Skip to main content
OpenTrials
Completed

NCT Number: NCT02239263

N6 Input Processing in Traditional CI Recipients

The purpose of this study is to evaluate the enhanced signal processing features of the Nucleus 6 Sound Processor on existing Nucleus cochlear implant recipients currently using the Nucleus 5 Sound Processor.

Completed

Looking for future studies?

Notify Me

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Greater than 12 years
  • Unilateral cochlear implant recipient (CI24RE, CI500, CI422)
  • Minimum of 3 months experience with the N5 sound processor
  • Prior documentation of sentence recognition testing in noise at a difficulty of +10 dB SNR or better
  • Native English speaker
  • Willingness to participate in and comply with all requirements of the protocol

Exclusion criteria

  • Unrealistic expectations
  • Unwillingness to comply with investigational requirements of the protocol
  • Additional handicaps that would prevent or restrict participation in the evaluations

Treatment and study plan

Nucleus 6 sound processor

Device

Primary outcomes

  1. Endpoint 1: Evaluation of Signal to Noise Ratio - Noise Reduction

    Time frame: Visit 2, 1 month after baseline testing

    Speech understanding in noise using AzBio sentences with and without the SNR - noise reduction algorithm enabled. Speech understanding at a fixed +10 dB signal to noise level in each condition (on/off) is scored as percent correct and then subtracted to demonstrate the percent difference (benefit) in performance of having the algorithm on vs off.

  2. Endpoint 2: Evaluation of SCAN

    Time frame: Visit 2, 1 month after baseline testing

    Speech understanding in noise using AzBio sentences with and without SCAN algorithm enabled. Speech understanding at a fixed +10 dB signal to noise level in each condition (on/off) is scored as percent correct and then subtracted to demonstrate the percent difference (benefit) in performance of having the algorithm on vs off.

Sponsors and collaborators

Lead sponsor

Cochlear

Industry

Registry information

Official study title

Investigation of Nucleus 6 Sound Processor Input Processing in Cochlear Implant Recipients.

Important dates

Study start
2014
Primary completion
2014
Study completion
2015
First posted
Sep 12, 2014
Registry last updated
Feb 26, 2021

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.