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OpenTrials
Completed

NCT Number: NCT03126825

CLEAR Clinical Study

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

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Key information

Conditions

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

Age range

6 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cochlear Limited Sydney, Sydney, New South Wales, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

CP910/CP920

Device

The approved CP910 or CP920 Sound Processor.

Primary outcomes

  1. CNC words

    Time frame: 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.

  2. SRT sentences

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Cochlear

Industry

Registry information

Official study title

Clinical Evaluation of the SpatialNR Noise Reduction Algorithm

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Apr 24, 2017
Registry last updated
Jan 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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