Phonak Audéo I90-Sphere (sand beige)Recalls & reported problems
Sonova AG · Class 2
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 07613389686593), received between Feb 23, 2026 and Feb 23, 2026 — classified as 1 injury.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component1
Patient problems
- Ear Pain1
- 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.
InjuryFeb 23, 2026Detachment of Device or Device Component
IT HAS BEEN BROUGHT TO MANUFACTURER'S ATTENTION THAT CERUTOP (WAX FILTER) OF CSHELL DOES NOT STAY IN HOLDER AND HAS REMAINED IN THE PATIENT'S EAR CANAL. THE PATIENT WENT TO HOSPITAL WHERE VARIOUS MEDICATIONS HAVE BEEN ADMINISTERED INCLUDING GENERAL ANAESTHESIA. PATIENT EXPERIENCED PAIN AND BLEEDING. CERUSTOP HAS EVENTUALLY BEEN REMOVED WITH IRRIGATION. CSHELL SN: (B)(6).
Patient problems: Ear Pain; Foreign Body In Patient
MAUDE report 24412003 ↗
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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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