Remote Programming of Adult and Pediatric Cochlear Implant Recipients: Clinical Trial Results.

OBJECTIVE

To evaluate the efficacy and safety of remote cochlear implant (CI) programming. The primary efficacy objective was to demonstrate that speech recognition in quiet after remote fitting is no worse than speech recognition in quiet after in-person office fitting. The primary safety endpoint was the absence of unanticipated adverse device effects related to remote programming.

STUDY DESIGN AND SETTING

Prospective within-subjects interventional study at 5 US centers.

PARTICIPANTS

17 CI recipients (12 electric-only [EO] hearing; 5 with aidable residual hearing) with a minimum of 6 months of CI experience.

INTERVENTION

Programming conducted in person and remotely via a smartphone application.

MAIN OUTCOME MEASURES

Speech recognition, fitting duration, and subjective questionnaires.

RESULTS

In the EO cohort, mean AzBio speech recognition for in-person created programs was 89.28% (SE = 3.48), compared with 91.94% (SE = 2.76) for programs created remotely. The combined EO and aidable residual hearing cohort's mean speech recognition for programs created in person was 89.04% (SE = 2.66) versus 90.99% (SE = 2.09) for remotely created programs. The observed value for EO and pooled cohorts was <0.001, indicating that speech recognition in quiet after remote fitting is no worse than that after in-person fitting. Absolute differences in fitting durations between programming methods ranged from 3 to 11 minutes. The total time spent for a typical CI office visit ranged from 1 to more than 4 hours for 88.3% of study participants.

CONCLUSIONS

Remote programming provides noninferior outcomes to in-person programming and represents an important step toward improving the accessibility and affordability of obtaining audiology services by eliminating the need to travel. Participants and audiologists rated remote programming positively.