UnknownNot Applicable

Evaluation of Performance and Usability of N6 in the Paediatric Population

Australia, New Zealand30 participantsStarted 2012-11

Plain-language summary

The purpose of this study is to evaluate the performance and usability of the N6 system in children with the N5 system.

Who can participate

Age range

5 Years – 14 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age 5-14 years, currently using N5 * Minimum speech perception ability in noise of 30% at +10 decibels (dB) signal-to-noise ratio (SNR). * Minimum of 2 years cochlear implant (CI) experience, including at least 6 months experience with their current processor * Excellent verbal reporters * Excellent record of attending clinical appointments. * Attend a regular school, * English 1st language. * Excellent record of compliance with habilitation tasks. Exclusion Criteria: * Cognitive impairment, or other significant impairment that would impact on their ability to undertake task requirements * Inability to attend study appointments.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Group usability performance data for N6 versus N5

Timeframe: Nov 2012-June 2013

Trial details

NCT IDNCT01800929

SponsorCochlear, Asia Pacific

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2013-06

Contact for this trial

Robert Cowan, PhD

+61294286555 r.cowan@unimelb.edu.au

View on ClinicalTrials.gov More Transplants and Implants trials

Who can participate

Age range

5 Years – 14 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.