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

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/14/2020

Event Type  malfunction  

Event Description

Patient called on behalf of her husband with a complaint involving hearing aids she ordered from audien hearing which they still have not received.Patient stated that her and her husband tried calling numbers they were given when they placed the order, but nobody picks up.Patient said they were promised one day delivery, but still have not received the devices.Patient said she believes audien hearing is a scam business and wanted to report them to the fda.

• Brand Name: HEARING AID
• Type of Device: HEARING AID, AIR CONDUCTION
• MDR Report Key: 10167724
• MDR Text Key: 195946077
• Report Number: MW5095067
• 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 Family Member or Friend
• Type of Report: Initial
• Report Date: 06/17/2020
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 79 YR