FDA Adverse Event Malfunction Summary report: N

SIGNIA PURE CHARGE AND GO 7AX

MDR report key: 19684034 · Received July 3, 2024

Report

Report Number
MW5157045
Event Type
Malfunction
Date Received
July 3, 2024
Date of Event
July 1, 2024
Report Date
July 1, 2024
Manufacturer
SIGNIA GMBH / WS AUDIOLOGY
Product Code
OSM
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
CA, US
Reporter Occupation
PATIENT
Health Professional
*

Narratives

Description of Event or Problem · 0

THIS IS A COMPLAINT ABOUT CURRENT POLICY AND REQUIREMENTS FOR HEARING AID PROVIDERS. I NEED TO SEND ONE OF MY HEARING AIDS OUT FOR REPAIR, WHICH IS AT MINIMUM A 2 WEEK PROCESS. HOWEVER, MY PROVIDER DOES NOT PROVIDE LOANERS IN ANY CAPACITY FOR ME TO USE WHILE MY DEVICE IS GETTING REPAIRED. THIS IS THE EQUIVALENT OF BEING SENT HOME WITH ONLY ONE LENS IN MY GLASSES. I CANNOT PERFORM MY WORK RESPONSIBILITIES IN A PROFESSION FASHION WITHOUT BOTH MY HEARING AID DEVICES. THIS IS A SERIOUS GAP IN CURRENT FDA POLICY FOR THESE DEVICES AND THOSE OF US THAT DEPEND ON THEM TO LIVE OUR LIVES. FURTHERMORE, MY PROVIDER MADE CLEAR THAT THE INDUSTRY NO LONGER HAS DEVICES FOR COMPLETING WHAT IS CALLED A BOX TEST TO ENSURE THE DEVICES ARE WORKING ACCORDING TO MANUFACTURER SPECIFICATIONS. I WAS TOLD THAT THESE BOX TEST DEVICES ARE RARELY USED TODAY. FURTHERMORE, REGULATIONS ARE NEGLIGENT TO NOT REQUIRE A REAL EAR MEASUREMENT TEST AS A PART OF STANDARD HEARING AID FITTING PROCEDURE. THE CURRENT RELIANCE ON MANUFACTURER PRESETS AND ALGORITHMS IS A MASSIVE DISSERVICE TO PATIENTS AND STAGGERINGLY UNDERUTILIZED APPLICATION OF THE FAR SUPERIOR PROCESSING POWER AVAILABLE IN THE LIVE SOUND AND RECORDING STUDIO SETTINGS. LIMITING MICROPHONES AND DEVICES TO A BANDWIDTH OF 100HZ-9.5KHZ DEPRIVES PATIENTS OF A NATURAL SOUND AND FULL MUSIC. THE ARCHAIC FOCUS ON SPEECH RECOGNITION AS THE PRIMARY GOAL OF TREATMENT IS GROSSLY NEGLIGENT TO THE IDEA OF PROVIDING THE BEST POSSIBLE AUDIO QUALITY TO THE LISTENER. A PAIR OF (B)(6) DEVICES SHOULD BE ABLE TO REPRODUCE RECORDED MUSIC IN AT LEAST AN EQUAL IF NOT MUCH GREATER QUALITY THAN A (B)(6) PAIR OF EARBUDS. PLEASE REACH OUT TO THE AUDIO PROFESSIONAL COMMUNITY WITH THE CURRENT TOP OF THE LINE MICROPHONE AND RECEIVER DATA TO GET AN IDEA OF JUST HOW BAD HEARING AIDS ARE.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1458406 SIGNIA PURE CHARGE AND GO 7AX HEARING AID, AIR-CONDUCTION WITH WIRELESS TECHNOLOGY, PRESCRIPTION OSM SIGNIA GMBH / WS AUDIOLOGY C&G 7AX

Patients

Seq Age Sex Outcome Treatment
1 36 YR Male