GN ReSound 21303872Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05708296194544), received between Jul 14, 2022 and Jul 14, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Patient Device Interaction 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 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.

• InjuryJul 14, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  ON (B)(6) 2022, THE PATIENT HAD THE INITIAL FITTING OF HEARING AIDS. ON (B)(6) 2022, PATIENT NOTICED REDNESS, SORENESS AND SWOLLEN LYMPH NODE ON LEFT SIDE. ON (B)(6) 2022, IT WAS REPORTED THAT PATIENT HAD PAIN/PRESSURE AND IRRITATION IN THROAT PUSHING TOWARD LYMPH NODES. THE PATIENT THEN FELT A LUMP BEHIND THE RIGHT EAR. ON (B)(6) 2022, IT WAS REPORTED THAT THE PATIENT'S FACE HAD SWELLED UP FROM HER JAW TO HER EAR, AND WORSEN IN PAIN IN FACE AND WAS UNABLE TO TALK. EXACT DATE OF WHEN THIS OCCURRED IS UNKNOWN. ON (B)(6) 2022, IT WAS REPORTED THAT THE SYMPTOMS WERE BETTER AFTER NOT WEARING THE HEARING AIDS AND TAKING THE MEDICATION. PATIENT HAD SEEN HER PRIMARY PRACTITIONER WHO HAD PRESCRIBED MEDICATION - NOT FURTHER SPECIFIED. PATIENT REPORTS THAT SHE IS HIGHLY ALLERGIC TO NICKEL AND LATEX. HCP STATES THAT HE/SHE IS UNSURE HOW THE PATIENT COULD HAVE COME IN CONTACT WITH ANY OF THAT VIA THE RESOUND ONE RECEIVER BEING PLASTIC.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 15013596 ↗