Self Fitting Hearing Aid Clinical Investigation

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

Study Overview

• Status: Completed
• Conditions: Hearing Loss, Sensorineural
• Intervention / Treatment: Device: Self fitting hearing device

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Eden Prairie, Minnesota, United States, 55344
      • Starkey Laboratories

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
1. Perceived hearing aid benefit- Abbreviated Profile of Hearing Aid Benefit (APHAB)	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.	The timeframe for this data collection will be unaided, and 14 days post-fitting.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
1. Speech intelligibility - Quick Speech in Noise Test (QuickSIN)	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.	Timeframe for this data collection will be unaided, and 14-days post-fitting.

Collaborators and Investigators

• Sponsor: Starkey Laboratories, Inc
• Investigators: Study Director: Michelle Hicks, PhD, VP education and Clinical Studies

Study record dates

Study Major Dates

• Study Start (Actual): August 18, 2022
• Primary Completion (Actual): October 3, 2022
• Study Completion (Actual): October 10, 2022

Study Registration Dates

• First Submitted: October 28, 2022
• First Submitted That Met QC Criteria: November 4, 2022
• First Posted (Actual): November 10, 2022

Study Record Updates

• Last Update Posted (Actual): November 10, 2022
• Last Update Submitted That Met QC Criteria: November 4, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: self fitting
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Seizures; Hearing Loss; Hearing Loss, Sensorineural
• Other Study ID Numbers: GQ-PRO-06093

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Overall data that does not identify the individual will be made available upon request, and summaries of the study data and data analysis will be provided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes