Download 13th International Conference on Cochlear Implants and Other

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Transcript
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The NeuEar project: Developing a neurotrophic cochlear implant for severe hearing loss
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Tornøe J. , Fransson A. , Ulfendahl M. , Konerding W. , Scheper V. , Schwieger J. , Mistrik P. , Dhanasingh A. ,
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Kiran R. , Melchionna T. , Wahlberg L.
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NsGene A/S, Ballerup, Denmark, 2Karolinska Institutet, Department of Neuroscience, Stockholm, Sweden, 3Hannover Medical School,
VIANNA, Hannover, Germany, 4MED-EL GmbH, Innsbruck, Austria
NeuEar is an EU-funded consortium bringing together four corporate and academic partners with the common
goal of improving the efficiency of the current cochlear implant (CI) technology. By combining the CI with a
neurotrophin-releasing medical device, we are addressing the progressive and underlying degeneration of
auditory neurons (ANs) that ultimately leads to significant neuronal loss after long periods of deafness. The loss
of endogenous neurotrophic factors normally expressed by hair cells, such as brain derived neurotrophic factor
(BDNF) and neurotrophin-3 (NT-3), is a strong mediator of AN degeneration. Intra-cochlear delivery of
neurotrophic factors with beneficial protective and/or regenerative effects on ANs could significantly improve the
CI/patient interface, leading to a better treatment of profoundly deaf patients.
The goal of the NeuEar project is to combine a cochlear implant from MED-EL GmbH, Austria with neurotrophic
factor delivery from an encapsulated-cell Brain Repair medical device developed by NsGene A/S, Denmark.
Academic partners from the Hannover Medical School, Germany and Karolinska Institutet, Sweden are testing
the combination of stimulating electrodes with neurotrophin-releasing devices in cat and guinea pig deafness
models, respectively.
The primary objectives of the NeuEar project are to: 1) develop genetically modified cells for encapsulation and
long-term overexpression of selected neurotrophins from the Brain Repair device, 2) develop a clinically relevant
Brain Repair implant prototype capable of chronic secretion of neurotrophic factors combined with a cochlear
electrode array, 3) evaluate and optimize safety and functional effects in in vitro and in vivo assays and, 4)
evaluate the long-term safety and efficacy in a large animal model of a clinically relevant CI/Brain Repair implant.
The final project goal is to have an implant prototype with animal safety and functional data available to support
further development and clinical testing by the end of the project in the fall of 2015.
We present data from recent studies of deafened animals where animal-specific electrodes were combined with
miniaturized Brain Repair prototype devices developed for animal cochlear implantation. The long-term effect of
Brain Repair device delivery of the neurotrophic factors GDNF and BDNF was evaluated by periodic
measurement of electrically evoked auditory brainstem responses (eABR) during chronic implantation.
Treatment benefits were evaluated in the end of the study by the measurement of anatomical neural tissue
characteristics such as spiral ganglion cell density and related surface area. The extent of fibrous tissue growth
in the scala tympani was also compared to control animals. We report results on the effect of long-term local
treatment with neurotrophic factors delivered by the Brain Repair device on cochlear implant performance.
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