Cochlear™ Osia® OSI200 Implant Physician's Guide

About this guide

This guide applies to the Cochlear™ Osia® OSI200 Implant and is intended for surgical staff involved in implanting the device.

Surgeons implanting the device should be experienced in cochlear implant and/or bone conduction implant surgery or have received appropriate information and/or training to perform the surgery.

Prior to implantation, ensure all device users are appropriately trained on the surgical procedure, and are thoroughly familiar with the information in this guide and the product labeling. This guide includes important information on MRI, indications, contraindications, potential complications and adverse effects, warnings and precautions.

A surgical procedure for implanting the device is also explained.

This guide does not take into account any particular circumstances or factors relevant to an individual patient or case. Other surgical approaches and variations are practised and may be more appropriate in certain circumstances. After considering all relevant circumstances, factors and information in each case, the appropriate surgical procedure is determined by the relevant physician exercising independent medical judgment.

Symbols used in this guide

• Note ? Important information or advice.
• Caution (no harm) ⚠️ Special care to be taken to ensure safety and effectiveness. Could cause damage to equipment.
• Warning (harmful) ❗ Potential safety hazards and serious adverse reactions. Could cause harm to person.

Warnings and cautions for device use

This section does not contain all the important information required to use and implant the device, only critical information to implant the device safely and effectively. Read the full Physician's Guide before implanting the device.

WARNING

Pre-operative

• Prior to implantation, a clinical assessment should be made to ensure that there is adequate bone quality and quantity in the area of implantation to support a successful implantation of both the BI300 Implant and the OSI200 Implant. Conditions affecting bone quality and quantity could for example be patient age, abnormal anatomy, irradiated bone, previous surgeries or other medical conditions as per clinical judgement. If assessed to be required, a pre-operative CT scan could be performed.
• Prior to implantation, make a clinical assessment of the patient's skin condition and skin thickness in the area of the actuator and coil to avoid potential post-surgical skin issues. Too thin skin over the actuator or coil areas may potentially lead to post-surgical skin problems or skin breakdown. Too thick skin over the coil area may lead to retention problems or link communication problems.
• Post-operative wound infection may be prevented by administering a broad spectrum antibiotic before and during surgery.
• The implant is sterilised using Ethylene Oxide (EtO). After the sterilisation process, residual EtO is less than 0.4 mg per device. This residual level is suitable for a recipient with a body weight of 7 kg or greater (Calculated with guidance from EN ISO 10993-7).

Medical treatments generating induced currents, heat and vibration

• Electrosurgical instruments can induce radio frequency currents that could flow through the implant. When using bipolar electrosurgical instruments on the head and neck of a patient, the cautery electrodes must not contact the implant and should be kept more than 1 cm (1½ in) from the implant.
• High currents induced into the device can damage tissue and damage the implant.

Do not use:

• Monopolar electrosurgical instruments on the head or neck of an Osia implant patient.
• Therapeutic or medical diathermy on the head or neck. Therapeutic or medical diathermy may be used below the neck.
• Neurostimulation directly over the implant.
• Ultrasound fields can be inadvertently concentrated at the implant and cause tissue damage or damage the implant.
• Electroconvulsive therapy can cause tissue damage or damage to the implant. Do not use electroconvulsive therapy on an implant patient under any circumstances.

Magnetic Resonance Imaging (MRI)

• The Osia OSI200 Implant is MR conditional. See "MRI safety information" on page 35.
• The OSI200 Implant has a removable magnet. At 3 T field strength, the magnet must be removed surgically before the patient undergoes an MRI procedure.

CAUTION

• When using sharp instruments near the implant, take care to avoid damaging the OSI200 Implant.
• The implant can be exposed to diagnostic ionising radiation (x-rays, CT-scan). The sound processor must be removed during diagnostic ionising radiation.
• Do not expose the implant to a total dose greater than 70Gy of therapeutic ionising radiation.

Intended use and indications

Intended use

The Cochlear Osia System uses bone conduction to transmit sounds to the cochlea (inner ear) with the purpose of enhancing hearing. Osia Implants are single use devices intended for long term implantation under the skin in the mastoid region of either side of the head. They are for professional use only.

Osia single use and reusable surgical instruments are used throughout the surgery to correctly position and attach the Osia implant.

Indications

The Osia 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 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., single-sided 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 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.

Contraindications

• Insufficient bone quality or quantity to support implantation of both the BI300 Implant and the OSI200 Implant
• Chronic or non-revisable vestibular or balance disorders that could prevent benefit from the device, as determined by good clinical judgment
• Abnormally progressive hearing loss
• Evidence that hearing loss is bilateral retrocochlear or bilateral central origin
• Evidence of conditions that would prevent good speech recognition potential as determined by good clinical judgment
• Skin or scalp conditions that may preclude attachment of the Sound Processor or that may interfere with the use of the Sound Processor

Potential complications and adverse effects

Prospective implant recipients should be advised of the following risks:

• General risks associated with surgery and general anaesthesia.
• Osseointegration failure - potential causes for failure of osseointegration include lack of adequate bone quantity/quality, trauma, infection, generalised diseases and surgical complications.
• Other medical complications that may require additional medical treatment, such as:
  • Concurrent Cerebrospinal Fluid (CSF) leakage
  • Subdural injury
  • Subcutaneous haematoma
  • Numbness, irritation, inflammation or breakdown of the skin flap
  • Infection
  • In some cases, extrusion of the device caused by a foreign body response to the device
  • Vertigo
• Failure of device component parts (both external and internal) could result in the perception of an uncomfortably loud sound sensation, intermittent sound, or no sound.
• Partial or full failure of the device could require removal or replacement of the implant.

Device description

The system works by converting sound in the environment into vibrations that transmit the sound to the cochlea (inner ear) via bone conduction.

The Osia System contains external and internal (implanted) components.

Implanted components

The Osia OSI200 Implant is surgically implanted under the skin behind the ear. It includes a coil to receive and forward the electrical signal to the actuator where the signal is decoded and transmitted via the BI300 Implant to the cochlea using bone conduction. The actuator connects to the BI300 Implant which osseointegrates with the bone. The OSI200 Implant is only compatible with a Cochlear Osia 2 Sound Processor.

External components

The external components include a sound processor, and associated accessories and cables.

The system is programmed by a Cochlear proprietary fitting software.

For more information on the sound processor, refer to the applicable Osia 2 Sound Processor User Manual.

How the implant is supplied

The OSI200 Implant, OSI200 Implant template, BI300 Implant, drills, non-magnetic plugs and replacement magnets are single-use items supplied separately.

The implant, non-magnetic plug and replacement magnet are supplied in sterile gas-permeable packaging. Ethylene oxide processing is indicated on the label of each sterile package.

The OSI200 Implant template, the BI300 Implant and the drills are sterilised using irradiation. The sterile processing and the expiration date are indicated on the label of each packaging.

Before opening the sterile package, inspect it carefully. Return the device and packaging to Cochlear if:

• The 'use by' date stamped on the outside package has expired.
• The sterile pack containing the implant is ruptured.
• For items sterilised using ethylene oxide, the EtO dot is green.

Storage

For long term storage, store at room temperature. Keep dry. Handle the package with care. Severe impact may rupture the sterile package inside.

Cochlear™ Osia® OSI200 Implant

OSI200 Implant (P1170466)

1. Coil
2. Removable magnet
3. Waist
4. Actuator
5. Fixation interface
6. Serial number and QR-code
7. Fixation screw

Images not to scale

NOTE Two fixations screws are available inside the OSI200 Implant sterile package, but only one fixation screw is needed to fix the actuator to the BI300 Implant.

Cochlear™ BI300 Implant

1. Fixation interface
Available in 3 mm (92128) and 4 mm (92129) lengths

Images not to scale

Surgical instruments and accessories

WARNING Do not use surgical instruments or accessories if they become non-sterile.

Instruments and accessories in this section are appropriate for use with the Osia OSI200 Implant.

Instruments for use during surgery are available to order separately.

The OSI200 Implant and the OSI200 Implant template are packed in separate sterile packaging.

Items used with the OSI200 Implant are referenced in the surgical procedure and MRI safety information sections of this guide.

All used items meant for disposal and/or decontamination must be in accordance to the institution's policy.

Reusable instruments

OSI200 Implant specific

BI300 Implant specific

Single use instruments (sterile)

OSI200 Implant specific

BI300 Implant specific

Drilling equipment

Accessories (sterile)

(Not required for standard surgery)

• Sterile non-magnetic plug (P1620901): To replace the implant magnet for implant recipients requiring MRI examinations.
• Sterile replacement magnet (P1620873): To replace the removed magnet or non-magnetic plug when MRI examinations are finished.
• Cover screw conical (92136): To cover the BI300 Implant when placed at the implant site but not used.

Images not to scale

OSI200 Implant specific

Bone bed indicator 17 mm (P1469690)

• To ensure adequate clearance above bone level.
• The indicator is delivered in two parts (body and pin) that have to be combined before use.
• Parts do not lock.

BI300 Implant specific

Screwdriver UniGrip 95 mm (90469): To tighten and untighten the actuator fixation screw.

Multi wrench with ISO adapter (92143 / C9866): Torque wrench to tighten and untighten the actuator fixation screw to the BI300 Implant.

Machine screwdriver UniGrip 25 mm (90381): In conjunction with Multi wrench with ISO adapter to tighten and untighten the actuator fixation screw.

Implant inserter (92142 / P1582230): To pick up and insert the BI300 Implant.

Drill indicator (91116): To assist in determining the angle of the handpiece while drilling.

Single use instruments (sterile)

WARNING

• For single use only. Not for implantation.
• Supplied sterile. Sterilised using irradiation. Do not resterilise.
• Do not use if packaging is damaged.

Images not to scale

OSI200 Implant template (P1291019): Template of the entire OSI200 Implant to mark the shape of the OSI200 Implant and the BI300 Implant position, check the size of the coil pocket and the appropriate position of the OSI200 Implant and the BI300 Implant. Two implant templates are needed in each surgery, one for use in the non-sterile field and one for use in the sterile field.

Conical guide drill 3+4 mm (93363): To pre-drill the implant site for the BI300 Implant. When the spacer is removed the depth allows the use of the 4mm implant.

Widening drill 3 mm with countersink (92140): To widen the pre-drilled implant site for the 3 mm BI300 Implant.

Widening drill 4 mm with countersink (92141): To widen the pre-drilled implant site for the 4 mm BI300 Implant.

Surgical procedure

The surgical procedure described in this guide is only one approach to implanting the Osia OSI200 Implant. The physician may determine that other approaches and variations should be performed.

Where a surgical instrument is mentioned in the procedure, see "Surgical instruments and accessories" on page 11.

The surgical procedure includes the following:

1. Preparation of implant site (page 17-20)
2. Coil pocket creation and incision (page 21-22)
3. BI300 Implant placement (page 23-27)
4. OSI200 Implant placement (page 28-31)
5. Closure (page 32)

NOTE A backup of the OSI200 Implant, BI300 Implant and the single use instruments are recommended for each surgery.

1. Preparation of implant site

Relevant products OSI200 Implant template

Additional: Hypodermic needle, Clamp, Marking Pen, Ruler

Images not to scale

Position of the OSI200 Implant and sound processor

The OSI200 Implant position is most optimal with the actuator close to and in horizontal line with the ear canal or slightly superior without touching the pinna (Fig.1). Make sure the sound processor will not interfere with the pinna and the placement of glasses. The sound processor should not be overlapped or shadowed by the pinna.

NOTE For those patients who may have compromised vascularity due to previous surgeries, consider a placement of the OSI200 Implant that minimizes the skin tension over the actuator. Finding a flat area on the bone surface for the actuator positioning can help to reduce the risk of skin tenting.

Variations of the actuator and coil position are possible depending on the anatomy and medical history of the patient.

The suggested placement is around 0° for the coil and the actuator. The maximal deviation should be 45° (Fig.2, Fig.3).

The microphones of the sound processor should be placed in line or slightly above the superior part of the pinna to ensure optimal acoustical outcome (Fig.4).

NOTE Placing the actuator closer to the ear canal may improve sound transfer to the cochlea. Depending on the anatomy, the OSI200 Implant position may need to be adjusted, e.g. mastoidectomy cases, reconstruction of the ear. If the recipient has a Cochlear Nucleus Implant on the contra-lateral side, make sure to have a minimal distance of 10 cm between the coils of the implants to avoid interference between the systems.

Preparation

1. Prepare the patient as for any craniofacial surgical procedure.
2. Use the OSI200 Implant template to plan the correct position and mark it on the skin (Fig.5). Make sure the sound processor will not interfere with the pinna and the placement of glasses. The sound processor should not be overlapped or shadowed by the pinna.
3. Mark the location of the BI300 Implant using the hole of the actuator area of the OSI200 Implant template and a hypodermic needle inserted down to the bone with marking ink, such as Methylene blue. To avoid deformation of the ear, the actuator should not touch the pinna.
4. Before local anaesthesia is injected, measure the soft tissue thickness by using a thin hypodermic needle, a clamp (Fig.6) and a ruler (Fig.7). Measurement points should be distributed over the coil area (Fig.8). Do not depress the tissue when measuring.

NOTE Two implant templates are needed in each surgery, one for use in the non-sterile field and one for use in the sterile field. If a template is used in a non-sterile field make sure to use a new OSI200 Implant template in the sterile field later on.

5. Incision

Fig.9-Fig.11 show possible incision options. Other variations are possible and depend on the patient's anatomy. Independent from the incision method, it is important to have a distance of 15 mm or more between the incision and the edge of the implant to avoid tension on the skin and possible post-surgical complications.

NOTE

• The transmitting range of the OSI200 Implant is 1 mm to 10 mm. However, a maximum skin flap thickness of 9 mm over the coil area is required for good magnet retention.
• Take patient hair and potential use of optional Cochlear SoftWear Pad into consideration when determining if soft tissue thinning is needed.

Incision type and position

Take the following into consideration when choosing the incision type:

• Ensure visibility and physical access to the implant area to allow for clearance of bone and for placement of the BI300 Implant.
• If tissue thinning is needed, the incision may need to be elongated accordingly.

NOTE A distance of 15 mm or more between the incision and the edge of the implant can help to avoid skin tension and reduce the risk for post-surgical complications.

2. Coil pocket creation and incision

Relevant products OSI200 Implant template

Additional: Scalpel, Elevator

Images not to scale

Coil pocket options

A. OSI200 Implant placement in periosteal pocket

Making the incision down and through the periosteum allows for a sub-periosteal coil pocket. This will give the possibility for a tighter fit of the periosteum over the implant.

NOTE Consider an off-set of the incisions (skin and periosteum) to reduce the risk for skin breakdown.

B. OSI200 Implant placement lateral to periosteum

Placing the coil lateral to the periosteum and/or muscle layer is an alternative to soft tissue thinning to achieve the desired skin flap thickness. For this approach, make the incision down to but not through the periosteum.

3. BI300 Implant placement

Relevant products

• Conical guide drill 3+4 mm
• Widening drill with countersinking 3 mm or 4 mm
• Implant inserter
• BI300 Implant 3 mm or 4 mm

Images not to scale

Preparation for BI300 Implant placement

1. Clear away the periosteum around the BI300 Implant location using a small cruciate incision. For uneven bone with sufficient thickness, it is possible to pre-polish the bone before placing the BI300 Implant. In that case clear away the periosteum to allow for bone polishing.
2. Locate the marking for the BI300 Implant site made previously. When opening up the site it may be necessary to change the implant position due to changed site preference or bone quality. Ensure that no critical considerations are affected, e.g. actuator position in relation to incision.

Drill with the guide drill

1. Use the drill indicator and abundant irrigation during all drilling procedures. Begin drilling with the conical guide drill with the 3 mm spacer at 2000 rpm (Fig.13).
2. Be certain to drill at an angle perpendicular to the bone surface to minimise the need for bone polishing later in the procedure.
3. While drilling, move the drill perpendicular up and down to ensure that irrigation reaches the tip of the drill. Coolant is critical to preserve osteocytes, which are crucial for the osseointegration process.
4. Check the bottom of the site repeatedly for bone, both visually and with a suitable instrument. Avoid penetrating the wall of the sigmoid sinus or damaging the dura mater.
5. If there is adequate bone thickness, remove the white spacer on the guide drill and continue drilling as appropriate to accommodate the required BI300 Implant. (Fig.14).

Drill with the widening drill

1. Keep the drill unit on 2000 rpm with coolant.
2. Use the corresponding widening drill, depending on the depth reached with the guide drill. Drill perpendicular with an up and down movement to ensure irrigation can sufficiently cool the bone during drilling (Fig.15). Minimise the countersink depth to avoid unnecessary bone polishing later in the procedure.

WARNING Do not widen the implant site larger than the actual drill size. Remove bone chips from the drill flutes.

BI300 Implant placement

WARNING The BI300 Implant must not come in contact with anything other than the ampoule and Implant inserter before being placed in the bone. The surface must be kept free from contamination for successful osseointegration.

1. Set the drill unit to a torque setting that suits the quality of the bone. If unsure of the bone quality, begin with a lower torque setting and gradually increase.

NOTE Ensuring that the BI300 Implant is angled perpendicular to the bone surface is extremely important as the BI300 Implant will dictate the angle of the actuator. A non-perpendicular placement of the actuator may tent the skin and tissue over the implant area or the actuator may touch the bone which can lead to improper connection to the BI300 Implant. Use the Drill indicator during guide drilling, widening, and inserting the BI300 Implant to ensure a perpendicular angle.

NOTE Compromised bone could for example be irradiated bone, bone with thin cortical layer, bone with air cells etc.

11. Open the ampoule upright by unscrewing the lid so the bottom section can be placed in a suitable holder on a tray.
12. Pick up the BI300 Implant using the implant inserter (Fig.16). Using any other instrument could damage the BI300 Implant inner threads.
13. With the drill indicator in place, insert the implant at an angle perpendicular to the bone surface.
14. Place the implant without coolant until the first threads of the implant are well within the bone (two rotations).
15. Once in the bone, continue placement with irrigation. The drill unit stops automatically and beeps when the preset torque is reached (Fig.17).
    • If the implant is not seated in the bone when the pre-set torque is reached, reverse one thread and increase the torque and reinsert the implant.
    • If the implant enters the site incorrectly, put the drill in reverse and unscrew the implant. Find the correct angle and re-insert the implant. If not successful the second time, a new site should be prepared.
16. Carefully remove the Implant inserter vertically from the implant.

CAUTION Using any other instrument could damage the BI300 Implant inner threads.

NOTE

• When placing the implant in hard bone, slight pressure may need to be applied during the initial insertion. The implant can be tightened manually with the Multi wrench with ISO adapter and the implant inserter. Ensure the correct instruments and torque are used.
• Be very careful not to loosen the implant through leverage, especially if implanting a patient with thin or compromised bone.
• Seal any unused drilled implant sites with bone wax or similar.

4. OSI200 Implant placement

Relevant products

• Bone bed indicator 17 mm
• Multi wrench with ISO adapter
• Machine screwdriver UniGrip 25 mm
• Screwdriver UniGrip 95 mm
• OSI200 Implant template
• OSI200 Implant

Images not to scale

Checking for clearance

1. Place the Bone bed indicator on the BI300 Implant and gently hand tighten it to the implant threads by turning the top knob. Make sure that it is properly tightened. Rotate the Bone bed indicator clockwise to check for interfering bone (Fig.18). This will allow sufficient clearance for the correct mounting of the OSI200 Implant.
2. If the Bone bed indicator only touches periosteum, remove the periosteum. If the Bone bed indicator touches bone, remove excess bone. First, open up the periosteum in that area and polish the bone using a standard otological high-speed drill. Check repeatedly that sufficient bone has been removed using the Bone bed indicator. Repeat the above until the bone bed indicator can be rotated 360° clockwise without applying force.

NOTE To ensure a good connection between the actuator and the BI300 Implant, it is important to provide sufficient clearance to the bone. The actuator should not be in contact with the bone, only the BI300 Implant.

3. If it is assessed in "1. Preparation of implant site" that soft tissue thinning is required, carefully thin the tissue over the entire coil area. Try to achieve a uniform skin thickness over the coil area for best contact with the sound processor. As an alternative to soft tissue thinning, consider placing the coil on top of the periosteum and/or muscle layer to achieve the desired skin flap thickness.

NOTE

• If soft tissue thinning is required, only soft tissue should be removed. In case of a periosteal pocket the periosteum is left untouched to ensure a tight pocket.
• Skin that is too thin may increase the risk of skin breakdown which may lead to infection and/or device extrusion.

CAUTION If skin thinning is performed over the area of the coil, ensure the skin thickness and vascularity is sufficient to prevent any post-surgical skin issues.

Preparation and insertion of the OSI200 Implant

WARNING

• Once the OSI200 Implant is in the surgical field, monopolar electrocautery must not be used.
• Bipolar electrosurgical instruments should be kept more than 1 cm (½ in.) from the implant.
• Care should be taken when handling the implant. Do not drop the actuator on a hard surface.

4. Make a final check with the OSI200 Implant template to ensure the coil fits well in the pocket and can be positioned correctly. Remove the template afterwards.
5. Open up the sterile packaging (Fig.19) and gently remove the lid above the implant (marked number 1) as well as the lid above the fixation screws (marked number 2). Two fixation screws are available, but only one of them is needed to fix the OSI200 Implant to the BI300 Implant.
6. Use the screwdriver UniGrip 95 mm to pick up the fixation screw from the implant blister pack using minimal force. Carefully screw the fixation screw into the actuator until it is fully seated (Fig.20).
7. Carefully remove the OSI200 Implant and place it with the coil first into the periosteal pocket. If a different surgical approach was chosen place it accordingly. If instruments are used for placement be aware to only use blunt ones to not harm the coil or waist area.
8. Place the centre of the actuator on top of the BI300 Implant and gently hand-tighten the fixation screw with the screwdriver, while holding the actuator with your fingers (Fig.21). The actuator should not be in contact with the bone, only the BI300 Implant.
9. Continue to tighten to 25 Ncm with the Machine screwdriver UniGrip and the Multi wrench with the ISO adapter, while holding the actuator with your fingers (Fig.22). Keep the implant orientation in mind and check that the implant coil or waist are not kinked before making the final attachment.

NOTE Keep in mind that the OSI200 Implant contains a magnet and may be attracted to other magnetic devices in the operating room.

5. Closure

1. Place the skin flap over the implant and suture the skin. If a periosteal flap was created consider suturing the flap off-set to the skin flap. Be careful to not harm the implant while suturing. Consider closing the skin and soft tissue in two separate layers.
2. Apply a pressure dressing for at least 24 hours (Fig.23).
3. After removing the pressure dressing, it is possible to use a normal wound dressing during the initial healing period.

Post-operative management

Monitor the patient as for all procedures involving general anaesthesia. Keep the pressure dressing on for at least one day, and then monitor and change the dressing as desired.

Fitting the sound processor

Do not fit the sound processor before the wound is sufficiently healed.

The initial fitting procedure for the sound processor should be scheduled approximately four weeks after the operation. In the event that the tissue is still too swollen, consider a later fitting. Fitting should be checked in regular intervals as per clinic protocol.

Registering the implant

Registration form

The registration form must be completed and returned to your closest Cochlear office or distributor by mail or fax immediately following implantation to validate product warranty.

Patient identification card

Fill out the complete patient identification card with all required details. Give the card to the patient or their carer. The patient or their carer should carry the patient identification card with them.

Identifying the implant

The implant model can be found on the patient's Cochlear patient identification card.

If the patient does not have their patient identification card with them, the implant type and model can be identified without surgical intervention using X-ray or the Cochlear Osia fitting software. (Fig. 24).

• Part 1 of serial number: 116002
• Part 2 of serial number: 00000X X (specific for each implant)

Explanting the implant

In rare circumstances, it may be necessary to explant an Osia OSI200 Implant. Please follow the steps below.

1. Inform your local Cochlear representative and contact Cochlear to order a Retrieved Device Kit. The kit must be used to transport the explanted device to Cochlear.
2. Read the instructions provided with the kit.
3. Before explanting the device, examine it for any defects. Note these on the form provided with the kit.
4. Try to keep the explanted device intact and undamaged.
5. Disconnect the actuator unit from the BI300 Implant using the screwdriver UniGrip 95 mm or the Multi Wrench with ISO adapter and Machine screwdriver UniGrip 25 mm.
6. If osseointegrated, the BI300 Implant can remain in place. Only remove it if absolutely necessary. If leaving in place, connect a new Osia OSI200 Implant, or place a cover screw to protect the internal threads of the implant.
7. Return the kit containing the explanted device to the Cochlear address nearest you. The applicable addresses can be found in the Retrieved Device kit.

Reporting problems

Legislation on medical devices requires the manufacturer to report adverse events to the appropriate authorities. Should such an incident occur, notify the nearest Cochlear office or its official distributor immediately.

MRI safety information

MR The Cochlear Osia OSI200 Implant is MR Conditional at 1.5 T with magnet in place or removed, and 3 T when magnet is removed. MRI examinations can be performed safely on a person with this implanted device only under very specific conditions. MRI examinations performed under different conditions may result in severe patient injury or device malfunction.

Clinicians and recipients should weigh the benefits and risks of completing an MR scan at 1.5 T by either 1) Keeping the magnet in place and using an MRI Kit 2) Removing the implant magnet and replacing it via surgical procedures or 3) Not performing the MR scan.

Full MRI safety information should be reviewed prior to determining the most appropriate course of action. Safety information is available:

• in the Cochlear™ Osia® Magnetic Resonance Imaging (MRI) Guidelines (supplied with the implant)
• by visiting www.cochlear.com/mri
• by calling your regional Cochlear office - contact numbers are available on the back cover of this guide.

Removing or replacing the magnet

MR All external components of the Cochlear Osia System (e.g. sound processors, remote assistants and related accessories) are MR Unsafe. The patient must remove all external components of their Cochlear Osia System before entering a room where an MRI scanner is located.

For Osia OSI200 Implant recipients requiring a single MRI examination or multiple MRI examinations over a period of time, the implant magnet is removed and replaced with a sterile non-magnetic plug.

In the magnet's absence, the plug prevents fibrous tissue growing into the recess. Such growth would make magnet replacement difficult. When there is no further need for MRI examinations, the non-magnetic plug is removed, and a replacement magnet is inserted.

The non-magnetic plug and replacement magnet are supplied separately in sterile packs. Both are single-use items.

WARNING

• Do not leave the magnet pocket empty. When removing the implant magnet, replace the magnet with a sterile non-magnetic plug.
• All replacement procedures should take place under sterile conditions.

CAUTION When removing or inserting a magnet or non-magnetic plug:

• Take care to not damage the implant silicone or coil wires. Do not suture directly over the implant silicone or the wires.
• Use a blunt instrument to lift the lip of the silicone elastomer recess.
• Exert minimal force and pressure to the implant during the procedure.

NOTE While the magnet is removed, the recipient must wear a retainer disc to hold the sound processor in place. Retainer discs are available from Cochlear.

Removing the magnet before implantation

For recipients requiring repeated MRI examinations in the foreseeable future, it may be appropriate to replace the magnet with a non-magnetic plug (available from Cochlear) before implantation of the OSI200 Implant.

1. In sterile conditions, remove the Osia OSI200 Implant from its sterile packaging and place it on a flat and stable surface, with the grey ring (denoting polarity) facing up (Fig.26 on page 37).
2. Using an elevator or similar instrument, lift the lip of the silicone elastomer recess around the magnet and remove the magnet from the implant. When removing the magnet, minimise the pressure applied to the implant coil.
3. Remove the sterile non-magnetic plug from its packaging. Lift the lip of the recess using an elevator and press the non-magnetic plug (Fig.25 on page 37) into position. Be careful not to exert undue pressure on the implant.
4. The Osia OSI200 Implant is now ready for implantation. Follow the surgical steps described earlier in this guide.

When there is no further need for MRI examinations, remove the non-magnetic plug and insert a replacement magnet following the steps in "Inserting a replacement magnet" on page 40.

Removing the magnet after implantation

For recipients requiring a single or multiple MRI examinations after implantation, remove the magnet and insert a non-magnetic plug. Perform the procedure in sterile conditions, using either general or local anaesthetic.

1. Make a small incision (Fig.27)
   • outside of the coil area
   • with good access to the magnet pocket
2. Cut through any fibrous growth around the implant and expose the magnet.
3. Using an elevator or similar instrument, carefully lift the lip of the silicone elastomer recess and remove the magnet. If a retaining suture runs across the magnet, move the suture out of the way.
4. Remove the sterile non-magnetic plug from its packaging. Lift the lip of the recess using an elevator and press the non-magnetic plug (Fig.25 on page 37) into position. Be careful not to exert undue pressure on the implant.
5. Close the wound in layers.

Inserting a replacement magnet

When MRI is no longer a regular necessity, remove the non-magnetic plug and insert a replacement magnet. Perform the procedure in sterile conditions, using either general or local anaesthetic.

1. Make a small incision (Fig.28)
   • outside of the coil area
   • with good access to the magnet pocket
2. Cut through any fibrous growth around the implant and expose the non-magnetic plug.
3. Using an elevator or similar instrument, carefully lift the lip of the silicone elastomer recess and remove the non-magnetic plug. If a retaining suture runs across the plug, move the suture out of the way.
4. Remove the sterile replacement magnet from its packaging. Use the elevator to lift the lip of the recess and press the replacement magnet with the grey ring (denoting polarity) facing up (Fig.26 on page 37) into position, keeping in mind that the silicone lip retains the replacement magnet. Be careful not to exert undue pressure on the implant. Non-magnetic instruments may be useful.
5. Close the wound in layers.

For additional information about magnet removal, contact Cochlear.

OSI200 Implant specifications

General information

Warranty

To the purchaser: the law in some countries requires that the written warranty for this Osia OSI200 Implant must be made available for the patient's review before it is sold to them. The Cochlear terms and conditions of warranty should therefore be given to the patient before implantation. The warranty is included in the document pack.

Symbols

The following symbols may appear on your implant packaging:

• !: Specific warnings or precautions associated with the device, which are not otherwise found on the label
• Manufacturer
• Date of manufacture
• REF: Catalogue number
• CE 0123: Authorised representative in the European Community, CE registration mark with notified body number
• i: Consult instructions for use
• Fragile, handle with care
• Sterile Barrier: Do not use if package (sterile barrier system) is damaged and check IFU
• Keep dry
• Do not re-use
• Do not use if package is damaged
• Rx Only: Caution: US law restricts this device to sale by, or on the order of, a physician
• MR Conditional
• MR Unsafe
• MD: Medical Device
• Use by date
• STERILE EO: Sterilised using ethylene oxide
• STERILE R: Sterilised using irradiation
• LOT: Batch code
• UDI: Unique device identifier

Privacy and the collection of personal information

During the process of receiving a Cochlear device, personal information about the user/recipient or their parent, guardian, carer and hearing health professional will be collected for use by Cochlear and others involved in care with regard to the device.

For more information please read Cochlear's Privacy Policy on www.cochlear.com or request a copy from Cochlear at the address nearest you.

A summary of clinical testing

The following section provides a summary of the clinical testing that has been performed to verify the safety and efficacy of the Osia System. Clinical testing was performed using either a predicate device for which substantial equivalence is claimed (i.e. Cochlear™ Osia™ OSI100 Implant together with the Cochlear™ Osia™ Sound Processor) or the actual device (i.e. Cochlear™ Osia™ OSI200 Implant together with the Cochlear™ Osia™ 2 Sound Processor) in experienced bone conduction hearing implant recipients¹.

Taken together, clinical testing shows that the Osia System is safe and efficacious, significantly improving objective and subjective hearing outcomes and health-related quality of life in subjects with conductive hearing loss, mixed hearing loss, and single-sided sensorineural deafness.

Clinical Performance of a New Implant System for Bone Conduction Hearing

A prospective, multicentre clinical investigation including 51 adults with conductive hearing loss² (CHL; n=14), mixed hearing loss (MHL; n=23), or single sided sensorineural deafness (SSD; n=14) was conducted to assess the safety and effectiveness of the Osia System³. Subjects were unilaterally (n=49), or bilaterally (n=2) implanted and served as their own controls (i.e. aided hearing with the Osia System vs. preoperative unaided hearing and pre-operative aided with a BP110 Power Sound Processor on a Baha Softband).

With a total follow-up period of 12 months, the primary efficacy and safety evaluations were performed after 3 and 6 months, respectively. The following variables were assessed:

• Hearing performance: Thresholds audiometry, free field at individual frequencies [0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0 and 8.0 kHz] and Pure Tone Average [PTA4, Mean of 0.5, 1, 2, and 4 kHz]; Speech in quiet [% correctly perceived words at 50dB, 65dB and 80dB SPL]; Adaptive speech in noise [speech-to-noise ratio, 50% speech understanding].
• Self-reported assessment: Speech, Spatial and Qualities of Hearing Scale (SSQ12); Abbreviated Profile of Hearing Aid Benefit (APHAB); Health Utilities Index (HUI®) 23S15Q; Comfort (VAS, 0-100%), Usage.
• Safety: Adverse Events, Device deficiencies, Surgical information; Bone conduction (BC) thresholds, preoperative and postoperative etc.

Effectiveness results

Hearing benefit and health related quality of life with the Osia System compared to pre-operative unaided hearing

Audiometric Thresholds

Hearing performance with the Osia System (aided) at 3 months was compared to the pre-operative unaided hearing performance, using free-field thresholds audiometry. Statistically significant improvements in Pure Tone Average (PTA4; mean of 0.5, 1, 2 and 4 kHz) with the Osia System were observed in the total population as well as the two separate sub-groups (p<0.0001). Table 1 shows the change in free-field hearing thresholds with the Osia System at 3 months, for both individual frequencies and PTA4 as compared to unaided listening. Improvements in audiometric thresholds were seen for all frequencies in both sub-groups when comparing the Osia System at 3 months with the unaided situation. All improvements were statistically significant except at 0.25 kHz in the SSD group.

Mean (SD; range Min to Max; n= is presented) * Negative value= improvement

Speech in Quiet and Noise

Hearing performance measured as 'adaptive speech recognition in noise' showed statistically significant improvement with the Osia System as compared to the unaided situation for both the total population and the separate sub-groups. Statistically significant improvements were also recorded for all test conditions for speech recognition in quiet for all patient groups. Table 2 presents the change in speech-to-noise ratio and speech in quiet for the total population as well as the separate sub-groups (CHL/MHL and SSD). Table 3 and table 4 present the change in speech understanding with the Osia System as compared to the preoperative unaided situation for each patient. The performance evaluation indicates which patients experienced significantly better (or poorer) hearing performance with the Osia System. Data shows that no patients experienced a poorer performance with the Osia System as compared to the pre-operative unaided situation.

Mean (SD; range Min to Max; n= is presented) * Negative value= improvement

Table 3: Pre- vs. post- operative (3 months aided) hearing performance comparisons per patient for the CHL / MHL subgroup. The performance evaluation indicates if the patient experienced a significantly better or poorer hearing performance with the Osia System. Similar mean that the change was not significant. ** means no value available.

Table 4: Pre- vs. post- operative (3 months aided) hearing performance comparisons per patient for the SSD subgroup. The performance evaluation indicates if the patient experienced a significantly better or poorer hearing performance with the Osia System. Similar mean that the change was not significant. ** means no value available.

Self-reported assessment of hearing performance

The short form of Speech, Spatial, and Qualities of Hearing questionnaire (SSQ-12) was used in the clinical investigation as it is designed to measure self-reported auditory disability, reflecting the reality of hearing in the everyday world. The study shows statistically significant improvements for all parameters (Total, Speech, Spatial and Quality) for both the total population and for the CHL/MHL sub-group when comparing the Osia System at 3 months with the pre-operative unaided situation. The SSD sub-group experienced a similar pattern with the exception for quality where no statistically significant improvement was recorded.

The Abbreviated Profile of Hearing Aid Benefit (APHAB) comprises of 24 items that are scored in the following four subscales: Ease of communication (EC), Reverberation (RV), Background noise (BN) and Aversiveness (AV). The Global score is the mean of the scores for all items in the EC, RV BN and AV subscales. When comparing the 3 month aided situation with the pre-operative unaided situation, statistically significant improvements were seen for all parameters except for Aversiveness for both total population and the two sub-groups.

Health status, health-related quality of life and utility scores

The generic quality of life scale, Health Utilities Index (HUI), was used to measure health status and health related quality of life. In the total population, statistically significant improvements with the Osia System were reported for the Comprehensive health state and Hearing attribute at 3 months. While the CHL/ MHL sub-group experienced improvements in their health status for the same attributes as the whole population, the small SSD sub-group did not experience any statistically significant difference in health status, as measured by HUI, 3 months after receiving the Osia System.

Table 5 presents the change in self-reported hearing outcomes and health related quality of life for the total populations as well as the different sub-groups after 3 months of aided hearing with the Osia System. Table 6 and 7 present the change in self-reported outcomes per patient. The performance evaluation indicates which patients experienced significantly better, poorer or similar scores with the Osia System as compared to the pre-operative unaided situation.

Mean (SD; range Min to Max; n= is presented)

Table 6: Pre- vs. post- operative (3 months aided) patient-reported outcomes per patient for the CHL / MHL sub-group. The performance evaluation indicates if the patient experienced a significantly better or poorer score with the Osia System. Similar mean that the change was not significant. - / ** means no value/evaluation available.

Table 7: Pre- vs. post- operative (3 months aided) patient-reported outcomes per patient for the SSD sub-group. The performance evaluation indicates if the patient experienced a significantly better or poorer score with the Osia System. Similar mean that the change was not significant. - / ** means no value/evaluation available.

Hearing performance with the Osia System compared to pre-operative aided hearing assessment using the BP110 Power Sound Processor on Softband

Prior to bone conduction hearing implant surgery, a pre-operative assessment of the anticipated post-operative hearing outcome is routinely performed using a Baha Sound Processor on a Softband. The Softband test allows the patient to pre-operatively experience hearing through the Sound Processor to get an indication of the post-operative hearing outcome. As such, in addition to assessing hearing performance with the Osia System as compared to the pre-operative unaided listening situation, pre-operative aided hearing performance with a BP110 Power Sound Processor on a Baha Softband was also collected. The Baha BP110 Power Sound processor was chosen as it has the same 55 dB fitting range as the Osia System.

Audiometric Thresholds

Table 8 presents the change in free-field hearing thresholds with the Osia System at 3 months, for both individual frequencies and PTA4 (mean of 0.5, 1, 2 and 4 kHz) as compared to pre-operative aided listening with the BP110 Power Sound Processor on Softband. Statistically significant improvements in mean free-field hearing thresholds (PTA4) were observed in the total population and in the CHL/MHL sub-group when comparing the Osia System with pre-operative BP110 on a Baha Softband. While a numerical improvement in PTA4 was observed in the SSD sub-group, this was not statistically significant.

When assessing the audiometric thresholds per frequency, the greatest improvements in free field thresholds were observed at the higher frequencies, i.e. 3 to 4 kHz and above, for both subgroups. This result is expected since passive transcutaneous bone conduction hearing systems (e.g. Baha Attract or Baha sound processors on Softband/ SoundArc) are associated with an attenuation of the signal as it is transmitted through the skin affecting mainly the high frequencies. While being a transcutaneous bone conduction hearing implant system, the vibrating unit (actuator) of the Osia System is placed subcutaneously which allows for direct mechanical stimulation of the skull bone without the loss of signal through the skin.

Speech in Quiet and Noise

Overall, there was a slight improvement in speech recognition in quiet at 65 dB SPL with the Osia System compared to pre-operative aided listening with BP110 on a Softband; however, when assessing the separate sub-groups, patients with a mixed / conductive hearing loss performed better with the Osia System than with BP110 on softband, with statistically significant improvement in word recognition scores at 65 dB and 80 dB SPL, while no significant difference was seen at any SPL for the SSD subgroup. When it comes to the adaptive speech in noise tests, both subgroups experienced a statistically significant improvement with the Osia System as compared to BP110 on softband.

Table 9: 3 months aided hearing with the Osia System vs. pre-operative aided hearing with BP110 Power on Softband. Table shows the change in speech-to-noise ratio and speech in quiet for the total population as well as the separate sub groups (CHL / MHL and SSD).

Mean (SD; range Min to Max; n= is presented) * Negative value= Improvement

Comfort and usage

Comfort with the use of the Osia System, measured using a visual analogue scale where 0% was defined as no comfort at all and 100% as most comfortable imaginable, showed a total mean comfort of 81% at 3 months and the mean reported daily use was 10.5 hours/day (SD 4.3, range 1.0-18.0 hours/day).

Analysis of the separate subgroups (CHL/MHL and SSD) showed similar trends as for the entire population.

Safety results

Serious Adverse Events (SAEs)

Four (4) Serious Adverse Events (SAEs) were reported within the first six months of the study. Two (2/4) SAEs were unrelated to the study device and/or procedure and the remaining two SAEs were judged as probably related to the procedure.

The procedure-related SAEs occurred in the same patient and stemmed from the same root cause, details are presented below:

SAE: Wound Infection leading to explantation

One study subject suffered a complicated post-operative wound infection which led to removal of the implant.

The subject (a 49-year-old Caucasian male, non-smoker, with mixed hearing loss due to chronic infection, with no surgery relevant medical history or medication) experienced an infection at the implant site, first observed 3 days after surgery.

The surgical procedure involved extensive soft tissue reduction followed by cauterization to stop heavy bleeding. The subject's hospitalization was prolonged due to excessive seroma at the implant site. Revision surgery (debridement and necrectomy) was performed 12 days later and the subject was discharged after an additional 12 days. Sixteen days later the subject was re-hospitalised due to skin necrosis at the implant site; the root cause was bacterial infection, whereby another revision surgery was performed (debridement, rotational skin flap). The subject was treated with antibiotics and could leave the hospital after 5 days. The subject was once again re-hospitalized after twenty days due to skin dehiscence at implant site, whereby surgery was performed to remove the implant.

Assessment of the explanted implant revealed the presence the pathogenic bacterium Klebsiella aerogenes (K. aerogenes) and the biofilm-forming bacterium Propionibacterium acnes (P. acnes).

The SAE was resolved by removing the Osia implant. The BI300 Implant was left in situ and covered with a cover screw in accordance with the recommended surgical procedure.

Other device or procedure related Adverse Events (AEs)

Nineteen (19) Adverse Events (AEs), judged as causally or probably related to the study device and/or procedure, were reported during the first six months of the study. Table 10 presents the details for these AEs:

* NOTE. AEs reported as ongoing at the 6 months primary safety evaluation - these have been resolved.

Bone conduction thresholds

Pre- and post-operative bone conduction thresholds were assessed, where shifts in thresholds, relative to the preoperative baseline, were to be reported as an adverse event (AE) when a shift at any frequency exceeds 15 dB HL.

Table 11 presents the unaided post-operative BC thresholds (PTA4, mean of 0.5, 1, 2 and 4 kHz) as compared to the baseline pre-operative BC thresholds for both the total population and for the separate sub-groups. Neither group data nor individual patient data demonstrate any significant thresholds shifts over time, indicating stable inner and middle ear function up to 12 months after implantation. Any individual fluctuations in BC thresholds are most likely due to testing artefact caused by the different placement of the bone oscillator.

Subjects Preference Regarding Hearing Performance and Functionality Using a New Sound Processor

The sound processor used in combination with the OSI200 Implant is the Osia 2 Sound Processor. This sound processor can also be used together with the predicate Osia System implant (i.e. The Cochlear™ Osia™ OSI100 Implant). Eleven (11) subjects (CHL n=2; MHL n=3; SSD n=6) who had completed the above-mentioned clinical investigation were included in this open, single center, prospective, within-subject comparison designed to evaluate the performance and overall preference when using the new Osia 2 Sound Processor. All subjects were active users of the predicate device and fitted with the Osia 2 Sound Processor at the first visit.

The study consisted of 2 to 3 visits over a period of six (6) weeks. Data for the overall objectives was collected before and after 6 weeks of Osia 2 Sound Processor use. Device test order was randomised and each subject was compared to his/her own results.

Effectiveness results

Audiometric Thresholds

Hearing performance with the Osia 2 Sound Processor was compared to that of the predicate sound procesor (Osia Sound Processor) using free-field thresholds audiometry. A statistically significant improvement in PTA4 was observed with the Osia 2 Sound Processor as compared to the predicate device.

Table 12 shows the change in free-field hearing thresholds with the Osia 2 Sound Processor at 6 weeks, for both individual frequencies and Pure Tone Average (PTA4; mean of 0.5, 1, 2 and 4 kHz) as compared to the predicate device.

Speech in Quiet and Noise

Both sound processors provided good and comparable hearing benefit with regards to speech recognition in quiet and adaptive speech in noise. No significant differences were seen when comparing the two Osia Sound Processors.

Self-reported assessment of hearing aid outcomes

The short form of 'Speech, Spatial, and Qualities of Hearing questionnaire' (SSQ-12) was used to measure self-reported auditory disability, reflecting the reality of hearing in the everyday world.

For the 'Abbreviated Profile of Hearing Aid Benefit' (APHAB) only the 'aided subscale' was assed (i.e. rating of the non-aided subscale was not assess in this study).

The 'Quebec User Evaluation of Satisfaction with assistive Technology' (QUEST version 2) questionnaire was used to collect information on subjects' preference regarding aesthetics, comfort, usage time and ease of use. Each item was scored using a 5-point scale ranging from 1 to 5, where: 1 (not satisfied at all), 2 (not very satisfied), 3 (more or less satisfied), 4 (quite satisfied), to 5 (very satisfied).

The questionnaires were answered at Visit 1 with respect to "pre-study experience" using the predicate device and at Visit 3 with respect to the past 6 weeks period using the Osia 2 Sound Processor alone without Wireless accessories.

No significant differences in SSQ scores were seen when comparing the two sound processors; however, when looking at the individual and mean values the Speech score was improved with the Osia 2 Sound Processor for all subjects except one (1) who had no change between Visit 3 and Visit 1, the Spatial score was improved for eight (8) subjects and decreased for three (3) subjects, the Quality score was improved for six (6) subjects, decreased for four (4) and remained unchanged for one (1). Finally, the Total score was improved for eight (8) subjects, deceased for one (1) and two (2) had no change.

A numerical improvement in APHAB scores was recorded for all four subscales and for the global score with the Osia 2 Sound Processor indicating an added benefit with the new sound processor over the predicate device.

Overall the subjects were "more or less satisfied" to "very satisfied" with all variables for both sound processors with an overall QUEST score of 4.61 (SD 0.40) for the Osia 2 Sound Processor and 4.38 (SD 0.36) for the predicate device. The two variables that improved the most with the new sound processor were 'Dimensions' and 'Effectiveness' (the degree to which the device meets the subject's needs).

Subjects Overall Preference

Based on their subjective experience of the overall hearing performance together with the sound quality, aesthetics, comfort, and usability experience of the sound processors, the subjects were asked to state their preferred choice of sound processor. The subject should in relation to this final choice indicate what influenced his/her decision the most (several options possible):

Hearing performance, Sound quality, Aesthetic, Comfort and sound processor ease of use, Possibility to use Wireless accessories, Possibility of iPhone pairing, Other (free text)

All eleven (11) subjects chose the Osia 2 Sound Processor as preferred sound processor. There was an even distribution between the factors influencing the choice, but the 'Possibility to use wireless accessories' was important for 10 of the 11 subjects and 'Sound quality' was important for the choice for eight (8) of the subjects.

Safety results

No serious adverse event (SAEs) or adverse event of special interest (AESIs) were reported.

One (1) adverse event (AE) was reported as related to the Osia 2 Sound Processor (skin irritation under the sound processor). The AE was resolved after five days of temporary non-use and adding a SoftWear pad to the sound processor.

Evaluation of the hearing performance of a new bone conduction hearing implant system using a simulation model

The substantial equivalence between the Osia 2 System (i.e. The Cochlear™ Osia™ OSI200 Implant and the Osia 2 Sound Processor) and the predicate device (i.e. The Cochlear™ Osia™ OSI100 Implant and Osia Sound Processor) was demonstrated in a single centre, single-blinded, randomised, prospective clinical investigation using an Osia System Simulation model. This unique investigational design allows for "in-patient" comparison of the different generation Osia implants and sound processors, which would otherwise not be possible. The aim was to show non-inferiority of the Osia 2 System to the predicate device.

The study included twenty (20) adult Bone conduction hearing implant recipients with conductive hearing loss (CHL; n=10) or mixed hearing loss (MHL; n=10).

The following variables were assessed:

• Hearing performance: Thresholds audiometry, free field at individual frequencies [0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0 and 8.0 kHz] and Pure Tone Average [PTA4, Mean of 0.5, 1, 2, and 4 kHz]; Speech in quiet [% correctly perceived words at 50dB, 65dB and 80dB SPL]; Adaptive speech in noise [speech-to-noise ratio, 50% speech understanding].
• Subjective rating of sound: e.g. loudness, sound quality, speech understanding, own voice, artefacts and feedback after listening to sound clips.

Effectiveness results

Hearing performance with the Osia 2 System compared to predicate device

Audiometric Thresholds

Hearing performance with the Osia 2 System was compared to that of the predicate device using free-field thresholds audiometry. No differences between the systems were seen in terms of PTA4 (mean of 0.5, 1, 2 and 4 kHz); however, when looking at the individual frequencies the Osia 2 System was significantly better at 0.25 and 0.75 kHz, but worse at 4 and 6 kHz compared to the predicate device.

Speech in Quiet and Noise

Both provided good and comparable hearing benefit with regards to speech recognition in quiet and adaptive speech in noise; hence the Osia 2 System fulfills the non-inferiority criteria (Table 14).

Mean (SD; range Min to Max; n= is presented) * negative value = improvement

Subjective Rating of Sound

For 'Sound Quality'; 'Internal noise'; 'Artefacts'; 'Feedback'; 'Voice clarity' and 'Loudness' there was no significant difference between the Osia 2 System and the predicate device. The only difference was seen for the test 'Quiet conversation' where the Osia 2 System was regarded as being softer than the predicate device (p=0.016).

Safety results

No adverse events or device deficiencies were reported.

Cochlear Ltd (ABN 96 002 618 073)

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株式会社日本コクレア(Nihon Cochlear Co Ltd) 〒113-0033 東京都文京区本郷2-3-7 お茶の水元町ビル Tel: +81 3 3817 0241 Fax: +81 3 3817 0245

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www.cochlear.com

This material is intended for health professionals. If you are a consumer, please seek advice from your health professional about treatments for hearing loss. Outcomes may vary, and your health professional will advise you about the factors which could affect your outcome. Always read the instructions for use. Not all products are available in all countries. Please contact your local Cochlear representative for product information.

Cochlear, 科利耳, コクレア, 코클리어, Hear now. And always, Osia, SmartSound, the elliptical logo, and marks bearing an ® or ™ symbol, are either trademarks or registered trademarks of the Cochlear group of companies (unless otherwise noted).

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