Validating a Self-fitting Hearing Aid

Study Overview
=================
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.

Official Title
-----------------
Validating a Self-fitting Hearing Aid

Conditions
-----------------
Hearing and Vision Loss

Intervention / Treatment
-----------------
* Other: Fitting algorithm


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: mild to moderate hearing loss ability to follow written directions, Exclusion Criteria: inability to use software during first visit

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: audiologist arm<br>A research audiologist will fit the participant with the hearing devices according to usual clinical best practice procedures. | Other: Fitting algorithm<br>* The best fitting algorithm will be selected by the audiologist (arm 1) or software.<br>|
| Active Comparator: self-fit arm<br>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<br>* The best fitting algorithm will be selected by the audiologist (arm 1) or software.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Abbreviated profile of hearing aid benefit | Survey of subjective benefit | 2-3 weeks | 
| Speech in noise test, AZ Bio sentences | Sentence recognition test in background noise | Immediately after fitting | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective sound quality rating | Participants rate the quality of sound through hearing aids | 2-3 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hearing aids, self-fitting