Validation of 2 Novel BTE Hearing Aid Models Varying With Respect to Regular-power or Super-power Gain Specifications
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Sonova AG
- Enrollment
- 14
- Locations
- 1
- Primary Endpoint
- Number of Participants With 'Total Impression' Sound Quality as 'Good'
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
BTE hearing aid model
BTE or SP-BTE (super power) hearing aid fitting
Intervention: BTE hearing aid (Device)
Outcomes
Primary Outcomes
Number of Participants With 'Total Impression' Sound Quality as 'Good'
Time Frame: 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 Outcomes
- 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))
- Number of Participants Reporting Perceived Differences With Both of the App Boost Controls(initial appointment (day of fitting of hearing aids))
- Number of Participants Reporting Perceived Differences With Both of the App Slider Controls(initial appointment (day of fitting of hearing aids))