MAUDE Adverse Event Report: APPLE, INC. APPLE AIRPODS PRO; AIR-CONDUCTION HEARING AID SOFTWARE

Model Number	A3047
Health Effect - Clinical Codes	Tinnitus (2103); Unspecified Ear or Labyrinth Problem (4474)
Date of Event	03/15/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Apple earpods in "noise cancellation" mode caused tinnitus, a ringing and clogged ear sensation.Condition subsided naturally after 24 hours.

• Brand Name: APPLE AIRPODS PRO
• Common Device Name: AIR-CONDUCTION HEARING AID SOFTWARE
• Manufacturer (Section D): APPLE, INC.
• MDR Report Key: 21731376
• Report Number: MW5168414
• Device Sequence Number: 15406549
• Product Code: SCR
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 03/26/2025

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
• Operator of Device: Lay User/Patient
• Device Model Number: A3047
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/31/2025
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CYCLOBENZAPRINE.; MAGNESIUM.; QULIPTA.; ZYRTEC.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 48 YR
• Patient Sex: Female
• Patient Weight: 61 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White