We thank the patients and their families for their trust in taking part in this study. The study was academically funded and supported by the Medical University Vienna, the General Hospital Vienna, and the Research Center for Molecular Medicine (CeMM) of the Austrian Academy of Sciences. We gratefully acknowledge funding from the Vienna Science and Technology Fund (LS16-034 to GSF and UJ), the Austrian Science Fund (F4704-B20 to PV, F4711-B20 to GSF, and P27132-B20 to PBS), and the European Molecular Biology Organization Long Term Fellowship (1543-2012 to GIV, 733-2016 to TP). BS acknowledges
The present multicentric clinical study involves 19 centres, 16 of them in German-speaking countries, 1 British, 1 Polish and 1 Hungarian. 60 postlingually deafened adults with a mean age of 47.5 years (20–70) and a mean duration of deafness of 5.3 years (0.5–20) have been evaluated with the MED-EL COMBI 40 cochlear implant which implements a high-rate continuous-interleaved-sampling strategy with 8 channels. Safety and effectiveness data have been collected. Speech perception tests include a 16-consonant, an 8-vowel, a sentence and a monosyllabic-word test in all languages and a 2-digit figure test in all languages but English. Test intervals are 1,3,6 months and 1 year after first fitting. 41 of the 60 postlingually deafened adult study patients have completed their 6-month evaluation. While their pre-operative monosyllabic-word score was 0%, their mean monosyllabic-word score 6 months after first fitting was 48% (8–90) with a median of 50%. The mean sentence understanding was 84% (24–100) with a median of 90%. The respective values for the 1-year evaluations with 25 patients are a mean of 50% (5–85), with a median of 60%, for the monosyllables and a mean of 89% (30–100), with a median of 97%, for the sentences.
Pneumococcal otogenic meningitis is a rare postsurgical complication that can develop following stapedectomy or after cochlear implantation. The bacterial infection can be fatal in some instances. A recent increase in the incidence of otogenic meningitis among cochlear implant wearers is of concern. The majority of meningitis cases are associated with a 2-component electrode manufactured by one cochlear implant company. The device with the added ‘positioner’ component has been withdrawn from the market (FDA Public Health Web Notification: Cochlear Implant Recipients may be at Greater Risk for Meningitis, Updated: August 29, 2002, www.fda.gov/cdrh/safety/cochlear.html). Not all cases have been subsequent to otitis media and symptoms have developed from less than 24 h up to a few years after implantation. The purpose of this paper is to review and discuss the pathogenesis, pathology/bacteriology and to elaborate on some clinical features of otogenic meningitis in implanted children and adults. Essential aspects of surgery, electrode design, and cochleostomy seal are discussed. Conclusions are drawn from the available data and recommendations are made for good practice in cochlear implantation and follow-up.
Our standard diagnostic procedure consists of establishing diagnosis by Doppler color flow sonography, angiography for detailing the vascularization of the tumor, and selective embolization to enable safer surgery with less bleeding. Early surgery is recommended to minimize major risks.
Conclusion. Achieving deep insertions, as well as good speech perception results, the FLEX soft electrode array allows for some preservation in subjects with measurable low frequency hearing, even after a period of time. This opens the door for future research in electrode design, hearing preservation research and drug delivery systems. Objectives. The FLEX soft electrode is designed to be atraumatic to the structures of the cochlea during deep insertion of a cochlear implant electrode. This paper reports on the surgical and functional outcomes in implantations with the FLEX soft electrode array. Patients and methods. Twenty-three adult subjects received a FLEX soft electrode array and were assessed on speech perception tests (monosyllables, sentences in quiet and in noise), a subjective questionnaire (Nijmegen Cochlear Implant Questionnaire) and a pure-tone audiogram. Results at 1, 3, 6 and 12 months post first fitting were compared to scores from the preoperative interval. Results. Surgery was uneventful in all cases, the surgical handling was satisfactory and correct position of the electrode was achieved in all cases. Hearing could be preserved (as determined by the audiogram) in half of the subjects who had measurable audiograms preoperatively at the 1 month test interval, and in a quarter of subjects after 12 months of device use, despite deep insertion of the electrode. Speech perception scores showed significant improvement over time, as did quality of life scores, and were comparable to results with the standard electrode array as used in the COMBI 40'/ and PULSARCI 100 .
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