MRI-safe cochlear implant approved by FDA


cochlear implants

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A cochlear implant designed especially for use in magnetic resonance imaging (MRI) scans has been approved by the US Food and Drug Administration (FDA).

Cochlear implants are problematic for their users when they need to undergo MRI scans. The powerful magnets used in the scanning device can dislodge the tiny magnets in a cochlear implant (CI), causing pain to patients and damage to the CI.

Australian-based hearing implant technology firm Cochlear Limited has announced approval by the FDA for its Cochlear Nucleus Profile Plus Series, which has immediately been made commercially available in the United States. Recipients will have access to 3.0 and 1.5 Tesla (T) MRI scans without the need for internal magnet removal or use of a head wrap, says Cochlear.

The new implant series boasts the state-of-the-art features needed to compete in the marketplace—direct audio streaming from Android devices, compatibility for connection with Apple devices, etc.—and Cochlear says its Nucleus 7 Sound Processor can help people locate a misplaced sound processor, track progress with the hearing tracker feature, and reduce background noise.

Cochlear says the implant is still awaiting approval by Health Canada.

Source: Industry Dive