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Evaluation of BiCROS Fitting Benefits

Primary Purpose

Unilateral Deafness

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
BiCROS fitting
Monaural hearing aid fitting
Unaided condition
Sponsored by
Sonova AG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Unilateral Deafness

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • unaidable hearing loss in worse ear (>N6)
  • aidable hearing loss (N3 to N5) on the other ear
  • fluent English speaker

Exclusion Criteria:

- aidable hearing loss in both ears

Sites / Locations

  • National Centre for Audiology
  • Sonova Innovation Centre Toronto

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Speech Intelligibility with CROS device

Arm Description

The focus of this study is on Speech Intelligibility (SI), evaluated by the US Matrix Test, which measures a speech recognition threshold (SRT) in dB SNR (signal to noise ratio). Therefore each participant will perform the tests with the experimental rechargeable CROS transmitter (CROS) in different interventions, like comparison to monaural fitting and unaided condition. All participants will perform the same tests. The order of the intervention in the speech test is randomized, but will be performed in the same visit by each participant.

Outcomes

Primary Outcome Measures

Speech intelligibility in Noise measured with US Matrix Test (noise from a defined loudspeaker)
Measuring the Signal to Noise Ratio change in decibels for speech from the front loudspeaker and noise from the better ear's side

Secondary Outcome Measures

Speech intelligibility in Noise measured with US Matrix Test (diffuse noise)
Measuring the Signal to Noise Ratio change in decibels for speech from the front loudspeaker in surrounding noise
Reports of Subjective quality of hearing as assessed by the SSQ
Measured after home trial with the Speech, Spatial and Qualities of Hearing Scale (Gatehouse, 2004)
Reports of Subjective quality of hearing as assessed by the Bern Benefit Questionnaires
Measured after home trial with the Bern Benefit in Single-Sided Deafness Questionnaire (Komps et al, 2011)
Sound quality ratings for Total Impression and Clarity using Gabriellson et al (1990) Ratings Scales
Ratings of speech in quiet and in noise presented via loudspeakers
Subjective preference of hearing aid condition
3 alternative forced choice (A, B, no preference or ABX) paradigm with three repetitions for speech in noise presented via loudsepakers
Listening effort in noise using 7 point scale (Johnson et al, 2015)
Measuring listening effort for speech in multi-talker babble presented via loudspeaker

Full Information

First Posted
April 8, 2022
Last Updated
March 31, 2023
Sponsor
Sonova AG
Collaborators
Western University, Canada
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1. Study Identification

Unique Protocol Identification Number
NCT05379231
Brief Title
Evaluation of BiCROS Fitting Benefits
Official Title
Evaluate the Benefit of a BiCROS Hearing Aid Fitting
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
July 11, 2022 (Actual)
Primary Completion Date
March 21, 2023 (Actual)
Study Completion Date
March 21, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sonova AG
Collaborators
Western University, Canada

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
23 candidates for BiCROS hearing aids will be recruited and fitted with a hearing aid and a CROS device. Following a real-world trial, each participant will be tested on a range of outcome measures including speech recognition in noise, ratings of listening effort, and ratings of preference.
Detailed Description
Unilateral Hearing Loss (UHL) can be defined as any degree of permanent hearing loss on one ear with normal hearing in the opposite ear. Unilateral hearing loss can be debilitating associated with audiological, psychosocial and educational challenges. Audiological challenges include the reduced ability to localize sounds, reduced awareness on the unaidable side and difficulties hearing in noise or at a distance. One solution for unaidable UHL is Contralateral Routing of Signals (CROS) and Bilateral Contralateral routing of signals (BiCROS) using a so-called CROS transmitter together with a hearing aid. The rationale for this clinical investigation is to collect clinical data with a rechargeable CROS transmitter to evaluate the benefits of a BiCROS fitting compared to the alternative treatment option, the monaural hearing aid fitting, and to no treatment in noisy listening situations. Hearing tests, ear impressions and hearing aid fitting visits are mainly conducted at the National Centre for Audiology in London, Ontario. Those visits are available at the Sonova Innovation Centre Toronto in Mississauga, Ontario, upon request. Outcome measurements are only conducted at the National Centre for Audiology in London, Ontario.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Unilateral Deafness

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Speech Intelligibility with CROS device
Arm Type
Experimental
Arm Description
The focus of this study is on Speech Intelligibility (SI), evaluated by the US Matrix Test, which measures a speech recognition threshold (SRT) in dB SNR (signal to noise ratio). Therefore each participant will perform the tests with the experimental rechargeable CROS transmitter (CROS) in different interventions, like comparison to monaural fitting and unaided condition. All participants will perform the same tests. The order of the intervention in the speech test is randomized, but will be performed in the same visit by each participant.
Intervention Type
Other
Intervention Name(s)
BiCROS fitting
Intervention Description
Each participant will be fitted with the experimental CROS device on the unaidable ear and with a compatible hearing aid on the other ear.
Intervention Type
Other
Intervention Name(s)
Monaural hearing aid fitting
Intervention Description
Each participant will be fitted with a hearing aid on the better hearing ear and no device on the unaidable ear. Monaural hearing aid fitting acts as control intervention.
Intervention Type
Other
Intervention Name(s)
Unaided condition
Intervention Description
No treatment, i.e. the participants are not fitted with a CROS device and/ or hearing aid. Unaided condition acts as control intervention.
Primary Outcome Measure Information:
Title
Speech intelligibility in Noise measured with US Matrix Test (noise from a defined loudspeaker)
Description
Measuring the Signal to Noise Ratio change in decibels for speech from the front loudspeaker and noise from the better ear's side
Time Frame
7 months
Secondary Outcome Measure Information:
Title
Speech intelligibility in Noise measured with US Matrix Test (diffuse noise)
Description
Measuring the Signal to Noise Ratio change in decibels for speech from the front loudspeaker in surrounding noise
Time Frame
7 months
Title
Reports of Subjective quality of hearing as assessed by the SSQ
Description
Measured after home trial with the Speech, Spatial and Qualities of Hearing Scale (Gatehouse, 2004)
Time Frame
7 months
Title
Reports of Subjective quality of hearing as assessed by the Bern Benefit Questionnaires
Description
Measured after home trial with the Bern Benefit in Single-Sided Deafness Questionnaire (Komps et al, 2011)
Time Frame
7 months
Title
Sound quality ratings for Total Impression and Clarity using Gabriellson et al (1990) Ratings Scales
Description
Ratings of speech in quiet and in noise presented via loudspeakers
Time Frame
7 months
Title
Subjective preference of hearing aid condition
Description
3 alternative forced choice (A, B, no preference or ABX) paradigm with three repetitions for speech in noise presented via loudsepakers
Time Frame
7 months
Title
Listening effort in noise using 7 point scale (Johnson et al, 2015)
Description
Measuring listening effort for speech in multi-talker babble presented via loudspeaker
Time Frame
7 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: unaidable hearing loss in worse ear (>N6) aidable hearing loss (N3 to N5) on the other ear fluent English speaker Exclusion Criteria: - aidable hearing loss in both ears
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan Scollie
Organizational Affiliation
Western University, Canada
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Centre for Audiology
City
London
State/Province
Ontario
ZIP/Postal Code
N6G 1H1
Country
Canada
Facility Name
Sonova Innovation Centre Toronto
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L5L1J3
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

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Evaluation of BiCROS Fitting Benefits

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