Recall Z-1681-2010 ยท ESD Hearing Aid, Air-Conduction, Prescription
InSound Medical, Inc.
InSound Medical, Inc, Lyric in-canal hearing aid.
| Date | May 26, 2010 (initiated Jan 19, 2010) |
| Status | Terminated |
| Reason | Manufacturing error could result in electrolyte leakage from the product's battery. |
| Root cause | Process design |
| Action | InSound sent to its consignees a "Dear Lyric Provider" letter of explanation on 2/1/2010. |
| Quantity | 2019 units |
| Distribution | Distribution only in US ( nationwide). No foreign consignees involved. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K081136 | LYRIC HEARING AID Insound Medical, Inc., May 8, 2008 |