GN ReSound 21227500Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05708296176557), received between Aug 6, 2020 and Aug 6, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Patient-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. 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.

• MalfunctionAug 6, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED BY CUSTOMER SERVICE: LOUD, SCRATCHY STATIC SOUND FROM NEW DEVICE. NEW HP CUSTOM QUATTRO EXHIBIT LOUD, SCRATCHY STATIC SOUND. HCP NOT ABLE TO CONTROL VIA USUAL FB TECHNIQUES. RAN CALIBRATION. CHANGED DFS ULTRA TO STRONG. INCREASED MPO. REDUCED HIGH FREQ GAIN. CLOSED VENT. NOTHING WORKED. ORDERING NEW QUATTRO HS WITH MEDIUM POWER INSTEAD. STATES THIS IS HER 3RD HP CUSTOM FITTING WITH FB/STATIC SOUND. INTERPRETATION BY CORPORATE QUALITY, PMS&V TEAM: THE PERCEIVED LOUD SOUND LEVEL OF THE DEVICE CAN POTENTIALLY HARM THE REMANINING HEARING OF THE PATIENT. NO INDICATIONS OF ANY SUCH HARM IS PROVIDED IN THE COMPLAINT, BUT IT CANNOT BE RULED OUT. THE DEVICE IS EQUIPPED WITH A HIGH POWER RECEIVER. WE WILL NOT BE ABLE TO FINALIZE INVESTIGATION IN TIME FOR THE 30 DAY TIME LIMIT, WHY THIS IS AN INITIAL REPORT. PREVIOUSLY AN INITIAL REPORT HAS BEEN SENT - THIS IS THE FOLLOW-UP/FINAL REPORT.

  Patient problems: Hearing Impairment

  MAUDE report 10372365 ↗