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| Name | Class |
|---|---|
| Sonova Canada Inc. | INDUSTRY |
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The present study will confirm the clinical benefit of 2 different released hearing aid models for speech understanding (in noise). Participants with mild to severe hearing impairment will be fit binaurally with Unitron hearing aids and will perform a standardized speech discrimination test in noise with and without hearing aids.
Each participant will be asked to wear a set of BTE and RIC hearing aids and complete the Hearing in Noise Test (HINT) aided and unaided. The investigators will be assessing their speech intelligibility in noise for each condition during the same appointment to determine the SNR50 (the Signal-to-Noise ratio necessary for a participant to recognize the speech material correctly 50 percent of the time).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | The same group of participants undergo the same testing conditions. Each participant is fit with the BTE and the RIC hearing aids and then complete the speech intelligibility testing - Hearing in Noise Test (HINT) - aided and unaided during one-time visit. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hearing aid | Device | Participants will complete testing aided and unaided. The hearing aids have been fit to compensate for their hearing loss. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Speech Intelligibility Test in Noise | Sentences are presented through a speaker in front of the participant's head. Background noise is presented through other seven speakers arranged around the participant. The senteces are presented at varying levels (both louder and softer) than the fixed level of the noise. The SNR50 is the Signal-to-Noise Ratio (SNR) expressed in decibels (dB) at which the participant can repeat 50% of the words correctly. For example, an SNR50 of +3 means that the participant repeated 50% of the words back correctly when the sentences were presented at a level that was 3dB louder than the noise. Lower scores indicate better performance. | 2 hours appointment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jinyu Qian, PhD | jinyu.qian@sonova.com | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Unitron Hearing | Kitchener | Ontario | N2E 1Y6 | Canada |
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All 25 participants enrolled met the inclusion criteria established for this study.
Participants were recruited from the existing participant local database. The first participant was enrolled on January 10, 2022 and the last participant was enrolled on January 28, 2022.
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| ID | Title | Description |
|---|---|---|
| FG000 | Experimental | The same group of participants undergo one similar intervention. Each participant is fit with the BTE and the RIC hearing aids and then complete the speech intelligibility testing aided and unaided. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
The same group of 25 participants undergo one similar intervention
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| ID | Title | Description |
|---|---|---|
| BG000 | Experimental | All participants are fit with the BTE and the RIC hearing aids and then complete speech intelligibility testing aided and unaided. |
| 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 Test in Noise | Sentences are presented through a speaker in front of the participant's head. Background noise is presented through other seven speakers arranged around the participant. The senteces are presented at varying levels (both louder and softer) than the fixed level of the noise. The SNR50 is the Signal-to-Noise Ratio (SNR) expressed in decibels (dB) at which the participant can repeat 50% of the words correctly. For example, an SNR50 of +3 means that the participant repeated 50% of the words back correctly when the sentences were presented at a level that was 3dB louder than the noise. Lower scores indicate better performance. | The data for two participants had to be removed from the final analysis. In both cases, the speech intelligibiliy test could not be completed in one or more study conditions. | Posted | Mean | Standard Deviation | decibel (dB) Signal-to-Noise Ratio | 2 hours appointment |
|
1 day
Hearing instruments do not generally cause mortality or serious adverse events. All participants underwent testing under the study conditions during one day appointment session. Therefore, all participants are combined for the Adverse Events reported.
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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 | Experimental | All participants performed the HINT test in a sound room setting and SNR50 scores were obtained under the three study conditions. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Manager | Sonova AG | 519 895 0100 | 2135 | carolina.rubiano@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 4, 2022 | Jan 10, 2023 | 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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| ID | Term |
|---|---|
| D006310 | Hearing Aids |
| ID | Term |
|---|---|
| D000076251 | Wearable Electronic Devices |
| D055615 | Electrical Equipment and Supplies |
| D004864 | Equipment and Supplies |
| D012682 | Sensory Aids |
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One similar intervention; 2 groups based on hearing aid model.
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| 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 |
|
| Speech Intelligibility in Noise | Sentences are presented through a speaker in front of the participant's head. Background noise is presented through other seven speakers arranged around the participant. The senteces are presented at varying levels (both louder and softer) than the fixed level of the noise. The SNR50 is the Signal-to-Noise Ratio at which te participant can repeat 50% of the words correctly. For example, an SNR50 of +3 means that the participant repeated 50% of the words back correctly when the sentences were presented at a level that was 3dB louder than the noise. Lower scores indicate better performance. | Mean | Standard Deviation | decibels (dB) Signal-to-Noise Ratio |
|
The same group of participants undergo one similar intervention. Each participant is fit with the BTE and the RIC hearing aids and then complete the speech intelligibility testing aided and unaided. |
|
|
|
| 0 |
| 25 |
| 0 |
| 25 |
| 0 |
| 25 |
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| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |