MAUDE Adverse Event Report: AUDIEN HEARING AUDIEN ATOM; HEARING AID, AIR-CONDUCTION, OVER THE COUNTER

Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Purchased otc (over the counter) hearing aids (b)(6) 2023.Use it 1-2 hrs once a week.Today one unit does not work.Fully recharged both, still no change.Tried customer support at "support@audienhearing.Com".They wanted my credit card number! reference report: mw5153348.

• Brand Name: AUDIEN ATOM
• Common Device Name: HEARING AID, AIR-CONDUCTION, OVER THE COUNTER
• Manufacturer (Section D): AUDIEN HEARING; 10733 n frank lloyd wright blvd; ste 103; scottsdale AZ 85259
• MDR Report Key: 19002641
• Report Number: MW5153347
• Device Sequence Number: 19057679
• Product Code: QUF
• Combination Product (Y/N): N
• Initial Reporter State: HI
• 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): 03/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/28/2024
• Patient Sequence Number: 1
• Patient Age: 80 YR
• Patient Sex: Male
• Patient Weight: 64 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian