CLEAR Clinical Study

NCT03126825 | Completed

• 1 other identifier: CLTD5606
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Hearing Loss

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

Conventional CI

OTHER

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.

Device: CP910/CP920 with noise reduction on; Device: CP910/CP920

Hybrid CI

OTHER

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.

Device: CP910/CP920 with noise reduction on; Device: CP910/CP920

Interventions

CP910/CP920 with noise reduction on DEVICE

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

Conventional CI; Hybrid CI

CP910/CP920 DEVICE

The approved CP910 or CP920 Sound Processor.

Conventional CI; Hybrid CI

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cochlear: lead

Study Sites (2)

Cochlear Limited Sydney

Sydney, New South Wales, 2109, Australia

Location

Cochlear Limited Melbourne

Melbourne, Victoria, 3002, Australia

Location

MeSH Terms

Conditions

Hearing Loss

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Mary Beth Brinson, Phd

  Head of Global Clinical Affairs

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2017
• First Posted: April 24, 2017
• Study Start: May 1, 2017
• Primary Completion: August 13, 2017
• Study Completion: September 1, 2017
• Last Updated: January 17, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

AU (2)