Results of a double-blinded placebo controlled trial on the efficacy of high-dose systemic steroids for hearing preservation in cochlear implantation.

Aim: To assess whether a single, peri-operative, high dose of methylprednisolone can improve hearing preservation following cochlear implantation (CI). Methods: Patients with hearing at 85 dB or better at 500 Hz in the ear to be implanted were randomly allocated to either treatment (methylprednisolone, 1g i.v. on induction of anaesthesia) or control (normal saline infusion). All patients received a routine "anaesthetic" dose of dexamethasone (8 mg i.v. on induction of anaesthesia). Implantation was undertaken with Cochlear's Slim Straight electrode via the round window. Audiometry was performed prior to implantation, and again at 3 and 12 months. The primary outcome was the level of residual hearing 12 months following cochlear implantation. Secondary outcomes included audiometry, lectrode impedance, and speech perception scores at 3 and 12 months after surgery. Results: Forty-six patients were enrolled into the control group and 48 patients received the steroid. There was no statistical difference in hearing at 12 months, nor at 3 months following surgery. Electrode impedances did not differ between the groups. Conclusions: There is an extensive experimental literature to suggest that steroids can reduce the loss of residual hearing during CI surgery, including when the steroid is given systemically. This paper demonstrates that high-dose local steroid injection at surgery is not effective in preventing a loss of residual hearing. Similarly, electrode impedances are not reduced by the high-dose steroid regime. Recent studies have suggested that steroid treatment may be more effective if used for a period of weeks after implantation. Future studies should explore this approach, or prolonged local steroid delivery via the cochlear implant. [ABSTRACT FROM AUTHOR]