Cochlear implantation with a dexamethasone-eluting electrode array: First-in-human safety and performance results

Area of Science:

• Otorhinolaryngology
• Biomedical Engineering
• Neuroscience

Background:

• Cochlear implantation is standard for severe-to-profound sensorineural hearing loss.
• Implantation can cause hearing loss due to trauma and inflammation.
• Sustained local drug delivery from electrode arrays may preserve residual hearing.

Purpose of the Study:

• Evaluate the safety and feasibility of the CIDEXEL system (Mi1200 SYNCHRONY CI with FLEX28 DEX array).
• Assess electrode impedance, hearing preservation, and speech perception.
• Gather surgeon feedback on intraoperative handling.

Main Methods:

• Single-arm, exploratory, open-label, prospective, longitudinal, monocentric study.
• Nine participants received the CIDEXEL system.
• Follow-up up to 9 months post-implantation.

Main Results:

• No device- or procedure-related serious adverse events occurred.
• Low and stable electrode impedance levels were maintained.
• Good residual hearing preservation (≤15 dB loss) in most participants.
• Speech perception outcomes were comparable to non-eluting arrays.
• Surgeons reported similar handling and insertion to conventional arrays.

Conclusions:

• The CIDEXEL system is safe and feasible for cochlear implantation.
• It effectively preserves residual hearing and provides good speech perception.
• The device demonstrates comparable surgical handling to standard electrode arrays.