Status:
COMPLETED
Validation of Novel BTE and SP Hearing Aid Models
Lead Sponsor:
Sonova AG
Collaborating Sponsors:
Sonova Canada Inc.
Conditions:
Hearing Loss
Eligibility:
All Genders
18-85 years
Phase:
NA
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 particip...
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. ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 14 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 13 2021
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT04882787
Start Date
May 14 2021
End Date
July 13 2021
Last Update
August 12 2024
Active Locations (1)
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1
Unitron Hearing
Kitchener, Ontario, Canada, N2E 1Y6