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COMPLETED
NCT05709223
NA

Comparing the Performance of a Categorical Loudness Scaling Based Fitting With a Behavioural Fitting in Adults With a Nucleus Cochlear Implant 3 Months Post-activation

Sponsor: Cochlear

View on ClinicalTrials.gov

Summary

This study aims to collect data in newly implanted cochlear implant-recipients to inform future development of fitting methods to optimally and efficiently program a cochlear implant.

Official title: Feasibility, Prospective, Within-subject, Interventional Study Comparing the Performance of a Categorical Loudness Scaling Based Fitting With a Behavioural Fitting in Adults With a Nucleus Cochlear Implant in the First 3 Months Post-activation

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

17

Start Date

2023-03-14

Completion Date

2025-02-26

Last Updated

2026-05-15

Healthy Volunteers

No

Conditions

Interventions

DEVICE

Categorical loudness scaling based fitting using the research fitting system.

The research fitting system is used in combination with other devices as part of a hearing implant system. It is intended to create and modify hearing profiles, to monitor the performance of the system and to facilitate firmware updates of the system.

DEVICE

Behavioural fitting using Custom Sound Suite (CSS 6.3) Software

The comparator is the commercially available fitting method (i.e., the behavioural measurement of active channels) using Custom Sound Suite (CSS 6.3) software

Locations (4)

Cochlear Americas

Lone Tree, Colorado, United States

Cochlear Sydney

Sydney, Sydney, Australia

HEARnet

Carlton, Victoria, Australia

Medizinische Hochschule Hannover (MHH)

Hanover, Hannover, Germany