Innovations in Clinical Care of CE Approved Nucleus Cochlear Implant Recipients

Not Applicable

Completed

• Conditions: Hearing Loss
• Interventions: Device: Cochlear Implant and sound processor device fitting paradigm or diagnostic/measurement technique; Device: Standard of care fitting or diagnostic measurement of Cochlear Implant and sound processor

• Registration Number: NCT05270876
• Lead Sponsor: Cochlear

Brief Summary

This study is to evaluate new approaches to device fitting and diagnostics for cochlear implant users. The evaluation can be performed in the laboratory in an acute session or in real world environments with take-home device use to further validate their benefits. Each feature will be tested in a sub-study specific to that hearing care model. On average, each sub-study is expected to include approximately 20 subjects.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-10-19
• Study First Submitted: 2021-09-28
• Study First Submitted QC: 2022-02-25
• Study First Posted: 2022-03-08
• Primary Completion: 2023-03-06
• Study Completion: 2023-03-06
• Results First Submitted: 2024-10-16
• Status Verified: 2024-12
• Results First Submitted QC: 2024-12-01
• Results First Posted: 2024-12-05
• Last Update Submitted: 2025-02-27
• Last Update Posted: 2025-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Users of a CE approved Nucleus cochlear implant, resulting in open set speech understanding
• At least three months of experience with the cochlear implant.
• Older than 18 years when entering the study.
• Subject is fluent speaker in the language used for assessments.
• Open set speech understanding sufficient to complete the study protocol as judged by the investigator.
• Willing and able to provide written informed consent

Exclusion Criteria

• Unable or unwilling to comply with the requirements of the clinical investigation as determined by the investigator.
• Additional health factors, known to the investigator, that would prevent or restrict participation in the audiological evaluations.
• Investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as a spouse, parent, child, or sibling.
• Cochlear employees or employees of Contract Research Organizations or contractors engaged by Cochlear for the purposes of this investigation.
• Currently participating, or participated within the last 30 days, in another interventional clinical investigation/trial involving an investigational drug or device.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Investigational	Cochlear Implant and sound processor device fitting paradigm or diagnostic/measurement technique	Recipients of cochlear implant or suitable for implantation
Standard of Care	Standard of care fitting or diagnostic measurement of Cochlear Implant and sound processor	Recipients of cochlear implant or suitable for implantation

Primary Outcome Measures

Name	Time	Method
Mean Difference Between Standard and Novel Fitting Method for Monosyllabic Word Scores in Quiet	0 to 4 weeks after fitting	The difference between mean CNC scores (reported as percentage of correct answers) in quiet between the standard and novel fitting method

Trial Locations

Locations (5)

Sint-Augustinus Antwerpen; 🇧🇪 Wilrijk, België, Belgium

AZ Sint-Jan Brugge-Oostende AV; 🇧🇪 Brugge, België, Belgium

HEARnet Clinical Studies - The University of Melbourne; 🇦🇺 Carlton, Victoria, Australia

Cochlear Ltd. Melbourne; 🇦🇺 East Melbourne, Victoria, Australia

Cochlear Technology Centre Belgium; 🇧🇪 Mechelen, Belgium