Self Fitting Hearing Aid Clinical Investigation
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Starkey Laboratories, Inc
- Enrollment
- 40
- Locations
- 2
- Primary Endpoint
- 1. Perceived hearing aid benefit- Abbreviated Profile of Hearing Aid Benefit (APHAB)
Study Overview
Brief Summary
Pre-market Clinical Investigation whose primary purpose is to evaluate efficacy and effectiveness of self-fitting hearing aids
Detailed Description
The purpose of this study is to evaluate the outcomes of hearing aids with patient-driven fitting (PD) and clinician-driven fitting (CD). The participants will be 40 adults with mild to moderate symmetrical hearing loss. For each hearing aid fitting strategy, the participant will wear the hearing aids for 10 days. Lab and field outcomes will be measured. This study will determine if perceived hearing benefit and speech recognition performance with the PD fitting method is non-inferior to that with the CD fitting method.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- None
Masking Description
participant is not told which fitting method they have been assigned to
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Native English speakers
- •Ability to complete questionnaires and laboratory assessments
- •Symmetric, mild to moderate sensorineural hearing loss
- •Informed consent completed with signature
- •Healthy outer ear/middle ear status
- •Limited hearing aid use (non-owners of hearing aids)
- •Exclusion criteria:
- •Inability to visit the Starkey Headquarters building for testing
- •Central or middle ear hearing pathology
- •Medical contraindications to wearing hearing aids
- •Learning disability, major cognitive handicap, or serious neurological or psychiatric disease that would prevent or restrict participation, as determined by the PI or designee
- •Hearing loss outside of the specified criteria (Mild to Moderate Sensorineural hearing loss)
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
1. Perceived hearing aid benefit- Abbreviated Profile of Hearing Aid Benefit (APHAB)
Time Frame: The timeframe for this data collection will be unaided, and 14 days post-fitting.
This data will be collected through the APHAB (Abbreviated Profile of Hearing Aid Benefit). This is a 24-item survey of hearing aid benefit. This test will be administered in the unaided hearing aid condition, and in both the traditional and new fitting method conditions. Scores report the reduction in reported problems, and a higher score shows a larger reduction in problems in one condition than the other.
Secondary Outcomes
- 1. Speech intelligibility - Quick Speech in Noise Test (QuickSIN)(Timeframe for this data collection will be unaided, and 14-days post-fitting.)