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US Grants Compassionate Use Authorization for Hearing Device Made With 3D Printer

US grants compassionate use authorization for listening to aids with 3D printers

Faizan Hashmi

2 days ago

Thu March 11, 2021 | 11:40 p.m.

WASHINGTON (UrduPoint News / Sputnik – March 11, 2021) A hearing aid created by the Veterans Administration (VA) using a 3D printer received approval from the Food and Drug Administration (FDA) for use on patients with a collapsed ear canal, said the VA on Thursday.

“VA was given the opportunity to prescribe an experimental 3D-printed audiological device specifically designed for a single patient,” said Beth Ripley, director of 3D printing at VA, in a press release. “The 76-year-old veteran patient has a rare disease that causes the ear canal to collapse and muffles sounds.”

The 3D printed stent is inserted into the external ear canal to prevent it from collapsing and allowing sound to pass through.

The device was designed and manufactured in a VA medical center in the state of South Carolina, according to the VA.

In 2017, VA launched a 3D printing network that has since expanded to more than 60 VA medical centers to explore potential applications of the technology in clinical settings.

The FDA’s merciful use approval allows patients access to prototype drugs, biologics, and medical devices for medical treatment outside of clinical trials when no comparable or satisfactory alternative therapy options exist.