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 intraoperatively, 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. (Registered as NCT02392403 on ClinicalTrials.gov PRS)
Objectives In clinical practice, characterization of speech comprehension for cochlear implant (CI) patients is typically administered by a set of suprathreshold measurements in quiet and in noise. This study investigates speech comprehension of the three most recent cochlear implant sound processors; CP810, CP910, and CP1000 (Cochlear Limited). To compare sound processor performance across generations and input dynamic range changes, the state‐of‐the art signal processing technologies available in each sound processor were enabled. Outcomes will be assessed across a range of stimulation intensities, and finally analyzed with respect to normal hearing listeners. Methods In a prospective study, 20 experienced postlingually deafened CI patients who received a Nucleus CI in the ENT department of the University Hospital of SH in Kiel were recruited. Speech comprehension was measured in quiet at 40, 50, and 65 dBSPL with monosyllabic words as well as by speech reception threshold for two‐digit numbers. In noise, speech reception thresholds were measured with the adaptive German matrix test with speech and noise in front. Results We found that high levels of open‐set speech comprehension are achieved at suprathreshold presentation levels in quiet. However, results at lower test levels have remained mostly unchanged for tested sound processors with default dynamic range. Expanding the lower limit of the acoustic input dynamic range yields better speech comprehension at lower presentation levels. In noise the application of ForwardFocus improves the speech reception. Overall, a continuous improvement for speech perception across three generations of CI sound processors was found. Conclusions Findings motivate further development of signal pre‐processing, an additional focus of clinical work on lower stimulation levels, and automation of ForwardFocus. Level of evidence 2.
Purpose Hearing performance data was collected from a large heterogeneous group of subjects implanted with the Coch-lear™ Nucleus® CI532 with Slim Modiolar Electrode, for the purposes of postmarket clinical follow-up. Data was analysed for factors which may predict postoperative speech recognition scores. Methods Data was collected retrospectively from five German clinics for 159 subjects from March 2017 to August 2018. Hearing thresholds and recognition scores for monosyllabic words in quiet and sentences in noise were measured preoperatively and at 3 and 6 months postoperatively. Results There was a mean gain of 44% points (95% CI 39-49%) at 6 months in monosyllable scores in quiet for implanted ears. Preoperative hearing thresholds in implant ears increased systematically with decreasing age; however, younger subjects had better baseline monosyllable scores with hearing aids compared with older subjects. Baseline performance alone explained 14% of the variation in postoperative scores. Residual hearing was preserved on average to within 22 dB at 250 Hz and 30 dB at 500 Hz of preoperative levels. Conclusions In a large and varied cohort of routinely treated hearing-impaired adults, speech recognition with the CI532 for German monosyllabic words in quiet at 6 months was equivalent to performance reported at one year or more in other published studies. Although younger subjects had poorer preoperative pure-tone thresholds, they had better preoperative word recognition scores compared with older subjects, and also had higher post implant scores. Further research is required to identify if this phenomenon is just applicable to German health system assessment and referral practices.
Background: The perimodiolar CI532 Slim Modiolar electrode has been designed to bring the electrode contacts close to auditory nerve while reducing cochlear trauma during its insertion. It is currently unknown to what extent the electrode position and electrophysiological outcomes of the Slim Modiolar electrode differ from other perimodiolar electrodes. Objectives: The objective was to compare the electrode position and electrophysiological outcomes between the CI532 Slim Modiolar and CI512 Contour Advance electrode. Method: Forty-six adult patients received a Slim Modiolar or Contour Advance electrode. Electrode types were compared using intraoperative electrode impedances, evoked compound action potential (ECAP) and stapedius reflex thresholds, as well as position parameters from postoperative computed tomography or digital volume tomography images (medial-lateral position, electrode-to-modiolus distance, insertion angle). Results: The medial-lateral position indicates a closer modiolar placement of the Slim Modiolar compared with the Contour Advance. Individual electrode contact measurements, however, showed significantly larger electrode-to-modiolus distances and higher ECAP thresholds for the Slim Modiolar in the basal region. On contacts E20–22 the Slim Modiolar is slightly closer to the modiolus compared with the Contour Advance, but this did not result in lower ECAP thresholds. Conclusions: Perimodiolar electrodes can vary in their intracochlear position, leading to divergent electrophysiological outcomes. To detect these differences, investigations must be done for each electrode contact rather than using a global factor for the whole electrode array. While the electrode dislocation rate is lower with the Slim Modiolar than with the Contour Advance, electrode-to-modiolus proximity is smaller and ECAP thresholds are lower with the Contour Advance in the basal cochlear region.
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