Innovations in Clinical Care of CE Approved Nucleus Cochlear Implant Recipients

A Feasibility, Prospective, Repeated-measures Investigation to Investigate Innovations in Clinical Care in Adult and Paediatric Recipients Implanted With CE Approved Nucleus Cochlear Implants: an Umbrella Investigation

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.

Study Overview

• Status: Completed
• Conditions: Hearing Loss
• Intervention / Treatment: Device: Cochlear Implant and sound processor device fitting paradigm or diagnostic/measurement technique

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • Victoria
    • Carlton, Victoria, Australia, 3052
      • HEARnet Clinical Studies - The University of Melbourne
    • East Melbourne, Victoria, Australia, 3002
      • Cochlear Ltd. Melbourne
• Belgium
  • Mechelen, Belgium, 2800
    • Cochlear Technology Centre Belgium
  • België
    • Brugge, België, Belgium, 8000
      • AZ Sint-Jan Brugge-Oostende AV
    • Wilrijk, België, Belgium, 2610
      • Sint-Augustinus Antwerpen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Study cohort; Recipients of cochlear implant or suitable for implantation Interrupted time series: recipients received standard and novel fitting method	Device: 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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Cochlear

Study record dates

Study Major Dates

• Study Start (Actual): October 19, 2020
• Primary Completion (Actual): March 6, 2023
• Study Completion (Actual): March 6, 2023

Study Registration Dates

• First Submitted: September 28, 2021
• First Submitted That Met QC Criteria: February 25, 2022
• First Posted (Actual): March 8, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 27, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Ear Diseases; Hearing Disorders; Hearing Loss
• Other Study ID Numbers: AI5763

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No