A Perth-based bio-tech company has received the go-ahead to release an award-winning device designed to treat common childhood ear infections in the United States.
EarFlo Device Launched in US Market
Perth Biodesign has officially launched the EarFlo device in the US market after obtaining the required Food and Drug Administration (FDA) registration. The company is now preparing the necessary documentation to submit to Australian regulatory authorities, with hopes of making the device available in Australia by mid to late 2027.
How EarFlo Works
The device addresses the underlying ear pressure associated with chronic infections in children. Disguised as a sippy cup, this non-invasive technology treats negative middle ear pressure during natural drinking. By correcting this pressure imbalance, it helps manage fluid buildup in young children—a condition known as otitis media with effusion. This condition affects the hearing of millions of children worldwide and is the most common reason for a child to visit a doctor.
Founders and Development
Intan Oldakowska and Matthew Oldakowski, both biomedical engineering senior lecturers now based at The University of Western Australia, co-founded Perth Biodesign. They trained at Stanford Biodesign in the US, where they conceived the design concept and later developed the EarFlo device with local colleagues.
Dr Oldakowska emphasised the importance of early intervention during critical developmental stages to minimise the long-term impact of hearing-related conditions on children's learning and wellbeing. “We see this as a new paradigm of care, enabling earlier treatment at home to help reduce developmental delays and improve quality of life at scale,” she said.
Clinical Research Results
EarFlo works by delivering a precisely controlled puff of air through the nose into the eustachian tube during swallowing, helping to equalise pressure in the middle ear and reduce fluid buildup associated with otitis media with effusion. Peer-reviewed clinical research revealed that 86 per cent of children experienced immediate improvement in middle ear pressure. After four weeks, 86 per cent had significantly improved hearing, and 89 per cent avoided surgery, according to EarFlo Chief Medical Officer Peter Santa Marria, a professor and division chief of otology and neurotology at the University of Pittsburgh.
Upcoming Innovation Summit
Perth Biodesign will host its inaugural innovation summit this month, bringing together leaders in healthcare, investment, research, government, and the startup sector at the University of Western Australia. The summit will take place at the University Club on Monday, May 18, from 8am to 4pm, followed by a 10th anniversary dinner at Fraser's Kings Park from 6pm.
