GN ReSound RE9CIC-W-MPRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05708296174782), received between Jan 16, 2020 and Jul 28, 2022 — classified as 2 injuries.

The most frequently reported specific device problem is “Fitting Problem” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJul 28, 2022Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT 41 YEAR OLD MALE PATIENT HAS INFECTIONS IN HIS EAR DUE TO HEARING AIDS SO THEY WANT TO TRY REMAKING IT SO THAT IT FITS BETTER AND IS NOT IRRITATING THE INSIDE OF THE EAR. EVERY 6 TO 9 MONTHS, USER'S RIGHT EAR CANAL WOULD BECOME INFLAMED AND REQUIRE A DOCTOR'S VISIT AND A WEEK OF EAR DROPS (UNKNOWN) IN ORDER FOR THE DEVICE TO FIT AGAIN. THE USER EXPERIENCED REDNESS, PAIN, AND SWELLING. SINCE THE USER HAD THE DEVICE ALMOST 3 YEARS AGO THE RIGHT EAR HAS BECOME INFLAMED 3 TIMES. EACH TIME REQUIRED A VISIT TO THE DOCTOR AND PRESCRIPTION OF EAR DROPS UNTIL SWELLING AND REDNESS WENT AWAY. RECOMMENDATION FROM HCP WAS TO REMAKE THE DEVICE. THE PATIENT HAS MAINTAINED(CLEANED) THE DEVICE AS SPECIFIED IN THE USER GUIDE. THE REACTION IS RELATED TO THE PHYSICAL FIT OF THE DEVICE AND A REMAKE OF THE DEVICE HAS BEEN PERFORMED. THE PATIENT HAS NO HISTORY OF ALLERGIES, HYPERSENSITIVITY OR FUNGAL INFECTIONS. THE PATIENT HAD NOT USED ANOTHER HEARING AID BEFORE AND EXPERIENCED SIMILAR EVENTS. THE MEDICAL DIAGNOSIS AND OTHER RELEVANT MEDICAL HISTORY IS UNKNOWN. ONSET AND STOP DATE OF THE EVENT IS UNKNOWN. HCP UNSURE OF START AND STOP DATE, THE PATIENT HAD TO USE DROPS (UNKNOWN DETAI

  Patient problems: Unspecified Infection

  MAUDE report 15119306 ↗
• InjuryJan 16, 2020Patient-Device Incompatibility; Patient Device Interaction Problem; Patient-Device Incompatibility; Patient Device Interaction Problem

  POSSIBLE ALLERGIC REACTION. PATIENT DEVELOPED A SKIN IRRITATION/ITCHING IN OUTER EAR CANAL FROM HER ITE (IN THE EAR) CICS (COMPLETELY IN CANAL) BUT THERE WERE NOT OPENINGS (CUTS OR BLISTERS) IN THE SKIN. SHE REPORTED TO AN URGENT CARE FOR MEDICATION. MEDICATION WAS PRESCRIBED AT URGENT CARE, TYPE OF MEDICATION UNKNOWN.

  Patient problems: Irritation; Wheal(s)

  MAUDE report 9597525 ↗