Innovations in Clinical Care of CE Approved Nucleus Cochlear Implant Recipients

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

Mean Difference Between Standard and Novel Fitting Method for Monosyllabic Word Scores in Quiet

Time frame: 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

Sponsors and collaborators

Lead sponsor

Cochlear

Industry

Registry information

Official study title

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

Important dates

Study start: 2020
Primary completion: 2023
Study completion: 2023
First posted: Mar 8, 2022
Registry last updated: Mar 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed