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NextGov: FDA Approves VA-Made 3D-Printed Hearing Device for South Carolina Veteran

Published by Brandi Vincent


(Michael Romeo III/Ralph H. Johnson VA Medical Center)


It’s rooted in the patient’s unique idea to use a drinking straw to open up his hearing pathway.


The Food and Drug Administration recently approved the Veterans Affairs Department’s request to prescribe an experimental, 3D-printed device developed in-house to a 76-year-old patient facing a rare form of hearing loss.


“This was collaborative care. There are many illnesses, you know. For example, I have lung issues and heart issues and liver issues—I mean, I have more issues than issues have issues. But, in this particular case, I could participate in the solution,” that veteran patient, Michael Nicoletti, told Nextgov Monday. “And they were very open to that. They wanted my input. They wanted my feedback.”


The move marks the first time FDA granted compassionate use authorization to VA. Moving forward, the department will continue to leverage its 3D-printing network to address patient-specific medical needs that might not be met yet by off-the-shelf products. In separate interviews this week, Nicoletti, and VA’s Dr. Beth Ripley, briefed Nextgov on how the investigational, audiological device came to be, the infrastructure that made it possible and what might follow....


Read the full article on NextGov here.

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