MAUDE Adverse Event Report: AUDIEN HEARING / BUDGET HEARING AIDS LLC BTE HEARING AID; HEARING AID, AIR-CONDUCTION, OVER THE COUNTER

Model Number BTE

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/30/2024

Event Type  malfunction  

Event Description

I was inserting the receiver for my left hearing aid into my ear.As i was putting it into the ear canal the wire attaching it to the behind the ear portion of the hearing aid broke off flush with the receiver.Because the receiver was not fully inserted into the ear canal i was able to remove it without medical assistance.Once fully inserted in the canal, it would be beyond reach without a medical procedure.

• Brand Name: BTE HEARING AID
• Type of Device: HEARING AID, AIR-CONDUCTION, OVER THE COUNTER
• Manufacturer (Section D): AUDIEN HEARING / BUDGET HEARING AIDS LLC
• MDR Report Key: 18660951
• MDR Text Key: 334897355
• Report Number: MW5151140
• Device Sequence Number: 1
• Product Code: QUF
• 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: 02/04/2024

1 Device was Involved in the Event

• Date FDA Received: 02/06/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: BTE
• Device Catalogue Number: 202304
• Device Lot Number: BTE01
• Was Device Available for Evaluation?: No