GN ReSound 20661402Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05708296095063), received between Sep 8, 2020 and Sep 8, 2020 — 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.

• InjurySep 8, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  AS REPORTED BY THE LOCAL HEARING AID DEALER: PATIENT HAVING HIGH PAIN RELATED TO THE PROGRAMMING ON THE RIGHT AND I WANT THE LEFT TO BE CHECKED AS WELL. HE STATES THAT THE LEFT IS NOT THE ISSUE, BUT I WOULD LIKE TO HAVE A FULL CHECK OF THIS. CAN YOU PLEASE INCLUDE A DIAGNOSIS OF THIS ON THE PPWK THAT IS SENT BACK WITH THE DEVICE? PATIENT COMPLAINS OF CAUSING HIS RIGHT EAR TO HAVE A LOT OF PAIN. HE HAS LINX 2 DEVICES THAT DO NOT CAUSE PAIN AND THEY HAVE SIMILAR PROGRAMMING. I WOULD LIKE TO HAVE THIS DEVICE REPLACES IF POSSIBLE, AS I FEAR THERE IS SOMETHING WRONG WITH THE CIRCUITRY. INTERPRETATION BY THE COUNTRY SALES OFFICE: FIRST, I SHOULD MENTION THAT THE USER HAS BEEN WEARING THE REPLACEMENT DEVICES AND HAS NOT HAD THE ISSUE WITH PAIN. THE NEW DEVICES, PROGRAMMED USING THE SAME NOAH FILE, HAS NOT CAUSED THE USER TO REPORT HAVING ANY PAIN. SO THAT IS GOOD NEWS. I ASKED HCP TO EXPLAIN THE SITUATION. HE SAID HE COULD NOT DETERMINE THE CAUSE OF THE PAIN AND COULD NOT DETERMINE IF IT WAS PHYSICAL PAIN FROM THE DEVICE OR IF IT WAS A LOUD SOUND. THE HCP MADE MANY ADJUSTMENTS TO HOW THE DEVICE FIT ON THE EAR AND THE USER HAD LS61 DEVICES THAT DID NOT HAVE THIS ISSUE. AT THE SAME TIME, TH

  Patient problems: Partial Hearing Loss; Skin Irritation

  MAUDE report 10501075 ↗