Hearing Loss
Conditions
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.
Interventions
Sponsors
Cochlear
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Endpoint 1: Evaluation of Signal to Noise Ratio - Noise Reduction | 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. |
| Endpoint 2: Evaluation of SCAN | 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. |
Countries
United States
Participant flow
Pre-assignment details
As of the date of database closure, 34 of the 40 enrolled subjects completed Visit Two (endpoint testing).
Participants by arm
| Arm | Count |
|---|---|
| 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) | 40 |
| Total | 40 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Protocol Violation | 6 |
Baseline characteristics
| Characteristic | N6 Input Processing Features - SNR-NR & SCAN |
|---|---|
| Age, Continuous | 47 years STANDARD_DEVIATION 21.6 |
| Sex: Female, Male Female | 24 Participants |
| Sex: Female, Male Male | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 40 | 0 / 40 |
| serious Total, serious adverse events | 0 / 40 | 0 / 40 |
Outcome results
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.
Time frame: Visit 2, 1 month after baseline testing
| Arm | Measure | Value (MEAN) |
|---|---|---|
| N6 Input Processing Features - SNR | Endpoint 1: Evaluation of Signal to Noise Ratio - Noise Reduction | -5.9 difference in percent correct scores |
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.
Time frame: Visit 2, 1 month after baseline testing
| Arm | Measure | Value (MEAN) |
|---|---|---|
| N6 Input Processing Features - SNR | Endpoint 2: Evaluation of SCAN | -26.9 difference in percent correct scores |