Signia Siemens INSIO 1PXRecalls & reported problems
Ws Audiology Usa, Inc. · Signia Siemens INSIO 1PX 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 04056839035788), received between Jun 11, 2024 and Jun 11, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Patient Device Interaction Problem” (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
- Patient Device Interaction Problem1
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 11, 2024Patient Device Interaction Problem; Patient Device Interaction Problem
IN THIS EVENT, CUSTOMER REPORTED A SHARP LOUD SOUND FROM LEFT HEARING AID WHEN HE WAS INSERTING THE AID. THIS WAS FOLLOWED BY PAIN IN LEFT SIDE OF HEAD AND ONGOING TINNITUS. CUSTOMER WAS ASSESSED BY HEARING CARE PROFESSIONAL (04/29/2024) AND LEFT EAR WAS SHOWING SOME MINOR CONDUCTIVE DECLINE, AS COMPARED TO HIS TESTING IN MARCH. CLINICIAN CONDUCTED HEARING ASSESSMENT AND TYMPANOMETRY REVEALED TYPE B TYMPANOGRAMS, CONSISTENT WITH A CONDUCTIVE COMPONENT TO HEARING LOSS. ALSO OBSERVED WAS AN ACTIVE EAR INFECTION AND THE CUSTOMER WAS PRESCRIBED ANTIBIOTICS TO TREAT INFECTION; CONSISTENT WITH THE TYMPANOMETRIC RESULTS. THE MAXIMUM OUTPUT SPL (SOUND PRESSURE LEVEL) FROM THE DEVICE IS LIMITED BY SAFETY LIMITER. RESULTS OF TECHNICAL INVESTIGATION: LEFT HEARING AID WAS RETURNED FOR INVESTIGATION. BASED ON ACOUSTIC TEST RESULT, HEARING AID IS FUNCTIONING WITHIN SPECIFICATION. THE MAXIMUM GAIN THAT THE HA CAN GIVE IS ONLY 52.1 DECIBEL AND MAX OSPL90 IS 111.5 DECIBEL, WHICH IS WITHIN THE DEVICE SPECIFICATION. THE MAX OUTPUT LEVEL IS LOW BY INDUSTRY STANDARDS AND WOULD NOT BE ASSOCIATED WITH A CONDUCTIVE HEARING LOSS. INTERNAL AUDIOLOGIST EVALUATION: THE TYPE B TYMPANOGRAM (CONSISTENT WITH A CO
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 19510450 ↗
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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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