Clinical trial NCT02671032: CHANGE Feasibility Study
Official title: Characterisation of Audiological Outcomes With the Nucleus CI532 Cochlear Implant in Adult Subjects.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Loss
Keywords: Cochlear Prosthesis Implantation
Lead sponsor: Cochlear
Sponsor class: INDUSTRY
Collaborators: name: The Hearing Cooperative Research Centre
name: Royal Victoria Eye and Ear Hospital
First posted: 2016-02-02
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Report on Degree of Hearing as Measured by Pure Tone Audiogram
timeFrame: 6 months and 12 months post activation
measure: Report on Clinical Performance in Quiet and Noise
timeFrame: 3 months, 6 months and 12 months post activation
measure: Report of Medical/Surgical and Device Related Adverse Events.
timeFrame: 12 months post activation.
Secondary outcomes:
measure: Report on Patient Reported Outcome Measures for Speech, Spatial and Qualities of Hearing Scale (SSQ)
timeFrame: Preoperative and 6 months post activation
measure: Glasgow Benefit Inventory (GBI).
timeFrame: 6 months post activation
Other outcomes:
Locations:
city: Carlton
country: Australia
facility: The Hearing Cooperative Research Centre
state: Victoria
city: East Melbourne
country: Australia
facility: Royal Victorian Eye and Ear Hospital
state: Victoria
Study officials:
affiliation: HEARing CRC
name: Robert Cowan, DipAud PhD
role: PRINCIPAL_INVESTIGATOR
References: