(120 days)
No
The summary describes a bone conduction hearing system with an implant and external sound processor, focusing on mechanical vibration and signal processing. There is no mention of AI, ML, or related concepts in the intended use, device description, or performance studies.
Yes
The device is intended to treat hearing loss by compensating for conductive hearing loss, mixed hearing loss, or single-sided deafness (SSD), which is a clear therapeutic indication.
No
Explanation: The Osia 2 System is described as a device that compensates for hearing loss by mechanically vibrating the skull bone and cochlea. Its purpose is to provide sound amplification, not to diagnose a condition. The "Indications for Use" section lists patient criteria based on existing hearing assessments (e.g., pure tone average) rather than defining processes for the device itself to make a diagnosis.
No
The device description explicitly states that the Osia 2 System is made up of several components, including a surgically implanted Osia Implant (OSI200) and an external sound processor. This indicates the device includes significant hardware components beyond just software.
Based on the provided information, the Osia 2 System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- The Osia 2 System is a surgically implanted device and external sound processor designed to mechanically vibrate the skull bone to improve hearing. It directly interacts with the patient's body to provide a therapeutic benefit (improved hearing), not to analyze biological samples.
The description clearly outlines its function as a hearing aid system that bypasses parts of the ear to stimulate the cochlea, which is a completely different purpose than an IVD.
N/A
Intended Use / Indications for Use
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.
Product codes
PFO
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.
In normal operation, the Osia System functions as follows:
- The external sound processor captures and digitally processes sound.
- 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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
mastoid region of either side of the head, skull bone, mastoid bone
Indicated Patient Age Range
12 years of age or older
Intended User / Care Setting
professional use only, surgical setting
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical Performance:
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. The clinical evaluation did not reveal significant differences in hearing performance between either system in regard to adaptive speech recognition (p-value > 0.05). The stimulation study did not raise new issues of safety nor effectiveness for the Osia 2 System and supported substantial equivalence between the Osia 2 System and the predicate Osia System.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
p-value > 0.05 for adaptive speech recognition
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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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) |
|---|---|
| ----------------------------------------------------------------------------------------------- | --------------------------------------------- |
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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 - Macquarie
1 University Avenue
Macquarie University, NSW 2109
Australia
(Establishment Number 9076254) |
| Contact: | Chinda Hemmavanh, Ph.D
Senior Regulatory Affairs Specialist
Cochlear Americas
chemmavanh@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 system |
| 21 CFR 874.3340, Class II | |
| Classification Panel | Ear, Nose, and Throat |
| Product Code: | PFO |
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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 system |
| 21 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.
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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).
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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.
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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) | |||
|---|---|---|---|
| Device | |||
| Component or | |||
| Technological | |||
| Characteristic | Osia System | ||
| Implant: OSI100 Implant | |||
| Predicate K190589 | Osia 2 System | ||
| Implant: OSI20 | |||
| Implant | |||
| Proposed Device | |||
| Implant | |||
| Receiver Coil | The receiver coil is inductively matched to the | ||
| coil of the externally worn sound processor. It | |||
| picks up the signal and conducts the signal to the | |||
| actuator via a lead. | Same | ||
| Implant Actuator | The implant uses a piezoelectric actuator to | ||
| generate the mechanical vibration that is sent to | |||
| the patient skull. | Same | ||
| Actuator | |||
| Dampening Pads | The predicate OSI100 Implant does not have | ||
| dampening pads in the actuator. | The actuator has | ||
| design has been | |||
| improved by adding a | |||
| damping system | |||
| consisting of eight | |||
| silicone damping pads | |||
| to improve shock | |||
| performance. | |||
| The addition of the | |||
| silicone pads does not | |||
| raise new issue of | |||
| safety nor | |||
| effectiveness. | |||
| Link between | |||
| Received Coil | |||
| and Actuator | The predicate device had a stimulator/coil that | ||
| received the signal from the sound processor. The | |||
| signal was then transferred to the piezoelectric | |||
| actuator via a lead. | The smaller design of | ||
| the implant does not | |||
| require a lead. | |||
| The proposed device | |||
| has the stimulator- | |||
| electrical assembly | |||
| and actuator housed | |||
| together. The coil is | |||
| one unit that is | |||
| attached directly into | |||
| the | |||
| stimulator/actuator, | |||
| and the coil provides | |||
| the signal that is | |||
| transferred to the | |||
| piezoelectric actuator. | |||
| Osseointegrated | |||
| component | The Osia System that is fixed to the bone by the | ||
| OSI300 implant (K100360) | Same | ||
| Device | |||
| Component or | |||
| Technological | |||
| Characteristic | Osia System | ||
| Implant: OSI100 Implant | |||
| Predicate K190589 | Osia 2 System | ||
| Implant: OSI20 Implant | |||
| Proposed Device | |||
| Implant and | |||
| Sound Processor | |||
| Inductive Link | The Osia System contains an electromagnetic | ||
| inductive link (also known as radio-frequency | |||
| link) between the external sound processor coil | |||
| and the implant coil. The inductive link allows | |||
| sound data and power to be transmitted to the | |||
| implant. | Same | ||
| Implant Power | |||
| Source | The stimulator contains dedicated electronics | ||
| whose power is supplied by the batteries in the | |||
| external sound processor. | Same | ||
| Sound Processor | The Osia System have sound processors that are | ||
| worn on the head behind the ear and held in place | |||
| by magnets. Both are powered by standard | |||
| hearing aid batteries and have multiple color | |||
| variants. | Same | ||
| Sound Processor | |||
| Wireless | |||
| Capabilities | The Osia Sound Processor does not have the | ||
| ability to connect wirelessly with the fitting | |||
| software nor wireless accessories. | The Osia 2 Sound | ||
| Processor has an | |||
| additional ability to | |||
| connect wirelessly to | |||
| the Osia Fitting | |||
| Software 2.0 | |||
| The Osia 2 Sound | |||
| Processor can connect | |||
| to wireless | |||
| accessories. | |||
| Fitting Software | |||
| Level of | |||
| Concern | The fitting software platform have a minor level | ||
| of concern and are used for the same purpose | Same | ||
| Fitting Software | |||
| Features | The Osia Fitting Software 1.0 can set up to 4 | ||
| programs within a sound processor. | Osia Fitting Software | ||
| 2.0 (OFS 2.0) can also | |||
| set up to 4 programs | |||
| within a sound | |||
| processor, and has | |||
| these additional | |||
| features: | |||
| • OFS 2.0 interact | |||
| with two different | |||
| programming | |||
| interfaces: Wired | |||
| Hipro2 and Noah | |||
| Link wireless | |||
| Device | |||
| Component or | |||
| Technological | |||
| Characteristic | Osia System | ||
| Implant: OSI100 Implant | |||
| Predicate K190589 | Osia 2 System | ||
| Implant: OSI20 | |||
| Implant | |||
| Proposed 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 | |||
| Implant | |||
| Reliability | |||
| Testing and | |||
| Performance | |||
| Data | The implant went under 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. | Same | ||
| Implant Lifetime | Minimum of 6 years | Minimum of 10 years | |
| Osia System | |||
| Performance | |||
| Data | The Osia System went under performance testing | ||
| for: Intra-operability, Compatibility between | |||
| interfaces, Functional testing, System | |||
| performance, Safety and Measurement functions. | Same | ||
| Osia System | |||
| EMC 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 | Same | |
| Including additional | |||
| EMC testing to AIM | |||
| Standard 7351731 | |||
| Device | |||
| Component or | |||
| Technological | |||
| Characteristic | Osia System | ||
| Implant: OSI100 Implant | |||
| Predicate K190589 | Osia 2 System | ||
| Implant: OSI20 | |||
| Implant | |||
| Proposed 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 Magnet | |||
| Exception: The Osia 2 System implant does not have a platinum plate electrode. | |||
| Sound Processor | |||
| Contact | 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 | |
| Implant | |||
| Biocompatibility | 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 | |||
| Device | |||
| Component or | |||
| Technological | |||
| Characteristic | Osia System | ||
| Implant: OSI100 Implant | |||
| Predicate K190589 | Osia 2 System | ||
| Implant: OSI20 | |||
| Implant | |||
| Proposed Device | |||
| Test Description | Standard | ||
| Cytotoxicity | ISO10993-5: 2009 | ||
| Intracutaneous | |||
| reactivity/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 and | |||
| chronic toxicity | ISO10993-11:2006 | ||
| Pyrogenicity | ISO10993-11:2006 | ||
| Exhaustive | |||
| Extraction | ISO10993-18: 2005 | ||
| Extract Analysis | ISO10993-18:2005 | ||
| Particulate matter | EN45502-1:2015 | ||
| Sterility | The implant is provided sterile and is implanted | ||
| in a surgical setting like the predicate. The sound | |||
| processor is provided non-sterile. | Same | ||
| Clinical | |||
| Performance | 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. The clinical evaluation did not reveal significant | |||
| differences in hearing performance between either system in regard to | |||
| adaptive speech recognition (p-value > 0.05). The stimulation study did not | |||
| raise new issues of safety nor effectiveness for the Osia 2 System and | |||
| supported substantial equivalence between the Osia 2 System and the | |||
| predicate Osia System. |
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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.
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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.
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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.
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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.