Please read this before considering which brand to implant. I have 2 sons who are deaf and slowly going blind. At the rate the parts break from Cochlear Americas my sons most likely will go blind before being able to understand words. Please read and see if this is a company you want to do business with.
Cochlear and the elliptical logo are trademarks of Cochlear Limited.
January 8, 2010
Delivered by email - firstname.lastname@example.org
TO: Mrs. Geisendorff
Cochlear Americas’ (“Cochlear”) customer service department forwarded your demands to me,
due to your threat of litigation. Cochlear appreciate that you provided us additional time to
evaluate and respond to your demands. Please forward this letter to your lawyer if you have
First of all, please note that it is very unlikely that a valid legal claim exists against Cochlear
relating to the issues your children have had with their Cochlear sound processor parts. The
1976 Medical Devices Amendments (“MDA”) provide clear pre-emption of state claims for
FDA PMA approved Class III devices. Your sons’ cochlear implant devices are Class III
devices that were approved pursuant to the PMA process. Courts consistently uphold this
preemption, which eliminates state asserted product liability, negligence, strict liability, and
implied warranty claims. See e.g., Riegel v. Medtronic, 128 S. Ct. 999 (U.S. 2008).
Additionally, the wear and tear issues your sons are experiencing are not design defects. It
appears that your sons’ are primarily having issues related to the external part called the bayonet,
which attaches the sound processor to the controller. This type of issue does occur periodically,
especially with child recipients. Children are inclined to have slightly more breakages with the
external parts. You have received the appropriate remedies in accordance with the warranty on
the products. The warranty provides the remedy for any product found “not to be of
merchantable quality, reasonably fit for the purpose or purposes for which it was supplied, or if it
has defects in workmanship or materials during the warranty period.” Among the remedies are
to replace the product, which Cochlear has consistently done in your sons’ situations. A copy of
the warranty card is attached.
We regret your dissatisfaction with your sons’ Cochlear implant external device. However,
Cochlear has satisfied its obligations to you. It has provided your sons with replacement parts as
needed, at no charge, all in accordance with the warranty on the parts.
Cochlear and the elliptical logo are trademarks of Cochlear Limited. 2
Nevertheless, Cochlear remains willing to try to address some of your inconvenience and general
dissatisfaction with your sons’ parts. We would like to have one of our clinical application
specialists (“CAS”) arrange to meet with you at your audiologist’s offices to review each of your
sons’ processors and associated parts to see if we can provide you with any suggestions to
minimize the wear and tear on the parts and to assess the condition of the existing parts. If there
are parts needing replacement, the CAS can facilitate the replacement with equivalent Freedom
parts. If you would like to take advantage of this offer, please contact Sara Causin at 504-834-
7852 and she will make the arrangements.
cc: Tanya Anderpont at Ochsner Clinic