Innovations in Clinical Care of CE Approved Nucleus Cochlear Implant Recipients

NCT05270876 | Completed Results

• 1 other identifier: AI5763
• Study Type: interventional
• Target: 20
• Locations: 2 countries
• Sites: 5

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Study cohort

OTHER

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

Interventions

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

Study cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cochlear: lead

Study Sites (5)

HEARnet Clinical Studies - The University of Melbourne

Carlton, Victoria, 3052, Australia

Location

Cochlear Ltd. Melbourne

East Melbourne, Victoria, 3002, Australia

Location

AZ Sint-Jan Brugge-Oostende AV

Bruges, België, 8000, Belgium

Location

Sint-Augustinus Antwerpen

Wilrijk, België, 2610, Belgium

Location

Cochlear Technology Centre Belgium

Mechelen, 2800, Belgium

Location

MeSH Terms

Conditions

Hearing Loss

Interventions

Cochlear Implants; Diagnosis; Weights and Measures

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Neural Prostheses; Implantable Neurostimulators; Electrodes, Implanted; Electrodes; Electrical Equipment and Supplies; Equipment and Supplies; Prostheses and Implants; Hearing Aids; Sensory Aids; Investigative Techniques

Results Point of Contact

• Title: PRS Specialist
• Organization: Cochlear

cltd-prs-admin@cochlear.com

+61294286555

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Participants were masked to which fitting method they had at any point in the study
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Interrupted time series

Study Record Dates

• First Submitted: September 28, 2021
• First Posted: March 8, 2022
• Study Start: October 19, 2020
• Primary Completion: March 6, 2023
• Study Completion: March 6, 2023
• Last Updated: March 10, 2025
• Results First Posted: December 5, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

BE (3); AU (2)