Phonak Brand 050-0889-P3Recalls & reported problems
Sonova AG · Phonak Audéo L90-R (sandalwood) · Class 2
All models of Phonak Brand (25)
Data updated Oct 16, 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 07613389477818), received between May 19, 2023 and May 19, 2023 — classified as 1 injury.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 16, 2026.
Most reported problems
Device problems
- Insufficient Device Problem Information1
- Output Problem1
Patient problems
- Hearing Impairment1
- Tinnitus1
- Vertigo1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 19, 2023Output Problem; Insufficient Device Problem Information; Output Problem; Insufficient Device Problem Information
HCP REPORTED THAT AFTER THE HEARING AID CAME BACK FROM REPAIR IN MARCH 2023, THE PATIENT HEARD STATIC AND A LOUD SOUND IN THE LEFT HEARING AID. FOLLOWING THE EVENT THE PATIENT HAS EXPERIENCED A DECREASE IN HEARING, VERTIGO AND TINNITUS IN LEFT EAR. THE PATIENT SAW AN ENT ON (B)(6) 2023 AND WAS PRESCRIBED ORAL STEROIDS. THE PATIENT HAS DISCONTINUED THE USE OF THE HEARING AIDS AND RETURNED THEM TO HCP. THIS IS AN INITIAL REPORT. INVESTIGATION IS ONGOING. SUPPLEMENTAL REPORTS WILL BE SUBMITTED UPON AVAILABILITY OF FURTHER INFORMATION.
Patient problems: Hearing Impairment; Tinnitus; Vertigo
MAUDE report 16962200 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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