Clinical Evaluation of a Cochlear Implant System

Not Applicable

Completed

• Conditions: Sensorineural Hearing Loss
• Interventions: Device: Nucleus 7 Cochlear Implant System

• Registration Number: NCT03467399
• Lead Sponsor: Cochlear

Brief Summary

The primary objective of this study is to assess the usability of a Cochlear implant system.

Detailed Description

Measure participant ratings on satisfaction of a Cochlear implant system via use of validated and non-validated questionnaires.

Study Timeline

• Study Start: 2016-07-01
• Study First Submitted: 2016-09-16
• Primary Completion: 2017-09-07
• Study Completion: 2017-09-07
• Status Verified: 2018-03
• Study First Submitted QC: 2018-03-09
• Last Update Submitted: 2018-03-09
• Study First Posted: 2018-03-16
• Last Update Posted: 2018-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

1. Eighteen years of age or older
2. At least 6 months experience with a Nucleus 24 series or later implant in at least one implanted ear
3. At least 3 months experience with the CP810,CP920 or CP910 sound processor
4. Fluent speaker in the language used to assess speech perception performance
5. Willingness to participate in and to comply with all requirements of the protocol
6. Able to score 30% or more at +15 SNR with CI alone on a sentence in babble test

Exclusion Criteria

1. Unrealistic expectations on the part of the subject, regarding the possible benefits, risks and limitations that are inherent to the procedure and prosthetic device
2. Additional disabilities that would prevent participation in evaluations
3. Nucleus 22 Implant

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cochlear implant users	Nucleus 7 Cochlear Implant System	This is a within-subject, repeated measures study. There was one arm in this study, each subject served as their own control. All subjects received all interventions.

Primary Outcome Measures

Name	Time	Method
Cochlear implant subjects' ratings on hearing performance, connectivity, streaming, phone use, comfort, retention, ease of use and controls obtained with their own Sound Processor and the CP1000 Sound Processor.	One year	Non-inferiority of subjects' overall satisfaction ratings for the CP1000 Sound Processor and related components measured following 3 months of use, compared to subjects' overall satisfaction rating for their own Sound Processor and related components measured at study onset.

Secondary Outcome Measures

Name	Time	Method
Speech perception performance of the CP1000 Sound Processor in quiet and in noise.	One year	Data to substantiate the speech perception scores of the subjects for different quiet and noise conditions for different configurations of sound processor and / or accessories.

Trial Locations

Locations (1)

Cochlear Ltd; 🇦🇺 Sydney, New South Wales, Australia