Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
48 participants
INTERVENTIONAL
2017-05-01
2017-09-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
CP910/CP920 with noise reduction on
This intervention uses the approved Nucleus 6 system (CP910/CP920 and accessories) but adds the investigational noise reduction algorithm.
CP910/CP920
The approved CP910 or CP920 Sound Processor.
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.
CP910/CP920 with noise reduction on
This intervention uses the approved Nucleus 6 system (CP910/CP920 and accessories) but adds the investigational noise reduction algorithm.
CP910/CP920
The approved CP910 or CP920 Sound Processor.
Interventions
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CP910/CP920 with noise reduction on
This intervention uses the approved Nucleus 6 system (CP910/CP920 and accessories) but adds the investigational noise reduction algorithm.
CP910/CP920
The approved CP910 or CP920 Sound Processor.
Eligibility Criteria
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Inclusion Criteria
2. Recipient of a CI500 Series (CI512 or CI522) or CI24RE Series (CI24REH or CI422) cochlear implant
3. At least three months CI experience in ear to be assessed
4. At least three months experience with the CP810,CP920 or CP910 sound processor
5. Fluent speaker in the local language used to assess clinical performance
6. Open-set speech perception ability
7. Use of or eligibility for hybrid acoustic component (hybrid population only)
Exclusion Criteria
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 or that would affect the scientific integrity of the study.
6 Years
ALL
No
Sponsors
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Cochlear
INDUSTRY
Responsible Party
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Principal Investigators
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Mary Beth Brinson, Phd
Role: STUDY_DIRECTOR
Head of Global Clinical Affairs
Locations
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Cochlear Limited Sydney
Sydney, New South Wales, Australia
Cochlear Limited Melbourne
Melbourne, Victoria, Australia
Countries
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Other Identifiers
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CLTD5606
Identifier Type: -
Identifier Source: org_study_id
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