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| Name | Class |
|---|---|
| Sonova Canada Inc. | INDUSTRY |
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Listeners will conduct sound quality ratings of recordings talkers in a moving car processed using three different microphone processing strategies: an investigational adaptive directional microphone, an omnidirectional microphone and a fixed directional microphone. Participants will listen to the recordings streamed via commercially-available and individually-prescribed hearing aids, and conduct ratings onsite in the lab. The procedure will involve a training session and within-subject repeated measures. Stimuli will be randomized.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants with hearing loss. | Experimental | Participants with hearing loss. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Investigational adaptive directional microphone strategy | Device | A receiver-in-canal hearing aid developed by the Study Sponsor used with the investigational adaptive directional microphone strategy that is expected to improve sound quality of speech in a car. |
| Measure | Description | Time Frame |
|---|---|---|
| Speech Clarity | The sound quality ratings will be conducted via a computer-based questionnaire that contains sound samples that participants listen to and rate. Sound quality rating scales are continuous and range from 0 (worst) to 100 (best) with 5 descriptors unique to the dimension at 5 intervals on the scale (0, 25, 50, 75, 100) Participants will be instructed to "Please rate the clarity of speech". Speech clarity ratings will be measured on a 100-point continuous slider from worst to best (0-Very unclear, 25- Unclear, 50-Slightly clear, 75-Clear, 100-Very clear). Speech clarity ratings are expected to be impacted by how intelligible the speech is. Participants will rate and compare speech clarity between the investigational and comparator features. | Up to 6 hours over 3 2-hour sessions |
| Noise Annoyance | The sound quality ratings will be conducted via a computer-based questionnaire that contains sound samples that participants listen to and rate. Sound quality rating scales are continuous and range from 0 (worst) to 100 (best) with 5 descriptors unique to the dimension at 5 intervals on the scale (0, 25, 50, 75, 100) Participants will be instructed to "Please rate how annoying the noise is". Noise annoyance ratings will be measured on a 100-point continuous slider from worst to best (0- Extremely annoying, 25-Very annoying, 50-Moderately annoying, 75-Slightly annoying, 100-Not at all annoying). Noise annoyance ratings are expected to be impacted by how bothersome the background noise in the recordings is. Participants will rate and compare noise annoyance between the investigational and comparator features. | Up to 6 hours over 3 2-hour sessions |
| Spatialization | The sound quality ratings will be conducted via a computer-based questionnaire that contains sound samples that participants listen to and rate. Sound quality rating scales are continuous and range from 0 (worst) to 100 (best) with 5 descriptors unique to the dimension at 5 intervals on the scale (0, 25, 50, 75, 100) Participants will be instructed to "Please rate your confidence that the talker is in [a location]", with the local being either passenger of rear left. Spatialization ratings will be measured on a 100-point continuous slider from worst to best (0-I don't know where the talker is, 25-The talker might be to my [location], 50-The talker is probably to my [location], 75-The talker is to my [location], 100-The talker is definitely to my [location]). Spatialization ratings are expected to be impacted by how well the recordings preserve spatial perception. Participants will rate and compare spatialization between the investigational and comparator features. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sonova Innovation Centre Toronto | Mississauga | Ontario | L5L1J3 | Canada |
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| ID | Title | Description |
|---|---|---|
| FG000 | Participants With Hearing Loss | Participants with hearing loss who are candidates for hearing aids |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Participants With Hearing Loss. | Participants with hearing loss. Investigational adaptive directional microphone strategy: A receiver-in-canal hearing aid developed by the Study Sponsor used with the investigational adaptive directional microphone strategy that is expected to improve sound quality of speech in a car. Comparator omnidirectional microphone strategy: A receiver-in-canal hearing aid developed by the Study Sponsor used with the comparator omnidirectional microphone strategy that is used with the default settings as specified in the manufacturer's fitting software. Comparator fixed directional microphone strategy: A receiver-in-canal hearing aid developed by the Study Sponsor used with the comparator fixed directional microphone strategy that is used with the default settings as specified in the manufacturer's fitting software. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 Clarity | The sound quality ratings will be conducted via a computer-based questionnaire that contains sound samples that participants listen to and rate. Sound quality rating scales are continuous and range from 0 (worst) to 100 (best) with 5 descriptors unique to the dimension at 5 intervals on the scale (0, 25, 50, 75, 100) Participants will be instructed to "Please rate the clarity of speech". Speech clarity ratings will be measured on a 100-point continuous slider from worst to best (0-Very unclear, 25- Unclear, 50-Slightly clear, 75-Clear, 100-Very clear). Speech clarity ratings are expected to be impacted by how intelligible the speech is. Participants will rate and compare speech clarity between the investigational and comparator features. | Two participants' data were omitted due to their results suggesting that they did not understand the task. | Posted | Mean | Standard Error | units on a scale | Up to 6 hours over 3 2-hour sessions |
|
Adverse event data were recorded over the course of a single 2-hour study session.
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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 | Participants With Hearing Loss. | Participants with hearing loss who are candidates for hearing aids |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jinyu Qian, PhD; VP Sonova Innovation Centre Toronto | Sonova Canada | 647-262-4826 | jinyu.qian@sonova.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Jan 27, 2022 | Oct 27, 2022 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| ID | Term |
|---|---|
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
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A single cohort of participants will receive and be assessed in all treatment/intervention
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Hearing aid processing settings are randomized and double blinded.
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| Comparator omnidirectional microphone strategy | Device | A receiver-in-canal hearing aid developed by the Study Sponsor used with the comparator omnidirectional microphone strategy that is used with the default settings as specified in the manufacturer's fitting software. |
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| Comparator fixed directional microphone strategy | Device | A receiver-in-canal hearing aid developed by the Study Sponsor used with the comparator fixed directional microphone strategy that is used with the default settings as specified in the manufacturer's fitting software. |
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| Up to 6 hours over 3 2-hour sessions |
| Transition Annoyance | The sound quality ratings will be conducted via a computer-based questionnaire that contains sound samples that participants listen to and rate. Sound quality rating scales are continuous and range from 0 (worst) to 100 (best) with 5 descriptors unique to the dimension at 5 intervals on the scale (0, 25, 50, 75, 100) Participants will be instructed to "Please rate how annoying the transitions are". Transitions annoyance ratings will be measured on a 100-point continuous slider from worst to best (0-Extremely annoying, 25-Very annoying, 50-Moderately annoying, 75-Slightly annoying, 100-Not at all annoying). Transition annoyance ratings are expected to be influenced by presence of unexpected sounds or transitions that occur in different microphone modes and different listening situations. Participants will rate and compare transition annoyance between the investigational and comparator features. | Up to 6 hours over 3 2-hour sessions |
| Overall Impression | The sound quality ratings will be conducted via a computer-based questionnaire that contains sound samples that participants listen to and rate. Sound quality rating scales are continuous and range from 0 (worst) to 100 (best) with 5 descriptors unique to the dimension at 5 intervals on the scale (0, 25, 50, 75, 100) Participants will be instructed to "All things considered, please rate overall preferences". Overall preferences ratings will be measured on a 100-point continuous slider from worst to best (0-Bad, 25-Poor, 50-Fair, 75-Good, 100-Excellent). Overall impression ratings are expected to be impacted by participants' overall preferences for the different stimuli. Participants will rate and compare overall impression between the investigational and comparator features. | Up to 6 hours over 3 2-hour sessions |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Hearing loss severity | Count of Participants | Participants |
|
Participants with hearing loss. Investigational adaptive directional microphone strategy: A receiver-in-canal hearing aid developed by the Study Sponsor used with the investigational adaptive directional microphone strategy that is expected to improve sound quality of speech in a car. Comparator omnidirectional microphone strategy: A receiver-in-canal hearing aid developed by the Study Sponsor used with the comparator omnidirectional microphone strategy that is used with the default settings as specified in the manufacturer's fitting software. Comparator fixed directional microphone strategy: A receiver-in-canal hearing aid developed by the Study Sponsor used with the comparator fixed directional microphone strategy that is used with the default settings as specified in the manufacturer's fitting software. |
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| Primary | Noise Annoyance | The sound quality ratings will be conducted via a computer-based questionnaire that contains sound samples that participants listen to and rate. Sound quality rating scales are continuous and range from 0 (worst) to 100 (best) with 5 descriptors unique to the dimension at 5 intervals on the scale (0, 25, 50, 75, 100) Participants will be instructed to "Please rate how annoying the noise is". Noise annoyance ratings will be measured on a 100-point continuous slider from worst to best (0- Extremely annoying, 25-Very annoying, 50-Moderately annoying, 75-Slightly annoying, 100-Not at all annoying). Noise annoyance ratings are expected to be impacted by how bothersome the background noise in the recordings is. Participants will rate and compare noise annoyance between the investigational and comparator features. | Two participants' data were omitted due to their results suggesting that they did not understand the task. | Posted | Mean | Standard Error | units on a scale | Up to 6 hours over 3 2-hour sessions |
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| Primary | Spatialization | The sound quality ratings will be conducted via a computer-based questionnaire that contains sound samples that participants listen to and rate. Sound quality rating scales are continuous and range from 0 (worst) to 100 (best) with 5 descriptors unique to the dimension at 5 intervals on the scale (0, 25, 50, 75, 100) Participants will be instructed to "Please rate your confidence that the talker is in [a location]", with the local being either passenger of rear left. Spatialization ratings will be measured on a 100-point continuous slider from worst to best (0-I don't know where the talker is, 25-The talker might be to my [location], 50-The talker is probably to my [location], 75-The talker is to my [location], 100-The talker is definitely to my [location]). Spatialization ratings are expected to be impacted by how well the recordings preserve spatial perception. Participants will rate and compare spatialization between the investigational and comparator features. | Two participants' data were omitted due to their results suggesting that they did not understand the task. | Posted | Mean | Standard Error | units on a scale | Up to 6 hours over 3 2-hour sessions |
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| Primary | Transition Annoyance | The sound quality ratings will be conducted via a computer-based questionnaire that contains sound samples that participants listen to and rate. Sound quality rating scales are continuous and range from 0 (worst) to 100 (best) with 5 descriptors unique to the dimension at 5 intervals on the scale (0, 25, 50, 75, 100) Participants will be instructed to "Please rate how annoying the transitions are". Transitions annoyance ratings will be measured on a 100-point continuous slider from worst to best (0-Extremely annoying, 25-Very annoying, 50-Moderately annoying, 75-Slightly annoying, 100-Not at all annoying). Transition annoyance ratings are expected to be influenced by presence of unexpected sounds or transitions that occur in different microphone modes and different listening situations. Participants will rate and compare transition annoyance between the investigational and comparator features. | Two participants' data were omitted due to their results suggesting that they did not understand the task. The "fixed directional" outcome measure is not included for the transition annoyance comparator since that program does not contain transitions that can be rated and compared to the other test conditions. | Posted | Mean | Standard Error | units on a scale | Up to 6 hours over 3 2-hour sessions |
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| Primary | Overall Impression | The sound quality ratings will be conducted via a computer-based questionnaire that contains sound samples that participants listen to and rate. Sound quality rating scales are continuous and range from 0 (worst) to 100 (best) with 5 descriptors unique to the dimension at 5 intervals on the scale (0, 25, 50, 75, 100) Participants will be instructed to "All things considered, please rate overall preferences". Overall preferences ratings will be measured on a 100-point continuous slider from worst to best (0-Bad, 25-Poor, 50-Fair, 75-Good, 100-Excellent). Overall impression ratings are expected to be impacted by participants' overall preferences for the different stimuli. Participants will rate and compare overall impression between the investigational and comparator features. | Two participants' data were omitted due to their results suggesting that they did not understand the task. | Posted | Mean | Standard Error | units on a scale | Up to 6 hours over 3 2-hour sessions |
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| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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