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
February 2009 -
Advanced Bionics Discontinues CII BTE Processor
May 2009 - Advanced Bionics Launches 'Connect To
Mentor' Web Site For Prospective Cochlear Implant Recipients
July 2009 - Advanced Bionics Launches New Pediatric
Accessories
September 2009 - Advanced Bionics Launches Automated
Service for Sound Processor Replacement
November 2009 - Sonova Announces the Acquisition of
Advanced Bionics
December 2009 - Customize Your Advanced Bionics Sound
Processors With Eye-Catching Looks From Skinit
January 2010 - CLEARVOICE FOR ADVANCED BIONICS' HIRES
FIDELITY 120
February 2010 - Advanced Bionics Launches ClearVoice in
Europe, Asia and Canada
April 2010 - Advanced Bionics President/CEO Jeff Greiner
Resigns
April 2010 - Advanced Bionics Technology Focus Group
September 2010 - Advanced Bionics Launches Harmony Sound
Processor for C1 Recipients
December 2010 - Sonova announces voluntary recall of
Advanced Bionics HiRes 90K cochlear implant
February 2011 - Sonova Preparing to Bring Back Recalled
Ear Implants
March 2011 - Advanced Bionics Presents Strengthened
Management Team
April 2011 - Advanced Bionics HiRes 90K Implant Returns
to European, Other Markets
July 2011 - FDA Reviewing Advanced Bionics
Documentation for Approval to Resume Implants
August 2011 - Detailed Explanation of Issue with Advanced
Bionics HiRes 90K
September 2011 - Advanced Bionics HiRes 90K cochlear
implant re-enters US market
October 2011 - Advanced Bionics Introduces Waterproof
"Neptune" Processor
December 2011 - Waterproof CI Processor Approved in US
and Canada
December 2011 - Hands-On Preview of the Advanced Bionics
Neptune CI Processor
January 2012 - Waterproof Neptune Sound Processor from
Advanced Bionics Receives TÜV Approval
~~~~~~~~~~~~~~~~~~~
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.
~~~~~~~~~~~~~~~~~~~
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.
~~~~~~~~~~~~~~~~
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.
~~~~~~~~~~~~~~~~~~~
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.
~~~~~~~~~~~~~~~~~
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
~~~~~~~~~~~~~~~~~
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
~~~~~~~~~~~~~~~~
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
~~~~~~~~~~~~~~~~~
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
~~~~~~~~~~~~~~~~~
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.
~~~~~~~~~~~~~~~~~
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
~~~~~~~~~~~~~~~~~
February 2009
Unfortunately because of changes in the
availability of parts, AB is unable to continue to provide support for its
CII BTE processor. As of February 8, 2009, AB discontinued manufacturing
the CII BTE and declared the product obsolete. This means that extended
warranty plans for the CII BTE will no longer be available for purchase
from AB. Repairs to a CII BTE will be made if parts are available, but
these repairs will not be guaranteed. On January 1, 2010, AB will
discontinue all support for the CII BTE, including repairs.
Full Story
~~~~~~~~~~~~~~~~~
January 2010
The real
world is full of sounds from a variety of sources that compete for your
patients' attention. AB's ClearVoice(tm)* strategy, built on HiRes
Fidelity 120(r)** technology, is designed to automatically analyze and
adapt to each listening situation that patients encounter throughout the
day, separating the distracting noises from what they want to hear most-speech.ClearVoice
has been developed so that recipients can hear their spouse in a
restaurant, their child in the car, their teacher in the classroom, or
their favorite singer on the radio-without ever needing to change a
program or make an adjustment to their sound processor.The Harmony(r)
HiResolution(r) Bionic Ear System with this groundbreaking technology
innovation from AB is designed to provide patients with these important
benefits:
* Improved
speech clarity
* Greater
ease of listening
*
Diminished stress and fatigue
Full Story
~~~~~~~~~~~~~~~~~
April 2010
Below is a link to a letter he sent to the
community announcing his resignation. Based on the timing (shortly after
the acquisition of the company by Sonova, I'm guessing the folks at Sonova
want to replace him with their own person.
Full Story
~~~~~~~~~~~~~~~~~
February 2010
Sonova Holding AG is preparing to reintroduce the
HiRes 90K hearing implants, possibly as soon as April, following a recall
last year, a company spokesman said. The company voluntarily recalled the
HiRes 90K hearing implant worldwide in November after a malfunction led to
"severe pain, overly loud sounds and/or shocking sensations" in two cases.
"We know the problem; we know how it can be solved," the spokesman, Holger
Schimanke, said in an interview today. "It could be April. There's also a
likelihood it could be autumn. Nothing's final." The U.S. Food and Drug
Administration will decide when sales can resume there, and the Staefa,
Switzerland-based company has no clear time frame for when that could
happen, Schimanke said. The implants, made by its Advanced Bionics unit,
may become available outside of the U.S. sooner, he said.
Full Story
~~~~~~~~~~~~~~~~~
August 2011
If you've wondered exactly what the issue with the
Advanced Bionics HiRes 90K was, here's a clear and detailed explanation in
a letter to the Malaysian Ministry of Health. Thanks to bhNEWS for the
lead to this story.
Full Story
~~~~~~~~~~~~~~~~~
October 2011
Introducing Neptune(tm)*, the first and only
SWIMMABLE sound processor in the world with the revolutionary freestyle(tm)
design for the most flexible wearing styles ever-from Advanced Bionics,
the global leader in cochlear implant technology.
Full Story
* Pending Regulatory Approval
~~~~~~~~~~~~~~~~~
December 2011
Advanced Bionics recently announced the FDA
approval of its swimmable Neptune cochlear implant processor. The
processor has an IP (ingress protection) rating of 68, which means that it
is dust-tight (6) and can be immersed continuously in water even greater
than one meter (8). The warranty states that the "waterproof" guarantee is
for sweat, bathwater,and swimming. Note that oceans/lakes are not
included, as it is impossible to test for the types of water in all of
those varied bodies (HINT: if something happens to your processor in such
a body of water, you can just say it "got wet" when you call for a
replacement). Last week, I had the opportunity to get my hands on a
Neptune processor. Here are my impressions:
Full Story
