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

Not Applicable

Completed

• Conditions: hearing loss; Ear - Deafness

• Registration Number: ACTRN12618001593224
• Lead Sponsor: Cochlear Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-09-25
• Study Completion: 2022-04-20
• Last Update Posted: 18 July 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 10

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Mean speech perception performance for an open-set CNC monosyllabic word recognition measure with the external Sound Processor (EH mode) in the unilateral listening condition at six months post-activation [6 months post activation];2. Mean speech perception performance for AuSTIN sentence in noise recognition measure with the external Sound Processor (EH mode) in the unilateral listening condition at six months post-activation [ six months post-activation ];3. Mean speech perception performance for an open-set CNC monosyllabic word recognition measure without the external Sound Processor (IH mode) in the unilateral listening condition at six months post-activation [six months post-activation ]

Secondary Outcome Measures

Name	Time	Method
1. Patient Satisfaction Survey (PSS) at six months post-activation [6 months post activation ];2. Tinnitus Handicap Inventory (THI) score at six months post activation [6 months post activation ];3. Mean global Health Utility Index mark 3 (HUI3) score at six months post-activation[6 months post activation ]