MAUDE MDR 6736274

MDR report key
6736274
Report number
MW5071169
Event key
0
Event type
3
Date of event
2017-06-28
Date received
2017-07-20
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
305
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1SIGNIA HEARING SYSTEM BY SIEMENSSIGNIA HEARING SYSTEM BY SIEMENSSIVANTOS, INC.ESDPURE PRIMAXI Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-07-2001. O; 2. S

Event Narratives#

D

Patient 1

MY HEARING CAPABILITY HAD BEEN IMPAIRED FOR SEVERAL YEARS BEFORE THIS YEAR. THE AUDIOLOGIST SUGGESTED THAT I SHOULD HAVE A HEARING AID IN 2016. BUT I WAS RELUCTANT TO HAVE ONE. THIS YEAR MY AUDIOLOGIST SUGGESTED AGAIN. SO I DECIDED TO HAVE ONE TO SEE IF THE HEARING AID REALLY COULD HELP ME. I BOUGHT FOR MY BOTH EARS, ONE PAIR OF HEARING AIDS WITH THE BRAND NAME (B)(6), WHICH COST ME MORE THAN (B)(6). I USED IT FOR ABOUT ONE MONTH AND FOUND THE DEVICE AMPLIFIED BOTH NOISE AND HUMAN CONVERSATION. IT DOES NOT HELP ME. TOTALLY UNEXPECTED TO ME, AFTER I REMOVED THE HEARING AIDS I FOUND MY HEARING ABILITY HAD BEEN SERIOUSLY DETERIORATED. BEFORE I BOUGHT THE HEARING AIDS, I COULD MAKE CONVERSATION WITH MY WIFE IF SHE SPOKE A LITTLE LOUDER AND I ALSO COULD HEAR WHAT I PLAYED ON MY PIANO AS A PIECE OF MUSIC. NOW I COULD NOT TALK TO MY WIFE AS BEFORE; SHE MUST SPEAK VERY LOUDLY. ALSO I COULD NO LONGER HEAR THE MUSIC WHEN I PLAY MY PIANO. I COULD NO LONGER HEAR MUSIC BUT SOME SEPARATE SOUNDS WITH DIFFERENT PITCHES. I AM REPORTING WHAT I EXPERIENCED IS INTENDED ONLY TO WARN HEARING IMPAIRED PERSONS THAT HEARING AIDS MIGHT NOT BE A GOOD SOLUTION AND IT MIGHT CAUSE ONE'S HEARING CAPABILITY DETERIORATED EVEN WITH A MOST EXPENSIVE HEARING AID.