Evaluating Hearing Aid Service Delivery Models
2 other identifiers
interventional
323
1 country
1
Brief Summary
The purpose of this study is to compare the outcomes for two different hearing-aid delivery models. In one model, the audiologist selects and fits the hearing aid and, in the other model, the consumer does this directly.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2012
Longer than P75 for not_applicable
1 active site
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
October 24, 2012
CompletedStudy Start
First participant enrolled
November 1, 2012
CompletedFirst Posted
Study publicly available on registry
February 11, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2018
CompletedResults Posted
Study results publicly available
July 23, 2019
CompletedJuly 23, 2019
July 1, 2019
5.3 years
October 24, 2012
May 23, 2019
July 3, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Profile of Hearing Aid Performance Benefit (PHAB)
Change from unaided to aided performance on the Profile of Hearing Aid Performance with the difference in aided and unaided scores labeled Profile of Hearing Aid Benefit (PHAB), a self-report measure of benefit. The aided and unaided PHAP scores are proportions of time difficulties encountered in various listening situations. Low PHAP scores indicate less frequent difficulties. When subtracting aided from unaided PHAP scores, a positive PHAB score reflects less frequent problems when wearing a hearing aid compared to without. The range of possible PHAB scores are -1.0 to +1.0 with 0.0 indicating no difference between aided and unaided performance. There are seven subscales of the PHAP/PHAB and the scores reported are based on the arithmetic means of the five subscales that deal with speech communication, PHABglobal. These include the following subscale scores: EC (Ease of Communication), FT (Familiar Talkers), BN (Background Noise), Reverberation (RV) and Reduced Cues (RC).
two times: at hearing-aid fit and at 6-weeks post-fit
Secondary Outcomes (1)
Connected Speech Test (CST) Benefit
two times: at hearing-aid fit and at 6-weeks post-fit
Study Arms (3)
Audiologist-Based
EXPERIMENTALAudiologist selects hearing aid for patient
Consumer Decides
EXPERIMENTALConsumer selects hearing aid
Placebo
PLACEBO COMPARATORPatient fitted with hearing aid that is acoustically transparent.
Interventions
All subjects received hearing aids, some selected by audiologist, some selected by consumer, and some programmed as placebo devices.
Eligibility Criteria
You may qualify if:
- yrs of age
- Native English speaker
- no prior hearing aid use
- ability to read 18 point font
You may not qualify if:
- hearing loss too severe or too mild for hearing aid
- middle-ear conductive pathology present
- asymmetrical hearing loss
- presence of dementia, Parkinson's disease, or other neurological disorder
- \- subject not interested in purchasing hearing aids
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
IU Department of Speech & Hearing Sciences
Bloomington, Indiana, 47405-7002, United States
Related Publications (2)
Humes LE, Kinney DL, Main AK, Rogers SE. A Follow-Up Clinical Trial Evaluating the Consumer-Decides Service Delivery Model. Am J Audiol. 2019 Mar 15;28(1):69-84. doi: 10.1044/2018_AJA-18-0082.
PMID: 30938563DERIVEDHumes 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: 28252160DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Larry E. Humes
- Organization
- Indiana University, Department of Speech and Hearing Sci
Study Officials
- PRINCIPAL INVESTIGATOR
Larry E. Humes, PhD
Indiana University
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Distinguished Professor
Study Record Dates
First Submitted
October 24, 2012
First Posted
February 11, 2013
Study Start
November 1, 2012
Primary Completion
February 28, 2018
Study Completion
February 28, 2018
Last Updated
July 23, 2019
Results First Posted
July 23, 2019
Record last verified: 2019-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF
- Time Frame
- Already available online with Open Access publication of the study in March, 2017.
- Access Criteria
- Open Access to protocol, study forms, and detailed results via publication in March, 2017. De-identified data available from investigator upon request.
Study protocol, study forms, and final publication all available via Open Access publication in the American Journal of Audiology in March, 2017. De-identified individual data available from PI upon request.