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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

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.

Condition or disease Intervention/treatment Phase
Cochlear Implant Hearing Disability Hearing Disorders and Deafness Device: Naida Hearing Aid Device: Naida Contralateral Routing of Sound Device Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Naida Hearing Aid Naida CROS Device
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Recipients With Limited Bimodal Benefit: HA or CROS
Estimated Study Start Date : December 1, 2019
Estimated Primary Completion Date : December 1, 2020
Estimated Study Completion Date : March 20, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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 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

Naida CROS Device
The same cohort will cross over to each arm.
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




Primary Outcome Measures :
  1. 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).

  2. 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)

  3. 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


Secondary Outcome Measures :
  1. Demographics [ Time Frame: At Baseline ]
    Age, Gender, Hearing History



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04155138


Contacts
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Contact: Debora L Hogan, M.Sc.N. 6137378899 ext 72968 dhogan@ohri.ca
Contact: David Schramm, MD 6137378899 ext 72968 dschramm@toh.ca

Locations
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Canada, ON - Ontario
The Ottawa Hospital Not yet recruiting
Ottawa, ON - Ontario, Canada, K1H 8L6
Contact: Debora L Hogan, MScN    6137378899 ext 72968    sisterssejour@hotmail.com   
Contact: David Schramm, MD    6137378899 ext 72968    dschramm@toh.ca   
Sponsors and Collaborators
Ottawa Hospital Research Institute
Advanced Bionics

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Responsible Party: Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT04155138     History of Changes
Other Study ID Numbers: CRRF 842
First Posted: November 7, 2019    Key Record Dates
Last Update Posted: November 7, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ottawa Hospital Research Institute:
cochlear implant
hearing aid
cros device
bimodal
Additional relevant MeSH terms:
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Deafness
Hearing Disorders
Hearing Loss
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms