Evaluation of the CochSyn Device in Clinical Practice (Earditech 2)

February 6, 2026 updated by: University Ghent
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

65

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Antwerp, Belgium
        • University Hospital Antwerp (UZA)
      • Ghent, Belgium
        • University Hospital Ghent
      • Liège, Belgium
        • CHU de Liège

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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

  • 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.

Exclusion Criteria:

  • 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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Test group (self-reported hearing difficulties)
30 subjects with self-reported hearing difficulties according to the Hearing Handicap Inventory for the Elderly - Screening Version (HHIE-s) questionnaire (score of >4)
Device: CochSyn device
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.
Experimental: Control group (no self-reported hearing difficulties)
30 subjects without self-reported hearing difficulties according to the Hearing Handicap Inventory for the Elderly - Screening Version (HHIE-s) questionnaire (score of ≤4)
Device: CochSyn device
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.
Experimental: DeaFNess Autosomal dominant 9 (DFNA9) subgroup (genetically tested and confirmed)
10 subjects (+3 potential drop-outs) genetically tested and confirmed to have DeaFNess Autosomal dominant 9 (DFNA9) related hearing loss
Device: CochSyn device
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical performance CochSyn device: speech intelligibility
Time Frame: Through study completion, an average of 2,5 hours
A significant multiple regression model that predicts speech intelligibility (quantified using the speech reception threshold) based on markers of hearing
Through study completion, an average of 2,5 hours
Clinical performance CochSyn device: self-reported hearing difficulties
Time Frame: Through study completion, an average of 2,5 hours
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.
Through study completion, an average of 2,5 hours
Reliability of the CochSyn test
Time Frame: Through study completion, an average of 2,5 hours
The difference between the EFR measure in a test-retest setting, where the same measurement is performed twice during the experiment.
Through study completion, an average of 2,5 hours
Device related safety events of the CochSyn device
Time Frame: Through study completion, an average of 2,5 hours
The cumulative rate of device related safety events throughout the study.
Through study completion, an average of 2,5 hours
Technical performance of the CochSyn device
Time Frame: Through study completion, an average of 2,5 hours
The cumulative rate of device deficiencies throughout the study.
Through study completion, an average of 2,5 hours
Usability of the CochSyn device
Time Frame: Through study completion, an average of 2,5 hours
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.
Through study completion, an average of 2,5 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Ghent

Investigators

  • Study Director: Sarah Verhulst, Prof., University Ghent

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 29, 2025

Primary Completion (Actual)

January 22, 2026

Study Completion (Actual)

January 22, 2026

Study Registration Dates

First Submitted

July 10, 2025

First Submitted That Met QC Criteria

July 25, 2025

First Posted (Actual)

July 29, 2025

Study Record Updates

Last Update Posted (Actual)

February 10, 2026

Last Update Submitted That Met QC Criteria

February 6, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ONZ-2025-0104

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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