GN Hearing 21654200Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05708296210312), received between Apr 18, 2023 and Apr 18, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Biocompatibility” (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

Recent adverse event reports

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

• InjuryApr 18, 2023Biocompatibility; Biocompatibility

  IT WAS REPORTED (20-MAR-2023): HCP FIT PATIENT WITH SILICONE MICRO MOLDS IN BOTH EARS ON (B)(6) 2023.. THE PATIENT CALLED WITHIN A COUPLE OF DAYS INDICATING THAT THEY HAD A MILD ITCHING IN BOTH EARS AFTER BEING FIT WITH THE NEW MOLDS. THE PATIENT CALLED THE ENT OFFICE AND WAS PRESCRIBED AN STEROID CREAM FOR THE ITCHING BUT WAS NOT TOLD TO STOP WEARING THE MOLDS. THE PT HAS CONTINUED TO WEAR THEM ALL ALONG TILL NOW AND IS WONDERING IF ANY HYPOALLERGENIC COATING COULD BE PUT ON THESE SILICONE MOLDS OR IF THEY SHOULD SWITCH BACK TO ACRYLIC MOLDS (ONES THE PATIENT ORIGINALLY HAD BEFORE SWITCHING TO SILICONE). ADVISED HCP TO HAVE PATIENT STOP USING THE SILICONE MOLDS. CUSTOMER ADVISORS SUGGESTED SWITCHING BACK TO ACRYLIC MOLDS WITH A SOFT COAT WHICH IS A THERMOPLASTIC MATERIAL AND FEELS LIKE SILICONE BUT IS NOT SILICONE. PATIENT HAS HAD SILICONE MOLDS BEFORE AND HAS HAD ITCHING BEFORE ABOUT A YEAR AGO.

  Patient problems: Discomfort; Erythema; Skin Inflammation/ Irritation

  MAUDE report 16760779 ↗