Validating a Self-fitting Hearing Aid
- Conditions
- Hearing and Vision Loss
- Interventions
- Other: Fitting algorithm
- Registration Number
- NCT05246904
- Lead Sponsor
- University of Minnesota
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 41
- mild to moderate hearing loss ability to follow written directions,
- inability to use software during first visit
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description audiologist arm Fitting algorithm A research audiologist will fit the participant with the hearing devices according to usual clinical best practice procedures. self-fit arm Fitting algorithm 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.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Subjective sound quality rating 2-3 weeks Participants rate the quality of sound through hearing aids
Trial Locations
- Locations (1)
University of Minnesota
🇺🇸Minneapolis, Minnesota, United States