LAWSUITS NEWS & LEGAL INFORMATION
Clarion Cochlear Implants
Clarion Cochlear implants (Implantable Cochlear Stimulators) have been recalled several times: the latest recalls, in 2004 and 2006, were due to a potential moisture failure within the implant. Adverse events such as pain, hearing loss and other problems have been associated with the cochlear implant's malfunction. As well, the implants can cause scar tissue to form which could make the implant of a replacement device difficult or even impossible.
A cochlear implant is an electronic device that "consists of a number of basic components that function in a similar manner" including the external hardware and internal device. Cochlear implants are intended to restore a level of auditory sensation to adults and children with severe-to-profound hearing loss via electrical stimulation of the auditory nerve.
Recalls
Cochlear implants are subject to failure and there are many reasons why cochlear implants fail, but most fail due to manufacturing errors and errors result in recalls. The European Consensus (2005) says two other reasons are loss of follow up and medical reasons: Cochlear implants that need to be removed due to infection or for biological failures but are functioning normally are considered to be removed for medical reasons.
The first cochlear implant--the Nucleus Mini 22 channel--was recalled in April1995, due to a power supply inside the implanted part of the cochlear implant malfunctioning and causing device failure.
In 2002, the US Food and Drug Administration (FDA) issued a warning that cochlear implants were associated with meningitis; in response, Advanced Bionics recalled its Clarion model cochlear implants. In 2003, the manufacturer received FDA approval to market the HiRes90k Implantable Cochlear Stimulator, but it also received a Class III category by the FDA—the most stringent regulatory category for devices.
Two more recalls by Advanced Bionics, a subsidiary of Boston Scientific Corporation, followed: The Clarion CII-x HiResolution 90k (HiRes90k) bionic ear system was first recalled in 2004. Symptoms associated with device failure included intermittent functioning; sudden sensation of discomfort or pain; sudden loud noise or popping sound; complete loss of sound, and unwillingness of a child to wear his or her external headpiece.
The manufacturer recalled the HiRes90k in March 2006 after receiving notice from the FDA. At the same time, Advanced Bionics also notified patients with such implants and instructed them to contact their health care providers if they suffered symptoms of device failure.
The reason for the latest recall was that the California hearing device manufacturer failed to advise the FDA in a change of components suppliers yet still sold and distributed a device which hadn't received approval from the FDA. (When a new supplier is used, which means the components in the device change, the FDA must be notified by the maker so that tests can be performed on the new device to ensure that similar problems, in this case, like the ones occurring, don't happen again.)
Two years later, in March 2008, the FDA announced it was seeking penalties of $2.2 million against Advanced Bionics 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. In July 2008 Advanced Bionics reached a $1.1 million settlement with the agency.
History
In 1980 the Food and Drug Administration (FDA) began to regulate cochlear implants and in 1984 they approved the use of the 3M/House cochlear implant device for use in adults. According to the House Ear Institute (2006), in1989 they were the first to implant a 5-year-old with a multi-channel cochlear implant. Advanced Bionics Corporation began clinical trials of its device in 1992 and became FDA approved in 1996 for use in adults. The first internal device manufactured by Advanced Bionics was the CLARION 1.2 in 1996. In 1997 the FDA approved the device for use in children.
Implant Failures
According to the FDA, each company has different ways of dealing with cochlear implant failures. Advanced Bionics voluntarily recalled its CLARION and HiResolution cochlear implants—meaning that if the implants were already implanted no action was to take place (they were not to be explanted). However, any internal implants in doctors offices or in stock at the company were to be recalled and taken back.
When a cochlear implant fails the company has policies on how they will deal with the failed device. All companies will replace a failed device with their own device free of charge if they are still under warranty. A cochlear implant is under warranty for ten years (www.cochlear.com). This means that if the device is an Advanced Bionics device, Advanced Bionics will replace it with another Advanced Bionics device and cover all of the cost if the device is still under warranty.
If you or a loved one has problems with a cochlear implant device, you may also want to seek legal help.
Published on May-20-09
A cochlear implant is an electronic device that "consists of a number of basic components that function in a similar manner" including the external hardware and internal device. Cochlear implants are intended to restore a level of auditory sensation to adults and children with severe-to-profound hearing loss via electrical stimulation of the auditory nerve.
Recalls
Cochlear implants are subject to failure and there are many reasons why cochlear implants fail, but most fail due to manufacturing errors and errors result in recalls. The European Consensus (2005) says two other reasons are loss of follow up and medical reasons: Cochlear implants that need to be removed due to infection or for biological failures but are functioning normally are considered to be removed for medical reasons.
The first cochlear implant--the Nucleus Mini 22 channel--was recalled in April1995, due to a power supply inside the implanted part of the cochlear implant malfunctioning and causing device failure.
In 2002, the US Food and Drug Administration (FDA) issued a warning that cochlear implants were associated with meningitis; in response, Advanced Bionics recalled its Clarion model cochlear implants. In 2003, the manufacturer received FDA approval to market the HiRes90k Implantable Cochlear Stimulator, but it also received a Class III category by the FDA—the most stringent regulatory category for devices.
Two more recalls by Advanced Bionics, a subsidiary of Boston Scientific Corporation, followed: The Clarion CII-x HiResolution 90k (HiRes90k) bionic ear system was first recalled in 2004. Symptoms associated with device failure included intermittent functioning; sudden sensation of discomfort or pain; sudden loud noise or popping sound; complete loss of sound, and unwillingness of a child to wear his or her external headpiece.
The manufacturer recalled the HiRes90k in March 2006 after receiving notice from the FDA. At the same time, Advanced Bionics also notified patients with such implants and instructed them to contact their health care providers if they suffered symptoms of device failure.
The reason for the latest recall was that the California hearing device manufacturer failed to advise the FDA in a change of components suppliers yet still sold and distributed a device which hadn't received approval from the FDA. (When a new supplier is used, which means the components in the device change, the FDA must be notified by the maker so that tests can be performed on the new device to ensure that similar problems, in this case, like the ones occurring, don't happen again.)
Two years later, in March 2008, the FDA announced it was seeking penalties of $2.2 million against Advanced Bionics 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. In July 2008 Advanced Bionics reached a $1.1 million settlement with the agency.
History
In 1980 the Food and Drug Administration (FDA) began to regulate cochlear implants and in 1984 they approved the use of the 3M/House cochlear implant device for use in adults. According to the House Ear Institute (2006), in1989 they were the first to implant a 5-year-old with a multi-channel cochlear implant. Advanced Bionics Corporation began clinical trials of its device in 1992 and became FDA approved in 1996 for use in adults. The first internal device manufactured by Advanced Bionics was the CLARION 1.2 in 1996. In 1997 the FDA approved the device for use in children.
Implant Failures
According to the FDA, each company has different ways of dealing with cochlear implant failures. Advanced Bionics voluntarily recalled its CLARION and HiResolution cochlear implants—meaning that if the implants were already implanted no action was to take place (they were not to be explanted). However, any internal implants in doctors offices or in stock at the company were to be recalled and taken back.
When a cochlear implant fails the company has policies on how they will deal with the failed device. All companies will replace a failed device with their own device free of charge if they are still under warranty. A cochlear implant is under warranty for ten years (www.cochlear.com). This means that if the device is an Advanced Bionics device, Advanced Bionics will replace it with another Advanced Bionics device and cover all of the cost if the device is still under warranty.
If you or a loved one has problems with a cochlear implant device, you may also want to seek legal help.
Clarion Cochlear Implant Legal Help
If you or a loved one has suffered damages in this case, please click the link below and your complaint will be sent to a lawyer who may evaluate your claim at no cost or obligation.Published on May-20-09
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