GN ReSound 20413905Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05708296145157), received between Sep 14, 2020 and Sep 14, 2020 — classified as 1 malfunction.

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.

• MalfunctionSep 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE LOCAL HEARING AID DEALER: HA MADE A SOUND LIKE AN "EXPLOSION"; SEE DETAILS BELOW.PATIENT WAS FIT WITH RE961S & UP MOLDS APPROX 3 WEEKS AGO. CHARGER SERIAL # (B)(4); EARMOLD #19090340. THE SEQUENCE OF EVENTS: THE CHARGER, WITH THE HAS IN IT, WAS DROPPED. THE NEXT DAY, THE L AID MADE A "BIT OF A WEIRD NOISE", OTHERWISE ALL WAS OK. THE FOLLOWING DAY, PATIENT WORE THE HAS TO A HOT YOGA CLASS WHERE SHE PERSPIRED PROFUSELY. DURING THE CLASS, THE L AID MADE A "SOUND LIKE AN EXPLOSION". THE L AID IS NOW DEAD; PATIENT IS UNABLE TO TURN IT ON OR TO CHARGE IT. THE PATIENT DID NOT REPORT ANY HEARING LOSS OR TINNITUS AFTER HEARING THAT SOUND. SHE HAS NOT SEEN A PHYSICIAN ABOUT THE INCIDENT. AS PER (B)(4), CUSTOMER IS GOING TO FAX IN A REMAKE FORM; TFTS WILL DO AN ADVANCE REMAKE ON THE MOLD. ORDERED REPLACEMENT HA & CHARGER. CUSTOMER WILL RETURN THE HA, MOLD, CHARGER ATTN: QE. HAVE THE SYMPTOM(S) DISAPPEARED COMPLETELY? YES.

  Patient problems: Partial Hearing Loss; Skin Irritation

  MAUDE report 10526990 ↗