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

Not Applicable

Completed

• Conditions: Hearing Loss, Sensorineural; Tinnitus

• Registration Number: NCT05292534
• Lead Sponsor: Sonova AG

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.

Study Timeline

• Study First Submitted: 2022-03-09
• Study First Submitted QC: 2022-03-22
• Study First Posted: 2022-03-23
• Study Start: 2022-06-01
• Primary Completion: 2023-09-20
• Study Completion: 2023-09-20
• Status Verified: 2024-04
• Results First Submitted: 2024-04-24
• Results First Submitted QC: 2024-07-01
• Last Update Submitted: 2024-07-01
• Results First Posted: 2024-07-05
• Last Update Posted: 2024-07-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Tinnitus Functional Index Evaluation (TFI)	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.

Trial Locations

Locations (1)

The State University of New York at Buffalo; 🇺🇸 Buffalo, New York, United States