Advanced Bionics is preparing to recall some of their HiRes 90K cochlear implants due to potential defects that could cause pain and loud noises for individuals who have the devices implanted in their ears.
The cochlear implant recall was announced on Tuesday by Advanced Bionics, which says it has notified the FDA of the recall. According to the company, they decided to recall the cochlear implants after confirming at least two cases where patients experienced malfunctions that resulted in severe pain, overly loud sounds and shocking sensations eight to 10 days after the cochlear implants were activated.
A Cochlear inplant, or bionic ear, is an electrionic device that is surgically implanted to provide a senses of sound for individuals who are profoundly deaf or hard of hearing.
The recall affects certain HiRes 90k cochlear implant devices, and the company indicates that the risk of problems appears to be remote at present. An estimated, 28,000 implants have been distributed and the company has not provided an estimate as to how many patients may be at risk for problems.
Advanced Bionics is a subsidiary of Sonova Holding, which purchased the company last year. Sonova officials said that Advanced Bionics is working closely with the FDA to identify the issue with the hearing aid implants and resolve it. However, at the time of the recall on Tuesday, the cause of the cochlear implant problems was not known.
The Advanced Bionics HiRes 90k cochlear implant has been recalled twice before. The first time was in 2004 for symptoms that are similar to those that led to the current recall; sudden pain, loud noises, popping sounds and intermittent functioning. The second recall was in 2006, when the FDA notified the company that it had changed components in the device without notifying the FDA and getting approval. Advanced Bionics paid the government $1.1 million in 2008 to settle penalties resulting from that recall.
In June, Cochlear Americas, a competitor of Advanced Bionics in the cochlear hearing aid field, paid the U.S. Department of Justice (DOJ) $880,000 for violating the Anti-kickback Act and False Claims Act. The charges came as the result of a whistleblower lawsuit in which the company was accused of paying kickbacks to physicians who prescribed their version of the cochlear hearing aid implant.
The FDA warns that the cochlear implants have a number of potential health risks. The agency lists the possibility of meningitis, facial nerve damage, cerebrospinal fluid leakage (leakage of brain fluids), infection, vertigo, and other potential problems.
A number of cochlear implant lawsuits have already been filed against Advanced Bionics as a result of alleged prior problems with their devices
Photo via Wikimedia Commons, public domain work of the National Institutes of Health
CORRECTION 12/10/2010: An earlier version of this article indicated that 28,000 of the cochlear implants were recalled. While the press release issued by Advanced Bionics does not indicate how many of the devices were included in this action, the company is only retrieving unimplanted devices in distribution. No estimates have been provided by the company about the number of patients who may be at risk of suffering complications. We apologize for any confusion and concerned patients should speak with their physician.