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OpenTrials
Completed

NCT Number: NCT03467399

Clinical Evaluation of a Cochlear Implant System

The primary objective of this study is to assess the usability of a Cochlear implant system.

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Key information

Conditions

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

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cochlear Ltd

Sydney, New South Wales, 2109, Australia

About this study

Measure participant ratings on satisfaction of a Cochlear implant system via use of validated and non-validated questionnaires.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Eighteen years of age or older
  • At least 6 months experience with a Nucleus 24 series or later implant in at least one implanted ear
  • At least 3 months experience with the CP810,CP920 or CP910 sound processor
  • Fluent speaker in the language used to assess speech perception performance
  • Willingness to participate in and to comply with all requirements of the protocol
  • Able to score 30% or more at +15 SNR with CI alone on a sentence in babble test

Exclusion criteria

  • Unrealistic expectations on the part of the subject, regarding the possible benefits, risks and limitations that are inherent to the procedure and prosthetic device
  • Additional disabilities that would prevent participation in evaluations
  • Nucleus 22 Implant

Treatment and study plan

Nucleus 7 Cochlear Implant System

Device

A new cochlear implant sound processor system.

Primary outcomes

  1. Cochlear implant subjects' ratings on hearing performance, connectivity, streaming, phone use, comfort, retention, ease of use and controls obtained with their own Sound Processor and the CP1000 Sound Processor.

    Time frame: One year

    Non-inferiority of subjects' overall satisfaction ratings for the CP1000 Sound Processor and related components measured following 3 months of use, compared to subjects' overall satisfaction rating for their own Sound Processor and related components measured at study onset.

Secondary outcomes

  1. Speech perception performance of the CP1000 Sound Processor in quiet and in noise.

    Time frame: One year

    Data to substantiate the speech perception scores of the subjects for different quiet and noise conditions for different configurations of sound processor and / or accessories.

Sponsors and collaborators

Lead sponsor

Cochlear

Industry

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Mar 16, 2018
Registry last updated
Mar 16, 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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