Cochlear implant and inflammation reaction: Safety study of a new steroid-eluting electrode.

Dexamethasone is a common anti-inflammatory agent added to cochlear implants to reduce hearing loss due to electrode insertion trauma. We evaluated the safety of eluting silicone rods containing 10% dexamethasone in a Guinea pig model. Animals were implanted with a dexamethasone eluting silicone electrode (DER) or with a non-eluting electrode (NER). The control group only underwent a cochleostomy (CS). Prior to implantation and during the two weeks following implantation, the hearing status of the animals was assessed by means of Compound Action Potentials (CAPs) with an electrode placed near the round window. Two weeks after implantation, the mean click threshold shifts were 1 dB ± 10 dB in the DER group, 10 dB ± 10 dB in the NER group and -4 dB ± 10 dB in the control group. After two weeks the bullae of each animal were extracted to verify the presence of macrophages, the percent of tissue growth in the scala tympani and the tissue sealing around cochleostomy. Silicone electrodes samples were also explanted and examined for bacterial infection. Neither bacterial infection nor enhanced number of macrophages were observed. A limited, but not significant, tissue growth was found in the scala tympani between the experimental and the control group. The data suggest that, in the Guinea pig model, the use of DER is apparently safe as an anti-inflammatory slow-release additive to the cochlear implant.