Back to resultsSound Quality Comparisons With Different Hearing Aid Couplings and Venting Systems
Primary Purpose
Hearing Loss, Sensorineural
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Audeo P90 hearing aid with custom earmolds using dynamic venting
Audeo P90 hearing aid with Open domes
Audeo P90 hearing aid with Vented domes
Sponsored by
About this trial
This is an interventional other trial for Hearing Loss, Sensorineural
Eligibility Criteria
Inclusion Criteria:
- Mild to severe bilateral sensorineural hearing loss
- hearing must be symmetrical below 500 Hz
- must live within 30 miles of Aurora IL
Exclusion Criteria:
-
Sites / Locations
- Sonova US
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Custom earmolds, then Open domes, then Vented domes
Open domes, then Vented domes, then Custom earmolds
Vented domes, then Custom earmolds, then Open domes
Arm Description
Participants first fit with Audeo 90P hearing aids and custom earmolds with dynamic venting, then fit with the same hearing aids using open domes, then fit with the same hearing aids using vented domes.
Participants first fit with Audeo 90P hearing aids and open domes, then fit with the same hearing aids using vented domes, then fit with the same hearing aids using custom earmolds with dynamic venting.
Participants first fit with Audeo 90P hearing aids and vented domes, then fit with the same hearing aids using custom earmolds with dynamic venting, then fit with the same hearing aids using open domes.
Outcomes
Primary Outcome Measures
Sound Quality of Streamed Music Rating Scale
subjective rating on scale from 0 (worst) to 100 (best) for sound quality of streamed signal
Own Voice Sound Quality Rating Scale
subjective rating on a scale from 0 (worst) to 100 (best) for sound quality of participant's own voice quality.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05180630
Brief Title
Sound Quality Comparisons With Different Hearing Aid Couplings and Venting Systems
Official Title
Sound Quality and Occlusion Comparisons With Different Hearing Aid Couplings and Venting Systems
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
October 1, 2021 (Actual)
Primary Completion Date
February 28, 2022 (Actual)
Study Completion Date
April 22, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sonova AG
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
5. Study Description
Brief Summary
Participants will be comparing the sound quality of their own voice and the sound quality of streamed music using universal couplings and a custom earmold with a dynamic vent.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss, Sensorineural
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
17 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Custom earmolds, then Open domes, then Vented domes
Arm Type
Experimental
Arm Description
Participants first fit with Audeo 90P hearing aids and custom earmolds with dynamic venting, then fit with the same hearing aids using open domes, then fit with the same hearing aids using vented domes.
Arm Title
Open domes, then Vented domes, then Custom earmolds
Arm Type
Experimental
Arm Description
Participants first fit with Audeo 90P hearing aids and open domes, then fit with the same hearing aids using vented domes, then fit with the same hearing aids using custom earmolds with dynamic venting.
Arm Title
Vented domes, then Custom earmolds, then Open domes
Arm Type
Experimental
Arm Description
Participants first fit with Audeo 90P hearing aids and vented domes, then fit with the same hearing aids using custom earmolds with dynamic venting, then fit with the same hearing aids using open domes.
Intervention Type
Device
Intervention Name(s)
Audeo P90 hearing aid with custom earmolds using dynamic venting
Intervention Description
Audeo P90 hearing aids coupled to custom earmolds that use dynamic venting.
Intervention Type
Device
Intervention Name(s)
Audeo P90 hearing aid with Open domes
Intervention Description
Audeo P90 hearing aid coupled with non-custom, manufacturer open domes
Intervention Type
Device
Intervention Name(s)
Audeo P90 hearing aid with Vented domes
Intervention Description
Audeo P90 hearing aid coupled with non-custom, manufacturer vented domes
Primary Outcome Measure Information:
Title
Sound Quality of Streamed Music Rating Scale
Description
subjective rating on scale from 0 (worst) to 100 (best) for sound quality of streamed signal
Time Frame
1 day
Title
Own Voice Sound Quality Rating Scale
Description
subjective rating on a scale from 0 (worst) to 100 (best) for sound quality of participant's own voice quality.
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Mild to severe bilateral sensorineural hearing loss
hearing must be symmetrical below 500 Hz
must live within 30 miles of Aurora IL
Exclusion Criteria:
-
Facility Information:
Facility Name
Sonova US
City
Aurora
State/Province
Illinois
ZIP/Postal Code
60504
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Sound Quality Comparisons With Different Hearing Aid Couplings and Venting Systems
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