Aging Clinical Trial
Official title:
Evaluating Hearing Aid Service Delivery Models
Verified date | July 2019 |
Source | Indiana University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 323 |
Est. completion date | February 28, 2018 |
Est. primary completion date | February 28, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 55 Years to 79 Years |
Eligibility |
Inclusion Criteria: (for groups 1-4) - 55-79 yrs of age - Native English speaker - no prior hearing aid use - ability to read 18 point font Exclusion Criteria: (for groups 1-3) - 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 Exclusion Criteria : (for groups 1-4) - subject not interested in purchasing hearing aids |
Country | Name | City | State |
---|---|---|---|
United States | IU Department of Speech & Hearing Sciences | Bloomington | Indiana |
Lead Sponsor | Collaborator |
---|---|
Indiana University | National Institute on Deafness and Other Communication Disorders (NIDCD) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Connected Speech Test (CST) Benefit | A standardized speech-perception test, based on meaningful sentences and keyword scoring, the Connected Speech Test (CST) was administered unaided and aided. Each CST score represents the percentage of keywords (out of 50) repeated correctly following presentation via loudspeakers. Scores can range from 0 to 100% correct with higher scores indicating better speech perception. For the CST benefit scores reported below, unaided CST scores are subtracted from aided scores such that positive values represent better performance for aided than unaided listening. The possible range of CST benefit scores is -100 to +100 with 0 representing no difference between unaided and aided speech-perception performance. | two times: at hearing-aid fit and at 6-weeks post-fit |
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