Self Fitting Hearing Aid Clinical Investigation

NCT05612763 | Completed FDA Device

• 1 other identifier: GQ-PRO-06093
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hearing Loss, Sensorineural

Keywords

self fitting

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 1. Speech intelligibility - Quick Speech in Noise Test (QuickSIN)

  Timeframe for this data collection will be unaided, and 14-days post-fitting.

Study Arms (1)

Method of fit

EXPERIMENTAL

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

Interventions

Self fitting hearing device DEVICE

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

Method of fit

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Starkey Laboratories, Inc: lead

Study Sites (1)

Starkey Laboratories

Eden Prairie, Minnesota, 55344, United States

Location

MeSH Terms

Conditions

Hearing Loss, Sensorineural

Condition Hierarchy (Ancestors)

Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Michelle Hicks, PhD

  VP education and Clinical Studies

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: participant is not told which fitting method they have been assigned to
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: October 28, 2022
• First Posted: November 10, 2022
• Study Start: August 18, 2022
• Primary Completion: October 3, 2022
• Study Completion: October 10, 2022
• Last Updated: November 10, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)