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A world-first prosthetic eardrum being developed by a Perth company could dramatically change the lives of First Nations communities in WA and beyond who suffer from chronic middle ear disease.

According to the World Health Organisation, a rate of chronic suppurative otitis media above 4% is considered a public health emergency.

However, in some Aboriginal and Torres Strait islander communities across Australia the rates are as high as 12-15% in children, according to ClearDrum chief executive Philip Canner.

“That means 6,000 kids with the disease in WA,” Mr Canner said.

“It’s become normalised. More than 90% of people in these communities have some ear disease. If we can do anything, if this can start helping with that, that would be incredible.”

The cutting-edge device has the potential to significantly improve patient outcomes for the millions of people worldwide who suffer ruptured eardrums, as a result of trauma, infection or genetic causes.

It was invented by renowned local ear surgeon Marcus Atlas and developed by the Ear Science Institute Australia in Subiaco until the research and development effort was spun out to the start-up ClearDrum company in 2023.

Mr Canner said that in 30% of surgeries using autologous material, such as cartilage, to repair perforations in the tympanic membrane, the grafts can fail, requiring repeat surgeries.

“Even when they do work, our research, looking at the data, shows 60% will not fully recover their hearing,” he said.

The ClearDrum prosthetic implant, made using silk fibroin, is designed to have the same strength as cartilage but is see-through and has superior acoustic properties.

Mr Canner said the company has been doing trials with several ear surgeons on cadavers to make sure the product handles correctly and feels like a normal graft material.

“They were really positive,” he said. “Everyone found it easy to use and very straightforward requiring no new techniques.”

The company has finished bench-testing the product and is now gearing up for clinical trials and manufacturing through an FDA-registered American company.

“We’re looking to start clinical studies in 2026 and hope to launch in early 2028,” Mr Canner said.

This next phase of the project is being supported by a $143,316 grant from the State Government’s Future Health Research and Innovation program to ClearDrum’s chief technology officer and lead researcher Dr Filippo Valente.

Dr Valente, who has been working on the project since 2017, said that other methods of repairing the ear are really “just patches”. In the lab, they have been tested to see how quickly human tympanic membrane cells grow on the product, and the results compared to how ClearDrum performs.

“They grow at a much faster on ClearDrum, three to one, four to one,” he said.

“When we have tested ClearDrum on animals, there’s regeneration in a week.

“But that’s a test. The reality may be more complicated in patients.”

Dr Valente said that the device had to go through a lot of design verification, clinical trials and regulatory hurdles before it would be ready for mass production.

“We need to see how it performs over time,” he said. “Does it keep its elasticity? What is its shelf life? Then we can ship it to the world.”