Lenire is a medical device regulated by the USA Food and Drug Administration. Federal US law restricts this device to prescription by a healthcare professional who is experienced in the evaluation and management of tinnitus. Specialized providers will complete a thorough tinnitus & audiological assessment and will design a treatment plan that is right for you. If Lenire is determined the best option for you, your provider will schedule a fitting for the device that is customized to your tinnitus and hearing profile. Lenire is a single user device and is not intended for resale. You will find a list of Lenire providers on our website: Go to www.lenire.com and select ‘Find a Clinic.