Class 2 Device Recall Lyric Hearing Aid

• Date Initiated by Firm: January 19, 2010
• Date Posted: May 26, 2010
• Recall Status: Terminated on August 02, 2011
• Recall Number: Z-1681-2010
• Recall Event ID: 54473
• 510(K)Number: K081136
• Product Classification: hearing aid - Product Code ESD
• Product: InSound Medical, Inc, Lyric in-canal hearing aid.
• Code Information: All devices manufactured between 12/10/2009 and 12/24/2009. Expiration dates 12/10/2010 through 12/24/2010.
• Recalling Firm/ Manufacturer: InSound Medical, Inc.; 37500 Central Ct; Newark CA 94560-3454
• For Additional Information Contact: 510-792-4000 Ext. 470
• Manufacturer Reason for Recall: Manufacturing error could result in electrolyte leakage from the product's battery.
• FDA Determined Cause: Process design
• Action: InSound sent to its consignees a "Dear Lyric Provider" letter of explanation on 2/1/2010.
• Quantity in Commerce: 2019 units
• Distribution: Distribution only in US ( nationwide). No foreign consignees involved.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = ESD