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Hearing Loss, SensorineuralEarditech 2NCT07091071

Evaluation of the CochSyn Device in Clinical Practice

A study testing CochSyn device in people with Hearing Loss, Sensorineural and Cochlear Hearing Loss, run by University Ghent at 3 sites in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study investigates a new type of auditory evoked brain potentials for the quantification and classification of peripheral hearing damage (The CochSyn Test). The study will investigate the characteristics of this new auditory evoked potential marker in a cohort of people with and without self-reported hearing… Read more about this study

Who is it for?
Ages 18 to 77 yearsHealthy volunteers can take part
What is being tested?
CochSyn device
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
65 participants
Where
3 sitesBelgium
Study dates
29 Oct 2025to 22 Jan 2026
Phase
Interventional
Are there results?
None posted in the registry

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 to 77 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Age 18-77 years (limits included)
  • Ability to fill out a questionnaire and to perform a speech intelligibility test
  • Dutch or French as native language
  • Control group
  • No self-reported hearing difficulties according to HHIE-s questionnaire (score of ≤4)
  • Test group
Show all 9Show fewer
  • Self-reported hearing difficulties according to HHIE-s questionnaire (score of >4)
  • Subgroup DFNA9:
  • Genetically tested and confirmed to have DFNA9 related hearing loss. Note: This genetic testing was performed through standard of care testing, prior to participation in the study.

Who cannot join

  • Audiometric hearing loss classifications of Moderate, Moderately severe, Severe, Profound as defined by (Clark, 1981) of the tested ear
  • Asymmetrical hearing loss Note 1: Asymmetrical hearing loss is defined as an average difference of more than 15dB between both ears across the frequencies of 500, 1000, 2000 and 4000 Hz. The sum of loss in dB is divided by 4 and rounded up. A frequency not perceived is considered a loss of 120 dB.
  • Note 2: This exclusion criterium is not applicable for the DFNA 9 subgroup
  • Tinnitus with a clinical handicap index (TFI) > 25.
  • Patients with type AD, AS, B or C tympanograms
  • Conductive hearing loss on the tested ear at the discretion of the investigator
Show all 15Show fewer
  • Genetic hearing loss of the tested ear Note: This exclusion criterium is not applicable for the DFNA9 subgroup.
  • Congenital hearing loss of the tested ear Note: This exclusion criterium is not applicable for the DFNA9 subgroup.
  • Blocked ear canal(s) of the tested ear
  • Pregnant or breast-feeding
  • Hearing aid user on the tested ear
  • Middle ear surgery on the tested ear
  • Acute ear infection of the tested ear
  • Acute external auditory canal trauma on the tested ear
  • Participation in session 2 of previous clinical trial NCT06114680

Trial locations and contacts

3 sites in 1 country.

Belgium3 sites

  • University Hospital Antwerp (UZA)

    Antwerp

  • University Hospital Ghent

    Ghent

  • CHU de Liège

    Liège

Other trials in Belgium

About this study

This study investigates a new type of auditory evoked brain potentials for the quantification and classification of peripheral hearing damage (The CochSyn Test). The study will investigate the characteristics of this new auditory evoked potential marker in a cohort of people with and without self-reported hearing difficulties and test a new type of hardware that was developed to conduct the test (the CochSyn Device) in clinical practice.

Read the detailed description

Cochlear synaptopathy (CS) is a new type of sensorineural hearing loss (SNHL) and is related to ageing, noise exposure and ototoxicity. There is currently no diagnostic test of CS on the market, whereas CS is an important form of SNHL. CS occurs before the golden standard clinical hearing test (pure- tone audiogram in which participants raise their hand when hearing tones of different frequencies and the threshold of hearing is determined), shows any signs of hearing damage.

The sponsor has developed a new test, the CochSyn test that may quantify SNHL earlier than the audiogram. The newly developed test is based on auditory evoked potentials. This is a method in which an auditory stimulus is presented, and encephalogram (EEG) electrodes capture the sound-evoked brain potentials. The most popular auditory evoked potential metric to diagnose sensorineural hearing loss (SNHL) is the auditory brainstem response (ABR). Even though it can be assumed that the ABR wave-I amplitude will be sensitive to CS in humans, it may not be a differential marker for it, and hence other candidate auditory evoked potential markers for CS have been investigated. In particular, the envelope-following-response (EFR), has also been shown to be specific to CS.

The sponsor has performed several research studies on the CochSyn test that used commercially available research equipment in either humans or research animals . These data show that our marker is sensitive to ototoxic-induced CS in research animals and demonstrates an age-related decline in humans, and a superiority in terms of test-retest reliability and sensitivity compared to clinical ABR wave-I, or other evoked potential, markers. These promising data, the lack of a method to identify CS and the lack of commercially available hardware to conduct the CochSyn test in a clinical setting motivate the need for the development of the CochSyn test and device.

In this study, the sponsor wish to test the performance of its new method (the CochSyn test) in listeners with or without self-reported hearing difficulties using a newly developed hardware prototype (the CochSyn device), dedicated for the CochSyn test in clinical practice.

Being tested
CochSyn device
Keywords
Auditory Evoked Potentials, Envelope Following Response, Auditory Brainstem Response, Hearing Difficulties
Medical subject headings
Hearing Loss, Sensorineural, Hearing Loss, Hidden

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CochSyn deviceDevice

    The CochSyn device is intended for use in the evaluation of hearing-related disorders in adults using auditory evoked potentials. The CochSyn device records and analyses biopotential waveforms that can be used for hearing screening and diagnostic applications.

Study groups in NCT07091071
Study groupRoleWhat they receive
Test group (self-reported hearing difficulties)Experimental30 subjects with self-reported hearing difficulties according to the Hearing Handicap Inventory for the Elderly - Screening Version (HHIE-s) questionnaire (score of >4)
Receives: Device: CochSyn device
Control group (no self-reported hearing difficulties)Experimental30 subjects without self-reported hearing difficulties according to the Hearing Handicap Inventory for the Elderly - Screening Version (HHIE-s) questionnaire (score of ≤4)
Receives: Device: CochSyn device
DeaFNess Autosomal dominant 9 (DFNA9) subgroup (genetically tested and confirmed)Experimental10 subjects (+3 potential drop-outs) genetically tested and confirmed to have DeaFNess Autosomal dominant 9 (DFNA9) related hearing loss
Receives: Device: CochSyn device

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Clinical performance CochSyn device: speech intelligibility

    A significant multiple regression model that predicts speech intelligibility (quantified using the speech reception threshold) based on markers of hearing

    Measured: Through study completion, an average of 2,5 hours

  2. Clinical performance CochSyn device: self-reported hearing difficulties

    A significant multiple regression model that predicts self-reported hearing difficulties (quantified using the Hearing Handicap Inventory for the Elderly - Screening Version questionnaire) based on markers of hearing. HHIE-s score varies from 0 to 40. The higher the score the higher probability of hearing impairment.

    Measured: Through study completion, an average of 2,5 hours

  3. Reliability of the CochSyn test

    The difference between the EFR measure in a test-retest setting, where the same measurement is performed twice during the experiment.

    Measured: Through study completion, an average of 2,5 hours

  4. Device related safety events of the CochSyn device

    The cumulative rate of device related safety events throughout the study.

    Measured: Through study completion, an average of 2,5 hours

  5. Technical performance of the CochSyn device

    The cumulative rate of device deficiencies throughout the study.

    Measured: Through study completion, an average of 2,5 hours

  6. Usability of the CochSyn device

    Written feedback in form of a questionnaire and subjective comments of the test administrator on the usability of the test system for the measurements performed with the CochSyn Device after a measurement session, with regard to ease of use and comfort for both the clinician and the patient.

    Measured: Through study completion, an average of 2,5 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jul 2025
  2. Study start29 Oct 2025
  3. Primary completion22 Jan 2026
  4. Study completion22 Jan 2026

Resources

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
Diagnosis
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
65 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07091071
Sponsor's protocol ID
ONZ-2025-0104
Acronym
Earditech 2
Status last verified
Dec 2025
First submitted
10 Jul 2025
Last updated
10 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • van de Pol M, Verhulst S. Age-dependent traits: a new statistical model to separate within- and between-individual effects. Am Nat. 2006 May;167(5):766-73. doi: 10.1086/503331. Epub 2006 Mar 20.

    PubMed 16671020

  • Garrett M, Verhulst S. Applicability of subcortical EEG metrics of synaptopathy to older listeners with impaired audiograms. Hear Res. 2019 Sep 1;380:150-165. doi: 10.1016/j.heares.2019.07.001. Epub 2019 Jul 2.

    PubMed 31306930

  • Keshishzadeh S, Garrett M, Verhulst S. Towards Personalized Auditory Models: Predicting Individual Sensorineural Hearing-Loss Profiles From Recorded Human Auditory Physiology. Trends Hear. 2021 Jan-Dec;25:2331216520988406. doi: 10.1177/2331216520988406.

    PubMed 33526004

  • S. Verhulst, H. Van Der Biest, S. Keshishzadeh, H. Keppler, and I. Dhooge, "Supra-threshold envelope-following responses in the ageing population : an early marker of sensorineural hearing damage," in JOURNAL OF THE ACOUSTICAL SOCIETY OF AMERICA, Chicago, IL, USA, 2023, vol. 153, no. 3, Supplement, pp. A50-A50.

  • N. De Poortere, W. Van Ransbeeck, S. Keshishzadeh, H. Keppler, I. Dhooge, and S. Verhulst, "Music festivals : the effect of recreational noise exposure on young adults hearing," in ARO (Association for Research in Otolaryngology) 46th Annual Midwinter Conference, Abstracts, Orlando, Florida, 2023.

  • H. Van Der Biest, H. Keppler, I. Dhooge, S. Keshishzadeh, and S. Verhulst, "Cochlear synaptopathy in the ageing population," in 13th Speech in Noise Workshop, Abstracts, online, 2022.

  • Verhulst S, Altoe A, Vasilkov V. Computational modeling of the human auditory periphery: Auditory-nerve responses, evoked potentials and hearing loss. Hear Res. 2018 Mar;360:55-75. doi: 10.1016/j.heares.2017.12.018. Epub 2017 Dec 28.

    PubMed 29472062

  • Vasilkov V, Caswell-Midwinter B, Zhao Y, de Gruttola V, Jung DH, Liberman MC, Maison SF. Evidence of cochlear neural degeneration in normal-hearing subjects with tinnitus. Sci Rep. 2023 Nov 30;13(1):19870. doi: 10.1038/s41598-023-46741-5.

    PubMed 38036538

Questions about this trial

What is this clinical trial studying?

A study testing CochSyn device in people with Hearing Loss, Sensorineural and Cochlear Hearing Loss, run by University Ghent at 3 sites in Belgium.

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 9 inclusion and 15 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: finished, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Belgium. 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. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical performance CochSyn device: speech intelligibility (time frame: Through study completion, an average of 2,5 hours). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07091071, which also lists 8 linked publications.

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 10 Feb 2026.

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