Investigations of Ear Tip Performance, Perceptions, and Experiences
NCT ID: NCT05725824
Last Updated: 2024-07-29
Study Results
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View full resultsBasic Information
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COMPLETED
NA
30 participants
INTERVENTIONAL
2023-07-30
2024-01-17
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Third-party control
Ear canal impressions will be will be packaged and sent to a professional third-party manufacturer for fabrication in an acrylic material-type. These will serve as the control earmolds, by which the in-house study/intervention earmolds will be compared against. To control for style of earmolds, all earmolds will be made in a skeleton style with a sound bore that accommodates size #13 tubing and a separate select-a-vent (SAV).
BTE hearing aid with compatible earmolds
Hearing aids will be fit with three different types of customized earmolds. They will only wear each earmold group for the duration of the test (total = \~2.5 hours). Hearing aids will be programmed to a simulated mild, flat, sensorineural hearing loss of 30 dB HL from 250-8000Hz. A short washout period will follow completion of testing with ear earmold group.
In-house Study group_Resin
Custom earmold impressions will be scanned and edited using computer-aided design software. These 3D earmold meshes will then be converted to g-code using licensed software and sent to a stereolithography 3D printer for fabrication. Participants will only wear these study earmolds for the duration of testing.To control for style of earmolds, all earmolds will be made in a skeleton style with a sound bore that accommodates size #13 tubing and a separate select-a-vent (SAV).
BTE hearing aid with compatible earmolds
Hearing aids will be fit with three different types of customized earmolds. They will only wear each earmold group for the duration of the test (total = \~2.5 hours). Hearing aids will be programmed to a simulated mild, flat, sensorineural hearing loss of 30 dB HL from 250-8000Hz. A short washout period will follow completion of testing with ear earmold group.
In-house Study group_PLA
Custom earmold impressions will be scanned and edited using computer-aided design software. These 3D earmold meshes will then be converted to g-code using licensed software and sent to a fused deposition modeling 3D printer for fabrication. Participants will only wear these study earmolds for the duration of testing. To control for style of earmolds, all earmolds will be made in a skeleton style with a sound bore that accommodates size #13 tubing and a separate select-a-vent (SAV).
BTE hearing aid with compatible earmolds
Hearing aids will be fit with three different types of customized earmolds. They will only wear each earmold group for the duration of the test (total = \~2.5 hours). Hearing aids will be programmed to a simulated mild, flat, sensorineural hearing loss of 30 dB HL from 250-8000Hz. A short washout period will follow completion of testing with ear earmold group.
Interventions
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BTE hearing aid with compatible earmolds
Hearing aids will be fit with three different types of customized earmolds. They will only wear each earmold group for the duration of the test (total = \~2.5 hours). Hearing aids will be programmed to a simulated mild, flat, sensorineural hearing loss of 30 dB HL from 250-8000Hz. A short washout period will follow completion of testing with ear earmold group.
Eligibility Criteria
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Inclusion Criteria
* Normal otoscopy: patent ear canals with normal appearing eardrums and aerated middle ear, bilaterally.
* English as primary spoken language.
Exclusion Criteria
* history of extensive outer or middle ear surgery.
* history of neurological or cognitive disorder.
18 Years
89 Years
ALL
Yes
Sponsors
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University of Arizona
OTHER
Responsible Party
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Locations
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University of Arizona
Tucson, Arizona, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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STUDY00002336
Identifier Type: -
Identifier Source: org_study_id
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