Cochlear Osia System

K240155 · Cochlear Americas · PFO · Apr 18, 2024 · Ear, Nose, Throat

Device Facts

• Record ID: K240155
• Device Name: Cochlear Osia System
• Applicant: Cochlear Americas
• Product Code: PFO · Ear, Nose, Throat
• Decision Date: Apr 18, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.3340
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Cochlear Osia System uses bone conduction to transmit sounds to the cochlea (inner ear) with the purpose of enhancing hearing. The OSI300 Implant or OSI200 Implant is intended to be used as part of the Cochlear Osia System to convert information from the external Sound Processor into mechanical vibrations. Osia single-use and reusable surgical instruments are used throughout the surgery to correctly position and attach the Osia implant.

Device Story

The Osia System is an active implantable bone conduction hearing system. It consists of an internal implant (receiver/coil and actuator) and an external sound processor. The sound processor captures environmental sound, processes it digitally, and transmits power and data via a transcutaneous RF link to the implant. The implant converts the digital signal into an analog electrical signal, driving an actuator that produces mechanical vibrations. These vibrations are transmitted to the skull bone, bypassing the middle ear to stimulate the cochlea. The system is used by patients with conductive, mixed, or single-sided sensorineural hearing loss. It is configured by audiologists using dedicated fitting software. Patients benefit from improved speech intelligibility and quality of life. The system is MR conditional.

Clinical Evidence

A prospective, multi-center study evaluated safety and effectiveness in children ages 5-11. Safety was assessed by monitoring adverse events, which were found consistent with the 12+ age group. Effectiveness was demonstrated via parental questionnaires (SSO) and speech perception testing in quiet and adaptive noise. Results showed significant improvements in quality of life and speech perception post-implantation compared to preoperative unaided performance.

Technological Characteristics

Active implantable bone conduction system. Components: OSI300/OSI200 implant, BI300 osseointegrated implant, external sound processor, fitting software. Materials: Biocompatible per ISO 10993-1 and ISO 14708-7. Sterilization: Ethylene-oxide (EO) per ISO 11135. Connectivity: Wireless link to accessories/fitting software. Energy: RF inductive link. MR Conditional (1.5T/3T).

Indications for Use

Indicated for patients 5 years of age or older with conductive or mixed hearing loss (PTA BC threshold <= 55 dB HL) who benefit from amplification. Bilateral fitting indicated for symmetric conductive/mixed loss (BC threshold difference < 10 dB average or < 15 dB individual). Indicated for single-sided deafness (SSD) with profound sensorineural loss in one ear and normal hearing in the opposite ear (PTA air conduction threshold <= 20 dB HL). Also indicated for patients who are candidates for AC CROS hearing aids but cannot or will not use them. Recommended that patients have prior experience with air or bone conduction hearing aids.

Regulatory Classification

Identification

An active implantable bone conduction hearing system is a prescription device consisting of an implanted transducer, implanted electronics components, and an audio processor. The active implantable bone conduction hearing system is intended to compensate for conductive or mixed hearing losses by conveying amplified acoustic signals to the cochlea via mechanical vibrations on the skull bone.

Special Controls

In combination with the general controls of the FD&C Act, the active implantable bone conduction hearing system is subject to the following special controls:

*Classification.* Class II (special controls). The special controls for this device are:(1) Clinical performance testing must characterize any adverse events observed during implantation and clinical use, and must also demonstrate that the device performs as intended under anticipated conditions of use. (2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use, including the following: (i) Performance data must validate force output in a clinically relevant model. (ii) Impact testing in a clinically relevant anatomic model must be performed. (iii) Mechanical integrity testing must be performed. (iv) Reliability testing consistent with expected device life must be performed. (3) The patient-contacting components of the device must be demonstrated to be biocompatible. (4) Performance data must demonstrate the sterility of the patient-contacting components of the device. (5) Performance data must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the identified shelf life. (6) Performance data must demonstrate the wireless compatibility, electromagnetic compatibility, and electrical safety of the device. (7) Software verification, validation, and hazard analysis must be performed. (8) Labeling must include: (i) A summary of clinical testing conducted with the device that includes a summary of device-related complications and adverse events; (ii) Instructions for use; (iii) A surgical guide for implantation, which includes instructions for imaging to assess bone dimensions; (iv) A shelf life, for device components provided sterile; (v) A patient identification card; and (vi) A patient user manual.

Predicate Devices

• Cochlear Osia System (K231204)

Reference Devices

• BI300 Implant (K100360)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

April 18, 2024

Cochlear Americas Whitney Alexander Regulatory Affairs Specialist 10350 Park Meadows Dr Lone Tree. Colorado 80124

Re: K240155

Trade/Device Name: Cochlear Osia System Regulation Number: 21 CFR 874.3340 Regulation Name: Active Implantable Bone Conduction Hearing System Regulatory Class: Class II Product Code: PFO Dated: January 19, 2024 Received: January 19, 2024

Dear Whitney Alexander:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Shuchen Peng -S

Shu-Chen Peng, Ph.D. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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# Indications for Use

510(k) Number (if known) K240155

Device Name Cochlear™ Osia® System

#### Indications for Use (Describe)

The Osia System is intended for the following patients and indications:

· Patients 5 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 intents 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 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.

Type of Use (Select one or both, as applicable)

| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|----------------------------------------------|---------------------------------------------|
|----------------------------------------------|---------------------------------------------|

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# K240155 - 510(k) Summary

| A. Submitter Information<br>Submitted by: | Cochlear Americas<br>10350 Park Meadows Drive<br>Lone Tree, CO 80124 |
|-------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| On behalf of the manufacturer: | Cochlear Ltd - Macquarie<br>1 University Avenue<br>Macquarie University, NSW 2109<br>Australia<br>(Establishment Number 3009092818) |
| Contact: | Whitney Alexander<br>Senior Regulatory Affairs Specialist<br>Cochlear Americas<br>C: 719-337-8620<br>E: [e-mail] |
| B. Date Prepared | 19-January-2024 |
| C. Device Name and Classification | |
| Device Names: | Cochlear™ Osia® OSI300 Implant<br>Cochlear™ Magnet Cassette<br>Cochlear™ Non-Magnetic Cassette<br>Cochlear™ Osia® 2(I) Sound Processor<br>Cochlear™ Osia® OSI200 Implant<br>Cochlear™ Sterile Replacement Magnet<br>Cochlear™ Sterile Non-Magnetic Plug<br>Cochlear™ Osia® 2 Sound Processor<br>Cochlear™ Osia® Fitting Software 2<br>Cochlear™ Osia® Smart App |
| Trade/Proprietary Name: | Cochlear™ Osia® System |
| Common/Usual Name: | Osia System |
| Classification Name: | Active implantable bone conduction hearing system<br>21 CFR 874.3340, Class II |
| Classification Panel: | Ear, Nose, and Throat |
| Product Code: | REO |

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| D. Predicate Device | |
|-------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Names: | Cochlear™ Osia® OSI300 Implant<br>Cochlear™ Magnet Cassette<br>Cochlear™ Non-Magnetic Cassette<br>Cochlear™ Osia® 2(I) Sound Processor<br><br>Cochlear™ Osia® OSI200 Implant<br>Cochlear™ Sterile Replacement Magnet<br>Cochlear™ Sterile Non-Magnetic Plug<br>Cochlear™ Osia® 2 Sound Processor<br><br>Cochlear™ Osia® Fitting Software 2<br>Cochlear™ Osia® Smart App |
| Trade/Proprietary Name: | Cochlear™ Osia® System |
| Common/Usual Name: | Osia System |
| Classification Name: | Active implantable bone conduction hearing system<br>21 CFR 874.3340, Class II |
| Classification Panel: | Ear, Nose, and Throat |
| Product Code: | PFO |
| 510(k): | K231204 |

#### E. Purpose of Submission

This Traditional 510(k) seeks clearance for an updated pediatric indication for the Osia System. The previous Osia System was cleared under K231204 on August 18, 2023.

#### F. Device Description

The Osia System mechanically vibrates the skull bone and subsequently the cochlea to compensate for conductive hearing loss, mixed hearing loss, or single-sided sensorineural deafness (SSD).

The Osia System is made up of several components. The Osia Implant consists of a receiver/coil and an actuator/stimulator (vibrator) which is surgically implanted on the skull bone. The external component of the Osia System is a sound processor, worn off-the-ear, which picks up the sound from the environment, and sends, after processing, the information to the implant via a transcutaneous inductive link. This link is also referred to as radiofrequency (RF) link. Each Osia System is configured to meet an individual's hearing needs, using dedicated fitting software. The Osia System is illustrated in Figure 1 below.

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## Figure 1. Osia System, including the Implant and Osia Sound Processor

Image /page/5/Picture/1 description: The image shows a cross-section of a medical device implanted in bone. The device consists of several components, including an external device (1), an internal receiver (2), a connecting cable, and an anchor (4). The external device is placed on the skin (3) and transmits signals to the internal receiver, which is implanted in the bone. The anchor secures the device to the bone.

In normal operation, the Osia System functions as follows (referring to Figure 1):

- The external sound processor captures and digitally processes sound. 1.
- 2. The sound processor transmits power and digital information to the implant via an RF link.
- The implant electronics convert the digital information into an electric analog signal. 3.
- This electric analog signal drives the actuator to produce vibrations, which are transmitted to 4. the skull bone through the BI300 Implant (K100360).

The actuator converts the electrical signal into an amplified mechanical stimulation, bypassing the impaired middle ear (origin of the conductive part of the hearing loss) and providing some level of mechanical amplification in order to compensate for the damaged inner ear (sensorineural part of the hearing loss, in case of mixed hearing loss).

This change for the Osia System introduces an expanded indication from 12 years of age or older to 5 years of age or older.

## G. Intended Use

The Cochlear Osia System uses bone conduction to transmit sounds to the cochlea (inner ear) with the purpose of enhancing hearing.

The OSI300 Implant or OSI200 Implant is intended to be used as part of the Cochlear Osia System to convert information from the external Sound Processor into mechanical vibrations.

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

#### H. Indications for Use

The Osia System is intended for the following patients and indications:

- Patients 5 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

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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.

## I. MR Conditional

The Osia System's OSI300 implant is designed to allow the patient to be examined by an MRI at 1.5T and at 3T without having the implant magnet removed or required use of an MRI kit.

The Osia System's OSI100 and OSI200 implants are MR conditional with the implant magnet in place with the use of a Cochlear MRI Kit at 1.5T or with the magnet removed at 1.5T and 3.0T. The MRI Kit is intended to prevent the dislodgement of implanted magnets in a hearing implant during a Magnetic Resonance Imaging (MRI) procedure.

The MRI Kit is indicated for hearing implant recipients who require an MR scan at 1.5T and have been assessed by medical professionals as suitable for an MR scan.

The MRI Kit is indicated for a recipient with the following compatible Osia implants:

- Osia OSI100 implant
- Osia OSI200 implant .

#### J. Technological Characteristics and Comparison to Predicate

Like other active implantable bone conduction hearing systems, the Osia System is comprised of multiple components, including: an implant, sound processor, fitting software, and other cables and accessories. The Osia System is intended to compensate for conductive or mixed hearing loss or single sided deafness by conveying amplified acoustic signals to the cochlea via mechanical vibrations on the skull bone. These vibrations bypass the damaged parts of the outer and/or middle ear to stimulate the inner ear hair cells, allowing patients to clearly hear sounds and speech around them.

The Osia System with expanded indications and the predicate Osia System are identical systems. There are no changes to the devices within the system. which are surgically implanted in the mastoid bone, and an external sound processor is held in place on the patient's scalp by magnetic attraction between the implant and sound processor.

Table 1 summarizes a comparison of the technological characteristics of the currently available Osia 2 System (predicate device) with the updated Osia System (subject device).

| Technological<br>Characteristic | Osia System (Predicate, K231204) | Osia System (Subject) |
|---------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The Cochlear Osia System uses<br>bone conduction to transmit sounds | Same |
| Technological<br>Characteristic | Osia System (Predicate, K231204) | Osia System (Subject) |
| | to the cochlea (inner ear) with the<br>purpose of enhancing hearing.<br><br>The OSI300 Implant or OSI200<br>Implant is intended to be used as<br>part of the Cochlear Osia System to<br>convert information from the<br>external Sound Processor into<br>mechanical vibrations.<br><br>Osia single-use and reusable<br>surgical instruments are used<br>throughout the surgery to correctly<br>position and attach the Osia<br>implant. | |
| Indications | The Osia System is intended for the<br>following patients and indications:<br>Patients 12 years of age or older. Patients who have a conductive<br>or mixed hearing loss and still<br>can benefit from sound<br>amplification. The pure tone<br>average (PTA) bone conduction<br>(BC) threshold (measured at<br>0.5, 1, 2, and 3 kHz) should be<br>better than or equal to 55 dB<br>HL. Bilateral fitting of the Osia<br>System is intended for patients<br>having a symmetrically<br>conductive or mixed hearing<br>loss. The difference between the<br>left and right sides' BC<br>thresholds should be less than<br>10 dB on average measured at<br>0.5, 1, 2, and 3 kHz, or less than<br>15 dB at individual frequencies. Patients who have profound<br>sensorineural hearing loss in<br>one ear and normal hearing in<br>the opposite ear (i.e., single-<br>sided deafness or "SSD"). The<br>pure tone average air | Expanded to include<br>Patients 5 years of age<br>or older. |
| Technological<br>Characteristic | Osia System (Predicate, K231204) | Osia System (Subject) |
| | conduction hearing thresholds of the hearing ear should be<br>better than or equal to 20 dB HL<br>(measured at 0.5, 1, 2, and 3 kHz). The Osia System for SSD is also indicated for any patient<br>who is indicated for an air-conduction<br>contralateral routing of signals<br>(AC CROS) hearing aid, but<br>who for some reason cannot or<br>will not use an AC CROS. Prior to receiving the device, it<br>is recommended that an<br>individual have experience with<br>appropriately fitted air<br>conduction or bone conduction<br>hearing aids. | |
| Energy Used / Delivered | An external sound processor is used<br>to pick up surrounding sound and<br>transfer it to an implant through a<br>digital inductive link. That implant<br>picks up the signal and translates it<br>into vibrations. A second implant is<br>screwed into the bone (and<br>osseointegrates), and is attached to<br>the first implant, ensuring implant<br>anchoring and that vibrations are<br>transferred to the cochlea. | Same |
| System Compatibility | The Osia System includes an<br>implant, sound processor, surgical<br>tools and accessories, software,<br>programming cable, and fitting<br>software.<br><br>It is also capable of wireless<br>connection to accessories and fitting<br>software. | Same |
| Implant | OSI300 or OSI200 Implant | Same |
| Osseointegrated Implant | BI300 (K100360) | Same |
| Biocompatibility of Implant | Biocompatibility of the Osia<br>System has been evaluated and<br>tested. All tests were passed and | Same |
| Technological<br>Characteristic | Osia System (Predicate, K231204) | Osia System (Subject) |
| | confirm that the Osia System is<br>biocompatible. | |
| | The Osia implants were assessed as<br>biologically safe in accordance with<br>ISO 10993-1:2018, ISO 14708-<br>7:2013, and the FDA Guidance<br>"Use of International Standard ISO<br>10993-1, Biological evaluation of<br>medical devices - Part 1:<br>Evaluation of testing within a risk<br>management process” (2016), for a<br>permanent (>30 days) implant<br>device contacting tissue and bone<br>and can be considered safe for use. | |
| Sterilization of Implant | Each Osia Implant is delivered<br>ethylene-oxide (EO) sterilized and<br>packed into protective packaging.<br>Sterilization validation was<br>demonstrated to be in compliance<br>with ISO 11135: 2014. | Same, the sterilization<br>method remains the<br>same. |
| Shelf Life and Packaging-<br>Implant | Shelf-life of the Osia Implant is 2.5<br>years.<br><br>The packaging of the implant was<br>designed and validated to ensure the<br>sterility and integrity of the<br>individually packaged and sealed<br>devices during sterilization,<br>distribution and storage over the<br>labeled shelf life according to EN<br>45502-1 Cl. 12.1 and compliance<br>with EN ISO 1160711607 – 2009<br>+A1:2014. | Same, the shelf life<br>remains the same. |
| Implant Reliability Testing<br>and Non-Clinical<br>Performance Data | The verification tests for<br>performance and reliability of the<br>Osia Implants include those related<br>to:<br>Acoustic Output, Link Integrity,<br>Fixation Screw, Static Load, Coil<br>Impact, Cyclic Load, Static Load,<br>Lifetime Testing, Hermeticity, Coil<br>Robustness, Fluid Ingress,<br>Particulate Matter Testing, | Same, the results of<br>bench testing of each<br>implant remains<br>unchanged with the<br>indication change. |
| Technological<br>Characteristic | Osia System (Predicate, K231204) | Osia System (Subject) |
| Clinical Data | Maximum Surface Temperature,<br>and Environmental Conditioning.<br><br>Clinical data was gathered to determine the safety and<br>effectiveness of the Osia system in children ages 5-11. Safety<br>was demonstrated through the reports of adverse events<br>related to the device and procedure being similar to those<br>experienced by the population identified by the predicate<br>indications for use with this device. Effectiveness was<br>demonstrated by both patient-reported outcomes by the<br>participants' parent as well as through improved speech<br>intelligibility in both quiet and noise. | |
| MRI Compatibility | The Osia System is MR<br>Conditional. | Same, the Osia System<br>remains MR<br>Conditional. The MR<br>Conditions have not<br>changed as a result of<br>the expanded<br>indication. |
| Sound Processor | Osia 2 Sound Processor and Osia<br>2(I) Sound Processor | Same, the compatible<br>sound processors<br>remain unchanged. |
| Sound Processor Function | The Osia System requires the use of<br>an externally worn sound processor<br>that is worn on the head behind the<br>ear.<br><br>The Osia Sound Processor's main<br>function is to receive sound using<br>its two microphones, perform signal<br>processing and deliver power and<br>an audio stream to the Osia implant<br>via the RF link. | Same, the sound<br>processor function<br>remains unchanged. |
| Sound Processor Magnet | The Osia 2 Sound Processor uses<br>standard axial magnets that are<br>compatible with the OSI100 and<br>OSI200 implant magnets.<br><br>The Osia 2(I) Sound Processor uses<br>imaging magnets with diametric<br>polarization that are compatible<br>with the OSI300 implant magnet. | Same, the compatible<br>sound processor<br>magnets remain<br>unchanged. |
| Sound Processor Firmware | The Osia 2 Sound Processor chipset<br>includes two distinct blocks: one<br>block is based on the GN Hearing | Same, the sound<br>processor firmware is |
| Technological<br>Characteristic | Osia System (Predicate, K231204) | Osia System (Subject) |
| | C4.5/Palpatine platform, and is<br>responsible for receiving the<br>microphone input, performing<br>signal processing, and delivering an<br>analogue output signal that is fed<br>into the differential input of the<br>other block, the NEO-XS chip. The<br>NEO-XS block is responsible for<br>transferring the audio signal to the<br>implant via the RF link. | not impacted by the<br>expanded indication. |
| Contact and<br>Biocompatibility of Sound<br>Processor | The Osia 2 Sound Processor and<br>Osia 2(I) Sound Processor are<br>intact-skin contacting devices for<br>permanent use.<br><br>Testing was completed on the sound<br>processor outer materials to<br>demonstrate biocompatibility in<br>accordance with ISO / EN ISO<br>10993-1: October 2009 Biological<br>evaluation of medical devices Part<br>1: Evaluation and testing within a<br>risk management process. | Same, the contact and<br>biocompatibility of the<br>sound processor<br>remains unchanged. |
| Shelf Life and Packaging -<br>Sound Processor | The Osia 2 Sound Processor and<br>Osia 2(I) Sound Processor are not<br>provided in sterile packaging and do<br>not have a restricted shelf life. | Same |
| Fitting Software | The Osia Fitting Software 2 is used<br>by the audiologist to configure all<br>patient related data in the sound<br>processor. The fitting software is an<br>application running on a Windows<br>PC. | Same, the fOsia Fitting<br>Software 2 is not<br>impacted by the<br>expanded indication<br>change. |
| Smart App | It is a stand-alone software.<br>The Osia Smart App is a software<br>application intended to remotely<br>control and monitor the Osia 2<br>Sound Processor directly from a<br>smartphone.<br>Available for Android and iOS. | Same, the Osia Smart<br>App is not impacted by<br>the expanded indication<br>change. |

#### Table 1: Comparison Summary of Osia System

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As required by the Special Controls identified for this device type, a summary of the clinical data

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is provided in the product labelling.

## K. Clinical Performance Data

A pivotal, prospective, multi-center study that uses each participant as their own control was performed to determine the safety and effectiveness of the Osia system in children ages 5-11 and demonstrate substantial equivalence of the expanded indications for use to the cleared indications for use.

The primary objective was to demonstrate safety by quantifying the type, frequency, and severity of adverse events.

Secondary effectiveness objectives included:

- To compare preoperative performance compared to postoperative ● performance in parental questionnaires (SSO) using the Osia System.
- To compare preoperative unaided bone conduction thresholds to ● postoperative unaided bone conduction thresholds.
- To compare unaided preoperative speech perception performance in quiet to . aided speech perception performance postoperatively using the Osia System.
- To compare unaided preoperative adaptive speech in noise performance to ● aided adaptive speech in noise performance using the Osia System.

The results demonstrate that adverse events and safety considerations for the expanded indication remain consistent with adverse events for individuals ages 12 and older. Additionally, children ages 5-11 implanted with the Osia System demonstrate significant improvement in quality of life as evidenced in parental questionnaires and in speech perception as evidenced in testing in quiet and in adaptive noise. These results provide objective evidence that the Osia System is effective in an expanded pediatric population.

#### L. Conclusion

Based on the technological characteristics, substantial equivalence comparison to the predicate device, and the indications for use, supported by clinical data, the change to expand the pediatric indications for use of Cochlear Osia System has been shown to be as safe and effective for its intended use as the cleared indications for the predicate Osia System.