Study Results
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View full resultsBasic Information
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COMPLETED
NA
40 participants
INTERVENTIONAL
2021-06-18
2021-12-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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Pro-Fit followed by Self Fit
Hearing aids fit by a professional hearing care provider using best practices followed by patient ...
Hearing aids
Earbud style hearing aids fit to both ears
Self-Fit followed by ProFit
Hearing aids fit by patient followed by ...
Hearing aids
Earbud style hearing aids fit to both ears
Interventions
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Hearing aids
Earbud style hearing aids fit to both ears
Eligibility Criteria
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Inclusion Criteria
* Mix of male and female subjects (aiming for a representative balance)
* Mix of prior hearing-aid use (aiming for 70-80% persons with no prior hearing aid use)
* 18-75 years old (aiming for primarily 50-70 years old, with avg. age \~65 years)
* Apple iPhone (iOS 14 compatible or greater, as required for the SELF-FIT app)
* Able to read and comprehend English
* Patient willing to provide informed consent
Exclusion Criteria
* Self-reported ear-related pathology (including chronic severe dizziness or chronic severe tinnitus)
18 Years
75 Years
ALL
Yes
Sponsors
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Northwestern University
OTHER
Sertoma Speech and Hearing Center
OTHER
Vanderbilt University
OTHER
GN Hearing A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Todd Ricketts, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Vanderbilt University
Sumitrajit Dhar, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Northwestern University
Locations
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Sertoma Speech and Hearing Center
Palos Hills, Illinois, United States
Vanderbilt University
Nashville, Tennessee, United States
Countries
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References
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Cox RM, Alexander GC. The abbreviated profile of hearing aid benefit. Ear Hear. 1995 Apr;16(2):176-86. doi: 10.1097/00003446-199504000-00005.
Killion MC, Niquette PA, Gudmundsen GI, Revit LJ, Banerjee S. Development of a quick speech-in-noise test for measuring signal-to-noise ratio loss in normal-hearing and hearing-impaired listeners. J Acoust Soc Am. 2004 Oct;116(4 Pt 1):2395-405. doi: 10.1121/1.1784440.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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X-Men
Identifier Type: -
Identifier Source: org_study_id
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