Back to resultsBenefits of Assistive Listening Device for Speech Intelligibility
Primary Purpose
Hearing Loss
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Roger microphone
Phonak Audeo hearing aid
Sponsored by
About this trial
This is an interventional other trial for Hearing Loss
Eligibility Criteria
Inclusion Criteria:
- adults with bilateral moderate to moderate severe sensorineural hearing loss, pure tone average must be between 40 and 69 dB HL (decibel Hearing Level)
Exclusion Criteria:
-
Sites / Locations
- Hearts for Hearing
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Experimental
Arm Description
Participants with bilateral moderate to severe sensorineural hearing loss
Outcomes
Primary Outcome Measures
Speech Intelligibility in Noise
The percent of correctly repeated words, when a list of 10 sentences is presented in noise. Ten sentences are presented at a certain loudness level while background noise is presented simultaneously at a specific loudness level. The number of words repeated correctly is calculated from the total number of words presented.
Secondary Outcome Measures
Full Information
NCT ID
NCT05072470
First Posted
September 28, 2021
Last Updated
February 10, 2023
Sponsor
Sonova AG
Collaborators
Hearts for Hearing
1. Study Identification
Unique Protocol Identification Number
NCT05072470
Brief Title
Benefits of Assistive Listening Device for Speech Intelligibility
Official Title
Benefits of an Assistive Listening Device for Speech Intelligibility in Noise
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
October 18, 2021 (Actual)
Primary Completion Date
December 13, 2021 (Actual)
Study Completion Date
December 13, 2021 (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 an assistive listening device and hearing aid, and compared to speech intelligibility in noise using hearing aids alone.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss
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
Participants with bilateral moderate to severe sensorineural hearing loss
Intervention Type
Device
Intervention Name(s)
Roger microphone
Intervention Description
Commercially available transmitter microphone which sends distant speech signals to a receiver that is attached/embedded into hearing aids.
Intervention Type
Device
Intervention Name(s)
Phonak Audeo hearing aid
Intervention Description
Commercially available receiver-in-canal hearing aid
Primary Outcome Measure Information:
Title
Speech Intelligibility in Noise
Description
The percent of correctly repeated words, when a list of 10 sentences is presented in noise. Ten sentences are presented at a certain loudness level while background noise is presented simultaneously at a specific loudness level. The number of words repeated correctly is calculated from the total number of words presented.
Time Frame
Day 1 of a one day study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
adults age 18 or older with bilateral moderate to moderate severe sensorineural hearing loss, pure tone average must be between 40 and 69 dB HL (decibel Hearing Level)
experienced hearing aid users
symmetric hearing loss (no more than 15 dB difference between the ears at three contiguous frequencies)
good written and spoken English language skills
healthy outer ear as confirmed by otoscopy
Exclusion Criteria:
contradictions to medical device noted upon otoscopy
known hypersensitivity or allergy to materials of investigational device or comparator
inability to produce reliable test results
known psychological problems
self reported symptoms of dizziness or vertigo
Facility Information:
Facility Name
Hearts for Hearing
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73120
Country
United States
12. IPD Sharing Statement
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Benefits of Assistive Listening Device for Speech Intelligibility
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