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

Abstract

Cochlear implantation is the standard of care for individuals with severe-to-profound sensorineural hearing loss. However, implantation itself can degrade residual hearing, for example due to insertional trauma and subsequent inflammatory processes. One potential method to mitigate this loss of residual hearing is through the local and sustained delivery of anti-inflammatory drugs released from the electrode array. To this end, a dexamethasone eluting electrode array (FLEX28 DEX) was developed by MED-EL.

Here we present the results from a first-in-human feasibility study of the CIDEXEL system (the Mi1200 SYNCHRONY cochlear implant combined with the FLEX28 DEX array). A single-arm, exploratory, open-label, prospective, longitudinal, and monocentric study design with sequential block enrolment was used. Nine participants were implanted with the CIDEXEL and were followed up to 9 months post first fitting. The primary aim was to evaluate the safety of the device. The secondary aims were to assess: 1) electrode impedance levels; 2) hearing preservation rates; 3) speech perception outcomes; and 4) subjective feedback from the surgeons regarding their experience with the device during the operation.

There were no device- or procedure-related serious adverse events. Low and stable impedance levels were observed across all electrode sites (basal, medial and apical). In the majority of participants, good preservation of residual hearing (≤15 dB hearing loss) was achieved. The participants showed speech perception test results which were comparable to those with a non-eluting FLEX28 array. Surgeons reported that the CIDEXEL had similar handling and insertion properties to a conventional electrode array.