Nuheara submits self-fitting hearing aid for FDA approval

Australian hearing firm Nuheara, which mostly develops earbuds with different degrees of hearing improving technology, has filed a registration with the FDA regarding a product designed for direct-to-consumer sales in the US.

Photo: Nuheara / PR

A new player is taking a step toward the regulatory approved medical device market in the US.

On Tuesday, Australian hearing aid firm Nuheara has announced that it has submitted a 510(k) registration with the US Food and Drug Administration (FDA) for its self-fitting hearing aid, a press release reports.

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