SIGNIA HEARING SYSTEM BY SIEMENS PURE PRIMAX

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-07-20 for SIGNIA HEARING SYSTEM BY SIEMENS PURE PRIMAX manufactured by Sivantos, Inc..

Event Text Entries

[80950985] 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.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5071169
• MDR Report Key: 6736274
• Date Received: 2017-07-20
• Date of Report: 2017-07-20
• Date of Event: 2017-06-28
• Date Added to Maude: 2017-07-24
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: PATIENT
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Details

• Brand Name: SIGNIA HEARING SYSTEM BY SIEMENS
• Generic Name: SIGNIA HEARING SYSTEM BY SIEMENS
• Product Code: ESD
• Date Received: 2017-07-20
• Model Number: PURE PRIMAX
• Operator: LAY USER/PATIENT
• Device Availability: Y
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: SIVANTOS, INC.

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other; 2. Deathisabilit	2017-07-20