GN ReSound RE9ITC-DWT-UPRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05708296188017), received between Nov 26, 2020 and Jun 27, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 27, 2025Fracture; Fracture

  IT WAS REPORTED THAT A HEARING AID BROKE INSIDE THE USER'S EAR. THE FACEPLATE CAME OFF OF THE HEARING AID, AND SUBSEQUENT ATTEMPTS TO REMOVE THE REST OF THE DEVICE CAUSED DAMAGE TO THE SHELL AND THE EAR CANAL. THE DEVICE WAS REMOVED BY THE WIFE OF THE USER. USER DID NOT SEEK MEDICAL ATTENTION FOLLOWING THE INCIDENT. FURTHER FOLLOW UP IS EXPECTED.

  Patient problems: Laceration(s)

  MAUDE report 22343830 ↗
• MalfunctionNov 26, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  SUDDEN POWER SURGE PER CUSTOMER STATED "APPEARS WE USED THE WRONG WORD TO DESCRIBE WHAT WAS HAPPENING...THE PT WILL BE WEARING HIS HEARING AIDS AND THEY WILL SUDDENLY GET LOUD AND THEN GET TO A "NORMAL" VOLUME SETTING. THIS IS NOT HURTING HIS EARS AND HE COULD BE DOING ANYTHING AS THIS HAPPENS RANDOMLY THROUGHOUT THE DAY. SUDDENLY GET LOUD AND THEN GET TO A "NORMAL" VOLUME SETTING QUESTIONNAIRE: WAS THE SOUND PAINFUL AND/OR DID IT CAUSE HARM TO THE PATIENT OR OTHER PERSON? CLAIMED NO BUT POTENTIALLY COULD BE HAS THE PATIENT BEEN IN CONTACT WITH A PROFESSIONAL? NO PLEASE CHOOSE THE DURATION OF THE SOUND? UP TO 10 SEC WHAT TYPE OF RECEIVER? ULTRA POWER (UP) INTERPRETATION OF THE EVENT BY MANUFACTURER; DEVICES SEEMS RANDOMLY TO GET LOUD AND THEN GOES BACK TO NORMAL AGAIN. NO CLAIMED HARM DUE TO THE LOUD SOUND BUT WE NEED TO INVESTIGATE THE DEVICES FIRST. THE RECEIVER IS AN ULTRA POWER. REQUESTED TO BE RETURNED AND ON ITS WAY BACK BUT NOT YET IN OUR POSSESION FOR INVESTIGATION. WE WILL NOT BE ABLE TO FINALIZE INVESTIGATION IN TIME FOR THE 30 DAY TIME LIMIT, WHY THIS IS AN INITIAL REPORT. FINAL CONCLUSION IN SECTION H10.

  Patient problems: Partial Hearing Loss; Skin Irritation

  MAUDE report 10910789 ↗