FDA approves new MR-safe hearing device from Cochlear

June 17, 2019 By Danielle Kirsh Leave a Comment

Cochlear Ltd. (ASX:COH) today announced that it received FDA approval for its Cochlear Nucleus cochlear implant and its Nucleus 7 sound processor.

The Nucleus Profile Plus implant is designed for safe use in MRI scans and offer easier access to 1.5 and 3.0 Tesla MRI scans without having to remove its internal magnet or use a head wrap. The implant is built from the company’s Nucleus Profile Series implant that features an accessible magnet that can be removed if needed during an outpatient procedure.

“For more than two decades, Cochlear has been pleased to provide Nucleus Cochlear Implant recipients with access to MRIs,” president of Cochlear Americas Tony Manna said in a press release. “Now with the approval of the Nucleus Profile Plus Implant, we are able to provide our cochlear implant recipients MRI access without the need to remove the internal magnet or needing a head wrap at 1.5 and 3.0 T, improving the experience for both healthcare professionals and their patients. We are delivering this new innovation without sacrificing our longstanding cochlear implant reliability track record, our thin implant design and the easy to access magnet that ensures our recipients have continued MRI access now and in the future.”

Cochlear’s Nucleus 7 sound processor enables direct audio streaming from Android devices directly to the cochlear implant sound processor without the need for another intermediary device or attachments to the sound processor. With the new approval, Nucleus 7 users can connect to compatible Apple and Android devices without compromising size, weight and battery life of the sound processor, according to the company. Android streaming capabilities are dependent on the phone manufacturers implementing Google’s Audio Streaming for Hearing Aids function into operating system updates.

“When a person chooses a cochlear implant, it begins a partnership between them and the cochlear implant company for the rest of their life. As the most chosen cochlear implant manufacturer with recipients all around the world, we at Cochlear understand our responsibility to innovate reliable implants and upgradeable sound processors that meet the needs of our customers today and in the future,” Patricia Trautwein, VP of marketing and product management at Cochlear Americas, said. “In addition, our commitment extends beyond the product portfolios to include service innovations being realized with future-thinking connectivity that are transforming hearing healthcare.”

Cochlear is commercially launching the Nucleus Profile Plus Series Cochlear Implant later this month. The Nucleus 7 Sound Processor’s expanded connectivity features will be commercially available this fall.

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