Ear Science Institute Australia is developing a world-first prosthetic eardrum based on silk fibroin biomaterial using silk spun from silkworms to repair chronic ruptured eardrums.
ClearDrum is an implantable device developed by Ear Science and invented by world-renowned ear, hearing and skull base surgeon scientist based in Perth, Professor Marcus Atlas AM.
The transparent membrane is blended from silk using silk fibroin from Bombyx Mori, an FDA-approved natural protein derived from silk spun by silkworms. It has been tested on tympanic membrane related human cell lines and found to support the growth of tympanic membrane cells, promoting tissue regeneration.
Each year there are millions of eardrum (tympanic membrane) perforations worldwide as the result of trauma, barotrauma, drugs, infection or genetic causes.
A Western Australian government grant will aid preparations for manufacturing and clinical trials of the implant. Ear Science said it was a cutting-edge innovation representing a major advancement in the treatment of chronic ear conditions, with the potential to significantly improve patient outcomes.
It said most small, acute perforations would heal independently but larger, more complex or chronic perforations required surgical intervention – tympanoplasty – to repair the tympanic membrane using autologous graft material such as temporalis fascia, cartilage or perichondrium.
Chronic middle ear disease leading to eardrum perforation is one of the major causes of hearing loss in Indigenous populations in Western Australia and across the world.
“Our innovation will change the way the tympanic membrane is repaired and enhance the treatment and quality of life of patients worldwide,” Prof Atlas said.
Ear Science researchers have spent 10 years researching and developing the implant, based on silk fibroin, a natural biopolymer that is safe to use in humans. The researchers developed expertise to enable the mechanical properties and biodegradability profile of silk biomaterials to be changed.
The device was developed to provide an off-the-shelf implant that addresses the difficulties with current treatments in a single, straightforward surgical procedure. Ear Science partnered with Deakin University’s Future Fibres Hub to develop the prototype.
Professor Atlas and the institute’s research and development manager, biomedical scientist Dr Filippo Valente, have been the main minds behind the invention.
Dr Valente has led the research and development of ClearDrum since 2020. He leads a research program in silk biomaterials and collaborates with clinical and business units to develop medical applications and solutions for patients.
The research for the implant was spun out into a startup company, ClearDrum, in 2022-2023 of which Dr Valente is Chief Technology Officer.
“The state government support of researchers like me being able to translate their science into clinically in-demand products is a testament to their vision for an innovative WA in biomedical science product development,” Dr Valente said.
WA Medical Research Minister Mr Stephen Dawson said on 24 October 2024 that the pioneering project was one of eight successful WA Innovation Fellowships winning a share of $1 million from the Cook Government’s groundbreaking Future Health Research and Innovation Fund (FHRI Fund.)
Dr Valente received a FHRI grant of $143,316 to further develop the device.
More than US$5 million has been invested so far to complete early-stage development, final prototyping and pre-clinical testing.
Another Ear Science researcher, Dr Christo Bester, received $137,872 from the fund to continue his work on precision diagnostics in cochlear implant recipients and understanding the healing process.
Dr Bester said: “The funding from the WA’s FHRI Fund will enable new research into understanding how a person’s healing response to cochlear implantation affects their ability to use the device.
“This work is going to open new treatment and counselling opportunities after a person receives their cochlear implant to help them have the best possible outcomes now and for the rest of their life.
“This work is innovative as it will pave the way for Ear Science to develop drug therapies to further enhance the patient experience and outcomes.”
The Cook Government established the FHRI Fund in 2020, which is backed by the State’s almost $1.8 billion sovereign wealth fund. This has resulted in nearly $250 million being available over the next four years to support health and medical research and innovation in Western Australia.
“WA’s incredible innovators continue to produce groundbreaking and life-changing technology, such as this amazing collection of work being carried out by this year’s successful Innovation Fellowship recipients,” Dawson said.
“On behalf of the Cook Government I congratulate all the recipients. We proudly support the work these incredible innovators are undertaking here in WA which contributes to improving the health outcomes of Western Australians.
“Innovative projects like these are life changing for people who suffer from debilitating medical conditions and diseases.”
Dr Valente obtained his PhD in 2017 from the University of Padua (Italy) and the KTH University (Sweden) with a thesis on the development and biocompatibility of lipid nanoparticles for the delivery of drugs in the inner ear.
He joined Ear Science to work on novel biomaterials and therapeutics for chronic middle ear disease. While in Perth, he undertook training at the Centre for Entrepreneurial Research and Innovation and Biodesign Australia, to specialise in commercialisation of research products.
Dr Valente previously obtained funding from BioMedTech Horizon program to help bring the innovation to the market.
