Archived – Notification to HiRes 90K Cochlear Implant Users – Advanced Bionics – For the Public

PUBLIC ADVISORY
Health Canada Endorsed Important Safety Information on HiRes™90K Cochlear Implants

September 29, 2004

Subject: IMPORTANT NOTIFICATION TO HiRes™90K COCHLEAR IMPLANT USERS

Dear Cochlear Implant User or Parents:

We are writing with updated information about the implanted part of your cochlear implant system, called HiRes™90K. We trust that your implant continues to provide benefits and improved quality of life. You may have already heard news about your implant, and we hope this will help your understanding.

After one year (12 months), 98.9% of the HiRes™90K are still in use. Advanced Bionics continues to seek the highest possible reliability for its implantable medical products. To this end, we have recently conducted an extensive review of the HiRes™90K and wish to share the results.

Some HiRes™90K implants have been removed for medical reasons (such as infection), and a few others simply stopped working. Our examination of these implants indicates 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, although we have not yet determined whether these implants were affected by the moisture. In light of this information, we are taking steps to reduce and control moisture levels in new implants. In addition, we have recalled unimplanted products for testing. This recall began on September 24, 2004 and you might have read about it.

What does this information mean for you? Your implant could stop working prematurely, if it is adversely affected by this moisture. In this event, it would become necessary to get a new cochlear implant.

What are the signs and symptoms that a HiRes™90K might be starting to fail?

You or your child may experience:

• a sudden sensation of discomfort or pain
• a sudden loud noise or popping sound
• an intermittent functioning
• a complete loss of sound
• in children, an unwillingness to wear the external headpiece

What should I do if I or my child has any of these signs or symptoms?

1. Try the backup cable, then the headpiece (if separate), and then the sound processor.
2. If signs or symptoms persist, remove the headpiece and contact your hearing care provider. Your clinic has a simple and quick way to test whether your HiRes™90K implant is fully functional.

Do I need to do anything if I do not have these signs or symptoms? No.

How can I get further information? If you have any questions regarding this letter, please call Advanced Bionics at 1-877-454-5038 between the hours of 5 AM and 5 PM Pacific Time, Monday through Friday.

Advanced Bionics appreciates the trust you have put in our product. We pledge to you our continued energies to improve the reliability of our medical technology.

Sincerely,

original signed by

Jeffrey H. Greiner
President and Co-Chief Executive Officer

The identification, characterization, and management of medical device-related adverse incidents are dependent on the active participation of health care professionals in adverse incident reporting programmes. Any occurrences of serious and/or unexpected adverse incidents in patients using HiRes™90K Implants should be reported to Health Canada at the following address:

Any suspected adverse incident can also be reported to:
Health Products and Food Branch Inspectorate
HEALTH CANADA
Address Locator: 3002C
Ottawa, Ontario K1A 0K9
Tel: The Inspectorate Hotline 1-800-267-9675
For other inquiries: please refer to contact information.

The Medical Devices Problem Report Form and Guidelines can be found on the Health Canada web site.