Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:42 PM
Ignite Modification Date:
2025-12-24 @ 3:42 PM
NCT ID:
NCT01749592
Eligibility Criteria:
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 years.
* Exposure to radiation with a cumulative effective dose of 5 mSV within the last 5 years (including the ongoing year).
* Increased risk profile for general anesthesia due to cardiovascular comorbidity.
* Metallic implants constituting an exclusion criterium for MEG procedures of the brain.
* Pregnancy (a pregnancy test will be performed in women in the reproductive age group before study enrolment and before postoperative PET scan) and lactation.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT01749592
Study Brief:
Protocol Section:
NCT01749592