Self Fitting Hearing Aid Clinical Investigation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-18

Study Completion Date

2022-10-10

Brief Summary

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Pre-market Clinical Investigation whose primary purpose is to evaluate efficacy and effectiveness of self-fitting hearing aids

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Detailed Description

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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.

Conditions

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Hearing Loss, Sensorineural

Study Design

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Allocation Method

NA

Intervention Model

SEQUENTIAL

The participants will have three lab sessions and two field trials. In the first session, every participant will receive PD and CD fittings. The wearing schedule orders for all the participants will be counterbalanced. For the first field trial, half of the participants will wear the hearing aids with PD and the other half of the participants will wear the hearing aids with CD. In session two, outcomes for the first hearing aid condition will be measured. Then, the participants will wear hearing aids with the other type of fitting strategy for the second field trial. After that, they will return to the lab for session 3, in which outcomes for the second hearing aid condition will be measured. Outcome measures include a self-report field evaluation (Abbreviated Profile of Hearing Aid Benefit, or APHAB) and a lab-based speech recognition test (Quick Speech-in-Noise Test, Quick-SIN).

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

participant is not told which fitting method they have been assigned to

Study Groups

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Method of fit

Devices are fit using either a clinician completed fitting process or a patient completed fitting process. Then the alternate fitting method is used to repeat the process. The order of which method used is counterbalanced.

Group Type EXPERIMENTAL

Self fitting hearing device

Intervention Type DEVICE

comparison of outcomes when device is fit by clinician or self fit

Interventions

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Self fitting hearing device

comparison of outcomes when device is fit by clinician or self fit

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Native English speakers
2. Ability to complete questionnaires and laboratory assessments
3. Symmetric, mild to moderate sensorineural hearing loss
4. Informed consent completed with signature
5. Healthy outer ear/middle ear status
6. Limited hearing aid use (non-owners of hearing aids)

Exclusion Criteria

1. Inability to visit the Starkey Headquarters building for testing
2. Central or middle ear hearing pathology
3. Medical contraindications to wearing hearing aids
4. Learning disability, major cognitive handicap, or serious neurological or psychiatric disease that would prevent or restrict participation, as determined by the PI or designee
5. Hearing loss outside of the specified criteria (Mild to Moderate Sensorineural hearing loss)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes