As an attorney who represents those who have experienced Advanced Bionics HiRes90k cochlear implant failures, I wanted to report on a recent news story concerning the parent of Advanced Bionics, Sonova of Switzerland. In case you are unaware, visit my Advanced Bionics lawsuit page that contains voluminous information on the vendor B HiRes90k failures that have affected more than 1,000 persons worldwide.

Sonova’s year-end profits were $262 million, despite the continued failures of Advanced Bionics HiRes90k units. As this post is written, Advanced Bionics HiRes90k cochlear implants are off the market in the USA because of reliability concerns. It is the third time since 2004 that Advanced Bionics cochlear implants are off the market. To read more about Sonova’s profits, please click HERE.

If you would like more information about an Advanced Bionics HiRes90k, Clarion 1.2 or CII lawsuit, please do not hesitate to contact us. Our team of attorneys is representing recipients of the Advanced Bionics HiRes90k across the world, and have active lawsuits in state and federal courts. We are not a referral agency – we will be YOUR lawyers.

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MEMPHIS, TN – May 6, 2011 — The law firm of Glassman, Edwards, Wyatt, Tuttle & Cox in Memphis, Tennessee, led by attorneys Tim Edwards and Ed Wallis, have settled a products liability case against Advanced Bionics, LLC, the maker of the HiRes90k cochlear implant, for a confidential sum.  The settlement was reached on behalf of a minor child who received a product alleged to contain a defective component that was never approved for sale by the FDA.  The device was later recalled in both September 2004 and March 2006, and led to a lawsuit filed by the FDA against Advanced Bionics.  Advanced Bionics later settled the FDA lawsuit by agreeing to pay a $1.1 Million fine.

Advanced Bionics manufactured a cochlear implant, a medical device implanted in the skull of the profoundly deaf and hard of hearing.  Plaintiffs alleged that the cochlear implant was defective in that it contained an unapproved, unqualified and untested critical component known as a feed-thru.  The feed-thru was manufactured by a supplier known as AstroSeal.  After the minor child was implanted with the device, which was later twice recalled in 2004 and 2006, the minor plaintiff’s device failed and he was required to undergo explantation surgery under a general anesthetic.  The minor plaintiff was deaf for an extended period of time and suffered medical bills, pain and suffering and permanent loss of enjoyment of life.  His parents also experienced emotional pain and suffering as a result of their child’s implantation with the device which is failing at an unprecedented rate. 

Causes of action were brought against Advanced Bionics for negligence, negligence per se, strict liability, violation of the Tennessee Consumer Protection Act, fraud, intentional infliction of emotional distress, negligent infliction of emotional distress and punitive damages.  Allegations included that the defendant Advanced Bionics failed to take FDA required corrective actions, failed to adequately train and police, failed to document or validate design models of the cochlear implant, failed to follow FDA reporting, failed to conduct quality audits and verify quality systems, failed to conduct management reviews, failed to meet specifications for the device, failed to document or validate management processes, failed to submit a PMA supplement for the AstroSeal feed-thru and failed to conduct root cause and risk analysis on the device.  Plaintiffs furthermore alleged that Advanced Bionics failed to test the Advanced Bionics Hi-Res 90K cochlear implant in an environment that mimicked the human body before the device was sold to the general public. 

Plaintiffs pled in their Complaint that they incurred numerous damages as a result of the conduct of Advanced Bionics including but not limited to personal injury, pain and suffering, emotional distress and mental anguish, a loss of enjoyment of life, developmental delays, economic damages, hearing loss and unnecessary surgery. 

“It was a privilege to represent the family of young Logan Estep and fight for justice on their behalf,” said lead counsel Tim Edwards, who grandson also has two cochlear implants.  Mr. Edwards followed that “Our firm remains committed to seeking justice against others similarly situated to Logan.”

If you would like more information about an Advanced Bionics HiRes90k, Clarion 1.2 or CII lawsuit, please do not hesitate to contact us. Our team of attorneys is representing recipients of the Advanced Bionics HiRes90k across the world, and have active lawsuits in state and federal courts. We are not a referral agency – we will be YOUR lawyers.

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As noted by one European publication: Shares in Swiss hearing aid maker Sonova (SOON.VX) slide 2.9 percent, underperforming a 0.5 weaker European healthcare sector index .SXDP, after a broker downgrade. Cheuvreux cuts its rating for Sonova to “Underperform” from “Outperform” and lowers the price target to 130 Swiss francs from 150 francs. The recall of a cochlear implant by Sonova’s subsidiary Advanced Bionics announced in November could weigh on the group’s profit, Cheuvreux says.

We are cochlear implant attorneys, having helped persons across the globe for more than two years. We have been on the forefront of litigation involing Advanced Bionics cochlear implants. Our team of cochlear implant lawyers stand ready to discuss with you the rights you or your loved one have if your cochlear implant device failed, including if you want more information on a products liability claim. We are specifically looking at claims for Advanced Bionics cochlear implants that were implanted from 2003 to the present and have failed prematurely while in the human body, or are currently malfunctioning.

If you would like more information about an Advanced Bionics HiRes90k, Clarion 1.2 or CII lawsuit, please do not hesitate to contact us. Our team of attorneys is representing recipients of the Advanced Bionics HiRes90k across the world, and have active lawsuits in state and federal courts. We are not a referral agency – we will be YOUR lawyers.

FOR MORE INFORMATION –

CALL TOLL FREE: 1-800-632-1404

EMAIL: click here

FILL OUT THIS FORM:

For a free worldwide case evaluation: CALL 1-800-632-1404 or FILL OUT FORM TO THE RIGHT

We are cochlear implant attorneys, having helped persons across the globe. Our team of cochlear implant lawyers stand ready to discuss with you the rights you or your loved one have if your cochlear implant device failed. We are specifically looking at claims for Advanced Bionics cochlear implants that were implanted from 2003 to the present and have failed prematurely while in the human body.

If you would like more information about an Advanced Bionics HiRes90k, Clarion 1.2 or CII lawsuit, please do not hesitate to contact us. Our team of attorneys is representing recipients of the Advanced Bionics HiRes90k across the world, and have active lawsuits in state and federal courts. We are not a referral agency – we will be YOUR lawyers.

FOR MORE INFORMATION –

CALL TOLL FREE: 1-800-632-1404

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The FDA released a public notification about the 2010 Advancaed Bionics and Sonova recall of the HiRes90k cochlear implant. That notification can be found by clicking HERE and reads as follows:

HiRes 90K Cochlear Implant Device: Recall – Malfunction

[Posted 11/27/2010]

AUDIENCE: Audiology, Patients

ISSUE: Advanced Bionics (AB) announced that it will voluntarily recall its HiRes 90K cochlear implant device and is retrieving all unimplanted devices in distribution. This action is being taken in response to two confirmed instances where the product experienced a malfunction requiring explantation. These recipients experienced severe pain, overly loud sounds and/or shocking sensations at 8-10 days after initial activation of their device.

BACKGROUND: AB is continuing to evaluate the root cause(s) of the problem and is working closely with the FDA to address their questions and concerns, and institute changes to the product to ensure that the HiRes 90K has the highest quality for patients who use the device. This voluntary action is being taken to ensure continued patient safety and product quality.  The risk of any significant adverse medical events appears to be remote at present.

RECOMMENDATION: Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178 

[11/24/2010- Press Release - Advanced Bionics (AB)]

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FREE WORLDWIDE CASE EVALUATION BY CALLING 1-800-632-1404

Up to 1,000 persons could experience device failures based on the latest Advanced Bionics recall. This recall is now the third recall of the cochlear implant manufacturer since 2004. The first was in 2004, the second 2006. Now, in 2010, Advanced Bionics (and parent Sonova) have recalled again.

Advanced Bionics continues to have problems with the manufacturer of its devices. As attorneys who have been fighting for the rights of patients since 2007, our firm stands ready to seek justice for you. Please call us today at 1-800-632-1404 for help.

Here is the text of a letter sent to patients:

Dear Cochlear Implant Recipient or Parent,

Our mission at Advanced Bionics is to improve the lives of the hearing
impaired, and the safety and well-being of our recipients is our first priority. Because we are committed to ensuring that our products are as safe as possible, we are voluntarily informing you that we have become aware of an issue with the HiRes 90K cochlear implant. The issue can result in pain, overly loud sounds, and/or sudden shock sensation in the implanted ear while the implant is receiving power. Thus far, our investigation shows that of the more than 28,000 implanted HiRes 90K devices, only two explanted devices have been confirmed to have this issue. There are 9 other patients with similar symptoms which our investigations have not yet ruled out as related to this issue. For the two confirmed cases, there were no symptoms upon initial activation of device. However, the patients experienced symptoms after 8-10 days of use. Both recipients were re-implanted with HiRes 90K devices and their clinicians report that they are progressing
well. We are conducting an extensive investigation of this issue using an
independent scientific research organization. Their current analysis suggests that, if present, the issue will first occur within 90 days of device use. However, the onset of symptoms may be delayed after initial activation, and they may continue to occur intermittently. In the unlikely event that this symptom occurs, continued device use may lead to damage to the inner ear and/or the auditory nerve. If you or your child experience
pain related to implant use, remove the external equipment immediately and contact your cochlear implant clinician to schedule an appointment. If the evaluation of your device identifies this problem, device replacement is advised. It is important to note that it is not unusual for cochlear implant recipients to experience overly loud sounds. Most of these cases can be resolved with standard troubleshooting, such as the replacement of external equipment. The vast majority of these cases are not signs of the issue described above and do not require explant of the device. We will notify you again as more information from our investigation becomes available. We sincerely regret any concern this notification may cause. Advanced Bionics assures you that we will correct this issue and continue to improve our product reliability.

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On November 23, 2010, Sonova AG, the parent company of Advanced Bionics, issued a voluntary, worldwide recall of all Advanced Bionics HiRes90k cochlear implant devices. The press release was issued in Stafa Switzerland on November 23, 2010 by Sonova AG CEO Dr. Valentin Chapero and CFO Oliver Walker. For a copy of the press release or to learn more information about this recall, please contact attorney Ed Wallis at +1 901-527-2125 or +1 800-632-1404. You can also send Mr. Wallis an EMAIL BY CLICKING HERE.

News of this 2010 cochlear implant recall spread on November 23, 2010 when the Wall Street Journal (11/23, Mijuk) reported that Sonova Holding AG will recall its HiRes 90K cochlear implants after reports that two patients experienced severe pain and excessively loud noises. A spokesman for the company estimated that “about 1,000 patients” have received the implant over the past two weeks and could be at risk. The spokesman added, “Should another patient or patients suffer from side effects, Sonova will sponsor the removal of the implant.”

Do not let Advanced Bionics pressure you into thinking you should not contact an attorney. With three recalls of this medical device in a 6 year period, you or your loved one have the right to choose whether to seek legal counsel to protect your rights and to seek justice on your behalf.

Our team of attorneys is representing recipients of the Advanced Bionics HiRes90k across the world, and have active lawsuits in state and federal courts. We are not a referral agency – we will be YOUR lawyers.

FOR MORE INFORMATION –

CALL TOLL FREE: 1-800-632-1404

EMAIL: click here

FILL OUT THIS FORM:

For a free case evaluation: CALL 1-800-632-1404 or FILL OUT FORM TO THE RIGHT

On November 23, 2010, Sonova AG, the parent company of Advanced Bionics, issued a voluntary, worldwide recall of all Advanced Bionics HiRes90k cochlear implant devices. The press release was issued in Stafa Switzerland on November 23, 2010 by Sonova AG CEO Dr. Valentin Chapero and CFO Oliver Walker. For a copy of the press release or to learn more information about this recall, please contact attorney Ed Wallis at +1 901-527-2125 or +1 800-632-1404. You can also send Mr. Wallis an EMAIL BY CLICKING HERE.

As reported by the recall press release, there have been at least two instances thus far where a HiRes90k cochlear implant experienced a malfunction requiring explantation. The recipients of these devices experiences, per the company, “severe pain, overly loud sounds and/or shocking sensations, at 8-10 days after initial activation of their device.” The failures required an unnecessary surgery of the cochlear implant recipient.

Advanced Bionics is no stranger to recalls of the HiRes90k. The company recalled all HiRes90k devices in September 2004 after users experienced device failures attributable to high moisture inside the devices. Then, in March 2006, Advanced Bionics issued another recall of their HiRes90k devices, this time recalling all devices with the vendor B / AstroSeal feedthrough. A feedthrough is a critical component in the HiRes90k device, and the FDA sued Advanced Bionics in 2007 for selling adulerated medical devices across the world, which contained AstroSeal feedthroughs. Advanced Bionics settled the lawsuit with the FDA by paying a $1.1 Million dollar fine. Then CEO Jeff Greiner personally paid $75,000 to the FDA.

Attorneys Tim Edwards and Ed Wallis are representing persons across the globe who have received Advanced Bionics cochlear implants that have failed. Mr. Edwards and Mr. Wallis continue to offer their services to clients and will provide a free case evaluation and consultation.

BREAKING NEWS: Based on the November 23, 2010 recall of the HiRes90k, our firm is now accepting free case evaluations and consultations for devices that have failed that are the subject of this recall. If you or a loved one experienced a failure 8-10 days after activation of an Advanced Bionics HiRes90k cochlear implant device, contact us immediately and we will fly to you to meet and discuss your rights. We continue to offer free case evaluations for other failed Advanced Bionics cochlear implants.

Do not let Advanced Bionics pressure you into thinking you should not contact an attorney. With three recalls of this medical device in a 6 year period, you or your loved one have the right to choose whether to seek legal counsel to protect your rights and to seek justice on your behalf.

FOR MORE INFORMATION –

CALL TOLL FREE: 1-800-632-1404

EMAIL: click here

FILL OUT THIS FORM:

For a free case evaluation: CALL 1-800-632-1404 or FILL OUT FORM TO THE RIGHT

If you are reading thsiis page, you or a loved one may be dealing with a failing Advanced Bionics cochlear implant device. We are representing clients across the world with this defective device, and we would be honored to speak with you about your particular problems.

AN OVERVIEW OF THE PROBLEM:

Advanced Bionics is in the business of manufacturing cochlear implant devices.

Advanced Bionics hired Astro Seal to manufacture an important component part of its cochlear implant device known as a feedthru assembly. The feedthru is the part that conducts electrical signals from the hermetically (waterproof) sealed implanted part to the electrode array. A cochlear implant is a Class III medical prosthesis designed to enable profoundly deaf persons to “hear” by directly stimulating auditory nerves leading to the brain by means of an electrode array strategically positioned in the cochlear of the inner ear.  Unlike hearing aids, cochlear implants do not amplify sound. Instead a miniature computer/sound processor, worn outside the body, selectively processes sound into coded signals. Such signals are transmitted by wireless electromagnetic conduction to an implantable cochlear stimulator (ICS) that is surgically implanted in the patient’s body.

The ICS receives these coded signals and interprets them using its sophisticated microelectronic architecture to send specialized patterns of electrical current to the electrodes inserted inside of the cochlea. Multiple electrodes along the length of the electrode array emit electrical currents in the form of electrical stimulation pulses to the surrounding hearing nerve receptors based on scientific knowledge that different parts of the cochlear are sensitive to different sound frequencies. Nerve fibers then send this information to the brain for central processing, interpretation, and perception as sound.

Cochlear implant surgery requires general anesthesia and often involves a procedure called a mastoidectomy, in which an incision is cut and an indent is drilled into the skill to allow the attachment of the implant. Once the implant is attached, the electrode array is inserted in the delicate coiled cochlear of the inner ear by making a hole called a cochleonstomy and inserting the electrode array and pushing it through as gently as possible to avoid trauma to the inner surfaces. Post-surgery vertigo and nausea are common. Paralysis of the facial nerves is a rare but possible risk of surgery, as is tinnitus and damage to the vestibular system.

After surgery, initial programming of the external processor is not done until the incision has healed, which typically takes two to five weeks. At such initial stimulation and programming, the individual electrodes are programmed at appropriate threshold and amplitude levels based on the patient’s response to stimulation which is then used to create an electrode “map.” Once all of the electrodes are mapped, the processor is turned on and the cochlear implant patient can “hear.” This programming process continues to be fine-tuned at later appointments throughout the first year with the external processor eventually being programmed with multiple maps for different auditory environments.

In normal hearing, the cochlear is stimulated by hundreds of thousands of hair cells. The stimulation of the cochlear through implanted electrodes is very different. Thus, cochlear implant demands a long training period in which the cochlear implant recipient’s brain must learn how to decode and recognize sound. The perception of sound by cochlear implant users is very different from normal hearing. Cochlear implant patients who have lost their hearing often describe the initial stimulation as hearing tinny “buzzes” and “whistles” that had no relation to what they remembered as sound and felt that they would never be able to comprehend. Gradually through aural training and listening experience, the brain may learn to decode sound. Over time, some cochlear implant recipients learn to distinguish sounds well enough so that they can talk on the telephone through the cochlear implant or listen to TV without closed-captioning.

REPLACEMENT OF DEFECTIVE COCHLEAR IMPLANTS:

When a defective cochlear implant is replaced, the electrode array may not be reimplanted in the same position in the cochlear, leading to different threshold and amplitude settings. As a result, rather than starting off by “hearing” at the comprehension level where the defective implant failed, a cochlear implant patient may have to go through a second aural rehabilitation before the replacement implant functions at the same level as the first implant did. There is no guarantee that a replacement cochlear implant will ever function at the same level as the first. In some cases, due to cochlear scarring or nerve damage from explant surgery, different electrode positioning, or other causes, a cochlear implant patient may not function as well with the replacement implant.

Different cochlear implant manufacturers use different sound coding strategies. Thus, when a defective implant is replaced with a new device by a different cochlear implant manufacturer, an entire new sound system needs to be learned. Bilateral implantation is increasingly becoming a desirable option for young children based on recent clinical research findings. The reasoning is that bilateral sound assures that sound is processed through both sides of the brain, which enables the brain to mature and to learn to process bilateral information during a period where maximum brain plasticity and linguistic development occurs.

DEFECTIVE PRODUCT: MOISTURE-RELATED DEFECTS IN ADVANCED BIONICS’ COCHLEAR IMPLANTS

The internal component of the HiRes90k cochlear implant embedded in the body is exposed to a moist and saline environment. In order for a cochlear implant to function reliability, its internal electronic circuits must be kept clean, dry, and free of moisture. Thus, it is critical that the internal circuitry is hermetically sealed in an airtight moisture proof container. Excess of moisture found inside the internal component of a cochlear implant sometimes results from moisture that is sealed in during the manufacturing process. Also, moisture may leak in at some point afterward if there is a breach in the hermetic seal.

A variety of techniques exist to determine the effectiveness of the seal of cochlear implants. Residual gas analysis (“RGA”), for example, is an analytical technique used primarily for hermeticity quality assurance and failure analysis purposes. In RGA, the test device is placed in a sealed chamber and punctured. The interior gases are then sucked out and analyzed. RGA can reveal the percentage of water vapor within a supposedly sealed medical device.

Advanced Bionics knew that federal law and regulations required that the implanted component of its cochlear implant had to be water proof, hermetically sealed, and without excessive moisture content. Astro Seal knew that the component parts it supplied to Advanced Bionics had to be capable of providing a hermetic seal to prevent excessive moisture from entering into the cochlear devices that Astro Seal’s component parts were integrated into.

The Advanced Bionics failure analysis report for some Plaintiffs first cochlear implant determined that the cause of the failure of the implant was excess moisture in the implanted ICS device caused by a breach of hermeticity. Advanced Bionics fully attributed the failure of their implant to be “a feedthru hermeticity issue from one feedthru vendor” and stated in the failure analysis report that the “feedthru assemblies from this vendor were no longer being used.” The “one feedthru vendor” mentioned in the failure analysis report has been identified as being Astro Seal.

The Advanced Bionics failure analysis reports for another adult Plaintiff stated that her second implant failed as a result of shorts in the inserted electrode array that were caused by damage to the parylene wire coating on electrodes EI, E14, EIS and EI6 where the electrodes passed through the adjacent contacts. Scanning electronic microscopy (SEM) analysis also revealed cracked conductive epoxy on the P3 (IE Ring).

FDA INVESTIGATION

Because of its concern about the hermeticity failures, the FDA conducted an onsite inspection of Advanced Bionics’ facility and determined that an excessive moisture problem existed with the HiRes90k. On September 24, 2004, Advanced Bionics initiated a Class II Recall of all of its un-implanted HiRes90k devices and sent a letter to its HiRes90k implant recipients, explaining that moisture had been found on the internal circuitry of removed implants and that their implants “could stop working prematurely” if their implant was affected by this moisture problem.

On February I, 200S, the FDA issued a “Warning Letter” in which FDA reported that as a result of the inspection, the FDA had determined that Advanced Bionics devices were adulterated within the meaning of section SOI(h) of the Federal Food, Drug and Cosmetic Act. In the summer of 2004, Advanced Bionics merged with Boston Scientific Corporation however Boston Scientific Corporation unwinded the merger in the summer of 2007. On January 2S, 2006, when the two companies were still merged, the FDA issued Boston Scientific corporate-wide warning letter to improve their safety standards.

In March 2006, Advanced Bionics initiated another Class II recall of all unimplanted HiRes90k cochlear implants. This time, the recall was limited to devices containing feedthru components manufactured by Astro Seal.

FOR HELP TODAY:

If you or a loved one has an Advanced Bionics Clarion, CII, C1.2 or HiRes90k cochlear implant device that has experienced popping, crackling, humming, buzzing or intermittent functioning, your device could be failing. We can help with this problem, and you may be entitled to monetary compensation.

While we are based in Memphis, Tennessee, we have clients across the country (and world). We have filed lawsuits across the country, and are looking for clients in your area. If you are interested in a no obligation, no cost case evaluation, please contact us immediately and we will fly to you to discuss the specific aspects of your case:

For a no obligation, no cost case evaluation or consultation, and to learn more about a potential Advanced Bionics class action lawsuit please contact us immediately and we will fly to you to discuss the specific aspects of your case:

CALL TOLL FREE: 1-800-632-1404

EMAIL: click here

FILL OUT THIS FORM:

For a free case evaluation: CALL 1-800-632-1404or FILL OUT FORM TO THE RIGHT

If you are reading thsi page, you or a loved one may be dealing with a failing Advanced Bionics cochlear implant device. We are representing clients across the world with this defective device, and we would be honored to speak with you about your particular problems.

If you or a loved one has an Advanced Bionics Clarion, CII, C1.2 or HiRes90k cochlear implant device that has experienced popping, crackling, humming, buzzing or intermittent functioning, your device could be failing. We can help with this problem, and you may be entitled to monetary compensation.

While we are based in Memphis, Tennessee, we have clients across the country (and world). We have filed lawsuits across the country, and are looking for clients in your area. If you are interested in a no obligation, no cost case evaluation, please contact us immediately and we will fly to you to discuss the specific aspects of your case:

For a no obligation, no cost case evaluation or consultation, and to learn more about a potential Advanced Bionics class action lawsuit please contact us immediately and we will fly to you to discuss the specific aspects of your case:

CALL TOLL FREE: 1-800-632-1404

EMAIL: click here

FILL OUT THIS FORM: