FDA classifies tinnitus relief device as Class II

The Food and Drug Administration has officially classified a specific type of medical device for treating tinnitus into Class II. The device, known as the Lenire, uses both sound and mild electrical stimulation to help relieve ringing in the ears. By placing it in Class II, the FDA determined that standard regulations combined with specific safety controls are enough to ensure the device works safely.

Why it matters: This is an administrative classification that lowers the regulatory barrier for one specific medical technology. It does not change laws or create new taxes, but it does make it faster and cheaper for manufacturers to bring tinnitus treatments to patients. For most people, this means more options may become available in the coming years as companies navigate the simpler Class II rules.

Who it affects

• Manufacturers of medical devices designed to treat tinnitus using acoustic or electrical stimulation

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This final order was issued by the FDA and published in the Federal Register on March 6, 2023; check the original document at 88 FR 14759 for full regulatory details.

Agency: Health and Human Services Department, Food and Drug Administration
Source: Federal Register — read the official document