Self Fitting Hearing Aid Clinical Investigation

Sponsor

Starkey Laboratories, Inc (Industry)

Overall Status

Completed

CT.gov ID

NCT05612763

Collaborator

(none)

Enrollment

Location

Arm

1.7

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Hearing Loss, Sensorineural	Device: Self fitting hearing device	N/A

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

Actual Enrollment :

40 participants

Allocation:

N/A

Intervention Model:

Sequential Assignment

Intervention Model Description:

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).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).

Masking:

None (Open Label)

Masking Description:

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

Primary Purpose:

Treatment

Official Title:

Self Fitting Hearing Aid Clinical Investigation

Actual Study Start Date :

Aug 18, 2022

Actual Primary Completion Date :

Oct 3, 2022

Actual Study Completion Date :

Oct 10, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Device: Self fitting hearing device comparison of outcomes when device is fit by clinician or self fit

Arm

Intervention/Treatment

Experimental: 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.

Device: Self fitting hearing device

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

Outcome Measures

Primary Outcome Measures

1. Perceived hearing aid benefit- Abbreviated Profile of Hearing Aid Benefit (APHAB) [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 Outcome Measures

1. Speech intelligibility - Quick Speech in Noise Test (QuickSIN) [Timeframe for this data collection will be unaided, and 14-days post-fitting.]
This data will be collected with the QuickSIN, which is an adaptive measure of speech recognition in background noise. Outcome score is reported in "dB SNR loss." A reduced SNR loss is a better score and implies that the lower score performs better than the higher score.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Starkey Laboratories	Eden Prairie	Minnesota	United States	55344

Sponsors and Collaborators

Starkey Laboratories, Inc

Investigators

Study Director: Michelle Hicks, PhD, VP education and Clinical Studies

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Starkey Laboratories, Inc

ClinicalTrials.gov Identifier:

NCT05612763

Other Study ID Numbers:

GQ-PRO-06093

First Posted:

Nov 10, 2022

Last Update Posted:

Nov 10, 2022

Last Verified:

Nov 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Yes

Keywords provided by Starkey Laboratories, Inc

self fitting

Additional relevant MeSH terms:

Hearing Loss

Hearing Loss, Sensorineural

Seizures

Study Results

No Results Posted as of Nov 10, 2022