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OpenTrials
Completed

NCT Number: NCT02727842

Usability of the CP950 Sound Processor

Studying usability and gaining feedback of the CP950 Sound Processor in experienced 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

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rocky Mountain Ear Center, Englewood, Colorado, United States

Loading trial locations.

About this study

One month protocol, with 2 study visits. The aim of the study to is to gain patient and audiologist feedback on their experience and usability with the device and wireless programming pod.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • At least 6 months experience with a Nucleus 24 series or later implant in at least one implanted ear
  • Subjects age 12 and older who are cognitively and developmentally able to complete all study related questionnaires as deemed by the principal investigator or delegated staff
  • At least 3 months experience with the CP810,CP920 or CP910 sound processor
  • Ability to use 2 zinc air batteries with their current program (MAP)
  • Willingness to participate in and to comply with all requirements of the protocol for the duration of the trial

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
  • Implant types not currently supported by the CP950 sound processor (i.e.,N22)

Treatment and study plan

CP950 Sound Processor

Device

An off-the-ear processor configuration with identical functionality to the commercially approved CP910/920 processor

Wireless programming pod

Device

The CP950 Sound Processor will be programmed by the wireless programming pod, which is needed as the interface to commercially approved programming software

Primary outcomes

  1. Patient Satisfaction Through Usability of the CP950 Sound Processor as Measured by the CP950 Take Home Questionnaire

    Time frame: 1 month

    To evaluate usability of the CP950 sound processor using the CP950 Take Home Questionnaire for existing cochlear implant users.

    Specifically:

    • Patient Reported Hearing Performance
    • Retention & Comfort
    • Ease of use
    • Use of remote controls
    • Look & feel
    • Reliability
    • Maintenance & use

Sponsors and collaborators

Lead sponsor

Cochlear

Industry

Registry information

Official study title

Usability of the CP950 Sound Processor With Experienced Cochlear Implant Users

Acronym: C950

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Apr 5, 2016
Registry last updated
Sep 12, 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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