MAUDE Adverse Event Report: HEARING AIDS FOR SENIORS RECHARGEABLE WITH NOISE CANCELLING, 16 CHANNELS BLUETOO; SELF-FITTING AIR-CONDUCTION HEARING AID, OVER THE COUNTER

Model Number B0C1YSDT32

Device Problems Crack (1135); Degraded (1153); Device Emits Odor (1425); Device Markings/Labelling Problem (2911)

Patient Problem Unspecified Ear or Labyrinth Problem (4474)

Event Date 07/25/2023

Event Type  Injury  

Event Description

Additional information received on 08/14/2023 for mw5120370 to change procode to quh.

• Brand Name: HEARING AIDS FOR SENIORS RECHARGEABLE WITH NOISE CANCELLING, 16 CHANNELS BLUETOO
• Type of Device: SELF-FITTING AIR-CONDUCTION HEARING AID, OVER THE COUNTER
• MDR Report Key: 17425602
• MDR Text Key: 322287189
• Report Number: MW5120370
• 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,Followup
• Report Date: 07/27/2023

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 Model Number: B0C1YSDT32
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/28/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/14/2023
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 66 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White