Skip to main content
Clinical Trials/NCT05292534
NCT05292534
Completed
N/A

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

Sonova AG1 site in 1 country38 target enrollmentJune 1, 2022

Overview

Phase
N/A
Intervention
Not specified
Conditions
Hearing Loss, Sensorineural
Sponsor
Sonova AG
Enrollment
38
Locations
1
Primary Endpoint
Tinnitus Functional Index Evaluation (TFI)
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 1, 2022
End Date
September 20, 2023
Last Updated
last year
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Sponsor
Sonova AG
Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

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.

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.

Study Sites (1)

Loading locations...

Similar Trials