(113 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on mechanical vibration and signal processing, not AI/ML algorithms.
Yes
The device is intended to enhance hearing and compensate for hearing loss, which directly addresses a health condition.
No
The device is described as enhancing hearing by transmitting sounds to the inner ear, compensating for various types of hearing loss. Its purpose is to treat hearing impairment, not to diagnose it.
No
The device description explicitly states the system is made up of several components, including a surgically implanted hardware component (Osia Implant) and an external sound processor, in addition to fitting software and a smart app. The performance studies also detail hardware verification and validation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to enhance hearing by transmitting sounds to the inner ear through bone conduction. This is a therapeutic and assistive function, not a diagnostic one.
- Device Description: The device mechanically vibrates the skull bone to compensate for hearing loss. It's a physical intervention, not a test performed on biological samples to diagnose a condition.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for the diagnosis, monitoring, or prognosis of a disease or condition based on analysis of biological samples.
The device is a surgically implanted hearing aid system, which falls under the category of medical devices, but not specifically In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Osia System is intended for the following patients and indications:
· Patients 12 years of age or older.
· Patients who have a conductive or mixed hearing loss and still can benefit from sound amplification. The pure tone average (PTA) bone conduction (BC) threshold (measured at 0.5, 1, 2, and 3 kHz) should be better than or equal to 55 dB HL.
· Bilateral fitting of the Osia System is 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., single-sided 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
Product codes (comma separated list FDA assigned to the subject device)
PFO
Device Description
The Osia System mechanically vibrates the skull bone and subsequently the cochlea to compensate for conductive hearing loss, mixed hearing loss, or single-sided sensorineural deafness (SSD).
The Osia System is made up of several components. The Osia Implant (OSI300) consists of a receiver/coil and an actuator/stimulator (vibrator) which is surgically implanted on the skull bone. The external component of the Osia System is a sound processor, worn off-the-ear, which picks up the sound from the environment, and sends, after processing, the information to the implant via a transcutaneous inductive link. This link is also referred to as radiofrequency (RF) link. Each Osia System is configured to meet an individual's hearing needs, using dedicated fitting software.
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 via an RF link.
- The implant electronics convert the digital information into an electric analog signal.
- This electric analog signal drives the actuator to produce vibrations, which are transmitted to the skull bone through the BI300 Implant (K100360).
The actuator converts the electrical signal into an amplified mechanical stimulation, bypassing the impaired middle ear (origin of the conductive part of the hearing loss) and providing some level of mechanical amplification in order to compensate for the damaged inner ear (sensorineural part of the hearing loss, in case of mixed hearing loss).
The updated Osia System introduces:
- The OSI300 Implant with a rotatable magnet,
- The Cochlear Magnet and Non-Magnetic Cassettes for the OSI300 implant
- The Osia 2(I) Sound Processor for compatibility with the OSI300 implant,
- New dedicated 'Imaging' magnets (denoted as (I) magnets) for the Osia 2(I) Sound Processor,
- New magnet tool for the (I) magnets,
- Updates to the cleared Osia Fitting Software 2 to support the OSI300 implant along with other improvements, and
- Minor updates to the Osia Smart App.
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
Indicated Patient Age Range
12 years of age or older.
Intended User / Care Setting
professional use only.
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
Bench testing was conducted to compare the updated Osia System with the cleared Osia 2 System.
Verification activities for the new OSI300 Implant included performance testing re-executed to support:
- Functional verification
- Fixation Screw verification
- Safety and Reliability verification related to MRI Safety, Maximum Surface Temperature, Coil Tensile and Flexural Robustness, Magnet Retention, Fluid Ingress, Implant Impact, Coil Impact, Release of Particulate Matter, ESD
- Environmental Testing verification
Previously completed validation and usability testing was leveraged where applicable for the updated Osia System.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Substantial equivalence to the predicate device was accomplished through non-clinical bench testing related to functionality and performance testing, hardware and interface testing, as well as system and subsystem level testing.
The results demonstrate the updated Osia System, including the new OS1300 Implant and Osia 2(I) sound processor, along with the modified Osia 2 Sound Processor, Osia Fitting Software 2, and Osia Smart App are functionally equivalent to the cleared Osia 2 System.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 18, 2023
Cochlear Denis DiMartino Senior Regulatory Affairs Specialist 10350 Park Meadows Drive Lone Tree, Colorado 80124
Re: K231204
Trade/Device Name: Cochlear™ Osia® System; Cochlear™ Osia® OSI300 Implant; Cochlear™ Magnet Cassette; Cochlear™ Non-Magnetic Cassette; Cochlear™ Osia® 2(1) Sound Processor; Cochlear™ Osia® Fitting Software 2; Cochlear™ Osia® Smart App Regulation Number: 21 CFR 874.3340 Regulation Name: Active implantable bone conduction hearing system Regulatory Class: Class II Product Code: PFO Dated: July 19, 2023 Received: July 19, 2023
Dear Denis DiMartino:
We have reviewed vour Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976. the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies.combination product submissions. The general controls provisions of the Act include requirements for annu al registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal
1
statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801): medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Shuchen Peng -S Shu-Chen Peng, Ph.D. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K231204
Device Name Cochlear™ Osia® System
Indications for Use (Describe)
The Osia System is intended for the following patients and indications:
· Patients 12 years of age or older.
· Patients who have a conductive or mixed hearing loss and still can benefit from sound amplification. The pure tone average (PTA) bone conduction (BC) threshold (measured at 0.5, 1, 2, and 3 kHz) should be better than or equal to 55 dB HL.
· Bilateral fitting of the Osia System is intents having a symmetrically conductive or mixed hearing loss. The difference between the left and right sides' BC thresholds should be less than 10 dB on average measured at 0.5, 1, 2, and 3 kHz, or less than 15 dB at individual frequencies.
· Patients who have profound sensorineural hearing loss in one ear and normal hearing in the opposite ear (i.e., singlesided deafness or "SSD"). The pure tone average air conduction hearing ear should be better than or equal to 20 dB HL (measured at 0.5, 1, 2, and 3 kHz).
• The Osia System for SSD is also indicated for any patient who is indicated for an air-conduction contralateral routing of signals (AC CROS) hearing aid, but who for some reason cannot or will not use an AC CROS.
· Prior to receiving the device, it is recommended that an individual have experience with appropriately fitted air conduction or bone conduction hearing aids
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image is a logo for Cochlear, a company that specializes in hearing solutions. The logo features a stylized graphic of three overlapping, curved shapes in a golden color, resembling sound waves emanating outwards. Below the graphic, the company name "Cochlear" is written in a bold, sans-serif font, also in golden color. Underneath the name, there is a tagline that reads "Hear now. And always" in a smaller, lighter font.
510(k) Summary
| A. Submitter Information | |
|---|---|
| Submitted by: | Cochlear Americas |
| 10350 Park Meadows Drive | |
| Lone Tree, CO 80124 | |
| On behalf of the manufacturer: | Cochlear Ltd – Macquarie |
| 1 University Avenue | |
| Macquarie University, NSW 2109 | |
| Australia | |
| (Establishment Number 3009092818) | |
| Contact: | Denis DiMartino |
| Senior Regulatory Affairs Specialist | |
| Cochlear Americas | |
| C: 508-304-4356 | |
| E: ddimartino@cochlear.com | |
| B. Date Prepared | 19-July-2023 |
| C. Device Name and Classification | |
| Device Names: | Cochlear™ Osia® OSI300 Implant |
| Cochlear™ Magnet Cassette | |
| Cochlear™ Non-Magnetic Cassette | |
| Cochlear™ Osia® 2(I) Sound Processor | |
| Cochlear™ Osia® Fitting Software 2 | |
| Cochlear™ Osia® Smart App | |
| 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 |
| D. Predicate Device | |
| Device Names: | Cochlear™ Osia® OSI200 Implant |
| Cochlear™ Osia® 2 Sound Processor | |
| Cochlear™ Osia® Fitting Software 2 | |
| Cochlear™ MRI Kit |
4
Image /page/4/Picture/0 description: The image contains the logo for Cochlear, a company that specializes in hearing solutions. The logo features a stylized, golden-yellow symbol resembling three overlapping sound waves or cochlear spirals. Below the symbol is the company name, "Cochlear," also in golden-yellow. Underneath the name is the tagline "Hear now. And always" in a smaller font size.
| Trade/Proprietary Name: | Cochlear™ Osia® 2 System |
|---|---|
| Common/Usual Name: | Osia System |
| Classification Name: | Active implantable bone conduction hearing system |
| 21 CFR 874.3340, Class II | |
| Classification Panel: | Ear, Nose, and Throat |
| Product Code: | PFO |
| 510(k): | K220922 |
E. Purpose of Submission
This Traditional 510(k) seeks clearance for an updated Osia System, which includes a new OSI300 Implant, a new Cochlear Magnet Cassette and Non-Magnetic Cassette, and a new Osia 2(I) Sound Processor. Additionally, the updated Osia System includes modifications to existing components (Osia 2 Sound Processor, Osia Fitting Software 2, and Osia Smart App). The previous Osia System, Osia 2 System (predicate), was cleared under K220922 on July 27th, 2022.
F. Device Description
The Osia System mechanically vibrates the skull bone and subsequently the cochlea to compensate for conductive hearing loss, mixed hearing loss, or single-sided sensorineural deafness (SSD).
The Osia System is made up of several components. The Osia Implant (OSI300) consists of a receiver/coil and an actuator/stimulator (vibrator) which is surgically implanted on the skull bone. The external component of the Osia System is a sound processor, worn off-the-ear, which picks up the sound from the environment, and sends, after processing, the information to the implant via a transcutaneous inductive link. This link is also referred to as radiofrequency (RF) link. Each Osia System is configured to meet an individual's hearing needs, using dedicated fitting software. The Osia System is illustrated in Figure 1 below.
Figure 1. Osia System, including the OSI300 Implant Osia 2(I) Sound Processor
Image /page/4/Picture/8 description: The image shows a cross-sectional view of a medical implant. The implant consists of several components, including an external device (1), an internal receiver (3), and a connection to the bone (4). The implant is placed beneath the skin (3) and is designed to interface with the bone structure (2). The image provides a detailed view of the implant's placement and its interaction with the surrounding tissues.
In normal operation, the Osia System functions as follows (referring to Figure 1):
- The external sound processor captures and digitally processes sound. 1.
-
- 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.
5
Image /page/5/Picture/0 description: The image contains the logo for Cochlear, a company that specializes in hearing solutions. The logo features three curved shapes nested together, resembling an ear or sound waves, in a golden color. Below the symbol, the company name "Cochlear" is written in a similar golden hue, with the registered trademark symbol to the right. Underneath the name, the tagline "Hear now. And always" is displayed in a smaller font, emphasizing the company's commitment to long-term hearing support.
-
- This electric analog signal drives the actuator to produce vibrations, which are transmitted to the skull bone through the BI300 Implant (K100360).
The actuator converts the electrical signal into an amplified mechanical stimulation, bypassing the impaired middle ear (origin of the conductive part of the hearing loss) and providing some level of mechanical amplification in order to compensate for the damaged inner ear (sensorineural part of the hearing loss, in case of mixed hearing loss).
- This electric analog signal drives the actuator to produce vibrations, which are transmitted to the skull bone through the BI300 Implant (K100360).
The updated Osia System introduces:
- The OSI300 Implant with a rotatable magnet, ●
- The Cochlear Magnet and Non-Magnetic Cassettes for the OSI300 implant ●
- The Osia 2(I) Sound Processor for compatibility with the OSI300 implant, ●
- New dedicated 'Imaging' magnets (denoted as (I) magnets) for the Osia 2(I) Sound Processor,
- New magnet tool for the (I) magnets, ●
- Updates to the cleared Osia Fitting Software 2 to support the OSI300 implant along with ● other improvements, described further below, and
- Minor updates to the Osia Smart App.
G. Intended Use
The Cochlear Osia System uses bone conduction to transmit sounds to the cochlea (inner ear) with the purpose of enhancing hearing. Osia Implants are single use devices intended for long term implantation under the skin in the mastoid region of either side of the head. They are for professional use only.
H. Indications for Use
The Osia System is intended for the following patients and indications:
- Patients 12 years of age or older.
- . Patients who have a conductive or mixed hearing loss and still can benefit from sound amplification. The pure tone average (PTA) bone conduction (BC) threshold (measured at 0.5, 1, 2, and 3 kHz) should be better than or equal to 55 dB HL.
- Bilateral fitting of the Osia System is intended for patients having a symmetrically ● conductive or mixed hearing loss. The difference between the left and right sides' BC thresholds should be less than 10 dB on average measured at 0.5, 1, 2, and 3 kHz, or less than 15 dB at individual frequencies.
- Patients who have profound sensorineural hearing loss in one ear and normal hearing in . the opposite ear (i.e., single-sided deafness or "SSD"). The pure tone average air conduction hearing thresholds of the hearing ear should be better than or equal to 20 dB HL (measured at 0.5, 1, 2, and 3 kHz).
- The Osia System for SSD is also indicated for any patient who is indicated for an 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.
6
Image /page/6/Picture/0 description: The image shows the logo for Cochlear, a company that specializes in hearing solutions. The logo features a stylized, abstract symbol in a golden color, resembling three curved shapes nested within each other. Below the symbol, the company name "Cochlear" is written in a clear, sans-serif font, also in golden color. Underneath the company name, the tagline "Hear now. And always" is displayed in a smaller font size.
I. MR Conditional
The OSI300 implant is designed to allow the patient to be examined by an MRI at 1.5T and at 3T without having the implant magnet removed or required use of an MRI kit.
J. Technological Characteristics and Comparison to Predicate
Like other active implantable bone conduction hearing systems, the Osia System is comprised of multiple components, including: an implant, sound processor, fitting software, and other cables and accessories. The Osia System is intended to compensate for conductive or mixed hearing loss or single sided deafness by conveying amplified acoustic signals to the cochlea via mechanical vibrations on the skull bone. These vibrations bypass the damaged parts of the outer and/or middle ear to stimulate the inner ear hair cells, allowing patients to clearly hear sounds and speech around them.
Both the updated Osia System and the predicate Osia System are surgically implanted in the mastoid bone, and an external sound processor is held in place on the patient's scalp by magnetic attraction between the implant and sound processor.
The updated Osia System, which includes a new OSI300 Implant and Osia 2(1) Sound Processor, and modifications to the Osia 2 Sound Processor, Osia Fitting Software 2, and Osia Smart App, has the same intended use and the same fundamental operating principles as the predicate Osia 2 System. The updated Osia System introduces the OSI300 Implant and Osia 2(1) Sound Processor to allow for the patient to be examined by an MRI at 1.5T and 3T without having the implant magnet removed or requiring use of an MRI kit.
Table 1 summarizes a comparison of the technological characteristics of the currently available Osia 2 System (predicate device) with the updated Osia System (subject device).
| Technological
Characteristic | Osia 2 System (Predicate,
K220922) | Osia System (Subject) |
|-------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The Cochlear Osia System uses
bone conduction to transmit sounds
to the cochlea (inner ear) with the
purpose of enhancing hearing. Osia
Implants are single use devices
intended for long term implantation
under the skin in the mastoid region
of either side of the head. They are
for professional use only. | Same |
| Indications | The Osia System is intended for the
following patients and indications:
• Patients 12 years of age or
older.
• Patients who have a conductive
or mixed hearing loss and still | Same |
| Technological
Characteristic | Osia 2 System (Predicate,
K220922) | Osia System (Subject) |
| | can benefit from sound
amplification. The pure tone
average (PTA) bone conduction
(BC) threshold (measured at
0.5, 1, 2, and 3 kHz) should be
better than or equal to 55 dB
HL. Bilateral fitting of the Osia
System is intended for patients
having a symmetrically
conductive or mixed hearing
loss. The difference between the
left and right sides' BC
thresholds should be less than
10 dB on average measured at
0.5, 1, 2, and 3 kHz, or less than
15 dB at individual frequencies. Patients who have profound
sensorineural hearing loss in
one ear and normal hearing in
the opposite ear (i.e., single-
sided deafness or "SSD"). The
pure tone average air
conduction hearing thresholds
of the hearing ear should be
better than or equal to 20 dB HL
(measured at 0.5, 1, 2, and 3
kHz). The Osia System for SSD is
also indicated for any patient
who is indicated for an air-
conduction
contralateral routing of signals
(AC CROS) hearing aid, but
who for some reason cannot or
will not use an AC CROS. Prior to receiving the device, it
is recommended that an
individual have experience with
appropriately fitted air
conduction or bone conduction
hearing aids. | |
| Energy Used / Delivered | An external sound processor is used
to pick up surrounding sound and | Same |
| Technological
Characteristic | Osia 2 System (Predicate,
K220922) | Osia System (Subject) |
| | transfer it to an implant through a
digital inductive link. That implant
picks up the signal and translates it
into vibrations. A second implant is
screwed into the bone (and
osseointegrates), and is attached to
the first implant, ensuring implant
anchoring and that vibrations are
transferred to the cochlea. | |
| System Compatibility | The Osia 2 System includes an
implant, sound processor, surgical
tools and accessories, software,
programming cable, and fitting
software.
It is also capable of wireless
connection to accessories and the
fitting software. | Same |
| Implant | OSI200 Implant | Different. Introducing
the OSI300 implant,
which is designed with
a rotatable magnet to
allow the patient to be
examined by an MRI at
1.5T and at 3T without
having the implant
magnet removed or
requiring use of an
MRI kit |
| Osseointegrated Implant | BI300 (K100360) | Same |
| Biocompatibility of Implant | Biocompatibility of the Osia
System has been evaluated and
tested. All tests were passed and
confirm that the Osia System is
biocompatible.
The OSI200 Implant was assessed
as biologically safe in accordance
with ISO 10993-1:2018, ISO
14708-7:2013, and the FDA
Guidance “Use of International
Standard ISO 10993-1, Biological
evaluation of medical devices – Part
1: Evaluation of testing within a | Same - The changes to
the implant do not
impact the product
characteristics that
were verified with the
predicate. There is no
change to the surfaces
and materials of the
device that contacts the
body. Verification is
leveraged from the
previous OSI200
Implant device cleared
by the FDA under |
| Technological | Osia 2 System (Predicate,
K220922) | Osia System (Subject) |
| Characteristic | | |
| | risk management process” (2016),
for a permanent (>30 days) implant
device contacting tissue and bone
and can be considered safe for use. | K191921 with
additional testing
performed for the coil
magnet assembly. |
| Sterilization of Implant | Each OSI200 Implant is delivered
ethylene-oxide (EO) sterilized and
packed into protective packaging.
Sterilization validation was
demonstrated to be in compliance
with ISO 11135: 2014. | Same, the sterilization
method remains the
same for the OSI300
Implant. |
| Shelf Life and Packaging-
Implant | Shelf-life of the OSI200 Implant is
2.5 years.
The packaging of the implant was
designed and validated to ensure the
sterility and integrity of the
individually packaged and sealed
devices during sterilization,
distribution and storage over the
labeled shelf life according to EN
45502-1 Cl. 12.1 and compliance
with EN ISO 1160711607 – 2009
+A1:2014. | Same, the shelf life
remains the same for
the OSI300 Implant. |
| Implant Reliability Testing
and Performance Data | The verification tests for
performance and reliability of the
OSI200 Implant include those
related to:
Acoustic Output, Link Integrity,
Fixation Screw, Static Load, Coil
Impact, Cyclic Load, Static Load,
Lifetime Testing, Hermeticity, Coil
Robustness, Fluid Ingress,
Particulate Matter Testing,
Maximum Surface Temperature,
and Environmental Conditioning. | Similar, some test
results previously
cleared were not re-run
and new tests for the
OSI300 implant were
conducted. |
| MRI Compatibility | The Osia System is MR
Conditional. | The Osia System
remains MR
Conditional; however,
MR Conditions have
changed:
The OSI300 implant is
designed to allow the
patient to be examined |
| Technological
Characteristic | Osia 2 System (Predicate,
K220922) | Osia System (Subject)
Hear now. And always |
| Sound Processor | Osia 2 Sound Processor | by an MRI at 1.5T and
at 3T without having
the implant magnet
removed or requiring
use of an MRI kit.
Similar.
The Osia 2(I) sound
processor is nearly
identical to the Osia 2
sound processor,
except that the RF link
circuitry is tuned in
production with a 4(I)
magnet to attain an
optimum RF link
performance for the
strongest 4(I) magnet,
which is to be used for
the largest skin flap
thickness range. |
| Sound Processor Function | The Osia 2 System requires the use
of an externally worn sound
processor that is worn on the head
behind the ear.
The Osia 2 Sound Processor's main
function is to receive sound using
its two microphones, perform signal
processing and deliver power and
an audio stream to the OSI200
implant via the RF link. | Same, with new
OSI300 Implant. |
| Sound Processor Magnet | The Osia 2 Sound Processor uses
standard axial magnets (M1, M2,
M3, M4) that are compatible with
the OSI100 and OSI200 implant
magnets. | Different, the updated
magnets for the Osia
2(I) sound processor
allow for compatibility
with the magnet
introduced in the
OSI300 Implant. |
| Sound Processor Firmware | The Osia 2 Sound Processor chipset
includes two distinct blocks: one
block is based on the GN Hearing
C4.5/Palpatine platform, and is
responsible for receiving the | Similar, the firmware
has been updated with
new functionalities to
support the OSI300
Implant. |
| Technological
Characteristic | Osia 2 System (Predicate,
K220922) | Osia System (Subject) |
| | microphone input, performing
signal processing, and delivering an
analogue output signal that is fed
into the differential input of the
other block, the NEO-XS chip. The
NEO-XS block is responsible for
transferring the audio signal to the
implant via the RF link. | |
| Contact and
Biocompatibility of Sound
Processor | The Osia 2 Sound Processor is an
intact-skin contacting device for
permanent use.
Testing was completed on the sound
processor outer materials to
demonstrate biocompatibility in
accordance with ISO / EN ISO
10993-1: October 2009 Biological
evaluation of medical devices Part
1: Evaluation and testing within a
risk management process. | Same |
| Shelf Life and Packaging -
Sound Processor | The Osia 2 Sound Processor is not
provided in sterile packaging and
does not have a restricted shelf life. | Same, for the Osia 2(I)
Sound Processor. |
| Fitting Software | The Osia Fitting Software 2 is used
by the audiologist to configure all
patient related data in the sound
processor. The fitting software is an
application running on a Windows
PC.
It is a stand-alone software. | Similar, new features
are available in the
Osia Fitting Software 2
to support the changes
to the Osia 2(I) Sound
Processor and OSI300
Implant. |
| Smart App | The Osia Smart App is a software
application intended to remotely
control and monitor the Osia 2
Sound Processor directly from a
smartphone.
Available for Android and iOS. | Similar. The Osia
Smart App has been
updated to support
identification of the
Osia 2(I) sound
processor and OSI300
implant. |
Table 1: Comparison Summary of Osia System
7
Image /page/7/Picture/0 description: The image is the logo for Cochlear, a company that specializes in hearing solutions. The logo features a stylized, golden-yellow spiral shape resembling a cochlea, which is the part of the inner ear responsible for hearing. Below the spiral is the company name, "Cochlear," also in golden-yellow. Underneath the name is the tagline, "Hear now. And always," in a smaller font, emphasizing the company's commitment to long-term hearing solutions.
8
Image /page/8/Picture/0 description: The image contains the logo for Cochlear, a company that specializes in hearing solutions. The logo features a stylized graphic of three overlapping, curved shapes in a golden color, resembling sound waves or the inner ear. Below the graphic, the company name "Cochlear" is written in a bold, sans-serif font, also in the same golden color. Underneath the company name, the tagline "Hear now. And always" is displayed in a smaller, lighter font.
9
Image /page/9/Picture/0 description: The image contains the logo for Cochlear, a company that specializes in hearing solutions. The logo features a stylized, abstract representation of the cochlea, the spiral-shaped part of the inner ear, rendered in a golden color. Below the cochlea graphic, the company name "Cochlear" is printed in a bold, sans-serif font, also in golden color. Underneath the company name, the tagline "Hear now. And always" is displayed in a smaller, lighter font.
10
Image /page/10/Picture/0 description: The image contains the logo for Cochlear, a company that specializes in hearing solutions. The logo features a stylized graphic of three overlapping, curved shapes in a golden color, resembling sound waves or a cochlea. Below the graphic, the company name "Cochlear" is written in a matching golden color, and underneath that, the tagline "Hear now. And always" is displayed in a smaller font.
11
Image /page/11/Picture/0 description: The image contains the logo for Cochlear, a company that specializes in hearing solutions. The logo features a stylized graphic of three overlapping, curved shapes in a golden color, resembling sound waves or the inner ear. Below the graphic, the company name "Cochlear" is written in a bold, sans-serif font, also in the same golden color. Underneath the company name, the tagline "Hear now. And always" is displayed in a smaller, lighter font.
Additional details on the new features and functionalities for the subject devices are provided below:
12
Image /page/12/Picture/0 description: The image contains the logo for Cochlear. The logo features a stylized, golden-yellow graphic of three curved shapes nested within each other, resembling a cochlea. Below the graphic is the word "Cochlear" in a matching golden-yellow color, and beneath that is the tagline "Hear now. And always" in a smaller font.
OSI300 Implant
- The OSI300 implant is designed with a rotatable magnet to allow the patient to be ● examined by an MRI at 1.5T and at 3T without having the implant magnet removed or requiring use of an MRI kit.
- . The standard magnets used in the predicate implant devices are replaced by imaging magnets which have a different magnetization polarity. This change enables 1.5T and 3T MRI examinations with magnet in place, and without the need for a supporting bandage or splint. The Cochlear Magnet Cassette provides retention of the sound processor for the OSI300 implant, as the Cochlear Sterile Replacement Magnet does for the OSI200 implant. The Magnet Cassette on the OSI300 implant contains a magnet which can rotate when subjected to magnetic fields. It is intended to be used to replace the magnet of the hearing implant that has been removed to facilitate a medical procedure.
- The Non-Magnetic Cassette serves the same function for the OSI300 implant as the ● Cochlear Sterile Non-Magnetic Plug serves for the OSI200 implant. It is intended to be used temporarily in place of the magnet cassette of a hearing implant after the implant magnet cassette is removed.
Osia 2(I) Sound Processor
- The Osia 2(I) Sound Processor is developed from the Osia 2 Sound Processor with fine tuning of the radiofrequency (RF) link to optimize compatibility with the OSI300 implant
- The hardware remains unmodified from the predicate device. O
- The firmware has been updated to allow the Sound Processor to detect the O updated OSI300 implant
- Relevant finetuning improvements have also been made to the Osia 2 Sound O processor, and the new firmware version is used in both the Osia 2 Sound Processor and the Osia 2(I) Sound Processor.
- New Imaging Magnets (1(1), 2(1), 3(1), and 4(1)), with updated magnetization polarity ● compared to the standard magnets used for the Osia 2 Sound Processor, are introduced for retention of the Osia 2(I) Sound Processor to the magnet cassette of the OSI300 Implant.
- The Osia 2(I) Magnet Tool serves the same function as the Osia 2 Magnet tool, i.e., use for removal of the sound processor magnet from the sound processor base. It was updated for the changed magnetization polarity of the (1) magnets used for the Osia 2(1) sound processor.
Osia Fitting Software 2
- Updated to be able to identify Osia 2(I) Sound Processor and OSI300 Implant ●
- Updated Cochlear Baha Prescription to improve the sound quality and to reduce the sharpness of the sound
Osia Smart App
- Updated to support identification of Osia 2(I) Sound Processor and OSI300 Implant ●
- Minor user interface updates and bug fixing ●
13
Image /page/13/Picture/0 description: The image contains the logo for Cochlear, a company that specializes in hearing solutions. The logo features a stylized, golden-yellow symbol resembling a series of overlapping 'C' shapes, possibly representing sound waves or the cochlea itself. Below the symbol, the company name "Cochlear" is printed in a matching golden-yellow color, with the tagline "Hear now. And always" underneath in a smaller font.
K. Performance Data
Bench testing was conducted to compare the updated Osia System with the cleared Osia 2 System. Substantial equivalence to the predicate device was accomplished through non-clinical bench testing related to functionality and performance testing, hardware and interface testing, as well as system and subsystem level testing.
Verification activities for the new OSI300 Implant included performance testing re-executed to support:
- . Functional verification
- Fixation Screw verification
- Safety and Reliability verification related to MRI Safety, Maximum Surface Temperature, Coil Tensile and Flexural Robustness, Magnet Retention, Fluid Ingress, Implant Impact, Coil Impact, Release of Particulate Matter, ESD
- Environmental Testing verification
The following verification testing performed on the cleared OSI200 Implant remains applicable to the new OSI300 Implant and were leveraged with justification from the predicate device.
- Safety and Reliability verification related to Diagnostic Ultrasound, Therapeutic Ionising Radiation, Implant High Power Electric Fields
- Surgical Implementation ●
- Sterilization ●
- . Sterile Barrier
- Shelf-Life
Validation activities were completed for the OSI300 Implant and the Osia 2(I) Sound Processor to confirm that user needs were met. Previously completed validation and usability testing was leveraged where applicable for the updated Osia System.
Verification related to the OSI300 Implant was completed and concluded that the changes do not affect the safety and effectiveness of the device related to the:
- OSI300 Implant ●
- Sound Processor and its accessories ●
- Osia Fitting Software 2 ●
- . Osia Smart App
The results demonstrate the updated Osia System, including the new OS1300 Implant and Osia 2(I) sound processor, along with the modified Osia 2 Sound Processor, Osia Fitting Software 2, and Osia Smart App are functionally equivalent to the cleared Osia 2 System.
L. Conclusion
Based on the indications for use, technological characteristics, and substantial equivalence comparison to the predicate device, supported by non-clinical data, the updated Cochlear Osia System has been shown to be as safe and effective for its intended use as the predicate device.