Final Results of the CIDEXEL-Study

Introduction Electrode insertion trauma (EIT) leads to growth of scar tissue around the electrode, damage to neuronal structures, and loss of residual hearing. In this context, local prolonged immunosuppressive pharmacotherapy via the electrode array itself could improve the outcome of CI-patients, especially those with EAS.

Methods A total of 9 patients were implanted with a dexamethasone-releasing cochlear implant electrode and then followed up to 9 months postoperatively (n=8). The primary objective of this study was to investigate the safety profile by analysis of adverse events. In addition, impedances, pre- and postoperative pure tone audiograms, speech perception in noise and surgical feedback were evaluated.

Results Handling and insertion properties were described as almost identical compared to non-eluting electrodes from the same manufacturer. There were no device- or procedure-related serious adverse events. Final results show remarkably low and stable impedance values ​​across all areas of the electrode (basal, medial and apical). Very good preservation of residual hearing (≤15 dB hearing loss) was achieved in the majority of patients.

Conclusion The use of the new dexamethasone-eluting electrode was safe and resulted in lower impedances and better hearing preservation compared to patients with a standard electrode. This may have been achieved by successfully mitigating the immunological EIT and by suppressing the intracochlear foreign body reaction.

MED-EL

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Artikel online veröffentlicht:
12. Mai 2023