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| Name | Class |
|---|---|
| Western University, Canada | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hearing aid fitting | Device | A participant will wear a hearing aid with and without a CROS device on the unaidable ear. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Speech Intelligibility in Noise Measured With US Matrix Test (Diffuse Noise) | Measuring the Signal to Noise Ratio change in decibels (dB) for speech from the front loudspeaker in surrounding noise 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 from a circle of 8 surrounding speakers from 45° to 315° at a level of 65 dB (A) with the participant seated in the centre of the circle. |
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Inclusion Criteria:
Exclusion Criteria:
- aidable hearing loss in both ears
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| Name | Affiliation | Role |
|---|---|---|
| Susan Scollie | Western University, Canada | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Centre for Audiology | London | Ontario | N6G 1H1 | Canada | ||
| Sonova Innovation Centre Toronto |
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2 participants had to be excluded from continuing in the study before assignment because they did not meet the inclusion criteria.
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| ID | Title | Description |
|---|---|---|
| FG000 | Complete Sample | All participants first underwent a Home Visit where they all received a BiCROS fitting in the automatic mode, and then underwent an in-lab visit where all participants were randomized and counter-balanced into receiving 5 interventions (BiCROS Fitting with beamformer, BiCROS Fitting Omni, Monaural Fitting with Beamformer, Monaural Fitting Omni, and Unaided) in a different order/sequence. BiCROS fitting with beamformer: fitted with the experimental CROS device on the unaidable ear and with a compatible hearing aid on the other ear. A beamformer will be enabled during this measurement. BiCROS fitting omni: 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. Monaural hearing aid fitting with beamformer: fitted with a hearing aid on the better hearing ear and no device on the unaidable ear. A beamformer will be enabled during the measurement. Monaural hearing aid fitting omni: fitted with a hearing aid on the better hearing ear and no device on the unaidable ear. The microphone will be omnidirectional. Unaided condition: No intervention, the participants are not fitted with a CROS device and/or hearing aid. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Home Visit |
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| In-lab Visit |
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| ID | Title | Description |
|---|---|---|
| BG000 | Complete Sample | All participants will perform the same tests in all conditions. 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. BiCROS fitting: Each participant will be fitted with the experimental CROS device on the unaidable ear and with a compatible hearing aid on the other ear. Monaural hearing aid fitting: Each participant will be fitted with a hearing aid on the better hearing ear and no device on the unaidable ear. Unaided condition: No intervention, the participants are not fitted with a CROS device and/or hearing aid. Since the characteristics of each "arm" are unrelevant for the study outcome, there has been no separate analysis on each "arm". |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Although each ear receives a different device configuration depending on the condition (except for the unaided condition), the participant is assigned as a whole, and assignment is not by ears. | Posted | Mean | Standard Deviation | dBSRT | At the appointment following the 4 weeks home trial each participant went on wearing the BiCROS fitting |
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From the first appointment the participant was enrolled and assessed, until the last appointment that concluded the home trial and study participation. The whole duration was about 5-6 weeks per participant.
Studies involving the trial of a hearing aid are usually classified as low risk studies with low probability for serious adverse events or all-cause mortality.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Complete Sample | All participants will perform the same tests in all conditions. The order of the conditions is randomized but will be performed in the same visit by each participant. 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. BiCROS fitting: Each participant will be fitted with the experimental CROS device on the unaidable ear and with a compatible hearing aid on the other ear. Monaural hearing aid fitting: Each participant will be fitted with a hearing aid on the better hearing ear and no device on the unaidable ear. Unaided condition: No intervention, the participants are not fitted with a CROS device and/or hearing aid. Since all participants wore the same condition for the home trial and performed testing with all conditions in the appointment afterwards, Adverse Events are not reported by different arms. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ear infection | Ear and labyrinth disorders | Systematic Assessment | Patient has had ear infections in the past (prior to study commencement). Developed a bilateral ear infection in the past week and had visited their physician for it. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Susan Scollie | National Centre for Audiology | 519 661-2111 | 88948 | scollie@nca.uwo.ca |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 3, 2022 | Apr 16, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D046088 | Hearing Loss, Unilateral |
| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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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).
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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.
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| Unaided condition | No Intervention | No intervention, the participants are not fitted with a CROS device and/or hearing aid. |
| 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 | Measured after home trial with the Speech, Spatial and Qualities of Hearing Scale-Benefit (Gatehouse, 2004). The scale ranges from -5 to 5, where negative values indicate that the condition under test is worse than the comparator, 0 indicates no change, and positive values indicate a benefit of the condition under test compared to the comparator. | 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 | Measured after home trial with the Bern Benefit in Single-Sided Deafness Questionnaire (Komps et al, 2011). The scale ranges from -5 to 5, where negative values indicate that the condition under test is better wihtout the hearing aid, 0 indicates no change, and positive values indicate a benefit with the hearing aid. | 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 | Ratings of speech in noise presented via loudspeakers using Gabriellson et al (1990) Ratings Scales. Scales include Clarity and Total Impression, and range from 1 to 10. The higher the rating, the better the Clarity and Total Impression. | At the appointment following the 4 weeks home trial each participant went on wearing the BiCROS fitting |
| 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 | At the appointment following the 4 weeks home trial each participant went on wearing the BiCROS fitting |
| Listening Effort in Noise Using 7 Point Scale (Holmes et. al., 2018) | Measuring listening effort for speech in multi-talker babble presented via loudspeaker. The scale ranges from 1 to 7, and a higher rating indicates less listening effort. | At the appointment following the 4 weeks home trial each participant went on wearing the BiCROS fitting |
| Mississauga |
| Ontario |
| L5L1J3 |
| Canada |
| Monaural Hearing Aid Fitting With Beamformer |
|
| Monaural Hearing Aid Fitting Omni |
|
| Unaided Condition |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| BiCROS fitting candidate | Count of Participants | Participants |
|
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. |
| OG001 | BiCROS Omni | 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. |
| OG002 | Monaural With Beamformer | 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. |
| OG003 | Monaural Omni | 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. |
| OG004 | Unaided | No hearing aid fitting. |
|
|
| Secondary | Speech Intelligibility in Noise Measured With US Matrix Test (Diffuse Noise) | Measuring the Signal to Noise Ratio change in decibels (dB) for speech from the front loudspeaker in surrounding noise 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 from a circle of 8 surrounding speakers from 45° to 315° at a level of 65 dB (A) with the participant seated in the centre of the circle. | Although each ear receives a different device configuration depending on the condition (except for the unaided condition), the participant is assigned as a whole, and assignment is not by ears. | Posted | Mean | Standard Deviation | dBSRT | At the appointment following the 4 weeks home trial each participant went on wearing the BiCROS fitting |
|
|
|
| Secondary | Reports of Subjective Quality of Hearing as Assessed by the SSQ | Measured after home trial with the Speech, Spatial and Qualities of Hearing Scale-Benefit (Gatehouse, 2004). The scale ranges from -5 to 5, where negative values indicate that the condition under test is worse than the comparator, 0 indicates no change, and positive values indicate a benefit of the condition under test compared to the comparator. | Although each ear receives a different device configuration, the participant is assigned as a whole, and assignment is not by ears. | Posted | Mean | Standard Deviation | score on a scale | At the appointment following the 4 weeks home trial each participant went on wearing the BiCROS fitting |
|
|
|
| Secondary | 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). The scale ranges from -5 to 5, where negative values indicate that the condition under test is better wihtout the hearing aid, 0 indicates no change, and positive values indicate a benefit with the hearing aid. | Although each ear receives a different device configuration, the participant is assigned as a whole, and assignment is not by ears. | Posted | Mean | Standard Deviation | score on a scale | At the appointment following the 4 weeks home trial each participant went on wearing the BiCROS fitting |
|
|
|
| Secondary | Sound Quality Ratings for Total Impression and Clarity Using Gabriellson et al (1990) Ratings Scales | Ratings of speech in noise presented via loudspeakers using Gabriellson et al (1990) Ratings Scales. Scales include Clarity and Total Impression, and range from 1 to 10. The higher the rating, the better the Clarity and Total Impression. | Although each ear receives a different device configuration depending on the condition (except for the unaided condition), the participant is assigned as a whole, and assignment is not by ears. | Posted | Mean | Standard Deviation | score on a scale | At the appointment following the 4 weeks home trial each participant went on wearing the BiCROS fitting |
|
|
|
| Secondary | 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 | Posted | Count of Participants | Participants | At the appointment following the 4 weeks home trial each participant went on wearing the BiCROS fitting |
|
|
|
| Secondary | Listening Effort in Noise Using 7 Point Scale (Holmes et. al., 2018) | Measuring listening effort for speech in multi-talker babble presented via loudspeaker. The scale ranges from 1 to 7, and a higher rating indicates less listening effort. | Although each ear receives a different device configuration depending on the condition (except for the unaided condition), the participant is assigned as a whole, and assignment is not by ears. | Posted | Mean | Standard Deviation | score on a scale | At the appointment following the 4 weeks home trial each participant went on wearing the BiCROS fitting |
|
|
|
| 0 |
| 22 |
| 0 |
| 22 |
| 2 |
| 22 |
|
| Early withdrawal (unrelated) | Surgical and medical procedures | Systematic Assessment | Participant decided to withdraw from study for health reasons unrelated to the investigational device or study procedure. |
|
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| D012678 |
| Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Title | Measurements |
|---|---|
|
| Total Impression |
|
| Monaural |
|
| BiCROS |
|
| Directional |
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| Omnidirectional |
|