Osseointegrated Device: A hearing solution

Hearing loss is one of the world’s most common disabilities, with millions of people struggling every day to pick up on the sounds around them and communicate with their friends, family and co-workers . Untreated, hearing loss is a key risk factor for isolation, depression and dementia. In some cases, reduced hearing sensitivity may cause limited access to education or make it increasingly difficult to perform in the workplace. Thus, a reduction in the overall quality of life.

Although treatments for hearing loss all have the same goal, their approach and success rates vary. Reconstructive surgeries to treat the underlying condition can be a good option for people with Chronic Otitis Media (COM), Atresia/Microtia and Otosclerosis. However, with COM for example, clinical evidence shows that while many surgeries are successful, in 30% of cases there remains hearing loss that requires further treatment and repeat surgeries are common. Air conduction (AC) hearing aids can be a solution for conductive hearing loss, mixed hearing loss and single-sided sensorineural deafness (SSD), but some individuals prefer not to, or can’t wear them. In addition, wearing hearing aids can cause complications such as increasing the risk for ear infections that may negate their effectiveness. For many of these patients, bone conduction (BC) stimulation may be a better solution. Systems that use bone conduction have been shown to have several benefits when compared with AC hearing aids or middle ear reconstructive surgery. They can relieve the frustration related to hearing aid wear, increase user motivation and receptivity to habilitation, and provide the necessary amplification to overcome the patient’s hearing loss.

The Osia System uses digital piezoelectric stimulation to bypass barriers in the outer and middle ear. For individuals with single-sided sensorinueral deafness (SSD), the system transfers the sound from the deaf side to the hearing ear. There are three core components to the system: a sound processor, an active implant and a small titanium implant that bonds to the bone in a process known as osseointegration.

1. The sound processor captures sound in the air and digitally analyses the signal.

2. The processed signal and power are sent through a digital link to the active implant.

3. The Piezo Power transducer vibrates, sending vibrations through the implant to the bone.

4. The vibrations travel to the inner ear where they are converted into electrical impulses and sent to the brain to be interpreted as sound.

It’s the world’s first osseointegrated steady state implant (OSI) that uses digital piezoelectric stimulation. It is designed to help people live their lives and provide the performance needed to hear in challenging environment like noisy situations where the reported struggle is most. The system utilises innovative technologies specifically chosen and designed to work in and with the body.

At the heart of the Osia implant lies Piezo Power transducer that uses piezoelectric material to generate vibrations that are sent to the bone. The piezoelectric effect is the ability of certain materials to generate an electrical charge from mechanical stress, or in reverse, to generate vibrations from an electrical charge. Piezoelectric material is used in many applications, including microphones, watches, ultrasound machines, microscopes and high-end speakers. The advantages of the Piezo Power transducer include its sensitivity at high frequencies and its suitability for implantation where there is a high demand on power, size and reliability. The high output power and gain of the Osia System enables a fitting range of up to 55 dB SNHL to help you treat a broad range of patients. A large dynamic range has been shown in studies to improve patients’ ability to understand speech in noise, and it also provides capacity should the patient’s hearing loss worsen over time. The monolithic design ensures a consistent distance between the sound processor’s microphones and the transducer to minimise feedback. Fitting data show that patients using the Osia System have access to an average 12 dB more available gain at high frequencies, compared with patients using a percutaneous bone conduction implant system with an equivalent fitting range.

The Osia System features SmartSound iQ signal processing suite that scans the soundscape 200 times per second to select the best signal processing strategy for the patient’s sound environment. With this information, the signal processing aims to deliver a clear signal, helping the patient fully take in their surroundings. Its modified features are aimed to enhance speech quality, reduce noise and increase comfort.

The Osia System has been the subject of two multicentre clinical investigations. In the published study, patients demonstrated a significant improvement in hearing in both noise and quiet when using the Osia System compared to a transcutaneous BC system with equivalent fitting range. Patients demonstrate an average 7.4 dB improvement in hearing in noise and an average improvement of up to 58% in hearing in quiet. The study also reported that patients demonstrated a clinically significant improvement in health-related quality of life when using the system compared to the unaided and transcutaneous BC system aided situation. One of the benefits of Piezo Power technology is its suitability for MRI. With no magnetic material in the transducer, patients with an OSI200 Implant can undergo a MR scan at both 1.5 T and 3 T. In addition, testing demonstrates that the performance of the transducer remains consistent after MR exposure at 1.5 T and 3 T.

The slim, off-the-ear sound processor is light and comfortable to wear, weighing only 9.4 g sitting streamlined against the head with 10.4mm projection. It is dust and moisture resistant and carries an IP57 rating. It supports sound streaming directly to the sound processor from any compatible Apple device. For Android and other smartphones, patients can stream using the Cochlear Wireless Phone Clip. It also connects with a range of wireless devices. The Osia Smart App lets the recipient control and adjust their sound processor easily and discreetly. From a smartphone or Apple Watch, they’ll be able to tune the sound the way they want to hear it and monitor their status and settings.

A case report- Patient presented with a history of previous surgery with a 10 year old facial nerve paralysis and reduced hearing in the right ear. The client was diagnosed with a petrous apex cholesteotoma with grade VI facial paralysis and hearing loss in the right ear. The audiological evaluation revealed profound hearing loss in the right and normal hearing sensitivity in the left. Considering the nature of hearing loss i.e single sided deafness and the lifestyle and needs of the individual, Osia was decided to be an ideal solution for the hearing deficit. The patient underwent a complete excision of tumor via a Transcochlear Subtotal Petrosectomy by Dr Sampath Chandra Prasad Rao and team. This was combined with facial plastic work by Dr Vishwas KV. After the combined procedures, an Osia implant was places on the ipsilateral side.

At Bangalore Cochlear Implant Institute, Dr. Sampath Chandra Prasad Rao supported by an excellent team of ENT surgeons and Audiologist Ms. Navni Pattali provide client specific hearing rehabilitation solutions. For any information connect with us through info@bciinstitute.net. Ph: +91 6366888883