N/A
N=65
Feasibility and Acceptability of Using Low-Gain Hearing Aids for Bothersome Tinnitus
Tinnitus · Hearing Aids · Normal Hearing
Bottom Line
View on ClinicalTrials.gov: NCT03904264 ↗Enrolled (actual)
65
Serious AEs
—
Results posted
Nov 2023
Primary outcome: Primary: Tinnitus Functional Index Change — 53.31; 44.10; 64.93 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Receiver in the canal (RIC) hearing aids (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Sep 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Tinnitus Functional Index Change |
53.31; 44.10; 64.93 | — |
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.
Eligibility Criteria
Inclusion Criteria
Inclusion criteria for the Hearing Aid study include:
- a score of 5 or greater on section A the Tinnitus and Hearing Survey during the telephone screening; and
- air conduction hearing thresholds of 25 dB HL or better from .25 kHz through 4 kHz bilaterally as measured at the first study visit;
- must not be a current hearing aid user; and
- capable of consenting and participating (including ability to communicate in English).
Inclusion criteria for the VA Clinician Interviews:
-simply VA audiologists willing to participate.
Exclusion Criteria
Exclusion criteria for the Hearing Aid study include:
- an air conduction hearing threshold greater than 25 dB HL from .25 kHz through 4 kHz;
- significant conductive hearing loss-defined as an air-bone gap of 15 dB at more than two frequencies in one ear, or an air-bone gap greater than 20 dB at any one frequency;
- suspicion of secondary (somatic) tinnitus, or Meniere's disease (either of which can be ruled out with an examination by an appropriate physician);
- currently a hearing aid user; or
- any mental, emotional, or health conditions that would preclude full study participation.
Exclusion criteria for the VA Clinician Interviews are:
- not an audiologist
- not a VA employee.
Data sourced from ClinicalTrials.gov (NCT03904264). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.