Development of Custom Sound® Pro software utilising big data and its clinical evaluation

Abstract

Objectives

To inform and optimise a cochlear implant (CI) fitting software design through an analysis of big data to define array-specific comfort (C) level profiles, frequently-used MAP parameters, and the minimum number of Neural Response Telemetry thresholds (tNRT) needed to create an accurate profile. To evaluate the software’s ease of use and completion time for AutoNRT^®s.

Design

MAPs analysis. Clinical study evaluating software use in creating MAPs, addressing sound-quality issues and setting patient goals.

Study sample

MAPs (N = 39,885); CI recipients (N = 47) and clinicians (N = 19).

Results

Distinct C-level profiles were observed for lateral-wall, contour, and slim-modiolar electrode arrays. Default settings were used for most MAP parameters (13/16) except for Pulse Width, Rate, and Maxima. Nine tNRT measurements were required for an accurate C-level profile. Measurement-time of nine tNRTs via the new algorithm was comparable to five tNRTs using the previous algorithm. Nearly all (99%) clinical tasks were completed by clinicians with the first use of the software. Most CI recipients (79.5%) rated goal-setting as valuable.

Conclusion

Custom Sound Pro fitting software developed based on big data analysis incorporates a guided fitting workflow and expected fitting ranges. It helps to improve clinical efficiency, is easy to use and supports patient-centred care.

Keywords:

• Fitting
• cochlear implant
• programming
• NRT
• ECAP
• population mean

Acknowledgements

The authors thank the CI recipients and clinicians who participated in the study. The authors also thank Bernadette Pickering, Esti Nel, Suzanne Hayley and Toby Cumming for their involvement in the conduct of the study. Thanks to Beejal Vyas-Price, Ben Fernee, Janine Del Dot and Josie Wyss for review of the manuscript. Cochlear Limited sponsored this study.

Author contributors

SM was involved in the design of CSPro, study design, ethics submission, data collection, data analysis, and write-up of the draft manuscript. CB was involved in data analysis for the development phase. Both authors reviewed the draft manuscript and provided their approval for submission for publication.

Disclosure statement

SM and CB are employees of Cochlear Ltd.

Correction Statement

This article has been corrected with minor changes. These changes do not impact the academic content of the article.