Volume 21 Issue 1

HOH-LD-News
Vol. 21, Issue 1
October 2, 2004

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Table of Contents
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- Article 1: Advanced Bionics Recalls Cochlear Implants
- Article 2: The Benefits of Deafness
- Article 3: Totally Implantable Envoy in Clinical Trials
- Article 4: Gallaudet Announces Contests for Teens with Hearing Loss
- Classifieds - Two Travel Opportunities and one Education Opportunity
- Contact Information and Disclaimers

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Contact information and disclaimers are at the end of this newsletter.
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- Article 1: Advanced Bionics Recalls Cochlear Implants
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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.

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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

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- Article 2: The Benefits of Deafness
By Cheryl Heppner
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Editor: Deafness has benefits, you say? It may be a tough concept for some, but the thoughts of the folks in the ALDAcon panel may change your mind. This has been a bad year for us, conference-wise. Thanks to Cheryl for her usual great job of sharing what goes on at these wonderful gatherings.

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Shawn Lovley put together a panel of late-deafened people for ALDAcon today to talk about the benefits of acquired deafness as opposed to the frustrations. I was one of the panelists and enjoyed the experience of hearing from the others. I thought you might enjoy it too.

Shawn Lovley enjoys not having to listen to telemarketers and rap music. He also is grateful for all the great people he's met through the Association of Late-Deafened Adults

Carolyn Piper said that the experience of being deaf helps her to reinvent and become a different person -- "Pain is God's reset button." She cited Helen Hayes, who after the death of her husband, commented that for a long time she was "crazy as a loon" and should have been locked up in a straitjacket in a padded room. Hayes realized she had a choice, craziness and grief or a happy life, and the choice of which path she took was up to her.

Mark Dessert always saw himself as an average good guy but found himself on a new journey and developing a new identity because of deafness. It pushed him into a new field, forced him to confront his fears, and he now has really good friends who care about him.

Lori Heir has learned to be confident in her deafness and to advocate for herself. She is now involved in life, and likes that deafness makes her more unique. Once a very, very shy person, she learned to appreciate and value communication because of her hearing loss and now loves to challenge her limitations. She also loves helping others with hearing loss, learning sign language, and teaching other people about deafness to clear up their misconceptions. The absurd things that happen because of her hearing loss give her more occasions to laugh.

Dr. Roy Miller had a long list of benefits, which he broke into categories: - He gets a peaceful night's sleep each and every night because noises don't bother him -- loud parties, dogs barking, thunder and lightning, the patter of rain, sirens, snoring, etc. - He is less afraid or anxious because he can't hear sounds like music in horror movies, footsteps behind him on a dark street, creaking floors, cars backfiring. - In cities he is less stressed because he doesn't have to contend with annoyances like horns honking, the roar of traffic, babies crying in a restaurant, the clatter of subway trains, and loud rock music in night clubs. - When traveling his experiences are more easy and worry-free because he doesn't hear jet engines, and he gets to board planes first. He also pointed out that people in France sound just like people in Russia so he knows no linguistic boundaries. - His driving is more relaxing because he doesn't hear car horns honking at him, noisy mufflers, motorcycles roaring past, the wind gushing past an open window, and passengers' comments about his driving. - He feels he is more focused and productive at work because he doesn't hear copy machine operations, phones ringing, air conditioners blasting, fluorescent lights humming, gossip, and noises from other offices. - There are perks like sitting closer to the front at large gatherings because you need to see the interpreter, and the free Golden Eagle Passport for lifetime admission to all national parks.

I said "ditto" to all the comments of the previous panelists and added to their lists three things I appreciate about deafness: - The ability to concentrate and maintain intense focus - Enjoying small things I would not have appreciated, especially the ability to see music in movement -- the way a gifted interpreter can create it with signs, the rhythm of waves crashing, the rise and fall of a bird's chest as it sings. - After years of needing to observe people intently, often knowing when what they say does not match what they are thinking and feeling.

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- Article 3: Totally Implantable Envoy in Clinical Trials
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Editor: We've been following the story of the Envoy totally implantable hearing aid for a couple of years now, and are excited to see that they are in clinical trials. The technology (described towards the end of the article) is pretty interesting. If any of our readers are part of this trial, I'd love to hear your thoughts about this system.

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From the newsroom of the Business Wire, Tuesday, September 7, 2004

St. Croix Medical, Inc. Announces Advancements in US and German Pivotal Clinical Studies

Totally implantable Envoy(R) System restores quality of life in patients with hearing loss

MINNEAPOLIS -- St. Croix Medical, Inc. (SCM) announced today that its Envoy System has been implanted in several patients as part of the product's pivotal clinical study. This study follows an earlier study and will evaluate the safety and effectiveness of the company's device in patients with sensorineural hearing loss on a larger scale. Physicians in Greensboro, NC, Newport Beach, CA, Pittsburgh, PA and Koblenz, Germany have performed the first procedures.

"The enrollment of these patients in the US and German clinical trials is another step towards meeting the European and FDA requirements for market approval," said Hans Neisz, SCM's President and Chief Executive Officer. Neisz continued, "The preliminary results are very encouraging and endorse the system's capabilities to provide benefit to patients whose life is compromised or debilitated by their hearing loss."

Over 21.5 million adults in the United States suffer from sensorineural hearing loss. Conventional microphone-based hearing aids are the most common treatment today for sensorineural hearing loss. However, only 20 to 30% of the hearing impaired use hearing aids and many who try hearing aids stop after a short period. The most commonly sited limitations of hearing aids include poor understanding in noise, poor sound quality, whistling (acoustic feedback), battery life, poor fit and discomfort.

The technology platform of the Envoy System is different from all other microphone-based hearing devices (hearing aids, other middle ear implants or cochlear implants). The Envoy uses the eardrum to process the incoming sound and thereby preserving a natural way of hearing that particularly benefits patients in noisy environments.

Piezoelectric transducers sense minute mechanical vibrations at the eardrum and convert them into electrical signals. These electrical signals are then amplified and filtered by a "pacemaker-like" sound processor and transmitted to a second piezoelectric transducer that stimulates the inner ear naturally, and with significantly greater efficiency than acoustic devices. The Envoy System is the only hearing device that leverages the natural anatomical function of the ear and is expected to result in better clarity of sound, better word recognition and reduction of background noise. The proprietary microelectronics of the Envoy consumes a very small amount of electrical current, allowing the device to function for up to 4 years without maintenance. Being totally implantable, the Envoy System is invisible to the onlooker and eliminates the stigma that is often associated with hearing impairment.

SCM received an Investigational Device Exemption from the FDA, has completed Phase I clinical trials and is now actively enrolling patients to participate in the Phase II pivotal trial in both the United States and Germany.

About SCM

SCM was founded in 1995 to design, develop and market implantable devices for the treatment of sensory disorders. A privately held, Minnesota-based company, the current focus of the organization is to improve the quality of life for the millions of individuals suffering from sensorineural hearing loss.

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- Article 4: Gallaudet Announces Contests for Teens with Hearing Loss
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Editor: For several years Gallaudet University has been running an essay contest for teens with hearing loss. They're doing it again this year, and they've added an art contest! Here's the scoop.

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For Immediate Release Monday, September 27, 2004

Contact: Susan Flanigan Telephone: 202-651-5340 (Voice/TTY) E-Mail: Susan.Flanigan@gallaudet.edu

Gallaudet to Sponsor National Essay and Art Contests for Deaf and Hard of Hearing Teenagers Scholarships Awarded

(Washington) Every year Gallaudet University challenges deaf and hard of hearing students to express their thoughts about a particular topic. The theme for the sixth annual Gallaudet National Essay Contest for Deaf and Hard of Hearing Students and the World Around You magazine art contest is "A Life Turning Point." Students have the option of submitting a written essay or sharing their turning point through the medium of art, including pen and ink, pastel, watercolor, mixed media, acrylic, crayon, or pencil.

"Some students may face a turning point when they participate in their school's work experience program and decide to pursue a specific career," said World Around You editor and contest director Cathryn Carroll. "Other students may face a turning point when they finally tell a parent, counselor, teacher, or friend about a problem (i.e., depression, an eating disorder, a bully, drug abuse). Even reading a book can be a turning point. A student may read about a scientist and decide to make science a career."

"If you know of any deaf or hard of hearing teenagers between the ages of 15 and 19 who like to write, we encourage you to share with them the contest information and encourage them to send in an essay or art submission. All entries must be postmarked by February 11, 2005," said Carroll.

All contest participants will receive certificates of meritorious entry. Essay place winners will receive scholarship money for the college or postsecondary training of their choice ($1,000 first place, $500 second place, $300 third place, $100 two honorable mentions). All scholarship awards will be DOUBLED for winners who choose to attend Gallaudet University. The first place winner will also receive a scholarship to Gallaudet's Young Scholars' Program. The first place art contest winner will receive $100. Winners will be announced and winning entries will be printed in the spring issue of World Around You magazine published by the Laurent Clerc National Deaf Education Center.

"We would like to express appreciation to the generous donors who have once again offered books for our contest place winners," said Carroll. "They include Eric Albronda for his donation of Douglas Tilden: The Man and His Legacy, a story of the famous deaf sculptor, and Gallaudet University Press for books on deaf culture."

For more information, contact: Cathryn Carroll, Editor, World Around You, Gallaudet University, KDES, Suite 3600, 800 Florida Avenue, NE, Washington, DC 20002-3695; or visit the contest website at: essaycontest@gallaudet.edu for contest rules and an application form.

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- Classifieds
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Two Travel Opportunities and one Education Opportunity appear in this issue. (Ads appear after this brief table of contents.)

Travel Opportunity 1
Florida Tours & Entertainment
Cruises and Tours 2005

Travel Opportunity 2
Cruise for CI Users
From Los Angeles to Hawaii
January 19 to February 3, 2005

Education Opportunity 1
Play Therapy and Sandtray Training
Chesapeake Beach Professional Seminars

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Travel Opportunity 1
Florida Tours & Entertainment
Cruises and Tours 2005
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ASL Interpreter Service (ASLIS) provided
Assistive Listening Devices (ALD) for our hard of hearing clients available

Costa Rica - Nature's Museum June 9-18, 2005 ASLIS + ALD
$2,819.00 per person, dbl. occ., land and air Early Booking Bonus: $50.00 per person

Eastern Caribbean Cruise July 2-9, 2005 ASLIS
Coincides well with FAD's 40th Biennial Convention in Miami ending on July 2, 2005. Starting at $1,128.00 per person, dbl. occ., cruise only

Dream Tour of Ireland August 1-12, 2005 ASLIS + ALD
$2,990.00 per person, dbl. occ., land and air Early Booking Bonus: $50.00 per person

Alaska Inside Passage Cruise September 5-15, 2005 ASLIS
Coincides well with the Deaf Seniors of America National Conference in San Francisco ending on September 5, 2005. Starting at $1,389.00 per person, dbl. occ., cruise only

Canadian Rockies Train Tour October 9-17, 2005 ASLIS + ALD
$2,981.00 per person, dbl. occ., land and air Early Booking Bonus: $50.00 per person

Sierra Madre Express November 10-17, 2005 ASLIS + ALD
$3,295.00 per person, dbl. occ., land and train Early Booking Bonus: $50.00 per person

Visit our web site for more details: www.kerstinstravel.com

Do you want to receive our newsletter? Subscribe at kerstin@kerstinstravel.com

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Travel Opportunity 2
Cruise for CI Users
From Los Angeles to Hawaii
January 19 to February 3, 2005
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15 Day Cruise-Hawaiian Islands for Adult Cochlear Implant Users
*****SPECIAL FARE FOR THIS CI USER GROUP CRUISE
Leaving from Los Angeles January 19 to February 3, 2005

Join Auditory Verbal Therapist William and Carol Beitzel for an unique experience combining CI therapy with social interaction on a cruise. Learn to develop and enhance your effective comfort level skills using your cochlear implant. Come along with your spouse/SO for fun/relaxation while participating in an exciting complimentary individual/group therapy program.

Contact Bill at wave307@shaw.ca .

Cruise starts at $2099 USD (pp/dbl.occ)

Info/book-contact Evelyn Sinclair at CRUISE WORLD, INC. 101-1090 Waverley St., Winnipeg, MB,CANADA R3T 0P4
1-204-925-2120 or 1-800-463-2120
FAX 1-204-475-7171
EMAIL evelyn@cruiseworld.mb.ca

LUNCHEON AND TOUR AT ADVANCED BIONICS CORP.

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Education Opportunity 1
Play Therapy and Sandtray Training
Chesapeake Beach Professional Seminars
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CHESAPEAKE BEACH PROFESSIONAL SEMINARS
is interested in offering play therapy and sandtray training to deaf and hard of hearing clinicians who provide mental health services to children and families.

Interpreters using American Sign Language available.

If you work at a facility where there are a number of deaf and hard of hearing clinicians or you have access to a number of such clinicians, we could have the training at your facility.

Please get in touch with us immediately to talk about possibilities.
E-mail: cbps@radix.net.
website: www.cbpseminars.com

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- Contact Information and Disclaimers
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