LEGEND 6

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-12-29 for LEGEND 6 manufactured by Beltone.

Event Text Entries

[35063699] I purchased hearing aids (b)(6) 2015. I have had numerous issues with these hearing aids. I brought them back 1 week after having them. The right ear hearing aid stopped working. I was given another one a week and 2 days later. I asked (b)(6), the man who sold me the hearing aids to take them back the very first week in (b)(6). I was told to "give it another week. " i did and another, i went back a total of 2 times. Same issue in (b)(6). In (b)(6) of 2015, i went back 5 times for the same issue and now the left ear has stopped working. Again each time i went there i asked to please take them back because the noise was hurting my ears. I would walk by a tv, or walking to my car and the background noise was to harsh for me to take. I tried adjusting them, the way (b)(6) told me to and still nothing. In (b)(6) i was given a new ear domes and adjustments, and still that did not work. On (b)(6), i went back again and saw both (b)(6). This time both hearing aids had stopped working. (b)(6) told me that "there is nothing wrong with them. " yet, i could not hear and they would not turn on. I again stated i wanted to return the hearing aids and wanted my contract null and void. I was told by (b)(6) again, to give it another week. He would see what else he could do. He tried adjusting them and still nothing was stopping the background noise. On (b)(6), i came back again and demanded they take back the hearing aids for they both stopped working. (b)(6) advised me "there is nothing he can do". He told me it "must be me" using them wrong. I advised him that it was not me and reminded him the number of times i had come back since (b)(6) 2015. Again, he told me "there is nothing he can do. " i asked him to take back the hearing aides, that i wanted out of the contract and he told me no. Then i began to get very upset he told me "let me see what i can do. " he then told me he would be in touch. I never heard from him. On (b)(6), i was at a holiday party with family. I went to open a can of olives with a battery operated can opener. As i went to use the can opener the right hearing aid short circuited and a loud ringing occurred. The ringing was so loud other people around me heard it. I tried pushing the buttons to see if i could stop and it would not. Then the left hearing aid stopped working. Up till (b)(6), the hearing aids had been in my drawer. My daughters knew i was not wearing them because i was having a hard time in hearing people. I called (b)(6) and made an appointment on (b)(6) to bring the hearing aids back. I again saw (b)(6), i begged them to please take them back. I told them what had happened and got a good laugh out of them both. (b)(6) stood ther and blamed me and told me he cannot fix the background noise. He said to me again, "it must be you causing this issue. " it was not me. I was belittled in this store. I just took the hearing aids and left crying because of the way i feel. It was at this point i asked by daughter, (b)(6), to get involved. She researched my rights and i feel i have been deceived and taken advantage of. All i want is my contract to be canceled with (b)(6). For 6 months i have paid for a product that never worked, was never fixed and made fun of by this man. I feel as a senior citizen, i was nothing more than an easy target. I want these contracts null and void and want all the money i paid year to date back. Thank you.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5058852
MDR Report Key5341287
Date Received2015-12-29
Date of Report2015-12-29
Date of Event2015-12-21
Date Added to Maude2016-01-04
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameLEGEND 6
Generic NameLEGEND 6
Product CodeESD
Date Received2015-12-29
Model NumberLEGEND 6
Device Availability*
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerBELTONE


Patients

Patient NumberTreatmentOutcomeDate
10 2015-12-29

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