Innovations in Clinical Care of CE Approved Nucleus Cochlear Implant Recipients

NCT ID: NCT05270876

Last Updated: 2025-03-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-19
• Study Completion Date: 2023-03-06

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.

Conditions

Hearing Loss

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Study cohort

Recipients of cochlear implant or suitable for implantation Interrupted time series: recipients received standard and novel fitting method

Group Type: OTHER

Cochlear Implant and sound processor device fitting paradigm or diagnostic/measurement technique

Intervention Type: DEVICE

The investigational device will be a new device fitting paradigm or diagnostic/measurement technique implemented for use with the commercially available sound processor and implant.

Interventions

Cochlear Implant and sound processor device fitting paradigm or diagnostic/measurement technique

The investigational device will be a new device fitting paradigm or diagnostic/measurement technique implemented for use with the commercially available sound processor and implant.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cochlear

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

HEARnet Clinical Studies - The University of Melbourne

Carlton, Victoria, Australia

Cochlear Ltd. Melbourne

East Melbourne, Victoria, Australia

AZ Sint-Jan Brugge-Oostende AV

Bruges, België, Belgium

Sint-Augustinus Antwerpen

Wilrijk, België, Belgium

Cochlear Technology Centre Belgium

Mechelen, , Belgium

Countries

Australia; Belgium

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

AI5763

Identifier Type: -

Identifier Source: org_study_id