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Evaluating Hearing Aid Service Delivery Models

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Institute on Deafness and Other Communication Disorders (NIDCD)
Information provided by (Responsible Party):
Larry Humes, Indiana University
ClinicalTrials.gov Identifier:
NCT01788423
First received: October 24, 2012
Last updated: May 19, 2016
Last verified: May 2016
  Purpose
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.

Condition Intervention Phase
Presbycusis
Aging
Hearing Loss
Device: hearing aid
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluating Hearing Aid Service Delivery Models

Resource links provided by NLM:


Further study details as provided by Indiana University:

Primary Outcome Measures:
  • Change from baseline on the Profile of Hearing Aid Performance [ Time Frame: two times: at hearing-aid fit and at 6-weeks post-fit ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline on the Connected Speech Test [ Time Frame: two times: at hearing-aid fit and at 6-weeks post-fit ] [ Designated as safety issue: No ]

Estimated Enrollment: 180
Study Start Date: November 2012
Estimated Study Completion Date: October 2016
Estimated Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Audiologist-Based
Audiologist selects hearing aid for patient
Device: hearing aid
All subjects received hearing aids, some selected by audiologist, some selected by consumer, and some programmed as placebo devices.
Experimental: Consumer Decides
Consumer selects hearing aid
Device: hearing aid
All subjects received hearing aids, some selected by audiologist, some selected by consumer, and some programmed as placebo devices.
Placebo Comparator: Placebo
Patient fitted with hearing aid that is acoustically transparent.
Device: hearing aid
All subjects received hearing aids, some selected by audiologist, some selected by consumer, and some programmed as placebo devices.

  Eligibility

Ages Eligible for Study:   55 Years to 79 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 55-79 yrs of age
  • Native English speaker
  • no prior hearing aid use
  • ability to read 18 point font

Exclusion Criteria:

  • hearing loss too severe or too mild for hearing aid
  • middle-ear conductive pathology present
  • asymmetrical hearing loss
  • subject not interested in purchasing hearing aids
  • presence of dementia, Parkinson's disease, or other neurological disorder
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01788423

Locations
United States, Indiana
IU Department of Speech & Hearing Sciences
Bloomington, Indiana, United States, 47405-7002
Sponsors and Collaborators
Indiana University
National Institute on Deafness and Other Communication Disorders (NIDCD)
Investigators
Principal Investigator: Larry E. Humes, PhD Indiana University
  More Information

Responsible Party: Larry Humes, Distinguished Professor, Indiana University
ClinicalTrials.gov Identifier: NCT01788423     History of Changes
Other Study ID Numbers: 1111007504 
Study First Received: October 24, 2012
Last Updated: May 19, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by Indiana University:
presbycusis
hearing aids

Additional relevant MeSH terms:
Hearing Loss
Deafness
Presbycusis
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Hearing Loss, Sensorineural

ClinicalTrials.gov processed this record on September 28, 2016