- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05855005
Direct-to-Consumer Hearing Aids and Listening Effort
Investigation of Direct-to-consumer Hearing Aids on Conversation Efficiency and Listening Effort
Study Overview
Status
Intervention / Treatment
Detailed Description
Hearing loss is the third most common chronic health condition in the United States, affecting individuals of any age. According to the National Institute on Deafness and Other Communication Disorders approximately 15% of all adults over age 18 in the United States have reported some trouble with their hearing, and one in eight people in the United States (about 30 million) aged 12 and older have hearing loss in both ears. However, about 28.8 million US adults who could benefit from hearing aids do not wear them. The current model of dispensing hearing aids could be a barrier to adoption by those who could benefit from amplification. Possible barriers from the current model include cost and ability to visit a hearing care professional required to purchase, adjust and repair a hearing aid.
The Food and Drug Administration (FDA) issued a proposal in 2021 to make hearing care more accessible for Americans, known as the Over-the-Counter Hearing Aid Act, part of the FDA Reauthorization Act of 2017. Unlike conventional hearing aids, these devices will not require appointments to an audiologist for adjustments. Due to their affordability and easy access, DTC hearing aids have the potential to reach more individuals with hearing loss. Despite the many potential benefits that DTC hearing aids could offer, there is little research into their use to meet unique patient listening needs and the accuracy of self-guided hearing aid fittings.
The investigators will evaluate the benefit of DTC hearing aids via questionnaires and a conversation task the participant engages in with a familiar speaker.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Kendra Marks, AuD
- Phone Number: 8474670897
- Email: kendra.marks@northwestern.edu
Study Contact Backup
- Name: Grace Szatkowski, AuD
- Email: mailto:graceszatkowski2026@u.northwestern.edu
Study Locations
-
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Illinois
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Chicago, Illinois, United States, 60611
- Northwestern University
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Evanston, Illinois, United States, 60208
- Northwestern University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Speak English as their primary language
- No vision impairment that would interfere with the ability to complete study tasks (i.e., legally blind, severe cataracts, or macular degeneration)
- Bilateral mild to moderate sensorineural or mixed hearing loss
- Pass a cognitive screener
- Minimum Grade 10 education
- Ability to attend all study visits
- Eligible communication partner who can attend first study visit.
Exclusion Criteria:
- Clinically significant unstable or progressive medical conditions, or conditions which, in the opinion of the investigator(s) places the participant at unacceptable risk if he or she were to participate in the study
- History of unresolved communication difficulties following another neurological problem (i.e., stroke or brain tumor), neurodevelopmental disorder (i.e., Down's syndrome), or head/neck cancer
- Diagnosis of dementia or cognitive impairment
- Positive history of major psychiatric disorder (i.e., schizophrenia, significant untreated depression)
- Co-enrolled in other intervention studies targeting hearing, language, or communication strategies
- History or current fluctuating hearing loss
- Evidence of conductive hearing loss
- Current active hearing aid wearer (defined as wearing hearing aid(s) at least 4 hours a day for most days within the past year)
- Current active hearing aid wearer within 30-day trial period of purchased hearing aids from a licensed provider
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: DTC Hearing Aid
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DTC hearing aid programmed to the individual participant.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Diapix Conversation Task
Time Frame: Task is completed at first 1 day study visit, with and without hearing aids.
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Participant and their communication partner discuss pictures with slight differences and attempt to locate all the differences by discussion alone.
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Task is completed at first 1 day study visit, with and without hearing aids.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pupillometry and Recall Repeat Task (RRT)
Time Frame: Task will be completed at second 1 day study visit
|
Participant completes the RRT, a measure of memory and reported listening effort where the listener repeats pre-recorded sentences as they are presented and is then asked to recall them 15 seconds later.
The listener also provides subjective listening effort ratings.
While completing this task, the participant's pupil size will be measured.
|
Task will be completed at second 1 day study visit
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Pamela Souza, PhD, Northwestern University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STU00217791
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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.
Clinical Trials on Hearing Loss
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University of California, San FranciscoPatient-Centered Outcomes Research InstituteRecruitingHearing Loss | Hearing Loss, Sensorineural | Hearing Loss, Bilateral | Hearing Loss, Conductive | Hearing Loss, Noise-Induced | Hearing Loss, Unilateral | Hearing Loss, Mixed | Hearing Disorders in ChildrenUnited States
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Oticon MedicalRecruitingEar Diseases | Hearing Loss, Conductive | Hearing Loss Mixed | Hearing Disability | Conductive Hearing Loss | Conductive Hearing Loss, Bilateral | Conductive Hearing Loss, UnilateralUnited Kingdom
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MED-EL Elektromedizinische Geräte GesmbHCompletedHearing Loss | Hearing Loss, Sensorineural | Hearing Loss, Bilateral | Hearing Loss, Conductive | Hearing Loss, Unilateral | Hearing Loss, MixedAustria, Germany, United Kingdom
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Oticon MedicalNot yet recruitingSensorineural Hearing Loss, Bilateral | Sensorineural Hearing Loss, Severe | Sensorineural Hearing Loss, Profound
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Manchester University NHS Foundation TrustUniversity of ManchesterCompletedCochlear Hearing Loss | Sensorineural Hearing Loss, BilateralUnited Kingdom
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Oticon MedicalCompletedConductive Hearing Loss | Conductive and Sensori-neural Hearing Loss in the Same Ear | Unilateral, Profound Sensori-neural Hearing LossUnited States
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Frequency TherapeuticsCompletedHearing Loss, Sensorineural | Presbycusis | Noise Induced Hearing Loss | Sudden Hearing LossUnited States
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Frequency TherapeuticsCompletedHearing Loss, Sensorineural | Noise Induced Hearing Loss | Sudden Hearing LossUnited States
-
Otologic Pharmaceutics, Inc.CompletedHearing Loss | Sensorineural Hearing Loss | Noise-Induced Hearing LossUnited States
-
Otologics LLCUnknownMixed Conductive and Sensorineural Hearing Loss, Bilateral
Clinical Trials on DTC Hearing Aids
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Sonova AGToronto Metropolitan UniversityNot yet recruiting
-
University Hospital, ToursCompletedHearing Loss | Alzheimer's DiseaseFrance
-
Sonova AGCompletedSensorineural Hearing LossSwitzerland
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Jong Woo ChungCompletedAuditory Processing Disorder, CentralKorea, Republic of
-
Northwestern UniversityUniversity of Colorado, BoulderEnrolling by invitation
-
Sonova AGWestern University, Canada; Sonova Canada Inc.Recruiting
-
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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VA Office of Research and DevelopmentCompleted
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Manchester University NHS Foundation TrustUniversity of ManchesterCompletedCochlear Hearing Loss | Sensorineural Hearing Loss, BilateralUnited Kingdom
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Technical University of DenmarkCompleted