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Users of cochlear implants, bone-conduction hearing devices or middle-ear hearing devices may experience adverse effects on their cerebrospinal fluid (CSF). According to the FDA, if planted too closely to the CSF shunt system, the valve settings may over or underdrain. This fluid is drained from the brain, and transported to another part of the body where it can be absorbed. Such effects on the cerebrospinal spinal fluid can cause negative side effects such as: headaches, lethargy, irritability, vomiting, vision impairment, walking difficulty and an altered mental status.
As a way of helping prevent these symptoms, the FDA has created a set of recommendations to healthcare professionals and providers. This includes actions such as educating patients, contacting device manufacturers, and checking CSF shunt valve settings after placement of a device. There is also the consideration of whether or not there are magnets in a close range from other implanted devices when placing the programmable CSF shunt valve.
iData Research’s market analysis on hearing aids and audiology devices found that Cochlear implants, bone-conduction hearing devices, and middle hearing devices accounted for over 20% in 2016. New findings from the FDA on the magnets inside those particular hearing implants may cause a negative impact to revenue for these products in the market and limit growth.
As an informational topic, the FDA previously created a website on programmable CSF shunts for patients for the public. This included how cerebrospinal fluid shunt valves can be adversely affected by magnetic field interference. Common regular magnetic sources, like cellphones, magnets, tables, toys and security screening systems can also affect shunt valve settings.
For Further Information
To get in an in-depth market overview, as well as other drivers and limiting factors, please read iData Research’s’ U.S. Hearing Aid Market Analysis Report.