CHANGE Feasibility Study

Hearing Loss Clinical Trial

— CLTD5626  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02671032
• Other study ID #: CLTD5626
• Status: Completed
• Phase: N/A
• Start date: January 5, 2016
• Est. completion date: July 15, 2019

Study information

• Verified date: June 2021
• Source: Cochlear
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: July 15, 2019
• Est. primary completion date: July 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hearing Loss

Intervention

Device:
• Nucleus CI532 cochlear implant

Locations

Country	Name	City	State
Australia	The Hearing Cooperative Research Centre	Carlton	Victoria
Australia	Royal Victorian Eye and Ear Hospital	East Melbourne	Victoria

Sponsors (3)

Lead Sponsor	Collaborator
Cochlear	Royal Victoria Eye and Ear Hospital, The Hearing Cooperative Research Centre

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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