Phonak 050-0676-P3Recalls & reported problems
Sonova AG · Phonak Bolero M70-PR (sandalwood) · Class 2
- 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 07613275689783), received between Jun 23, 2025 and Jun 23, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Output 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
- Output Problem1
Patient problems
- Tinnitus1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 23, 2025Output Problem; Output Problem
THE HCP REPORTS THAT THE END USER HAS RECEIVED A POP TRAUMA DUE TO A FEEDBACK MEASUREMENT AFTER DELIVERY OF A NEW EARPIECE, WHICH HAS SIGNIFICANTLY INCREASED HIS ALREADY PREEXISTING TINNITUS AND HE CAN NO LONGER PARTICIPATE IN NORMAL LIFE.
Patient problems: Tinnitus
MAUDE report 22306712 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.