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

October 18, 2023 updated by: Sonova AG
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • New York
      • Buffalo, New York, United States, 14203
        • The State University of New York at Buffalo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Amplification-only
Hearing aid will be fit to prescribed participant hearing loss.
Device: hearing aid amplification
Hearing aid will be fit to prescribed participant hearing loss.
Active Comparator: 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.
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.
No Intervention: No intervention
Participants will return to their original unaided state.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tinnitus Functional Index evaluation (TFI)
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.
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sonova AG

Collaborators

The State University of New York at Buffalo

Investigators

  • Principal Investigator: Wei Sun, Ph.D., The State University of New York at Buffalo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2022

Primary Completion (Actual)

August 20, 2023

Study Completion (Actual)

August 20, 2023

Study Registration Dates

First Submitted

March 9, 2022

First Submitted That Met QC Criteria

March 22, 2022

First Posted (Actual)

March 23, 2022

Study Record Updates

Last Update Posted (Actual)

October 23, 2023

Last Update Submitted That Met QC Criteria

October 18, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SRF-481

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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