CHANGE Feasibility Study

NCT ID: NCT02671032

Last Updated: 2021-06-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-05
• Study Completion Date: 2019-07-15

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.

Conditions

Hearing Loss

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Implantation with Nucleus CI532 cochlear implant

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

Group Type: EXPERIMENTAL

Nucleus CI532 cochlear implant

Intervention Type: DEVICE

Interventions

Nucleus CI532 cochlear implant

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Hearing Cooperative Research Centre

OTHER

Sponsor Role: collaborator

Royal Victoria Eye and Ear Hospital

OTHER_GOV

Sponsor Role: collaborator

Cochlear

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert Cowan, DipAud PhD

Role: PRINCIPAL_INVESTIGATOR

HEARing CRC

Locations

The Hearing Cooperative Research Centre

Carlton, Victoria, Australia

Royal Victorian Eye and Ear Hospital

East Melbourne, Victoria, Australia

Countries

Australia

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CLTD5626

Identifier Type: -

Identifier Source: org_study_id