Hearing and Vision Loss
Conditions
Keywords
hearing aids, self-fitting
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.
Interventions
OTHERFitting algorithm
The best fitting algorithm will be selected by the audiologist (arm 1) or software.
Sponsors
University of Minnesota
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Subject)
Masking description
Participants will be randomly assigned and will not know which fit is first.
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* mild to moderate hearing loss ability to follow written directions,
Exclusion criteria
* inability to use software during first visit
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Abbreviated profile of hearing aid benefit | 2-3 weeks | Survey of subjective benefit |
| Speech in noise test, AZ Bio sentences | Immediately after fitting | Sentence recognition test in background noise |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subjective sound quality rating | 2-3 weeks | Participants rate the quality of sound through hearing aids |
Countries
United States
Outcome results
None listed