Barriers and Facilitators to OTC Hearing Aids Success
2 other identifiers
interventional
360
1 country
2
Brief Summary
Hearing aids can improve hearing, communication, and overall quality of life for people with hearing loss. However, not many people use hearing aids. A common reason is that hearing aids are expensive and hard to get. The traditional way to get hearing aids involves multiple visits to licensed audiologists for identifying hearing loss, customizing the aids, and ongoing maintenance. This traditional method is called the AUD pathway. Over-the-counter (OTC) hearing aids offer a different approach. They aim to make hearing aids more affordable and accessible, encouraging earlier use. In the OTC pathway, users diagnose their own hearing loss and fit and program the hearing aids themselves. Little is known about long-term effects of OTC hearing aids on users. This study aims to compare the experiences of people who choose the OTC pathway with those who choose the AUD pathway. It takes place in two locations: Iowa City, IA, and Nashville, TN. Participants, who have mild-to-moderate hearing loss, choose their preferred pathway and are followed for 12 months. In the OTC pathway, participants buy their hearing aids directly from OTC companies or retailers. In the AUD pathway, prescription hearing aids and fitting services are provided by audiology clinics at the University of Iowa and Vanderbilt University Medical Center. Participants are contacted 1, 6, and 12 months after starting to use their hearing aids. Researchers measure their satisfaction about hearing aids and other outcomes. If participants stop using their hearing aids, researchers assess their engagement with post-amplification hearing care. The results from both pathways are then compared.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2025
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 5, 2024
CompletedFirst Posted
Study publicly available on registry
July 12, 2024
CompletedStudy Start
First participant enrolled
March 15, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 1, 2029
May 21, 2025
May 1, 2025
4 years
July 5, 2024
May 20, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Hearing aid satisfaction as measured by the Satisfaction with Amplification in Daily Life (SADL)
The SADL is a questionnaire designed to measures subject's perceived hearing aid satisfaction. The score ranges from 1 (low satisfaction) to 7 (high satisfaction).
1-, 6-, and 12-month post-intervention
Secondary Outcomes (5)
Overall hearing aid outcome as measured by the International Outcome Inventory for Hearing Aids (IOI-HA)
1-, 6-, and 12-month post-intervention
Aided hearing-specific quality of life as measured by the the Revised Hearing Handicap Inventory (RHHI).
1-, 6-, and 12-month post-intervention
Hearing aid related issues as measured by the Hearing Aid Issues Survey
1-, 6-, and 12-month post-intervention
Hearing aid success as measured by the HA Use Questionnaire
1-, 6-, and 12-month post-intervention
Engagement with post-amplification hearing healthcare behaviors measured by the Hearing Healthcare Behavior Questionnaire
1-, 6-, and 12-month post-intervention
Study Arms (2)
AUD (audiologist-based)
ACTIVE COMPARATORIn this group, the audiologist-based fitting will be used to provide prescription hearing aids.
OTC (over-the-counter)
EXPERIMENTALIn this group, over-the-counter fitting will be used to provide over-the-counter hearing aids.
Interventions
Description hearing aids will be fitted by audiologists using established procedures.
In this group, over-the-counter hearing aids will be used by subjects. Subjects will take the full initiative and responsibility for learning and using hearing aids.
Eligibility Criteria
You may qualify if:
- adult-onset, perceived bilateral mild-to-moderate hearing loss
- no previous hearing aid experience
You may not qualify if:
- Non-native speaker of English
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Yu-Hsiang Wulead
- National Institute on Deafness and Other Communication Disorders (NIDCD)collaborator
- Vanderbilt University Medical Centercollaborator
- University of Manchestercollaborator
Study Sites (2)
University of Iowa
Iowa City, Iowa, 52242, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
Related Publications (7)
Brody L, Wu YH, Stangl E. A Comparison of Personal Sound Amplification Products and Hearing Aids in Ecologically Relevant Test Environments. Am J Audiol. 2018 Dec 6;27(4):581-593. doi: 10.1044/2018_AJA-18-0027.
PMID: 30458521BACKGROUNDChien W, Lin FR. Prevalence of hearing aid use among older adults in the United States. Arch Intern Med. 2012 Feb 13;172(3):292-3. doi: 10.1001/archinternmed.2011.1408. No abstract available.
PMID: 22332170BACKGROUNDGopinath B, Schneider J, Hartley D, Teber E, McMahon CM, Leeder SR, Mitchell P. Incidence and predictors of hearing aid use and ownership among older adults with hearing loss. Ann Epidemiol. 2011 Jul;21(7):497-506. doi: 10.1016/j.annepidem.2011.03.005. Epub 2011 Apr 21.
PMID: 21514179BACKGROUNDHumes LE, Rogers SE, Quigley TM, Main AK, Kinney DL, Herring C. The Effects of Service-Delivery Model and Purchase Price on Hearing-Aid Outcomes in Older Adults: A Randomized Double-Blind Placebo-Controlled Clinical Trial. Am J Audiol. 2017 Mar 1;26(1):53-79. doi: 10.1044/2017_AJA-16-0111.
PMID: 28252160BACKGROUNDLin FR, Niparko JK, Ferrucci L. Hearing loss prevalence in the United States. Arch Intern Med. 2011 Nov 14;171(20):1851-2. doi: 10.1001/archinternmed.2011.506. No abstract available.
PMID: 22083573BACKGROUNDNelson PB, Perry TT, Gregan M, VanTasell D. Self-Adjusted Amplification Parameters Produce Large Between-Subject Variability and Preserve Speech Intelligibility. Trends Hear. 2018 Jan-Dec;22:2331216518798264. doi: 10.1177/2331216518798264.
PMID: 30191767BACKGROUNDUrbanski D, Hernandez H, Oleson J, Wu YH. Toward a New Evidence-Based Fitting Paradigm for Over-the-Counter Hearing Aids. Am J Audiol. 2021 Mar 10;30(1):43-66. doi: 10.1044/2020_AJA-20-00085. Epub 2020 Dec 1.
PMID: 33264578BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yu-Hsiang Wu, PhD
University of Iowa
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
July 5, 2024
First Posted
July 12, 2024
Study Start
March 15, 2025
Primary Completion (Estimated)
April 1, 2029
Study Completion (Estimated)
April 1, 2029
Last Updated
May 21, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- The data will be available no later than the publication of the main findings.
- Access Criteria
- The data will be deposited in the Inter-University Consortium for Political and Social Research (ICPSR), and will be available to the public.
The proposed research will include data from a total of 360 participants with hearing loss recruited State of Iowa, State of Tennessee and surrounding areas. The final dataset will include self-reported hearing aid outcome data. All datasets and metadata that can be shared will be deposited in the Inter-University Consortium for Political and Social Research (ICPSR).