Skip to main content
OpenTrials
Completed

NCT Number: NCT05292534

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hearing Loss, Sensorineural Ear Diseases Hearing Disorders Hearing Loss Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms Tinnitus

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The State University of New York at Buffalo

Buffalo, New York, 14203, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

hearing aid amplification

Device

Hearing aid will be fit to prescribed participant hearing loss.

hearing aid amplification with an added sound

Device

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

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Sonova AG

Industry

Collaborators

  • State University of New York at Buffalo

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 23, 2022
Registry last updated
Jul 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.