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No reliable differences across conditions, unacceptable test-retest reliability
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| Name | Class |
|---|---|
| Sonova Canada Inc. | INDUSTRY |
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The stimuli consist of speech in quiet, speech in noise, reverberant speech, and music recorded with different hearing aid settings, post-processed for headphone presentation and incorporated in an online sound survey. Participants will receive tablets and headphones to conduct a sound quality rating at home. The survey will involve a training session and within-subject repeated measures. Stimuli presentation will be randomized by sound quality rating tool.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hearing aid 1 default amplification strategy | Experimental | Hearing aid 1 default amplification strategy: A receiver-in-canal (RIC) hearing aid developed by the study sponsor used with the default settings as specified in the study sponsor's fitting software. |
|
| Hearing aid 2 | Experimental | Hearing aid 2: A receiver-in-canal (RIC) hearing aid developed by the another hearing aid manufacturer used with the default settings as specified in the manufacturer's fitting software. |
|
| Hearing aid 1 strategy 1 | Experimental | Hearing aid 1 strategy 1: A receiver-in-canal (RIC) hearing aid developed by the study sponsor used with a modified compression strategy that is expected to improve sound quality. |
|
| Hearing aid 1 strategy 2 | Experimental | Hearing aid 1 strategy 2: A receiver-in-canal (RIC) hearing aid developed by the study sponsor used with a modified compression strategy that is expected to improve sound quality. |
|
| unaided | No Intervention | Unaided recording to be used for normalization of rating results. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Recording with hearing aid | Device | Each participant will listen to sound samples via headphones. Sound samples have been recorded with a hearing aid that was set to each participant's individual hearing loss and different amplification strategies, and an unaided reference. Participants will be asked to rate different aspects of sound quality while listening to the different sound samples. |
| Measure | Description | Time Frame |
|---|---|---|
| Sound Quality Rating | Participants moved through a self-guided, double-blinded sound survey which presented sound samples of all hearing aid conditions (see Arms/Groups for conditions) and asked participants to rate the sound quality dimensions on a scale. The rating dimensions and scales were based on a sound quality rating guidance document by Delta Labs (Danmark) ranging from 0 to 100 with step sizes of 1 and descriptive markers at 0 (worst), 20, 40, 60, 80 and 100 (best) depending on the dimension (Reverberation (only assessed for Speech in Quiet and Reverberant Speech), Sound Source Localization, Sound Source Separation, and Timbral Balance). Overall Preference was implemented as a ranking according to the 5-point Mean Opinion Score (bad (1), poor (2), fair (3), good (4), excellent (5); MOS, International Telecommunication Union, 1996). | 1 hour |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jinyu Qian, PhD | Sonova Canada Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sonova Innovation Centre Toronto | Mississauga | Ontario | L5L1J3 | Canada |
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| ID | Title | Description |
|---|---|---|
| FG000 | Sound Survey | Each participant will conduct a sound survey at home with equipment (tablet and headphones) that were shipped to the participant's place of residence. During the survey, sound samples were randomly assigned to the push buttons participants were clicking to listen to a sound: Hearing aid 1 default amplification strategy: A receiver-in-canal (RIC) hearing aid developed by the study sponsor used with the default settings as specified in the study sponsor's fitting software. Hearing aid 2: A receiver-in-canal (RIC) hearing aid developed by the another hearing aid manufacturer used with the default settings as specified in the manufacturer's fitting software. Hearing aid 1 strategy 1: A receiver-in-canal (RIC) hearing aid developed by the study sponsor used with a modified compression strategy that is expected to improve sound quality. Hearing aid 1 strategy 2: A receiver-in-canal (RIC) hearing aid developed by the study sponsor used with a modified compression strategy that is expected to improve sound quality. Unaided: Recordings made without hearing aids. Ratings for this sound sample were used for normalization of survey results. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Collected data was based on self-reports or data provided by the participants, and available information in our participant database. One successfully completed study participant's data set, which was collected in the early phase of the study design, was excluded from the analysis because the stimuli were changed afterwards. The analysis does not contain any of this participant's data or information, bringing the total number of analyzed participants down to 11.
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| ID | Title | Description |
|---|---|---|
| BG000 | Complete Sample | Each participant will listen to sound samples via headphones. Sound samples have been recorded with each of the devices listed under "intervention" which were set to each participant's individual hearing loss, and an unaided reference. Participants will be asked to rate different aspects of sound quality while listening to the different sound samples. |
| 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 | Sound Quality Rating | Participants moved through a self-guided, double-blinded sound survey which presented sound samples of all hearing aid conditions (see Arms/Groups for conditions) and asked participants to rate the sound quality dimensions on a scale. The rating dimensions and scales were based on a sound quality rating guidance document by Delta Labs (Danmark) ranging from 0 to 100 with step sizes of 1 and descriptive markers at 0 (worst), 20, 40, 60, 80 and 100 (best) depending on the dimension (Reverberation (only assessed for Speech in Quiet and Reverberant Speech), Sound Source Localization, Sound Source Separation, and Timbral Balance). Overall Preference was implemented as a ranking according to the 5-point Mean Opinion Score (bad (1), poor (2), fair (3), good (4), excellent (5); MOS, International Telecommunication Union, 1996). | The median and IQR is presented for each sound quality dimension (Reverberation, Sound Source Separation, Sound Source Location and Overall) in sound scene (speech in quiet, speech in noise, speech in reverberance, music). | Posted | Median | Inter-Quartile Range | units on a scale | 1 hour |
|
Data were collected as long as a participant was enrolled in the study, which was from the first to the second appointment. This time frame was about 2 weeks for each participant.
Point of Care Risk Assessment conducted at each visit, including questions regarding overall health.
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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 | Each participant will conduct a sound survey at home with equipment (tablet and headphones) that were shipped to the participant's place of residence. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jinyu Qian | Sonova Canada Inc. | 6472624826 | 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 | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 3, 2021 | Jun 9, 2023 | Prot_SAP_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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The acoustic output of the different devices had been recorded and the recordings have been presented in random order (random order created by the sound survey algorithm) to the participants in a digital sound survey, so neither the researcher nor the participant knew which recording the participant was listening to when rating.
|
| 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 |
|
| Hearing aid experience | Mean | Standard Deviation | years |
|
| Hearing loss | Count of Participants | Participants |
|
| Normal or corrected to normal vision | Count of Participants | Participants |
|
| Good cognitive abilities | Count of Participants | Participants |
|
| Description |
|---|
| OG000 | Hearing Aid 1 Default Amplification Strategy | A receiver-in-canal (RIC) hearing aid developed by the study sponsor used with the default settings as specified in the study sponsor's fitting software. |
| OG001 | Hearing Aid 2 | A receiver-in-canal (RIC) hearing aid developed by the another hearing aid manufacturer used with the default settings as specified in the manufacturer's fitting software. |
| OG002 | Hearing Aid 1 Strategy 1 | A receiver-in-canal (RIC) hearing aid developed by the study sponsor used with a modified compression strategy that is expected to improve sound quality. |
| OG003 | Hearing Aid 1 Strategy 2 | A receiver-in-canal (RIC) hearing aid developed by the study sponsor used with a modified compression strategy that is expected to improve sound quality. |
| OG004 | Unaided | A recording without any amplification. |
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 0 |
| 12 |
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| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |