Signia Siemens HA MOTION SP 2PX BGRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04038953855855), received between Mar 5, 2024 and Mar 5, 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.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMar 5, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  IN THIS EVENT, PATIENT IN FRANCE WITH A HISTORY OF OTITIS DEVELOPED OTITIS THREE TIMES IN HER LEFT EAR AFTER WEARING MOTION SP 2 PX HEARING AIDS WITH EARMOLDS. THE ENT DID NOT THINK THE OTITIS ORIGINATED FROM THE DEVICES, BUT THE INFECTION APPEARS TO FEED ON THE OCCLUSION OF THE EAR CANALS BY THE EARMOLDS. EARMOLDS INITIALLY MADE OF ACRYLIC AND REMADE WITH SILICONE. THE SAME TYPE OF HEARING AIDS AND EARMOLDS ARE DISTRIBUTED IN THE U.S. AS PROOF OF DESIGN THE MATERIALS ARE TESTED FOR BIOCOMPATIBLITY ACCORDING TO ISO 10993-1. THE DEVICE WAS NOT RETURNED; IT IS SPECULATED THAT THE ON-GOING INFECTION WHICH WAS PREVIOUSLY HAD BY THE USER WAS ADDITIONALLY CONTRIBUTED WHEN USING THE EARMOLDS WHICH CLOSED THE EAR CANALS. THIS ALLOWED FOR THE BUILD-UP OF BACTERIUM AGAINST THE USERS SKIN. THE FACT THAT THE OTITIS OCCURS WITH DIFFERENT ITEMS (EARMOLDS MADE OF SILICONE AND ACRYLIC RESIN) ALSO LEADS TO THE CONCLUSION THAT THE OTITIS IS NOT RELATED TO THE USED MATERIAL.

  Patient problems: Ear infection

  MAUDE report 18838693 ↗