Bone Conduction
by Michaela Coon

Interview with Dr. Jacob: Initial Cochlear Osia System experience

May 21, 2020
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Abraham Jacob, MD

Medical Director, Ear & Hearing

Center for Neurosciences in Tucson, Arizona

Dr. Jacob discusses the new Cochlear™ Osia® System, the world’s first and only Active Osseointegrated Steady-State Implant (OSI).  Selected for the Osia System control market release (CMR), he  uses 13 years of surgical cochlear implant/bone conduction experience to review his initial experience with the system.

What initially attracted you to the Cochlear™ Osia® System? 

Several things attracted me to the Osia System, including an added implant portfolio option.  The operation was easy to learn since site placement is similar to the Baha® System, but with many added benefits including:

  • Exceptional mid and high-frequency gain1
    • No external abutment required
    • Lightweight and cosmetically appealing external sound processor
    • Passive processor with active internal device

How does implanting the Osia System compare to the Baha Connect and Baha Attract?

The Osia System combines the cosmetic appeal and easy aftercare of Attract with substantially improved mid- and high-frequency gains. Our patients comment that the Osia System sounds fuller and more natural than what they experienced in their Baha Softband simulations prior to surgery.

The operation itself is more involved and scenario-based, typically taking about twice as long in patients getting an incision anterior to their implant and about three times as long in patients whose incisions are posterior to their implant. Overall, the operation takes 30-45 minutes in most patients. Positioning the head correctly is particularly important in Osia surgery where one has a larger body habitus or limited neck mobility.

What does the Osia System mean for patients with single-sided deafness (SSD)?

For SSD patients, the Osia System offers improved cosmetics, no external abutment and improved mid/high frequency gain.  The latter translates to improved sound quality, as described by the four patients whose devices have already been activated at our facility.

These patients have reported benefits such as immediate audibility at activation. This initial experience is fulfilling for the patient, surgeon, audiologist and all involved.

How is the Osia System changing your practice? What makes you excited about the system?

The powered internal device is a paradigm shift for delivering audibility through bone conduction. If there are no patient-specific or financial barriers to accessing this technology, I believe active implants would be first choice. It all comes down to thinking about patient benefit.

How many Osia Systems have you scheduled and/or implanted so far?

I have performed six operations in the past two months and have a list of 12 other patients interested in the device. Indications for surgery in my first six patients ranged from SSD to mixed-conductive hearing loss, some receiving anterior incisions and others requiring posterior incisions. It is all very exciting.

What are some best practices you’ve developed, or lessons learned through Osia System surgeries?

As mentioned, I have implanted some patients with SSD and some with mixed-conductive hearing losses.  Those without prior history of ear surgery received incisions anterior to their implant while posterior incisions were used in those with pre-existing mastoid cavities or history of acoustic neuroma resection. 

The posterior approach takes longer and can be a bit more difficult in patients having limited neck mobility and/or those with short necks. It’s important to gain more visibility to the site with these patients.  It’s important to position the head more deliberately in such patients to ensure adequate visibility.

With posterior incisions, I think being 10 mm from the posterior margin of the implant is fine.  With the anterior incision, it is important to be 10-15 mm anterior to the implant’s anterior margin. Lastly, I advise starting with a smaller incision and leaving markings if you need to expand during the course of the surgery.

What is the average time is takes you to surgically implant an Osia device? 

Implant time really depends on the patient and the incision.  With the anterior incision, it takes about 20-30 minutes from incision to implant in place.  Patients requiring the posterior incision take 30-50 minutes from incision to implant in place.  Closure is shorter for those requiring an anterior incision.  The longest operative time was for a posterior incision patient with thick neck and limited neck range of motion.

How does the addition of the Osia System to your armamentarium transform how you counsel patients?

We performed a total of 38 Baha Attract implants, Baha Connect implants and other bone conduction solutions in 2019 prior to Osia; therefore, our practice and our patients are very open to bone conduction as a viable and effective means of aural rehabilitation. Devices with an external abutment offered improved audibility while potentially sacrificing cosmesis and aftercare. With Osia, we now have the best of all worlds – great audibility and a small, light & comfortable sound processor.

As the one of first surgeons to implant the Osia System, do you have anything else to add?

Our initial impressions from the patients’ activated so far had improved gain, quality of the sound and cosmetics. Without barriers to access if bone conduction is the right option, the Osia System’s gain is a game-changer for both surgeons and patients.

For more information about the Osia System, subscribe to Cochlear ProNews or visit our website.

References:

  1. Dotevall M. Technical Report: Available gain in Osia vs Baha 5 Power. D1664198. Cochlear Bone Anchored Solutions AB, Sweden 2019

The Osia 2 System is intended for the following patients and indications: • Patients 12 years of age or older. • Patients who have a conductive or mixed hearing loss and still can benefit from sound amplification. The pure tone average (PTA) bone conduction (BC) threshold (measured at 0.5, 1, 2, and 3 kHz) should be better than or equal to 55 dB HL. • Bilateral fitting of the Osia 2 System is intended for patients having a symmetrically conductive or mixed hearing loss. The difference between the left and right sides’ BC thresholds should be less than 10 dB on average measured at 0.5, 1, 2, and 3 kHz, or less than 15 dB at individual frequencies. • Patients who have profound sensorineural hearing loss in one ear and normal hearing in the opposite ear (i.e., singlesided deafness or “SSD”). The pure tone average air conduction hearing thresholds of the hearing ear should be better than or equal to 20 dB HL (measured at 0.5, 1, 2, and 3 kHz). • The Osia 2 System for SSD is also indicated for any patient who is indicated for an air-conduction contralateral routing of signals (AC CROS) hearing aid, but who for some reason cannot or will not use an AC CROS. • Prior to receiving the device, it is recommended that an individual have experience with appropriately fitted air conduction or bone conduction hearing aids.

This article expresses the experience and opinions of Dr. Abraham Jacob. Please see Cochlear’s surgery recommendations as well prior to performing an Osia System surgery.

Related Posts
cochlear osia system piezoelectric stimulation

What is Piezoelectric Stimulation and why does it matter?

January 27, 2020

By George Cire, Principal Clinical Project Manager at Cochlear

The heart of any bone conduction system is the vibrator or actuator that functions as a mechanism to convert amplified sound to mechanical vibration, which can in turn drive the bones in the skull to access the bone conduction pathway to the cochlea or inner ear. The Cochlear™ Osia® System applies a new and innovative way to create a bone conduction transducer that will produce high frequencies and thus positively impact speech understanding. 

Evolution of Bone Conduction Technology  

Historically, the actuator is an electromagnetic device that contains a magnet, coil and counterweight.   By application of an alternating polarity signal from the sound processor to the actuator, an electromagnetic field is produced that excites the magnet element and counterweight. This produces movement or vibration within the actuator to change the electrical signal to vibration that can move through the bone conduction pathway to stimulate the cochlea, thus facilitating hearing. 

It’s easy to visualize the complex design of springs, magnets, coils and a counterweight that form a “moving mass” system that facilitates a mechanical interaction between parts.  The electromagnetic actuator can be placed against the skull externally where the vibration must traverse soft tissue before stimulating the bone conduction pathway, providing a transcutaneous bone conduction system. This method advantageously provides a non-surgical option for candidates that need or require a bone conduction amplification system.

Innovations with the Baha® System

The Baha Connect system was developed to provide a direct drive access system where a surgically implanted titanium fixture can be placed in the bone where it will osseointergrate.  Attached to this implanted fixture is a titanium abutment that protrudes through the skin and provides a snap coupling that accepts the Baha Sound Processor, referred to as a percutaneous system.

Later, the Baha Attract system allowed an implant magnet to attach to the implant fixture, positioning the tissue flap to be in place over the implant fixture and implant magnet.  Then the sound processor can be attached to an external magnet that is held in place with the magnetic attraction between a “sandwich of tissue” and the internal implant magnet to hold the entire system in place.   Vibration from the actuator in the sound processor then passes though the system to the internal components to excite the same bone conduction pathway described above in the Baha Connect system. 

It forms an alternative transcutaneous system that offers candidates for bone conduction hearing treatment with a more cosmetic system that does not require the same hygiene regimen as the Baha Connect system.  The direct drive Baha Connect system provides the most effective transfer of vibrational energy with out the damping effect of the skin between the vibrating actuator and the bone conduction pathway.1,2

The Osia System and Piezoelectric Technology

As a natural evolution of bone conduction technology, the Osia System was created to combine the best of the direct drive, Baha Connect system and the hygiene and cosmetic advantages of the Baha Attract system. The Osia System is a new approach to an active transcutaneous system. Like other bone conduction systems, the actuator is the “heart” of the process. Designers and engineers looked toward the use of piezoelectric technology to create a smaller and most robust actuator that had clear advantages over traditional electromagnetic technology. 1,2  

In piezoelectric technology, a crystalline material can be formed into compact wafers that are laminated or bonded together.  When an electrical current is applied to this crystalline material, contraction and expansion is created that follows the electrical signal.  Because these wafers are laminated, the design allows for carefully controlled vibration to occur with out the need for a complex mechanical design containing moving parts and springs.  The actual size of the piezoelectric actuator can be formed into a package for optimal temporal bone placement where it can be mated with an osseointegrated fixture to apply vibration to excite the bone conduction pathway.  Application of this approach can be accomplished with modifications to the existing knowledge base of traditional Baha surgery.

The remaining components of the Osia Implant System include the magnet/coil assembly and a demodulator. The external Osia sound processor contains a battery-operated circuit that acts to pick up the acoustic signals of interest and then to amplify them.  Additionally, this circuit creates a digitally encoded radio frequency link that permits the combination of the amplified acoustic signal to the digital RF carrier to supply power to the implant via an inductive link between two coils (one in the external processor and one in the implanted package).  These two coils are held in place with magnets that only serve to provide a secure coupling and alignment.  This elegant design allows for the critical power supply to be maintained in the externally worn device.

Through the design and efficiency of power in this system, the Osia device provides the ability for clinicians to treat up to a 55dB HL sensorineural hearing level. 1,2  It has the advantage of hearing performance seen in our direct drive Baha Connect system combined with the non-skin penetrating transcutaneous system that provides a more cosmetic approach to the application of bone conduction amplification. 1,2

Overall the Osia System, an active transcutaneous osseointergrated implant system, combines the hearing performance seen in the Baha Connect system and the convenience and attractiveness of the Baha Attract system.

To learn more subscribe to our ProNews Blog using the panel to the left to ensure you receive new blog post notifications and check out this webinar.

References:

  1. Dotevall M. Technical Report: Available gain in Osia vs Baha 5 Power. D1664198. Cochlear Bone Anchored Solutions AB, Sweden 2019
  2. D1478473 CIR final report 12 month Data, Cochlear Bone Anchored Solutions AB. Sweden October 2019
boy with mentor

The Baha® System can help your pediatric patients with mixed or conductive hearing loss

February 8, 2018

Hearyourway

For pediatric patients with mixed or conductive hearing loss (MHL/CHL) a bone conduction hearing solution may be the best treatment option. Through bone conduction, sound is delivered naturally through the bone directly to the cochlea, independent of the outer and middle ear.

The Cochlear™ Baha® System leverages this natural process by amplifying sound signals, converting them into vibrations and transmitting them to the cochlea. Many hearing care professionals agree that for MHL and CHL the Baha System is a more effective solution than air conduction devices.1 The Baha System offers a trio of powerful sound processors to meet individual needs. With access to Made for iPhone, Android compatibility and True Wireless™ accessories, patients are always connected to the sounds of life. The Baha System is unique in that it allows patients to demonstrate the benefits of the system prior to implantation. For pediatric patients under the age of five, non-surgical options are available until they are ready for implantation. The brand new SoundArc, and the similar Softband, are great options for children. The SoundArc and Softband give children the opportunity for early and consistent access to sound in order to promote speech and language development.

Candidacy and Evaluation

Candidacy evaluation for an implantable bone conduction system includes audiological testing as well as a personal trial with the Baha System. The patient’s air-bone gap can be a guide to the benefits that can be expected from choosing a Baha System. There may also be medical indications, which show that a bone conduction implant system will be the best solution. If possible, compare the results of the functional gain measurements in the sound field booth, with and without the sound processor.

MHL CHL in peds

Implantation can be achieved once the surgeon determines sufficient bone thickness and quality, which can vary among individuals. In the United States and Canada, labeling states that a bone-anchored implant can be placed at 5 years of age and older.

For infants or children who are not ready for implantation, Cochlear recommends the Baha Softband or the new Baha SoundArc. Both are nonsurgical options for children under age 5. This can be a good indication of the possible benefits the Baha System may provide for a child. It can also help make the decision easier to implant the child, once benefits have been observed.

It is critical to give pediatric patients early access to sound in order to promote speech and language development. Children who receive hearing rehabilitation before the age of six months perform significantly better in language tests at the age of 3 to 4 years than children who are treated later2. Studies conclude that delay in intervention may lead to permanent language deficit.2

Treatment and Fitting

When treating a pediatric Baha patient with MHL/CHL, it is important to choose the correct sound processor to ensure adequate power/gain. The benefit of a more powerful sound processor is most obvious at higher frequencies because these are weakened to a greater extent than low frequencies when passing through the skin.3 When using the SoundArc, Softband or Baha Attract System skin attenuation should be kept in mind.

Research suggests that pediatric patients with binaural MHL/CHL should be fitted with bilateral sound processors using the Baha Softband or SoundArc. 2, 4 Since early access to sound is crucial, it is best that a pediatric patient is fitted with Baha Sound Processors before the age of six months.2, 4

In conclusion, the Baha System offers a powerful portfolio of solutions for adults and pediatrics with MHL and CHL. The Baha portfolio includes different surgical and non-surgical options and a trio of powerful sound processors to meet individual needs.

If you are interested in bringing the Baha system into your clinical practice, please reach out to your Cochlear Field Team today. Don’t know who your Field Team members are?  Call: 1-800-523-5798 or 303-790-9010 and we can connect you today!

If you are already a Baha provider, please right-click and save the infographic below to use during counseling.

MHL CHL Baha

 Cochlear logo

* Play audiometry can be carried out with warble tones, speech or animal sounds.
References:
  1. Snik AF, Mylannus EA, Proops DW, et al. Consensus statements on the BAHA system where do we stand at present? The Annals of Otology, Rhinology & Laryngology 2005; 195:1-12.
  2. Yoshinaga-Itano C. Early Intervention after universal neo-natal hearing screening: impact on outcomes. Dev Disabil Res Rev. 2003;9(4):252-66.
  3. Håkansson B, Tjellström A., Rosenhall U. Hearing thresholds with direct bone conduction versus conventional bone conduction. Scand Audiol. 1984; 13(1):3-13.
  4. Dun CA, de Wolf MJ, Mylanus EA, Snik AF, Hol MK, Cremers CW. Bilateral bone-anchored hearing aid application in children: The Nijmegen experience from 1996 to 2008. Otol Neurotol. 2010; 31(4):615-23.
  5. Mylanus EAM, van der Pouw KCTM, Snik AFM, Cremers CWRJ. Intraindividual Comparison of the Bone-Anchored Hearing Aid and Air-Conduction Hearing Aids. Arch Otolaryngol Head Neck Surg. 1998; 124(3):271–276. doi:10.1001/archotol.124.3.268
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