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 range18 Years – 70 Years
SexALL
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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…