MAUDE Adverse Event Report: HEARX USA LEXIE B2 HEARING AIDS; SELF-FITTING AIR-CONDUCTION HEARING AID, OVER THE COUNTER

Model Number BMD014

Patient Problems Itching Sensation (1943); Foreign Body In Patient (2687); Unspecified Ear or Labyrinth Problem (4474)

Event Date 11/27/2023

Event Type  Injury  

Event Description

I have owned a pair of lexie b2 hearing aids for a year.They constantly screech, especially when i am talking.People hear the screech.I have asked lexie to fix them and they sent a replacement wire but the problem persists.In addition, my inner ear started to itch when using the hearing aids this thanksgiving which is an adverse event.Furthermore, another adverse event occurred when one of the tips became stuck in my ear canal for a brief moment, although i was able to remove it.These hearing aids omit a loud screeching noise and now have started to cause damage to my ear canal and are essentially unwearable.

• Brand Name: LEXIE B2 HEARING AIDS
• Type of Device: SELF-FITTING AIR-CONDUCTION HEARING AID, OVER THE COUNTER
• Manufacturer (Section D): HEARX USA
• MDR Report Key: 18266942
• MDR Text Key: 329888827
• Report Number: MW5148756
• Device Sequence Number: 1
• Product Code: QUH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 12/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: BMD014
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/04/2023
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 54 YR