P-CHAT: Comparison of Direct to Consumer Delivery Models for Hearing Devices (P-CHAT)

Patient-Centered Hearing Aid Trial: Comparison of Direct to Consumer Delivery Models for Hearing Devices

Satisfaction and benefit from hearing aids fit using two patient self fit methods will be compared against those fit using audiology-based best practices. Individuals between the ages of 50 and 79 years of age will be randomly assigned to one of three fitting methods. Benefit and satisfaction will be evaluated six weeks and six months after the initial fitting.

Study Overview

• Status: Completed
• Conditions: Hearing Loss; Hearing Aids
• Intervention / Treatment: Device: Hearing Aids

Detailed Description

Hearing aids are the most pertinent treatment for most adults with hearing loss, a pervasive chronic health problem in ~40% of those over the age of 60 years. Only 20% of these individuals purchase and use hearing aids. The Over-the-Counter Hearing Aid Act of 2017 is designed to increase affordability and accessibility, and thereby adoption, of hearing aids. While this legislation directs the Food and Drug Administration (FDA) to create and administer this new channel of hearing aid provision by 2020, best practices related to hearing aid provision without the involvement of a professional, licensed provider have not been explored and established. Patients do not have the evidence they need to decide between modes of acquiring hearing aids. The current proposal addresses the specific knowledge gap of efficacious direct-to-consumer hearing aid delivery models. Two methods of patient-driven methods of selecting and fitting hearing aids will be compared against audiology-based best practice fitting. Individuals who perceive mild or moderate hearing difficulty will be randomly assigned to one of three fitting arms. Satisfaction and benefit from hearing aids will be assessed at six weeks and six months after initial fit.

• Study Type: Interventional
• Enrollment (Actual): 584
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern Memorial Hospital
    • Evanston, Illinois, United States, 60208
      • Northwestern University Center for Audiology, Speech, Language, and Learning
    • Palos Hills, Illinois, United States, 60465
      • Sertoma Speech and Hearing Center
  • Texas
    • Galveston, Texas, United States, 77555
      • University of Texas Medical Branch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 50 - 79 years old.
• Mild or moderate hearing difficulty.
• Normal cognition.
• No prior hearing aid experience.
• Ability and willingness to pay privately ($650.00) for hearing aids
• Ability to read and understand English
• Symmetric hearing loss, no greater than moderate in degree

Exclusion Criteria:

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Audiology-Based Best Practice; Hearing aids will be fit using current best practices used by audiologists to fit hearing aids.	Device: Hearing Aids; Receiver-in-the-ear hearing aids.
Experimental: Consumer Decides; Hearing aids will be self fit by patients using an interactive application on a tablet computer. Patients will choose their preferred hearing aid settings after comparing four settings with varying loudness levels.	Device: Hearing Aids; Receiver-in-the-ear hearing aids.
Experimental: Efficient Fitting; Hearing aids will be self fit by patients using an interactive application on a tablet computer. Patients will choose their preferred hearing aid settings after comparing four settings with varying base and treble settings.	Device: Hearing Aids; Receiver-in-the-ear hearing aids.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Profile of Hearing Aid Benefit	66-item self-assessment, disability-based inventory. Participants answer the questionnaire twice, first prior to use of hearing aids and then after hearing aid use. The questionnaire is scored between 0-99% with higher values representing greater difficulty. Benefit is reported as the difference between the two scores with a higher number signifying greater benefit.	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hearing Handicap Inventory for the Elderly	A self-administered scale to identify problems related to hearing loss. The questionnaire has 25 items and can be scored between 0 and 100. The score after hearing aid use is subtracted from the baseline score (prior to hearing aid use) to obtain the benefit score. The higher the difference the greater the benefit.	6 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of Hearing Aid Use	Average hours of hearing aid use per day.	6 weeks

Collaborators and Investigators

• Sponsor: Northwestern University
• Collaborators: Leslie Rolph; Tom Wardzala; Malini Patel; Tracy Winn; Larry E. Humes; Mary Meskan
• Investigators: Principal Investigator: Sumitrajit Dhar, Northwestern University

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2020
• Primary Completion (Actual): April 1, 2024
• Study Completion (Actual): June 30, 2024

Study Registration Dates

• First Submitted: October 31, 2020
• First Submitted That Met QC Criteria: October 31, 2020
• First Posted (Actual): November 5, 2020

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 28, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Ear Diseases; Hearing Disorders; Hearing Loss
• Other Study ID Numbers: HL-2019C1-16094

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data will be shared at the Patient-Centered Outcomes Data Repository
• IPD Sharing Time Frame: 12 months after study completion through the PCORI data sharing platform.
• IPD Sharing Access Criteria: Requests will be evaluated first by PCODR staff who will then consult with PIs before approving access.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

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.: No