None listed
Conditions
Brief summary
The purpose of the feasibility study is to examine speech perception outcomes (quiet and noise) and safety (adverse events and adverse device effects) with the cochlear implant in eleven newly implanted adults who meet the eligibility criteria for the study.
Interventions
Cochlear Prosthesis Implantation.
All participants will receive the same treatment- implantation of the totally implantable cochlear implant TI1012 (surgery) and over night stay in hospital.
ENT surgeon will administer the intervention and will be follow up up by Audiologists in Cochlear clinic
There will be a 2 week gap from implantation (surgery) to activation at the clinic
Sponsors
Cochlear Ltd
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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.
Exclusion criteria
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.
Outcome results
None listed