Cochlear Osia System—Implantable Bone Conduction Hearing

The Cochlear™ Osia^® System bone conduction implant (also known as Cochlear Osia 2) is a unique solution in implantable hearing devices. First introduced in December 2019, Osia 2 is the world’s first active osseointegrated steady-state implant, meaning the active implant is located fully under the skin.

We’ll give you more information on what that means later in the article, but for now know that the Osia Hearing Implant System offers a unique hearing solution for individuals who suffer from conductive or mixed hearing loss or those with single-sided deafness (SSD). The Osia System provides improved hearing by bypassing the non-functioning areas of the auditory system.

Osia Hearing Implant System key features:

• Bone conduction implant utilizing a unique piezoelectric stimulation
• An active implant that sits fully under the skin
• A slim (10.4 mm) and lightweight (9.4 grams) sound processor design that sits off-the-ear
• SmartSound^® iQ signal processing for automatic sound adjustment including noise reduction and directionality
• A digital link between the external speech processor and the internal implant
• Direct wireless streaming for compatible Apple^® products and available accessories
• Available smartphone app, the Osia Smart App, for additional control and customization

Pros of Osia System

Cons of Osia System

Who is the Osia bone conduction implant system for?

The Osia System is FDA approved for persons 12 years and older who suffer from outer and/or middle ear issues, a mixed hearing loss, or Single-Sided-Deafness (SSD). For an explanation of the types of hearing loss, as well as how to read an audiogram, see the article How Do I Read a Hearing Test?

The more specific indications for Osia 2 are:

• Single-Sided Deafness (SSD)
  • Air conduction (AC) pure-tone average (PTA at 0.5, 1, 2 & 3 kHz) in better hearing ear ≤ 20 dB
• Conductive or Mixed Hearing Loss
  • Bone-conduction (BC) pure-tone average (PTA at 0.5, 1, 2 & 3 kHz) ≤ 55 dB
  • Bilateral candidates should have symmetric BC thresholds (< 10 dB difference between the ears on average (0.5, 1, 2 & 3 kHz) or < 15 dB difference at individual frequencies)

The Osia System may also be appropriate for individuals who have already been implanted with another bone conduction hearing solution, such as the Cochlear Baha^® device, but are looking for a different solution. However, the surgical placement of the bone implant is different than that of Baha and a consultation with your surgeon and audiologist is required.

Also note that regarding the 12-year age limit, some surgeons will go “off-label” and implant children younger than 12 years of age who are otherwise candidates for the device. This is dependent on several factors including bone density at the implant site and insurance coverage.

On a practical level, Osia may be preferred over more traditional bone conduction hearing solutions, as the implant is fully under the skin and the transducer drives the implant directly. Some bone-anchored hearing solutions utilize a percutaneous approach, meaning the implant protrudes through the skin and the speech processor/transducer is affixed to an abutment on the implant or magnetically via a surgically placed magnet under the skin. The percutaneous approach allows for the transducer to drive the implant directly but comes with the negative cosmetic consequences and the increased potential for skin complications such as infection.

The magnet approach, as seen with the Baha Attract system and the Osia System, is more cosmetically appealing, as the implant and a magnet are fully under the skin. However, the magnet and the skin are a barrier to driving the implant and can dampen the sound. That is, the overall gain (volume) and frequency (pitch) responses may be reduced compared to a direct-drive system.

Cochear's Baha Attract vs Baha Connect webpage provides a more in-depth explanation of "magnetic" versus "percutaneous/abutment" systems found in bone-conduction implants.

YouTube video showing key features of the Osia Hearing Implant System (video from Cochlear Corp).

Who makes the Osia bone conduction implant?

Osia 2 is made by Cochlear, a worldwide leader in cochlear implants and bone anchored hearing aids (Baha). Based in Sydney, Australia, but with a worldwide presence, Cochlear currently leads in market share with approximately 60% of the global sales of auditory implant devices. Osia 2 and the Baha 6 are the company’s two newest products in their bone conduction solutions portfolio.

Understanding bone-anchored hearing systems and the Osia System for conductive hearing losses

As a newer approach for bone conduction hearing solutions from Cochlear, Osia 2 was FDA approved in December 2019. Let’s review a bit more background information to help you understand the differences in the company’s bone anchored solutions.

Bone anchored hearing aids do not work like typical hearing aids which pick-up sound, process and amplify it, then deliver an acoustic signal into the ear canal. Instead, they rely on the fact that sound can be transmitted to the inner ear (cochlea) by vibrating bone (skull or teeth). This is done in cases where medical or hearing contraindications exist for a traditional air-conduction hearing aid.

For example, the Osia System is indicated in cases of chronic ear infections, outer- or middle-ear malformations, or significant conductive or mixed hearing losses. It's also indicated for Single-Sided Deafness (SSD) where the device is used on the deaf ear and sound is then transmitted via bone conduction to the better cochlea. Therefore, bone conduction devices work by bypassing the usual conduction of sound through the outer and middle ear and, instead, conduct sound via bone directly to the inner ear.

With Cochlear-brand devices, the bone vibration can be achieved two ways: non-surgically by placing a speech processor with a transducer that vibrates against the head, or surgically via a titanium implant and processor. The non-surgical option is achieved by a cloth headband or malleable headpiece which holds the processor against the skin of the head. There is also the unique Med-El ADHEAR system which consists of an adhesive adapter (a kind of high-tech “sticker”) that contains a place for the audio processor to click on. The vibrations transfer through the skin to the bone and then to the cochlea.

The non-surgical options allow for trialing bone conduction hearing without the need for surgery. This is advantageous, for example, when a child is too young for surgery, there are contraindications for surgery, or for anyone who simply wants to see how effective the device may be for them before committing to surgery.

The surgical option requires that a titanium implant, which resembles a small screw, be surgically placed in the bone of the skull near the ear. It acts as the vibration point for the Osia System as well as their Baha devices. However, the surgical placement of the implant varies by product, with the Osia implant having recommendations to be placed behind the ear and in line with the opening of the ear canal.

In contrast, the Baha implant may be placed higher behind the ear. After healing, the implant becomes osseointegrated (integrates with bone) into the skull and allows for a more efficient transfer of sound compared to vibrating the bone through the skin.

While Baha has two options for the bone implant—either to be percutaneous (through the skin) or having a magnet placed under the skin—the transducer and the processor are both external. However, with the Osia System both the implant and the transducer are under the skin, and only the speech processor is external.

The Osia System is made up of three distinct components:

1. The BI300 titanium implant (same one that is used for their Baha devices)
2. The Osia System implant (OSI200 or newer OSI300) that connects to the titanium implant and includes the transducer, antenna, digital link, and magnet
3. Osia System Sound processor, a head-level worn speech processor that is held in place by a magnet (aligns with internal magnet)

The Osia System has a different type of transducer than the Baha devices. That is, the Baha product utilizes an electromagnetic mechanical system to drive the transducer, much like a speaker system. You’ve probably seen a speaker diaphragm move in sync with the music; it’s similar technology to the Baha conduction system but on a much smaller scale.

However, the Osia System utilizes a piezoelectric transducer which vibrates the implant. Piezoelectric means that certain materials (like quartz) will convert electrical energy to mechanical energy (or vice versa). The entire Osia System—except the sound processor—is completely surgically implanted. This provides a more stable system, making it less prone to acoustic feedback (squeal). It is also more cosmetically appealing than the Baha devices, and the concerns that come with a percutaneous implant aren’t relevant.

The Osia System update for MRI scans at 3.0 Tesla (T)

If you've done any research regarding implantable hearing solutions, you may have read that the internal implants become problematic with MRI scans. As mentioned above, the internal implant contains a magnet which, at a minimum, interferes with the scan and, at worst, can cause damage to the implant and/or cause discomfort for the recipient during the scan. This is, of course, a concern and one that manufacturers have addressed with varying solutions.

The bottom line is that Osia 2 allows for MRI scans currently up to 1.5 Tesla (T), with precautions.

In August 2023, Cochlear announced an upcoming update to the Osia 2 system that will be available only to new implant recipients: the Osia System will be updated to include magnets that allow for 1.5 or 3.0 T scans with the internal magnet in place.

Currently, with Osia 2, if a 3.0 T scan is needed, the internal magnet needs to be surgically removed. This sounds scary, but is really a simple procedure and can be done on an out-patient basis. Once you have had all your necessary scans, the internal magnet is replaced.

Beyond the possible need for the internal magnet removal, there are a few things to keep in mind with any implant. For example, even if the device allows for MRI scans, the device itself, and certainly the magnet, will distort the scan results in the area of the implant. This isn't a problem if the area of interest is not in proximity of the implant. However, if it is, then removal of the magnet may be necessary regardless of whether you are getting a 1.5 or 3 T scan. Additionally, if you have an older device, imaging studies may still be possible but likely not at a 3.0 T strength unless the magnet is removed first.

Cochlear, and other implant manufacturers, provide MRI guidelines to physicians and this information is readily available online from Cochlear. If you have any questions, be sure to speak to your surgeon, and/or audiologist.

Finally, Cochlear's Osia System update is not available at the time of this writing. It is scheduled to be available in Fall 2023 and will be available only for new Osia System recipients. It appears that the only updates to the Osia System are solely in regards to the implant and MRI compatibility and do not affect other technical aspects of the device.

FAQs on the Osia System

Advantages of the Cochlear Osia System implant

Cochlear claims that the Osia System design provides, on average, 12 dB more high-frequency (high-pitch) gain than their Baha 5 Power product. That number, however, varies depending on the study and the product comparisons. For example, one small independent study compared Osia to two bone-anchored solutions using a softband and found, on average, a 7 dB improvement in hearing, especially in the high frequencies above 1000 Hz. As the authors of that study note, the cushioning of the skin with the softband approach to bone conduction solutions is inferior to percutaneous transduction. However, the study further indicates good speech recognition and overall satisfaction with the product even after several years of use.

Another study investigated the benefits of Osia 2 compared to other commonly implanted bone conduction solutions (Cochlear Baha and Med-El BONEBRIDGE) and found that Osia wearers with conductive and mixed hearing loss had an effective gain improvement of approximately 13 dB at 2000 Hz.

Cochlear further claims an average of 7.5 dB improvement in speech understanding in noise compared to the Baha BP110 Power (Baha 3) sound processor with softband placement. It should be noted that the Baha 3 is an older device, with the most current Baha generation being Baha 6.

Regardless, the various studies do indicate that Osia performs well in providing improved aided hearing compared to similar technology. The benefits are especially noted in the wearer’s access to high-frequency information, which can be important for speech recognition, particularly in noisy situations.

SmartSound processing in the Osia System

The Osia System also incorporates SmartSound^® iQ speech processing. This automatic sound processing system includes a scene classifier, noise reduction, and automatic directionality, among other features. The scene classifier samples your listening environment 200 times per second to determine your listening situation, such as quiet, speech in noise, or music. Once it defines an environment, the processor will automatically align features such as noise reduction and directionality to help provide a favorable listening experience. Osia shares this technology with other Cochlear products, such as Baha 5.

What's it like to use the Osia System?

As noted above, the Osia speech processor is worn off the ear and is held in place by a magnet that attracts to the internal magnet. Depending on your personal needs, several different magnet strengths are available to ensure a secure fit. Varied retention options are also available including hair clips and retention lines. If needed, a softband could also be used. You and your HCP can work together to help ensure you have a secure and functional fit of the device.

Osia is lightweight and generally cosmetically appealing, especially when compared to other bone conduction solutions. It should be noted that some patients experience skin soreness or irritation over time when wearing the speech processor. While not an overly common complaint it can happen, but can be mitigated by your HCP.

For example, a magnet strength change may help alleviate the problem or a soft pad can be added to make wearing the device more comfortable. The Osia 2 processor can also be worn with a headband if needed and some may prefer to use the headband for activities such as sports.

Like hearing aids, you’ll want to keep the speech processor as dry as possible. The Osia System incorporates some resistance to dust and moisture with an IP57 rating, although this is not as robust as most current hearing aids on the market that typically carry an IP68 rating.

For those who worry about sweat or moisture damaging the device or who enjoy swimming, Cochlear does offer an Aqua+ accessory. This clam-shell like accessory seals the sound processor while still allowing sound to be picked up by the microphones. Its IP68 rating allows you to swim at a depth of up to 1 meter (approximately 3 feet) and can be used approximately 50 times before needing replacement.

Do users like the Osia System?

Osia 2 has now been on the market for approximately 2 years. During that time overall acceptance of the device both by wearers and their HCPs has been good. In general, the device has the ability to provide superior overall gain compared to other bone-conduction hearing solutions, especially in high frequencies. This leads to good overall speech understanding for many patients, especially for those with better bone conduction hearing scores.

Several studies have also measured subjective improvement with the device and shown favorable results. One such study compared the Baha 5 Power on a softband to the Osia 2 and showed a statistically significant improvement in the Speech and Qualities scales of the Speech, Spatial and Qualities of Hearing (SSQ) questionnaire. In other words, the study participants preferred the overall sound quality of speech with the Osia System over the Baha 5 Power.

Using the controls and features the Osia System device

Osia has multiple options for controlling the device. First, there is a push button on the speech processor itself which allows the wearer to change programs. Your HCP can program up to 4 different listening situations. The push button also allows for the starting/stopping of a streamed audio signal.

Unfortunately, the push button cannot also be used to change volume, but an accessory such as the Osia Smart App will allow for this functionality, as well as treble and bass control. Note that your HCP must enable this feature for you to have control.

Alternatively, your HCP could use the program slots for volume changes. Additionally, with SmartSound iQ, the processor will automatically make some adjustments and the need for frequent volume changes are unlikely to be necessary.

Other accessories are also available, including the MiniMic 2+, Remote Control 2, and the Phone Clip (see below). Some of these, like the Remote Control 2, can also be used to change programs and volume on the speech processor.

Cochlear has a corporate relationship with GN ReSound, the world's fourth-largest hearing aid manufacturer. As such, they share technology and you’ll find that the Osia 2 accessories are almost identical to the GN ReSound accessories.

Osia 2 also has an LED on the speech processor which can help the wearer and/or a caregiver understand the device's status. For example, the light will flash orange for program changes with the number of flashes corresponding with the program number. Additionally, the wearer will hear audible indicators or “beeps” that also correspond in number to the program (e.g., 2 flashes of the LED and 2 beeps heard by the wearer when program 2 is selected). The LED and the audible indicators will also provide notice of volume changes, a low battery warning, or whether streaming is activated. The LED can also let a caregiver know if the implant is detected and a connection between the speech processor and the internal device is established.

Controlling Osia using the Smart App

The Osia Smart app is a free download from the Apple^® App Store and the Google Play™ store. The app allows you to change the sound processor's programs, volume, and tone (volume and tone changes need to be enabled by your HCP). It will also allow you to change the volume of your wireless accessories and even help you locate a lost sound processor. Additional features include the ability to view the sound processor status, such as battery level and hours of use. Finally, you have a support section that can provide online support and contact numbers should you need to call a Cochlear representative.

Cochlear-produced video (2022) about how to use the Osia Smart App on your Apple device.

At the time of this writing, the most recent version of the app is v1.0.4 which was updated in September 2022. The app is not complicated; however, it has ratings of only 3.4 (out of 5) for Apple and 3.3 for Android. The Google Play store notes that the app was verified on Samsung Galaxy phones, but Cochlear’s own compatibility page does not list any Android phones. The Osia System is compatible with both iPhone^® and iPads^® that use iOS 15 or later. Primary complaints seem to be regarding compatibility with various devices, connection issues, and confusion over the use of icons rather than written labels.

Keep in mind that it’s not uncommon for smartphone apps to rate poorly—and this is certainly the case for most hearing aids which usually have ratings between 2 to 3, primarily due to connectivity issues. However, you’ll likely find that the Osia Smart App will work best with Apple-verified products. Be sure to check the compatibility page to ensure the best functionality.

Apple and Android Bluetooth Connectivity with the Cochlear Osia System

The Osia speech processor utilizes 2.4 GHz Bluetooth^® Made for iPhone (MFi) technology and incorporates the Bluetooth LE protocol. This allows for direct streaming from compatible Apple products to your speech processor.

Unfortunately, hands-free phone calls are not currently available. That is, you can stream and hear the caller’s voice directly in your processor but still need to speak into the phone for the caller to hear your voice.

Bluetooth devices that are not compatible with Osia—like most Android devices—will require an additional accessory, the Phone Clip, to allow for streaming of calls or other audio.

The connectivity of the Osia System allows for you to pair up to 5 compatible devices, but will not allow for more than one device to be connected at one time. This means, for example, if you have two phones you like to use throughout the day, you can have both paired but will need to connect and disconnect as you use one phone or the other.

As noted with the Osia Smart App, connectivity issues (even with some Apple devices) have been noted by users.

Making phone calls with the Osia processor

Phone calls can be made with your compatible phone, once paired with the Osia processor. However, you can also use any phone using the traditional acoustic method of simply holding the phone to the processor microphones. This may take a bit of practice as acoustic feedback can occur.

Most people prefer to pair their phones and stream the conversation directly to the Osia processor. However, if you don't wish to do this or have compatibility/connectivity issues, using the acoustic method can work.

The Osia System and battery life

Osia utilizes a standard 675 zinc air battery which should provide a full day or more of use. Cochlear notes a battery life range of 21-34 hours.

How long the battery will last for your particular device is dependent on several factors including how your device is programmed. So, if you wear the device for 12 hours a day it’s possible to get more than one day of wearing out of the battery.

Unfortunately, a rechargeable battery is not an option and frequent battery changes will be required. A lot of people stash a battery in places like their wallet, purse, glovebox, office desk, etc., just in case they unexpectedly need one.

Longevity of the Osia System

The Osia System carries a speech processor product warranty of 2 years (from date of your activation), but the internal device is warranted for 10 years.

Although the speech processor only carries a 2-year warranty, the life of the product is likely to be longer, in the range of 3-5 years. Of course, this will depend on how much you use the device and how well you maintain it. In addition, the speech processor can be repaired out of warranty, and warranty service plans are available from Cochlear. The warranty service plans will cover the processor for one year and can be renewed as necessary.

Historically, Cochlear has done a good job of making its internal components backward compatible. That is, upgrades and improvements to the external speech processors do not mean you have to remove and replace the internal implant surgically. So you should have peace of mind if Cochlear releases a new higher-tech version of the Osia speech processor, it will likely work with the current implant.

Overall sound quality and performance in noise

In the 2 years that Osia 2 has been on the market, overall acceptance by wearers has been good and the device has provided good overall speech understanding, especially for those with better bone conduction hearing scores. Studies that pertain to the Cochlear Osia System indicate good speech recognition and overall satisfaction with the product even after several years of use.

Cochlear notes that Osia 2 has an average of 7.5 dB improvement in speech understanding in noise compared to the company's Baha 3 sound processing with soft band placement, although that's an older product (the most current Baha generation is Baha 6). But all evidence points to Osia improving hearing over both aided and unaided conditions compared to similar technology. In particular, it appears that the Osia System has the ability to improve access to high-frequency sounds which are important for speech recognition, particularly in noisy environments.

Biggest drawbacks of the Cochlear Osia System

Any hearing assistive device will have limitations and the Osia System is no exception. For example, some may find the frequent battery changes inconvenient. Also, for individuals with dexterity and/or visual issues, changing the battery may be frustrating. However, the size 675 battery is rather large and most should be able to handle the battery changes, especially with practice.

The lack of compatibility with most Android devices, without an accessory, is another significant drawback of the product. Android devices are common, and compatibility is almost considered a “given” with today’s technology. Some may also expect hands-free compatibility with both iPhone and Android products, but this is not available at this time.

Finally, the speech processor color options are somewhat limited with only 5 solid color options and no patterns. Other manufacturers offer many more color options for their bone conduction speech processors, especially for kids.

What's the closest competitor or alternative to Osia?

At this time, the Osia System does not have an equal competitor; that is, it is the first osseointegrated steady-state implant, meaning it incorporates a piezoelectric transducer and sits fully underneath the skin. The closest bone conduction hearing solution available on the market would be the Med-El BONEBRIDGE device. That device is also fully implantable but uses a more traditional transducer to vibrate the bone.

It should be noted that BONEBRIDGE can only fit a bone score of up to 45 dB SNHL. This means it will not accommodate more significant hearing losses that the Osia System may be able to address (up to 55 dB SNHL). However, the BONEBRIDGE implant is approved for persons 5 years and older compared to 12 years or older for Osia.

Should you get an Osia System bone conduction implant?

The Osia System is an excellent choice for those who are recommended as candidates for the device by their HCP. Specifically, Osia should be a good potential solution for people over 12 years of age with single-sided deafness (SSD) or conductive/mixed hearing losses that fall within the applicable fitting range of the device.

As a unique bone-conduction implant situated fully underneath the skin, it features a slim off-ear design and is designed to provide more useful high-frequency (high pitch) volume for better speech understanding. The Osia System also offers wireless streaming for Apple's Made for iPhone (MFi) devices (but not Android), can be controlled using the push button on the device or via the app, and also can be used in conjunction with several accessories that are common to hearing aids made by GN ReSound, a corporate partner of Cochlear and one of the five largest hearing aid manufacturers in the world.

Where can you get the Osia System bone conduction implant?

The Osia System is available only from surgeons who are trained in implanting the device. The surgery is generally performed by Ear, Nose and Throat (ENT) physicians who have experience in bone conduction solutions. The surgery itself is not complicated and is typically performed on an outpatient basis; however, training and certain surgical equipment are needed. You will also need to be evaluated by a qualified audiologist to measure your hearing loss and help determine your best hearing solution options.

If you believe you might be a candidate for the device based on your type and degree of hearing loss (noted in this article), take the time to discuss your options with your HCP. If they aren’t working directly with an ENT who implants the Osia System, they should be able to refer you to someone in your area.

In addition, you can visit Cochlear’s website to find further information. Cochlear can also assist with insurance coverage and product questions, and may even be able to refer you to a recipient in your area to discuss their experiences with Osia.