Hearing Loss
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEBTE hearing aid
Amplification
Sponsors
Sonova Canada Inc.
Sonova AG
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
2 groups based on hearing aid gain needs; one similar intervention
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* hearing aid candidacy (N2-N7 hearing loss) * healthy outer and middle ears * ability to complete questionnaires * willingness to use smartphone * informed consent documented by a signature * willingness to wear a binaural BTE fitting * willingness to use app and accessories * willingness to adhere to COVID protocols
Exclusion criteria
* contraindications to the MD in this study: known hypersensitivity or allergy to investigational product/earmold * limited mobility/not able to attend appointments * limited ability to describe listening impressions/experiences * inability to produce a reliable hearing test result * limited dexterity - to point that participant cannot manage hearing aid insertion/removal * known psychological disorders
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With 'Total Impression' Sound Quality as 'Good' | final appointment (end of 3 weeks home trial for BTE model, end of 7 weeks home trial for SP-BTE model) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number and Percentage of Participants Reporting No Reboots | 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) | 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)'. |
| Number of Participants Reporting Perceived Differences With Both of the App Boost Controls | initial appointment (day of fitting of hearing aids) | 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?' |
| Number of Participants Reporting Perceived Differences With Both of the App Slider Controls | initial appointment (day of fitting of hearing aids) | 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?' |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| BTE Hearing Aid Model BTE hearing aid fitting
BTE hearing aid: Amplification | 7 |
| SP-BTE Hearing Aid Model Super power BTE hearing aid fitting
BTE hearing aid: Amplification | 7 |
| Total | 14 |
Baseline characteristics
| Characteristic | BTE Hearing Aid Model | SP-BTE Hearing Aid Model | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 3 Participants | 5 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants | 4 Participants | 9 Participants |
| Hearing aid candidate | 7 Participants | 7 Participants | 14 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment Canada | 7 Participants | 7 Participants | 14 Participants |
| Sex: Female, Male Female | 3 Participants | 2 Participants | 5 Participants |
| Sex: Female, Male Male | 4 Participants | 5 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 7 | 0 / 7 |
| other Total, other adverse events | 0 / 7 | 0 / 7 |
| serious Total, serious adverse events | 0 / 7 | 0 / 7 |
Outcome results
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.
Time frame: final appointment (end of 3 weeks home trial for BTE model, end of 7 weeks home trial for SP-BTE model)
Population: Participant (fit with hearing aids binaurally)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| BTE Hearing Aid Model | Number of Participants With 'Total Impression' Sound Quality as 'Good' | Count of participants who reported score of 7 or above | 7 Participants |
| BTE Hearing Aid Model | Number of Participants With 'Total Impression' Sound Quality as 'Good' | Count of participants who reported score of 6 or below | 0 Participants |
| SP-BTE Hearing Aid Model | Number of Participants With 'Total Impression' Sound Quality as 'Good' | Count of participants who reported score of 7 or above | 6 Participants |
| SP-BTE Hearing Aid Model | Number of Participants With 'Total Impression' Sound Quality as 'Good' | Count of participants who reported score of 6 or below | 1 Participants |
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)'.
Time frame: 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)
Population: Participant (wearing binaural amplification, using accessories and smartphones with 2.4 GHz connectivity)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| BTE Hearing Aid Model | Number and Percentage of Participants Reporting No Reboots | Count of participants reporting 0 reboots | 6 Participants |
| BTE Hearing Aid Model | Number and Percentage of Participants Reporting No Reboots | Count of participants reporting 1 or more reboots | 1 Participants |
| SP-BTE Hearing Aid Model | Number and Percentage of Participants Reporting No Reboots | Count of participants reporting 0 reboots | 6 Participants |
| SP-BTE Hearing Aid Model | Number and Percentage of Participants Reporting No Reboots | Count of participants reporting 1 or more reboots | 1 Participants |
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?'
Time frame: initial appointment (day of fitting of hearing aids)
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| BTE Hearing Aid Model | Number of Participants Reporting Perceived Differences With Both of the App Boost Controls | Count of participants reporting a perceived difference, i.e. yes with both of the Boost controls | 7 Participants |
| BTE Hearing Aid Model | Number of Participants Reporting Perceived Differences With Both of the App Boost Controls | Count of participants reporting no perceived difference, i.e. no with both of the Boost controls | 0 Participants |
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?'
Time frame: initial appointment (day of fitting of hearing aids)
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| BTE Hearing Aid Model | Number of Participants Reporting Perceived Differences With Both of the App Slider Controls | Count of participants reporting a perceived difference, i.e. yes with both of the Slider controls | 6 Participants |
| BTE Hearing Aid Model | Number of Participants Reporting Perceived Differences With Both of the App Slider Controls | Count of participants reporting no perceived difference, i.e. no with both of the Slider controls | 1 Participants |