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Advanced Bionics CI

Advanced Bionics is one of three major CI manufacturers worldwide, and the only one headquartered in the US. Their CI is called the Clarion. Please select from the following links to learn more about this product.

March 2000 - Advanced Bionics has recently released a video that describes the history of the electrode array, and especially the new HiFocus Array

Sept 2000 - The FDA Approves the Clarion HiFocus Electrode.

March 2001 - Advanced Bionics announces the CII.

October 2001 - It looks like the CII (also called the Bionic Ear) is a success, in terms of assisting people to understand speech sooner and better. Here are the results of Advanced Bionic's initial research trials.

September 2002 - After a short time with no CI available in the North American market, Advanced Bionics just announced that the new CII has been approved by US and Canadian officials.

September 2004 - You've probably heard that Advanced Bionics has recalled several hundred cochlear implants, because of possible moisture contamination. Here's a notice from AB with additional information.

August 2006 - Advanced Bionics Technology Update: Harmony the Sound of the Future

September 2006 - Boston Scientific Announces FDA Approval of Harmony(TM) HiResolution(R)

October 2006 - Here's our report on the Advanced Bionics presentation at ALDAcon 2006.

November 2006 - Soap Opera Character Gets Cochlear Implant

November 2006 - Advanced Bionics HarmonyTM HiResolution(r) Bionic Ear System Debuts

January 2007 - The Bionic Ear Association 2007 Seminars

February 2007 - Friction Between Advanced Bionics Founder and Boston Scientific

February 2007 - Time to Undo Advanced Bionics Merger with Boston Scientific?

April 2007 - Advanced Bionics Announces Online Aural Rehab Program for Kids with CIs

August 2007 - Boston Scientific and Advanced Bionics to go Separate Ways

September 2007 - Advanced Bionics Deploys CEVA DSP Core

October 2007 - Advanced Bionics Announces Meningitis Vaccination Reimbursement and Incentive Program

January 2008 - Boston Scientific Completes Advanced Bionics Sale

March 2008 - FDA seeks $2.2 million fine against Advanced Bionics

July 2008 - Advanced Bionics Settles FDA Dispute

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HiFocus Video

Editor: Advanced Bionics (the company that makes the Clarion implant) has recently posted a new video to their website. The video discusses the history of cochlear implant electrodes and focuses on the new HiFocus Electrode System. And it's captioned!!!!

The downside is that it takes about 15 minutes to download on a 56K modem. But if you're interested in this technology, the video is well worth the download.

Here are portions of the press release.

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March 23,2000

In response to the unprecedented interest in the new CLARION HiFocus Electrode, Advanced Bionics produced special online video and animation to describe the history of cochlear implant electrode design and the new HiFocus Electrode. The online video is open captioned for the hearing impaired and features Janusz Kuzma, Director of Advanced Mechanical Research, who led the design of the Nucleus 22, Nucleus 24, CLARION Electrode Positioner and the new CLARION HiFocus Electrode System.

Advanced Bionics' purpose in producing this material is to share accurate, up-to-date information about the advances in cochlear implant technology, so that cochlear implant users, professionals and those considering cochlear implantation can accurately assess and fully understand the new technology.

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US and Canada Approve Advanced Bionics CII without Positioner

Editor: Those who have been following the story about the removal of the Advanced Bionics Clarion CI from North American markets will be interested in the recent announcement that both the FDA and Health Canada have approved the new CII without the Positioner. Note the CII includes the high resolution processing strategy that has only been available in clinical trials up to now.

For additional information, please visit www.advancedbionics.com or contact:
Emily McCargar
emilym@advancedbionics.com
661-917-4847

Here are excerpts from the press release.

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Valencia, CA, September 10, 2002 - Advanced Bionics(r) Corporation (Bionics) today announced it received approval from the U.S. Food & Drug Administration (FDA) and Health Canada to market its high resolution CLARION(r) CII Bionic EarT System.

The FDA approval includes the new High Resolution Sound Processing software, which had been in clinical trials for the last year. High Resolution Sound Processing is designed to provide deaf adults and children the fine details of sound and a more natural hearing nerve response.

"Ninety six percent (96%) of patients in the clinical trial preferred High Resolution Sound Processing to other conventional sound processing strategies," said Mary Joe Osberger, Ph.D., Director of Clinical Research. "Clinical studies demonstrate that music sounds better and speech sounds more natural for the majority of patients," she added.

The FDA approval now lowers the age at implantation in the United States from 18-months down to 12-months. The system is already available to Canadian children 12 months of age and older.

Bionics will begin distribution of the system immediately. The system configuration will not include the separate component called the Positioner, which had been used in previous models. Clinical data show that efficacy results are indistinguishable between systems configured with and without the Positioner.

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Advanced Bionics HarmonyTM HiResolution(r) Bionic Ear System Debuts

November 2006

What is the Harmony™ HiResolution(r) Bionic Ear System? Designed to enhance music appreciation and improve hearing in a variety of difficult listening environments, the Harmony System couples revolutionary internal sound processing (with the optional HiRes FidelityTM 120) with the new Harmony behind-the-ear (BTE) external sound processor. Full Story

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The Bionic Ear Association 2007 Seminars

January 2007

Now you can get answers to all your questions about cochlear implants, in person, at this free seminar. And, at the same time, you'll discover the Harmony HiResolution Bionic Ear, a truly extraordinary breakthrough in both performance and convenience. Join us and find out why the Harmony HiResolution Bionic Ear is the most advanced cochlear implant that can help you achieve your full hearing potential. Learn directly from cochlear implant professionals and interact with cochlear implant users about their experiences hearing the sounds of life.  Full Story

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Friction Between Advanced Bionics Founder and Boston Scientific

February 2007

Last August, Boston Scientific Corp. chief executive Jim Tobin sent a difficult letter to Alfred Mann , one of the company's division chiefs. After careful discussion with his top managers, Tobin wrote, he had concluded Mann must leave. It was no ordinary decision, and Mann was no ordinary subordinate. At 81 years old and with an estimated personal fortune of $2 billion, he ranks among the most successful inventors and entrepreneurs in the history of the medical device industry. His most recent success was selling one of his companies in 2004 for $742 million to Boston Scientific, the Natick life-science giant.    Full Story

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Time to Undo Advanced Bionics Merger with Boston Scientific?

February 2007

A contentious legal fight between Boston Scientific Corp. and a California subsidiary it bought in 2004 took a sharp twist this week when lawyers asked a judge to consider undoing the deal. Boston Scientific of Natick bought Advanced Bionics Corp. for $742 million nearly three years ago, and since last summer has been locked in a legal battle with the company's founder, Alfred Mann . When Mann sold his company to the Natick medical device maker, he crafted an arrangement to keep day-to-day control of his company. He claims Boston Scientific executives wrongfully tried to push him out last July. On Tuesday, New York federal judge Alvin Hellerstein agreed with Mann and issued an injunction temporarily blocking Boston Scientific from removing Mann from his position. He said the company must first pursue the lengthy dispute resolution process outlined in the original merger contract.  Full Story

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Advanced Bionics Announces Online Aural Rehab Program for Kids with CIs

April 2007

As part of our ongoing commitment to support the families and professionals who work with children who have cochlear implants, we are thrilled to announce The Listening Room for Kids.  The Listening Room for Kids is a unique, dynamic, and simple-to-use on-line aural rehabilitation program developed by Dave Sindrey, M.CI.Sc., Cert AVT.   The Listening Room is accessible for FREE through http://www.HearingJourney.com.  It's the only program of its kind designed to assist professionals and families in their efforts to maximize the hearing potential of children with cochlear implants.

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Advanced Bionics Announces Meningitis Vaccination Reimbursement and Incentive Program

October 2007

Meningitis, specifically Pneumococcal (bacterial) meningitis, is one of the most serious and life threatening risks for cochlear implant recipients. Fortunately, there are effective vaccinations against Pneumococcal infections that can immunize and protect against this significant form of bacterial meningitis disease. Unfortunately, many cochlear implant recipients do not get vaccinated, leaving them unnecessarily exposed to the potential health risks associated with bacterial meningitis. Advanced Bionics is proud to announce a new program intended to increase awareness among cochlear implant candidates, recipients, implant surgeons and audiologists who treat cochlear implant recipients, regarding the importance of proper meningitis vaccination. The key objective of this program is to increase awareness of the serious risk associated with meningitis and encourage adult cochlear implant recipients and parents of children with cochlear implants to seek vaccination immediately. The program provides a financial award to parents or guardians of all children (18 years of age and younger) implanted with Advanced Bionics cochlear implants, to vaccinate their children against Pneumococcal meningitis. In addition, the program will reimburse out-of-pocket Pneumococcal meningitis vaccination expenses, not covered by health insurance, for both children and adults with Advanced Bionics cochlear implants.  Full Story