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NCT03904264

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

Completed NA Results posted Last updated 21 November 2023
What this trial tests

NA trial testing Receiver in the canal (RIC) hearing aids in Tinnitus in 65 participants. Completed in 30 September 2022.

Timeline
24 February 2020
Primary endpoint
30 September 2022
30 September 2022

Quick facts

Lead sponsorVA Office of Research and Development
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationnon randomized
Designsingle group
Maskingnone
Primary purposeother
Enrollment65
Start date24 February 2020
Primary completion30 September 2022
Estimated completion30 September 2022
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

VA Office of Research and Development — full company profile →

Who can join

18 and older, any sex, with Tinnitus or Hearing Aids. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Tinnitus Functional Index Change Primary · The Tinnitus Functional index will be administered at baseline, 2-3 weeks after baseline, and 3 months after baseline

The Tinnitus Functional Index (TFI) is a statistically validated measure of the functional impact of tinnitus. The TFI was developed to be sensitive to changes in function as a result of intervention for tinnitus. Range is 0 - 100, higher numbers indicates greater level of distress and functional impact.

Baseline
GroupValue95% CI
Hearing Aid Study53.31± 22.68
2-3 weeks
GroupValue95% CI
Hearing Aid Study44.10± 23.02
3 months
GroupValue95% CI
Hearing Aid Study64.93± 25.25

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Tinnitus

Currently open trials in the same condition.

Other VA Office of Research and Development trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03904264.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing