CLEAR Clinical Study

NCT ID: NCT03126825

Last Updated: 2018-01-17

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-01

Study Completion Date

2017-09-01

Brief Summary

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

Detailed Description

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Conditions

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Hearing Loss

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

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.

Group Type OTHER

CP910/CP920 with noise reduction on

Intervention Type DEVICE

This intervention uses the approved Nucleus 6 system (CP910/CP920 and accessories) but adds the investigational noise reduction algorithm.

CP910/CP920

Intervention Type DEVICE

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.

Group Type OTHER

CP910/CP920 with noise reduction on

Intervention Type DEVICE

This intervention uses the approved Nucleus 6 system (CP910/CP920 and accessories) but adds the investigational noise reduction algorithm.

CP910/CP920

Intervention Type DEVICE

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.

Intervention Type DEVICE

CP910/CP920

The approved CP910 or CP920 Sound Processor.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cochlear

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Cochlear Limited Melbourne

Melbourne, Victoria, Australia

Site Status

Countries

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Australia

Other Identifiers

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CLTD5606

Identifier Type: -

Identifier Source: org_study_id

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