Validation of Novel BTE and SP Hearing Aid Models
- Conditions
- Hearing Loss
- Interventions
- Device: BTE hearing aid
- Registration Number
- NCT04882787
- Lead Sponsor
- Sonova AG
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 14
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description BTE hearing aid model BTE hearing aid BTE or SP-BTE (super power) hearing aid fitting
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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?'
Trial Locations
- Locations (1)
Unitron Hearing
🇨🇦Kitchener, Ontario, Canada