Recipients With Limited Bimodal Benefit: HA or CROS

November 4, 2019 updated by: Ottawa Hospital Research Institute
The rationale is to determine (in individuals with limited perceived bimodal benefit) whether the CROS device may be a better solution for obtaining two-sided input. If yes, this study would be practice-changing.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

It is well accepted that bilateral input can significantly improve speech understanding in noise for patients with cochlear implants. For cochlear implant (CI) recipients who have a CI on only one side, two sided input can be provided with simultaneous use of a hearing aid (HA) or a CROS device on the opposite side. The decision about which device to use depends on the level of residual hearing a recipient has in non CI-implanted ear, and more specifically what level of useable residual hearing s/he has. Access to useable low frequency hearing can not only improve speech understanding in noise, it can also improve sound quality, pitch perception and music perception.

Clinicians can reasonably predict that a recipient with hearing thresholds better than 60 dB HL at low frequencies (below 750 Hz) would benefit from amplification. For recipients with no measurable acoustic hearing in the contralateral ear, CROS would be a reasonable option, especially if bilateral implantation is not feasible or desired. However, it is more difficult to predict the appropriate device in individuals who have some measurable acoustic hearing but may be receiving limited benefit from it. This can be especially challenging because audiometric thresholds are not a reliable predictor of bimodal benefit. Additionally, acoustic hearing can provide subjective benefits which could hold different intrinsic value or significance for different individuals depending on their life style and listening needs.

Study Type

Interventional

Enrollment (Anticipated)

15

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 Contact

  • Name: Debora L Hogan, M.Sc.N.
  • Phone Number: 72968 6137378899
  • Email: dhogan@ohri.ca

Study Contact Backup

  • Name: David Schramm, MD
  • Phone Number: 72968 6137378899
  • Email: dschramm@toh.ca

Study Locations

  • Canada
    • ON - Ontario
      • Ottawa, ON - Ontario, Canada, K1H 8L6

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:

  • Adults (> 18 years of age)
  • Unilaterally implanted with an Advanced Bionics implant (CII or later)
  • At least six months of CI use
  • Limited bimodal benefit as perceived by the recipient and/or the clinician
  • Participants may or may not currently be using a hearing aid in the unimplanted ear.
  • Open set performance with current device configuration:
  • ≥40% AzBio sentence score in quiet (S0) and? (i.e. do both these apply)

If currently bimodal:

  • Hearing aid ear only CNC score <50%
  • AzBio Scores bimodal benefit <15% increase in score compared to CI only?
  • Unaided audiometric threshold of ≤100 dBHL up to 500 Hz
  • Ability and willingness to participate in multiple sets of open speech testing (and ongoing evaluation of HA and CROS benefit)

Exclusion Criteria:

  • Patients who are not proficient in English as the AzBio testing is available in English only.
  • Patients with agenesis of the contralateral ear

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: Other
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Naida Hearing Aid

Adults (> 18 years of age)

  • Unilaterally implanted with an Advanced Bionics implant (CII or later)
  • At least six months of CI use experience
  • Limited bimodal benefit as perceived by the recipient and/or the clinician
  • Participants may or may not currently be using a hearing aid in the unimplanted ear.

  • Open set performance with current device configuration:

    • ≥40% AzBio sentence score in quiet (S0)
    • If currently bimodal:
  • Hearing aid ear only CNC score <50%
  • AzBio Scores bimodal benefit <15%
  • Unaided audiometric threshold of ≤100 dBHL up to 500 Hz
  • Ability and willingness to participate in multiple sets of open speech testing (and chronically evaluate HA and CROS benefit)
Device: Naida Hearing Aid
hearing aid
Other Names:
  • HA
Device: Naida Contralateral Routing of Sound Device
This is a device that routes sound to the non-cochlear implanted ear.
Other Names:
  • CROS
Other: Naida CROS Device
The same cohort will cross over to each arm.
Device: Naida Hearing Aid
hearing aid
Other Names:
  • HA
Device: Naida Contralateral Routing of Sound Device
This is a device that routes sound to the non-cochlear implanted ear.
Other Names:
  • CROS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perception of speech by way of audiogram and AzBio word testing.
Time Frame: At Baseline, Week 6 and Week 12
Change in perception of speech by way of audiogram (hearing threshold across dB and frequencies) and AzBio word testing (% accuracy).
At Baseline, Week 6 and Week 12
7 point Likert study-specific scales illuminating subjective feedback of experience using HA or CROS
Time Frame: At Baseline, Week 6 and Week 12
Change in 7 point Likert study-specific scales illuminating subjective feedback of experience using HA or CROS. 1 (very dissatisfied) to 7 (very satisfied)
At Baseline, Week 6 and Week 12
Participant narrative illuminating subjective feedback of experience using HA or CROS
Time Frame: At Baseline, Week 6 and Week 12
Evolution of narrative interview themes illuminating subjective feedback of experience using HA or CROS
At Baseline, Week 6 and Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Demographics
Time Frame: At Baseline
Age, Gender, Hearing History
At Baseline

Collaborators and Investigators

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

Sponsor

Ottawa Hospital Research Institute

Collaborators

Advanced Bionics

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 (Anticipated)

December 1, 2019

Primary Completion (Anticipated)

December 1, 2020

Study Completion (Anticipated)

March 20, 2021

Study Registration Dates

First Submitted

October 18, 2018

First Submitted That Met QC Criteria

November 4, 2019

First Posted (Actual)

November 7, 2019

Study Record Updates

Last Update Posted (Actual)

November 7, 2019

Last Update Submitted That Met QC Criteria

November 4, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRRF 842

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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