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PHONAK 050-0485-P3Recalls & reported problems

Sonova AG · Phonak Audéo M70-R (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 07613275640043), received between Aug 21, 2023 and Aug 21, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Break” (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.

Most reported problems

Device problems

  • Break1
  • Detachment of Device or Device Component1

Patient problems

  • Foreign Body In Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryAug 21, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

    HCP HAS REPORTED THAT ON SATURDAY, (B)(6) 2023, PATIENT'S LEFT RECEIVER BROKE OFF AND REMAINED IN THE EAR CANAL. THE PATIENT HAD THE PART REMOVED FROM THE EAR AT EMERGENCY ROOM. DUE TO RECEIVER BEING ATTACHED TO THE CERUMEN IN THE EAR, THERE WAS SOME BLEEDING FOLLOWING THE REMOVAL. PATIENT HAS BEEN GIVEN ANTIBIOTIC DROPS FOR SEVERAL DAYS. THE PATIENT WAS SEEN BY THE HCP MONDAY, (B)(6). HCP CONFIRMED THAT THE EAR LOOKED GOOD AND HAS REPLACED THE BROKEN RECEIVER. PATIENT HAS BEEN WEARING HEARING AIDS SUCCESSFULLY WITHOUT FURTHER ISSUES. THIS IS AN INITIAL REPORT. SUPPLEMENTAL REPORTS WILL BE SUBMITTED UPON AVAILABILITY OF FURTHER INFORMATION.

    Patient problems: Foreign Body In Patient

    MAUDE report 17588099 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.