Clinical Evaluation of a Cochlear Implant System

Cochlear1 site in 1 country46 target enrollmentJuly 1, 2016

ConditionsSensorineural Hearing Loss

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Sensorineural Hearing Loss
Sponsor: Cochlear
Enrollment: 46
Locations: 1
Primary Endpoint: 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.
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

July 1, 2016

End Date

September 7, 2017

Last Updated

8 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Cochlear

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

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.

Time Frame: 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.