NCT07077070

Investigating Electrical Categorical Loudness Scaling Using a Mobile Research App in Experienced Adult Cochlear Implant Participants

A Feasibility, Prospective, Repeated-measures, Within-subject, Interventional Study Investigating the Electrical Categorical Loudness Scaling Using the Mobile Research App in the Home and In-clinic Situation in Experienced Adult Cochlear Implant Participants

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Cochlear · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This clinical study will evaluate a feature of the investigational Nexus Research System used for programming cochlear implants. Programming a cochlear implant-commonly referred to as MAP fitting-involves activating the device, allowing recipients to acclimatize to hearing sounds, and then fine-tuning the program based on the user's perception of loudness across different sounds. This process typically occurs over several visits and requires a clinician to collect data for the fine-tuning phase. The Nexus Research System includes an "Electrical Loudness Scaling" task, which participants can complete independently using a mobile application to collect the necessary data. Based on findings from previous studies, this feature has been revised to enable faster data collection. The current study will assess the performance of the updated feature. The study will involve experienced cochlear implant users. Participants will use the feature, undergo a series of hearing assessments-including evaluations of loudness perception-and provide feedback on the updated feature.

Conditions

• Hearing Loss, Sensorineural

Interventions

Type	Name	Description
DEVICE	Standard Electrical Categorical Loudness Scaling task (Standard-ELS)	The Standard-ELS task is conducted using the Mobile Research Application within the Nexus Research system. It is completed in two phases: the first phase identifies the lower and upper bounds of the loudness range based on participant ratings, while the second phase collects data from stimulations delivered within the established range.
DEVICE	Fast Electrical Categorical Loudness Scaling task (Fast-ELS)	The Fast-ELS task employs an algorithm to estimate the lower and upper bounds of the loudness range using a limited number of samples. This range is then refined by collecting additional samples across various loudness categories for comprehensive coverage.

Timeline

• Start date: 2025-10-21
• Primary completion: 2025-12-24
• Completion: 2025-12-24
• First posted: 2025-07-22
• Last updated: 2026-01-08

Locations

3 sites across 2 countries: United States, Belgium