Objectives: To report on electrode array measurements for the Nucleus® CI532 Slim Modiolar Electrode device including: ECAP thresholds, electrode impedances, and psychophysical comfort levels, as well as speech perception results pre- and post-operatively and standardized evaluations of quality of life.Methods: Forty-four subjects were implanted with the CI532. Electrically evoked compound action potential (ECAP) thresholds and impedances were measured using automatic Neural Response Telemetry intra-operatively, at activation and at six months post implant. Pre- and post-operative measures of words in quiet and sentences in noise were made in multiple languages. Quality of life was assessed using The Speech Spatial Qualities questionnaire (SSQ) and Glasgow Benefit Inventory (GBI).Results: Intra-operative ECAP thresholds were recorded successfully from 90% of electrodes tested. ECAP thresholds varied across the array and a post-hoc Dunn's test showed that median thresholds for electrodes E1–E13 were significantly greater than those for E17–E22 (all P < 0.001). Impedances increased significantly between surgery and activation. Speech recognition scores for words in quiet and sentences in noise showed a significant improvement for the group at six months, when using the cochlear implant, compared with pre-operative performance (P < 0.001). There was a significant increase compared to pre-operative ratings for all sections of the SSQ at six months post activation (P < 0.001). The GBI gave scores significantly above zero for the 'general' subscale and total score.Conclusion: Objective ECAP and impedance measures for this new electrode array were as expected and similar to results reported for other array types. Speech perception and quality of life improved significantly following implantation.Trial registration: ClinicalTrials.gov identifier: NCT02392403.
Objective To compare the incidence of dislocation of precurved versus straight flexible cochlear implant electrode arrays using cone-beam computed tomography (CBCT) image analyses. Study Design Consecutive nonrandomized case-comparison study. Settings Tertiary referral center. Patients Analyses of patients’ CBCT images after cochlear implant surgery. Intervention(s) Precurved and straight flexible electrode arrays from two different manufacturers were implanted. A round window insertion was performed in most cases. Two cases necessitated a cochleostomy. The patients’ CBCT images were reconstructed in the coronal oblique, sagittal oblique, and axial oblique section. Main Outcome Measures The insertion depth angle and the incidence of dislocation from the scala tympani to the scala vestibuli were determined. Results The CBCT images and the incidence of dislocation were analyzed in 54 patients (61 electrode arrays). Thirty-one patients were implanted with a precurved perimodiolar electrode array and 30 patients with a straight flexible electrode array. A total of nine (15%) scalar dislocations were observed in both groups. Eight (26%) scalar dislocations were observed in the precurved array group and one (3%) in the straight array group. Dislocation occurred at an insertion depth angle between 170 and 190 degrees in the precurved array group and at approximately 370 degrees in the straight array group. Conclusion With precurved arrays, dislocation usually occurs in the ascending part of the basal turn of the cochlea. With straight flexible electrode arrays, the incidence of dislocation was lower, and it seems that straight flexible arrays have a higher chance of a confined position within the scala tympani than perimodiolar precurved arrays.
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