While this is a bit of "old" news, but interesting to know. A friend of mine has AB, but cannot get the HiRes90 because she had an older implant, so it's not compatible at the moment. Be grateful, for those who have AB, that didn't get the bad batch. To me, I don't think it's really that big of a deal. There's always something slightly wrong with stuff like this such as pacemakers, steel rods in someone's back, transplants, etc. Need I go on? If my implant failed for whatever reason, I will not blame the company, but I will welcome them to have them investigate of what's wrong and how they can improve their design...that's the only way. And knowing how much BETTER my life is with my implant and hearing again, I would not hesitate to go through surgery again to get it fixed.
5. FDA Seeks Civil Penalties from Advanced Bionics
The U.S. Food and Drug Administration (FDA) today announced it is
seeking a $2.2 million penalty against a California cochlear implant
manufacturer for violations of federal law, including manufacturing
standards violations and the failure to notify the FDA of a change in
an outside supplier or vendor, which may have exposed recipients of
the devices to unnecessary health risks.
The cochlear implants pose a public health risk due to excessive
moisture, exposing patients to the risk of device failure, possible
surgery, and the potential for additional hearing loss. The agency's
complaint, originally filed this past November and amended on March
17, seeks penalties against California medical device manufacturer
Advanced Bionics, LLC and its president and co-CEO, Jeffrey H.
Greiner.
The complaint alleges that Advanced Bionics shipped cochlear implants
in the United States prior to filing appropriate supplemental
information with the agency, including a notice of changes made to
the devices that affected their safety and effectiveness.
On July 7, 2003, Advanced Bionics received FDA approval to market the
HiRes90k Implantable Cochlear Stimulator, a cochlear implant which is
surgically implanted under the skin behind the ear to treat severe to
profound hearing loss in adults and children. The cochlear implant is
considered a Class III medical device by the FDA—the most stringent
regulatory category for devices.
The complaint alleges that the company failed to comply with the
FDA's current Good Manufacturing Practice (GMP) requirements for
devices. GMP requires that companies manufacturing medical devices
for sale in the United States establish and follow quality systems
procedures to assure the safety and quality of their products.
Advanced Bionic's alleged GMP violations include the failure to
sufficiently evaluate and select a new vendor as the supplier of a
critical device component and the failure to adequately validate the
continued safety and effectiveness of the cochlear implant by testing
lots under actual or simulated use when the unapproved vendor's
component was used.
The complaint also states that Advanced Bionics shipped cochlear
implants in violation of the law between January 2005 and July 2006.
Two cochlear implants shipped and implanted after a March 2006 recall
contained the component from the unapproved vendor.
FDA's complaint states that the company's failure to file the
required supplement occurred after a 2001 inspection. At that time,
the company was cited for similar failures and made commitments to
correct the problems.
Courtesy: FDA News
5. FDA Seeks Civil Penalties from Advanced Bionics
The U.S. Food and Drug Administration (FDA) today announced it is
seeking a $2.2 million penalty against a California cochlear implant
manufacturer for violations of federal law, including manufacturing
standards violations and the failure to notify the FDA of a change in
an outside supplier or vendor, which may have exposed recipients of
the devices to unnecessary health risks.
The cochlear implants pose a public health risk due to excessive
moisture, exposing patients to the risk of device failure, possible
surgery, and the potential for additional hearing loss. The agency's
complaint, originally filed this past November and amended on March
17, seeks penalties against California medical device manufacturer
Advanced Bionics, LLC and its president and co-CEO, Jeffrey H.
Greiner.
The complaint alleges that Advanced Bionics shipped cochlear implants
in the United States prior to filing appropriate supplemental
information with the agency, including a notice of changes made to
the devices that affected their safety and effectiveness.
On July 7, 2003, Advanced Bionics received FDA approval to market the
HiRes90k Implantable Cochlear Stimulator, a cochlear implant which is
surgically implanted under the skin behind the ear to treat severe to
profound hearing loss in adults and children. The cochlear implant is
considered a Class III medical device by the FDA—the most stringent
regulatory category for devices.
The complaint alleges that the company failed to comply with the
FDA's current Good Manufacturing Practice (GMP) requirements for
devices. GMP requires that companies manufacturing medical devices
for sale in the United States establish and follow quality systems
procedures to assure the safety and quality of their products.
Advanced Bionic's alleged GMP violations include the failure to
sufficiently evaluate and select a new vendor as the supplier of a
critical device component and the failure to adequately validate the
continued safety and effectiveness of the cochlear implant by testing
lots under actual or simulated use when the unapproved vendor's
component was used.
The complaint also states that Advanced Bionics shipped cochlear
implants in violation of the law between January 2005 and July 2006.
Two cochlear implants shipped and implanted after a March 2006 recall
contained the component from the unapproved vendor.
FDA's complaint states that the company's failure to file the
required supplement occurred after a 2001 inspection. At that time,
the company was cited for similar failures and made commitments to
correct the problems.
Courtesy: FDA News