Electric Pace-pitched Hearing Achieves Natural Tonotopy
Netherlands30 participantsStarted 2019-03-18
Plain-language summary
In search of the best possible outcome for the severe hearing impaired who have regained the ability to hear by means of a cochlear implant (CI), electrical stimulation and the information it carries should match as closely as possible to what the human brain naturally has evolved to cope with and learned to process instead of relying on plasticity to adapt to an induced mismatch. At the moment, however, CI's are fitted with a 'one size fits all' principle. This is known to cause a mismatch between the frequencies presented by the CI electrode array and the frequencies represented at the corresponding natural acoustic location in an individual cochlea. In this study it is hypothesized that an individual imaged based fitting that pursues natural hearing alignment and is implemented from the start of the rehabilitation process, will improve the individual outcomes of electric hearing. The natural fitting strategy is thought to give rise to a steeper learning curve, result in a better performance in challenging listening situations, improve sound quality, complement better with residual acoustic hearing in the contralateral ear and win the preference of CI-recipients.
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:
* Adult (18y or older) and meeting the conventional Dutch CI criteria;
* Proficient speaker of Dutch language;
* Post-lingual onset of profound deafness (\> 4 years of age);
* Subject receives an Advanced Bionics implant with Midscala electrode and an Advanced Bionics sound processor;
* Prepared to use study specific hearing aid (Phonak) for the duration of the study;
* Rehabilitation at MUMC+ for the first year after surgery regarding CI as well as HA;
* Active participation in trial related procedures such as daily randomization and regular testing.
Exclusion Criteria:
* Physical or non-physical contraindications for MRI or CT imaging;
* Additional disabilities that may prevent active participation and testing as per protocol. If there are indications that the mental abilities to comply with the study procedures are insufficient, additional screening will be performed with the Mini-Mental State Examination. Patients will be excluded from the study when the resulting score is lower than 24;
* Cochlear or neural abnormalities that could affect outcome measures and/or compromise the placement of the electrode as assessed by the CI surgeon;
* Active participation in another prospective clinical trial;
* Pregnancy at time of imaging;
* Requirement for electric-acoustic activation prior to the first year follow-up;
* Having received a cochlear implant earlier (e.g. explantation or bilateral implantation).
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 understanding in quiet with cochlear implant
Timeframe: During the first 12 months of CI rehabilitation
2
Speech understanding in quiet with cochlear implant
Timeframe: During the first 12 months of CI rehabilitation
3
Speech understanding in noise with cochlear implant
Timeframe: During the first 12 months of CI rehabilitation
4
Patient preference
Timeframe: During the first 12 months of CI rehabilitation