with wireless technology7 reports
- Beltone 21625700Gn Hearing A/S · Hearing aid, air conduction with wireless technology7 reports
- GN Hearing 20863700Gn Hearing A/S · Hearing aid, air conduction with wireless technology5 reports
- Phonak Audéo I90-Sphere (graphite gray)Sonova AG · Hearing Aid, Air-Conduction With Wireless Technology, Prescription5 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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