The Effect of Mild-gain Amplification on Tinnitus Perception in Normal Hearing Adults
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Hearing Aid with NR_4.
- Who it may be relevant to
- Registry conditions: Tinnitus. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
This study investigated the effect of mild gain amplification (8dB covering 1 Hz to 8kHz) as tinnitus treatment for participants with normal hearing and compared these effects with an active placebo condition using hearing aids without amplification in a double-blinded crossover study. 12 participants with normal hearing and chronic tinnitus were included in the study. Two different hearing aid treatments were provided for 3 weeks each: mild gain amplification that provided 8dB gain in the frequency range from 1 Hz to 8 kHz and no amplification, acting as placebo. The effect of the two treatments on tinnitus distress was evaluated with the Tinnitus Functional Index (TFI) questionnaire. The effect of the treatment on tinnitus loudness and annoyance were evaluated with a visual analog scale (VAS).
Interventions
- Device Hearing Aid with NR_4
Amplification of approx. 8dB from 1 Hz to 8 kHz. No noise cancellation activated
Primary outcome measures
- Tinnitus Functional Index [Time frame: 3 weeks]
Secondary outcome measures (4)
- Tinnitus loudness [Time frame: 3 weeks]
- Tinnitus spectrum [Time frame: 3 weeks]
- Visual Analog Scale - annoyance [Time frame: 3 weeks]
- Visual Analog Scale - loudness [Time frame: 3 weeks]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Denmark · 1 center
- Hearing Systems Section — Lyngby
Identifiers
NCT: NCT07489807 · H-16036391-1