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The Effect of Mild-gain Amplification on Tinnitus Perception in Normal Hearing Adults

ConditionTinnitus
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorTechnical University of Denmark

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Meniere's disease, Tosclerosis, Stapedectomy, Stapedotomy and Tympanoplasty

Objective or pulsatile tinnitus

Hearing thresholds >25 dB from 125 Hz to 8 kHz

Trial design

Design model

Crossover

Treatments tested in this trial

  • Hearing Aid with NR_4

    Device

    Amplification of approx. 8dB from 1 Hz to 8 kHz. No noise cancellation activated

Treatment groups

15 Participants
are divided into 2 treatment groups
Group A: Experimental: mild gain amplification: (8dB, 1 Hz to 8 kHz)Experimental treatment 1 intervention
Group B: Placebo Comparator: no amplificationPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Technical University of Denmark

Lead sponsor

Source ClinicalTrials.gov
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