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

Primary Purpose

Hearing Loss, Sensorineural, Tinnitus

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
hearing aid amplification
hearing aid amplification with an added sound
Sponsored by
Sonova AG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hearing Loss, Sensorineural

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The State University of New York at Buffalo

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

No Intervention

Arm Label

Amplification-only

Amplification with added sound

No intervention

Arm Description

Hearing aid will be fit to prescribed participant hearing loss.

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

Participants will return to their original unaided state.

Outcomes

Primary Outcome Measures

Tinnitus Functional Index evaluation (TFI)
Tinnitus Functional Index (TFI) questionnaire results, ranging from 0 to 100, with higher numbers indicating more severe (worse) Tinnitus interference in the person's quality of life.

Secondary Outcome Measures

Full Information

First Posted
March 9, 2022
Last Updated
October 18, 2023
Sponsor
Sonova AG
Collaborators
The State University of New York at Buffalo
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1. Study Identification

Unique Protocol Identification Number
NCT05292534
Brief Title
Evaluation of the Clinical Benefit of the Hearing Aids Tinnitus Feature.
Official Title
Evaluation of the Clinical Benefit of the Hearing Aids Tinnitus Feature.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
June 1, 2022 (Actual)
Primary Completion Date
August 20, 2023 (Actual)
Study Completion Date
August 20, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sonova AG
Collaborators
The State University of New York at Buffalo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss, Sensorineural, Tinnitus

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Amplification-only
Arm Type
Active Comparator
Arm Description
Hearing aid will be fit to prescribed participant hearing loss.
Arm Title
Amplification with added sound
Arm Type
Active Comparator
Arm Description
Hearing aid will be fit to prescribed participant hearing loss and an added sound will be activated on the hearing aid.
Arm Title
No intervention
Arm Type
No Intervention
Arm Description
Participants will return to their original unaided state.
Intervention Type
Device
Intervention Name(s)
hearing aid amplification
Intervention Description
Hearing aid will be fit to prescribed participant hearing loss.
Intervention Type
Device
Intervention Name(s)
hearing aid amplification with an added sound
Intervention Description
Hearing aid will be fit to prescribed participant hearing loss and an added sound will be activated.
Primary Outcome Measure Information:
Title
Tinnitus Functional Index evaluation (TFI)
Description
Tinnitus Functional Index (TFI) questionnaire results, ranging from 0 to 100, with higher numbers indicating more severe (worse) Tinnitus interference in the person's quality of life.
Time Frame
TFI collected before intervention to serve as a baseline. TFI change from baseline will be assessed after each study condition, which will last 4 weeks/each. Up to 1 year of study completion, a follow-up TFI will be done for comparison reasons.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wei Sun, Ph.D.
Organizational Affiliation
The State University of New York at Buffalo
Official's Role
Principal Investigator
Facility Information:
Facility Name
The State University of New York at Buffalo
City
Buffalo
State/Province
New York
ZIP/Postal Code
14203
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22156949
Citation
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. Erratum In: Ear Hear. 2012 May;33(3):443.
Results Reference
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PubMed Identifier
26074306
Citation
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.
Results Reference
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Learn more about this trial

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

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