A study of electrical stimulation levels over 10 years for adults using Nucleus cochlear implants

© 2017 Dr. Emalka Ashanthi GajadeeraCochlear implants have improved sound perception for thousands of people with severe and profound sensorineural hearing loss. To ensure a good quality sound signal, the implant must be individually programmed throughout the user’s lifetime. Programming determines the electrical stimulation level requirements for each electrode of the implant. The frequency with which programming occurs has so far been based primarily on clinical experience and resources available to the clinic for programming purposes. To develop an evidence-based schedule for the frequency of programming, a comprehensive investigation of the change in electrical stimulation level requirements over time for a large group of adults is necessary. The overall purpose of this retrospective study was therefore to investigate the change in electrical stimulation levels up to 10 years postimplantation for a large group of adults using Nucleus cochlear implants. In addition, this study also aimed to investigate whether demographic characteristics and electrode array segments were predictive of the change in electrical stimulation levels. The Cochlear Implant Clinic of the Royal Victorian Eye and Ear Hospital, Victoria, Australia, has been providing programming services for cochlear implant users for over 25 years. The electrical stimulation data obtained at the programming sessions were extracted for 680 participants who used a Nucleus® cochlear implant over the course of 10 years. For each implant user, programming data for the following time points were extracted from Cochlear Limited’s TM Custom Sound 3.2® fitting software: 2, 3, 6, 9 months postimplantation and biennial time points from 1 year up to 10 years postimplantation. For each time point, the mean T level, C level, and dynamic range (DR) were calculated separately for four electrode array segments: apical (mean of electrodes 22, 20, 18), medial (16, 14, and 10) upper-basal (7, 6), and lower-basal (4, 3). The degree of change (DC) in levels between consecutive time points was also calculated. Long-term changes in electrical stimulation levels were also investigated for 128 participants from the same group who had adequate programming data up to 10 years postimplantation. The trends and amount of change in programming levels were investigated separately for the four electrode array segments using regression analyses. The effects of several demographic characteristics (e.g., aetiology and onset of hearing loss) were also investigated. For the 680 participants, the average T levels and C levels were consistent from 3 months and 6 months postimplantation, respectively. In terms of the degree of change between time points, the majority of participants showed an average of ≤ 20% change in levels as a function of DR after the 3- to 6-month time point comparison postimplantation. Long-term patterns of change for 128 individual participants showed that, for 42% of these participants, the electrical stimulation levels remained relatively stable without any significant trends for either the T levels or C levels, from 6 months up to 10 years postimplantation. Some significant changes in levels were evident up to 10 years postimplantation; however, changes were small, equating to less than 6% per year as a function of DR for 75% of the participants and a maximum of 10% change in levels for the remaining 25% of participants. Additional noteworthy findings include the following: 1. For the participants who showed more change in levels in the first 3 to 6 months postimplantation, approximately 70% of these participants showed a non-significant long-term trend in levels up to 10 years postimplantation, 2. The mean T levels and C levels were found to differ significantly for the four electrode array segments in the first 2 years postimplantation, but were relatively consistent in the long-term, and 3. The mean degree of change in levels as a function of DR was significantly greater for the Otosclerosis pathological group (n = 72) compared to all other groups, and for the prelingual onset of deafness group compared to the postlingual group. This thesis provided strong evidence that electrical stimulation levels change in the first 6 months but expected to remain relatively stable up to 10 years postimplantation for the majority of adults using Nucleus cochlear implants. Based on this evidence, a programming protocol for 10 years postimplantation has been proposed. The proposed protocol recommends more frequent programming sessions in the first 6 months compared to the number of sessions thereafter. The reduced number of sessions over an implant user’s lifetime will assist in managing the increasing caseload with the amount of resources currently available for programming. Given that the levels differed across the segments in the first 2 years postimplantation, but not in the long-term, the proposed protocol recommends measuring levels separately for the four segments in the early postimplantation period. This can then be limited to one or two segments beyond 2 years postimplantation. The protocol also suggests that more programming sessions may be required in the first two years for implant users with Otosclerosis and those with a prelingual onset of hearing loss