An interventional study of Hearing Aid with NR_4 in Tinnitus, sponsored by Technical University of Denmark. Recruiting at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-31.
Sponsored by Technical University of Denmark · Not applicable, Interventional, and Treatment
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).
444 studies on the registry are indexed under Tinnitus; 98 are open to participants now.
This study's planned enrollment of 15 is below the median of 60 across 368 interventional studies indexed under Tinnitus.
Browse Tinnitus studies →Technical University of Denmark is the lead sponsor of 10 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Device: mild gain amplification from hearing aids Amplification of 8dB from 1 Hz to 8 kHz No noise cancelling activated
Device: Hearing Aid with NR_4
Device: hearing aids with no amplification. No noise cancelling activated
Device: Hearing Aid with NR_4
Amplification of approx. 8dB from 1 Hz to 8 kHz. No noise cancellation activated
Tinnitus Functional Index
Questionnaire assessing tinnitus related distress, consisting on 25 questions that can be answered with likert scale from 0 to 10 where 10 is the most extreme negative value
Time frame: 3 weeks
Tinnitus loudness
Psychoacoustic measurement where participants match the loudness of their tinnitus to either a pure-tone or noisy sound. The loudness of the matched tone could be changed in 3 decibel steps.
Time frame: 3 weeks
Tinnitus spectrum
It was based on the method described by Noreña et al. (2002). The stimuli consisted of either 2-second pure tones (first condition) or 2-second one-third octave noise bands (second condition), with center frequencies spanning from 125 Hz to 14 kHz. These sounds were delivered monaurally through headphones to the ear in which tinnitus was perceived as most intense. When tinnitus perception was equal in both ears, stimulation was applied to the ear with the lower average thresholds at high frequencies. All stimuli were presented at an intensity corresponding to the loudness match of a 1 kHz pure tone, but never below 10 dB sensation level (SL).
Time frame: 3 weeks
Visual Analog Scale - annoyance
Likert scale from 0-10 where 0 = "My tinnitus is not annoying" and 10 = "My tinnitus is extremely annoying"
Time frame: 3 weeks
Visual Analog Scale - loudness
Likert scale from 0-10 where 0 = "I cannot hear my tinnitus" and 10 = "My tinnitus is extremely loud"
Time frame: 3 weeks
Plan to share: No — Due to GDPR regulations
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Technical University of Denmark