Evaluation of the Clinical Benefit of the Hearing Aids Tinnitus Feature.

NCT ID: NCT05292534

Last Updated: 2024-07-05

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-01

Study Completion Date

2023-09-20

Brief Summary

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Participants with hearing loss and Tinnitus will wear hearing aids with amplification-only or with an added sound, and have their tinnitus level evaluated before and after intervention.

Detailed Description

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2 groups of adults with hearing loss and chronic bothersome tinnitus and no experience with amplification will participate in a cross over intervention study with 2 conditions of 4 weeks each: 1. fit with hearing aid (HA) amplification-only, and 2. fit with HA amplification with an added sound, returning to their original unaided condition after undergoing the intervention phase.

Conditions

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Hearing Loss, Sensorineural Tinnitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Amplification-only

Hearing aid will be fit to prescribed participant hearing loss.

Group Type ACTIVE_COMPARATOR

hearing aid amplification

Intervention Type DEVICE

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.

Group Type ACTIVE_COMPARATOR

hearing aid amplification with an added sound

Intervention Type DEVICE

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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hearing aid amplification

Hearing aid will be fit to prescribed participant hearing loss.

Intervention Type DEVICE

hearing aid amplification with an added sound

Hearing aid will be fit to prescribed participant hearing loss and an added sound will be activated.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Hearing loss
* candidate for hearing aid amplification
* Bothersome chronic tinnitus (3 months+)

Exclusion Criteria

* age less than 18 years
* normal hearing
* tinnitus presence for less than 3 months
* tinnitus not bothersome enough to warrant intervention
* non hearing aid candidates
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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State University of New York at Buffalo

OTHER

Sponsor Role collaborator

Sonova AG

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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United States

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.

Reference Type BACKGROUND
PMID: 22156949 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26074306 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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SRF-481

Identifier Type: -

Identifier Source: org_study_id

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