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Dear Cochlear Implant Candidate:
Advanced Bionics® is committed to providing deaf and hard of hearing
people with accurate information on cochlear implant technology and its
use. As a cochlear implant candidate, it is important that you understand
new and vital health information regarding bacterial meningitis and
cochlear implantation. And, as a person considering Advanced Bionics'
technology to treat your hearing loss, we want to inform you of our
voluntary product changes, which may influence your decisions at this
time.
INFORMATION REGARDING MENINGITIS AND COCHLEAR IMPLANTS:
Recently a small number of American and European cochlear implant users
have been reported as having contracted bacterial meningitis. Meningitis
is a serious disease that infrequently occurs in the general population.
It may happen somewhat more frequently among persons with medical
implants, including cochlear implants. Some cases of meningitis are caused
by bacterial infection, which can be very serious. A small number of cases
of bacterial meningitis have been reported with different models of
cochlear implants, manufactured by Advanced Bionics® and one other
company. Because of this, we want you to know the following information:
* Cochlear implant users may have a higher risk for contracting bacterial
meningitis than the general population. The populations in which bacterial
meningitis most often occurs are young children under five years of age,
and the elderly. The U.S. Food and Drug Administration has noted that a
small percentage of deaf patients may have congenital abnormalities of the
inner ear that make them more prone to meningitis. Other factors
contributing to the possibility of meningitis may include ear infection,
weakened immune system, or prior history of
meningitis.
* The chance for contracting this disease is extremely low,
far less than 1%. This risk may be substantially reduced through
vaccination.
* Highly effective vaccinations exist for bacterial
meningitis. Detailed information is described in the attached document
titled "Recommended Vaccinations for Bacterial Meningitis".
* Common symptoms of meningitis include fever, irritability,
lethargy and loss of appetite. Older children and adults may experience a
headache, stiff neck, nausea and vomiting, and confusion. Parents should
be alert to the symptoms in young children. If symptoms occur, seek
medical care immediately and inform the doctor about your implant and the
possible risk of meningitis.
* Ear infections in some cases precede the occurrence of
meningitis. They should be treated promptly and aggressively. Talk to your
doctor promptly if you have an ear infection.
ACTIONS OF ADVANCED BIONICS®
Advanced Bionics® has been investigating the question of bacterial
meningitis with cochlear implant surgeons, regulatory agencies, and other
medical experts. The information thus far indicates that of the small
number of reported cases, a significant proportion has involved just two
centers in Europe. Based on the information currently available to us, the
incidence in Europe appears much higher than in North America, possibly
due to lower vaccination rates there than here.
Our policy is to be very cautious with our product designs. The
FDA-approved labeling of the CLARION® states that cochlear implants may in
rare cases cause a leak of the inner ear fluid, which may result in
meningitis. If a leak occurs, it may be associated with implantation of
the electrode array. Beginning in 1999, Advanced Bionics® recommended that
the electrode array be implanted with an Electrode Positioner, a separate
component, for easier positioning of the electrode close to the nerve.
Because of the recent reports of meningitis, we are investigating whether
the Positioner might somehow increase the risk of meningitis, without
sufficient corresponding benefit. We have therefore decided to suspend the
distribution of the Electrode Positioner with our product until we have a
better understanding of the reported cases of meningitis.
WHAT DOES THIS MEAN FOR CANDIDATES?
Despite the fact that our voluntary suspension of the Positioner will have
a negative impact on our short-term success, we firmly believe that the
safety of our customers must always come first. You should expect this
kind of conduct from the company in which you entrust important medical
matters such as cochlear implantation.
To help you in your decision-making process, we offer the following for
your consideration:
* Discuss with your clinician the advantages and disadvantages of
waiting for Advanced Bionics® to release its cochlear implant technology
without Positioner. You should know that we cannot at this time predict
how long it will take for approval of this change.
* IMPORTANT INFORMATION FOR PARENTS: Delaying
cochlear implantation by even a few months can have affect how well very
young children perform with a cochlear implant. Because of this fact, we
believe it is in the best interest of parents of young children to
consider the next point.
* Discuss with your clinician the advantages and disadvantages of an
alternate brand of cochlear implant technology. This may ensure that you
receive a cochlear implant now, which may outweigh the unique benefits of
the CLARION® CII Bionic Ear™ System.
Regardless of which brand of cochlear implant you ultimately select, it is
vital that you discuss vaccination against bacterial meningitis with your
doctor. We hope that this information helps you make a decision that is
right for you or your child. We encourage you to work with your clinician
and welcome you to contact us directly.
If you have additional questions regarding meningitis, please call
Advanced Bionics: (866) 566-8913 - Voice or Relay.
Sincerely,
Jeffrey H. Greiner
President and Co-Chief Executive Officer
Doug Lynch, Director, Marketing Communications at Advanced Bionics offered
further clarification:
"We suspended distribution of the Positioner worldwide. The CLARION CII
Bionic Ear System without Positioner is approved for use in Europe and
other nations. In the U.S. and Canada, the system is approved for use with
the Positioner. Therefore, we are not distributing products in the US and
Canada right now. We have submitted for approval of the system without the
Positioner and are awaiting response." |
