TinnitusNCT07489807
The Effect of Mild-gain Amplification on Tinnitus Perception in Normal Hearing Adults
A study testing Hearing Aid with NR_4 in people with Tinnitus, run by Technical University of Denmark at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tinnitus
- What is being tested?
- Hearing Aid with NR_4
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Apr 2025to 1 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Meniere's disease, Tosclerosis, Stapedectomy, Stapedotomy and Tympanoplasty
- Objective or pulsatile tinnitus
- Hearing thresholds >25 dB from 125 Hz to 8 kHz
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Hearing Systems Section
Lyngby
Joergensen, Postdoc, +45 45 25 25 25, healthtech-info@dtu.dk
About this study
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).
- Conditions
- Tinnitus
- Being tested
- Hearing Aid with NR_4
- Keywords
- Tinnitus, Hearing aids, Normal hearing
- Medical subject headings
- Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hearing Aid with NR_4Device
Amplification of approx. 8dB from 1 Hz to 8 kHz. No noise cancellation activated
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Hearing Aid with NR_4 |
| Placebo Comparator: no amplification | Placebo comparator | Device: hearing aids with no amplification. No noise cancelling activated Receives: Device: Hearing Aid with NR_4 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 weeks
Secondary outcomes (4)
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.
Measured: 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).
Measured: 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"
Measured: 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"
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2026
- Study start1 Apr 2025
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TinnitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Technical University of Denmark
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mie Joergensen, Technical University of Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07489807
- Sponsor's protocol ID
- H-16036391-1
- Status last verified
- Mar 2026
- First submitted
- 18 Mar 2026
- Last updated
- 31 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to GDPR regulations
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mild-gain Amplification on Tinnitus Perception in Normal Hearing Adults
- ClinicalTrials.gov ID
- NCT07489807
- Acronym / sponsor ID
- H-16036391-1
- Conditions
- Tinnitus
- Keywords
- Tinnitus, Hearing aids, Normal hearing
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Technical University of DenmarkUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 24 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: mild gain amplification: (8dB, 1 Hz to 8 kHz) | Experimental | Device: Hearing Aid with NR_4Device: mild gain amplification from hearing aids Amplification of 8dB from 1 Hz to 8 kHz No noise cancelling activated |
| Placebo Comparator: no amplification | Placebo comparator | Device: Hearing Aid with NR_4Device: hearing aids with no amplification. No noise cancelling activated |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Meniere's disease, Tosclerosis, Stapedectomy, Stapedotomy and Tympanoplasty
- Objective or pulsatile tinnitus
- Hearing thresholds >25 dB from 125 Hz to 8 kHz
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hearing Aid with NR_4Amplification of approx. 8dB from 1 Hz to 8 kHz. No noise cancellation activated | Device | Experimental: mild gain amplification: (8dB, 1 Hz to 8 kHz), Placebo Comparator: no amplification |
Primary outcome
Tinnitus Functional Index
Time frame: 3 weeks
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
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2026.
- Individual participant dataSharing planned: No. Due to GDPR regulations
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hearing Aid with NR_4 in people with Tinnitus, run by Technical University of Denmark at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tinnitus Functional Index (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2026.