Lexie Hearing Lexie LumenRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00858177007540), received between Sep 22, 2025 and Sep 22, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Break” (2 reports).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjurySep 22, 2025Break; Wireless Communication Problem; Patient Device Interaction Problem

  BOUGHT THROUGH WALGREEN'S. FOLLOWING THE STEPS IN THE "SAY HELLO TO YOUR LEXIES" BOOKLET, I USED A 2B SLIM TUBE AND TULIP DOME. LENGTH WAS CORRECT PER EAR MEASUREMENT CARD. I PUT THE HEARING AID ON AND PUT THE DOME JUST INSIDE THE EAR. I VERY, VERY LIGHTLY TAPPED THE SLIM TUBE WHICH PUSHED THE DOME INTO MY EAR. I FIGURED THIS WAS HOW IT WAS SUPPOSED TO BE. I PUT THE OTHER ONE ON THE SAME AS THE FIRST. I COULDN'T GET THE AIDES TO CONNECT TO MY IPHONE'S BLUETOOTH. SO, I WENT TO TAKE THEM OUT TO CHECK THE BATTERY PLACEMENT. WHEN I GENTLY TUGGED ON THE SLIM TUBE CLOSEST TO THE DOME. THE SLIM TUBE CAME OUT; THE DOME DID NOT - ON EITHER SIDE. I COULD NOT REACH FAR ENOUGH IN TO REMOVE THE DOMES. MY HUSBAND TRIED BUT COULD NOT SEE THE DOME TO TRY TO REACH IT IN EITHER EAR. I WENT TO AN IMMEDIATE CARE. THEY COULD SEE THE DOMES BUT WERE UNSUCCESSFUL WITH LONG TWEEZERS (EXTREMELY PAINFUL) AND SENT ME TO THE EMERGENCY ROOM. THEY USED ALLIGATOR FORCEPS AND WERE ABLE TO REMOVE THE DOMES FROM BOTH EARS. EXCRUCIATINGLY PAINFUL REMOVAL! I WAS GIVEN TOPICAL ANTIBIOTICS AS MY LEFT EARDRUM WAS BLEEDING FROM THE DIGGING, SCRAPING AND DIFFICULT REMOVAL. HOSPITAL KEPT THE DOMES TO THROW AWAY. I DO STILL

  Patient problems: Ear Pain; Ear injury; Foreign Body In Patient; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23107946 ↗
• InjurySep 22, 2025Break; Wireless Communication Problem; Patient Device Interaction Problem

  BOUGHT THROUGH WALGREEN'S. FOLLOWING THE STEPS IN THE "SAY HELLO TO YOUR LEXIES" BOOKLET, I USED A 2B SLIM TUBE AND TULIP DOME. LENGTH WAS CORRECT PER EAR MEASUREMENT CARD. I PUT THE HEARING AID ON AND PUT THE DOME JUST INSIDE THE EAR. I VERY, VERY LIGHTLY TAPPED THE SLIM TUBE WHICH PUSHED THE DOME INTO MY EAR. I FIGURED THIS WAS HOW IT WAS SUPPOSED TO BE. I PUT THE OTHER ONE ON THE SAME AS THE FIRST. I COULDN'T GET THE AIDES TO CONNECT TO MY IPHONE'S BLUETOOTH. SO, I WENT TO TAKE THEM OUT TO CHECK THE BATTERY PLACEMENT. WHEN I GENTLY TUGGED ON THE SLIM TUBE CLOSEST TO THE DOME. THE SLIM TUBE CAME OUT; THE DOME DID NOT - ON EITHER SIDE. I COULD NOT REACH FAR ENOUGH IN TO REMOVE THE DOMES. MY HUSBAND TRIED BUT COULD NOT SEE THE DOME TO TRY TO REACH IT IN EITHER EAR. I WENT TO AN IMMEDIATE CARE. THEY COULD SEE THE DOMES BUT WERE UNSUCCESSFUL WITH LONG TWEEZERS (EXTREMELY PAINFUL) AND SENT ME TO THE EMERGENCY ROOM. THEY USED ALLIGATOR FORCEPS AND WERE ABLE TO REMOVE THE DOMES FROM BOTH EARS. EXCRUCIATINGLY PAINFUL REMOVAL! I WAS GIVEN TOPICAL ANTIBIOTICS AS MY LEFT EARDRUM WAS BLEEDING FROM THE DIGGING, SCRAPING AND DIFFICULT REMOVAL. HOSPITAL KEPT THE DOMES TO THROW AWAY. I DO STILL

  Patient problems: Ear Pain; Ear injury; Foreign Body In Patient

  MAUDE report 23107934 ↗