NCT07489807

Brief Summary

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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
12mo left

Started Apr 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress53%
Apr 2025Jun 2027

Study Start

First participant enrolled

April 1, 2025

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

March 18, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 24, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

March 31, 2026

Status Verified

March 1, 2026

Enrollment Period

1.3 years

First QC Date

March 18, 2026

Last Update Submit

March 25, 2026

Conditions

Tinnitus

Keywords

TinnitusHearing aidsNormal hearing

Outcome Measures

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

    3 weeks

Secondary Outcomes (4)

  • Tinnitus loudness

    3 weeks

  • Tinnitus spectrum

    3 weeks

  • Visual Analog Scale - annoyance

    3 weeks

  • Visual Analog Scale - loudness

    3 weeks

Study Arms (2)

Experimental: mild gain amplification: (8dB, 1 Hz to 8 kHz)

EXPERIMENTAL

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

Placebo Comparator: no amplification

PLACEBO COMPARATOR

Device: hearing aids with no amplification. No noise cancelling activated

Device: Hearing Aid with NR_4

Interventions

Hearing Aid with NR_4DEVICE

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

Experimental: mild gain amplification: (8dB, 1 Hz to 8 kHz)Placebo Comparator: no amplification

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Meniere's disease, Tosclerosis, Stapedectomy, Stapedotomy and Tympanoplasty
  • Objective or pulsatile tinnitus
  • Hearing thresholds \>25 dB from 125 Hz to 8 kHz

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hearing Systems Section

Lyngby, Denmark

RECRUITING

MeSH Terms

Conditions

Tinnitus

Interventions

Hearing Aids

Condition Hierarchy (Ancestors)

Hearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Wearable Electronic DevicesElectrical Equipment and SuppliesEquipment and SuppliesSensory Aids

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Postdoc

Study Record Dates

First Submitted

March 18, 2026

First Posted

March 24, 2026

Study Start

April 1, 2025

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

June 1, 2027

Last Updated

March 31, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Due to GDPR regulations

Locations

DK(1)