Optimisation of Hybrid Fittings for Cochlear Implant Recipients

July 2, 2021 updated by: The Hearing Cooperative Research Centre

Optimisation of Hybrid Fittings for Newly Implanted Cochlear Implant Recipients

When providing amplification post-implantation to residual acoustic hearing in the implanted ear, the lower frequency boundary can be modified to minimize or avoid overlap between the frequencies coded through acoustic hearing and those presented through electrical stimulation. This boundary is termed the cross-over frequency (Fc) and the effect of modifying this parameter will be investigated in this study. To avoid the research being confounded by prior bias for a particular frequency allocation, the study will be conducted with newly implanted recipients.

This study will also investigate whether tests which measure the ability to use low frequency hearing and objective measures can predict the preferred Fc and speech performance benefit.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

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

  • Australia
    • Victoria
      • Melbourne, Victoria, Australia, 3002
        • The HEARing CRC

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Adult (≥18 years of age)
  2. Post-operative residual hearing in the implanted ear (defined as having an unaided threshold better than or equal to 80 dB HL at the 500 Hz frequency).
  3. Implanted with the CI500 or CI24RE-series cochlear implants
  4. User of the commercially available Nucleus 6 sound processor
  5. User of the ACE strategy
  6. Native speaker in the language used to assess speech perception performance
  7. Willingness to participate in and to comply with all requirements of the protocol

Exclusion Criteria:

  1. Additional handicaps that would prevent participation in evaluations
  2. Unrealistic expectations on the part of the subject, regarding the possible benefits, risks and limitations that are inherent to the procedure and investigational device

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cochlear Implant Recipients
Newly implanted cochlear implant recipients with post-implantation acoustic hearing.
Device: Hybrid fittings for cochlear implant recipients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Speech, Spatial and Qualities of Hearing (SSQ) scale
Time Frame: Testing at 18, 19, 22 and 25 weeks post-activation of cochlear implant
Preference rating assessed using SSQ scale
Testing at 18, 19, 22 and 25 weeks post-activation of cochlear implant
Word recognition scores in quiet
Time Frame: Testing at 12, 15, 18, 19, 22 and 25 weeks post-activation of cochlear implant
Open-set monosyllabic word scores in quiet
Testing at 12, 15, 18, 19, 22 and 25 weeks post-activation of cochlear implant
Speech recognition in noise
Time Frame: Testing at 12, 15, 18, 19, 22 and 25 weeks post-activation of cochlear implant
Open-set speech recognition in noise
Testing at 12, 15, 18, 19, 22 and 25 weeks post-activation of cochlear implant

Collaborators and Investigators

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

Sponsor

The Hearing Cooperative Research Centre

Collaborators

Royal Victoria Eye and Ear Hospital
Cochlear
University of Melbourne

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)

October 7, 2015

Primary Completion (Actual)

September 19, 2018

Study Completion (Actual)

May 8, 2020

Study Registration Dates

First Submitted

April 14, 2016

First Submitted That Met QC Criteria

May 4, 2016

First Posted (Estimate)

May 6, 2016

Study Record Updates

Last Update Posted (Actual)

July 6, 2021

Last Update Submitted That Met QC Criteria

July 2, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRC5610

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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.

Clinical Trials on Hearing Loss

Clinical Trials on Hybrid fittings for cochlear implant recipients

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Nigeria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe