Evaluation of Speech-in-noise Performance in Cochlear Implant Recipients With a CROS Device on the Contralateral Ear

April 14, 2022 updated by: University of Colorado, Denver

Evaluation of Speech-in-noise Performance in Cochlear Implant Recipients Using Either a Conventional Hearing Aid or a CROS Device on the Contralateral Ear

Speech understanding in noise remains the greatest challenge for people using cochlear implants, particularly when the speech of interest comes from the side of the head opposite to the implant. Recent findings in hearing technology allow for people to either use a hearing aid or a Contralateral Routing of Signal (CROS) device on the non-implanted ear. Differences in speech understanding may result depending on the device chosen by a person, and these differences may be measureable through speech discrimination measurement methods.

This study intends to determine whether or not a CROS device improves speech perception in noise when the source of the speech of interest originates from the side of the head opposite to the implant.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 89 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria*:

  • An Advanced Bionics cochlear implant recipient with at least 6 months of listening experience
  • Low frequency Pure Tone Audiometry (PTA)

Exclusion Criteria*:

  • Non-English speakers

    • Additional Inclusion and Exclusion criteria apply

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Cochlear Implant and Hearing Aid
Subject wears a hearing aid on the contralateral side of the cochlear implant. Subject will use a clinic-loaned Naida hearing aid for listening tests.
Device: Hearing Aid
Advanced Bionics Naida hearing aid
ACTIVE_COMPARATOR: Cochlear Implant alone
Subject only uses the cochlear implant; hearing on the contralateral side is unaided.
Other: Cochlear Implant Alone
No hearing device on contralateral ear
EXPERIMENTAL: Cochlear Implant and CROS
Subject wears the CROS device on the contralateral side of the cochlear implant. Subject will use a clinic-loaned CROS device.
Device: CROS
Advanced Bionics CROS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cochlear Implant: Signal to Noise Ratio (SNR) Threshold Obtained From IEEE (Speech Perception in Noise Test) Sentence in Noise Test.
Time Frame: 12 minutes

The IEEE test allows a researcher to evaluate how well a subject understands sentences in noisy situations. Primary Outcome #1 will assess how well the listener can hear with his/her cochlear implant. The listener will be tested without a contralateral device versus also wearing a contralateral device while listening to sentences coming from various directions along with competing noise coming from various directions. The directions of the sentences or noise are as follows:

  • Omni: from all directions
  • Ipsi: the same side
  • Front
  • Contra: Contralateral, from the opposite side of the implant Visits are flexible, based on participant preference and may be completed any time between enrollment and end of study. Testing takes about 12 minutes.
12 minutes
CI CROS: Signal to Noise Ratio (SNR) Threshold Obtained From IEEE (Speech Perception in Noise Test) Sentence in Noise Test.
Time Frame: 12 minutes

The IEEE test allows a researcher to evaluate how well a subject understands sentences in noisy situations. Primary Outcome #2 will assess how well the listener can hear wearing his/her cochlear implant and a CROS (Contralateral Routing of Signals device). A CROS is a device on the opposite ear that sends the nose to the cochlear implant. The listener will be tested without a contralateral device versus also wearing a contralateral device while listening to sentences coming from various directions along with competing noise coming from various directions. The directions of the sentences or noise are as follows:

  • Omni: from all directions
  • Ipsi: the same side
  • Front
  • Contra: Contralateral, from the opposite side of the implant Visits are flexible, based on participant preference and may be completed any time between enrollment and end of study. Testing takes about 12 minutes.
12 minutes
CI HA: Signal to Noise Ratio (SNR) Threshold Obtained From IEEE (Speech Perception in Noise Test) Sentence in Noise Test.
Time Frame: 12 minutes

The IEEE test allows a researcher to evaluate how well a subject understands sentences in noisy situations. Primary Outcome #3 will assess how well the listener can hear wearing his/her cochlear implant and hearing aid. The listener will be tested without a contralateral device versus also wearing a contralateral device while listening to sentences coming from various directions along with competing noise coming from various directions. The directions of the sentences or noise are as follows:

  • Omni: from all directions
  • Ipsi: the same side
  • Front
  • Contra: Contralateral, from the opposite side of the implant Visits are flexible, based on participant preference and may be completed any time between enrollment and end of study. Testing takes about 12 minutes.
12 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Colorado, Denver

Investigators

  • Principal Investigator: Melinda Anderson, PhD, University of Colorado, Denver

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 23, 2019

Primary Completion (ACTUAL)

February 11, 2021

Study Completion (ACTUAL)

February 11, 2021

Study Registration Dates

First Submitted

February 19, 2019

First Submitted That Met QC Criteria

March 5, 2019

First Posted (ACTUAL)

March 8, 2019

Study Record Updates

Last Update Posted (ACTUAL)

May 16, 2022

Last Update Submitted That Met QC Criteria

April 14, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18-1101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified data will be shared with Advanced Bionics.

IPD Sharing Time Frame

From first patient through Institutional Review Board (IRB) study close.

IPD Sharing Access Criteria

The de-identified data will be shared to with Advanced Bionics in a password protected Excel sheet downloaded from research database.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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