Self Fitting Hearing Aid Clinical Investigation

Not Applicable

Completed

• Conditions: Hearing Loss, Sensorineural
• Interventions: Device: Self fitting hearing device

• Registration Number: NCT05612763
• Lead Sponsor: Starkey Laboratories, Inc

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 Timeline

• Study Start: 2022-08-18
• Primary Completion: 2022-10-03
• Study Completion: 2022-10-10
• Study First Submitted: 2022-10-28
• Status Verified: 2022-11
• Study First Submitted QC: 2022-11-04
• Last Update Submitted: 2022-11-04
• Study First Posted: 2022-11-10
• Last Update Posted: 2022-11-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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)

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Method of fit	Self fitting hearing device	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Starkey Laboratories; 🇺🇸 Eden Prairie, Minnesota, United States