NCT07091071

Evaluation of the CochSyn Device in Clinical Practice

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 65 (actual)
• Sponsor: University Ghent · Academic / Other
• Sex: All
• Age: 18 Years – 77 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Hearing Loss, Sensorineural
• Cochlear Hearing Loss
• Cochlear Synaptopathy
• DFNA9

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-10-29
• Primary completion: 2026-01-22
• Completion: 2026-01-22
• First posted: 2025-07-29
• Last updated: 2026-02-10

Locations

3 sites across 1 country: Belgium