(120 days)
The Osia 2 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 2 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 2 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.
Cochlear™'s Osia 2 System mechanically vibrates the skull bone and subsequently the cochlea to compensate for conductive hearing loss, mixed hearing loss, or single-sided 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 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.
Here's an analysis of the provided information regarding the acceptance criteria and the study conducted for the Cochlear™ Osia™ 2 System:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document, a 510(k) summary, focuses on demonstrating substantial equivalence to a predicate device rather than explicitly stating acceptance criteria and detailed device performance metrics in a table. However, it does highlight key comparisons and generally indicates that the Osia 2 System either performs "Same" as the predicate or has "improved" features. The clinical study's conclusion also states "did not reveal significant differences in hearing performance."
Below is a reconstructed table based on the information provided, inferring acceptance criteria by the demonstrated equivalence to the predicate. Specific numerical performance values beyond those for hearing loss thresholds are not provided in this summary.
| Acceptance Criteria (Inferred from Predicate Equivalence) | Reported Device Performance (Osia 2 System) |
|---|---|
| Audiological Performance: Equivalent hearing performance in adaptive speech recognition to the predicate Osia System. The device should allow patients with specified hearing loss (conductive, mixed, profound sensorineural in one ear) to benefit from sound amplification / overcome hearing loss. | Clinical Performance: "The clinical evaluation did not reveal significant differences in hearing performance between either system [Osia 2 and predicate Osia System] in regard to adaptive speech recognition (p-value > 0.05)." Indications for Use: Meets specified hearing loss criteria (e.g., PTA bone conduction threshold better than or equal to 55 dB HL, PTA air conduction hearing thresholds better than or equal to 20 dB HL for SSD). |
| Implant Lifetime: Minimum of 6 years (based on predicate). | Implant Lifetime: Minimum of 10 years (Improved from predicate OSI100). |
| Magnetic Resonance (MR) Conditional: Equivalent or improved MR compatibility compared to the predicate device. | MR Conditional: OSI200 Implant is MR Conditional with magnet removed at 1.5 T and 3.0 T (explicitly stated). |
| Safety - Biocompatibility: Materials are biocompatible as per ISO 10993 standards for permanent implant device contacting tissue and bone (implant) and permanent surface device contacting intact skin (sound processor). | Biocompatibility: "Biocompatibility of the device system has been evaluated and tested. All tests were passed and confirm that the system is biocompatible." Refers to ISO 10993-1, -3, -5, -6, -10, -11, -18 and EN45502-1:2015. Direct contact materials are largely the same as the predicate (Titanium, Silicone), with the exception of the platinum plate electrode (Osia 2 does not have it). |
| Safety - Mechanical Reliability: Implant and system robustness under various conditions (e.g., environmental, acoustic, impact, cyclic load, fluid ingress, fixation, particulate matter). | Implant Reliability Testing & Performance Data: "Same" as predicate (underwent performance testing for Environmental Conditioning, Acoustic, Link Integrity, Maximum Surface Temperature, Coil Robustness, Coil Impact, Static Load, Cyclic Load, Fluid Ingress, Fixation, and Particulate Matter Testing). System Performance: "Same" as predicate (underwent functional testing, intra-operability, compatibility, system performance, safety and measurement functions). |
| Safety - Electromagnetic Compatibility (EMC): Meets relevant EMC standards. | Osia System EMC Testing: "Same" as predicate, "Including additional EMC testing to AIM Standard 7351731". (Radiated Emission, Conducted Emission, Immunity to Radiated RF Field (RRFF), Immunity to Proximity Fields from RF Wireless Communications Equipment, EN 45502-2-3 Clauses 27.3 and 27.4, Conducted RF disturbance, Exposure to RFID, Static Magnetic Field Immunity). |
| Other Functional Characteristics: Maintains core functional characteristics (e.g., receiver coil, actuator, inductive link, power source). Enhancements (e.g. wireless capabilities, fitting software features) should not negatively impact core function. | Implant Components: Receiver Coil "Same", Implant Actuator "Same", Osseointegrated component "Same", Inductive Link "Same", Implant Power Source "Same". Actuator Dampening Pads: Design "improved by adding a damping system... to improve shock performance. The addition... does not raise new issue of safety nor effectiveness." Link between Received Coil and Actuator: Smaller design does not require a lead; stimulator-electrical assembly and actuator housed together. Sound Processor Wireless Capabilities: Has additional ability to connect wirelessly to fitting software and accessories. Fitting Software Features: Osia Fitting Software 2.0 has additional features allowing wireless connection, accessory pairing, more settings, and factory reset. |
2. Sample Size Used for the Test Set and the Data Provenance
The document states: "Clinical performance data was gathered through a simulation study that allowed audiological testing of the Osia 2 Systems and Osia Systems without having to surgically implant the OSI200 Implant and OSI100 Implant, respectively."
- Sample Size: The exact sample size for the "simulation study" is not specified in the provided text.
- Data Provenance: The document does not explicitly state the country of origin. It indicates the study was a prospective simulation designed to assess audiological performance without physical implantation of the investigational device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not provided in the document. The study described is a "simulation study" for audiological testing. If human subjects were involved, the "ground truth" would likely be their measured hearing thresholds and subjective speech recognition scores. There is no mention of experts establishing ground truth in the context of diagnostic performance or image interpretation.
4. Adjudication Method for the Test Set
This information is not applicable and therefore not provided. The study described is an audiological performance simulation, not a diagnostic study requiring adjudication of interpretations.
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, not an AI-powered diagnostic tool requiring human reader interpretation of images or other data. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance was not performed or described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a hearing system, not a standalone algorithm. The "clinical performance data" discussed refers to the audiological efficacy of the device (or its simulated function), not the performance of an independent algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the audiological performance assessment, the "ground truth" would have been the measured audiological outcomes (e.g., adaptive speech recognition scores) of the participants in the simulation study. This is directly related to hearing function.
8. The sample size for the training set
This information is not applicable and therefore not provided. The device is a physical hearing aid system, not a machine learning algorithm that requires a training set in the conventional sense. The "simulation study" would involve testing against human participants or a defined audiological standard, not training a model.
9. How the ground truth for the training set was established
This information is not applicable as there is no training set for a machine learning algorithm.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol of the Department of Health & Human Services. To the right of the symbol, there is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".
November 15, 2019
Cochlear Americas Chinda Hemmavanh Senior Regulatory Affairs Specialist 13059 E Peakview Avenue Centennial, Colorado 80111
Re: K191921
Trade/Device Name: Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Osia Fitting Software 2.0, Osia SmartApp, Cochlear Osia Surgical Instruments Regulation Number: 21 CFR 874.3340 Regulation Name: Active implantable bone conduction hearing system Regulatory Class: Class II Product Code: PFO Dated: October 15, 2019 Received: October 16, 2019
Dear Chinda Hemmavanh:
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
{1}------------------------------------------------
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 (OS) 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,
for Michael J. Ryan Director DHT1C: Division of ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known)
Device Name Cochlear™ Osia™ 2 System
Indications for Use (Describe)
The Osia 2 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 2 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 2 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) |
|---|---|
| ----------------------------------------------------------------------------------------------- | --------------------------------------------- |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
Image /page/3/Picture/0 description: The image contains the logo for Cochlear. The logo consists of three yellow, curved shapes stacked on top of each other, resembling a stylized ear or sound wave. Below the graphic is the word "Cochlear" in a simple, sans-serif font, with the registered trademark symbol to the right of the word.
510(k) Summary
Cochlear Americas
A. Submitter Information
Submitted by:
| 13059 East Peakview Ave.Centennial, CO 80111 | |
|---|---|
| On behalf of the manufacturer: | Cochlear Ltd - Macquarie1 University AvenueMacquarie University, NSW 2109Australia(Establishment Number 9076254) |
| Contact: | Chinda Hemmavanh, Ph.DSenior Regulatory Affairs SpecialistCochlear Americaschemmavanh@cochlear.com(303) 264- 2318 (o)(303) 524-6825 (f) |
- 16-July-2019 Date Prepared B.
C. Device Name and Classification
| Trade/Proprietary Name: | Cochlear™ Osia™ 2 System |
|---|---|
| Common/Usual Name: | Osia 2 System |
| Classification Name: | Active implantable bone conduction hearing system21 CFR 874.3340, Class II |
| Classification Panel | Ear, Nose, and Throat |
| Product Code: | PFO |
{4}------------------------------------------------
Image /page/4/Picture/0 description: The image contains the Cochlear logo. 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 word "Cochlear" in a simple, sans-serif font.
D. Predicate Device
| 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): | K190589 |
E. Purpose of Submission
This Traditional 510(k) seeks clearance for an active implantable bone conduction hearing system, known as the Cochlear™ Osia™ 2 System. The Osia 2 System can be used by individuals aged 12 and older with mixed or conductive hearing loss, or single sided deafness to provide improved hearing.
F. Device Description
Cochlear™'s Osia 2 System mechanically vibrates the skull bone and subsequently the cochlea to compensate for conductive hearing loss, mixed hearing loss, or single-sided 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 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.
{5}------------------------------------------------
Image /page/5/Picture/0 description: The image shows the Cochlear logo. On the left side of the logo, there is a yellow symbol that looks like a stylized ear. To the right of the symbol, the word "Cochlear" is written in black font. Further to the right, the words "Hear now. And always" are written in a cursive, gray font.
Figure 1: Overview of the Osia 2 System, including the Osia 2 Sound Processor
Image /page/5/Picture/2 description: The image shows a medical device implanted in the body. The device consists of a sensor (1) placed on the skin, a lead (2) that runs under the skin, and a receiver (3) that is implanted in the bone (4). The sensor is used to collect data, which is then transmitted to the receiver.
In normal operation, the Osia System functions as follows (Figure1)
- The external sound processor captures and digitally processes sound. 1.
-
- The sound processor transmits power and digital information to the implant coil/receiver.
-
- 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).
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).
G. Intended Use
The Cochlear Osia 2 System uses bone conduction to transmit sounds to the cochlea (inner ear). Cochlear Osia OSI200 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.
Indications for Use H.
The Osia 2 System is intended for the following patients and indications:
- Patients 12 years of age or older. ●
- . Patients with a conductive or mixed hearing loss who can still benefit from sound amplification. The pure tone average bone-conduction hearing 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 2 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).
{6}------------------------------------------------
Image /page/6/Picture/0 description: The image shows the Cochlear logo. The logo consists of a yellow swirl design on the left and the word "Cochlear" in black text below it. To the right of the word "Cochlear" is the phrase "Hear now. And always" in a handwritten-style font.
- The Osia 2 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 2 System OSI200 Implant is MR Conditional with the implant magnet removed at 1.5 T and 3.0 T.
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 Osia 2 System and the predicate, Osia System, are surgically implanted in the mastoid bone and an external audio processor is held in place on the patients scalp by magnetic attraction between the implant and audio sound processor. Below in Figure 2 is a comparison of the Osia 2 System and the predicate Osia System. Table 1 summarizes a comparison of the features, functions, and performance data for the Osia 2 System and Osia System (Predicate device system).
Figure 2: Side by Side Comparison of the predicate device, Osia System (left) and the proposed device Osia 2 System (right).
Image /page/6/Picture/9 description: The image shows two different types of bone-anchored hearing aids (BAHA). On the left, the BAHA is a percutaneous device, where the sound processor is attached to an abutment that protrudes through the skin. On the right, the BAHA is a transcutaneous device, where the sound processor is attached to an external magnet that is placed over an internal magnet implanted under the skin. Both devices are implanted into the bone behind the ear.
{7}------------------------------------------------
Image /page/7/Picture/0 description: The image contains the logo for Cochlear. The logo consists of a stylized yellow spiral shape above the word "Cochlear" in a black sans-serif font. To the right of the logo, the words "Hear now" are written in a cursive font.
| Table 1. Comparison Summary of the Osia 2 System and Osia System (K190589) | |||
|---|---|---|---|
| DeviceComponent orTechnologicalCharacteristic | Osia SystemImplant: OSI100 ImplantPredicate K190589 | Osia 2 SystemImplant: OSI20ImplantProposed Device | |
| ImplantReceiver Coil | The receiver coil is inductively matched to thecoil of the externally worn sound processor. Itpicks up the signal and conducts the signal to theactuator via a lead. | Same | |
| Implant Actuator | The implant uses a piezoelectric actuator togenerate the mechanical vibration that is sent tothe patient skull. | Same | |
| ActuatorDampening Pads | The predicate OSI100 Implant does not havedampening pads in the actuator. | The actuator hasdesign has beenimproved by adding adamping systemconsisting of eightsilicone damping padsto improve shockperformance. | |
| The addition of thesilicone pads does notraise new issue ofsafety noreffectiveness. | |||
| Link betweenReceived Coiland Actuator | The predicate device had a stimulator/coil thatreceived the signal from the sound processor. Thesignal was then transferred to the piezoelectricactuator via a lead. | The smaller design ofthe implant does notrequire a lead.The proposed devicehas the stimulator-electrical assemblyand actuator housedtogether. The coil isone unit that isattached directly intothestimulator/actuator,and the coil providesthe signal that istransferred to thepiezoelectric actuator. | |
| Osseointegratedcomponent | The Osia System that is fixed to the bone by theOSI300 implant (K100360) | Same | |
| DeviceComponent orTechnologicalCharacteristic | Osia SystemImplant: OSI100 ImplantPredicate K190589 | Osia 2 SystemImplant: OSI20 ImplantProposed Device | |
| Implant andSound ProcessorInductive Link | The Osia System contains an electromagneticinductive link (also known as radio-frequencylink) between the external sound processor coiland the implant coil. The inductive link allowssound data and power to be transmitted to theimplant. | Same | |
| Implant PowerSource | The stimulator contains dedicated electronicswhose power is supplied by the batteries in theexternal sound processor. | Same | |
| Sound Processor | The Osia System have sound processors that areworn on the head behind the ear and held in placeby magnets. Both are powered by standardhearing aid batteries and have multiple colorvariants. | Same | |
| Sound ProcessorWirelessCapabilities | The Osia Sound Processor does not have theability to connect wirelessly with the fittingsoftware nor wireless accessories. | The Osia 2 SoundProcessor has anadditional ability toconnect wirelessly tothe Osia FittingSoftware 2.0The Osia 2 SoundProcessor can connectto wirelessaccessories. | |
| Fitting SoftwareLevel ofConcern | The fitting software platform have a minor levelof concern and are used for the same purpose | Same | |
| Fitting SoftwareFeatures | The Osia Fitting Software 1.0 can set up to 4programs within a sound processor. | Osia Fitting Software2.0 (OFS 2.0) can alsoset up to 4 programswithin a soundprocessor, and hasthese additionalfeatures:• OFS 2.0 interactwith two differentprogramminginterfaces: WiredHipro2 and NoahLink wireless | |
| DeviceComponent orTechnologicalCharacteristic | Osia SystemImplant: OSI100 ImplantPredicate K190589 | Osia 2 SystemImplant: OSI20ImplantProposed Device | |
| OFS 2.0 can be used to pair wireless accessories There are more settings and functions in OFS 2.0 (active gain setting, play test tones) The OFS 2.0 is able to do a factory reset | |||
| ImplantReliabilityTesting andPerformanceData | The implant went under performance testing for:Environmental Conditioning, Acoustic, LinkIntegrity, Maximum Surface Temperature, CoilRobustness, Coil Impact, Static Load, CyclicLoad, Fluid Ingress, Fixation, and ParticulateMatter Testing. | Same | |
| Implant Lifetime | Minimum of 6 years | Minimum of 10 years | |
| Osia SystemPerformanceData | The Osia System went under performance testingfor: Intra-operability, Compatibility betweeninterfaces, Functional testing, Systemperformance, Safety and Measurement functions. | Same | |
| Osia SystemEMC Testing | Electromagnetic Emissions Testing - Radiated Emission Electromagnetic Emissions Testing - Conducted Emission Electromagnetic Emissions Testing -Radiated Emission in Airborne Environment Electromagnetic Immunity Testing - Radiated RF Field (RRFF)- Immunity to Radiated RF EM fields at Enclosure Port Electromagnetic Immunity Testing - Radiated RF Field (RRFF)- Immunity to Proximity Fields from RF Wireless Communications Equipment Electromagnetic Immunity Testing - Radiated RF Field (RRFF)- EN 45502-2-3 Clauses 27.3 and 27.4 | SameIncluding additionalEMC testing to AIMStandard 7351731 | |
| DeviceComponent orTechnologicalCharacteristic | Osia SystemImplant: OSI100 ImplantPredicate K190589 | Osia 2 SystemImplant: OSI20ImplantProposed Device | |
| Implant Contact | The implant is categorised as a permanent (>30 days) implant device contacting tissue and bone, as defined by ISO 10993-1:2018 and EN ISO 10993-1:2009 / AC: 2010. | Same | |
| Implant Material | Direct contacting materials:• Titanium Fixation Screw• Titanium Chassis• Silicone Outer Moulding• Titanium Magnet• Platinum Plate Electrode | Same direct contact materials:• Titanium Fixation Screw• Titanium Chassis• Silicone Outer Moulding• Titanium MagnetException: The Osia 2 System implant does not have a platinum plate electrode. | |
| Sound ProcessorContact | The sound processor is categorised as a permanent (>30 days) surface device contacting intact skin, as defined by ISO 10993-1:2018 and EN ISO 10993-1:2009 / AC: 2010. | Same | |
| ImplantBiocompatibility | Biocompatibility of the device system has been evaluated and tested. All tests were passed and confirm that the system is biocompatible FDA guidance: Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" issued on June 16, 2016.Below are the standards that were verified through testing or justification based on components from currently approved/cleared medical devices. | Same | |
| • Electromagnetic Immunity Testing –Conducted RF disturbance (CRFD)• Electromagnetic Immunity Testing –Exposure to RFID• Static Magnetic Field Immunity Testing | |||
| DeviceComponent orTechnologicalCharacteristic | Osia SystemImplant: OSI100 ImplantPredicate K190589 | Osia 2 SystemImplant: OSI20ImplantProposed Device | |
| Test Description | Standard | ||
| Cytotoxicity | ISO10993-5: 2009 | ||
| Intracutaneousreactivity/irritation | ISO10993-10: 2010 | ||
| Systemic toxicity | ISO10993-11:2006 | ||
| Implantation | ISO10993-6: 2007 | ||
| Sensitization | ISO10993-10:2010 | ||
| Genotoxicity | ISO10993-3:2014 | ||
| Subchronic toxicity | ISO10993-11:2006 | ||
| Carcinogenicity andchronic toxicity | ISO10993-11:2006 | ||
| Pyrogenicity | ISO10993-11:2006 | ||
| ExhaustiveExtraction | ISO10993-18: 2005 | ||
| Extract Analysis | ISO10993-18:2005 | ||
| Particulate matter | EN45502-1:2015 | ||
| Sterility | The implant is provided sterile and is implantedin a surgical setting like the predicate. The soundprocessor is provided non-sterile. | Same | |
| ClinicalPerformance | Clinical performance data was gathered through a simulation study thatallowed audiological testing of the Osia 2 Systems and Osia Systemswithout having to surgically implant the OSI200 Implant and OSI100Implant, respectively. The clinical evaluation did not reveal significantdifferences in hearing performance between either system in regard toadaptive speech recognition (p-value > 0.05). The stimulation study did notraise new issues of safety nor effectiveness for the Osia 2 System andsupported substantial equivalence between the Osia 2 System and thepredicate Osia System. |
{8}------------------------------------------------
Image /page/8/Picture/0 description: The image contains the logo for Cochlear. The logo features three curved, nested shapes in a golden color, resembling a stylized ear or sound waves. Below the symbol, the word "Cochlear" is written in a simple, sans-serif font, with the registered trademark symbol next to it.
{9}------------------------------------------------
Image /page/9/Picture/0 description: The image contains the logo for Cochlear. 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 word "Cochlear" in a simple, sans-serif font, with the registered trademark symbol to the right of the name.
{10}------------------------------------------------
Image /page/10/Picture/0 description: The image contains the logo for Cochlear. The logo consists of three yellow, stylized, overlapping circles that resemble a cochlea, which is part of the inner ear. Below the circles, the word "Cochlear" is written in a simple, sans-serif font, with the registered trademark symbol to the right of the word.
{11}------------------------------------------------
Image /page/11/Picture/0 description: The image features the logo for Cochlear, a company specializing in hearing solutions. The logo consists of three overlapping, stylized "C" shapes in a warm yellow color, creating a visual effect of sound waves or a spiral. The company name, "Cochlear," is printed in a clean, sans-serif font below the graphic, with the registered trademark symbol appearing next to it.
As required by the Special Controls identified for this device type, a summary of the clinical data is provided in the product labeling.
K. Conclusion
Despite the physical differences and additional features of the Osia 2 System when compared to the predicate Osia System, they have substantially equivalent function, technology and intended use.
Based on the indications for use, technological characteristics, and substantial equivalence comparison to the predicate device, supported by clinical and non-clinical data, the Cochlear™ Osia 2 System has been shown to be as safe and effective for its intended use as the predicate device.
§ 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.