The product liability attorneys at SHOOP | A PROFESSIONAL LAW CORPORATION
continue to review potential claims and accept new cases involving the
recalled, Cochlear Nucleus CI512 implant.
While Cochlear maintained in December of 2011 that "less than 1% of
its CI512 implants had failed since the 2009 introduction into the stream
of commerce, the hard data and associated failure rates suggest an entirely
In fact, the study entitled, "Nucleus N5 CI500 series implant recall:
Hard failure rate at a major cochlear implantation center," conducted
in conjunction with the Department of Otolaryngology/ Head and Neck Surgery,
Tulane University School of Medicine, New Orleans, Louisiana, U.S.A.,
was very illuminating as to the Cochlear failure rates.
The study can be found online, here:
The idea of the study was simply to compare the cumulative failure percentage
("CFP") of the Cochlear Nucleus N5 (CI500 series) implant, differentiating
the before and after voluntary recalled, unimplanted devices, to those
of the Nucleus Freedom (CI24RE series) implant.
Therein, the cochlear implant procedures were conducted in their standard
fashion while a database was generated by way of merging information gleaned
from the operative case logs, an integrated clinical electronic medical
records system, and an external database of devices maintained by Cochlear Ltd.
Notably, of the two-hundred, eighty-nine (289) implants the Nucleus Freedom
CI24RE range at this institution, the cumulative failure percentage was
0%. There were 122 implants of the Nucleus N5 range device, yielding a
staggering 9.8%CFP; Eighty-two (82) of these N5s were manufactured in
advance of the December 2011 product recall and forty (40) were provided
after the recall. The 82 implants manufactured in advance of the recall
had only two (2) such associated, failures, while the forty (40) produced
afterward contained a staggering ten (10) such failures.
The study acknowledged that the cumulative failure percentage (CFP) of
the Cochlear Nucleus N5 series remains to be fully defined, and the 9.8%
failure rate for the Nucleus N5 was significant. The rates of failure
for the N5 implants manufactured before the product recall was 2.4%, and
the CFP after said recall was 25.0! This constitutes a -nearly six-times,
higher than the Cochlear-published value of 4.2% for all N5 implants registered globally.
Given the significance of the hard failure rates, Cochlear's on-call
audiologists will perform an "Integrity Test" for the device
to determine if the implant is still functioning properly, or if it otherwise
suffered a hard failure. This Integrity Test Report will indicate that
the device has "failed" a number of tests and Cochlear will
make note of this in their files. It is very important not to sign any
release with Cochlear if they provide any service or refund in relation
to the failed device.
Attorneys Don Liddy and David Shoop continue to represent people nationally
who were implanted with defective cochlear devices. If you have experienced
a confirmed failure of your cochlear implant, you should call the experienced
product liability attorneys at SHOOP | A PROFESSIONAL LAW CORPORATION
today for a free consultation to discuss your legal rights.
CALL US TODAY AT (866) 884-1717