GN ReSound RE9MIH-W-UPRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05708296174898), received between Jun 1, 2022 and Jun 1, 2022 — 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJun 1, 2022Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  COURTESY REMAKE - PATIENT IS HAVING A LOT OF EAR INFECTIONS, CHANGING TO IROS VENTS. SNS (B)(4). THE PATIENT HAS REPORTED FOLLOWING SYMPTOMS: REDNESS, PAIN, INFECTION, EAR DISCHARGE/FLUID IN THE EAR CANAL. THE REACTION IS PRESENT IN BOTH EARS. IT IS NOT A RECURRING PROBLEM. THE REACTION IS RELATED TO THE PHYSICAL FIT OF THE HEARING AID AND NEEDED LARGER VENTS FOR DRAINAGE. IT HAS DEVELOPED SLOWLY OVER A FEW WEEKS. PRIMARY CARE PHYSICIAN PRESCRIBED ANTIBIOTICS. THE MEDICAL DOCTOR RECOMMENDATION- STOP WEARING DEVICES FOR A WEEK WHILE THE ANTIBIOTICS TOOK EFFECT AND SWITCHING TO DEVICES WITH MORE VENTING. PATIENT DID NOT REPORT ANY KNOWN HISTORY OF ALLERGIES, HYPERSENSITIVITY, FUNGAL INFECTIONS OR IF THE MEDICAL PROFESSIONAL PERFORMED A SWAP FOR BACTERIA AND FUNGI.

  Patient problems: Skin Infection; Skin Inflammation/ Irritation

  MAUDE report 14564218 ↗