Medline MDSHEARAIDBK1Recalls & reported problems
Medline Industries, Inc. · OTC, HEARING AID, IN EAR, BLACK · Class 1
- 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 00197344013244), received between Nov 18, 2025 and Nov 18, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Inadequacy of Device Shape and/or Size1
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.
InjuryNov 18, 2025Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
ACCORDING TO THE CUSTOMER, HIS HEARING AIDS KEPT FALLING OUT. PER THE CUSTOMER, "THE RUBBER PIECE ON THE END THAT FITS IN HIS EAR WAS HOLLOW AND GOT STUCK AND HE HAD TO GO TO THE DOCTOR TO GET IT REMOVED."
Patient problems: Foreign Body In Patient
MAUDE report 23583896 ↗
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.