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 –

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

The Hearing Journal has released a report on the recall by Advanced Bionics of the cochlear implant device. This is the third Advanced Bionics recall of cochlear implants since September 2004, and former Advanced Bionics president of the auditory division James (Jim) Miller formerly stated that Advanced Bionics device failures were “continuing” at an “alarming” rate.

The Journal states: “Advanced Bionics (AB), the world’s second largest manufacturer of cochlear implant systems next to Cochlear Corp., notified the U.S. Food and Drug Administration (FDA) on November 23 that it would voluntarily recall its HiRes 90K cochlear implant device worldwide. AB, which is owned by Sonova Holding, parent company of Phonak and Unitron, removed the device from the market “as a precaution while the company works with the Food & Drug Administration to address the issue.” AB said that its action was being taken in response to two instances thus far where the product experienced a rare malfunction requiring explantation. The implant users reported severe pain, overly loud sounds, and/or shocking sensations, at 8 to 10 days after initial activation of their device. AB is working with the FDA to try identify the problem and institute changes to ensure that the problem does not recur. AB said, “This voluntary action is being taken as a precaution and the risk of adverse medical events is remote at present.”

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

EMAIL: click here

FILL OUT THIS FORM:

Advanced Bionics / Sonova recalled their cochlear implant the HiRes90k on November 23, 2010, and has now sent a letter to all patients asking they “acknowledge” understanding the recall. This is most likely a litigation tactic as the company likely hopes to prevent lawsuits from the unnecessary pain and suffering caused to patients.

European reporter Allison Connolly in Frankfurt reported on behalf of Bloomberg that “Sonova Holding AG expects the recall of its cochlear hearing implant to cost between 40 million and 45 million Swiss francs ($45.4 million) in profit, Chief Executive Officer Valentin Chapero Rueda said in an interview in today’s Bilanz. The recall will reduce sales by 4 percent, Rueda told Bilanz. He’s uncertain how long it will take before the company can distribute the implants in the U.S. again, according to the magazine. Sonova said last month it would remove the HiRes 90K cochlear implant, made by its Advanced Bionics unit, from the market because of a malfunction that led to “severe pain, overly loud sounds and/or shocking sensations” in two cases. About 28,000 people have received the implant, Rueda told the Swiss publication.”

We are cochlear implant lawyers who have filed lawsuits on behalf or represented persons who have received the Clarion 1.2, CII and HiRes90k cochlear implant. If you have questions about the November 2010 Sonova and Advanced Bionics recall or want to speak with an cochlear implant attorney, please contact us immediately for help.

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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.

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