Trial Outcomes & Findings for N6 Input Processing in Traditional CI Recipients (NCT NCT02239263)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

40 participants

Primary outcome timeframe

Visit 2, 1 month after baseline testing

Results posted on

2021-02-26

Participant Flow

As of the date of database closure, 34 of the 40 enrolled subjects completed Visit Two (endpoint testing).

Participant milestones

Participant milestones
Measure	N6 Input Processing Features - SNR-NR & SCAN Testing of the Nucleus 6 sound processing Signal to Noise Ratio - Noise Reduction (endpoint 1) and SCAN (endpoint 2)
Overall Study STARTED	40
Overall Study COMPLETED	34
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Reasons for withdrawal
Measure	N6 Input Processing Features - SNR-NR & SCAN Testing of the Nucleus 6 sound processing Signal to Noise Ratio - Noise Reduction (endpoint 1) and SCAN (endpoint 2)
Overall Study Protocol Violation	6

Baseline Characteristics

N6 Input Processing in Traditional CI Recipients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	N6 Input Processing Features - SNR-NR & SCAN n=40 Participants Testing of the Nucleus 6 sound processing Signal to Noise Ratio - Noise Reduction (endpoint 1) and SCAN (endpoint 2)
Age, Continuous	47 years STANDARD_DEVIATION 21.6 • n=93 Participants
Sex: Female, Male Female	24 Participants n=93 Participants
Sex: Female, Male Male	16 Participants n=93 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	N6 Input Processing Features - SNR n=34 Participants Endpoint 1: Assessment of Nucleus 6 sound processing feature SNR-NR
Endpoint 1: Evaluation of Signal to Noise Ratio - Noise Reduction	-5.9 difference in percent correct scores Interval -9.6 to -2.2

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	N6 Input Processing Features - SNR n=34 Participants Endpoint 1: Assessment of Nucleus 6 sound processing feature SNR-NR
Endpoint 2: Evaluation of SCAN	-26.9 difference in percent correct scores Interval -33.0 to -20.9

Adverse Events

N6 Input Processing Features - SNR-NR

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

N6 Input Processing Features - SCAN

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

Phone: 8005235798

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place