Cochlear announces partnership to trial new implant

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Cochlear (ASX:COH) has announced a new partnership with leading hearing health experts to conduct the largest ever international clinical study of an investigational implant that releases a glucocorticoid (anti-inflammatory) drug therapy directly to the cochlea.

The CI-DEX Study is a prospective, multi-centre, randomised and blinded study evaluating the effect of a glucocorticoid releasing cochlear implant in up to 120 adults in Australia and the US with moderate to profound sensorineural hearing loss.

The company said the study is the first-ever pivotal trial to investigate the potential of a cochlear implant with a drug-eluting electrode compared to a conventional cochlear implant.

It said investigators will measure if the device can reduce electrical impedance. This may be an indicator of the device minimising changes in the intra-cochlea environment, such as a reduction of fibrosis. Research suggests this may lead to better long-term preservation of the structure and function of the cochlea.

According to Professor Stephen O'Leary, lead investigator of the study and a senior specialist in the Otology and Cochlear Implant Clinics at The Royal Victorian Eye and Ear Hospital in Melbourne, "The study is a world-first in large scale research of direct drug delivery with a cochlear implant."

"Anti-inflammatory drugs are routinely used in cochlear implant surgery with the aim of reducing inflammation and fibrosis, which may support intra-cochlear structural and functional preservation and hearing outcomes. However, current use is highly varied and uncontrolled, and further research is required," said Professor O'Leary.

"This is the first cochlear implant to deliver a drug that may improve patient outcomes. It could be a leap forward in cochlear implant scope and capability."

Jan Janssen, Cochlear chief technology officer, said, "People that use our solutions deserve enduring commitment to advancing hearing technology. Cochlear leads the industry in investing more than AUD $180M annually in research and development to innovate and transform the lives of those living with hearing loss.

"Developing and testing new medical technology is a complicated process that takes many years. We hope that this pivotal study can build on our 40 years of experience in implantable hearing and provide valuable knowledge to further improve our leading technology portfolio and outcomes for recipients."


The study will commence in 2021 in selected centres in the U.S. and Australia.1 The trial device is limited to investigational use and is not commercially available.