MAUDE Adverse Event Report: UNKNOWN HEARING AID; HEARING AID, AIR CONDUCTION, PRESCRIPTION

Device Problem Defective Device (2588)

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

Event Date 05/15/2023

Event Type  malfunction  

Event Description

Patient called to report a failed hearing aid (left side).Hearing aids inserted on (b)(6) 2023 by her doctor.Both were working when she left the doctor's office.On (b)(6) 2023, the hearing aid in her left ear stopped working.

• Brand Name: HEARING AID
• Type of Device: HEARING AID, AIR CONDUCTION, PRESCRIPTION
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 17004231
• MDR Text Key: 316054596
• Report Number: MW5117853
• Device Sequence Number: 1
• Product Code: ESD
• 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: 05/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Is the Reporter a Health Professional?: No
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Sex: Female