Guest guest Posted March 10, 2006 Report Share Posted March 10, 2006 Hello Everyone, Tony Arnold, Vice President Auditory Marketing at Advanced Bionics has requested that I forward this letter to you. We know the importance of keeping individuals informed of the recall situation with Advanced Bionics. Please see the letter below for information and we encourage anyone with additional questions to contact us directly at the number provided. Very Sincerely, Sandy Mintz Consumer Services Supervisor Advanced Bionics Audiologist and HiRes 90k Cochlear Implant User March 10, 2006 Dear Advanced Bionics Consumer: We would like to inform you that Advanced Bionics has voluntarily recalled certain unimplanted HiRes90K cochlear implants. These implants may be linked to an elevated risk of moisture-related device failure. We are removing the affected unimplanted devices from the hospitals' inventory and replacing them with devices not affected by the recall. All affected doctors and audiologists have been informed of the situation and we are working with them to assure that upcoming surgeries are not affected. No action is required on your part. Advanced Bionics has proactively chosen to issue this recall in patients' best interest. Implants manufactured with a particular component from Supplier A are highly reliable demonstrated by a one-year Cumulative Survival Rate (CSR) greater than 99.5%. A 99.5% CSR means that of every 1000 implanted devices, 995 continue to operate properly at the end of one-year. Devices manufactured with a particular component from Supplier B have a one-year CSR of 97.5%. Because Advanced Bionics is focused on delivering products with the highest quality and reliability, we recalled all implants containing the components from Supplier B. FAQ's with more information are found on our website: www.bionicear.com. If you have any questions, please call Advanced Bionics at this special toll-free number: (877) 454-5038 between the hours of 5 AM and 5 PM Pacific Time, Monday through Friday. In Europe please contact + 33 389 65 98 00. Advanced Bionics is committed to ongoing product and technology enhancements to improve the quality of life for individuals with hearing loss. Quote Link to comment Share on other sites More sharing options...
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