Cochlear™ Osia® System; Cochlear™ Osia® OSI300 Implant; Cochlear™ Magnet Cassette; Cochlear™ Non-Magnetic Cassette; Cochlear™ Osia® 2(I) Sound Processor; Cochlear™ Osia® Fitting Software 2; Cochlear™ Osia® Smart App

K231204 · Cochlear · PFO · Aug 18, 2023 · Ear, Nose, Throat

Device Facts

• Record ID: K231204
• Device Name: Cochlear™ Osia® System; Cochlear™ Osia® OSI300 Implant; Cochlear™ Magnet Cassette; Cochlear™ Non-Magnetic Cassette; Cochlear™ Osia® 2(I) Sound Processor; Cochlear™ Osia® Fitting Software 2; Cochlear™ Osia® Smart App
• Applicant: Cochlear
• Product Code: PFO · Ear, Nose, Throat
• Decision Date: Aug 18, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.3340
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

Active implantable bone conduction hearing system; compensates for conductive/mixed hearing loss or single-sided deafness. System comprises OSI300 implant (receiver/coil and actuator) and external Osia 2(I) sound processor. Processor captures environmental sound; processes digitally; transmits power/data via transcutaneous RF link to implant. Implant converts digital signal to analog; drives actuator to vibrate skull bone; bypasses middle ear to stimulate inner ear. Used in clinical/home settings; operated by patient and audiologist (fitting). OSI300 features rotatable magnet for 1.5T/3T MRI compatibility without removal. Healthcare providers use Osia Fitting Software 2 to configure device to patient needs. Benefits include improved hearing and speech perception; MRI compatibility reduces need for surgical magnet removal.

Clinical Evidence

No clinical data. Substantial equivalence supported by non-clinical bench testing, including functional verification, fixation screw testing, MRI safety, maximum surface temperature, coil robustness, fluid ingress, and environmental conditioning. Validation activities confirmed user needs were met.

Technological Characteristics

Active implantable bone conduction system. OSI300 implant features rotatable magnet for 1.5T/3T MRI compatibility. External sound processor uses digital inductive RF link. Biocompatible materials per ISO 10993-1. Sterilization via ethylene-oxide (ISO 11135). Software-based fitting and smartphone app control. System includes magnet/non-magnetic cassettes for implant.

Indications for Use

Indicated for patients 12 years 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 avg 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 AC threshold <= 20 dB HL), or for patients indicated for AC CROS hearing aids who cannot or will not use them. Recommended 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® OSI200 Implant (K220922)
• Cochlear™ Osia® 2 Sound Processor (K220922)
• Cochlear™ Osia® Fitting Software 2 (K220922)
• Cochlear™ MRI Kit (K220922)

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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

August 18, 2023

Cochlear Denis DiMartino Senior Regulatory Affairs Specialist 10350 Park Meadows Drive Lone Tree, Colorado 80124

## Re: K231204

Trade/Device Name: Cochlear™ Osia® System; Cochlear™ Osia® OSI300 Implant; Cochlear™ Magnet Cassette; Cochlear™ Non-Magnetic Cassette; Cochlear™ Osia® 2(1) Sound Processor; Cochlear™ Osia® Fitting Software 2; Cochlear™ Osia® Smart App Regulation Number: 21 CFR 874.3340 Regulation Name: Active implantable bone conduction hearing system Regulatory Class: Class II Product Code: PFO Dated: July 19, 2023 Received: July 19, 2023

Dear Denis DiMartino:

We have reviewed vour 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 (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 located 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 annu al 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.

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

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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 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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

Enclosure

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## Indications for Use

510(k) Number (if known) K231204

Device Name Cochlear™ Osia® System

#### Indications for Use (Describe)

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 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) |
|-------------------------------------------------|
|-------------------------------------------------|

| <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) |
|--------------------------------------------------------------------------------------|
| <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) |

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Image /page/3/Picture/0 description: The image is a logo for Cochlear, a company that specializes in hearing solutions. The logo features a stylized graphic of three overlapping, curved shapes in a golden color, resembling sound waves emanating outwards. Below the graphic, the company name "Cochlear" is written in a bold, sans-serif font, also in golden color. Underneath the name, there is a tagline that reads "Hear now. And always" in a smaller, lighter font.

# 510(k) Summary

| A. Submitter Information | |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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: | Denis DiMartino<br>Senior Regulatory Affairs Specialist<br>Cochlear Americas<br>C: 508-304-4356<br>E: [e-mail] |
| B. Date Prepared | 19-July-2023 |
| 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® 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 |
| D. Predicate Device | |
| Device Names: | Cochlear™ Osia® OSI200 Implant<br>Cochlear™ Osia® 2 Sound Processor<br>Cochlear™ Osia® Fitting Software 2<br>Cochlear™ MRI Kit |

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Image /page/4/Picture/0 description: The image contains the logo for Cochlear, a company that specializes in hearing solutions. The logo features a stylized, golden-yellow symbol resembling three overlapping sound waves or cochlear spirals. Below the symbol is the company name, "Cochlear," also in golden-yellow. Underneath the name is the tagline "Hear now. And always" in a smaller font size.

| Trade/Proprietary Name: | Cochlear™ Osia® 2 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): | K220922 |

## E. Purpose of Submission

This Traditional 510(k) seeks clearance for an updated Osia System, which includes a new OSI300 Implant, a new Cochlear Magnet Cassette and Non-Magnetic Cassette, and a new Osia 2(I) Sound Processor. Additionally, the updated Osia System includes modifications to existing components (Osia 2 Sound Processor, Osia Fitting Software 2, and Osia Smart App). The previous Osia System, Osia 2 System (predicate), was cleared under K220922 on July 27th, 2022.

## 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 (OSI300) 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.

## Figure 1. Osia System, including the OSI300 Implant Osia 2(I) Sound Processor

Image /page/4/Picture/8 description: The image shows a cross-sectional view of a medical implant. The implant consists of several components, including an external device (1), an internal receiver (3), and a connection to the bone (4). The implant is placed beneath the skin (3) and is designed to interface with the bone structure (2). The image provides a detailed view of the implant's placement and its interaction with the surrounding tissues.

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.

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Image /page/5/Picture/0 description: The image contains the logo for Cochlear, a company that specializes in hearing solutions. The logo features three curved shapes nested together, resembling an ear or sound waves, in a golden color. Below the symbol, the company name "Cochlear" is written in a similar golden hue, with the registered trademark symbol to the right. Underneath the name, the tagline "Hear now. And always" is displayed in a smaller font, emphasizing the company's commitment to long-term hearing support.

- 4. This electric analog signal drives the actuator to produce vibrations, which are transmitted to 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).

The updated Osia System introduces:

- The OSI300 Implant with a rotatable magnet, ●
- The Cochlear Magnet and Non-Magnetic Cassettes for the OSI300 implant ●
- The Osia 2(I) Sound Processor for compatibility with the OSI300 implant, ●
- New dedicated 'Imaging' magnets (denoted as (I) magnets) for the Osia 2(I) Sound Processor,
- New magnet tool for the (I) magnets, ●
- Updates to the cleared Osia Fitting Software 2 to support the OSI300 implant along with ● other improvements, described further below, and
- Minor updates to the Osia Smart App.

## G. 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.

## H. Indications for Use

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.

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Image /page/6/Picture/0 description: The image shows the logo for Cochlear, a company that specializes in hearing solutions. The logo features a stylized, abstract symbol in a golden color, resembling three curved shapes nested within each other. Below the symbol, the company name "Cochlear" is written in a clear, sans-serif font, also in golden color. Underneath the company name, the tagline "Hear now. And always" is displayed in a smaller font size.

## I. MR Conditional

The 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.

## 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.

Both the updated Osia System and the predicate Osia System 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.

The updated Osia System, which includes a new OSI300 Implant and Osia 2(1) Sound Processor, and modifications to the Osia 2 Sound Processor, Osia Fitting Software 2, and Osia Smart App, has the same intended use and the same fundamental operating principles as the predicate Osia 2 System. The updated Osia System introduces the OSI300 Implant and Osia 2(1) Sound Processor to allow for the patient to be examined by an MRI at 1.5T and 3T without having the implant magnet removed or requiring use of an MRI kit.

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 2 System (Predicate,<br>K220922) | Osia System (Subject) |
|-------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The Cochlear Osia System uses<br>bone conduction to transmit sounds<br>to the cochlea (inner ear) with the<br>purpose of enhancing hearing. Osia<br>Implants are single use devices<br>intended for long term implantation<br>under the skin in the mastoid region<br>of either side of the head. They are<br>for professional use only. | Same |
| Indications | The Osia System is intended for the<br>following patients and indications:<br>• Patients 12 years of age or<br>older.<br>• Patients who have a conductive<br>or mixed hearing loss and still | Same |
| Technological<br>Characteristic | Osia 2 System (Predicate,<br>K220922) | Osia System (Subject) |
| | 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<br>conduction hearing thresholds<br>of the hearing ear should be<br>better than or equal to 20 dB HL<br>(measured at 0.5, 1, 2, and 3<br>kHz). The Osia System for SSD is<br>also indicated for any patient<br>who is indicated for an air-<br>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 | Same |
| Technological<br>Characteristic | Osia 2 System (Predicate,<br>K220922) | Osia System (Subject) |
| | 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. | |
| System Compatibility | The Osia 2 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 the<br>fitting software. | Same |
| Implant | OSI200 Implant | Different. Introducing<br>the OSI300 implant,<br>which is designed with<br>a rotatable magnet to<br>allow the patient to be<br>examined by an MRI at<br>1.5T and at 3T without<br>having the implant<br>magnet removed or<br>requiring use of an<br>MRI kit |
| 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<br>confirm that the Osia System is<br>biocompatible.<br><br>The OSI200 Implant was assessed<br>as biologically safe in accordance<br>with ISO 10993-1:2018, ISO<br>14708-7:2013, and the FDA<br>Guidance “Use of International<br>Standard ISO 10993-1, Biological<br>evaluation of medical devices – Part<br>1: Evaluation of testing within a | Same - The changes to<br>the implant do not<br>impact the product<br>characteristics that<br>were verified with the<br>predicate. There is no<br>change to the surfaces<br>and materials of the<br>device that contacts the<br>body. Verification is<br>leveraged from the<br>previous OSI200<br>Implant device cleared<br>by the FDA under |
| Technological | Osia 2 System (Predicate,<br>K220922) | Osia System (Subject) |
| Characteristic | | |
| | risk management process” (2016),<br>for a permanent (>30 days) implant<br>device contacting tissue and bone<br>and can be considered safe for use. | K191921 with<br>additional testing<br>performed for the coil<br>magnet assembly. |
| Sterilization of Implant | Each OSI200 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 for the OSI300<br>Implant. |
| Shelf Life and Packaging-<br>Implant | Shelf-life of the OSI200 Implant is<br>2.5 years.<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 for<br>the OSI300 Implant. |
| Implant Reliability Testing<br>and Performance Data | The verification tests for<br>performance and reliability of the<br>OSI200 Implant include those<br>related 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,<br>Maximum Surface Temperature,<br>and Environmental Conditioning. | Similar, some test<br>results previously<br>cleared were not re-run<br>and new tests for the<br>OSI300 implant were<br>conducted. |
| MRI Compatibility | The Osia System is MR<br>Conditional. | The Osia System<br>remains MR<br>Conditional; however,<br>MR Conditions have<br>changed:<br><br>The OSI300 implant is<br>designed to allow the<br>patient to be examined |
| Technological<br>Characteristic | Osia 2 System (Predicate,<br>K220922) | Osia System (Subject)<br><span style="font-size: smaller;">Hear now. And always</span> |
| Sound Processor | Osia 2 Sound Processor | by an MRI at 1.5T and<br>at 3T without having<br>the implant magnet<br>removed or requiring<br>use of an MRI kit.<br>Similar.<br><br>The Osia 2(I) sound<br>processor is nearly<br>identical to the Osia 2<br>sound processor,<br>except that the RF link<br>circuitry is tuned in<br>production with a 4(I)<br>magnet to attain an<br>optimum RF link<br>performance for the<br>strongest 4(I) magnet,<br>which is to be used for<br>the largest skin flap<br>thickness range. |
| Sound Processor Function | The Osia 2 System requires the use<br>of an externally worn sound<br>processor that is worn on the head<br>behind the ear.<br><br>The Osia 2 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 OSI200<br>implant via the RF link. | Same, with new<br>OSI300 Implant. |
| Sound Processor Magnet | The Osia 2 Sound Processor uses<br>standard axial magnets (M1, M2,<br>M3, M4) that are compatible with<br>the OSI100 and OSI200 implant<br>magnets. | Different, the updated<br>magnets for the Osia<br>2(I) sound processor<br>allow for compatibility<br>with the magnet<br>introduced in the<br>OSI300 Implant. |
| Sound Processor Firmware | The Osia 2 Sound Processor chipset<br>includes two distinct blocks: one<br>block is based on the GN Hearing<br>C4.5/Palpatine platform, and is<br>responsible for receiving the | Similar, the firmware<br>has been updated with<br>new functionalities to<br>support the OSI300<br>Implant. |
| Technological<br>Characteristic | Osia 2 System (Predicate,<br>K220922) | Osia System (Subject) |
| | 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. | |
| Contact and<br>Biocompatibility of Sound<br>Processor | The Osia 2 Sound Processor is an<br>intact-skin contacting device 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 |
| Shelf Life and Packaging -<br>Sound Processor | The Osia 2 Sound Processor is not<br>provided in sterile packaging and<br>does not have a restricted shelf life. | Same, for the Osia 2(I)<br>Sound Processor. |
| 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.<br>It is a stand-alone software. | Similar, new features<br>are available in the<br>Osia Fitting Software 2<br>to support the changes<br>to the Osia 2(I) Sound<br>Processor and OSI300<br>Implant. |
| Smart App | 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. | Similar. The Osia<br>Smart App has been<br>updated to support<br>identification of the<br>Osia 2(I) sound<br>processor and OSI300<br>implant. |

## Table 1: Comparison Summary of Osia System

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Image /page/7/Picture/0 description: The image is the logo for Cochlear, a company that specializes in hearing solutions. The logo features a stylized, golden-yellow spiral shape resembling a cochlea, which is the part of the inner ear responsible for hearing. Below the spiral is the company name, "Cochlear," also in golden-yellow. Underneath the name is the tagline, "Hear now. And always," in a smaller font, emphasizing the company's commitment to long-term hearing solutions.

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Image /page/8/Picture/0 description: The image contains the logo for Cochlear, a company that specializes in hearing solutions. The logo features a stylized graphic of three overlapping, curved shapes in a golden color, resembling sound waves or the inner ear. Below the graphic, the company name "Cochlear" is written in a bold, sans-serif font, also in the same golden color. Underneath the company name, the tagline "Hear now. And always" is displayed in a smaller, lighter font.

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Image /page/9/Picture/0 description: The image contains the logo for Cochlear, a company that specializes in hearing solutions. The logo features a stylized, abstract representation of the cochlea, the spiral-shaped part of the inner ear, rendered in a golden color. Below the cochlea graphic, the company name "Cochlear" is printed in a bold, sans-serif font, also in golden color. Underneath the company name, the tagline "Hear now. And always" is displayed in a smaller, lighter font.

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Image /page/10/Picture/0 description: The image contains the logo for Cochlear, a company that specializes in hearing solutions. The logo features a stylized graphic of three overlapping, curved shapes in a golden color, resembling sound waves or a cochlea. Below the graphic, the company name "Cochlear" is written in a matching golden color, and underneath that, the tagline "Hear now. And always" is displayed in a smaller font.

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Image /page/11/Picture/0 description: The image contains the logo for Cochlear, a company that specializes in hearing solutions. The logo features a stylized graphic of three overlapping, curved shapes in a golden color, resembling sound waves or the inner ear. Below the graphic, the company name "Cochlear" is written in a bold, sans-serif font, also in the same golden color. Underneath the company name, the tagline "Hear now. And always" is displayed in a smaller, lighter font.

Additional details on the new features and functionalities for the subject devices are provided below:

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Image /page/12/Picture/0 description: The image contains the logo for Cochlear. The logo features a stylized, golden-yellow graphic of three curved shapes nested within each other, resembling a cochlea. Below the graphic is the word "Cochlear" in a matching golden-yellow color, and beneath that is the tagline "Hear now. And always" in a smaller font.

## OSI300 Implant

- The OSI300 implant is designed with a rotatable magnet to allow the patient to be ● examined by an MRI at 1.5T and at 3T without having the implant magnet removed or requiring use of an MRI kit.
- . The standard magnets used in the predicate implant devices are replaced by imaging magnets which have a different mag…