Events

Recall of Device Recall Lyric Hearing Aid

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by InSound Medical, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    54473
  • Event Risk Class
    Class 2
  • Event Number
    Z-1681-2010
  • Event Initiated Date
    2010-01-19
  • Event Date Posted
    2010-05-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-08-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=88543
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    hearing aid - Product Code ESD
  • Reason
    Manufacturing error could result in electrolyte leakage from the product's battery.
  • Action
    InSound sent to its consignees a "Dear Lyric Provider" letter of explanation on 2/1/2010.

Device

Device Recall Lyric Hearing Aid
  • Model / Serial
    All devices manufactured between 12/10/2009 and 12/24/2009. Expiration dates 12/10/2010 through 12/24/2010.
  • Product Classification
    Ear, Nose, and Throat Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Distribution only in US ( nationwide). No foreign consignees involved.
  • Product Description
    InSound Medical, Inc, Lyric in-canal hearing aid.
  • Manufacturer
    InSound Medical, Inc.

Manufacturer

InSound Medical, Inc.
  • Manufacturer Address
    InSound Medical, Inc., 37500 Central Ct, Newark CA 94560-3454
  • Manufacturer Parent Company (2017)
    Sonova Holding Ag
  • Source
    USFDA