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 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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Cochlear™ Osia® System, an active implantable bone conduction hearing system. This submission primarily focuses on demonstrating substantial equivalence to a predicate device (Cochlear™ Osia® 2 System) for an updated version of the system.

The core of the submission involves bench testing to compare the updated system with the predicate. There is no evidence of a clinical study or performance study with patients designed to establish specific acceptance criteria directly tied to the device's clinical efficacy or diagnostic accuracy (e.g., sensitivity, specificity, AUC). The acceptance criteria, therefore, appear to be based on functional equivalency, safety, and performance compared to the predicate device through non-clinical means.

Here's a breakdown of the information based on your request, with an emphasis on what is not present in the provided text regarding specific performance criteria as typically understood in a clinical study for diagnostic or AI-based devices:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) submission and the provided text focuses on demonstrating substantial equivalence through non-clinical testing (bench testing), explicit quantitative clinical acceptance criteria like sensitivity, specificity, or AUC are not stated, nor are their corresponding reported device performance values from a clinical study. Instead, the "acceptance criteria" are implied by successful completion of various verification activities ensuring the updated device functions as intended and is as safe and effective as the predicate.

Acceptance Criterion (Implied by Verification Activities)	Reported Device Performance (Summary from Bench Testing)
Functional verification successful	Device functions as intended.
Fixation Screw verification successful	Fixation screw performs as intended.
Safety & Reliability verification related to MRI Safety successful	OSI300 allows MRI at 1.5T and 3T without magnet removal or MRI kit.
Safety & Reliability verification related to Maximum Surface Temperature successful	Maximum surface temperature within acceptable limits.
Safety & Reliability verification related to Coil Tensile and Flexural Robustness successful	Coil tensile and flexural robustness maintained.
Safety & Reliability verification related to Magnet Retention successful	Magnet retention maintained.
Safety & Reliability verification related to Fluid Ingress successful	Fluid ingress protection maintained.
Safety & Reliability verification related to Implant Impact successful	Implant impact resistance maintained.
Safety & Reliability verification related to Coil Impact successful	Coil impact resistance maintained.
Safety & Reliability verification related to Release of Particulate Matter successful	Release of particulate matter within acceptable limits.
Safety & Reliability verification related to ESD successful	ESD resistance maintained.
Environmental Testing verification successful	Device performs under specified environmental conditions.
Compatibility verification (Sound Processor to Implant) successful	Osia 2(I) Sound Processor is compatible and optimized for the OSI300 implant.
Software updates (Osia Fitting Software 2, Osia Smart App) function as intended	Software identifies new components and provides updated functionalities.
Biocompatibility of Implant verified	Evaluated as biologically safe per ISO 10993-1:2018, ISO 14708-7:2013, and FDA guidance.
Sterilization of Implant verified	In compliance with ISO 11135:2014.
Shelf Life and Packaging - Implant verified	Shelf-life, sterility, and integrity maintained.
Biocompatibility of Sound Processor verified	Demonstrated biocompatibility per ISO/EN ISO 10993-1.

2. Sample size used for the test set and the data provenance

The document explicitly states that bench testing was conducted. This implies that the "test set" consisted of physical devices, prototypes, or simulated scenarios in a lab environment. There is no mention of human subjects, patient data, or a clinical test set. Therefore, information regarding human sample size, country of origin, or retrospective/prospective nature is not applicable to the described study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Since the study described is non-clinical bench testing, the concept of "ground truth established by experts" in a clinical context (e.g., radiologist opinions) is not applicable. The "ground truth" for bench testing is derived from engineering specifications, established standards (e.g., ISO, FDA guidance), and physical measurements by engineers and technicians.

4. Adjudication method for the test set

As the evaluation was non-clinical bench testing, an adjudication method like 2+1 or 3+1 for clinical interpretation is not applicable. Test results are typically evaluated against pre-defined engineering criteria and specifications.

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

There is no mention of an MRMC study or any study involving human readers with or without AI assistance. The device is a hearing system, not an AI-assisted diagnostic tool for human interpretation.

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

The device itself is a hearing system that directly assists the patient, not a diagnostic algorithm. Therefore, the concept of "standalone algorithm performance" (in the typical AI/diagnostic sense) is not applicable. The device's performance is inherently "human-in-the-loop" as it's worn by a person to enhance hearing. However, its individual components' functional performance was evaluated independently through bench testing.

7. The type of ground truth used

For the non-clinical bench testing and verification activities, the "ground truth" used was based on:

Engineering specifications and design requirements of the device.
Established industry standards (e.g., ISO 10993-1:2018, ISO 14708-7:2013, ISO 11135:2014, EN 45502-1, EN ISO 11607-2009 +A1:2014).
FDA guidance documents.
Comparative data against the performance of the predicate device (Cochlear™ Osia® 2 System).

8. The sample size for the training set

This is not applicable as the document does not describe the development of an AI algorithm or model that requires a training set. The descriptions are about hardware revisions, firmware updates, and software modifications for a medical device.

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

This is not applicable as no training set for an AI algorithm or model is described.

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 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)
-------------------------------------------------

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 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 Americas10350 Park Meadows DriveLone Tree, CO 80124
On behalf of the manufacturer:	Cochlear Ltd – Macquarie1 University AvenueMacquarie University, NSW 2109Australia(Establishment Number 3009092818)
Contact:	Denis DiMartinoSenior Regulatory Affairs SpecialistCochlear AmericasC: 508-304-4356E: ddimartino@cochlear.com
B. Date Prepared	19-July-2023
C. Device Name and Classification
Device Names:	Cochlear™ Osia® OSI300 ImplantCochlear™ Magnet CassetteCochlear™ Non-Magnetic CassetteCochlear™ Osia® 2(I) Sound ProcessorCochlear™ Osia® Fitting Software 2Cochlear™ Osia® Smart App
Trade/Proprietary Name:	Cochlear™ Osia® 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 2Cochlear™ 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 system21 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.
1. 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.

1. 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

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).

TechnologicalCharacteristic	Osia 2 System (Predicate,K220922)	Osia System (Subject)
Intended Use	The Cochlear Osia System usesbone conduction to transmit soundsto the cochlea (inner ear) with thepurpose of enhancing hearing. OsiaImplants are single use devicesintended for long term implantationunder the skin in the mastoid regionof either side of the head. They arefor professional use only.	Same
Indications	The Osia System is intended for thefollowing patients and indications:• Patients 12 years of age orolder.• Patients who have a conductiveor mixed hearing loss and still	Same
TechnologicalCharacteristic	Osia 2 System (Predicate,K220922)	Osia System (Subject)
	can benefit from soundamplification. The pure toneaverage (PTA) bone conduction(BC) threshold (measured at0.5, 1, 2, and 3 kHz) should bebetter than or equal to 55 dBHL. Bilateral fitting of the OsiaSystem is intended for patientshaving a symmetricallyconductive or mixed hearingloss. The difference between theleft and right sides' BCthresholds should be less than10 dB on average measured at0.5, 1, 2, and 3 kHz, or less than15 dB at individual frequencies. Patients who have profoundsensorineural hearing loss inone ear and normal hearing inthe opposite ear (i.e., single-sided deafness or "SSD"). Thepure tone average airconduction hearing thresholdsof the hearing ear should bebetter than or equal to 20 dB HL(measured at 0.5, 1, 2, and 3kHz). The Osia System for SSD isalso indicated for any patientwho is indicated for an air-conductioncontralateral routing of signals(AC CROS) hearing aid, butwho for some reason cannot orwill not use an AC CROS. Prior to receiving the device, itis recommended that anindividual have experience withappropriately fitted airconduction or bone conductionhearing aids.
Energy Used / Delivered	An external sound processor is usedto pick up surrounding sound and	Same
TechnologicalCharacteristic	Osia 2 System (Predicate,K220922)	Osia System (Subject)
	transfer it to an implant through adigital inductive link. That implantpicks up the signal and translates itinto vibrations. A second implant isscrewed into the bone (andosseointegrates), and is attached tothe first implant, ensuring implantanchoring and that vibrations aretransferred to the cochlea.
System Compatibility	The Osia 2 System includes animplant, sound processor, surgicaltools and accessories, software,programming cable, and fittingsoftware.It is also capable of wirelessconnection to accessories and thefitting software.	Same
Implant	OSI200 Implant	Different. Introducingthe OSI300 implant,which is designed witha rotatable magnet toallow the patient to beexamined by an MRI at1.5T and at 3T withouthaving the implantmagnet removed orrequiring use of anMRI kit
Osseointegrated Implant	BI300 (K100360)	Same
Biocompatibility of Implant	Biocompatibility of the OsiaSystem has been evaluated andtested. All tests were passed andconfirm that the Osia System isbiocompatible.The OSI200 Implant was assessedas biologically safe in accordancewith ISO 10993-1:2018, ISO14708-7:2013, and the FDAGuidance “Use of InternationalStandard ISO 10993-1, Biologicalevaluation of medical devices – Part1: Evaluation of testing within a	Same - The changes tothe implant do notimpact the productcharacteristics thatwere verified with thepredicate. There is nochange to the surfacesand materials of thedevice that contacts thebody. Verification isleveraged from theprevious OSI200Implant device clearedby the FDA under
Technological	Osia 2 System (Predicate,K220922)	Osia System (Subject)
Characteristic
	risk management process” (2016),for a permanent (>30 days) implantdevice contacting tissue and boneand can be considered safe for use.	K191921 withadditional testingperformed for the coilmagnet assembly.
Sterilization of Implant	Each OSI200 Implant is deliveredethylene-oxide (EO) sterilized andpacked into protective packaging.Sterilization validation wasdemonstrated to be in compliancewith ISO 11135: 2014.	Same, the sterilizationmethod remains thesame for the OSI300Implant.
Shelf Life and Packaging-Implant	Shelf-life of the OSI200 Implant is2.5 years.The packaging of the implant wasdesigned and validated to ensure thesterility and integrity of theindividually packaged and sealeddevices during sterilization,distribution and storage over thelabeled shelf life according to EN45502-1 Cl. 12.1 and compliancewith EN ISO 1160711607 – 2009+A1:2014.	Same, the shelf liferemains the same forthe OSI300 Implant.
Implant Reliability Testingand Performance Data	The verification tests forperformance and reliability of theOSI200 Implant include thoserelated to:Acoustic Output, Link Integrity,Fixation Screw, Static Load, CoilImpact, Cyclic Load, Static Load,Lifetime Testing, Hermeticity, CoilRobustness, Fluid Ingress,Particulate Matter Testing,Maximum Surface Temperature,and Environmental Conditioning.	Similar, some testresults previouslycleared were not re-runand new tests for theOSI300 implant wereconducted.
MRI Compatibility	The Osia System is MRConditional.	The Osia Systemremains MRConditional; however,MR Conditions havechanged:The OSI300 implant isdesigned to allow thepatient to be examined
TechnologicalCharacteristic	Osia 2 System (Predicate,K220922)	Osia System (Subject)Hear now. And always
Sound Processor	Osia 2 Sound Processor	by an MRI at 1.5T andat 3T without havingthe implant magnetremoved or requiringuse of an MRI kit.Similar.The Osia 2(I) soundprocessor is nearlyidentical to the Osia 2sound processor,except that the RF linkcircuitry is tuned inproduction with a 4(I)magnet to attain anoptimum RF linkperformance for thestrongest 4(I) magnet,which is to be used forthe largest skin flapthickness range.
Sound Processor Function	The Osia 2 System requires the useof an externally worn soundprocessor that is worn on the headbehind the ear.The Osia 2 Sound Processor's mainfunction is to receive sound usingits two microphones, perform signalprocessing and deliver power andan audio stream to the OSI200implant via the RF link.	Same, with newOSI300 Implant.
Sound Processor Magnet	The Osia 2 Sound Processor usesstandard axial magnets (M1, M2,M3, M4) that are compatible withthe OSI100 and OSI200 implantmagnets.	Different, the updatedmagnets for the Osia2(I) sound processorallow for compatibilitywith the magnetintroduced in theOSI300 Implant.
Sound Processor Firmware	The Osia 2 Sound Processor chipsetincludes two distinct blocks: oneblock is based on the GN HearingC4.5/Palpatine platform, and isresponsible for receiving the	Similar, the firmwarehas been updated withnew functionalities tosupport the OSI300Implant.
TechnologicalCharacteristic	Osia 2 System (Predicate,K220922)	Osia System (Subject)
	microphone input, performingsignal processing, and delivering ananalogue output signal that is fedinto the differential input of theother block, the NEO-XS chip. TheNEO-XS block is responsible fortransferring the audio signal to theimplant via the RF link.
Contact andBiocompatibility of SoundProcessor	The Osia 2 Sound Processor is anintact-skin contacting device forpermanent use.Testing was completed on the soundprocessor outer materials todemonstrate biocompatibility inaccordance with ISO / EN ISO10993-1: October 2009 Biologicalevaluation of medical devices Part1: Evaluation and testing within arisk management process.	Same
Shelf Life and Packaging -Sound Processor	The Osia 2 Sound Processor is notprovided in sterile packaging anddoes not have a restricted shelf life.	Same, for the Osia 2(I)Sound Processor.
Fitting Software	The Osia Fitting Software 2 is usedby the audiologist to configure allpatient related data in the soundprocessor. The fitting software is anapplication running on a WindowsPC.It is a stand-alone software.	Similar, new featuresare available in theOsia Fitting Software 2to support the changesto the Osia 2(I) SoundProcessor and OSI300Implant.
Smart App	The Osia Smart App is a softwareapplication intended to remotelycontrol and monitor the Osia 2Sound Processor directly from asmartphone.Available for Android and iOS.	Similar. The OsiaSmart App has beenupdated to supportidentification of theOsia 2(I) soundprocessor and OSI300implant.

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 magnetization polarity. This change enables 1.5T and 3T MRI examinations with magnet in place, and without the need for a supporting bandage or splint. The Cochlear Magnet Cassette provides retention of the sound processor for the OSI300 implant, as the Cochlear Sterile Replacement Magnet does for the OSI200 implant. The Magnet Cassette on the OSI300 implant contains a magnet which can rotate when subjected to magnetic fields. It is intended to be used to replace the magnet of the hearing implant that has been removed to facilitate a medical procedure.
The Non-Magnetic Cassette serves the same function for the OSI300 implant as the ● Cochlear Sterile Non-Magnetic Plug serves for the OSI200 implant. It is intended to be used temporarily in place of the magnet cassette of a hearing implant after the implant magnet cassette is removed.

Osia 2(I) Sound Processor

The Osia 2(I) Sound Processor is developed from the Osia 2 Sound Processor with fine tuning of the radiofrequency (RF) link to optimize compatibility with the OSI300 implant
- The hardware remains unmodified from the predicate device. O
- The firmware has been updated to allow the Sound Processor to detect the O updated OSI300 implant
- Relevant finetuning improvements have also been made to the Osia 2 Sound O processor, and the new firmware version is used in both the Osia 2 Sound Processor and the Osia 2(I) Sound Processor.
New Imaging Magnets (1(1), 2(1), 3(1), and 4(1)), with updated magnetization polarity ● compared to the standard magnets used for the Osia 2 Sound Processor, are introduced for retention of the Osia 2(I) Sound Processor to the magnet cassette of the OSI300 Implant.
The Osia 2(I) Magnet Tool serves the same function as the Osia 2 Magnet tool, i.e., use for removal of the sound processor magnet from the sound processor base. It was updated for the changed magnetization polarity of the (1) magnets used for the Osia 2(1) sound processor.

Osia Fitting Software 2

Updated to be able to identify Osia 2(I) Sound Processor and OSI300 Implant ●
Updated Cochlear Baha Prescription to improve the sound quality and to reduce the sharpness of the sound

Osia Smart App

Updated to support identification of Osia 2(I) Sound Processor and OSI300 Implant ●
Minor user interface updates and bug fixing ●

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Image /page/13/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 a series of overlapping 'C' shapes, possibly representing sound waves or the cochlea itself. Below the symbol, the company name "Cochlear" is printed in a matching golden-yellow color, with the tagline "Hear now. And always" underneath in a smaller font.

K. Performance Data

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

Verification activities for the new OSI300 Implant included performance testing re-executed to support:

. Functional verification
Fixation Screw verification
Safety and Reliability verification related to MRI Safety, Maximum Surface Temperature, Coil Tensile and Flexural Robustness, Magnet Retention, Fluid Ingress, Implant Impact, Coil Impact, Release of Particulate Matter, ESD
Environmental Testing verification

The following verification testing performed on the cleared OSI200 Implant remains applicable to the new OSI300 Implant and were leveraged with justification from the predicate device.

Safety and Reliability verification related to Diagnostic Ultrasound, Therapeutic Ionising Radiation, Implant High Power Electric Fields
Surgical Implementation ●
Sterilization ●
. Sterile Barrier
Shelf-Life

Validation activities were completed for the OSI300 Implant and the Osia 2(I) Sound Processor to confirm that user needs were met. Previously completed validation and usability testing was leveraged where applicable for the updated Osia System.

Verification related to the OSI300 Implant was completed and concluded that the changes do not affect the safety and effectiveness of the device related to the:

OSI300 Implant ●
Sound Processor and its accessories ●
Osia Fitting Software 2 ●
. Osia Smart App

The results demonstrate the updated Osia System, including the new OS1300 Implant and Osia 2(I) sound processor, along with the modified Osia 2 Sound Processor, Osia Fitting Software 2, and Osia Smart App 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 System has been shown to be as safe and 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.