Back to resultsBenefit of Assistive Listening Device for Lateralization
Primary Purpose
Hearing Loss, Sensorineural
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Roger On microphone
Roger Select microphone
Sponsored by
About this trial
This is an interventional other trial for Hearing Loss, Sensorineural
Eligibility Criteria
Inclusion Criteria:
- Experienced hearing aid users, age 18 or older
- Bilateral, symmetric moderate to moderate-severe sensorineural hearing loss
- Good understanding of the English language
- Health outer ear as confirmed by otoscopy
- Informed consent as documented by signature
Exclusion Criteria:
- Contraindications to the medical device noted upon otoscopy
- Known hypersensitivity or allergies to materials of the investigations device or comparator
- Inability to produce reliable test results
- Known psychological problems
- Self reported symptoms of vertigo or dizziness
Sites / Locations
- Hearts for Hearing
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Experimental
Arm Description
All participants in the study fit with Phonak Audeo P hearing aids and compatible Phonak Roger receivers.
Outcomes
Primary Outcome Measures
Lateralization Hearing Ability
Participants indicate which direction (left, center, or right) target speech sentences are coming from while competing noise is also presented via four corner speakers. A higher number of correct responses indicates better lateralization ability. This will be done with two Roger microphone systems (Roger On and Roger Select)
Spatial Hearing Ability
Participants repeat sentences presented from the left speaker, while ignoring overlapping competing sentences presented from the right speaker. A higher percentage of correctly repeated words indicates a better spatial hearing score. This task will be performed using two Roger microphone systems (Roger On and Roger Select)
Secondary Outcome Measures
Full Information
NCT ID
NCT05072457
First Posted
September 28, 2021
Last Updated
May 17, 2023
Sponsor
Sonova AG
Collaborators
Hearts for Hearing
1. Study Identification
Unique Protocol Identification Number
NCT05072457
Brief Title
Benefit of Assistive Listening Device for Lateralization
Official Title
Benefit of Assistive Listening Device for Lateralization and Spatial Hearing
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
October 18, 2021 (Actual)
Primary Completion Date
December 13, 2021 (Actual)
Study Completion Date
July 2, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sonova AG
Collaborators
Hearts for Hearing
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
Speech intelligibility in noise will be evaluated in adults with moderate to moderate-severe sensorineural hearing loss using a Phonak Roger microphone and hearing aid with compatible Phonak Roger receiver. Target speech will be presented from multiple directions while competing diffuse background noise is presented simultaneously. Participants will repeat back words and percent correct is calculated.
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
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental
Arm Type
Experimental
Arm Description
All participants in the study fit with Phonak Audeo P hearing aids and compatible Phonak Roger receivers.
Intervention Type
Device
Intervention Name(s)
Roger On microphone
Intervention Description
Roger On microphone transmitter which is used with Roger receivers and Audeo P hearing aids
Intervention Type
Device
Intervention Name(s)
Roger Select microphone
Intervention Description
Roger Select microphone transmitter which is used with Roger receivers and Audeo P hearing aids
Primary Outcome Measure Information:
Title
Lateralization Hearing Ability
Description
Participants indicate which direction (left, center, or right) target speech sentences are coming from while competing noise is also presented via four corner speakers. A higher number of correct responses indicates better lateralization ability. This will be done with two Roger microphone systems (Roger On and Roger Select)
Time Frame
Day 1 of 1 day study
Title
Spatial Hearing Ability
Description
Participants repeat sentences presented from the left speaker, while ignoring overlapping competing sentences presented from the right speaker. A higher percentage of correctly repeated words indicates a better spatial hearing score. This task will be performed using two Roger microphone systems (Roger On and Roger Select)
Time Frame
Day 1 of 1 day study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Experienced hearing aid users, age 18 or older
Bilateral, symmetric moderate to moderate-severe sensorineural hearing loss
Good understanding of the English language
Health outer ear as confirmed by otoscopy
Informed consent as documented by signature
Exclusion Criteria:
Contraindications to the medical device noted upon otoscopy
Known hypersensitivity or allergies to materials of the investigations device or comparator
Inability to produce reliable test results
Known psychological problems
Self reported symptoms of vertigo or dizziness
Facility Information:
Facility Name
Hearts for Hearing
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73120
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Benefit of Assistive Listening Device for Lateralization
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