GN ReSound PZ8ITE-DW-UPRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05708296190591), received between Oct 28, 2020 and Dec 2, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (2 reports).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 2, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  AS REPORTED BY LOCAL CUSTOMER SERVICE: TV STREAMER SO LOUD W/ PZ8ITE-DW-UP HAS THAT HCP HAD TO DECREASE GAIN SIGNIFICANTLY. HCP REPORTED THE TV STREAMER (SN: (B)(6)) SO LOUD W/ PZ8ITE-DW-UP HAS THAT HCP HAD TO DECREASE GAIN SIGNIFICANTLY IN THE STREAMING ACCESSORIES PROGRAM. PT HEARS INTERMITTING SNAPPING/CLAPPING ONLY WHEN STREAMING, WORSE IN THE RIGHT EAR EVEN WITH REDUCED GAIN. PT DID NOT BRING THE TV STREAMER TO APPT TODAY. HCP DOES NOT HAVE A TV TO TEST OUT THE PT'S TV STREAMER OR A STORE TV STREAMER. HCP TRIED TO REDUCE GAIN AT 6 AND 8 KHZ. SHE ALSO UN-PAIRED THE TV STREAMER IN THE FSW. PT WILL RE-PAIR AT HOME TO SEE IF THAT RESOLVES THE ISSUE. IF NOT, THEY WILL CONSIDER SENDING IN THE TV STREAMER. HCP REPORTED ISSUES PAIRING THE TV STREAMER INITIALLY. 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? LESS THAN 2 SECONDS. WHAT TYPE OF RECEIVER? ULTRA POWER. FINAL REPORT SUMMARY AND CONCLUSION IN SECTION H10.

  Patient problems: Partial Hearing Loss; Skin Irritation

  MAUDE report 10934351 ↗
• MalfunctionOct 28, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  AS REPORTED BY LOCAL CUSTOMER SERVICE: HA IS STILL MAKING THE LOUD DISTORTION NOISY AFTER SERVICE. HA WAS JUST HERE FOR THIS PROBLEM AND WE REPLACED THE RECEIVER. THE DISTORTION IS LOUD ENOUGH FOR ME TO HEAR OVER THE PHONE. WE DID A RESTORE AND CONNECTED IN A TEST FILE, SAME RESULT. HCP IS SENDING THE HEARING AID IN AGAIN. COMPLAINT FILED. 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? LONGER THAN 10 SECONDS. WHAT TYPE OF RECEIVER? ULTRA POWER. COMMENT BY CORPORATE QUALITY: WE WILL NOT BE ABLE TO FINALIZE INVESTIGATION IN TIME FOR THE 30 DAY TIME LIMIT, WHY THIS IS AN INITIAL REPORT.

  Patient problems: Partial Hearing Loss; Skin Irritation

  MAUDE report 10746723 ↗