NCT05379231

Brief Summary

22 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 8, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 18, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

July 11, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 21, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 21, 2023

Completed
2.2 years until next milestone

Results Posted

Study results publicly available

June 11, 2025

Completed
Last Updated

June 11, 2025

Status Verified

March 1, 2023

Enrollment Period

8 months

First QC Date

April 8, 2022

Results QC Date

April 24, 2024

Last Update Submit

June 10, 2025

Conditions

Unilateral Deafness

Outcome Measures

Primary Outcomes (1)

  • Speech Intelligibility in Noise Measured With US Matrix Test (Noise From a Defined Loudspeaker)

    Measuring the Signal to Noise Ratio change in decibels (dB) for speech from the front loudspeaker and noise from the better ear's side with the US matrix Test. Results of the speech test will be the SRT (speech recognition threshold) in dB SNR (signal to noise ratio). The target speaker will be presented from 0° azimuth and is adaptive (start level at 65dB (A)). The noise will be presented on the better ear at an azimuth of 90° or 270° (depending on the site of the better ear), at a level of 65 dB (A).

    At the appointment following the 4 weeks home trial each participant went on wearing the BiCROS fitting

Secondary Outcomes (6)

  • Speech Intelligibility in Noise Measured With US Matrix Test (Diffuse Noise)

    At the appointment following the 4 weeks home trial each participant went on wearing the BiCROS fitting

  • Reports of Subjective Quality of Hearing as Assessed by the SSQ

    At the appointment following the 4 weeks home trial each participant went on wearing the BiCROS fitting

  • Reports of Subjective Quality of Hearing as Assessed by the Bern Benefit Questionnaires

    At the appointment following the 4 weeks home trial each participant went on wearing the BiCROS fitting

  • Sound Quality Ratings for Total Impression and Clarity Using Gabriellson et al (1990) Ratings Scales

    At the appointment following the 4 weeks home trial each participant went on wearing the BiCROS fitting

  • Subjective Preference of Hearing Aid Condition

    At the appointment following the 4 weeks home trial each participant went on wearing the BiCROS fitting

  • +1 more secondary outcomes

Study Arms (5)

BiCROS fitting with beamformer

EXPERIMENTAL

Each participant will be fitted with the experimental CROS device on the unaidable ear and with a compatible hearing aid on the other ear. A beamformer (directional microphone) will be enabled during this measurement. Although each ear receives a different device configuration depending on the condition, the participant is assigned as a whole, and assignment is not by ears.

Device: Hearing aid fitting

BiCROS fitting omni

EXPERIMENTAL

Each participant will be fitted with the experimental CROS device on the unaidable ear and with a compatible hearing aid on the other ear. The microphones will be omnidirectional. Although each ear receives a different device configuration depending on the condition, the participant is assigned as a whole, and assignment is not by ears.

Device: Hearing aid fitting

Monaural hearing aid fitting with beamformer

ACTIVE COMPARATOR

Each participant will be fitted with a hearing aid on the better hearing ear and no device on the unaidable ear. A beamformer (directional microphone) will be enabled during the measurement. Although each ear receives a different device configuration depending on the condition, the participant is assigned as a whole, and assignment is not by ears.

Device: Hearing aid fitting

Monaural hearing aid fitting omni

ACTIVE COMPARATOR

Each participant will be fitted with a hearing aid on the better hearing ear and no device on the unaidable ear. The microphone will be omnidirectional. Although each ear receives a different device configuration depending on the condition, the participant is assigned as a whole, and assignment is not by ears.

Device: Hearing aid fitting

Unaided condition

NO INTERVENTION

No intervention, the participants are not fitted with a CROS device and/or hearing aid.

Interventions

Hearing aid fittingDEVICE

A participant will wear a hearing aid with and without a CROS device on the unaidable ear.

BiCROS fitting omniBiCROS fitting with beamformerMonaural hearing aid fitting omniMonaural hearing aid fitting with beamformer

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • \- aidable hearing loss in both ears

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

National Centre for Audiology

London, Ontario, N6G 1H1, Canada

Location

Sonova Innovation Centre Toronto

Mississauga, Ontario, L5L1J3, Canada

Location

MeSH Terms

Conditions

Hearing Loss, Unilateral

Condition Hierarchy (Ancestors)

Hearing LossHearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Dr. Susan Scollie
Organization
National Centre for Audiology
scollie@nca.uwo.ca
519 661-2111

Study Officials

  • Susan Scollie

    Western University, Canada

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Participants were wearing the BiCROS fitting during home trial, where no masking was possible. For in-lab tests, the CROS device was deactivated for the monaural condition, allowing for some masking. The unaided condition could not be masked. Participants were not aware which beamformer configuration was active during in-lab tests.
Purpose
OTHER
Intervention Model
CROSSOVER
Model Details: All participants were wearing the BiCROS fitting during home trial, and tested in-lab with all conditions, randomized and counterbalanced (BiCROS fitting, monaural fitting, unaided).
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 8, 2022

First Posted

May 18, 2022

Study Start

July 11, 2022

Primary Completion

March 21, 2023

Study Completion

March 21, 2023

Last Updated

June 11, 2025

Results First Posted

June 11, 2025

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

CA(2)