Trial Outcomes & Findings for Evaluation of Nucleus 6 Sound Coding Algorithms (NCT NCT01854879)

Results Overview

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).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

97 participants

Primary outcome timeframe

Each assessment was completed acutely which equated to approximately 2 hours of testing

Results posted on

2020-11-23

Participant Flow

Participant milestones

Participant milestones
Measure	Nucleus 6 Nucleus 6 sound processor
Overall Study STARTED	97
Overall Study COMPLETED	92
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Nucleus 6 Nucleus 6 sound processor
Overall Study Could not complete testing within the scheduled time.	1
Overall Study screen fail	3
Overall Study incomplete data set	1

Baseline Characteristics

Evaluation of Nucleus 6 Sound Coding Algorithms

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Nucleus 6 n=92 Participants Nucleus 6 sound processor
Age, Continuous	52.4 years STANDARD_DEVIATION 21.5 • n=5 Participants
Sex: Female, Male Female	43 Participants n=5 Participants
Sex: Female, Male Male	49 Participants n=5 Participants

PRIMARY outcome

Timeframe: Each assessment was completed acutely which equated to approximately 2 hours of testing

Population: subjects enrolled who met candidacy criteria that had paired results for endpoint testing

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).

Outcome measures

Outcome measures
Measure	Nucleus 6 n=92 Participants Nucleus 6 sound processor
Percentage of Words Correct on AzBio Sentences in Noise S0N90	72.1 percentage of words correct Standard Deviation 13.6

Adverse Events

Nucleus 6

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Lori O'Neill Director of Research

Cochlear Americas

Phone: (303) 790-9010

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place