N6 Input Processing in Traditional CI Recipients

Not Applicable

Completed

• Conditions: Hearing Loss
• Interventions: Device: Nucleus 6 Sound Processor

• Registration Number: NCT02239263
• Lead Sponsor: Cochlear

Brief Summary

The purpose of this study is to evaluate the enhanced signal processing features of the Nucleus 6 Sound Processor on existing Nucleus cochlear implant recipients currently using the Nucleus 5 Sound Processor.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-05
• Study First Submitted: 2014-09-10
• Study First Submitted QC: 2014-09-11
• Study First Posted: 2014-09-12
• Primary Completion: 2014-11
• Study Completion: 2015-01
• Results First Submitted: 2020-11-03
• Status Verified: 2021-02
• Results First Submitted QC: 2021-02-24
• Last Update Submitted: 2021-02-24
• Results First Posted: 2021-02-26
• Last Update Posted: 2021-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Greater than 12 years
• Unilateral cochlear implant recipient (CI24RE, CI500, CI422)
• Minimum of 3 months experience with the N5 sound processor
• Prior documentation of sentence recognition testing in noise at a difficulty of +10 dB SNR or better
• Native English speaker
• Willingness to participate in and comply with all requirements of the protocol

Exclusion Criteria

• Unrealistic expectations
• Unwillingness to comply with investigational requirements of the protocol
• Additional handicaps that would prevent or restrict participation in the evaluations

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
N6 Input Processing Features	Nucleus 6 Sound Processor	-

Primary Outcome Measures

Name	Time	Method
Endpoint 1: Evaluation of Signal to Noise Ratio - Noise Reduction	Visit 2, 1 month after baseline testing	Speech understanding in noise using AzBio sentences with and without the SNR - noise reduction algorithm enabled. Speech understanding at a fixed +10 dB signal to noise level in each condition (on/off) is scored as percent correct and then subtracted to demonstrate the percent difference (benefit) in performance of having the algorithm on vs off.
Endpoint 2: Evaluation of SCAN	Visit 2, 1 month after baseline testing	Speech understanding in noise using AzBio sentences with and without SCAN algorithm enabled. Speech understanding at a fixed +10 dB signal to noise level in each condition (on/off) is scored as percent correct and then subtracted to demonstrate the percent difference (benefit) in performance of having the algorithm on vs off.

Trial Locations

Locations (4)

Rocky Mountain Ear Center; 🇺🇸 Englewood, Colorado, United States

Hospital of the University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

Center for Hearing and Balance; 🇺🇸 Chesterfield, Missouri, United States

Houston Ear Research Foundation; 🇺🇸 Houston, Texas, United States