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A cochlear implant is a surgically implanted medical device that is intended to aid hearing in profoundly deaf patients. The process of implanting and programming these hearing devices is long, complex and not without risks. Adding to the potential risks associated with implanting and programming cochlear implants are the risks associated with implant defects.
Certain cochlear implants manufactured by Advanced Bionics have been found to possess defects in hermeticity, which may require removal, re-implantation and reprogramming of a patient’s cochlear implant. Hermeticity is the extent to which a cochlear implant is waterproof. For a cochlear implant to function properly, it must be completely waterproof and not let in any moisture from the surrounding areas.
While Advanced Bionics and its partner manufacturers were aware of the requirement that all cochlear implants be hermetically sealed, they failed to produce a product that met such requirements. As a result, the Food and Drug Administration (FDA) conducted an investigation and found many of their cochlear implants defective. Moreover, numerous patients suffered damages caused by defective cochlear implants. In such cases, a patient may have the legal right to seek recovery of their medical expenses, other tangible losses, and pain and suffering.
If you or a loved one suffered harm due to a defective cochlear implant, please contact us to learn more about your best course of action in obtaining compensation for your losses and suffering.
What implant models may be defective? The defective cochlear implants are CLARION and HiResolution (HiRes90K) cochlear implants.
Who makes them? These defective cochlear implants are manufactured by Advanced Bionics. However, the component often found defective in Advanced Bionics cochlear implants is actually made by another manufacturer called Astro Seal. To make manufacturer issues a bit more complicated, Advanced Bionics was temporarily merged from 2004 through 2006 with Boston Scientific Corporation, whose name appears on some of the FDA investigations and subsequent actions. More information about the FDA action can be found below.
FDA Investigation of Defective Cochlear Implants
2004 Recall Out of concerns over moisture (hermeticity) problems associated with Advanced Bionics’ cochlear implants, the FDA initiated an investigation of the company’s facilities. They concluded that the HiResolution (or HiRes90k) possessed a moisture defect problem. As a result of discovering this defect, the FDA requested that the company (at this time Boston Scientific) voluntarily recall all unimplanted devices.
Furthermore, the company sent warning letters out to doctors and patients informing them of the problems associated with these affected cochlear implants. These letters explained that moisture had been found on the internal circuitry of removed cochlear implants and that this is a cause of premature failure of such devices.
At this time, the FDA did not recommend that patients with affected cochlear implants seek removal. However, some patients required removal of their defective cochlear implants due to implant malfunctioning and failure.
2006 Recall Despite this FDA investigation and the subsequent recall, Advanced Bionics continued to produce defective cochlear implants, putting additional patients at risk. In 2006, the company initiated yet another cochlear implant recall of the same devices. This time, the cochlear implant recall was limited only to devices containing a specific feed though component made by Astro Seal.
Symptoms of a cochlear implant defect
According to the FDA, symptoms associated with device failure include, but are not limited to:
According to the 2004 FDA recall announcement, patients who experience these defect symptoms are advised to try the backup cable, headpiece and the sound processor to rule out other causes of these difficulties. If such symptoms persist, the patient is encouraged to contact their doctor and determine the exact nature of the problem.
While the FDA has not recommended the removal of defective cochlear implants affected by these recalls, in some cases this is necessary. Unfortunately, patients who require the removal of these defective devices will require additional surgery with additional risks and side effects. Moreover, they will also have to undergo device reprogramming, which can be a lengthy process.
To understand what this requires, it is helpful to explore the function of cochlear implants, how they are implanted, how they are programmed, and what removal and re-implantation requires.