Quality and Regulatory
Maintaining the highest quality standards to meet international regulatory requirements and ensure patient safety.
Landmark Approval by the US Food and Drug Administration
Lenire is the first and only bimodal neuromodulation tinnitus treatment device approved by the United States FDA through the rigorous De Novo process.
Adheres to EU Quality and Regulatory Standards
Lenire is CE-Marked, meeting the essential safety, performance, and regulatory requirements for European commercial availability.
ISO Certification 13485
Neuromod’s ISO Certification (13485) ensures that Lenire meets the most stringent safety and quality standards.
Medical Device Single Audit Program
Neuromod’s robust quality management system meets the requirements of the MDSAP program.
Declaration of Conformity
MDD (03/42/EEC), RED (2014/53/EU), RoHS(2011/65/EU). Neuromod’s rigorous quality management system and comprehensive technical documentation ensure that Lenire consistently meets the highest safety, performance, and regulatory conformity standards.
View Declaration
