CHANGE Feasibility Study

Not Applicable

Completed

• Conditions: Hearing Loss
• Interventions: Device: Nucleus CI532 cochlear implant

• Registration Number: NCT02671032
• Lead Sponsor: Cochlear

Brief Summary

The purpose of the feasibility study is to examine audiological outcomes (audiometry and speech perception) and safety (adverse events and adverse device effects) with the Nucleus CI532 cochlear implant in group of adult subjects (n=12) who meet current criteria for cochlear implantation.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01-05
• Study First Submitted: 2016-01-27
• Study First Submitted QC: 2016-01-28
• Study First Posted: 2016-02-02
• Primary Completion: 2019-07-15
• Study Completion: 2019-07-15
• Results First Submitted: 2020-09-07
• Results First Submitted QC: 2020-11-19
• Results First Posted: 2020-11-20
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-08
• Last Update Posted: 2021-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

1. Meet current cochlear implant indications at the implanting centre
2. In addition to meeting current cochlear implant indications, subjects must also possess preoperative unaided hearing thresholds between 40 to 65 dB HL at 250 & 500Hz in the ear to be implanted.
3. Fluent speaker in the local language used to assess clinical performance
4. Eighteen years of age or older at the time of implantation with no upper age limit

Exclusion Criteria

1. Evidence of hearing loss prior to 5 years of age.
2. Sensorineural severe-to-profound hearing loss greater than 20 years at 2 kHz and above.
3. Simultaneous bilateral cochlear implantation or prior cochlear implantation in the ear to be implanted.
4. Additional disabilities that may affect the subject's participation or safety during the clinical investigation.
5. Medical or psychological conditions that contraindicate undergoing general anaesthesia or surgery.
6. 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.
7. Hearing impairment due to lesion or neuropathy of the acoustic nerve, VIII nerve or central auditory pathway.
8. Active middle-ear infection,
9. Tympanic membrane perforation
10. 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
11. Unwillingness or inability of the candidate to comply with all investigational requirements.
12. Patients with existing CSF shunts or drains, existing perilymph fistula, skull fracture or CSF leak.
13. Patients with recurrent episodes of bacterial meningitis.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Implantation with Nucleus CI532 cochlear implant	Nucleus CI532 cochlear implant	All participants will receive the same treatment - Implantation with Nucleus CI532 cochlear implant.

Primary Outcome Measures

Name	Time	Method
Report on Degree of Hearing as Measured by Pure Tone Audiogram	6 months and 12 months post activation	unaided audiogram at time intervals indicated above in ear to be implanted and implanted ear.
Report on Clinical Performance in Quiet and Noise	3 months, 6 months and 12 months post activation	Speech perception assessment with monosyllabic words and sentences percentage correct in competing noise at a fixed signal-to-noise ratio (+5dB).
Report of Medical/Surgical and Device Related Adverse Events.	12 months post activation.	Report of medical/surgical and device related adverse events compared to current approved labeling with regard to type, frequency and seriousness.

Secondary Outcome Measures

Name	Time	Method
Glasgow Benefit Inventory (GBI).	6 months post activation	Effect of intervention (implantation with CI532 cochlear implant) will be assessed at 6 months post activation with the Glasgow Benefit Inventory (GBI). Glasgow Benefit Inventory (GBI) is a measure of patient reported benefit developed especially for otorhinolaryngological interventions where scores range from -100 to 100, where a higher score corresponds to a better benefit outcome and a negative score value corresponds to a worse outcome.
Report on Patient Reported Outcome Measures for Speech, Spatial and Qualities of Hearing Scale (SSQ)	Preoperative and 6 months post activation	Effect of intervention (implantation with CI532 cochlear implant) will be assessed by the change in SSQ scores from preoperative to 6 months post activation, where scores follow a system of 0 = not at all and 10 = perfectly in response to questions.

Trial Locations

Locations (2)

The Hearing Cooperative Research Centre; 🇦🇺 Carlton, Victoria, Australia

Royal Victorian Eye and Ear Hospital; 🇦🇺 East Melbourne, Victoria, Australia