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Cochlear share price higher on FDA approval news

The Cochlear Limited (ASX: COH) share price is pushing higher on Monday morning.

At the time of writing the hearing solutions company’s shares are up 0.25% to $225.00.

Why is the Cochlear share price pushing higher?

The Cochlear share price was given a boost this morning with an announcement relating to its Osia 2 System.

The Osia 2 System is the world’s first active osseointegrated steady-state implant. it uses digital piezoelectric stimulation to bypass damaged areas of the natural hearing system and send sound vibrations directly to the cochlea.

This morning the company announced that it has received FDA clearance for the system. It has been indicated and approved in the United States for adults and children (12 years and older) with conductive hearing loss, mixed hearing loss, and single-sided sensorineural deafness.

As a result, Cochlear intends to commence the commercial rollout of the Osia 2 System in the United States during the second half of FY 2020. This will extend the company’s Acoustics product portfolio in the massive market. Availability in other countries will be subject to regulatory approvals.

This is the second FDA approval the company has received this year.

In June the company revealed the receipt of FDA approval for the Nucleus Profile Plus Series cochlear implant. That allowed Cochlear to commence an immediate launch in the United States.

The Nucleus Profile Plus Series cochlear implant is built on the world’s thinnest implant platform. It has been designed so that it can be used for routine 1.5 and 3 Tesla magnetic resonance imaging (MRI) scans without the need to remove the internal magnet.

Its release late in FY 2019 resulted in an uplift in sales. Management will no doubt be hoping that this latest approval gives its sales in FY 2020 a boost as well.

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James Mickleboro has no position in any of the stocks mentioned. The Motley Fool Australia's parent company Motley Fool Holdings Inc. owns shares of Cochlear Ltd. The Motley Fool Australia has recommended Cochlear Ltd. We Fools may not all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors. The Motley Fool has a disclosure policy. This article contains general investment advice only (under AFSL 400691). Authorised by Scott Phillips.

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