GN ReSound 20686205Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05708296145379), received between Dec 21, 2020 and Mar 31, 2022 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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. How this data works · Data updated Oct 13, 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.

• InjuryMar 31, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: PATIENT SYMPTOM: REDNESS, IRRITATION, INFLAMMATION, BLISTERS IN THE EAR CANAL (AREA IN CONTACT WITH THE DOMES). TIME OF USE BEFORE SYMPTOM APPEARED: 3 - 4 WEEKS (REACTION DEVELOPED GRADUALLY). THE SKIN REACTION HAS BEEN CONFIRMED BY DOCTOR. ENVIRONMENT: ACCORDING TO THE INFORMATION PROVIDED BY THE DISPENSER, THE REACTION DOES NOT SEEM TO BE CAUSED BY WEARING THE DEVICES IN A SPECIFIC ENVIRONMENT (HOME, OUTDOOR) THE PATIENT DOES NOT USE ANY CLEANING AGENT. THE PATIENT HAS NOT WORN HEARING AIDS BEFORE. HE TRIED TO IN THE PAST (YEARS AGO ACCORDING TO THE SHOP), BUT DESISTED BECAUSE HE DEVELOPED OTITIS WHEN WEARING THE INSTRUMENTS.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 13963415 ↗
• MalfunctionDec 21, 2020Device-Device Incompatibility; Patient Device Interaction Problem; Device-Device Incompatibility; Patient Device Interaction Problem

  AS REPORTED BY LOCAL CUSTOMER SERVICE: "LOUD SCREECH" IN RIGHT AID ONLY. WHEN THE RADIO WAS ON, WHEN THE "PITCH CHANGED" IT WAS SCREECHING. IT ALSO HAPPENED IN THE CAR. HE WOULD HAVE TO PULL THE MOLD OUT OF HIS EAR. HAPPENED MULTIPLE TIMES. "LOUD SCREECH" SOUNDED LIKE IT WAS COMING FROM THE HEARING AIDS. QUESTIONNAIRE: WAS THE SOUND PAINFUL AND/OR DID IT CAUSE HARM TO THE PATIENT OR OTHER PERSON? NO. HAS THE PATIENT BEEN IN CONTACT WITH A PROFESSIONAL? NO. PLEASE CHOOSE THE DURATION OF THE SOUND? UP TO 10 SECONDS. WHAT TYPE OF RECEIVER? HIGH POWER.

  Patient problems: Partial Hearing Loss; Skin Irritation

  MAUDE report 11045632 ↗