Live News • Jul 14
Cochlear Wins FDA Clearance for Osia 3 Sound Processor With Rechargeable Design Cochlear has received US FDA clearance for its new Osia 3 Sound Processor, a fully rechargeable active bone conduction device that offers improved sound quality, broader streaming support across Apple, Android and Bluetooth LE Audio, and remote care features, with US availability planned for early fall and other markets dependent on local regulatory approvals.
The Osia 3 Sound Processor expands Cochlear’s Osia System portfolio, adding a premium option that could strengthen its position in active bone conduction hearing solutions by offering more patient convenience and software-based fitting tools for clinicians.
Cochlear shares last traded at A$123.20, with the stock down 52.8% year to date, putting this product milestone against a backdrop of recent share price pressure.
This clearance gives Cochlear another differentiated device to offer in the US, and the key question for investors is how quickly clinicians and patients adopt Osia 3 and whether that uptake is enough to offset recent share price weakness. Announcement • Jul 13
Cochlear Limited Announces FDA Clearance of The Osia 3 Sound Processor Cochlear Limited received FDA clearance of the new Cochlear Osia 3 Sound Processor, the newest advancement of the Osia System. The Osia 3 Sound Processor is the first fully rechargeable active bone conduction sound processor, with up to 30 hours of battery life on a single charge. It features an on-the-go charging case that holds additional charges, similar to wireless earbuds. The Osia 3 Sound Processor offers improved clarity and sound quality, enhanced by the new signal processing platform and powerful lithium-ion battery. It now has a fitting range up to 65 dB HL bone conduction thresholds in the mid to high frequencies. The new Zaphium signal processing chip offers a wider frequency bandwidth than the previous generation and includes ForwardFocus technology, to help patients filter out the clutter of noise and focus on what matters. The Osia 3 Sound Processor joins Cochlear's industry-leading connectivity with streaming from Android, Apple, Bluetooth LE Audio and Auracast broadcast audio sources. Auracast broadcast audio allows patients to share music with a friend or tune into shared audio in places like cinemas, concert venues, lecture halls and airports, as more devices and venues adopt the technology. The Osia 3 Sound Processor is compatible with Remote Care, wireless fitting capability and improved data logging support for more convenient and intuitive fittings. With backwards compatibility, current Osia System patients who are eligible can benefit from upgrading to the Osia 3 Sound Processor no matter which Osia Implant model they have. The Osia 3 Sound Processor will be available in the United States in early fall. Availability in other countries is subject to regulatory approval. The Osia 3 Sound Processor has two versions, which differ only in magnet compatibility to the implant. The OSI300 Implant is compatible with the Osia 3(I) Sound Processor version. Cochlear Osia implants are MR Conditional, meaning they have demonstrated safety in the Magnetic Resonance Imaging (MRI) environment within defined conditions. Battery life varies for every user, according to the age of the battery, the programs used each day, implant type, the thickness of skin covering the implant, and the size and type of battery used. Streaming may decrease sound processor battery life depending on how often and for how long streaming is engaged. For information regarding the compatibility of Cochlear's sound processors with Apple or Android devices, visit www.cochlear.com/compatibility. Remote Assist for Osia for compatible Osia sound processors is intended for a follow-up adjustment or setup of a replacement or upgrade sound processor for suitable qualified patients based on clinical judgment. Only available at clinics that have enrolled in Remote Care. As Bluetooth LE Audio compatible devices become available, a sound processor firmware update will be required to use certain features. Auracast broadcast audio capability is subject to third party adoption of the Auracast protocol. The Osia 3 Sound Processor is designed to improve hearing outcomes for children and adults with conductive hearing loss, mixed hearing loss and single-sided deafness (SSD). In clinical studies, patients with the Osia 3 Sound Processor have demonstrated improved speech understanding and preferred the sound quality over the previous generation. In clinical research, recipients said they loved the Osia 3 Sound Processor's natural, comfortable, lifelike sound – with 97% satisfied or very satisfied with its overall sound quality. 
