CompletedNot Applicable

Evaluation of the CochSyn Device in Clinical Practice

Belgium65 participantsStarted 2025-10-29

Plain-language 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 difficulties and test a new type of hardware that was developed to conduct the test (the CochSyn Device) in clinical practice.

Who can participate

Age range

18 Years – 77 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 criteri…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Clinical performance CochSyn device: speech intelligibility

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

Clinical performance CochSyn device: self-reported hearing difficulties

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

Reliability of the CochSyn test

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

Device related safety events of the CochSyn device

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

Technical performance of the CochSyn device

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

Usability of the CochSyn device

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

Trial details

NCT IDNCT07091071

SponsorUniversity Ghent

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-01-22

View on ClinicalTrials.gov More Hearing Loss, Sensorineural trials

Plain-language summary

Who can participate

Age range

18 Years – 77 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Clinical performance CochSyn device: speech intelligibility

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

Clinical performance CochSyn device: self-reported hearing difficulties

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

Reliability of the CochSyn test

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

Device related safety events of the CochSyn device

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

Technical performance of the CochSyn device

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

Usability of the CochSyn device

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