Certification & Communication
New medical device
The Nouvelle-Aquitaine Région acknowledges its recognition and financial support to the research and devlopment and medical innovation project of the Mayfair Developments company owned by Natacha Chetritt-Bonneyrat, audiologist in La Rochelle, for the miniaturization of the medical device dedicated to the ØREBLUE® method in the management of patients suffering from tinnitus and hyperacusis.
The Sud-Ouest newspaper related it in its December 3, 2019 edition.
Receipt of registration declaration to the ANSM for the medical device dedicated to the ØREBLUE® method for the treatment of patients suffering from symptoms of tinnitus and hyperacusis.
Standard ISO 13485:2016
ISO 13485 is an international quality management standard that allows the implementation of regulatory requirements for medical devices and related services.
CE Médical Device Class IIa
The Medical CE according to the European Directive 93/42 / EEC Medical Devices is the official recognition that the certified device meets the safety and performance requirements imposed on health equipment, and guarantees that the benefit / risk has been clearly demonstrated.
Abstract Clinic Study
Abstract of the retrospective clinical study published on March 21, 2019 by
Dr. Gabrielle Cremer.
Study demonstrating the performance and safety of the device in the treatment of tinnitus and hyperacusis.