Clinical Evaluation of the SpatialNR Noise Reduction Algorithm
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Cochlear
- Enrollment
- 48
- Locations
- 4
- Primary Endpoint
- CNC words
Study Overview
Brief Summary
Acute in-booth assessment of a new noise reduction algorithm with cochlear implant recipients.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 6 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Conventional CI subject aged twelve years of age or older, or Hybrid subject aged 18 years or older
- •Recipient of a CI500 Series (CI512 or CI522) or CI24RE Series (CI24REH or CI422) cochlear implant
- •At least three months CI experience in ear to be assessed
- •At least three months experience with the CP810,CP920 or CP910 sound processor
- •Fluent speaker in the local language used to assess clinical performance
- •Open-set speech perception ability
- •Use of or eligibility for hybrid acoustic component (hybrid population only)
Exclusion Criteria
- •Unrealistic expectations on the part of the subject, regarding the possible benefits, risks, and limitations that are inherent to the investigational device
- •Unwillingness or inability of the candidate to comply with all investigational requirements
- •Additional handicaps that would prevent or restrict participation in the audiological evaluations or that would affect the scientific integrity of the study.
Arms & Interventions
Conventional CI
The conventional CI group will receive the noise reduction on and off signal processing test programs. This is a within subject repeated measures design, so all subjects will receive the same testing but in a counterbalanced order.
Intervention: CP910/CP920 with noise reduction on (Device)
Conventional CI
The conventional CI group will receive the noise reduction on and off signal processing test programs. This is a within subject repeated measures design, so all subjects will receive the same testing but in a counterbalanced order.
Intervention: CP910/CP920 (Device)
Hybrid CI
The Hybrid CI group will receive the noise reduction on and off signal processing test programs. This is a within subject repeated measures design, so all subjects will receive the same testing but in a counterbalanced order.
Intervention: CP910/CP920 with noise reduction on (Device)
Hybrid CI
The Hybrid CI group will receive the noise reduction on and off signal processing test programs. This is a within subject repeated measures design, so all subjects will receive the same testing but in a counterbalanced order.
Intervention: CP910/CP920 (Device)
Outcomes
Primary Outcomes
CNC words
Time Frame: 3 months
CNC words in quiet will be used to assess whether the investigational noise reduction algorithm performs no worse than the approved Nucleus 6 defaults.
SRT sentences
Time Frame: 3 months
SRT sentences in noise will be used to assess whether the investigational noise reduction algorithm performs no worse than the approved Nucleus 6 defaults.
Secondary Outcomes
No secondary outcomes reported