Phonak Brand 050-0790-P3Recalls & reported problems
Sonova AG · Phonak Audeo P50-13T · Class 2
All models of Phonak Brand (25)
Data updated Oct 18, 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 07613389509717), received between Feb 15, 2023 and Feb 15, 2023 — classified as 1 injury.
The most frequently reported specific device problem is “Noise, Audible” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Noise, Audible1
- Product Quality Problem1
Patient problems
- Acoustic Shock1
- Epistaxis1
- Hearing Impairment1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 15, 2023Product Quality Problem; Noise, Audible; Product Quality Problem; Noise, Audible
THE PATIENT PRESENTED TO HIS AUDIOLOGIST REPORTING OF A HIGH PITCHED SOUND AND REPORTED THAT HE HAD FELT A "SHOCK" FROM THE HEARING AID. THE PATIENT HAD REPORTEDLY VISITED THE EMERGENCY ROOM FOR MEDICAL ASSESSMENT FOLLOWING THE INITIAL EVENT. THE PATIENT PRESENTED WITH BLEEDING NOSE AND PAIN TO THE RIGHT SIDE OF THE FACE. AUDIOLOGICAL TESTING REVEALED CHANGES TO THE AUDIOGRAM AND THESE SYMPTOMS ARE YET TO BE RESOLVED. AUDIOLOGICAL TESTING CONDUCTED ONE MONTH AFTER THE REPORTED EVENT INDICATED HEARING LOSS AS SEVERE-TO-PROFOUND LOSS, WHEN PREVIOUSLY IT WAS CONSIDERED MILD-TO-MODERATE. THE PATIENT ALSO HAD DECREASE IN WORD RECOGNITION SCORES COMPARED TO PREVIOUS RESULTS. HE REPORTED "CONTINUING PAIN". SUBSEQUENT TESTING ANOTHER MONTH AND A HALF LATER INDICATED THAT THE PATIENT'S AUDIOGRAM PRESENTED AS A MODERATE LOSS, SHOWING SOME RECOVERY SINCE THE EARLIER VISIT. THE AUDIOLOGIST REPORTS THAT THE PATIENT'S WORD RECOGNITION SCORES ALSO IMPROVED COMPARED TO THE EARLIER SESSION. INVESTIGATION OF THIS EVENT IS STILL ONGOING AND WILL BE PART OF THE SUPPLEMENTAL REPORT. WHEN FURTHER INFORMATION IS AVAILABLE A SUPPLEMENTAL REPORT WILL BE SCHEDULED.
Patient problems: Acoustic Shock; Epistaxis; Hearing Impairment
MAUDE report 16383099 ↗
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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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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