Single-sided Deafness and Cochlear Implants (NCT01749592) | Clinical Trial Compass
CompletedNot Applicable
Single-sided Deafness and Cochlear Implants
Switzerland20 participantsStarted 2012-12
Plain-language summary
* As the left and right hemisphere are specialized for different auditory tasks, the proposed study aims at demonstrating different consequences of right or left-sided deafness for the affected individual.
* Furthermore, the question should be answered if auditory deficits and plastic changes can be partially reversed by cochlear implantation of the deaf ear.
* Multicenter, prospective, open, non-randomized clinical trial with 5 patients with right-sided and 5 patients with left-sided sensineural deafness.
* Pre-operative: Audiometry, Sound Localization Audiometry, PET, EEG/MEG
* Comparison of pre-operative investigations with 10 healthy subjects (age and gender matched control group)
* Cochlea implantation
* Follow-up Visits at 3, 6, 9 and 12 month post-operative: Audiometry, Sound Localization Audiometry, PET, EEG, Questionnaires
* Trial with medical device
Who can participate
Age range
18 Years – 70 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: • Patients with acquired single sided sensorineural deafness due to cochlear damage.
* Age: 18-70 years old.
* Onset of SSD within 6 months to 10 years before Study inclusion.
* Normal hearing on the contralateral ear (Hearing thresholds 0.125-2 kHz 25 dB HL or better, 4-8 kHz 35 dB HL or better, 100% speech discrimination at 80 dB SPL).
* Regular middle ear function on the hearing ear.
* Regular structure of the cochlea and the cochlear nerve (as demonstrated by MRI, MRI scans are included in the basic assessment of SSD and are no study-specific investigations).
* Fluency in the German language.
* Subject is willing to comply with all study requirements.
* Impairment in daily life as a consequence of SSD (communication problems, annoyance by tinnitus perception).
* Subject is not participating in another ongoing research study related to the SSD.
* Subject does not have unrealistic expectations, regarding the outcome of the intervention.
* Subject has had a trial with conventional acoustic measures in SSD (CROSS, BAHA).
Exclusion criteria: • Uncertainty of correct diagnosis of SSD.
* Retrocochlear cause of SSD (Deafness due to lesions of the acoustic nerve or central auditory pathways).
* Active middle ear infections.
* Ossification of the cochlear that prevents electrode insertion.
* Tympanic membrane perforation.
* Psychiatric comorbidities such as depression or cognitive deficits.
* Severe coexisting illness with a medium survival of less than 5 yea…
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.