Investigation of an Outcomes-Driven, Computer-Assisted Approach to CI Fitting in Newly Implanted Patients

Abstract

Objective: To evaluate the efficacy of outcomes received by newly implanted cochlear implant recipients when an outcomes-driven, computer-assisted approach to cochlear implantation fitting was used. This approach, referred to as "Fitting to Outcome eXpert," or FOX, was developed by Otoconsult in Antwerp, Belgium.

Design: Thirty-one newly implanted subjects participated in a nonrandomized, single-subject, repeated measures design that involved a within-subject comparison of preoperative and postoperative speech recognition scores. Sound processors for all subjects were programmed using the FOX software that utilized the evidence-based results of various psychoacoustic tests to adjust MAP parameters and improve performance. Additionally, mean word and sentence recognition scores obtained by the subjects programmed with FOX were compared to results obtained by newly implanted patients enrolled in the Nucleus CI532 clinical trial whose devices were programmed using traditional methods.

Results: Subjects whose sound processors were programmed using FOX obtained a mean 6-month postactivation Consonant Nucleus Consonant word score of 60.2% correct. This represented an improvement of 46% age points when mean preactivation and postactivation scores were compared and represented a statistically significant change in score (p < 0.001). This mean score is similar to the mean 6-month Consonant Nucleus Consonant Word score of 61% obtained by 96 subjects enrolled in the Nucleus CI532 trial. Additionally, subjects in this study obtained a mean 6-month postactivation AzBio Sentence score of 42.7% correct when stimuli were presented at 65 dBA using a +10 signal-to-noise ratio. This score is also similar to the mean score of 43% obtained by 96 subjects enrolled in the Nucleus CI532 trial using the same test material and signal-to-noise ratio. Patients enrolled in this study attended 43% fewer programming appointments than the number reported by cochlear implantation centers in recent surveys of clinical care.

Conclusion: The results of this study support the use of an outcomes-driven, computer-assisted approach to supplement the management of newly implanted cochlear implant recipients. Subjects whose devices were programmed using such an approach demonstrated mean postoperative word in quiet and sentence in noise scores comparable to those obtained by subjects in the Nucleus CI532 clinical trial whose devices were programmed using traditional programming techniques. Use of this approach positively impacted patient care by reducing the number of postoperative visits needed to optimize sound processor programs, simplified patient testing via the use of direct streaming, and ensured that patients received consistent programming of their sound processor, regardless of the location where the programming was performed.

Trial registration: ClinicalTrials.gov NCT03304106.