Dexamethasone-Eluting Cochlear Implant Electrode: A first in human study

Introduction The development of dexamethasone (DEX)-eluting cochlea implant (CI) electrodes may provide an option to achieve long-term local exposure of the cochlea to the substance along the entire scala tympani. The current focus of the use of dexamethasone (DEX) is to suppress the inflammatory reaction and foreign body response in order to minimize fibrous tissue growth and to preserve residual hearing.

Methods The principal objective of this study is to exploratively investigate the safety profile of a new DEX eluting electrode through the analysis of adverse events. Additionally, we evaluate electrode impedance (IFT), unaided pre- and post-op audiograms, electrically evoked compound action potentials (ECAP’s), speech intelligibility in noise and the surgeon’s subjective feedback on electrode design and ease of use during surgery.

Results By now, n=4 patients were included in the study and implanted with a DEX CI. Surgeons reported no difference in handling and insertion compared to non-eluting electrodes of the same manufacturer. No serious adverse events or device deficiencies occurred so far. Preliminary results of the first activation appointment (~4 weeks postoperative) (n=3) show low impedance values across all electrodes and partial to complete hearing preservation.

Conclusions The new DEX eluting CI electrode shows preliminary safety and effectiveness. Further analysis upon study conclusion and a controlled study design in a bigger pool of subjects are needed to obtain confirmatory data on safety and effectiveness. These results support the correlation between low impedance and reduced fibrotic tissue formation and the use of DEX as a suitable therapeutic agent in combination with a CI.

Poster-PDF A-1450.pdf

Conflict of interest

Der Erstautor gibt keinen Interessenskonflikt an.

Publication History

Article published online:
13 May 2021