MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-03-31 for LYRIC HEARING AID LYRIC 3 manufactured by Phonak Ag.
[41940289]
The lyric 3 hearing aid is implanted in the ear canal and is supposed to last 2-3 months before the battery dies. The patient then has their audiologist replace the hearing aid with a new one. The lyric 3 is sold as a 12 month subscription for (b)(6). I began my lyric subscription for tow lyrics on (b)(6) 2015. As of (b)(6) 2016 approximately 14 lyric hearing aids implanted in my ear canals have malfunctioned in the first week after implantation. Two of these failures occurred as i was driving home from the audiologist. Every failure requires a visit to my audiologist for replacement. I cannot get out of my 12 month contract and lyric will not refund my money.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5061472 |
| MDR Report Key | 5546944 |
| Date Received | 2016-03-31 |
| Date of Report | 2016-03-31 |
| Date of Event | 2015-07-08 |
| Date Added to Maude | 2016-04-05 |
| 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 |
| Brand Name | LYRIC HEARING AID |
| Generic Name | HEARING AID |
| Product Code | ESD |
| Date Received | 2016-03-31 |
| Model Number | LYRIC 3 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHONAK AG |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-03-31 |