On March 22, 2019, the treatment device dedicated to the ØREBLUE® method obtained CE Medical Certification Class IIa in accordance with European Directive 93/42 / EEC Medical Devices (certified by BSI under CE certificate number 667381).
This certification is officially registered with the ANSM (the National Agency for the Safety of Medicines and Health Products).
On the same date, the abstract of the benchmark retrospective clinical study was also published.
The Certification procedure was instructed by an independent certification body for a period of 17 months, during which time we were prohibited (for a procedural matter) from communicating on the method and its results, both to the general public, and to with health professionals.
Since May 2019, Mrs Natacha CHETRITT-BONNEYRAT has been meeting more and more ENT departments, both in Paris and in the provinces, in order to present her research work and present the ØREBLUE® method.
We invite any interested person (ENT doctors, hearing aid specialists, or health professionals) to send us a request for information by writing to us at the email address email@example.com, mentioning their name, first name, position and company, and phone number.
We regret to note that despite our numerous requests, the France Acouphènes association did not wish to learn about the ØREBLUE® Protocol.