Phonak Brand 050-0797-P3Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613389509809), received between Apr 20, 2022 and Apr 27, 2022 — classified as 2 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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.

• InjuryApr 27, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT REPORTED SUDDEN LOUDNESS ON TWO SEPARATE OCCASIONS WHILE WIRELESS STREAMING. AUDIOGRAM SHOWS CHANGE TO THE HEARING THREASHOLDS AND ONSET OF TINNITUS. THE COMPANY IS IN THE PROCESS OF OBTAINING FURTHER INFORMATION WHICH WILL BE CONTAINED IN THE FOLLOW UP REPORT. THIS IS THE INITIAL REPORT.

  Patient problems: Partial Hearing Loss; Tinnitus

  MAUDE report 14218571 ↗
• InjuryApr 20, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT REPORTED SUDDEN LOUDNESS ON TWO SEPARATE OCCASIONS WHILE WIRELESS STREAMING. AUDIOGRAM SHOWS CHANGE TO THE HEARING THREASHOLDS AND ONSET OF TINNITUS. THE COMPANY IS IN THE PROCESS OF OBTAINING FURTHER INFORMATION WHICH WILL BE CONTAINED IN THE FOLLOW UP REPORT. THIS IS THE INITIAL REPORT.

  Patient problems: Partial Hearing Loss; Tinnitus

  MAUDE report 14160971 ↗