Harvard's 3D Printed Eardrum Repair Patch Is Ready For Market

Shown on left is an illustration of native tympanic membrane with its pattern of radial & concentric collagen fibers. The team developed a synthetic polymer-based ink system that enabled them to 3D print a device mimicking that same pattern, as illustrated in the middle & shown as an actual 3D printed device on right.
Credit: Illustrations by Shawna Snyder, Photo by Wyss Institute at Harvard University

Perforations within the eardrum cause pain & impaired hearing, and may be tricky to repair. The PhonoGraft, developed by Harvard scientists, may be a 3D-printed implant which can patch up the damage by encouraging natural cells to regrow, and now it’s entered commercial production.

Tympanic membrane , better referred to as the eardrum, is a thin, circular piece of tissue that vibrates in response to sound waves & converts those into electrical signals that the brain can interpret. But it can’t do this job also if it’s punctured by foreign objects like cotton tips or injuries from extremely loud noises. to form matters worse, thereupon barrier open viruses & bacteria can get into inner ear & cause serious infection.

Currently best treatment is what’s referred to as a tympanoplasty, which involves repairing the hole using grafts of the patient’s own tissue. But the last result doesn’t conduct sound also as a healthy eardrum, the procedure requires making an incision behind the ear, and it can often fail & need to be performed again.

The PhonoGraft is meant to solve those problems. The implant mimics the intricate shape of the natural eardrum, which is patterned with “spokes” sort of a bike wheel, and it’s made from a specially developed synthetic polymer-based ink for 3D printing. Not only does the implant itself work to revive hearing, but it provides a scaffold for the recipient’s own cells to regenerate. Tests in chinchillas, which have similar ear anatomy & hearing ranges to humans, proved promising.

PhonoGraft device is installed through ear canal using a noninvasive endoscopic procedure, whereas existing method involves making an incision behind the ear, which is far more invasive (top row). 3D printed device mimics the circular & radial pattern of collagen fibers of native eardrum, while simultaneously matching its acoustic & mechanical properties. Once installed, it initiates regeneration of native eardrum tissue (bottom row).
Credit: Illustrations by Shawna Snyder

“Three months after implanting our optimized graft into the chinchilla’s ear, we had genuine eureka moment,” says Aaron Remenschneider, a researcher on the project. “The hearing tests indicated full restoration of sound conduction, which has been an enormous hurdle. Then we took our first peek down the ear-canal with endoscope. What we were seeing was merely the ghost of our graft that was being replaced with new tissue – a beautifully reconstructed eardrum with its radial-circular pattern.”

As another bonus, the PhonoGraft are often inserted through ear-canal , making the method less invasive.

In order to bring the device to-market, Harvard’s Wyss Institute spun out a startup called Beacon Bio, which was recently acquired by Desktop Health – a step that makes-it-ready for market, apparently. The team is now working to get FDA clearance to bring the PhonoGraft to human patients. Other similar implants also are within the works, like the ClearDrum in Australia.

The team demonstrates the device in the video below.