MAUDE Adverse Event Report: EARGO INC. EARGO 7 OTC HEARING AID; SELF-FITTING AIR-CONDUCTION HEARING AID, OVER THE COUNTER

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Total Hearing Loss (4473)

Event Date 04/19/2023

Event Type  Other  

Event Description

Patient was sold an otc hearing aid by eargo and the patient has unilateral hearing loss.The patient was not told to see an audiologist by eargo due to the unilateral hearing loss.

• Brand Name: EARGO 7 OTC HEARING AID
• Type of Device: SELF-FITTING AIR-CONDUCTION HEARING AID, OVER THE COUNTER
• Manufacturer (Section D): EARGO INC.
• MDR Report Key: 16877064
• MDR Text Key: 314648741
• Report Number: MW5117278
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/19/2023

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?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/04/2023
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 51 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White