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FDA MedWatch Safety Alert: Programmable CSF Shunts and Magnetic Field Interference with Implanted Hearing Devices

July 16, 2019 - 10:32pm

To increase awareness about potential complications in patients implanted with both programmable cerebrospinal fluid (CSF) shunt systems and some hearing implants that contain magnets, such as cochlear implants, bone conduction hearing devices, or middle ear hearing devices, the U.S. Food and Drug Administration (FDA) issued a letter to healthcare providers on July 16. According to the FDA letter, magnetic interactions between these devices may occur when implanted in close proximity to each other. These interactions may lead to unintended changes to the programmable CSF shunt valve settings. Learn more about recommendations for preventing unintended setting changes, background information on this topic, and how to report problems to the FDA. 

Read the FDA's Letter to Healthcare Providers