CHANGE Feasibility Study (CLTD5626)

Characterisation of Audiological Outcomes With the Nucleus CI532 Cochlear Implant in Adult Subjects.

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.

Study Overview

• Status: Completed
• Conditions: Hearing Loss
• Intervention / Treatment: Device: Nucleus CI532 cochlear implant

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • Victoria
    • Carlton, Victoria, Australia, 3053
      • The Hearing Cooperative Research Centre
    • East Melbourne, Victoria, Australia, 30002
      • Royal Victorian Eye and Ear Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Implantation with Nucleus CI532 cochlear implant; All participants will receive the same treatment - Implantation with Nucleus CI532 cochlear implant.	Device: Nucleus CI532 cochlear implant

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Report on Patient Reported Outcome Measures for Speech, Spatial and Qualities of Hearing Scale (SSQ)	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.	Preoperative and 6 months post activation
Glasgow Benefit Inventory (GBI).	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.	6 months post activation

Collaborators and Investigators

• Sponsor: Cochlear
• Collaborators: The Hearing Cooperative Research Centre; Royal Victoria Eye and Ear Hospital
• Investigators: Principal Investigator: Robert Cowan, DipAud PhD, HEARing CRC

Study record dates

Study Major Dates

• Study Start (Actual): January 5, 2016
• Primary Completion (Actual): July 15, 2019
• Study Completion (Actual): July 15, 2019

Study Registration Dates

• First Submitted: January 27, 2016
• First Submitted That Met QC Criteria: January 28, 2016
• First Posted (Estimate): February 2, 2016

Study Record Updates

• Last Update Posted (Actual): June 9, 2021
• Last Update Submitted That Met QC Criteria: June 8, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: Cochlear Prosthesis Implantation
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Hearing Loss
• Other Study ID Numbers: CLTD5626

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Cochlear do not have an approved platform for sharing IPD. Data may be provided to individual researchers on request.