Charleston VA Granted First Ever “Compassionate Use” Approval for 3D-Printed Hearing Device by FDA

Press Release

The Ralph H. Johnson VA Medical Center 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.

“With our new Charleston 3D Innovation Center, we are on the cutting edge of patient care for our Veterans and we work hard every day to take their care to the next level,” said Scott Isaacks, Director and CEO of the Ralph H. Johnson VA Medical Center.  “This was the first of many initiatives we are planning aimed at improving the lives of our Veterans using this emerging technology.”

With this compassionate use approval, a 3D printed stent was inserted into the ear canal of a 76-year-old Veteran patient with a rare medical condition that caused the ear canal to collapse.  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.
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It is very exciting to use our 3D printing technology to customize care for our Veterans! pic.twitter.com/gVhSWjt0wv

— Ralph H. Johnson VA Medical Center (@CharlestonVAMC) March 16, 2021

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