Phonak 050-0675-P5Recalls & reported problems
Sonova AG · Phonak Bolero M50-PR (champagne) · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613275689721), received between Jul 29, 2025 and Jul 29, 2025 — classified as 1 injury.
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Patient Device Interaction Problem1
Patient problems
- Hypersensitivity/Allergic reaction1
- Itching Sensation1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 29, 2025Patient Device Interaction Problem; Patient Device Interaction Problem
THE MANUFACTURER WAS NOTIFIED ABOUT A PATIENT SHOWING A STRONG REACTION IN THE AREA WHERE THE HEARING AID IS WORN WITH SCALY, REDDENED, ITCHY SKIN. THE PATIENT ONLY WEARS A HEARING AID MONAURALLY, THE REACTION IS PROBABLY DUE TO WEARING THE HEARING AID, AS THERE ARE NO SIGNS OF IT ON THE OTHER EAR. THE PATIENT HAS BEEN PRESCRIBED AN OINTMENT BY THE ENT.
Patient problems: Hypersensitivity/Allergic reaction; Itching Sensation
MAUDE report 22641703 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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