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 airconduction 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.

Device Description

The Osia 2 System, also known as 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 2 System is made up of several components. The Osia implant (OSI200) consists of a receiver/coil and an actuator/stimulator (vibrator) which is surgically implanted on the skull bone. The external component of the Osia 2 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 2 System is configured to meet an individual's hearing needs, using dedicated fitting software.
In normal operation, the Osia System functions as follows:

1. The external sound processor captures and digitally processes sound.
1. The sound processor transmits power and digital information to the implant coil/receiver.
1. The implant stimulator/actuator converts the digital information into an electric analogue signal that is converted to vibrations by the implant piezoelectric actuator.
This implant is fixed to the bone by the BI300 implant (K100360). 4.
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 2 System consists of modifications to the cleared OSI200 Implant, Osia 2 Sound Processor and Osia Fitting Software 2. All other components of the system remain unchanged from the cleared predicate.
The Cochlear MRI Kit is being introduced for use by Osia recipients. The MRI Kit is an accessory that enables an MR scan at 1.5T without the need to surgically remove a compatible Osia implant's magnet.

AI/ML Overview

The provided document is a 510(k) Summary for the Cochlear Osia 2 System. It describes the device, its intended use, indications for use, and a comparison to a predicate device. The primary purpose of this submission is seeking clearance for an updated Osia 2 System, which includes modifications to existing components (OSI200 Implant, Osia 2 Sound Processor, Osia Fitting Software 2) and the introduction of a new accessory, the Cochlear MRI Kit.

The core of the "acceptance criteria" and "proof" in a 510(k) submission like this is demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific quantitative performance metrics against a defined standard (which would be more typical for a PMA or de novo submission). Therefore, the "acceptance criteria" here largely refers to the criteria for demonstrating substantial equivalence, and the "study" is the collection of non-clinical (bench) testing performed to support this claim.

Here's an attempt to extract and describe the information requested based on the provided text, recognizing that a 510(k) summary primarily focuses on substantial equivalence rather than explicit performance criteria against a predefined threshold:

1. A table of acceptance criteria and the reported device performance

Since this is a 510(k) for an updated device, the primary "acceptance criterion" is functional equivalence and maintaining safety and effectiveness compared to the predicate device. The "reported device performance" is the conclusion that this equivalence was achieved through testing.

Acceptance Criterion (Implicit for 510(k))	Reported Device Performance
OSI200 Implant Modifications (PCA, Power Switch, Restart Time):
No adverse effect on the safety and effectiveness of the device.	"Verification related to the OSI200 Implant was completed based on changes to the printed circuit assembly (PCA) and concluded that the PCA does not affect the safety and effectiveness of the device." Performance testing was re-executed for Functional, Safety and Reliability (Accelerated Life, Maximum Surface Temperature, Diagnostic Ultrasound, Therapeutic Ionizing Radiation, ESD, High Power Electric Fields), and Environmental Testing. Validation activities for Intended Implant Lifetime were re-executed.
Osia Fitting Software 2 Modifications:
New functionalities (detect updated OSI200, activate gain) do not affect safety and effectiveness.	"Verification related to the Osia Fitting Software 2 was performed on a series of software builds which confirmed that the new functionalities added to the fitting software to allow it to detect the updated OSI200 implant and activate the gain setting do not affect safety and effectiveness of the device."
Osia 2 Sound Processor Firmware Modifications:
New functionalities (detect updated OSI200, activate gain, sleep mode) do not affect safety and effectiveness.	"Verification results related to the sound processor's firmware confirm that the new functionalities added to the sound processor firmware to allow it to detect the updated OSI200 implant and activate the gain setting do not affect safety and effectiveness of the device."
Cochlear MRI Kit Performance:
Safe and effective operation at 1.5T MRI with implant magnet in place.	"The Cochlear MRI Kit underwent verification testing of the MRI Kit when used at 1.5T with Osia implants..." "The Osia System remains MR Conditional; however, MR Conditions have changed to allow MR scans at 1.5T with the implant magnet in place with the use of a Cochlear MRI Kit." (This fulfills the purpose of the MRI Kit accessory).
Usability of the MRI Kit and accompanying documentation.	"...and underwent summative usability testing to evaluate the usability of the MRI Kit and accompanying documentation by specialized healthcare professionals." (Results implicitly positive to support clearance).
Overall System Performance:
Functionally equivalent to the cleared Osia 2 System.	"The results demonstrate the updated Osia 2 System, including the modified OSI200 Implant, Osia 2 Sound Processor, and Osia Fitting Software 2 and new Cochlear MRI Kit, are functionally equivalent to the cleared Osia 2 System."
As safe and effective as the predicate device for its intended use.	"Based on the indications for use, technological characteristics, and substantial equivalence comparison to the predicate device, supported by non-clinical data, the updated Cochlear Osia 2 System has been shown to be as safe and as effective for its intended use as the predicate device."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document primarily discusses bench testing and verification/validation activities for hardware, software, and accessories. It does not mention clinical trials with human subjects. Therefore, the concept of "sample size" in the context of a "test set" for clinical data or "data provenance" (country/retrospective/prospective) is not directly applicable here. The testing is non-clinical.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This section is not applicable as the document describes non-clinical (bench) testing, software verification, and usability testing for an accessory, not a diagnostic AI system requiring expert-established ground truth on medical images or patient data. The "summative usability testing" for the MRI Kit involved "specialized healthcare professionals," but their specific number, qualifications, or their role in establishing a "ground truth" (rather than evaluating usability) are not detailed.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable as the device is not software for diagnostic image interpretation or a similar application that would require expert adjudication for ground truth.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This is not applicable. The device is an active implantable bone conduction hearing system and an associated MRI kit, not an AI-assisted diagnostic tool. No MRMC study or AI assistance to human readers is mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable. The device is a physical hearing implant system and an MRI accessory, not an algorithm. The testing described is performance testing of the device components and system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This is not applicable. For this type of device (hearing implant, MRI accessory), "ground truth" typically relates to engineering specifications, functional performance requirements, regulatory standards (e.g., for MRI compatibility), and safety profiles, which are assessed through bench testing and verification activities. It does not involve "ground truth" from medical images or patient outcomes in the sense of diagnostic accuracy.

8. The sample size for the training set

This is not applicable. The document describes a medical device (hardware and firmware/software) and its accessory, not a machine learning or AI model that requires a "training set."

9. How the ground truth for the training set was established

This is not applicable for the same reason as point 8.

Summary

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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 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.

July 27, 2022

Cochlear Americas Samata Veluvolu Principal Regulatory Specialist 10350 Park Meadows Drive Lone Tree. Colorado 80124

Re: K220922

Trade/Device Name: Cochlear Osia 2 System, Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Cochlear Osia Fitting Software 2, Cochlear MRI Kit Regulation Number: 21 CFR 874.3340 Regulation Name: Active implantable bone conduction hearing system Regulatory Class: Class II Product Code: PFO Dated: June 23, 2022 Received: June 24, 2022

Dear Samata Veluvolu:

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 (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 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.

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

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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/cdrl-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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

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 Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K220922

Device Name Cochlear™ Osia® 2 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 intended for patients having a symmetrically conductive or mixed hearing loss. The difference between the left and right sides' BC thresholds should be less than 10 dB on average measured at 0.5, 1, 2, and 3 kHz, or less than 15 dB at individual frequencies.

· Patients who have profound sensorineural hearing loss in one ear and normal hearing in the opposite ear (i.e., singlesided deafness or "SSD"). The pure tone average air conduction hearing thresholds of the hearing ear should be better than or equal to 20 dB HL (measured at 0.5, 1, 2, and 3 kHz).

· The Osia System for SSD is also indicated for any patient who is indicated for an airconduction 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)
X Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image contains the logo for Cochlear, a company that specializes in hearing solutions. The logo features a stylized, golden-yellow graphic of three overlapping curved shapes, resembling sound waves or the inner ear. Below the graphic, the company name "Cochlear" is written in a matching golden-yellow color, with the registered trademark symbol to the right. Underneath the company name, the tagline "Hear now. And always" is displayed in a smaller font, emphasizing the company's commitment to long-term hearing solutions.

510(k) Summary

A. Submitter Information
Submitted by:	Cochlear Americas10350 Park Meadows DriveLone Tree, CO 80124
On behalf of the manufacturer:	Cochlear Ltd – Macquarie1 University AvenueMacquarie University, NSW 2109Australia(Establishment Number 9076254)
Contact:	Samata VeluvoluPrincipal Regulatory SpecialistCochlear AmericasC: 302-542-6468E: sveluvolu@cochlear.com
B. Date Prepared	26-July-2022
C. Device Name and Classification
Device Names:	Cochlear™ Osia® OSI200 ImplantCochlear™ Osia® 2 Sound ProcessorCochlear™ Osia® Fitting Software 2Cochlear™ MRI Kit
Trade/Proprietary Name:	Cochlear™ Osia® 2 System
Common/Usual Name:	Osia System
Classification Name:	Active implantable bone conduction hearing system21 CFR 874.3340, Class II
Classification Panel:	Ear, Nose, and Throat
Product Code:	PFO
D. Predicate Device
Device Names:	Cochlear™ Osia® OSI200 ImplantCochlear™ Osia® 2 Sound ProcessorCochlear™ Osia® Fitting Software 2
Trade/Proprietary Name:	Cochlear™ Osia® 2 System
Common/Usual Name:	Osia System

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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 graphic resembling a cochlea, the spiral-shaped part of the inner ear. Below the graphic, the company name "Cochlear" is printed in a matching golden-yellow color, with the registered trademark symbol next to it. Underneath the company name, the tagline "Hear now. And always" is displayed in a smaller font, emphasizing the company's commitment to long-term hearing solutions.

Classification Name:	Active implantable bone conduction hearing system21 CFR 874.3340, Class II
Classification Panel:	Ear, Nose, and Throat
Product Code:	PFO
510(k):	K191921

E. Purpose of Submission

This Traditional 510(k) seeks clearance for an updated Osia 2 System, which includes modifications to existing Osia 2 System components (the OSI200 Implant, Osia 2 Sound Processor and Osia Fitting Software 2) and requests clearance of a Cochlear MRI Kit accessory for use by Osia recipients. The second generation Osia 2 System (predicate), was cleared under K191921 on November 15, 2019.

F. Device Description

The Osia 2 System is made up of several components. The Osia implant (OSI200) consists of a receiver/coil and an actuator/stimulator (vibrator) which is surgically implanted on the skull bone. The external component of the Osia 2 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 2 System is configured to meet an individual's hearing needs, using dedicated fitting software. The Osia 2 System is illustrated in Figure 1 below.

Figure 1. Overview of the Osia 2 System, including the Osia 2 Sound Processor

Image /page/4/Picture/8 description: This image shows a medical implant device. The device consists of four labeled parts. Part 1 is a black electronic component that sits on top of the skin. Part 2 is a thin, flexible component that is implanted under the skin, and part 3 is a rigid component that is attached to the bone with a screw, labeled as part 4.

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

1. The external sound processor captures and digitally processes sound.
1. The sound processor transmits power and digital information to the implant coil/receiver.

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Image /page/5/Picture/0 description: The image shows the logo for Cochlear, a company that specializes in hearing solutions. The logo features a stylized, abstract representation of a cochlea, the spiral-shaped part of the inner ear, rendered in a golden color. Below the cochlea graphic, 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, emphasizing the company's commitment to providing long-term hearing solutions.

1. The implant stimulator/actuator converts the digital information into an electric analogue signal that is converted to vibrations by the implant piezoelectric actuator.
This implant is fixed to the bone by the BI300 implant (K100360). 4.

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 2 System consists of modifications to the cleared OSI200 Implant, Osia 2 Sound Processor and Osia Fitting Software 2. All other components of the system remain unchanged from the cleared predicate.

The Cochlear MRI Kit is being introduced for use by Osia recipients. The MRI Kit is an accessory that enables an MR scan at 1.5T without the need to surgically remove a compatible Osia implant's magnet.

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 airconduction 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 nested, curved shapes. 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, completing the logo.

I. MR Conditional

The Osia System's 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 2 System is comprised of multiple components, including: an implant, sound processor, fitting software, and other cables and accessories. The Osia 2 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 2 System and the predicate Osia 2 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 2 System, which includes modifications to the cleared OSI200 Implant, Osia 2 Sound Processor and Osia Fitting Software 2, has the same intended use, the same overall functional characteristics, and the same fundamental operating principles as the predicate Osia 2 System. The updated Osia System introduces the MRI Kit as a new accessory for use with compatible Osia implants.

Table 1 summarizes a comparison of the technological characteristics of the currently available Osia 2 System (predicate device) with the updated Osia 2 System (subject device). Additional details related to the changes are provided below the table.

TechnologicalCharacteristic	Osia 2 System (Predicate,K191921)	Osia 2 System (Subject)
Energy Used / Delivered	An external sound processoris used to pick up surroundingsound and transfer it to animplant through a digitalinductive link. That implantpicks up the signal andtranslates it into vibrations. A	Same

	Table 1: Comparison Summary of Osia 2 System
--	----------------------------------------------	--	--	--

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Image /page/7/Picture/0 description: The image contains 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 auditory portion of the inner ear. Below the spiral is the company name, "Cochlear," also in golden-yellow. Underneath the name is the tagline, "Hear now. And always."

TechnologicalCharacteristic	Osia 2 System (Predicate, K191921)	Osia 2 System (Subject)
	second implant is screwedinto the bone (andosseointegrates), and isattached to the first implant,ensuring implant anchoringand that vibrations aretransferred to the cochlea.
System Compatibility	The Osia 2 System includesan implant, sound processor,surgical tools and accessories,software, programming cable,and fitting software.It is also capable of wirelessconnection to accessories andthe fitting software.	The Osia 2 System has thesame system compatibilitywith the addition of theCochlear MRI Kit.
OSI200 Implant	The OSI200 Implant consistsof the following majorcomponents: fixation screw,lead/coil, actuator, stimulator,and magnet.	Same, except the OSI200Implant's printed circuitassembly (PCA) has beenupdated.
Osseointegrated ImplantRadiation Safety	BI300 (K100360)	Same
Radiation Safety	The Osia System iscompatible for use with x-ray,CT scans, radiation therapy,and PET.The Osia System is MRConditional.	The Osia System iscompatible for use with x-ray,CT scans, radiation therapy,and PET.The Osia System remains MRConditional; however, MRConditions have changed toallow MR scans at 1.5T withthe implant magnet in placewith the use of a CochlearMRI Kit.
OSI200 Implant magnetconditions for MRI	The OSI200 Implant is MRconditional with the implantmagnet removed at 1.5T and3.0T.	The OSI200 Implant is MRconditional with the implantmagnet in place with the useof a Cochlear MRI Kit at1.5T, or removed at 1.5T andremoved at 3.0T.
Sound Processor	The Osia 2 System requiresthe use of an externally wornsound processor that is wornon the head behind the ear	Same, except the Osia 2Sound Processor firmware(for the second block) isupdated with new
TechnologicalCharacteristic	Osia 2 System (Predicate,K191921)	Osia 2 System (Subject)

	The Osia 2 Sound Processor'smain function is to receivesound using its twomicrophones, perform signalprocessing and deliver powerand an audio stream to theOSI200 implant via the RFlink.The Osia 2 Sound Processorchipset includes two distinctblocks: one block isresponsible for receiving themicrophone input, performingsignal processing, anddelivering an analogue outputsignal that is fed into thedifferential input of the otherblock. The second block isresponsible for transferringthe audio signal to theimplant via the RF link.	functionalities to support thechanges to the OSI200Implant.

Fitting Software	The Osia Fitting Software 2 isused by the audiologist toconfigure all patient relateddata in the sound processor.The fitting software is anapplication running on aWindows PC.It is a stand-alone software	Same, except new featuresare available in the OsiaFitting Software 2 to supportthe changes to the OSI200Implant.

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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, golden-yellow spiral shape resembling a cochlea, which is the auditory portion of the inner ear. Below the spiral is the company name, "Cochlear," also in golden-yellow. Underneath the name is the tagline, "Hear now. And always."

Additional details on the new features and functionalities added to predicate components are provided below:

OSI200 Implant

The Printed Circuit Assembly (PCA) quantization level setting has been updated. ●
A power switch has been enabled to control the implant gain setting to reduce the noise ● floor, if required.
New circuitry has been added to improve implant restart time when the implant resets due . to power supply being at critical voltages.

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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 three curved shapes stacked on top of each other, resembling a stylized ear or sound wave. Below the symbol is the company name, "Cochlear," in a bold, sans-serif font. Underneath the name is the tagline, "Hear now. And always."

Verification related to the OSI200 Implant was completed based on changes to the printed circuit assembly (PCA) and concluded that the PCA does not affect the safety and effectiveness of the device. See K. Performance Data for more details on bench testing completed.

Osia Fitting Software 2

The updated software has the ability to detect the updated OSI200 Implant. ●
Additional functionality has been added to activate the implant gain setting feature, if required.

Verification related to the Osia Fitting Software 2 was performed on a series of software builds which confirmed that the new functionalities added to the fitting software to allow it to detect the updated OSI200 implant and activate the gain setting do not affect safety and effectiveness of the device.

Osia 2 Sound Processor

. The updated sound processor has the ability to detect the updated OSI200 Implant.
. Additional functionality has been added to activate the implant gain setting feature, if required.
Configured sleep mode in sound processor to improve system startup process. .

The Osia 2 Sound Processor hardware remains unmodified from the predicate device. Verification results related to the sound processor's firmware confirm that the new functionalities added to the sound processor firmware to allow it to detect the updated OSI200 implant and activate the gain setting do not affect safety and effectiveness of the device.

K. Performance Data

Bench testing was conducted to compare the updated Osia 2 System with the cleared Osia 2 System. Substantial equivalence to the predicate device was accomplished through non-clinical data related to functionality and performance testing, hardware and interface testing, as well as system and subsystem level testing.

Verification activities for the modified OSI200 Implant included performance testing re-executed to support:

. Functional verification
Safety and Reliability verification related to Accelerated Life, Maximum Surface ● Temperature, Diagnostic Ultrasound, Therapeutic Ionising Radiation, ESD, High Power Electric Fields
Environmental Testing verification ●

The following verification testing performed on the cleared OSI200 Implant remains applicable to the modified OSI200 Implant and were leveraged with justification from the predicate device.

Fixation Screw verification ●
. Safety and Reliability verification related to Static and Cyclic Load, Impact, Robustness, Fluid Ingress, Release of Particulate Matter, Biological Safety, System EMC Compliance, MRI Safety
Surgical Implementation
Sterilization ●
. Sterile Barrier

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Image /page/10/Picture/0 description: The image is a logo for Cochlear, a company that specializes in hearing solutions. The logo features a stylized, golden-yellow graphic of three curved shapes nested within each other, resembling a cochlea. Below the graphic is the company name, "Cochlear," in a bold, sans-serif font, also in golden-yellow. Underneath the name is the tagline, "Hear now. And always.", in a smaller, lighter font.

. Shelf-Life
Validation activities re-executed for the OSI200 Implant were limited to Intended Implant Lifetime. Validation for the Osia 2 System included tests re-executed to validate the functionality and performance of the updated system.

The Cochlear MRI Kit underwent verification testing of the MRI Kit when used at 1.5T with Osia implants, and underwent summative usability testing to evaluate the usability of the MRI Kit and accompanying documentation by specialized healthcare professionals.

The results demonstrate the updated Osia 2 System, including the modified OSI200 Implant, Osia 2 Sound Processor, and Osia Fitting Software 2 and new Cochlear MRI Kit, are functionally equivalent to the cleared Osia 2 System.

L. Conclusion

Based on the indications for use, technological characteristics, and substantial equivalence comparison to the predicate device, supported by non-clinical data, the updated Cochlear Osia 2 System has been shown to be as safe and as effective for its intended use as the predicate device.

Regulation Number and Section

§ 874.3340 Active implantable bone conduction hearing system.

(a)
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.(b)
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.