CENTENNIAL, Colo., Aug. 22, 2016 /PRNewswire/ -- Cochlear Limited (ASX: COH), the global leader in implantable hearing solutions, announces today the U.S. Food and Drug Administration (FDA) approved Nucleus implants for magnetic resonance imaging (MRI) use up to 3.0T with the magnet removed. Additionally, with the use of the Cochlear Nucleus Implant Bandage and Splint Kit, Nucleus implants are approved for 1.5T MRI with the magnet in place.
Inside each cochlear implant is a magnet, and nearly 20 years ago Cochlear was the first to introduce a key safety feature to ensure MRI compatibility for its implants: a removable magnet. The removable magnet ensures customer safety and comfort if an MRI is needed and an alternative imaging option is not available. The magnet is easy to remove and replace with a minor procedure if needed.
Cochlear's removable magnet is the gold standard for MRI and is reinforced by radiologists. Of radiology professionals surveyed, 97 percent do not recommend conducting MRI scans on patients with magnets in their bodies.1 The ability to remove the magnet provides optimal image quality and reduced artifact, a shadow cast by the magnet.2
"Cochlear has always taken the lead in adapting our implants to MRI technology to ensure customer safety and comfort, as well as protecting the efficacy of our Cochlear implant products that our customers depend on to hear," said Tony Manna, President of Cochlear North America. "We are proud to be able to provide a range of MRI options–including the removable magnet and the splint kit–for our customers and their medical professionals to ensure safety, efficiency and convenience for all."
If a 1.5T MRI with the magnet in place is needed, the Cochlear Nucleus Implant Bandage and Splint Kit can be ordered by clinics and hospitals, individual radiology clinics and Cochlear customers. The kits will be provided at no charge when ordered to minimize any financial burden to our customers and medical professionals.
Customers, hospitals and clinics looking to order the Bandage and Splint Kit should contact Cochlear Clinic Customer Service at 1-877-883-3101 or camclinicservices@cochlear.com.
Hospital and clinics with questions on the Bandage and Splint Kit or on magnet removal should visit www.cochlear.com/warnings or contact Cochlear Surgical Support at 1-877-279-5411.
Nucleus implants compatible with the updated FDA MRI approval include: CI512, CI522, CI532, CI24(RE)CA, CI24(RE)ST and Hybrid L24.
An MRI is a diagnostic tool to obtain images of organs and tissues using a very powerful magnetic field measured in tesla (T). MRIs can range in strength from 0.2T to 7.0T, with 1.5T being the most common.
About Cochlear Implants
Cochlear implants are a proven medical option for infants as young as 12 months old with profound hearing loss in both ears, children aged two and older with severe-to-profound hearing loss, and adults with moderate-to-profound hearing loss in both ears. They are electronic devices that bypass damaged hair cells in the inner ear, or cochlea, and stimulate the hearing nerve directly.
According to the National Institute on Deafness and Other Communication Disorders, roughly 58,000 adults and 38,000 children have received cochlear implants in the United States.3 Nearly two million Americans could be candidates for cochlear implant technology, but only five percent of patients who can benefit have been treated.4,5
About Cochlear Limited (ASX: COH)
Cochlear is the global leader in implantable hearing solutions. The company has a global workforce of 2,800 people and invests more than AUS$100 million a year in research and development. Products include cochlear implants, bone conduction and acoustic implants, which are designed to treat a range of moderate to profound types of hearing loss.
Over 450,000 people of all ages, across more than 100 countries, now hear because of Cochlear.
www.cochlear.com/us
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[1] Radiology Poll conducted by Penn, Schoen, Berland, August 2015. Data on File. |
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[2] F. Risi, A. S. (2004). Magnetic resonance imaging safety of Nucleus 24 cochlear implants at 3.0 T International Congress Series. International Congress Series 1273, (pp. 394-398). |
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[3] National Institute on Deafness and Other Communication Disorders. Cochlear Implants [Internet]. Available from: https://www.nidcd.nih.gov/health/cochlear-implants. |
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[4] Blanchfield, B.B., et. al. (2001). The severely to profoundly hearing-impaired population in the United States: Prevalence estimates and demographics. JAAA. 12, 183-189. |
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[5] Internal Cochlear Data on File. June, 2009. |
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©Cochlear Limited 2016. All rights reserved. Hear now. And always and other trademarks and registered trademarks are the property of Cochlear Limited or Cochlear Bone Anchored Solutions AB. The names of actual companies and products mentioned herein may be the trademarks of their respective owners. |
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SOURCE Cochlear Limited
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