GN ReSound FT8ITC-DW-UPRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05708296088997), received between Nov 19, 2020 and Nov 19, 2020 — classified as 1 malfunction.

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 18, 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.

• MalfunctionNov 19, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  AS REPORTED BY LOCAL CUSTOMER SERVICE: CONTINUOUS LOUD PIERCING NOISE. INTERNAL STATIC. IN WARRANTY UNTIL 4/2021. CONTINUOUS LOUD PIERCING NOISE. 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? ULTRA POWER. FINAL EVALUATION IN SECTION H10.

  Patient problems: Partial Hearing Loss; Skin Irritation

  MAUDE report 10867603 ↗