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

Not Applicable

Completed

• Conditions: Hearing Loss, Sensorineural; Tinnitus
• Interventions: Device: hearing aid amplification; Device: hearing aid amplification with an added sound

• 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

Arm && Interventions

Group	Intervention	Description
Amplification-only	hearing aid amplification	Hearing aid will be fit to prescribed participant hearing loss.
Amplification with added sound	hearing aid amplification with an added sound	Hearing aid will be fit to prescribed participant hearing loss and an added sound will be activated on the hearing aid.

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