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CLEAR Clinical Study

Primary Purpose

Hearing Loss

Status
Completed
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
CP910/CP920 with noise reduction on
CP910/CP920
Sponsored by
Cochlear
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hearing Loss

Eligibility Criteria

6 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Conventional CI subject aged twelve years of age or older, or Hybrid subject aged 18 years or older
  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:

  1. Unrealistic expectations on the part of the subject, regarding the possible benefits, risks, and limitations that are inherent to the investigational device
  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.

Sites / Locations

  • Cochlear Limited Sydney
  • Cochlear Limited Melbourne

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Conventional CI

Hybrid CI

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

CNC words
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
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 Outcome Measures

Full Information

First Posted
April 20, 2017
Last Updated
January 16, 2018
Sponsor
Cochlear
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1. Study Identification

Unique Protocol Identification Number
NCT03126825
Brief Title
CLEAR Clinical Study
Official Title
Clinical Evaluation of the SpatialNR Noise Reduction Algorithm
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
May 1, 2017 (Actual)
Primary Completion Date
August 13, 2017 (Actual)
Study Completion Date
September 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cochlear

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Acute in-booth assessment of a new noise reduction algorithm with cochlear implant recipients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Conventional CI
Arm Type
Other
Arm Description
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.
Arm Title
Hybrid CI
Arm Type
Other
Arm Description
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 Type
Device
Intervention Name(s)
CP910/CP920 with noise reduction on
Intervention Description
This intervention uses the approved Nucleus 6 system (CP910/CP920 and accessories) but adds the investigational noise reduction algorithm.
Intervention Type
Device
Intervention Name(s)
CP910/CP920
Intervention Description
The approved CP910 or CP920 Sound Processor.
Primary Outcome Measure Information:
Title
CNC words
Description
CNC words in quiet will be used to assess whether the investigational noise reduction algorithm performs no worse than the approved Nucleus 6 defaults.
Time Frame
3 months
Title
SRT sentences
Description
SRT sentences in noise will be used to assess whether the investigational noise reduction algorithm performs no worse than the approved Nucleus 6 defaults.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary Beth Brinson, Phd
Organizational Affiliation
Head of Global Clinical Affairs
Official's Role
Study Director
Facility Information:
Facility Name
Cochlear Limited Sydney
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2109
Country
Australia
Facility Name
Cochlear Limited Melbourne
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3002
Country
Australia

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Currently no plan to make IPD available to other researchers.

Learn more about this trial

CLEAR Clinical Study

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