N6 Input Processing in Traditional CI Recipients

NCT02239263 | Completed Results

• 1 other identifier: CAM5555
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 4

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.

Conditions

Hearing Loss

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (1)

N6 Input Processing Features

EXPERIMENTAL

Device: Nucleus 6 Sound Processor

Interventions

Nucleus 6 Sound Processor DEVICE

N6 Input Processing Features

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Cochlear: lead

Study Sites (4)

Rocky Mountain Ear Center

Englewood, Colorado, 80113, United States

Location

Center for Hearing and Balance

Chesterfield, Missouri, 63017, United States

Location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Houston Ear Research Foundation

Houston, Texas, 77074, United States

Location

MeSH Terms

Conditions

Hearing Loss

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Lori O'Neill Director of Research
• Organization: cochlear

loneill@cochlear.com

8005235798

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2014
• First Posted: September 12, 2014
• Study Start: May 1, 2014
• Primary Completion: November 1, 2014
• Study Completion: January 1, 2015
• Last Updated: February 26, 2021
• Results First Posted: February 26, 2021

Record last verified: 2021-02

Locations

US (4)