A Study of Objective Fitting for Focused Multipolar Stimulation (NCT05763342) | Clinical Trial Compass
CompletedNot Applicable
A Study of Objective Fitting for Focused Multipolar Stimulation
Spain15 participantsStarted 2024-02-08
Plain-language summary
The purpose of this exploratory study is to trial various objective and behavioural fitting methods for potential use with Focused Multipolar Stimulation programming.
Who can participate
Age range
18 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
. Moderately severe to profound sensorineural hearing loss in both ears. (i.e., \>55 dB HL pure-tone average loss)
. Candidate for unilateral cochlear implantation according to locally approved criteria.
. Aged 18 years or over.
. Fluent speaker in the language used to assess speech perception performance.
. 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.
. 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 Organisations or contractors engaged by Cochlear for the purposes of this investigation.
. Pregnant at the time of surgery.
. Prisoners, or anyone in custody.
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
1
Speech reception threshold (SRT) in noise as a signal-to-noise ratio for 50% correct score.
. Current participation, or participation in another interventional clinical study/trial in the past 30 days, involving an investigational drug or device.
. Previous or existing cochlear-implant recipient.
. Evidence of severe or greater sensorineural hearing loss in the ear to be implanted prior to five years of age.