Evaluation of Nucleus 6 Sound Coding Algorithms

The purpose of the study was to evaluate the features of the Nucleus 6 Sound Processor (CP900 series) on existing Nucleus recipients who currently use the previous generation sound processor, the Cochlear Nucleus CP810 (also commonly known as the Nucleus 5), with a Cochlear Nucleus CI24RE, CI512 or CI422 cochlear implant. The features evaluated included an enhanced Automatic Gain Control (eAGC), the option to provide acoustic amplification in combination with traditional electric stimulation through an acoustic component, and three input processing algorithms: Signal to Noise Ratio - Noise Canceller (SNR-NC), Wind Noise Reduction (WNR) and Automatic Scene Analyzer (SCAN).

As is customary for a single-subject research design, study results will be analyzed for each subject individually. For evaluations where testing took place under two conditions (i.e. Endpoint 2, 3, 4, and 5) a non-inferiority hypothesis test based on the paired comparisons of the % of words correct will be performed. For each subject, the paired difference (P1 minus P2) will be calculated and the mean difference will be tested statistically against a non-inferiority null hypothesis of 10%. Successful rejection of the null hypothesis allows for a conclusion that the performance under the test condition 2 (based on the Nucleus 6 sound processor) will be non-inferior to the test condition 1 (based on the Nucleus 5 sound processor).

Ho: P1 - P2 ≥ 10% Ha: P1 - P2 < 10%

We hypothesize acceptance of the null hypothesis for the Nucleus 6 features.

Testing will be based on a paired t-test with a one-sided 0.05 alpha level. The value of 10% was selected as the non-inferiority margin as one that can be tested with reasonable power and was clinically meaningful.

Study Overview

• Status: Completed
• Conditions: Hearing Loss
• Intervention / Treatment: Device: Nucleus 6 sound processor

• Study Type: Interventional
• Enrollment (Actual): 97
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Eight years of age or older
2. CI24RE, CI500 or CI422 series Nucleus cochlear implant types (commercially approved)
3. At least 3 months experience with the cochlear implant
4. Post-linguistic onset of bilateral sensorineural hearing loss, with no congenital component to the hearing loss
5. Native speaker of English, the language used to assess speech perception performance
6. Willingness to participate in and to comply with all requirements of the protocol

Exclusion Criteria:

1. Unrealistic expectations on the part of the subject, regarding the possible benefits, risks, and limitations that are inherent to the prosthetic device 2. Unwillingness or inability of the candidate to comply with all investigational requirements 3. Additional handicaps that would prevent or restrict participation in the audiological evaluations

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nucleus 6	Device: Nucleus 6 sound processor

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Words Correct on AzBio Sentences in Noise S0N90	Individuals were tested with AzBio Sentences in Noise using a speech front (0 degrees) and noise presented to the implant ear (90 degrees) using the following features: enhanced Automatic Gain Control (eAGC), Signal to Noise Ratio - Noise Canceller (SNR-NC), Wind Noise Reduction (WNR) and Automatic Scene Analyzer (SCAN).	Each assessment was completed acutely which equated to approximately 2 hours of testing

Collaborators and Investigators

• Sponsor: Cochlear

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (Actual): May 1, 2013
• Study Completion (Actual): May 1, 2013

Study Registration Dates

• First Submitted: May 13, 2013
• First Submitted That Met QC Criteria: May 15, 2013
• First Posted (Estimate): May 16, 2013

Study Record Updates

• Last Update Posted (Actual): November 23, 2020
• Last Update Submitted That Met QC Criteria: November 4, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: background noise; speech performance; wind noise
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Hearing Loss
• Other Study ID Numbers: CT004

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No