Overview

This trial is active, not recruiting.

Conditions presbycusis, aging, hearing loss
Treatment hearing aid
Phase phase 1/phase 2
Sponsor Indiana University
Collaborator National Institute on Deafness and Other Communication Disorders (NIDCD)
Start date November 2012
End date October 2016
Trial size 180 participants
Trial identifier NCT01788423, 1111007504

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Audiologist selects hearing aid for patient
hearing aid
All subjects received hearing aids, some selected by audiologist, some selected by consumer, and some programmed as placebo devices.
(Experimental)
Consumer selects hearing aid
hearing aid
All subjects received hearing aids, some selected by audiologist, some selected by consumer, and some programmed as placebo devices.
(Placebo Comparator)
Patient fitted with hearing aid that is acoustically transparent.
hearing aid
All subjects received hearing aids, some selected by audiologist, some selected by consumer, and some programmed as placebo devices.

Primary Outcomes

Measure
Change from baseline on the Profile of Hearing Aid Performance
time frame: two times: at hearing-aid fit and at 6-weeks post-fit

Secondary Outcomes

Measure
Change from baseline on the Connected Speech Test
time frame: two times: at hearing-aid fit and at 6-weeks post-fit

Eligibility Criteria

Male or female participants from 55 years up to 79 years old.

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

Additional Information

Official title Evaluating Hearing Aid Service Delivery Models
Principal investigator Larry E. Humes, PhD
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by Indiana University.