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Recipients With Limited Bimodal Benefit: HA or CROS

Primary Purpose

Cochlear Implant, Hearing Disability, Hearing Disorders and Deafness

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Naida Hearing Aid
Naida Contralateral Routing of Sound Device
Sponsored by
Ottawa Hospital Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Cochlear Implant focused on measuring cochlear implant, hearing aid, cros device, bimodal

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Ottawa Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Naida Hearing Aid

Naida CROS Device

Arm Description

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)

The same cohort will cross over to each arm.

Outcomes

Primary Outcome Measures

Perception of speech by way of audiogram and AzBio word testing.
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
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
Evolution of narrative interview themes illuminating subjective feedback of experience using HA or CROS

Secondary Outcome Measures

Demographics
Age, Gender, Hearing History

Full Information

First Posted
October 18, 2018
Last Updated
November 4, 2019
Sponsor
Ottawa Hospital Research Institute
Collaborators
Advanced Bionics
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1. Study Identification

Unique Protocol Identification Number
NCT04155138
Brief Title
Recipients With Limited Bimodal Benefit: HA or CROS
Official Title
Recipients With Limited Bimodal Benefit: HA or CROS
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Unknown status
Study Start Date
December 1, 2019 (Anticipated)
Primary Completion Date
December 1, 2020 (Anticipated)
Study Completion Date
March 20, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ottawa Hospital Research Institute
Collaborators
Advanced Bionics

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cochlear Implant, Hearing Disability, Hearing Disorders and Deafness
Keywords
cochlear implant, hearing aid, cros device, bimodal

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Naida Hearing Aid Naida CROS Device
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Naida Hearing Aid
Arm Type
Other
Arm Description
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)
Arm Title
Naida CROS Device
Arm Type
Other
Arm Description
The same cohort will cross over to each arm.
Intervention Type
Device
Intervention Name(s)
Naida Hearing Aid
Other Intervention Name(s)
HA
Intervention Description
hearing aid
Intervention Type
Device
Intervention Name(s)
Naida Contralateral Routing of Sound Device
Other Intervention Name(s)
CROS
Intervention Description
This is a device that routes sound to the non-cochlear implanted ear.
Primary Outcome Measure Information:
Title
Perception of speech by way of audiogram and AzBio word testing.
Description
Change in perception of speech by way of audiogram (hearing threshold across dB and frequencies) and AzBio word testing (% accuracy).
Time Frame
At Baseline, Week 6 and Week 12
Title
7 point Likert study-specific scales illuminating subjective feedback of experience using HA or CROS
Description
Change in 7 point Likert study-specific scales illuminating subjective feedback of experience using HA or CROS. 1 (very dissatisfied) to 7 (very satisfied)
Time Frame
At Baseline, Week 6 and Week 12
Title
Participant narrative illuminating subjective feedback of experience using HA or CROS
Description
Evolution of narrative interview themes illuminating subjective feedback of experience using HA or CROS
Time Frame
At Baseline, Week 6 and Week 12
Secondary Outcome Measure Information:
Title
Demographics
Description
Age, Gender, Hearing History
Time Frame
At Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Debora L Hogan, M.Sc.N.
Phone
6137378899
Ext
72968
Email
dhogan@ohri.ca
First Name & Middle Initial & Last Name or Official Title & Degree
David Schramm, MD
Phone
6137378899
Ext
72968
Email
dschramm@toh.ca
Facility Information:
Facility Name
The Ottawa Hospital
City
Ottawa
State/Province
ON - Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Debora L Hogan, MScN
Phone
6137378899
Ext
72968
Email
sisterssejour@hotmail.com
First Name & Middle Initial & Last Name & Degree
David Schramm, MD
Phone
6137378899
Ext
72968
Email
dschramm@toh.ca

12. IPD Sharing Statement

Plan to Share IPD
No

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Recipients With Limited Bimodal Benefit: HA or CROS

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