Mild 8 dB hearing amplification for tinnitus in adults with normal hearing
The Effect of Mild-gain Amplification on Tinnitus Perception in Normal Hearing Adults
This test tries wearing hearing aids that add a small (8 dB) boost to see if they reduce tinnitus symptoms in adults with normal hearing.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Technical University of Denmark Academic / other |
| Locations | 1 site (Lyngby) |
| Trial ID | NCT07489807 on ClinicalTrials.gov |
What this trial studies
This double-blinded crossover study enrolled 12 adults with chronic, bothersome tinnitus and normal audiograms to compare two hearing-aid settings delivered for three weeks each. One condition provided a mild 8 dB gain from 1 Hz to 8 kHz and the other provided no amplification as an active placebo. Outcomes included changes in tinnitus-related distress measured by the Tinnitus Functional Index (TFI) and ratings of tinnitus loudness and annoyance on visual analog scales (VAS). Participants were inexperienced hearing-aid users and were screened to exclude objective/pulsatile tinnitus and certain middle-ear disorders.
Who should consider this trial
Good fit: Adults with chronic bothersome subjective tinnitus for at least three months, normal hearing thresholds (≤25 dB HL from 125 Hz to 8 kHz), and no prior hearing-aid experience are the ideal candidates.
Not a fit: People with objective or pulsatile tinnitus, Meniere's disease, a history of stapedectomy/stapedotomy/tympanoplasty, or hearing loss >25 dB HL are unlikely to benefit from this specific approach.
Why it matters
Potential benefit: If successful, mild-gain amplification via hearing aids could reduce tinnitus distress, perceived loudness, and annoyance for some adults with normal hearing.
How similar studies have performed: Hearing-aid amplification has shown benefit for tinnitus in people with hearing loss, but using a mild 8 dB gain in people with strictly normal hearing is less well studied and evidence is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Daily bothersome tinnitus for at least 3 months (TFI\>15) * Normal hearing (25 dB HL from 125 Hz to 8 kHz) * Inexperienced hearing aid user Exclusion Criteria: * Meniere's disease, Tosclerosis, Stapedectomy, Stapedotomy and Tympanoplasty * Objective or pulsatile tinnitus * Hearing thresholds \>25 dB from 125 Hz to 8 kHz
Where this trial is running
Lyngby
- Hearing Systems Section — Lyngby, Denmark (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.