Cochlear cleared to sell new device in US

Cochlear Limited (ASX:COH) has secured approval to sell its new Nucleus Hybrid L24 Cochlear Implant System in the US.

The system is designed to augment hearing in patients with severe to profound hearing loss in high frequencies, but who are still able to hear low-frequency sounds with or without a hearing aid.

It uses electrical stimulation for high frequencies and acoustic amplification for low frequencies.

The US FDA approved the new device after evaluating a clinical study involving 50 patients with moderate to profound high-frequency hearing loss. The majority of these reported statistically significant improvements in word and sentence recognition at six months post application.

While 68% of patients experienced one or more adverse events, including low-frequency hearing loss, the FDA took the view that the benefits of the device outweigh the risks for those who do not benefit from traditional hearing aids.

Other adverse events included tinnitus electrode malfunction and dizziness. The FDA said 22 developed profound or total low-frequency hearing loss in the implanted ear and six of these replaced the new system with a standard cochlear implant.

People with severe high-frequency hearing loss can have trouble understanding people with higher-pitched voices, hearing faint sounds and in some cases, hearing sirens and high-pitched safety alarms.

Cochlear (ASX:COH) shares were trading 2.4% higher at $57.940 as of around 1.30 pm on Friday.