HEARING AID

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-17 for HEARING AID manufactured by Listen Clear.

Event Text Entries

[176019292] Listen clear falsely markets their amplified hearing devices as an fda approved hearing aid. They charged me (b)(6) for one? Hearing aid? And when i received the device and realized it was not a hearing aid they refused to refund my money and continued to debit my card each month for the (b)(6) payment. I finished paying in (b)(6) 2019. The device i ordered was for my father who was not able to use it as a hearing aid and it barely worked as an amplified sound device. No amount of complaints or calls or anything else worked with listen clear. They continue to this day (google it) to market their garbage as hearing aids which are clearly not a medical device and certainly not approved by fda. How is this possible? This was a complete waste of money and time and i wonder how they continue to be in business when both their sales force and public advertising continues to state this is an fda approved hearing aid. I have complained to the (b)(6) in my area to no avail and since they are not in my state the negative ratings do nothing to affect their business in marketing their garbage as fda approved devices. Are you going to do something or not? I can get a picture if needed. Fda safety report id # (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5092349
MDR Report Key9610511
Date Received2020-01-17
Date of Report2020-01-16
Date of Event2016-11-28
Date Added to Maude2020-01-21
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT FAMILY MEMBER OR FRIEND
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameHEARING AID
Generic NameHEARING AID, AIR CONDUCTION
Product CodeESD
Date Received2020-01-17
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerLISTEN CLEAR


Patients

Patient NumberTreatmentOutcomeDate
10 2020-01-17

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