CLEAR Clinical Study

Hearing Loss Clinical Trial

Official title:

Clinical Evaluation of the SpatialNR Noise Reduction Algorithm

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03126825
• Other study ID #: CLTD5606
• Status: Completed
• Phase: N/A
• First received: April 20, 2017
• Last updated: January 16, 2018
• Start date: May 1, 2017
• Est. completion date: September 1, 2017

Study information

• Verified date: January 2018
• Source: Cochlear
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: September 1, 2017
• Est. primary completion date: August 13, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hearing Loss

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Australia	Cochlear Limited Melbourne	Melbourne	Victoria
Australia	Cochlear Limited Sydney	Sydney	New South Wales

Sponsors (1)

Lead Sponsor	Collaborator
Cochlear

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 months
Primary	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.	3 months