Evaluation of the Clinical Benefit of the Hearing Aids Tinnitus Feature.
NCT ID: NCT05292534
Last Updated: 2024-07-05
Study Results
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View full resultsBasic Information
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COMPLETED
NA
38 participants
INTERVENTIONAL
2022-06-01
2023-09-20
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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Amplification-only
Hearing aid will be fit to prescribed participant hearing loss.
hearing aid amplification
Hearing aid will be fit to prescribed participant hearing loss.
Amplification with added sound
Hearing aid will be fit to prescribed participant hearing loss and an added sound will be activated on the hearing aid.
hearing aid amplification with an added sound
Hearing aid will be fit to prescribed participant hearing loss and an added sound will be activated.
No intervention
Participants will return to their original unaided state.
No interventions assigned to this group
Interventions
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hearing aid amplification
Hearing aid will be fit to prescribed participant hearing loss.
hearing aid amplification with an added sound
Hearing aid will be fit to prescribed participant hearing loss and an added sound will be activated.
Eligibility Criteria
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Inclusion Criteria
* candidate for hearing aid amplification
* Bothersome chronic tinnitus (3 months+)
Exclusion Criteria
* normal hearing
* tinnitus presence for less than 3 months
* tinnitus not bothersome enough to warrant intervention
* non hearing aid candidates
18 Years
ALL
No
Sponsors
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State University of New York at Buffalo
OTHER
Sonova AG
INDUSTRY
Responsible Party
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Principal Investigators
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Wei Sun, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
State University of New York at Buffalo
Locations
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The State University of New York at Buffalo
Buffalo, New York, United States
Countries
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References
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Meikle MB, Henry JA, Griest SE, Stewart BJ, Abrams HB, McArdle R, Myers PJ, Newman CW, Sandridge S, Turk DC, Folmer RL, Frederick EJ, House JW, Jacobson GP, Kinney SE, Martin WH, Nagler SM, Reich GE, Searchfield G, Sweetow R, Vernon JA. The tinnitus functional index: development of a new clinical measure for chronic, intrusive tinnitus. Ear Hear. 2012 Mar-Apr;33(2):153-76. doi: 10.1097/AUD.0b013e31822f67c0.
Henry JA, Griest S, Thielman E, McMillan G, Kaelin C, Carlson KF. Tinnitus Functional Index: Development, validation, outcomes research, and clinical application. Hear Res. 2016 Apr;334:58-64. doi: 10.1016/j.heares.2015.06.004. Epub 2015 Jun 12.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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SRF-481
Identifier Type: -
Identifier Source: org_study_id
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