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Feasibility and Acceptability of Using Low-Gain Hearing Aids for Bothersome Tinnitus

NCT03904264 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2023-11-21

Study results available
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Summary

Tinnitus - defined as ringing, humming, or other sounds in the ears or head - is a very common problem for Veterans. Hearing aids that deliver low-level amplification are being used by audiologists to help people with tinnitus who also have normal hearing. However, there is a lack of research evidence showing that this practice is effective. Despite this fact, the practice clearly is spreading. Reports from audiologists in the field as well as research presentations refer to hearing aids being used in this way. Use of hearing aids has been shown to reduce distress from tinnitus for people with hearing loss. Additionally, the use of external sound to help reduce the impact of tinnitus has been shown to be effective. There is clearly a gap in the research regarding the use of hearing aids as a therapeutic method to manage tinnitus when hearing is considered normal. This study will obtain pilot data evaluating people with normal hearing and bothersome tinnitus to find out whether low-level amplification through hearing aids may provide benefit.

Conditions

  • Tinnitus
  • Hearing Aids
  • Normal Hearing

Interventions

DEVICE

Receiver in the canal (RIC) hearing aids

The RIC hearing aids fitted to subjects in arm 1 of the study will be manufactured by Widex.

Sponsors & Collaborators

  • VA Office of Research and Development

    lead FED

Principal Investigators

  • Tara Zaugg, AuD · VA Portland Health Care System, Portland, OR

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-24
Primary Completion
2022-09-30
Completion
2022-09-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03904264 on ClinicalTrials.gov