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FDA grants VA first ever compassionate use for 3D-printed hearing device

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WASHINGTON — The Department of Veterans Affairs (VA) received compassionate use approval from the Food and Drug Administration (FDA) in February for a groundbreaking in-house developed medical device to help improve the quality of life of a Veteran with a rare hearing condition.
FDA’s compassionate use authorization allows patients access to prototype medications, biologics and medical devices for medical treatment outside of clinical trials when no comparable or satisfactory alternative therapy options exists.
“VA was granted the ability to prescribe an experimental 3D printed audiological device specifically designed for a single patient,” said VA Director of 3D Printing Network Beth Ripley, M.D., PhD. “The 76-year-old Veteran patient has a rare medical condition that causes the ear canal to collapse and muffle sound.”
The 3D printed stent is inserted in the external ear canal to keep it from collapsing and allow sound to pass through. The device is not surgically implanted and can be easily removed by the patient. This unique hearing aid was designed and created by the integrated 3D printing network team at the Ralph H. Johnson VA Medical Center in Charleston, South Carolina.
In 2017, VA started integrating and developing its 3D Printing Network. Since then, the network has expanded to more than 60 VA medical centers exploring possible uses of the technology in clinical settings

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