Back to resultsSpeech Intelligibility in Quiet and Noise for New vs. Legacy Hearing Aids
Primary Purpose
Hearing Loss, Sensorineural, Hearing Loss
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
New Receiver-in-Canal Device
Legacy Receiver-in-Canal Device
Sponsored by
About this trial
This is an interventional treatment trial for Hearing Loss, Sensorineural
Eligibility Criteria
Inclusion Criteria:
- Adults, minimum age of 18
- Native English speakers
- Ability to complete questionnaires and laboratory assessments
- Symmetric, mild to moderately-severe sensorineural hearing loss
- Informed consent completed with signature
Exclusion Criteria:
- Inability to visit the Starkey Headquarters building for testing
- Central or middle ear hearing problems
- Medical contraindications to wearing hearing aids
- Learning disability, major cognitive handicap, or serious neurological or psychiatric disease that would prevent or restrict participation, as determined by the PI or designee
Sites / Locations
- Starkey
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Hearing Aid 1
Hearing Aid 2
Arm Description
New Receiver-in-Canal device, successor of previous device generation
Legacy Receiver-in-Canal device that is currently available on the market
Outcomes
Primary Outcome Measures
Speech intelligibility (% words repeated back correctly) in quiet and noise for new vs. legacy hearing aids
IEEE sentences will be presented to the research participants in quiet and in background noise. The percent words repeated back correctly will be scored and serve as the reported result of this outcome measure.
Secondary Outcome Measures
First fit ratings of sound quality on subjective questionnaires for the new vs. legacy hearing aids
This data will be collected through lab testing following the first fit of the hearing aids. Participants will answer questionnaire items related to their impressions of sound quality. Results will be collected using a 7-point Likert scale, and ratings (1-7) will be analyzed using descriptive statistics. Statistical measures for repeated measurements will be used to understand any differences between hearing aid conditions.
Safety of the new, receiver-in-canal devices through tracking of adverse events
This data will be collected through the tracking of adverse events.
Full Information
NCT ID
NCT05101083
First Posted
October 18, 2021
Last Updated
January 13, 2022
Sponsor
Starkey Laboratories, Inc
1. Study Identification
Unique Protocol Identification Number
NCT05101083
Brief Title
Speech Intelligibility in Quiet and Noise for New vs. Legacy Hearing Aids
Official Title
Speech Intelligibility in Quiet and Noise for New Versus Legacy Hearing Aids
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
October 25, 2021 (Actual)
Primary Completion Date
January 10, 2022 (Actual)
Study Completion Date
January 10, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Starkey Laboratories, Inc
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This clinical investigation is designed to compare audiological performance (i.e., measurements of sound quality and speech understanding) between Starkey's new receiver-in-canal device and a commercially available legacy receiver-in-canal device.
Detailed Description
Starkey is investigating a new hearing aid with several new audiological features. These features have been assessed for benefit, individually, but this clinical investigation will serve as a test for safety and efficacy with all hearing aid features, together. The design of this study is a single-blinded, crossover design and will be conducted at Starkey's headquarters in Eden Prairie, MN.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss, Sensorineural, Hearing Loss
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Crossover Assignment - Each participant will experience both test conditions (counterbalanced)
Masking
Participant
Allocation
Randomized
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Hearing Aid 1
Arm Type
Experimental
Arm Description
New Receiver-in-Canal device, successor of previous device generation
Arm Title
Hearing Aid 2
Arm Type
Active Comparator
Arm Description
Legacy Receiver-in-Canal device that is currently available on the market
Intervention Type
Device
Intervention Name(s)
New Receiver-in-Canal Device
Intervention Description
Successor of previous device generation
Intervention Type
Device
Intervention Name(s)
Legacy Receiver-in-Canal Device
Intervention Description
Receiver-in-canal device available on the market
Primary Outcome Measure Information:
Title
Speech intelligibility (% words repeated back correctly) in quiet and noise for new vs. legacy hearing aids
Description
IEEE sentences will be presented to the research participants in quiet and in background noise. The percent words repeated back correctly will be scored and serve as the reported result of this outcome measure.
Time Frame
Four weeks
Secondary Outcome Measure Information:
Title
First fit ratings of sound quality on subjective questionnaires for the new vs. legacy hearing aids
Description
This data will be collected through lab testing following the first fit of the hearing aids. Participants will answer questionnaire items related to their impressions of sound quality. Results will be collected using a 7-point Likert scale, and ratings (1-7) will be analyzed using descriptive statistics. Statistical measures for repeated measurements will be used to understand any differences between hearing aid conditions.
Time Frame
Four weeks
Title
Safety of the new, receiver-in-canal devices through tracking of adverse events
Description
This data will be collected through the tracking of adverse events.
Time Frame
Four weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Adults, minimum age of 18
Native English speakers
Ability to complete questionnaires and laboratory assessments
Symmetric, mild to moderately-severe sensorineural hearing loss
Informed consent completed with signature
Exclusion Criteria:
Inability to visit the Starkey Headquarters building for testing
Central or middle ear hearing problems
Medical contraindications to wearing hearing aids
Learning disability, major cognitive handicap, or serious neurological or psychiatric disease that would prevent or restrict participation, as determined by the PI or designee
Facility Information:
Facility Name
Starkey
City
Eden Prairie
State/Province
Minnesota
ZIP/Postal Code
55344
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Speech Intelligibility in Quiet and Noise for New vs. Legacy Hearing Aids
We'll reach out to this number within 24 hrs