From lab to clinic: How EarDiTech used the EIC Tech to Market Venture Building journey to shape a hearing health start-up

Brussels, November 25th 2024

Summary

›EarDiTech, a Ghent University spinout, aims to detect and treat hidden hearing loss using a patented EEG diagnostic and a personalized sound algorithm.
›The start-up joined the EIC Tech to Market Venture Building Programme in September 2023 and completed its four-phase pathway from tech demo to venture support.
›Concrete milestones include initial clinical trials of the CochSyn Test, a working prototype of the CoNNear Algorithm, and early industry conversations with clinicians and manufacturers.
›Key challenges were commercial strategy and regulatory planning, addressed through tailored mentoring, market validation and partner outreach supplied by the Programme.
›Near term priorities are CE marking in Europe, preparing for FDA review, embedding the CochSyn Test into diagnostic platforms and licensing or partnering the CoNNear Algorithm with hearing aid makers.

From lab to clinic: EarDiTech’s EIC Tech to Market Venture Building trajectory

EarDiTech is a health technology start-up spun out of Ghent University that focuses on what is often called hidden hearing loss. The company says it has developed a patented, portable EEG diagnostic called the CochSyn Test to detect early auditory-nerve synapse damage and an algorithmic treatment module called CoNNear to adapt sound processing to an individual profile. EarDiTech entered the EIC Tech to Market Venture Building Programme in September 2023 and reports that it completed the programme’s four phases from Tech Demo Days to Venture Support Services.

Hidden hearing loss explained:Hidden hearing loss describes cases where standard audiometry shows clinically normal hearing thresholds yet the person experiences difficulty in noisy environments or other listening situations. This can be caused by damage to synapses connecting inner hair cells to auditory nerve fibers. EarDiTech cites epidemiological estimates that roughly 12 percent of people with clinically normal hearing may have this condition, with prevalence increasing in middle age and older cohorts.

The technology stack: CochSyn Test and CoNNear Algorithm

CochSyn Test:Described by EarDiTech as a patented precision diagnostic, the CochSyn Test is an EEG-based portable measurement system designed to detect and quantify synaptic damage at the auditory nerve. The test aims to reveal the early signs of permanent hearing damage before standard audiometry or conventional diagnostics register deficits. In principle, a sensitive electrophysiological measure can identify neural dysfunction that behavioural tests miss. The company has reported completion of initial clinical trials but wider validation and regulatory conformity will be needed for clinical adoption.

CoNNear Algorithm:CoNNear is positioned as a personalized treatment tool. It uses the individual auditory profile derived from the CochSyn Test to adapt sound processing and improve speech intelligibility in challenging listening conditions. Functionally, this is an embedded signal processing algorithm that could be adopted by hearing aid manufacturers or diagnostic platform vendors. EarDiTech reports a working prototype ready for real-world testing.

Why this matters and the limits of current claims

Early detection of neural components of hearing damage could change clinical pathways if it leads to actionable interventions and reimbursement. Untreated hearing impairment has been associated with social withdrawal, workplace productivity losses and higher risk of cognitive decline, which is why detection of early pathology is attractive to clinicians and health systems. That said, claims of preventive impact need careful qualification. Demonstrating that a diagnostic leads to improved long term outcomes requires longitudinal trials and health economic evidence. Similarly, integration of a bespoke algorithm into existing hearing devices depends on successful technical partnerships and regulatory clearances.

The EIC Tech to Market Venture Building Programme role

EarDiTech participated in the EIC Tech to Market Venture Building Programme which is aimed at translating EIC Pathfinder and Transition research into marketable ventures. The Programme follows a four-phase path: Tech Demo Days, Opportunities Exploration, Team Creation and Venture Support Services. Through workshops, mentor sessions and market feedback, the programme is designed to help research teams build viable business models and assemble founding teams. Note that the EIC Tech to Market Programme was reported as paused and expected to resume in 2026. The programme still serves as a useful case study of the sort of venture building supports the European Innovation Council aims to provide.

Four programme phases:Tech Demo Days provide exposure and feedback from market actors. Opportunities Exploration offers feasibility guidance and business insight recommendations. Team Creation focuses on recruitment, entrepreneurs in residence and talent brokerage. Venture Support Services deliver advisory expertise on IP, finance, regulatory and HR needs and on-demand services through EIC proactive management.

Challenges faced and how the Programme helped

EarDiTech reports that its principal challenge was moving from engineering and patents to a monetizable business model. Early teams emerging from academia often lack experience in pricing, distribution and regulatory strategy. Through workshops and one-on-one mentoring the Programme provided market research inputs and pricing strategy guidance which helped the team refine where the CochSyn Test and CoNNear Algorithm might fit in the value chain. The start-up says it pivoted toward partnerships with hearing aid manufacturers and diagnostic companies rather than a direct to consumer or solely clinic sales model.

Team transformation:According to the interview with Sarah Verhulst, the team went from 'engineers with ideas and patents' to a group with a business and regulatory mindset able to present to investors and market partners. The Programme emphasised real-world feedback loops to validate business strategy.

Concrete milestones achieved during the Programme

Milestone	Description	Status reported by EarDiTech
Industry outreach	Discussions with otolaryngologists, audiologists, hearing aid manufacturers and diagnostic companies to assess integration pathways	Ongoing engagement and exploratory talks
Clinical validation	Initial clinical trials for the CochSyn Test demonstrating diagnostic effectiveness in targeted cohorts	Completed initial trials, broader validation pending
Algorithm prototype	Working prototype of CoNNear ready for real-world testing	Prototype completed
Business model pivot	Shifted focus toward partnerships and licensing with device manufacturers and diagnostic platforms	Business model refined with Programme support

Support resources ranked by value

EarDiTech singled out access to industry experts, tailored mentoring sessions and workshops on commercialization as the most valuable elements. These resources helped validate the value proposition, refine pricing and channel strategies and introduce regulatory thinking early in product development.

Next steps and regulatory roadmap

EarDiTech’s near term plan is to finalise both the CochSyn Test and CoNNear Algorithm for commercial launch while pursuing regulatory clearances. In Europe this means navigating the medical device regulatory framework and obtaining CE marking. For the U.S. market the company intends to prepare for FDA review. The start-up plans to embed the CochSyn Test into diagnostic platforms and to expand collaborations with hearing aid manufacturers to implement the CoNNear Algorithm. Continued outreach to audiologists and other health providers is intended to drive clinical adoption.

Regulatory and commercial caveats:Regulatory approval timelines and requirements vary by device classification and claimed intended use. Clinical efficacy shown in initial trials does not automatically translate to market access. Reimbursement and integration into clinical workflows will require additional evidence on clinical utility and cost effectiveness. Partnering with established manufacturers can accelerate adoption but also introduces negotiation over IP, data access and revenue sharing.

Broader context in the EU innovation ecosystem

The European Innovation Council supports deep tech teams through funding streams such as Pathfinder and Transition with follow-on business acceleration services like Tech to Market. Venture building initiatives aim to reduce the gap between research outputs and commercial ventures by offering market intelligence, talent matchmaking and regulatory guidance. For medtech and digital health ventures, the combination of EU financing, local clinical networks and regulatory planning is essential but not sufficient. Teams still need robust validation, manufacturing scale up and payer engagement to reach sustainable revenue. The EIC programme model helps fill early gaps but longer term scaling often requires private capital and strategic industry partners.

Assessment and outlook

EarDiTech illustrates a plausible route from academic research to an early-stage commercial offering in a niche of audiology that is currently underserved by standard diagnostics. The EIC Tech to Market Venture Building Programme appears to have provided tangible benefits in market framing, team building and contacts. Still, the path ahead includes substantial work on regulatory approval, larger clinical validation, commercial partnerships and potential reimbursement pathways. These are typical hurdles for medtech start-ups and will determine whether the CochSyn Test and CoNNear Algorithm become widely adopted tools or remain promising prototypes.

How EarDiTech summarised the experience:In three words the team chose Innovative. Supportive. Transformative. That description captures the Programme impact on their internal capabilities but does not substitute for the evidence and regulatory milestones still required for market success.

Practical information and next actions for interested parties

Companies, clinicians and investors interested in following EarDiTech or exploring partnerships should note that the start-up is based in Ghent, Belgium and can be reached through its website. For innovators seeking similar supports the EIC Tech to Market Programme offers entrepreneurship training and venture building services but was reported paused and expected to restart in 2026. The EIC also runs separate calls for experts and entrepreneurs in residence to support these programmes when active.