Benefits From Bimodal Fittings With Cochlear Implant and Hearing Aid vs Bilateral Hearing Aids (NCT04919928) | Clinical Trial Compass
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Benefits From Bimodal Fittings With Cochlear Implant and Hearing Aid vs Bilateral Hearing Aids
Denmark60 participantsStarted 2022-02-01
Plain-language summary
Hearing-aid (HA) users with insufficient HA may be better helped with a "Bimodal solution" when replacing the HA with a Cochlear implant (CI) to the poorer hearing ear and a HA to the better hearing ear.
This randomised controlled trial can show the benefit in terms of better speech perception of the bimodal solution with CI to the poorest hearing ear compared to binaural hearing aids.
It can clarify if HAs users with insufficient HAs benefit will benefit from the bimodal solution when adding a CI to the poorer hearing ear in terms of better speech perception.
It can report the degree of perceived hearing handicap in bimodal CI-users versus bilateral HA-users by hearing -specific patient reported outcome measures (PROM) questionnaires.
And it can contribute to a specific cochlear implant candidacy criterion related to the transition from HA treatment to the CI treatment.
The purpose of this study is to determine if bimodal treatment with a hearing aid to the better hearing ear and CI to the poorer hearing ear increases the ability to understand speech and improve quality of life compared to patients that are treated with hearing aids only.
The benefit of bimodal fittings compared to the best possible bilateral HA treatment will be evaluated.
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
* Adults \>18 years old.
* Fluent in Danish, including reading and writing
* Acquired post-lingual deafness
* Use of bilateral HAs for at least one year prior to evaluation for cochlear implantation candidacy. This to ensure, that both ears have received auditive stimulation
* PTA \> 40 dB HL in the ear considered for CI implantation and PTA≥40 and ≤ 70dB HL in the contralateral ear in best aided condition, in quiet and in noise and in free field.
* SIS \<70% in best aided condition in the ear considered for CI implantation and SIS ≥30% and ≤70% in best aided condition in the contralateral ear, in quiet and in noise and in free field.
Exclusion Criteria
* Vestibular loss in the ear not considered for CI implantation
* Surgical issues interfering with the site of implantation or anatomical contraindications such as cochlear malformations, which will be determined using MRI or CT-scans.
* Auditory nerve lesions.
* Central auditory pathway pathologies.
* Otosclerosis.
* Single sided deafness (SSD).
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
Hearing in Noise Test (HINT) Speech identification scores