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Recipients With Limited Bimodal Benefit: HA or CROS

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ClinicalTrials.gov Identifier: NCT04155138
Recruitment Status : Not yet recruiting
First Posted : November 7, 2019
Last Update Posted : November 7, 2019
Sponsor:
Collaborator:
Advanced Bionics
Information provided by (Responsible Party):
Ottawa Hospital Research Institute

Tracking Information
First Submitted Date  ICMJE October 18, 2018
First Posted Date  ICMJE November 7, 2019
Last Update Posted Date November 7, 2019
Estimated Study Start Date  ICMJE December 1, 2019
Estimated Primary Completion Date December 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 4, 2019)
  • 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).
  • 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)
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: November 4, 2019)
Demographics [ Time Frame: At Baseline ]
Age, Gender, Hearing History
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Recipients With Limited Bimodal Benefit: HA or CROS
Official Title  ICMJE Recipients With Limited Bimodal Benefit: HA or CROS
Brief Summary 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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:
Naida Hearing Aid Naida CROS Device
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE
  • Cochlear Implant
  • Hearing Disability
  • Hearing Disorders and Deafness
Intervention  ICMJE
  • Device: Naida Hearing Aid
    hearing aid
    Other Name: HA
  • Device: Naida Contralateral Routing of Sound Device
    This is a device that routes sound to the non-cochlear implanted ear.
    Other Name: CROS
Study Arms  ICMJE
  • 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)
    Interventions:
    • Device: Naida Hearing Aid
    • Device: Naida Contralateral Routing of Sound Device
  • Naida CROS Device
    The same cohort will cross over to each arm.
    Interventions:
    • Device: Naida Hearing Aid
    • Device: Naida Contralateral Routing of Sound Device
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: November 4, 2019)
15
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 20, 2021
Estimated Primary Completion Date December 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Debora L Hogan, M.Sc.N. 6137378899 ext 72968 dhogan@ohri.ca
Contact: David Schramm, MD 6137378899 ext 72968 dschramm@toh.ca
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04155138
Other Study ID Numbers  ICMJE CRRF 842
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Ottawa Hospital Research Institute
Study Sponsor  ICMJE Ottawa Hospital Research Institute
Collaborators  ICMJE Advanced Bionics
Investigators  ICMJE Not Provided
PRS Account Ottawa Hospital Research Institute
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP