Neuromod's Lenire tinnitus device gains EU MDR and MDSAP certification
The bimodal neuromodulation device, already FDA-authorized, now meets the EU's stricter device rules and a multi-country quality audit.
Irish company Neuromod Devices says its Lenire tinnitus treatment has been certified under the EU’s Medical Device Regulation (MDR). It also passed the MDSAP audit, a single quality audit recognized by regulators in several countries. Lenire pairs sounds played through headphones with mild electrical stimulation of the tongue. The FDA granted it De Novo authorization in 2023.
The EU MDR is considerably stricter than the previous rules, and many neurotech companies are still working through recertification.
Learn more: Neuroplasticity · Neuromod Devices