Cochlear receives FDA clearance for three new hearing devices

All of the products announced today will be able to connect to smartphones to track hearing information and control the device.
By Mallory Hackett
09:18 am
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Cochlear Limited announced yesterday the U.S. Food and Drug Administration clearance of three new products to be added to the company’s suite of hearing technology devices, all of which can connect to smartphones.

The Premarket Approval clearances went to the Kanso 2 Sound Processor, the Nucleus 7 Sound Processor for Nucleus 22 Implant recipients and the Custom Sound Pro fitting software. The new products will be commercially available in the U.S. and Canada later this year, according to the company.

The Kanso 2 Sound Processor is an off-the-ear cochlear implant that is compatible with Apple and Android devices, as well as the Nucleus Smart App. With the app, users can control their device and receive hearing information. 

The Nucleus 22 is now compatible with the Nucleus 7, meaning that Nucleus 22 implant recipients can upgrade to the newer behind-the-ear sound processor which has smartphone connectivity. Now, people with a Nucleus 22 implant will be able to connect the device to their smartphone.

Cochlear has also released Custom Sound Pro fitting software for clinicians supporting Nucleus implants. The software includes a patient dashboard and goal-setting feature to promote engagement between appointments. 

WHY IT MATTERS

About 13% of people over the age of 12 in the U.S. have hearing loss in both ears, according to the National Institutes of Health

Since the FDA first approved cochlear implants in the mid-1980s, about 58,000 devices have been implanted in adults and 38,000 in children, according to the NIH.

The devices are designed for children and adults who are deaf or severely hard-of-hearing. Although it doesn’t restore hearing, it can give a “useful representation of sounds” to help people understand speech, according to the NIH. 

As this technology has been developed over the last 40 years, more and more implant recipients have improved their ability to hear. 

THE LARGER TREND

Cochlear has been working on integrating its technology into smartphones in recent years. 

In 2017, the Nucleus 7 Sound Processor became the first cochlear implant sound solution made specifically for use with iPhones, iPods and iPads. 

Then last year, the company teamed up with Google to connect the Nucleus 7 to Android devices.

ON THE RECORD

“Cochlear continues to develop and introduce products to support the best lifelong hearing experience for our recipients and their care team,” said Tony Manna, the president of Cochlear Americas, in a statement. “Our new technology can better meet the individual needs and lifestyles of our recipients and is the result of persistent efforts to improve hearing outcomes.”

 

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