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:
2025-12-25 @ 2:41 AM
Ignite Modification Date:
2025-12-25 @ 2:41 AM
NCT ID:
NCT04571333
Eligibility Criteria:
Inclusion Criteria:
* Minimum age of eighteen (18) years at time of enrolment
* Bilateral sensorineural hearing loss with no or limited benefit from a hearing aid (\>70 dB HL PTA4)
* Post-lingual onset of deafness
* No or limited benefit from hearing aids for less than 10 years.
* A maximum score of 50% on a monosyllables test in the language of the test centre in the ear to be implanted
* General health condition, psychological and emotional condition deemed compatible with the treatment and tests performed in this study and realistic expectations, as deemed appropriate by the implanting surgeon/implant board
* Fluency in the test language with excellent proficiency, as appropriate to perform speech testing
* Evidence of up-to-date vaccinations against meningitis, as per recommendations by the applicable national body
* Signed and dated informed consent before the start of any study-specific procedure
Exclusion Criteria:
* Lack of compliance with any inclusion criterion
* Previously having received an implant on the location chosen for placing the cochlear implant
* Having received a hearing implant from another manufacturer than MED-EL on the contralateral ear
* Pre-existing condition known to necessitate MRI scans after implantation of the Mi2000
* Women being pregnant or nursing
* Women of child-bearing age not reporting to use effective contraception
* Contraindication to surgery in the middle and inner ear
* Contraindication to general anaesthesia
* Cochlear malformations, ossification or other obliteration of the cochlea, history of meningitis preventing placement of the electrode array, as confirmed by medical examination
* Acute cholesteatoma
* Acute external or middle ear infections
* Perforated tympanic membrane
* Known intolerance to any of the materials used for the implant or accessories
* Non-functional auditory nerve and/or upper auditory pathway including a history of vestibular schwannoma
* Factors preventing appropriate placement of the stimulator housing and the microphone, including fixation with screws, in the bone of the skull
* Unstable Meniere's disease, Auditory Neuropathy, Epilepsy not responding to treatment
* Unrealistic expectations of the subject
* Permanent inability and/or unwillingness to participation in post-operative care and rehabilitation
* Known intellectual disability and/or psychological diseases
* Participation in other pharmacological clinical trials within four weeks prior to enrolment
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04571333
Study Brief:
Protocol Section:
NCT04571333