Back to resultsValidating a Self-fitting Hearing Aid
Primary Purpose
Hearing and Vision Loss
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Fitting algorithm
Sponsored by
About this trial
This is an interventional health services research trial for Hearing and Vision Loss focused on measuring hearing aids, self-fitting
Eligibility Criteria
Inclusion Criteria:
- mild to moderate hearing loss ability to follow written directions,
Exclusion Criteria:
- inability to use software during first visit
Sites / Locations
- University of Minnesota
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
audiologist arm
self-fit arm
Arm Description
A research audiologist will fit the participant with the hearing devices according to usual clinical best practice procedures.
Participants will follow manufacturer's printed instructions to complete the self-hearing test using the hearing aids and a provided app to program their hearing aids.
Outcomes
Primary Outcome Measures
Abbreviated profile of hearing aid benefit
Survey of subjective benefit
Speech in noise test, AZ Bio sentences
Sentence recognition test in background noise
Secondary Outcome Measures
Subjective sound quality rating
Participants rate the quality of sound through hearing aids
Full Information
NCT ID
NCT05246904
First Posted
January 31, 2022
Last Updated
April 24, 2023
Sponsor
University of Minnesota
1. Study Identification
Unique Protocol Identification Number
NCT05246904
Brief Title
Validating a Self-fitting Hearing Aid
Official Title
Validating a Self-fitting Hearing Aid
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
March 17, 2022 (Actual)
Primary Completion Date
November 1, 2022 (Actual)
Study Completion Date
February 28, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
Eargo, Inc. has developed a hearing aid that contains self-fitting gain software that allows adults with mild-to-moderate hearing loss to test their hearing sensitivity and program hearing aids to match their measured hearing loss. Traditionally, hearing aids are custom programmed by a hearing health professional based on a professional hearing test. This technology has the potential to improve affordability and accessibility of hearing aids for adults with mild-to-moderate hearing loss. We propose to validate Eargo's self-fitting software in a clinical trial comparing self-fitting hearing aid outcomes to the same hearing aid fit by a professional following usual clinical best practice for fitting hearing aids.
Detailed Description
The study will recruit 30-50 adults age 18 and over with mild-to-moderate hearing loss in both ears. We will aim to recruit a sample with roughly equal number of males and females and new and experienced hearing aid users (defined by any hearing aid use within the previous 6 months). Hearing loss will be measured using the results of a standard clinical hearing test.
We will use a within-subject, crossover design in which all participants will complete both field trial hearing aid conditions (self-fit and clinically fit hearing aids). The order of the field trials will be randomized across participants to account for any potential order effects. After each field trial, participants will visit the lab to complete study outcome measures, including hearing aid benefit, subjective sound quality, and speech in noise intelligibility testing.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing and Vision Loss
Keywords
hearing aids, self-fitting
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Participants will be randomly assigned to arm 1 (audiologist fit) or arm 2 (self fit) first. After 2-3 weeks they will be tested and then assigned to the opposite arm.
Masking
Participant
Masking Description
Participants will be randomly assigned and will not know which fit is first.
Allocation
Randomized
Enrollment
41 (Actual)
8. Arms, Groups, and Interventions
Arm Title
audiologist arm
Arm Type
Active Comparator
Arm Description
A research audiologist will fit the participant with the hearing devices according to usual clinical best practice procedures.
Arm Title
self-fit arm
Arm Type
Active Comparator
Arm Description
Participants will follow manufacturer's printed instructions to complete the self-hearing test using the hearing aids and a provided app to program their hearing aids.
Intervention Type
Other
Intervention Name(s)
Fitting algorithm
Intervention Description
The best fitting algorithm will be selected by the audiologist (arm 1) or software.
Primary Outcome Measure Information:
Title
Abbreviated profile of hearing aid benefit
Description
Survey of subjective benefit
Time Frame
2-3 weeks
Title
Speech in noise test, AZ Bio sentences
Description
Sentence recognition test in background noise
Time Frame
Immediately after fitting
Secondary Outcome Measure Information:
Title
Subjective sound quality rating
Description
Participants rate the quality of sound through hearing aids
Time Frame
2-3 weeks
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:
mild to moderate hearing loss ability to follow written directions,
Exclusion Criteria:
inability to use software during first visit
Facility Information:
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Validating a Self-fitting Hearing Aid
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