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Validating a Self-fitting Hearing Aid

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ClinicalTrials.gov Identifier: NCT05246904
Recruitment Status : Active, not recruiting
First Posted : February 18, 2022
Last Update Posted : February 8, 2023
Sponsor:
Information provided by (Responsible Party):
University of Minnesota

Study Description
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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.

Condition or disease Intervention/treatment Phase
Hearing and Vision Loss Other: Fitting algorithm Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention 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: Single (Participant)
Masking Description: Participants will be randomly assigned and will not know which fit is first.
Primary Purpose: Health Services Research
Official Title: Validating a Self-fitting Hearing Aid
Actual Study Start Date : March 17, 2022
Actual Primary Completion Date : November 1, 2022
Estimated Study Completion Date : February 28, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: audiologist arm
A research audiologist will fit the participant with the hearing devices according to usual clinical best practice procedures.
 Other: Fitting algorithm
The best fitting algorithm will be selected by the audiologist (arm 1) or software.
Active Comparator: self-fit arm
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.
 Other: Fitting algorithm
The best fitting algorithm will be selected by the audiologist (arm 1) or software.


Outcome Measures
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Primary Outcome Measures :
  1. Abbreviated profile of hearing aid benefit [ Time Frame: 2-3 weeks ]
    Survey of subjective benefit

  2. Speech in noise test, AZ Bio sentences [ Time Frame: Immediately after fitting ]
    Sentence recognition test in background noise


Secondary Outcome Measures :
  1. Subjective sound quality rating [ Time Frame: 2-3 weeks ]
    Participants rate the quality of sound through hearing aids


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • mild to moderate hearing loss ability to follow written directions,

Exclusion Criteria:

  • inability to use software during first visit
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05246904


Locations
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United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
University of Minnesota
More Information
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Responsible Party: University of Minnesota
ClinicalTrials.gov Identifier: NCT05246904    
Other Study ID Numbers: STUDY00015143
First Posted: February 18, 2022    Key Record Dates
Last Update Posted: February 8, 2023
Last Verified: February 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Keywords provided by University of Minnesota:
hearing aids, self-fitting
Additional relevant MeSH terms:
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Deaf-Blind Disorders
Seizures
Neurologic Manifestations
Nervous System Diseases
Deafness
Hearing Loss
Hearing Disorders
Ear Diseases
 Otorhinolaryngologic Diseases
Sensation Disorders
Blindness
Vision Disorders
Eye Diseases
Abnormalities, Multiple
Congenital Abnormalities