CHANGE Feasibility Study

NCT02671032 | Completed Results

• 1 other identifier: CLTD5626
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 2

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

Keywords

Cochlear Prosthesis Implantation

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Report on Patient Reported Outcome Measures for Speech, Spatial and Qualities of Hearing Scale (SSQ)

  Preoperative and 6 months post activation

• Glasgow Benefit Inventory (GBI).

  6 months post activation

Study Arms (1)

Implantation with Nucleus CI532 cochlear implant

EXPERIMENTAL

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

Device: Nucleus CI532 cochlear implant

Interventions

Nucleus CI532 cochlear implant DEVICE

Implantation with Nucleus CI532 cochlear implant

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Meet current cochlear implant indications at the implanting centre
• 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.
• Fluent speaker in the local language used to assess clinical performance
• Eighteen years of age or older at the time of implantation with no upper age limit

You may not qualify if:

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

Sponsors & Collaborators

• Cochlear: lead
• The Hearing Cooperative Research Centre: collaborator
• Royal Victoria Eye and Ear Hospital: collaborator

Study Sites (2)

The Hearing Cooperative Research Centre

Carlton, Victoria, 3053, Australia

Location

Royal Victorian Eye and Ear Hospital

East Melbourne, Victoria, 30002, Australia

Location

MeSH Terms

Conditions

Hearing Loss

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Bernadette Pickering
• Organization: Cochlear

bpickering@cochlear.com

+61296115909

Study Officials

• Robert Cowan, DipAud PhD

  HEARing CRC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2016
• First Posted: February 2, 2016
• Study Start: January 5, 2016
• Primary Completion: July 15, 2019
• Study Completion: July 15, 2019
• Last Updated: June 9, 2021
• Results First Posted: November 20, 2020

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

AU (2)