N6 Input Processing in Traditional CI Recipients

Hearing Loss Clinical Trial

Official title:

Investigation of Nucleus 6 Sound Processor Input Processing in Cochlear Implant Recipients.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02239263
• Other study ID #: CAM5555
• Status: Completed
• Phase: N/A
• Start date: May 2014
• Est. completion date: January 2015

Study information

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

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 2015
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hearing Loss

Intervention

Device:
• Nucleus 6 Sound Processor

Locations

Country	Name	City	State
United States	Center for Hearing and Balance	Chesterfield	Missouri
United States	Rocky Mountain Ear Center	Englewood	Colorado
United States	Houston Ear Research Foundation	Houston	Texas
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Cochlear

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Endpoint 1: Evaluation of Signal to Noise Ratio - Noise Reduction	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.	Visit 2, 1 month after baseline testing
Primary	Endpoint 2: Evaluation of SCAN	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.	Visit 2, 1 month after baseline testing