HEARING AID ("SIEMENS PURE BINAX")

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-12-07 for HEARING AID ("SIEMENS PURE BINAX") manufactured by Siemens / Signia/ Sivantos.

Event Text Entries

[94477466] I've had an experienced with my siemens pure binax hearing aids that i wish to bring to your attention. I am a (b)(6) male who has been using hearing aids for about two years. For the last several weeks, i have felt a pinch, prick or sharp but moderate pain first on the back of my left ear, where my hearing aid sits between my ear and my head, and then more recently on my right ear, also. It increased slowly over time and was annoying, but i could bear it, and i thought perhaps i has scratched my ear or been nicked during a haircut. Although the fact that my right ear started experiencing the same sensation argued against that. Also, i had a scratching sensation on the skin behind my ears whenever i removed the hearing aid. A few nights ago, when i was taking the acts off for the right, i thought to look closely for signs of blood that might indicate a small cut that was causing the discomfiture. I was rather starting to see a pin protrude about 4 mm form the ear side (as opposed to the head side) of the device between the "ce" mark and the "carat" logo. The protruding pin must have been cutting my ear. I checked the right device, and it, too, had the corresponding pin protruding, but only about 2 mm. I used the head of a screwdriver to push them back in, as i am sure they should not have protruded, and, indeed, the pain is gone. I do not, of course, know how frequent this is, but had i continued using the aid uncorrected. It could have caused a cut, not just discomfort and slight pain. (i have a photo of the device with the pin protruding, but do not use a way to upload it here. )
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5073835
• MDR Report Key: 7100764
• Date Received: 2017-12-07
• Date of Report: 2017-12-06
• Date of Event: 2017-12-01
• Date Added to Maude: 2017-12-08
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 0
• 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 Sequence Number: 0

• Brand Name: HEARING AID ("SIEMENS PURE BINAX")
• Generic Name: HEARING AID ("SIEMENS PURE BINAX")
• Product Code: ESD
• Date Received: 2017-12-07
• Operator: LAY USER/PATIENT
• Device Availability: Y
• Device Eval'ed by Mfgr: I
• Device Sequence No: 0
• Device Event Key: 0
• Manufacturer: SIEMENS / SIGNIA/ SIVANTOS

Device Sequence Number: 1

• Brand Name: HEARING AID ("SIEMENS PURE BINAX")
• Generic Name: HEARING AID ("SIEMENS PURE BINAX")
• Product Code: ESD
• Date Received: 2017-12-07
• Operator: LAY USER/PATIENT
• Device Availability: Y
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: SIEMENS / SIGNIA

Patients

Patient Number	Treatment	Outcome	Date
1	0		2017-12-07