Regulatory status

Raisonance is not a medical device

Raisonance is intended for documentation, workflow, and administrative support for audiology professionals. It is not intended to diagnose, prevent, monitor, predict, prognose, or treat any condition, and it is not intended to provide clinical decision support. On that basis, it is not a medical device under EU Medical Device Regulation (EU) 2017/745.

Intended purpose

Raisonance assists audiologists in structuring consultation information, completing the patient record, and drafting notes and reports. Its outputs are administrative and documentary aids that the clinician reviews and validates.

What Raisonance does not do

• It does not diagnose hearing loss or any other condition.
• It does not recommend treatment or hearing-aid settings.
• It does not triage, screen, or flag pathology.
• It does not make or replace any clinical decision.

Clinical oversight

A qualified clinician must review every output. The clinician retains full responsibility for clinical decisions and for the accuracy of validated records and reports.

Changes to intended purpose

If the intended purpose of Raisonance ever changes such that it could fall within the scope of the Medical Device Regulation, we will carry out the required regulatory assessment before making any such functionality or claim available.