Broadband Amplification as Tinnitus Treatment

Not Applicable

Completed

• Conditions: Tinnitus, Subjective
• Interventions: Device: Broadband amplification from hearing aids; Device: Band-limited amplification from hearing aids

• Registration Number: NCT05271825
• Lead Sponsor: Technical University of Denmark

Brief Summary

* The effect of broadband amplification was tested in a double-blinded crossover study

* Its effect was compared to an active placebo treatment

* An improvement in tinnitus distress was found after use of broadband amplification

* No effect was found on the tinnitus loudness

Detailed Description

This study investigated the effect of broadband amplification (125 Hz to 10 kHz) as tinnitus treatment for participants with high-frequency hearing loss and compared these effects with an active placebo condition using band-limited amplification (125 Hz to 3-4 kHz). A double-blinded crossover study. 23 participants with a high-frequency (≥ 3 kHz) hearing loss and chronic tinnitus were included in the study and 17 completed the full treatment protocol. Two different hearing aid treatments were provided for 3 months each: broadband amplification that provided gain in the frequency range from 125 Hz to 10 kHz and band-limited amplification that only provided gain in the low frequency range (≤ 3-4 kHz). The effect of the two treatments on tinnitus distress was evaluated with the Tinnitus Handicap Inventory (THI) and the Tinnitus Functional Index (TFI) questionnaires. The effect of the treatment on tinnitus loudness was evaluated with a visual analog scale (VAS) for loudness and a psychoacoustic loudness measure. Furthermore, the tinnitus annoyance was evaluated with a VAS for annoyance. The tinnitus pitch was evaluated based on the tinnitus likeness spectrum.

Study Timeline

• Study Start: 2019-05-01
• Primary Completion: 2021-02-28
• Study Completion: 2021-02-28
• Study First Submitted: 2022-02-16
• Study First Submitted QC: 2022-02-27
• Study First Posted: 2022-03-09
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-09
• Last Update Posted: 2024-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

Inclusion Criteria

• Chronic tinnitus
• hearing thresholds (<=25 dB HL) up to 2000 Hz and hearing loss at frequencies above 2 kHz
• inexperienced hearing aid user

Exclusion Criteria

• objective or pulsatile tinnitus
• Ménière's disease, otosclerosis, stapedectomy, stapedotomy or tympanoplasty

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Broadband amplification	Broadband amplification from hearing aids	broadband amplification: (125 Hz to 10 kHz)
Band-limited amplification	Band-limited amplification from hearing aids	band-limited amplification (125 Hz to 3-4 kHz)

Primary Outcome Measures

Name	Time	Method
Tinnitus Handicap Inventory	3 months	Questionnaire assessing tinnitus related distress. 25 questions that can be answered with yes(4 points), sometimes (2 points), no (0 points)
Tinnitus Functional Index	3 months	Questionnaire assessing tinnitus related distress. 25 questions that can be answered with likert scale from 0-10 (or 0-100%) where 10 is the most extreme negative value

Secondary Outcome Measures

Name	Time	Method
Visual Analog Scale - annoyance	3 months	Likert scale from 0-10 where 0 = "My tinnitus is not annoying" and 10 = "My tinnitus is extremely annoying"
Visual Analog Scale - loudness	3 months	Likert scale from 0-10 where 0 = "I cannot hear my tinnitus" and 10 = "My tinnitus is extremely loud"
Tinnitus loudness	3 months	Psychoacoustic measurement. Participants are asked to 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.
Tinnitus spectrum	3 months	The tinnitus spectrum rating method was adapted from Noreña et al. (2002). As the stimuli, either 2-s long pure tones (1st condition) or 2-s long 1/3-octave noise bands (2nd condition) with center frequencies ranging from 125 Hz to 14 kHz were used. The stimuli were presented monaurally via headphones to the ear corresponding to the loudest tinnitus perception. In case the tinnitus percept was the same in both ears, the stimuli were presented to the ear with the lowest average high-frequency thresholds. All stimuli were presented at the level matched to the tinnitus loudness for a 1 kHz pure tone, but always at or above 10 dB sensation level (SL).

Trial Locations

Locations (1)

Technical University of Denmark; 🇩🇰 Kongens Lyngby, Denmark