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| Name | Class |
|---|---|
| Sonova Canada Inc. | INDUSTRY |
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Participants will wear one set of 2 different BTE hearing aid models based on the gain required by their hearing loss. The hearing aids will be programmed based on a prescriptive approach and participants will be sent out for either one home trial with the less powerful BTEs or for two home trials with the SP (super power) BTEs.
During this study each participant will be asked to wear a set of BTE hearing aids home and wear them daily. We will be assessing their evaluation of the BTEs during and after their home field trial. They will be asked to report on their use with different apps/accessories. Subjective performance ratings will be collected.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BTE hearing aid model | Experimental | BTE or SP-BTE (super power) hearing aid fitting |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BTE hearing aid | Device | Amplification |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With 'Total Impression' Sound Quality as 'Good' | Participants with 'good' response of 7 or higher on 'Total Impression' scale; Gabrielsson citation/article includes seven perceptual scales and a scale for 'Total Impression' which is described as 'an overall judgment of how good you think the reproduction is'. Possible scores from 0 to 10 with descriptors provided: 0 (min), 1 (very bad), 3 (rather bad), 5 (midway), 7 (rather good), 9 (very good), 10 (max) A higher score reflects a better outcome. | final appointment (end of 3 weeks home trial for BTE model, end of 7 weeks home trial for SP-BTE model) |
| Measure | Description | Time Frame |
|---|---|---|
| Number and Percentage of Participants Reporting No Reboots | Participants to report perceived unwanted reboots of the hearing aids as an indicator of system stability (with use of 2.4 GHz connectivity including accessories and smartphones). Possible responses for perceived reboots (i.e., instances when the amplified sound dropped out and then returned) are: 'No (0) reboots perceived' or 'Reboots perceived (1 or more)'. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jinyu Qian, PhD | Sonova AG | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Unitron Hearing | Kitchener | Ontario | N2E 1Y6 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 3398490 | Background | Gabrielsson A, Schenkman BN, Hagerman B. The effects of different frequency responses on sound quality judgments and speech intelligibility. J Speech Hear Res. 1988 Jun;31(2):166-77. doi: 10.1044/jshr.3102.166. | |
| 25425874 | Background | Valente M, Van Vliet D. The Independent Hearing Aid Fitting Forum (IHAFF) Protocol. Trends Amplif. 1997 Mar;2(1):6-35. doi: 10.1177/108471389700200102. No abstract available. |
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| ID | Title | Description |
|---|---|---|
| FG000 | BTE Hearing Aid Model | (same arm, different group) hearing aid providing 'less' amplification for less severe hearing losses (mild to moderately-severe) BTE hearing aid: Amplification |
| FG001 | SP-BTE (Super Power) Hearing Aid Model | (same arm, different group) hearing aid providing more amplification for greater (severe to profound) hearing losses BTE hearing aid: Amplification |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
mild to moderately-severe hearing loss appropriate for 'regular' BTE fitting with 3 week take home trial vs severe to profound hearing loss appropriate for 'super power' BTE fitting with 7 week take home trial duration
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| ID | Title | Description |
|---|---|---|
| BG000 | BTE Hearing Aid Model | BTE hearing aid fitting BTE hearing aid: Amplification |
| BG001 | SP-BTE Hearing Aid Model | Super power BTE hearing aid fitting BTE hearing aid: Amplification |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Number of Participants With 'Total Impression' Sound Quality as 'Good' | Participants with 'good' response of 7 or higher on 'Total Impression' scale; Gabrielsson citation/article includes seven perceptual scales and a scale for 'Total Impression' which is described as 'an overall judgment of how good you think the reproduction is'. Possible scores from 0 to 10 with descriptors provided: 0 (min), 1 (very bad), 3 (rather bad), 5 (midway), 7 (rather good), 9 (very good), 10 (max) A higher score reflects a better outcome. | Participant (fit with hearing aids binaurally) | Posted | Count of Participants | Participants | final appointment (end of 3 weeks home trial for BTE model, end of 7 weeks home trial for SP-BTE model) |
|
2 months
Point of Care Risk Assessment conducted at each visit, including questions regarding health primarily due to COVID (in addition to online COVID screening form) e.g., how are you feeling? and ensuing discussion
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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 | BTE Hearing Aid Model | BTE hearing aid fitting BTE hearing aid: Amplification |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jinyu Qian, Director Innovation Centre Toronto | Sonova | 905-677-1167 | 5873 | 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 | May 13, 2021 | Jul 8, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 23, 2021 | Feb 17, 2022 | ICF_001.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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2 groups based on hearing aid gain needs; one similar intervention
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| at any time during home trial, reported at or by final appointment(end of 3 weeks home trial for BTE model, end of 7 weeks home trial for SP-BTE model) |
| Number of Participants Reporting Perceived Differences With Both of the App Boost Controls | Number of SP-BTE participants reporting perceived differences from adjustment of the app's Boost controls. Stimuli were presented in a sound room to check the Clarity & Comfort Boosts in the app (available in Automatic Program). To comment on the effect of the Boosts, participants listened to simulated acoustic scenarios, initially under default settings (i.e., with no Boost), then with each Boost (Comfort then Clarity) activated separately (by pressing a button on a screen in the app). Yes/No answer to confirm a perceived difference -- 'Did you notice a difference?' | initial appointment (day of fitting of hearing aids) |
| Number of Participants Reporting Perceived Differences With Both of the App Slider Controls | Number of SP-BTE participants reporting perceived differences from adjustment of two of the app's Slider controls. Stimuli were presented in a sound room to check the Enhance Speech and Reduce Noise sliders in the app (available in Manual Program). To comment on the effect of the Sliders, participants were asked to adjust the Enhance Speech and Reduce Noise Sliders (separately) to the Maximum and Minimum settings (by sliding the setting indicator across the available range). Yes/No answer to confirm a perceived difference -- 'Did you notice a difference?' | initial appointment (day of fitting of hearing aids) |
| Background | Likert, Rensis. A technique for the measurement of attitudes. Archives of Psychology. 1932; 140: 1-55. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| 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 | Count of Participants | Participants |
|
| Hearing aid candidate | Count of Participants | Participants |
|
| OG001 |
| SP-BTE Hearing Aid Model |
super power hearing aid fitting BTE hearing aid: Amplification |
|
|
| Secondary | Number and Percentage of Participants Reporting No Reboots | Participants to report perceived unwanted reboots of the hearing aids as an indicator of system stability (with use of 2.4 GHz connectivity including accessories and smartphones). Possible responses for perceived reboots (i.e., instances when the amplified sound dropped out and then returned) are: 'No (0) reboots perceived' or 'Reboots perceived (1 or more)'. | Participant (wearing binaural amplification, using accessories and smartphones with 2.4 GHz connectivity) | Posted | Count of Participants | Participants | at any time during home trial, reported at or by final appointment(end of 3 weeks home trial for BTE model, end of 7 weeks home trial for SP-BTE model) |
|
|
|
| Secondary | Number of Participants Reporting Perceived Differences With Both of the App Boost Controls | Number of SP-BTE participants reporting perceived differences from adjustment of the app's Boost controls. Stimuli were presented in a sound room to check the Clarity & Comfort Boosts in the app (available in Automatic Program). To comment on the effect of the Boosts, participants listened to simulated acoustic scenarios, initially under default settings (i.e., with no Boost), then with each Boost (Comfort then Clarity) activated separately (by pressing a button on a screen in the app). Yes/No answer to confirm a perceived difference -- 'Did you notice a difference?' | SP-BTE Participant (wearing binaural amplification, using smartphone app interactive controls); no data were collected for participants in the "BTE hearing aid model" Arm/Group. | Posted | Count of Participants | Participants | initial appointment (day of fitting of hearing aids) |
|
|
|
| Secondary | Number of Participants Reporting Perceived Differences With Both of the App Slider Controls | Number of SP-BTE participants reporting perceived differences from adjustment of two of the app's Slider controls. Stimuli were presented in a sound room to check the Enhance Speech and Reduce Noise sliders in the app (available in Manual Program). To comment on the effect of the Sliders, participants were asked to adjust the Enhance Speech and Reduce Noise Sliders (separately) to the Maximum and Minimum settings (by sliding the setting indicator across the available range). Yes/No answer to confirm a perceived difference -- 'Did you notice a difference?' | SP-BTE Participant (wearing binaural amplification, using smartphone app interactive controls); no data were collected for participants in the "BTE hearing aid model" Arm/Group. | Posted | Count of Participants | Participants | initial appointment (day of fitting of hearing aids) |
|
|
|
| 0 |
| 7 |
| 0 |
| 7 |
| 0 |
| 7 |
| EG001 | SP-BTE Hearing Aid Model | SP-BTE (super power) hearing aid fitting BTE hearing aid: Amplification | 0 | 7 | 0 | 7 | 0 | 7 |
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| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |