• 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.

Device Description

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

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

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study details for the Cochlear Osia System, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly define "acceptance criteria" in a quantitative, pass/fail format for this specific submission, as this submission is for an expanded pediatric indication, not a new device. However, the study aims to demonstrate safety and effectiveness in the expanded population in comparison to the existing predicate. The "acceptance criteria" can be inferred from the study's objectives and the conclusion of substantial equivalence.

Acceptance Criteria (Inferred from Study Objectives)	Reported Device Performance
Safety: Adverse events and safety considerations for children ages 5-11 are consistent with those experienced by individuals 12 and older (the predicate population).	Results demonstrated that adverse events and safety considerations for the expanded indication remained consistent with adverse events for individuals ages 12 and older.
Effectiveness (Quality of Life): Significant improvement in quality of life for children ages 5-11.	Children ages 5-11 implanted with the Osia System demonstrated significant improvement in quality of life as evidenced in parental questionnaires.
Effectiveness (Speech Perception - Quiet): Improved speech perception performance in quiet postoperatively.	Children ages 5-11 implanted with the Osia System demonstrated significant improvement in speech perception as evidenced in testing in quiet.
Effectiveness (Speech Perception - Adaptive Noise): Improved adaptive speech in noise performance postoperatively.	Children ages 5-11 implanted with the Osia System demonstrated significant improvement in speech perception as evidenced in testing in adaptive noise.
Substantial Equivalence: The expanded pediatric indication is as safe and effective as the cleared indications for the predicate Osia System.	Based on technological characteristics, substantial equivalence comparison to the predicate device, and the indications for use supported by clinical data, the change to expand the pediatric indications for use of Cochlear Osia System has been shown to be as safe and effective for its intended use as the cleared indications for the predicate Osia System.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not explicitly stated for the "test set" in a traditional sense. The document refers to a "pivotal, prospective, multi-center study... to determine the safety and effectiveness of the Osia system in children ages 5-11." The number of participants in this study is not numericaly provided.
Data Provenance: The study was a "pivotal, prospective, multi-center study." The country of origin of the data is not specified.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This submission is for a medical device (hearing system), not an AI/software device requiring "ground truth" derived from expert consensus on images or similar data. The "ground truth" is based on clinical outcomes relevant to hearing devices:

Adverse Events: Clinical reporting by medical professionals during the study.
Quality of Life: Patient-reported outcomes via parental questionnaires.
Speech Perception: Objective audiological testing (unaided vs. aided performance).
Bone Conduction Thresholds: Audiological measurements by qualified audiologists.

The document does not mention a specific number of experts or their qualifications in terms of establishing a "ground truth" for the test set in the same way an imaging AI algorithm might. The clinical data itself serves as the evidence.

4. Adjudication Method for the Test Set

Not applicable in the context of this device and study. The data collected (adverse events, questionnaire results, audiological test results) are direct clinical observations and measurements, not subjective evaluations requiring adjudication by multiple experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This study focuses on the clinical performance of the device itself in a specific patient population, not on human readers' interpretation of data with and without AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, in a way. The device itself (Cochlear Osia System) is the "algorithm only" in the context of its function as an active implantable bone conduction hearing system. Its performance (improvements in hearing, quality of life, speech perception) is measured as a standalone effect of the device on the patient, without human intervention during the hearing process. The human element comes in during the fitting and programming of the device by audiologists. The study's effectiveness measures (parental questionnaires, speech perception tests) evaluate the device's functional outcome.

7. The Type of Ground Truth Used

The "ground truth" for this study is derived from various clinical measures and outcomes:

Safety: Reports of adverse events during the prospective study.
Effectiveness (Quality of Life): Patient-reported outcomes from parental questionnaires (SSQ - Speech, Spatial and Qualities of Hearing).
Effectiveness (Hearing Thresholds): Audiological measurements of bone conduction thresholds.
Effectiveness (Speech Perception): Audiological tests measuring speech perception in quiet and in adaptive noise.

8. The Sample Size for the Training Set

The document does not mention a "training set." This study is a clinical trial evaluating a medical device, not an AI algorithm that requires training data in the computational sense. The device itself (the Osia System) has undergone prior development and testing, but that is distinct from a "training set" for a machine learning model.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no "training set" in the context of this device and the provided document.

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

April 18, 2024

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

Re: K240155

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

Dear Whitney Alexander:

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

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

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

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

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

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

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

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Indications for Use

510(k) Number (if known) K240155

Device Name Cochlear™ Osia® System

Indications for Use (Describe)

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

· Patients 5 years of age or older.

· Prior to receiving the device, it is recommended that an individual have experience with appropriately fitted air conduction or bone conduction hearing aids.

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

Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)
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K240155 - 510(k) Summary

A. Submitter InformationSubmitted 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:	Whitney AlexanderSenior Regulatory Affairs SpecialistCochlear AmericasC: 719-337-8620E: walexander@cochlear.com
B. Date Prepared	19-January-2024
C. Device Name and Classification
Device Names:	Cochlear™ Osia® OSI300 ImplantCochlear™ Magnet CassetteCochlear™ Non-Magnetic CassetteCochlear™ Osia® 2(I) Sound ProcessorCochlear™ Osia® OSI200 ImplantCochlear™ Sterile Replacement MagnetCochlear™ Sterile Non-Magnetic PlugCochlear™ Osia® 2 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:	REO

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D. Predicate Device
Device Names:	Cochlear™ Osia® OSI300 ImplantCochlear™ Magnet CassetteCochlear™ Non-Magnetic CassetteCochlear™ Osia® 2(I) Sound ProcessorCochlear™ Osia® OSI200 ImplantCochlear™ Sterile Replacement MagnetCochlear™ Sterile Non-Magnetic PlugCochlear™ Osia® 2 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
510(k):	K231204

E. Purpose of Submission

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

F. Device Description

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

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

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

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

The external sound processor captures and digitally processes sound. 1.
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.
This electric analog signal drives the actuator to produce vibrations, which are transmitted to 4. the skull bone through the BI300 Implant (K100360).

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

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

G. Intended Use

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

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

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

H. Indications for Use

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

Patients 5 years of age or older. ●
Patients who have a conductive or mixed hearing loss and still can benefit from sound ● amplification. The pure tone average (PTA) bone conduction (BC) threshold (measured at 0.5, 1, 2, and 3 kHz) should be better than or equal to 55 dB HL.
. Bilateral fitting of the Osia System is intended for patients having a symmetrically conductive or mixed hearing loss. The difference between the left and right sides' BC thresholds should be less than 10 dB on average measured at 0.5, 1, 2, and 3 kHz, or less than 15 dB at individual frequencies.
Patients who have profound sensorineural hearing loss in one ear and normal hearing in the opposite ear (i.e., single-sided deafness or "SSD"). The pure tone average air

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conduction hearing thresholds of the hearing ear should be better than or equal to 20 dB HL (measured at 0.5, 1, 2, and 3 kHz).

The Osia System for SSD is also indicated for any patient who is indicated for an air-● conduction contralateral routing of signals (AC CROS) hearing aid, but who for some reason cannot or will not use an AC CROS.
Prior to receiving the device, it is recommended that an individual have experience with ● appropriately fitted air conduction or bone conduction hearing aids.

I. MR Conditional

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

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

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

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

Osia OSI100 implant
Osia OSI200 implant .

J. Technological Characteristics and Comparison to Predicate

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

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

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

TechnologicalCharacteristic	Osia System (Predicate, K231204)	Osia System (Subject)
Intended Use	The Cochlear Osia System usesbone conduction to transmit sounds	Same
TechnologicalCharacteristic	Osia System (Predicate, K231204)	Osia System (Subject)
	to the cochlea (inner ear) with thepurpose of enhancing hearing.The OSI300 Implant or OSI200Implant is intended to be used aspart of the Cochlear Osia System toconvert information from theexternal Sound Processor intomechanical vibrations.Osia single-use and reusablesurgical instruments are usedthroughout the surgery to correctlyposition and attach the Osiaimplant.
Indications	The Osia System is intended for thefollowing patients and indications:Patients 12 years of age or older. Patients who have a conductiveor mixed hearing loss and stillcan 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 air	Expanded to includePatients 5 years of ageor older.
TechnologicalCharacteristic	Osia System (Predicate, K231204)	Osia System (Subject)
	conduction hearing thresholds of the hearing ear should bebetter 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 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 andtransfer 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.	Same
System Compatibility	The Osia System includes animplant, sound processor, surgicaltools and accessories, software,programming cable, and fittingsoftware.It is also capable of wirelessconnection to accessories and fittingsoftware.	Same
Implant	OSI300 or OSI200 Implant	Same
Osseointegrated Implant	BI300 (K100360)	Same
Biocompatibility of Implant	Biocompatibility of the OsiaSystem has been evaluated andtested. All tests were passed and	Same
TechnologicalCharacteristic	Osia System (Predicate, K231204)	Osia System (Subject)
	confirm that the Osia System isbiocompatible.
	The Osia implants were assessed asbiologically safe in accordance withISO 10993-1:2018, ISO 14708-7:2013, and the FDA Guidance"Use of International Standard ISO10993-1, Biological evaluation ofmedical devices - Part 1:Evaluation of testing within a riskmanagement process” (2016), for apermanent (>30 days) implantdevice contacting tissue and boneand can be considered safe for use.
Sterilization of Implant	Each Osia 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.
Shelf Life and Packaging-Implant	Shelf-life of the Osia Implant is 2.5years.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.
Implant Reliability Testingand Non-ClinicalPerformance Data	The verification tests forperformance and reliability of theOsia Implants include those relatedto:Acoustic Output, Link Integrity,Fixation Screw, Static Load, CoilImpact, Cyclic Load, Static Load,Lifetime Testing, Hermeticity, CoilRobustness, Fluid Ingress,Particulate Matter Testing,	Same, the results ofbench testing of eachimplant remainsunchanged with theindication change.
TechnologicalCharacteristic	Osia System (Predicate, K231204)	Osia System (Subject)
Clinical Data	Maximum Surface Temperature,and Environmental Conditioning.Clinical data was gathered to determine the safety andeffectiveness of the Osia system in children ages 5-11. Safetywas demonstrated through the reports of adverse eventsrelated to the device and procedure being similar to thoseexperienced by the population identified by the predicateindications for use with this device. Effectiveness wasdemonstrated by both patient-reported outcomes by theparticipants' parent as well as through improved speechintelligibility in both quiet and noise.
MRI Compatibility	The Osia System is MRConditional.	Same, the Osia Systemremains MRConditional. The MRConditions have notchanged as a result ofthe expandedindication.
Sound Processor	Osia 2 Sound Processor and Osia2(I) Sound Processor	Same, the compatiblesound processorsremain unchanged.
Sound Processor Function	The Osia System requires the use ofan externally worn sound processorthat is worn on the head behind theear.The Osia Sound Processor's mainfunction is to receive sound usingits two microphones, perform signalprocessing and deliver power andan audio stream to the Osia implantvia the RF link.	Same, the soundprocessor functionremains unchanged.
Sound Processor Magnet	The Osia 2 Sound Processor usesstandard axial magnets that arecompatible with the OSI100 andOSI200 implant magnets.The Osia 2(I) Sound Processor usesimaging magnets with diametricpolarization that are compatiblewith the OSI300 implant magnet.	Same, the compatiblesound processormagnets remainunchanged.
Sound Processor Firmware	The Osia 2 Sound Processor chipsetincludes two distinct blocks: oneblock is based on the GN Hearing	Same, the soundprocessor firmware is
TechnologicalCharacteristic	Osia System (Predicate, K231204)	Osia System (Subject)
	C4.5/Palpatine platform, and isresponsible for receiving themicrophone 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.	not impacted by theexpanded indication.
Contact andBiocompatibility of SoundProcessor	The Osia 2 Sound Processor andOsia 2(I) Sound Processor areintact-skin contacting devices 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, the contact andbiocompatibility of thesound processorremains unchanged.
Shelf Life and Packaging -Sound Processor	The Osia 2 Sound Processor andOsia 2(I) Sound Processor are notprovided in sterile packaging and donot have a restricted shelf life.	Same
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.	Same, the fOsia FittingSoftware 2 is notimpacted by theexpanded indicationchange.
Smart App	It is a stand-alone software.The Osia Smart App is a softwareapplication intended to remotelycontrol and monitor the Osia 2Sound Processor directly from asmartphone.Available for Android and iOS.	Same, the Osia SmartApp is not impacted bythe expanded indicationchange.

Table 1: Comparison Summary of Osia System

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

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is provided in the product labelling.

K. Clinical Performance Data

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

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

Secondary effectiveness objectives included:

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

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

L. Conclusion

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

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.