- Cochlear is partnering with leading hearing health experts to conduct the largest ever, multi-center, randomised controlled trial (RCT) of an investigational cochlear implant that releases a glucocorticoid (anti-inflammatory) drug therapy directly to the cochlea.1
- The study is the first ever pivotal RCT to investigate the safety and effectiveness of a cochlear implant with a drug eluting electrode compared to a conventional cochlear implant.
- Investigators will measure if the device can reduce electrical impedance, which may be an indicator of the device minimising changes in the intra-cochlear 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.2-7
Sydney, Australia – 18 February 2021: Cochlear Limited (ASX: COH), the global leader in implantable hearing solutions, has today announced it is partnering with leading hearing health experts to conduct the largest ever international clinical study of an investigational cochlear implant that releases a glucocorticoid (anti-inflammatory) drug therapy directly to the cochlea.
The CI-DEX Study is a pivotal, prospective, multi-centre, randomised, blinded study evaluating the effect of a glucocorticoid releasing cochlear implant in up to 120 adults in Australia and the United States with moderate to profound sensorineural hearing loss.1 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. Investigators will measure if the device can reduce electrical impedance, which may be an indicator of the device minimising changes in the intra-cochlea environment, such as a reduction of fibrosis.1 Research suggests this may lead to better long-term preservation of the structure and function of the cochlea.2-7
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, 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."
There is increasing evidence that lower electrode impedance post-surgery is indicative of a reduction in post-surgical fibrosis2-4 associated with surgical trauma to the inner structures of the ear; and that a drug eluting electrode may reduce inflammation5 and have a cascade effect to minimise fibrosis, and inhibit osteoneogenesis6, although further research is required. Research has also shown that the therapeutic benefit of an anti-inflammatory, such as dexamethasone, is greater and longer lasting when applied locally through a sustained and controlled release via the electrode compared to topical application.7,8
Jan Janssen, Chief Technology Officer at Cochlear, 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 investigational cochlear implant will administer a controlled, sustained release of dexamethasone directly to the cochlea for at least 28 days post-implantation. The study objectives aim to measure the performance of a dexamethasone eluting electrode in an adult population with post-lingual, bilateral, moderate to profound sensorineural hearing loss, including the reduction of electrical impedance, speech recognition and safety outcomes.1
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.
About Cochlear Limited (ASX: COH)
Cochlear is the global leader in implantable hearing solutions. The company has a global workforce of more than 4,000 people and invests more than AUD$180 million each year in research and development. Products include cochlear implants, bone conduction implants and acoustic implants, which healthcare professionals use to treat a range of moderate to profound types of hearing loss.
Since 1981, Cochlear has provided more than 600,000 implantable devices, helping people of all ages, in more than 180 countries, to hear.
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- The CI-DEX Study. Available at https://clinicaltrials.gov/ct2/show/NCT04750642 (last accessed February 2021).
- Bas E, Bohorquez J, Goncalves S, et al. Electrode array-eluted dexamethasone protects against electrode insertion trauma induced hearing and hair cell losses, damage to neural elements, increases in impedance and fibrosis: A dose response study. Hear Res. 2016 Jul; 337:12-24.
- Wilk M, Hessler R, Mugridge K, et al. Impedance Changes and Fibrous Tissue Growth After Cochlear Implantation Are Correlated and Can Be Reduced Using a Dexamethasone Eluting Electrode. PLoS One. 2016 Feb 3;11(2):e0147552.
- Wrzeszcz A, Steffens M, Balster S, et al. Hydrogel Coated and Dexamethasone Releasing Cochlear Implants: Quantification of Fibrosis in Guinea Pigs and Evaluation of Insertion Forces in a Human Cochlea Model. J Biomed Mater Res B Appl Biomater. 2015 Jan;103(1):169-78.
- Farhadi, M., Jalessi, M., Salehian, P., et al. Dexamethasone eluting cochlear implant: Histological study in animal model. Cochlear Implants Int. 2013;14, 45–50.
- Chambers S, Newbold C, Stathopoulos D, et al. Protecting Against Electrode Insertion Trauma Using Dexamethasone. Cochlear Implants Int. 2019 Jan;20(1):1-11.
- Needham K, Stathopoulos D, Newbold C, et al. Electrode impedance changes after implantation of a dexamethasone-eluting intracochlear array. Cochlear Implants Int. 2020 Mar;21(2):98-109.
- Briggs R, O’Leary S, Birman C, et al. Comparison of electrode impedance measures between a dexamethasone-eluting and standard Cochlear™ Contour. Hear Res. 2020 May; 390:107924
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CAUTION Investigational device. Limited by United States law to investigational use.
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