Feasibility of the Cochlear™ Nucleus® Cochlear Implant in a Newly Implanted Adult Population.

Cochlear Ltd0 个研究点目标入组 10 人开始时间: 2018年9月25日最近更新: 2023年7月18日

适应症

试验速览

暂无简介。

•1. A bilateral or unilateral moderately severe to profound postlinguistic sensorineural hearing loss and who have compromised functional hearing with hearing aids or receive no benefit with hearing aids.
•2. Fluent speaker in the local language used to assess clinical performance as judged by the investigator.
•3. Eighteen years of age or older at the time of enrolment with no upper age limit.
•4. A 30 day trial and/or experience with appropriately fit hearing aids.

•1. Deafness due to lesions of the acoustic nerve or central auditory pathway.
•2. Active middle-ear infections.
•3. Tympanic membrane perforation.
•4. Ossification, malformation or any other cochlear anomaly, such as common cavity, that might prevent complete insertion of the electrode array, as confirmed by medical examination.
•5. Evidence of severe-to-profound hearing loss prior to 5 years of age.
•6. Pre-existing cochlear or bone conduction implant.
•7. Medical or psychological conditions that contraindicate general anaesthesia or surgery.
•8. Additional disabilities that may affect the subject’s participation or safety during the clinical investigation.
•9. Unrealistic expectations on the part of the subject, regarding the possible benefits, risks, and limitations that are inherent to the surgical procedure(s) and prosthetic devices as determined by the Investigator.
•10. Unwillingness or inability of the candidate to comply with all investigational requirements as determined by the Investigator.
•11. Existing CSF shunts or drains, existing perilymph fistula, skull fracture or CSF leaks
•12. Recurrent episodes of bacterial meningitis.
•13. Pre-existing skin condition that could jeopardize wound healing as judged by the investigator e.g. psoriasis, dermatitis, use of corticosteroids, uncontrolled diabetes.
•14. Pre-existing medical condition that requires serial MRI and CT.
•15. Pre-existing medical condition of peripheral neuropathy.

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