MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-01-18 for LYRIC INVISIBLE IN-THE-CANAL HEARING AID UNK manufactured by Phonak.
[36938976]
I have worn lyric (phonak) hearing aids since approximately (b)(6) 2014. Even when they function properly i have feedback issues that my dispenser has never been able to fully address. The solution has been to turn down amplification, reducing the effectiveness. I have never gotten more than four or five weeks out of an aid. My complaint is that in recent months some devices fail almost immediately. To illustrate, i had both replaced (b)(6) 2016, the right failed (b)(6) and the left failed (b)(6). Both were replaced (b)(6); the right failed (b)(6) and i'm waiting for the left to fail as i type this on (b)(6). I have mild nerve deafness and do not function well without working aids. Further, i typically commute via bicycle and not hearing overtaking vehicles is dangerous. My dispenser is (b)(6). They've acknowledged problems with the lyric and will fit me with a different device, tbd, in (b)(6). I paid for a lyric subscription that expires early april.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5059563 |
| MDR Report Key | 5384810 |
| Date Received | 2016-01-18 |
| Date of Report | 2016-01-18 |
| Date of Event | 2016-01-17 |
| Date Added to Maude | 2016-01-22 |
| 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 INVISIBLE IN-THE-CANAL HEARING AID |
| Generic Name | LYRIC INVISIBLE IN-THE-CANAL HEARING AID |
| Product Code | ESD |
| Date Received | 2016-01-18 |
| Model Number | UNK |
| Device Expiration Date | 2016-01-31 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHONAK |
| Brand Name | LYRIC INVISIBLE IN-THE-CANAL HEARING AID |
| Generic Name | LYRIC INVISIBLE IN-THE-CANAL HEARING AID |
| Product Code | ESD |
| Date Received | 2016-01-18 |
| Model Number | UNK |
| Device Expiration Date | 2016-01-31 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | PHONAK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-01-18 |