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

NCT04618315 | Completed Results DMC FDA Device

• 1 other identifier: HL-2019C1-16094
• Study Type: interventional
• Target: 584
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Hearing Aids; Hearing Loss

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Hearing Handicap Inventory for the Elderly

  6 weeks

Other Outcomes (1)

• Duration of Hearing Aid Use

  6 weeks

Study Arms (3)

Audiology-Based Best Practice

ACTIVE COMPARATOR

Hearing aids will be fit using current best practices used by audiologists to fit hearing aids.

Device: Hearing Aids

Consumer Decides

EXPERIMENTAL

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

Efficient Fitting

EXPERIMENTAL

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

Interventions

Hearing Aids DEVICE

Receiver-in-the-ear hearing aids.

Audiology-Based Best Practice; Consumer Decides; Efficient Fitting

Eligibility Criteria

• Age: 50 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (4)

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

Northwestern University Center for Audiology, Speech, Language, and Learning

Evanston, Illinois, 60208, United States

Location

Sertoma Speech and Hearing Center

Palos Hills, Illinois, 60465, United States

Location

University of Texas Medical Branch

Galveston, Texas, 77555, United States

Location

MeSH Terms

Conditions

Hearing Loss

Interventions

Hearing Aids

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Wearable Electronic Devices; Electrical Equipment and Supplies; Equipment and Supplies; Sensory Aids

Limitations and Caveats

This study was initiated in 2020 before the approval of OTC hearing aids. Therefore, the devices used may not represent the quality of OTC hearing aids at any given time. The fitting methods used were derived from previous validation studies by the investigators. These results may not be valid for all self-fitting methods used in OTC hearing aids. Finally, the participants enrolled may not represent the demographic distribution of the United States or the areas in which the study was conducted.

Results Point of Contact

• Title: Sumitrajit Dhar
• Organization: Northwestern University

s-dhar@northwestern.edu

847 491 8542

Study Officials

• Sumitrajit Dhar

  Northwestern University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The principle investigators and the audiologists conducting the outcome measures will be blinded to group assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Three arm blinded randomized control trial.

Study Record Dates

• First Submitted: October 31, 2020
• First Posted: November 5, 2020
• Study Start: December 1, 2020
• Primary Completion: April 1, 2024
• Study Completion: June 30, 2024
• Last Updated: March 6, 2025
• Results First Posted: March 6, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 12 months after study completion through the PCORI data sharing platform.
• Access Criteria: Requests will be evaluated first by PCODR staff who will then consult with PIs before approving access.

Locations

US (4)