- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04618315
Patient-Centered Hearing Aid Trial (P-CHAT)
November 23, 2023 updated by: Sumit Dhar, Northwestern University
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
Active, not recruiting
Conditions
Intervention / Treatment
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
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Sumit Dhar, PhD
- Phone Number: 847 491 2470
- Email: s-dhar@northwestern.edu
Study Contact Backup
- Name: Mary Meskan, PhD
- Phone Number: 847 467 0123
- Email: Mary.meskan@northwestern.edu
Study Locations
-
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Illinois
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Chicago, Illinois, United States, 60611
- Northwestern Memorial Hospital
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Evanston, Illinois, United States, 60208
- Northwestern University Center for Audiology, Speech, Language, and Learning
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Palos Hills, Illinois, United States, 60465
- Sertoma Speech and Hearing Center
-
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Texas
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Galveston, Texas, United States, 77555
- University of Texas Medical Branch
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
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.
|
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.
|
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.
|
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
Time Frame: 6 weeks
|
66-item self-assessment, disability-based inventory.
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6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hearing Handicap Inventory for the Elderly
Time Frame: 6 weeks
|
A self-administered scale to identify problems related to hearing loss.
|
6 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Duration of hearing aid use
Time Frame: 6 weeks
|
Average hours of hearing aid use per day.
|
6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2020
Primary Completion (Actual)
November 16, 2023
Study Completion (Estimated)
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)
November 27, 2023
Last Update Submitted That Met QC Criteria
November 23, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HL-2019C1-16094
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Clinical Trials on Hearing Aids
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Sonova AGToronto Metropolitan UniversityNot yet recruiting
-
University Hospital, ToursCompletedHearing Loss | Alzheimer's DiseaseFrance
-
Jong Woo ChungCompletedAuditory Processing Disorder, CentralKorea, Republic of
-
Sonova AGCompletedSensorineural Hearing LossSwitzerland
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Sonova AGWestern University, Canada; Sonova Canada Inc.Recruiting
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Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityRecruitingHearing Loss, Sensorineural | Cognitive Function Abnormal | Age-related Hearing Loss | Hearing AidChina
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Technical University of DenmarkCompleted