Gajadeera Emalka A, Galvin Karyn L, Dowell Richard C, Busby Peter A
1Department of Audiology and Speech Pathology, The University of Melbourne, Melbourne, Victoria, Australia; 2Cochlear Implant Clinic, Royal Victorian Eye and Ear Hospital, Melbourne, Victoria, Australia; 3HEARing Cooperative Research Centre, Melbourne, Victoria, Australia; and 4Cochlear Limited, Melbourne, Victoria, Australia.
Ear Hear. 2017 May/Jun;38(3):357-367. doi: 10.1097/AUD.0000000000000405.
To examine electrical stimulation data over 24 months postimplantation in adult implant users. The first aim was to calculate mean T and C levels for seven time points, for four cochlear segments, and two array types. The second aim was to (a) analyze the degree of change in each of the T and C levels as a function of dynamic range for six consecutive time point comparisons, for the four segments, and (b) to determine the proportion of participants with an acceptable degree of change. The third aim was to examine relationships between demographic factors and degree of change.
T levels, C levels, and dynamic ranges were extracted for 680 adults using Nucleus implants for the following postimplant time points: 2-, 3-, 6-, 9-, 12-, 18-, and 24-month. For each time point, mean levels were calculated for the four segments. The degree of change in each of the levels was analyzed for six consecutive time point comparisons. The criterion for an acceptable degree of change was ≤20% of DR.
Mean T level was significantly lower for the 2-month time point compared with all time points after the 3-month time point. Mean C level was significantly lower for the 2- and 3-month time points compared with all other time points. Mean T level was significantly lower for the apical compared with all other segments and for the lower-basal compared with the upper-basal segment. Mean C level was significantly different across all four segments. Mean C level for the basal segments was 4 CLs higher for the perimodiolar array compared with the straight array. No significant differences were evident for the mean degree of change between consecutive time point comparisons. For all segments, approximately 65 to 75% of the participants showed an average acceptable degree of change in levels from the 3- to 6-month comparison. The mean degree of change in T levels was significantly greater for the basal segments compared with all other segments. The mean degree of change in levels was significantly greater for the otosclerosis group compared with all other groups, and for the prelingual onset of deafness group compared with the postlingual group.
Given the very large cohort, this study provides evidence for the mean levels and the degree of change in these levels that should be expected for four segments in the first 24 months postimplantation for adults using Nucleus implants. The mean T and C levels were consistent after the 3- and 6-month time points postimplant, respectively. The degree of change was variable between individuals. For each segment, however, a large percentage of participants showed an average change of ≤20% in each of the T and C levels from the 3- to 6-month comparison. Given the large degree of change in levels for some groups, the results provide strong evidence in favor of frequent monitoring of levels in the first 24 months postimplantation for patients with otosclerosis, prelingual onset of deafness, and those who exhibit >20% change in levels after 3 months postimplantation.
研究成年植入者植入后24个月内的电刺激数据。首要目标是计算七个时间点、四个耳蜗节段和两种电极阵列类型的平均T值和C值水平。第二个目标是:(a) 针对四个节段,分析六个连续时间点比较中,每个T值和C值水平随动态范围变化的程度;(b) 确定变化程度可接受的参与者比例。第三个目标是研究人口统计学因素与变化程度之间的关系。
提取了680名使用Nucleus植入物的成年人在以下植入后时间点的T值水平、C值水平和动态范围:2个月、3个月、6个月、9个月、12个月、18个月和24个月。对于每个时间点,计算四个节段的平均水平。分析了六个连续时间点比较中每个水平的变化程度。变化程度可接受的标准为≤动态范围的20%。
与3个月时间点之后的所有时间点相比,2个月时间点的平均T值水平显著更低。与所有其他时间点相比,2个月和3个月时间点的平均C值水平显著更低。与所有其他节段相比,顶端节段的平均T值水平显著更低;与上部基底节段相比,下部基底节段的平均T值水平显著更低。所有四个节段的平均C值水平存在显著差异。与直电极阵列相比,蜗周电极阵列的基底节段平均C值水平高4dB。连续时间点比较之间的平均变化程度没有显著差异。对于所有节段,约65%至75%的参与者在3至6个月的比较中显示出平均可接受的水平变化程度。与所有其他节段相比,基底节段的T值水平平均变化程度显著更大。与所有其他组相比,耳硬化症组的水平平均变化程度显著更大;与语后聋组相比,语前聋组的水平平均变化程度显著更大。
鉴于样本量非常大,本研究为使用Nucleus植入物的成年患者植入后前24个月内四个节段的平均水平及其变化程度提供了证据。植入后3个月和6个月时间点之后,平均T值和C值水平分别保持稳定。个体之间的变化程度存在差异。然而,对于每个节段,很大比例的参与者在3至6个月的比较中显示出T值和C值水平平均变化≤20%。鉴于某些组的水平变化程度较大,研究结果有力地证明了应对耳硬化症患者、语前聋患者以及植入后3个月后水平变化>20%的患者在植入后前24个月内进行频繁的水平监测。