Signia Siemens INSIO 7PXRecalls & reported problems
Ws Audiology Usa, Inc. · Signia Siemens INSIO 7PX Hearing Aid · 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 04056839129753), received between Mar 19, 2024 and Mar 19, 2024 — classified as 1 injury.
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
- Appropriate Device Problem Term/Code Not Available1
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.
InjuryMar 19, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
IN THIS EVENT, PATIENT INGESTED HIS HEARING AID (WITHOUT BATTERY) AND WENT TO THE EMERGENCY ROOM. PATIENT WAS SENT HOME AND HEARING AID WAS PASSED THRU HIS BODY. DOCTOR CONFIRMED THE DEVICE WAS INTACT AND CUSTOMER IS DOING OK AFTER THE EVENT. THE SHELL IS MADE OF POLY(METHYL METHACRYLATE) AND POLYAMIDE. SWALLOWING THE HEARING AIDS IS A MISUSE AND IS IDENTIFIED IN THE USER GUIDE.
Patient problems: Foreign Body In Patient
MAUDE report 18934515 ↗
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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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