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
~~~~~~~~~~~~~~~~~~~
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: Regular readers know that the CLARION HiFocus Electrode seems
to significantly improve the performance of the CLARION Cochlear
Implants. Available experimentally for some time, they are now approved
by the FDA for postlingually deafened adults. Here are excerpts from the
press release.
~~~~~~~~~~~~~~~~
California-based Advanced Bionics Corporation today announced that
its new CLARION HiFocus Electrode has received approval from the U.S.
Food and Drug Administration (FDA) for use in postlingually deafened
adults.
"Scientists have attempted for many years to develop an
electrode that can selectively stimulate targeted groups of hearing
nerve fibers," announced Jeff Greiner, President of Advanced
Bionics. "The HiFocus Electrode is the first FDA approved
technology which is designed to achieve this goal," Mr. Greiner
added.
The HiFocus Electrode is a critical component of the CLARION cochlear
implant system and is responsible for delivering sound information in
the form of electrical current to the deafened ear. The new technology
allows, for the first time, focused directional coupling between a
cochlear implant system and a deaf patient's auditory nerve, which may
result in major performance benefits to deaf patients.
"Advanced Bionics is proud to be the first in the race to get
this technology to market because patient performance results have
exceeded our expectations," stated Albert Maltan, Vice President of
Product Management.
"The HiFocus Electrode provides deaf adults with the ability to
hear significantly better than they could with any other hearing device
technology before surgical implantation," noted Dr. Mary Joe
Osberger, Director of Clinical Research. Dr. Osberger further reported
that "with the new electrode, less electrical current is required
to elicit hearing in deaf adults, which is evidence that the electrode
is positioned in close proximity to the auditory nerve. And, the clear
majority of adults (> 90%) hear best when the HiFocus Electrode
delivers information to multiple electrode contacts at the same time
simultaneously, which suggests that the electrode is focusing
stimulation on the targeted nerve fibers."
"During my junior year at Purdue I went completely deaf after
contracting spinal meningitis," said Scott Hebl, a 23-year-old
recipient of the CLARION Cochlear Implant with HiFocus Electrode.
"It was the most frightening experience of my life. I couldn't hear
my friends. I couldn't hear my professors. I couldn't hear a thing. I
didn't know what the future would hold for me or if I could finish my
degree and live my life normally," recalled Scott. "Getting my
hearing back was amazing. I went from total silence to hearing and have
since finished my degree, reconnected with friends and family, and
returned to listening to music again. What a miracle!"
CLARION HiFocus Electrode Design Features
The HiFocus Electrode is designed to consistently deliver focused
stimulation toward the auditory nerve as a result of the invention of
special dielectric partitions and directionally focused electrode
contacts. Dielectric partitions are "pillow-like" elevations
less than 1 mm high that are engineered to prevent electrical current
from spreading to un-targeted nerve fibers. The partitions are further
designed to buffer the inner wall of the fragile cochlea from contact
with the platinum iridium electrode contacts.
The 16 independent electrode contacts are spaced along the inner
surface of the electrode array, and are oriented toward the neural
elements. The electrode array has soft forward bending properties to
facilitate easy surgical insertion into the pea-sized human cochlea, and
is engineered to avoid constrictive pressure against the inner cochlear
wall. The HiFocus Electrode is guided into position during surgery by
the use of the patented Electrode Positioning System(TM) (Positioner).
The Positioner is also designed to occupy the space in the human cochlea
where scar (fibrous) tissue can form. This may be important for cochlear
implant users, especially children, who will make use of future
technologies in their lifetimes.
How a Cochlear Implant Works
Multichannel cochlear implants are a clinically proven treatment for
severe to profound sensorineural hearing loss in both ears (nerve
deafness) and have been in use since the 1980s. They consist of
externally worn and surgically implanted components. The externally worn
components capture sound in the environment and process it into digital
code. The digital code is transmitted via radio waves to the surgically
implanted electronics, which deliver electrical impulses via the
electrode array. The electrode array is inserted into the inner ear and
delivers electrical current to hearing nerve fibers. The nerve fibers
then carry the electrical signals to the brain where they are heard as
sound.
Candidates for Cochlear Implants
Deaf children as young as 12 months and adults of all ages are
considered candidates for a cochlear implant if they have severe to
profound sensorineural hearing loss (greater than 70 dB) in both ears.
Cochlear implants are covered by most private health insurance carriers
and Medicare, and are available at leading medical centers around the
world.
Committed to Helping People Overcome Disabilities
Founded by noted philanthropist and businessman Alfred E. Mann,
Advanced Bionics is committed to helping people overcome their
disabilities and achieve independence through the use of innovative
bionic devices. Advanced Bionics evolved from the world's second largest
heart pacemaker manufacturer (Pacesetter Systems) and the largest
manufacturer of external and implantable insulin pumps (MiniMed, Inc. (NASDAQ:MNMD)
). It is the only American manufacturer of multichannel cochlear
implants and invests millions of dollars annually for product
improvements, research and development and next generation products. The
company employs over 350 scientists, engineers and professionals around
the globe and is one of the fastest growing medical device manufacturers
in the world. Its experience in implantable prostheses and
miniaturization demonstrates the company's commitment to advanced
technology for the disabled.
~~~~~~~~~~~~~~~~~~~
March 2001
Editor: Advanced Bionics recently announced that its CLARION(r) CII
Bionic Ear(tm) System received limited U.S. Food and Drug Administration
(FDA) approval for the treatment of deafness in children and adults. The
limitation is that it must be operated in the "conventional"
(emulation) mode for now. The complete capabilities of the CII will not
revealed until this restriction is lifted, hopefully in the next year.
Here are portions of the press release.
~~~~~~~~~~~~~~~~~~~
Introducing the CLARION(r) CII Bionic Ear(tm) System*
. FDA APPROVED when operating in software restricted conventional
cochlear implant mode**
. Available April 2001 at all CLARION Implant Centers
. Internal memory banks support powerful BROADBAND capabilities
. More than 10 times FASTER than any other conventional cochlear
implant for high resolution signal delivery
. Up to 31 stimulation channels deliver the HIGHEST FIDELITY sound
signal possible
. Innovative HIGH RESOLUTION software upgrade will allow users to
take advantage of future technological developments
. Smart Control Electronics provide POWER efficiency for extended
operating times with the CII BTE(tm)
Advancements in cochlear implant technology over the past twenty
years have demonstrated that the ability to provide more sound
information to the hearing nerve has resulted in increased user
PERFORMANCE. Conventional cochlear implants have been limited in their
ability to deliver a full or complete sound signal. The newly FDA
APPROVED CLARION(r) CII Bionic Ear(tm) is a new generation cochlear
implant with vastly increased performance capability never before seen
in the industry. The CII Bionic Ear is designed to increase user
performance through both powerful and INNOVATIVE technology.
"The CII Bionic Ear is clearly a major leap forward in implant
technology. The CII provides a host of new research options for the
scientific community, which will foster the development of
next-generation speech processors to improve speech understanding and
sound quality for implant users"
Dr. Robert Shannon, Ph.D., Director of Auditory Implant Research at the
House Ear Institute in Los Angeles and one of the world's leading
authorities in the field of Auditory Perceptual Research.
In high resolution mode, the CLARION(r) CII Bionic Ear(tm) can
deliver sound information to the hearing nerve up to 1,000,000 times per
second through 31 distinct audio processing channels. Special state-
of-the-art safeguard electronics are designed to ensure that the high
resolution CII Bionic Ear delivers the full broadband sound information
to the hearing nerve safely and effectively. The system also utilizes
the latest advances in focusing electrode technology and powerful
miniature sound processor electronics to provide the HIGHEST FIDELITY to
its users.*
Alternatively, the CII Bionic Ear can also operate in EMULATION mode
where its high resolution functions are limited by software to that of
the proven and leading conventional CLARION cochlear implant.
"The electronic platform of the CLARION CII Bionic Ear provides
the versatility required to implement many exciting advances from
research on cochlear implants. Its extraordinary capability to deliver
the fine details of sound in high resolution will provide the hearing
health profession with a powerful tool to manage children and adults
with severe and profound hearing loss. This is how deafness will be
treated worldwide over the next decade."
Dr. Gerald Loeb, M.D., Professor of Biomedical Engineering at USC, a
world renowned scientist who was one of the original developers of
cochlear implants and whose research has been published in Science,
Journal of Neuroscience, Annals of Otology, Rhinology and Laryngology,
and Scientific American.
In emulation mode, the CII Bionic Ear is restricted to the
implementation of sound processing strategies such as CIS, MPS, and SAS,
and is fully commercially approved for use in both adults and children
18 months or older.
The CII Bionic Ear electronics are also designed for optimal POWER
efficiency. The rechargeable battery module of the full capability CII
BTE(tm) (Behind-the-Ear) sound processor provides extended operating
times between recharge cycles and results in low battery replacement
cost. The CII BTE (for use with the CII Bionic Ear System) and the
Platinum BTE(tm) (for use with current users) are fully FDA approved.
Users who receive the CII Bionic Ear in emulation mode (available at all
CLARION cochlear implant centers) can switch to high resolution
broadband sound delivery mode at a later date through a simple software
upgrade that does not require any surgery. HIGH RESOLUTION mode software
is being evaluated as part of clinical trials in a limited number of
clinics and is expected to receive regulatory clearance from the FDA
within the next year.
* CAUTION: High Resolution broadband information sound delivery is
limited to investigational use only.
** Approved for use in both adults and children 18 months or older.
~~~~~~~~~~~~~~~~~~~
Editor: You've probably heard that the new "Bionic Ear" -
also called the CII - from Advanced Bionics seems to offer significant
improvement over previous CIs. Here are excerpts from the Advanced
Bionics press release announcing the initial results of their clinical
trials. The article is actually from August; I managed to lose it in my
"highly sophisticated" <grin> filing system. The results
are sufficiently interesting that I decided to publish the article now,
anyway.
~~~~~~~~~~~~~~~~~~~
Advanced Bionics Corporation released preliminary results from the
North American clinical trial studying the high resolution Bionic Ear
Mode* software for the CLARION CII Bionic Ear System.
"After just 3 days experience listening with the high resolution
Bionic Ear Mode, study patients heard an average of 15 times better than
they could before receiving the bionic ear," reported Mary Joe
Osberger, Ph.D., Director of Clinical Research. "The first 8
patients programmed in the investigational Bionic Ear Mode scored, on
average, 60% correct on the most difficult single syllable word tests
without lipreading. The most recent clinical trial with conventional
Cochlear Implant technology demonstrated that mean scores did not reach
this level even after a full 3 months of listening experience. While the
results are preliminary due to the small sample size, it is clear that
these patients derived benefit from the new bionic ear technology,"
Dr. Osberger added.
CLARION CII Bionic Ear System
"The CLARION CII Bionic Ear System is designed to deliver vastly
more sound information to the hearing nerve than conventional Cochlear
Implants," stated Edward Overstreet, Ph.D., Clinical Engineer and
neuroscientist. "When programmed in the investigational Bionic Ear
Mode, sound information can be delivered up to 1,000,000 times each
second, compared to under 20,000 times each second with other Cochlear
Implant technology."
"The Bionic Ear differs from conventional Cochlear Implant
technology in that it delivers substantially more sound information to
the auditory nerve. It is expected that deaf and hard of hearing
children and adults will have significantly improved hearing with the
Bionic Ear," reported Dr. Franklin Rizer, M.D., a leading surgeon
and researcher at the Lippy Group for ENT in Warren, Ohio.
There are an estimated 740,000 deaf adults and children in the United
States who may benefit from this new medical breakthrough. Adults with
severe-to-profound bilateral nerve deafness may participate in the
clinical trial. Deaf children and adults who are not candidates for the
clinical trial, yet want to receive the CLARION CII Bionic Ear System,
may be implanted with the technology and have it programmed in
FDA-approved Cochlear Implant Mode software. These adults and children
will have access to full sound for better hearing when the Bionic Ear
Mode software is approved and commercially released.
Most health insurance carriers including Medicare cover the cost of
the implanted device and surgery, which takes between two and four hours
and is typically done on an outpatient basis.
~~~~~~~~~~~~~~~~~~~
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.
~~~~~~~~~~~~~~~~~~~
Editor: 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.
~~~~~~~~~~~~~~~~~~~
September 27, 2004
Dear Clinicians:
Advanced Bionics is asking you to return, immediately, all unused
Advanced Bionics implantable cochlear stimulators: the CLARION(r) 1.2,
the CLARION(r) CII, and the HiResTM90K. The recall arises from our
concern about the possible presence of residual moisture in, or a
potential loss of hermeticity of, the implantable cochlear stimulators.
This recall is being made with the knowledge of the United States Food
and Drug Administration.
Advanced Bionics has conducted a review of the reliability rates and
failure modes of these products, which has led to this action. We would
like to share the results and our decisions.
a.. The CLARION(r) 1.2, the oldest of the three models, is still in
use by 92.0% of the recipients after 5 years. The CLARION(r) CII remains
in 97.7% of patients after 3 years. While some of these devices have
been removed for medical reasons (such as infection), most simply
stopped working. Our investigation into these failures indicates that
the most common cause was moisture in the stimulator that resulted in a
premature loss of function.
b.. The HiResTM90K, our newest model, has had an explant rate of 1.1%
at 12 months. Roughly half of these have been for medical reasons. Our
investigations of the failures indicate that, in at least one instance,
a significant cause was unexplained moisture on the internal circuitry.
We have also found some residual moisture in other units that were
hermetically sealed, although we have not yet determined whether these
devices were affected by the moisture.
c.. Advanced Bionics is taking additional steps to reduce and control
moisture levels in new units of the HiResT90K cochlear stimulator. We do
not know how long this process will take, but until it is completed, we
will not be able to supply cochlear implants. Please be assured that we
are working on these improvements as quickly as possible. If you have a
candidate scheduled for cochlear implant surgery, we recommend that you
use a cochlear implant from another manufacturer or postpone implant
surgery. We regret the inconvenience this interruption will cause you
and your patients.
In addition, Advanced Bionics will soon be writing each cochlear
implant user about the possibility of premature failure. Your patients
may contact you with questions or for counseling, so we wanted you to be
aware of the information in our letter before it is sent to users. They
will be told that the signs and symptoms of failure are a sudden
sensation of discomfort or pain, a sudden loud noise or popping sound,
an intermittent functioning, a complete loss of sound, and in children,
an unwillingness to wear the external headpiece. They will be advised
that, if they experience any of these signs or symptoms, they should
first try the backup cable, then the backup headpiece (if separate), and
then the backup sound processor. If the signs or symptoms persist, they
will be advised to remove the headpiece and contact their hearing care
providers. They will be told that hearing clinics have a simple and
quick way to test whether the implanted cochlear stimulator is fully
functional.
If you have any questions regarding this letter, please call the
Advanced Bionics implant hotline at 1-877-454-5038 between the hours of
5 AM and 5 PM Pacific Time, Monday through Friday.
Centers that we have shipped devices to, but where the implant
registrations are outstanding, will receive a list of those devices with
the serial number and shipment date. The document will be sent no later
than September 28, 2004, close of business and will provide the
information on how to return the products. It is important that the
device registration and the product return be handled expeditiously.
Thank you in advance for your cooperation on this matter and we
apologize for the inconvenience.
Sincerely,
Jeffrey H. Greiner
President and Co-Chief Executive Officer
