Initial Results of a Safety and Feasibility Study of Auditory Brainstem Implantation in Congenitally Deaf Children

Abstract

Objective To determine the safety and feasibility of the auditory brainstem implant (ABI) in congenitally deaf children with cochlear aplasia and/or cochlear nerve deficiency. Study Design Phase I feasibility clinical trial of surgery in 10 children, ages 2 to 5 years, over a 3 year period. Setting Tertiary children’s hospital and university-based pediatric speech/language/hearing center. Intervention(s) ABI implantation and post-surgical programming. Main outcome measure(s) The primary outcome measure is the number and type of adverse events during ABI surgery and post-surgical follow-up, including behavioral mapping of the device. The secondary outcome measure is access to and early integration of sound. Results To date, nine children are enrolled. Five children have successfully undergone ABI surgery and postoperative behavioral programming. Three children were screen failures, and one child is currently undergoing candidacy evaluation. Expected adverse events have been documented in three of the five children who received the ABI. One child experienced a cerebral spinal fluid (CSF) leak, which resolved with lumbar drainage. One child demonstrated vestibular side effects during device programming, which resolved by deactivating one electrode. One child experienced postoperative vomiting resulting in an abdominal radiograph. Four children have completed their 1-year followup and have speech detection thresholds of 30 to 35 dB HL. Scores on the IT-MAIS/MAIS range from 8 to 31 (out of a total of 40), and the children are demonstrating some ability to discriminate between closed-sets words that differ by number of syllables (pattern perception). Conclusions ABI surgery and device activation appears to be safe and feasible in this preliminary cohort.

Performance with an Auditory Brainstem Implant and Contralateral Cochlear Implant in Pediatric Patients

“…In its judicious use so far by experienced teams, ABI surgery in this population is safe and may be efficacious in well-selected pediatric patients [Noji et al, 2015;Puram and Lee, 2015;Puram et al, 2016;Shah et al, 2016;Wilkinson et al, 2017]. In one study, long-term outcomes in 35 children who received ABI due to severe inner ear malformations were evaluated.…”

Auditory brainstem stimulation with a conformable microfabricated array elicits responses with tonotopically organized components

“…Unfortunately, the higher currents necessary for auditory responses at the periphery of the array may be responsible for activation of other nearby structures in the brainstem. In fact, side effects are a common problem in adult ABI users (Herrmann et al, 2015; McCreery et al, 1998; Ramsden et al, 2016; Wilkinson et al, 2016) and require that such electrodes be turned off during programming. Thus, conformable arrays for a next-generation human ABI may be an important step toward fewer side effects and thus more useable electrodes to provide tonotopy…”

Longitudinal Changes in Electrically Evoked Auditory Event-Related Potentials in Children With Auditory Brainstem Implants: Preliminary Results Recorded Over 3 Years

“…However, despite better ABI outcomes observed in non-tumor patients compared to those reported in patients with NF2, the amount of ABI benefit varies substantially among individual users (e.g. Otto et al, 2002; Colletti et al, 2009; Colletti et al, 2014; Colletti & Shannon, 2005; Puram et al, 2016; Sennaroǧlu et al, 2011; Wilkinson et al, 2017).…”

“…The ABI has been used in non-tumor, hearing-impaired adults and children who had contradictions to cochlear implantation since 2000 (e.g. Colletti et al, 2000, 2001, 2002; Puram et al, 2016; Wilkinson et al, 2017). Non-tumor adult ABI users typically show better auditory capabilities than patients with NF2 (e.g.…”

“…Colletti & Shannon, 2005; Colletti et al, 2009). The ABI provides auditory perception in most pediatric patients (Colletti et al, 2014; Colletti & Shannon, 2005; Puram et al, 2016; Sennaroǧlu et al, 2011; Sennaroǧlu & Sennaroǧlu, 2013; Wilkinson et al, 2017). In some children, it also supports speech and language development and improves cognitive functions, including selective visual/spatial attention and multisensory reasoning (Colletti, 2007; Colletti et al, 2014; Colletti & Shannon, 2005; Sennaroǧlu et al, 2011; Sennaroǧlu & Sennaroǧlu, 2013).…”