Earlier this month, Cochlear received FDA clearance for the Osia 2 System, the first active osseointegrated steady-state implant (OSI). The Osia System represents a new type of bone conducting hearing solution that uses digital piezoelectric stimulation to transmit sound vibration directly to the inner ear. While present in other auditory equipment and some medical devices, piezoelectricity has not previously been used in this type of hearing implant. The Piezo Power transducer allows the Osia System to transmit without any moving parts and avoids the use of natural hearing systems which may be damaged or functioning improperly in individuals with hearing loss. The transducer’s ability to amplify high frequencies is particularly important for understanding speech.
Evidence for the Osia System comes from a one-year, multicenter clinical investigation using a first-generation version of the device. Compared to unaided and aided preoperative testing, patients experienced significant improvements in both their ability to hear noise and quiet as well as in their health-related quality of life. With the clearance, the Osia System will be available in the U.S. through limited release for patients 12 years and older. Full commercial availability in the U.S. is planned for early 2020.
According to Rom Mendel, President of Cochlear Acoustics, “The Osia System was developed through our efforts to listen to the recipients and clinicians who utilize our hearing implants every day. So far, we have been overwhelmed by the positive reception of the Osia System by both clinicians and patients, and it’s been incredible to see the improvement in recipients’ lives as they are able to hear better in the areas where we know they struggle.”
To learn more about Cochlear’s new offering, Medgadget spoke with Mats Dotevall, Director of Design and Development and Director of Clinical Affairs at Cochlear Acoustics.
Medgadget: What is Cochlear’s state of the art today when it comes to implantable hearing technologies?
Mats Dotevall: Within bone conduction hearing implants, the state of the art technology is the Cochlear Baha System that rests upon a 40-year legacy of continuous innovations. It’s a well-proven implant system with various connection options and a range of small, smart, and powerful sound processors.
Medgadget: What is the Osia System’s core innovation and how does it work?
Dotevall: The principal innovation of the Osia System lies in the heart of the implant, which contains the Piezo Power transducer made of piezoelectric material. The design is completely different than traditional bone conduction transducers, and with no movement between the parts, it is designed to deliver long-term performance and durability when implanted. Driven by a wireless digital link, this transducer expands and contracts to create powerful vibrations that stimulate the inner ear while optimizing the transfer of power and sound quality. Piezoelectricity has been used for years in many products like microphones, high-end speakers, and medical equipment, but this is the first time it is being used in this type of hearing implant application. One of the many advantages of the Piezo Power transducer is its ability to amplify high frequencies, the area of sound most important for speech understanding.
More information on how the Osia System works can be found here: https://www.multivu.com/players/English/8453251-cochlear-osia-hearing-implant-system/
Medgadget: Are there certain types of patients who benefit most from the Osia System?
Dotevall: The Osia System is available to treat hearing loss associated with an array of conditions including chronic otitis media (COM), otosclerosis, and atresia/microtia. In the U.S., it can be used by adults and children 12 years and older with conductive hearing loss, mixed hearing loss and single-sided sensorineural deafness (SSD).
Medgadget: What functionality does the Osia System have to interact with the patient’s mobile device or other technology platforms? Are other integrations planned for the Osia System?
Dotevall: The Osia System includes Made for iPhone technology, which means recipients can make phone calls, listen to music in high-quality stereo sound, watch videos and have FaceTime calls streamed directly to their hearing implant. It is also compatible with Cochlear’s True Wireless accessories. The new Osia Smart App also lets the user adjust the sound processor easily from a compatible smartphone or Apple Watch.
Medgadget: The results of a Cochlear’s clinical study using the Osia System were recently presented at OSSEO 2019 International Congress. What were some of the results from the study?
Dotevall: We’ve seen a significant improvement in patients’ ability to hear in noise and quiet. The results from the clinical investigation show a significant, average improvement of 7.4 dB in hearing in noise and an average improvement of up to 58% in hearing in quiet when compared to a 55 dB transcutaneous bone conduction system.
Medgadget: What’s next for the Osia System? When will it be available in the US now that is has FDA approval?
Dotevall: Full U.S. commercial availability for eligible patients is expected in early 2020. Health Canada approval for the Osia 2 System is expected in early 2020. Availability in other countries is subject to regulatory approvals.
Here’s a video Cochlear released to promote the Osia system:
Product page: Osia System…
Flashbacks: Cochlear Nucleus 7 Cochlear Implant: Seen at CES 2019; First Cochlear Implants FDA Approved for Single-Sided Deafness Asymmetric Hearing Loss