CLEAR Clinical Study

Not Applicable

Completed

• Conditions: Hearing Loss

• Registration Number: NCT03126825
• Lead Sponsor: Cochlear

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-04-20
• Study First Submitted QC: 2017-04-21
• Study First Posted: 2017-04-24
• Study Start: 2017-05-01
• Primary Completion: 2017-08-13
• Study Completion: 2017-09-01
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-16
• Last Update Posted: 2018-01-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
CNC words	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	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.

Trial Locations

Locations (2)

Cochlear Limited Sydney; 🇦🇺 Sydney, New South Wales, Australia

Cochlear Limited Melbourne; 🇦🇺 Melbourne, Victoria, Australia