Clinical Evaluation of a Cochlear Implant System

Cochlear46 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Sensorineural Hearing Loss

Interventions

Nucleus 7 Cochlear Implant SystemDEVICE

A new cochlear implant sound processor system.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 100 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Cochlear Ltd

Sydney, New South Wales, Australia

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.

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.

Time frame: One year

Secondary Outcomes

Speech perception performance of the CP1000 Sound Processor in quiet and in noise.

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.

Time frame: One year

Data from ClinicalTrials.gov

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