Phonak Brand 063-0510-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613389452037), received between Apr 17, 2025 and Apr 17, 2025 — classified as 2 injuries.

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.

• InjuryApr 17, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT HAS BEEN BROUGHT TO THE MANUFACTURERS ATTENTION THAT THE PATIENT SUFFERED FROM SWELLING AND REDNESS IN THE EAR POTENTIALLY LINKED TO THE USE OF HEARING AIDS. INITIALLY SUSPECTED ALLERGY REACTION WAS DISPROVED BY THE PATIENT'S DAUGHTER. ACCORDING TO THE PATIENT'S DAUGHTER, THE PATIENT HAS VISITED A FAMILY DOCTOR, WHO DIAGNOSED EAR INFECTION AND PRESCRIBED ANTIBIOTICS DROPS (CIPROFLOXACIN) ON (B)(6). PATIENT'S DAUGHTER REPORTS THE INFECTION IS IMPROVING GREATLY WITH ANTIBIOTICS TREATMENT. SHE ALSO UNDERLINES THAT THE PATIENT HAS NO ALLERGIES OR A HISTORY OF ALLERGIES. THE EVENT CONCERNS BOTH EARS AND BOTH DEVICES: 2505W19F & 2505W19G. A SEPARATE REPORT HAS BEEN FILED FOR DEVICE2505W19F: 3005085999-2025-00008.

  Patient problems: Ear infection

  MAUDE report 21858387 ↗
• InjuryApr 17, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT HAS BEEN BROUGHT TO THE MANUFACTURERS ATTENTION THAT THE PATIENT SUFFERED FROM SWELLING AND REDNESS IN THE EAR POTENTIALLY LINKED TO THE USE OF HEARING AIDS. INITIALLY SUSPECTED ALLERGY REACTION WAS DISPROVED BY THE PATIENT'S DAUGHTER. ACCORDING TO THE PATIENT'S DAUGHTER, THE PATIENT HAS VISITED A FAMILY DOCTOR, WHO DIAGNOSED EAR INFECTION AND PRESCRIBED ANTIBIOTICS DROPS (CIPROFLOXACIN) ON (B)(6). PATIENT'S DAUGHTER REPORTS THE INFECTION IS IMPROVING GREATLY WITH ANTIBIOTICS TREATMENT. SHE ALSO UNDERLINES THAT THE PATIENT HAS NO ALLERGIES OR A HISTORY OF ALLERGIES. THE EVENT CONCERNS BOTH EARS AND BOTH DEVICES: (B)(6). A SEPARATE REPORT HAS BEEN FILED FOR DEVICE (B)(6): 3005085999-2025-00009.

  Patient problems: Ear infection

  MAUDE report 21855537 ↗