Feasibility of the Mi2000 Totally Implantable Cochlear Implant in Severely to Profoundly Deaf Adu… (NCT04571333) | Clinical Trial Compass
CompletedNot Applicable
Feasibility of the Mi2000 Totally Implantable Cochlear Implant in Severely to Profoundly Deaf Adults.
Belgium, Germany6 participantsStarted 2020-09-07
Plain-language summary
This clinical investigation aims to collect data on the use of the Mi2000 system, a totally implantable cochlear implant system, for the first time in human subjects.
Who can participate
Age range18 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:
* 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 malforma…