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A University of Pretoria professor who made history with the world’s first successful middle-ear transplant using 3D-printed bones is preparing to begin clinical trials that could help restore hearing for dozens of South Africans.
The trials, expected to begin in June at Steve Biko Academic Hospital in Pretoria, will involve 45 patients with conductive hearing loss caused by damage to the middle ear.
Prof Mashudu Tshifularo, from the University of Pretoria’s faculty of health sciences, first made global headlines in 2019 when he and his team performed the groundbreaking surgery on a 40-year-old man using a 3D-printed titanium middle-ear bone implant.
At the time, the procedure was hailed as the first of its kind in the world and placed SA at the forefront of medical innovation.
Speaking to TimesLIVE, Tshifularo explained the procedure in simple terms. “We are replacing the broken middle-ear bone with the exact replica of what is broken. It’s like doing a hip replacement, you are replacing it with the exact hip.
“So in other words, it will restore the broken bone with normal fit-for-purpose and specifically for the patient because we take X-rays and then we go and remanufacture what is broken and then we re-implant it back to the patient.”
The surgery uses advanced robotics and 3D-printing technology to replace damaged middle-ear bones with titanium implants specially designed for each patient.
Tshifularo said the procedure differs from current hearing-loss treatments because it recreates the exact anatomy of the damaged ear bones.
“For conductive hearing loss, this one replicates the anatomy, the weight, the size, the shape, the position,” he said.
“So in other words, I’m replicating everything that has been missing. And that’s why it’s the first advanced technology in this area of middle-ear reconstruction.”
The procedure itself takes about three hours and uses advanced robotics to remove the damaged middle-ear bones and replace them with the 3D-printed titanium bones.
This is minimally invasive, carries significantly less risk than conventional procedures and leaves minimal scarring. The titanium used to manufacture the ossicles is biocompatible, meaning it can be introduced into the ear without causing harmful reactions.
The project is a collaboration involving the Council for Scientific and Industrial Research, HH Industries and Marcus Medical, with funding support from the Motsepe Foundation.
The 45 patients selected for the trials all suffer from severe conductive hearing loss.
“They need to have a conductive hearing loss and then we have specific criteria as per the protocol of how bad their hearing must be,” said Tshifularo.
“In other words, their bones must be completely damaged and they need replacement.”
He said the innovation could eventually reduce dependence on hearing aids and may also help children born with hearing defects.
Reflecting on the first surgery performed in 2019, Tshifularo said the outcome had been highly successful. “It was very good. It was almost 100% uneventful, in other words, no complications. And the patient’s happy.”
He added that if the clinical trials proved successful, the treatment could become available to South Africans immediately.
Tshifularo described the innovation as “a very, very big breakthrough” and “a game changer”.
“We are the first in the whole world,” he said. “So everybody will have to follow our footsteps. We are pioneers.”
But beyond the medical breakthrough, Tshifularo said he hoped the innovation inspired young black children to believe in themselves and pursue careers in science and innovation.
“The black child, wherever they are, in whichever area, they must believe in themselves,” he said.
“We have arrived and we are recognised on the table of innovators.”
TimesLIVE
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