(522 days)
Not Found
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and provides no other indication of AI/ML technology in the device description or performance studies.
Yes.
The device treats hearing loss by restoring sound amplification and improving speech recognition and hearing thresholds.
No
The BONEBRIDGE system is a bone conduction hearing implant system designed to amplify sound and improve hearing for individuals with specific types of hearing loss. It functions as a treatment or assistive device rather than a tool for diagnosing medical conditions or diseases. While it uses existing audiometric data (like pure tone average bone conduction thresholds) for patient selection, the device itself does not perform diagnostic measurements.
No
The device description explicitly states that the BONEBRIDGE consists of a surgically implanted Bone Conduction Implant and an external Audio Processor, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device for treating hearing loss by directly stimulating the bone, bypassing the outer and middle ear. This is a therapeutic intervention, not a diagnostic test performed on samples from the body.
- Device Description: The device consists of an implant and an external processor, both designed to transmit sound vibrations to the bone. This is consistent with a hearing aid system, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a disease or condition based on in vitro testing.
- Performance Studies: The performance studies focus on improvements in hearing and speech understanding, which are outcomes related to the device's therapeutic function, not its diagnostic accuracy.
In summary, the BONEBRIDGE bone conduction hearing implant system is a medical device intended for the treatment of hearing loss, not for performing in vitro diagnostic tests.
N/A
Intended Use / Indications for Use
The BONEBRIDGE bone conduction hearing implant 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 45 dB HL.
- . Bilateral fitting of the BONEBRIDGE 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 BONEBRIDGE 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 fit air conduction or bone conduction hearing aids.
Product codes
PFO
Device Description
The BONEBRIDGE consists of a Bone Conduction Implant that is surgically implanted in the mastoid bone and an external Audio Processor that is held in place on the patient's scalp by magnetic attraction between the implant and the Audio Processor (Figure 1).
The Bone Conduction Implant ("BCI"), also referred to as BCI 601 in this document, is an implantable hearing prosthesis that is surgically implanted on the skull in order to directly vibrate the mastoid bone, which in turn stimulates the inner ear. The BCI consists of the Receiver Coil, Attachment Magnet, Demodulator, Transition Link, Floating Mass Transducer (BC-FMT) and anchor holes for the Cortical Screws (Figure 1 & Figure 2). The implanted Receiver Coil picks up the signal from the Audio Processor transcutaneously and the signal is then demodulated and sent to the BC-FMT. The BC-FMT is implanted in the mastoid region of the skull and vibrates in a controlled manner in response to the signal. These vibrations are then transmitted via the skull bones to the inner ear, bypassing the damaged parts of the outer and/or middle ear to stimulate the inner ear hair cells; thus, allowing patients to clearly hear sounds and speech around them. The BCI is provided sterile as part of the BCI 601 Implant Kit.
The Audio Processor available for use with the BONEBRIDGE is the SAMBA BB. The Audio Processor is attached to the head and BCI with a magnet and is powered by a standard hearing aid battery (Zinc-Air 675 or equivalent).
The SAMBA BB features a standard base in anthracite and 16 cover color and design variants. In addition, the SAMBA features a remote control (Figure 4).
The Audio Processors contain dual microphones that pick up sound and speech from the environment and convert them into a signal that can be transmitted across the skin to the BCI. The signal transmitted by the Audio Processor is transferred to the Receiver Coil and relayed to the BC-FMT. The controlled vibrations of the BC-FMT are then interpreted as sound. The Audio Processor does not contain software and can be fitted to meet the patient's needs using separate software.
The SAMBA BB features a left and right variant as well as 5 magnet strength options to accommodate for variations in the thickness of the skin flap overlying the implant.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
mastoid bone, skull bone, skull
Indicated Patient Age Range
12 years of age or older
Intended User / Care Setting
Physician / Not Found
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)
Overall study design:
A prospective, single arm, open-label, pre-market study (BB001) was conducted among 12 adult and 12 pediatric patients with mild-to-moderate degree of mixed (MHL) or conductive hearing loss (CHL) up to 3 months post implantation. 10 adults and 8 children in the BB001 study along with additional 35 adults were recruited into a post-market follow-up study (BB002) to investigate the long-term safety and effectiveness of BONEBRIDGE. A prospective, single arm, open-label, post-market study (BB 003) was conducted among 13 adult patients with Single Sided Deafness (SSD) (unilateral severe to profound sensorineural hearing loss) up to 12 months post implantation. Subjects were unilaterally implanted with the BONEBRIDGE implant system and served as their own controls (i.e., preoperative unaided = no treatment, comparted to postoperative aided with the BONEBRIDGE implant system).
Effectiveness results:
The results from BB 001 and BB 002 studies demonstrate the following benefits for subjects with the MHL and CHL:
- There was statistically and clinically significant benefit (average 63.3% improvement (p
§ 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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DE NOVO CLASSIFICATION REQUEST FOR BONEBRIDGETM
REGULATORY INFORMATION
FDA identifies this generic type of device as:
Active implantable bone conduction hearing system. 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.
NEW REGULATION NUMBER: 21 CFR 874.3340
CLASSIFICATION: II
PRODUCT CODE: PFO
BACKGROUND
DEVICE NAME: BONEBRIDGE™ SYSTEM (BONEBRIDGE™)
SUBMISSION NUMBER: DEN170009
DATE OF DE NOVO: February 16, 2017
CONTACT: MED-EL Elektromedinische Geraete GmbH Fuerstenweg 77 A Innsbruck, A-6020 Austria
INDICATIONS FOR USE
The BONEBRIDGE bone conduction hearing implant 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 45 dB HL.
- . Bilateral fitting of the BONEBRIDGE 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.
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- 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 BONEBRIDGE 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 fit air conduction or bone conduction hearing aids.
LIMITATIONS
Prescription Use only: Federal (USA) law restricts this device to sale by or on the order of a physician. Limitations on device use are included in the Instructions for Use as Contraindications, Warnings, and Precautions.
Contraindications
- Chronic or non-revisable vestibular or balance disorders
- . Abnormally progressive hearing loss
- . Evidence of conditions that would prevent good speech recognition potential as determined by good clinical judgment.
- . Skin or scalp conditions that may preclude attachment of the audio processor or that may interfere with the use of the audio processor.
- . Skull size or abnormality that would preclude appropriate placement of the BONEBRIDGE implant as determined by CT scan.
Warnings
- . Potential risks may be, but are not limited to, local skin numbness or pain, infection, transient tinnitus, vertigo or headache, dural erosion/compression, CSF leak, bleeding/hematoma from injury to sigmoid sinus, subdural hematoma, infection, and facial nerve injury.
- . It is recommended that BCI recipients receive age appropriate vaccinations including a vaccination against pneumococcal meningitis prior to implantation.
- . Electromagnetic fields produced by other electrical equipment such as cell phones, metal detectors microwaves, RFID systems and commercial theft detection systems (also known as electronic article surveillance [EAS]) may interfere with the device. In the event that the patient perceives unexpected noise or interference in the presence of these devices, move away from the source to mitigate the potential interference. Remove the processor and if you have further concerns, contact your hearing healthcare professional.
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PLEASE REFER TO THE LABELING FOR A MORE COMPLETE LIST OF WARNINGS, PRECAUTIONS AND CONTRAINDICATIONS.
DEVICE DESCRIPTION
The BONEBRIDGE consists of a Bone Conduction Implant that is surgically implanted in the mastoid bone and an external Audio Processor that is held in place on the patient's scalp by magnetic attraction between the implant and the Audio Processor (Figure 1).
Image /page/2/Figure/3 description: The image shows a BCI implant with an audio processor. The BCI implant consists of a receiver coil and attachment magnet, a demodulator, and a transducer. The image also shows a flow diagram of how the BCI implant works, starting with acoustic input, optimized transfer, and force output to the skull.
Figure 1: Diagram of the BONEBRIDGE
Bone Conduction Implant
The Bone Conduction Implant ("BCI"), also referred to as BCI 601 in this document, is an implantable hearing prosthesis that is surgically implanted on the skull in order to directly vibrate the mastoid bone, which in turn stimulates the inner ear. The BCI consists of the Receiver Coil, Attachment Magnet, Demodulator, Transition Link, Floating Mass Transducer (BC-FMT) and anchor holes for the Cortical Screws (Figure 1 & Figure 2). The implanted Receiver Coil picks up the signal from the Audio Processor transcutaneously and the signal is then demodulated and sent to the BC-FMT. The BC-FMT is implanted in the mastoid region of the skull and vibrates in a controlled manner in response to the signal. These vibrations are then transmitted via the skull bones to the inner ear, bypassing the damaged parts of the outer and/or middle ear to stimulate the inner ear hair cells; thus, allowing patients to clearly hear sounds and speech around them. The BCI is provided sterile as part of the BCI 601 Implant Kit.
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Image /page/3/Figure/0 description: The image shows a medical device with its dimensions labeled. The device has two main sections: a coil section and a transducer section. The coil section includes an attachment magnet, a receiver coil, and a demodulator, with a length of 69 mm (2.72 in.) and a height of 4.5 mm (0.18 in.). The transducer section includes anchor holes, a transition link, and a height of 8.7 mm (0.34 in.) and 23.8 mm (0.94 in.).
Figure 2 Bone Conduction Implant
Attachment Magnet
The Attachment Magnet of the BCI is located in the center of the Receiver Coil. The Attachment Magnet of the BCI attracts the Attachment Magnet of the Audio Processor to hold the Audio Processor in place on the user's head. The magnet has a triangular symbol on the side that should be facing the surgeon at the time of implantation.
Receiver Coil
The Receiver Coil is inductively matched to the telemetry coil of the external Audio Processor. It picks up the audio signal and conducts the signal to the Demodulator via a lead.
Demodulator
The Demodulator's electronic circuitry extracts the audio signal from the signal picked up by the Receiver Coil and converts it to a signal that elicits vibration in the Floating Mass Transducer. In this process, the Demodulator provides a surge protection for the Floating Mass Transducer from potential external interference sources by limiting the maximum amount of current transmitted to the Floating Mass Transducer. This protection ensures that the maximum Floating Mass Transducer force output will not be exceeded under reasonably foreseeable circumstances, such as strong magnetic field exposure.
Floating Mass Transducer
The Bone Conduction Floating Mass Transducer (BC-FMT) is an electromagnetic transducer. The BC-FMT titanium housing has two extensions, or "wings" with anchor holes to fix the BC-FMT to the skull behind the ear, using the Cortical Screws. When a signal from the Demodulator reaches the BC-FMT, the magnets inside the BC-FMT vibrate accordingly and these vibrations are transferred to the mastoid bone via the osseointegrated Cortical Screws.
Transition Link
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The Transition Link connects the Demodulator to the BC-FMT and can be bent, if necessary, to fit the implant bed. The transition can be bent to a ±90° angle about the horizontal plane and to a ±30° angle in the vertical plane, as needed.
BCI 601 Implant Kit
The BCI 601 implant and the surgical tools are provided to the customer in the BCI 601 Implant Kit (Figure 3). The BCI 601 Implant Kit is provided sterile (Ethylene Oxide) and each of its components is intended for single-use.
Image /page/4/Picture/3 description: This image shows a BCI 601 implant kit. The kit includes a C-sizer, T-sizer, cortical screws, emergency screw, BCI 601, and a drill bit with stopper. All of the items are arranged in a clear plastic container with individual compartments for each item.
Figure 3 BCI 601 Implant Kit
Audio Processor
The Audio Processor available for use with the BONEBRIDGE is the SAMBA BB. The Audio Processor is attached to the head and BCI with a magnet and is powered by a standard hearing aid battery (Zinc-Air 675 or equivalent).
The SAMBA BB features a standard base in anthracite and 16 cover color and design variants. In addition, the SAMBA features a remote control (Figure 4).
Image /page/4/Picture/8 description: The image shows three views of a MED-EL hearing aid device. The device is primarily black with a gray base. The MED-EL logo is visible on the rightmost device. The hearing aid has a round, disc-like shape with a slightly raised center.
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Image /page/5/Picture/0 description: The image shows three views of a Med-El device. The device has a screen and several buttons. The buttons are labeled with numbers 1-8. The Med-El logo is visible at the bottom of the device.
Figure 4 SAMBA Audio Processor (above) & Remote Control (below)
The Audio Processors contain dual microphones that pick up sound and speech from the environment and convert them into a signal that can be transmitted across the skin to the BCI. The signal transmitted by the Audio Processor is transferred to the Receiver Coil and relayed to the BC-FMT. The controlled vibrations of the BC-FMT are then interpreted as sound. The Audio Processor does not contain software and can be fitted to meet the patient's needs using separate software.
The SAMBA BB features a left and right variant as well as 5 magnet strength options to accommodate for variations in the thickness of the skin flap overlying the implant.
Surgical Tools & Accessories
The BCI is implanted using the following surgical accessories provided by MED-EL:
- Coil-Sizer A template representing the Receiver Coil and the Demodulator section ● ("C-Sizer") used to aid the surgeon in (1) determining the optimal BCI placement on the head before incising the skin; (2) determining the exact location of the seat before drilling; and (3) verifying the size of the seat before placing the BCI;
- . Transducer-Sizer - A template representing the Floating Mass Transducer section ("T-Sizer") used to (1) outline the exact size of the seat before drilling; (2) verify the size of the seat before placing the BCI; (3) provide guidance for the drill to ensure the correct distance between the two anchor holes; and (4) correct the orientation and depth of the anchor holes. Additionally, the C-Sizer and the T-Sizer can be connected to represent the complete BCI by inserting the bulge of the C-Sizer into the slot of the T-Sizer;
- Two Cortical Screws used fix the BC-FMT to the skull;
- One Emergency Screw which can be used in the case that fixation with one of the ● Cortical Screws is not successful; and
- . Drill Bit with Stopper used for drilling the fixation points of the BCI.
BCI Lifts & BCI Sizer Kit
There are also two optional accessories to the BONEBRIDGE system:
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- The BCI Lifts: If the necessary drill depth for the BCI 601 cannot be achieved for . anatomical reasons, the BCI Lifts can be used. The use of the BCI Lifts together with the BCI 601 reduces the necessary drill depth for the Bone Conduction - Floating Mass Transducer (BC-FMT) in the skull bone.
- . The BCI Sizer Kit: The BCI Sizer Kit can be used by surgeons during surgery to more easily measure insertion depth for the BONEBRIDGE.
Software
Specific software and hardware are needed to fit (also referred to as program) the BONEBRIDGE audio processor. It should be noted, however, that neither the BCI 601 nor the audio processors contain software.
MED-EL provides the following accessories with the BONEBRIDGE system:
- . SYMFIT 7.0 software – A software database that allows programming of the Audio Processor with an off-the-shelf software.
- . Programming Cable – A cable to connect the audio processor with the interface box.
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SUMMARY OF NONCLINICAL/BENCH STUDIES
The non-clinical/bench studies conducted on the BONEBRIDGE System are summarized in the sections below.
BIOCOMPATIBILITY /MATERIALS
MED-EL has evaluated and tested the biocompatibility of the BONEBRIDGE System in accordance with ISO 10993-1:2009, Biological Evaluation of Medical Devices - Part 1: Evaluation and testing within a risk management process and the FDA Guidance Document, docket number FDA-2013-D-0350. Use of International Standard ISO 10993-1. "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process".
SAMBA BB Audio Processor Biocompatibility
Image /page/7/Picture/5 description: The image shows two different views of a MED-EL hearing aid device. The device has a white top and a gray bottom. The MED-EL logo is printed on the side of the device in the right image.
Figure 5 SAMBA BB
The SAMBA BB is classified as an intact-skin contacting device for permanent use. Accordingly, the biological effects cvtotoxicity. sensitization and irritation / intracutaneous reactivity testing were addressed for those components, which are in actual patient contact (the outer cover, the base, the battery cover, and the hairclip hanger).
BCI 601 Biocompatibility
The BCI 601 is implanted in and above the mastoid bone and as such, is a device in permanent tissue/bone contact. The BCI is fixed to the skull using standard implantable titanium alloy screws (Cortical Screws). Testing, as presented in Table 1, was performed in accordance with FDA's Good Laboratory Practices (GLP) regulation, 21 CFR Part 58. The results of the evaluation were supported by an experimentally performed material characterization study including determination of particulate matter. All tests were passed and confirm that the BONEBRIDGE BCI 601 is biocompatible.
| Test Description | Standard | Assessment | Result |
|---|---|---|---|
| Cytotoxicity - MEM elution | ISO 10993-5:2009 | Tested | Passed |
| Intracutaneous reactivity / Irritation | ISO 10993-10:2010 | Tested | Passed |
| Systemic Toxicity - ISO Acute Systemic | ISO 10993-11:2006 | Tested | Passed |
| Injection Test | |||
| Implantation | ISO 10993-6:2007 | Tested | Passed |
| Sensitization | ISO 10993-10:2010 | Tested | Passed |
| Genotoxicity | ISO 10993-3:2003 | Tested | Passed |
Table 1 BONEBRIDGE BCI 601 Biocompatibility Evaluation
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| Test Description | Standard | Assessment | Result |
|---|---|---|---|
| Subchronic Toxicity | ISO 10993-11:2006 | Tested | Passed |
| ISO 10993-6:2007 | |||
| Carcinogenicity and Chronic Toxicity | ISO 10993-11:2006 | Justification | |
| per test report | Passed | ||
| Pyrogenicity | ISO 10993-11:2006 | Tested | Passed |
| Exhaustive Extraction | ISO 10993-18:2005 | Tested | Passed |
| Extract Analysis – GC/MS fingerprint and | ISO 10993-18:2005 | Tested | Passed |
| Inductive Coupled Plasma Spectroscopy (ICP) | |||
| Particulate Matter (BCI and Screws) | EN45502-1:1997 | Tested | Passed |
BCI Lifts Biocompatibility
BCI Lifts have the same intended use and bone/tissue contact as the BCI 601. The same tests were passed and confirm that the BCI Lifts are biocompatible.
Surgical Tools Biocompatibility
The Surgical Tools are provided together with the BCI 601 implant in the BCI 601 Implant Kit. The Surgical Tools include the C-Sizer, T-Sizer, and Drill Bit with Stopper, which are all intended for transient use during the surgical operation only and have limited tissue/bone contact (16 hours | Passed | | | | | | | | | | |
| Noise Floor | In a completely assembled BONEBRIDGE system, with no acoustic input, the residual noise that is generated by the electronic circuitry in the AP and BCI should be " No skull fractures were present in the samples tested. Therefore, the test objective was reached. However, implant hermeticity was a stated acceptance criterion of the test. One implant demonstrated a fine leak following subjection to an impact of 3.5J.
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| Failure Mode (FM) | Sample
Conditioning | FM Test Post-
Conditioning | Result |
|---------------------------------------------------------------------------------------|------------------------|-------------------------------|-------------------------------|
| 6. Fracture of cortical screws due to
fatigue and stress corrosion | Subgroup B | Visual inspection | Failure mode did
not occur |
| 7. Vibration induced failure of
weld seams of hermetic
transducer encapsulation | Subgroup B | Visual inspection | Failure mode did
not occur |
No implant failures were observed during conditioning. Following conditioning, all BCIs samples passed functional testing and visual inspection for evidence of fatigue. Furthermore, subgroup B samples were also subjected and passed leak testing followed by residual gas analysis testing.
-
Screw Torque/Force Stability .
Testing was conducted to establish the maximum torque and force that the fixation screws can withstand. -
. Bending
BCI bending testing was performed to ensure that the functionality of the BCI will not be affected upon geometric fitting to the patient's skull for implantation.
Physical Characteristics
MED-EL has performed Implant Physical Characteristics and Simulated Surgical Implantation testing to verify that the implant physical characteristics are according to its specifications and to validate that the specifications are adequate for safe implantation. Additionally, Simulated Surgical Implantation testing validated that the surgical tools facilitate safe and reproducible surgery.
-
. Implant Physical Characteristics
Physical characterization testing was conducted on three BCI units to verify the BC-FMT dimensions, design symmetry, coil/attachment dimensions, and implant surface coating. All BCI 601 units met the physical characteristics requirement set up in the BCI design specification. -
. Simulated Surgical Implantation
Simulated surgical implantation testing was conducted in order to validate that the designs of the BCI and the Surgical Tools allow implantation and fixation to the bone without undue damage to nearby body structures. In the simulated implantation testing, the BCI was implanted with the supplied surgical tools into temporal bone or half-head cadaver specimen.
Compatibility with External Pressure, Variations in Pressure and Acceleration MED-EL has assessed compatibility of the BCI with expected external pressure. pressure variations, and acceleration. Specifically, vibration, shock, dynamic impact, atmospheric pressure, water pressure, chronic implant movement, skull fracture and impact testing at 2.5J
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was performed. In each test, the BCI units were tested to the device requirements, conditioned appropriately, and tested again to the device requirements to assess whether the BCI could withstand the conditioning.
Compatibility with Medical Treatment or Examination Environment
MED-EL has assessed compatibility of the BCI with standard diagnostic or medical treatment modalities including diagnostic ultrasound, surgical diathermy, X-ray and Computed Tomography (CT), and radiation therapy and Positron Emission Tomography (PET). To evaluate the compatibility, in each test, BCI units were tested to the device requirements, conditioned per the modality, and tested again to the device requirements.
-
Diagnostic Ultrasound
Diagnostic ultrasound compatibility testing was conducted per EN 45502-1:1997: one group was exposed to 500 W/m2 ±5 % using spatial peak, temporal average mode in frequency of 2-5 MHz with a duty cycle of 50 % ±10 %. The other group was exposed to temporal average intensity of ≥1500 mW/cm² in frequency of 2-5 MHz with a duty cycle of 20 %. Before and after conditioning, implants were assessed per the manufacturing test requirements. All units met the acceptance criteria. -
. Surgical Diathermy
Surgical diathermy compatibility testing was conducted as per EN 45502-2-1:2004. Each BCI unit was separately placed in a metal box filled with saline and exposed to electrical energy (10 pulses, pulse duration of 1 second and pulse relaxation of 5 seconds, at 500 kHz, 20 Vpp) that is typically provided by bipolar electrocauters. Following the exposure via this test, the BCIs were tested for functionality. Device requirements were met before and after conditioning with diathermy. All samples met the specified requirements and no functional degradation was observed following conditioning. -
. X-ray and CT
X-ray and CT compatibility testing was conducted to assess whether exposure to X-ray and CT would have an influence on implant performance. Since the maximum beam energy of an X-ray (60-80keV) is substantially less than that of a CT scan (≤140keV), MED-EL has tested the BCI to the maximum dose of energy delivered in a CT scan to verify the compatibility of the BCI to X-ray and CT. In the testing, BCI 601 implants were placed in an acrylic glass phantom that was exposed to a maximum dose CT using state of the art CT scan. The functionality of the BCI was tested before and after exposure to the CT. The testing demonstrated that implants met the manufacturing requirements before and after the CT scan; the acceptance criteria were met. -
. Radiation Therapy and PET
Radiation therapy and PET imaging compatibility testing was conducted to assess whether exposure to ionizing (gamma) radiation. which is utilized by both procedures, impacts the functionality of the BCI. Since radiation therapy is typically applied in doses of up to 60 Gy and employs higher doses of radiation than PET scan, a worst-case radiation therapy dose of 100 Gy was used for testing. During testing, a single 100 Gy dose was applied in a single irradiation cycle, which is a more severe condition than that of standard clinical use (high
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irradiation doses are applied over several weeks). Before and after gamma radiation conditioning, the BCIs were tested to ensure that the device met its requirements and no performance degradation occurred due to radiation exposure. All BCI units met the device requirements both before and after conditioning.
Temperature Resistance
Testing was performed to verify the BCI operating and storage temperature ranges. The samples were tested to support operational temperature of 18-43°C. Functionality of the BCls was verified after the samples were conditioned at 18°C ±3°C for 4 hours and at 43°C+3°C. All units were reported to be fully functional. To verify the storage temperature, BCI samples were verified to operate after conditioning between -20℃ and 60℃. Following conditioning, all samples were tested for functionality and were found to operate as intended.
BCI Lifts & Sizer Kit Testing
Performance
Two tests were performed to confirm that the BCI Lifts fulfill their performance requirements. The first test is the BCI Lifts performance test. This test addresses: performance, distortion, frequency response, and linearity. All test samples fulfilled the acceptance criteria. The second test addressed the final performance requirement, torque/force stability. As the stability of the test items far exceeded the acceptance criteria, it was concluded that the combination of the BCI 601 implant, BCI Lifts and the cortex screws fulfills this performance requirement. No performance characteristics were identified for the BCI Sizer Kit. The ability of surgeons to effectively use the equipment has been addressed through usability testing.
Mechanical Safety
In addition, the BCI Lifts were tested to demonstrate that they are able to withstand the forces expected to be exerted on the devices during daily use. The test results demonstrated the mechanical stability and safety of the BCI Lifts. The BCI Sizer Kit is used intraoperatively to aid surgeons in placing the BCI 601. The BCI Sizer Kit components are intended for single use in the operating theatre and are not subject to a large degree of mechanical stress during normal use. Shipping and storage testing has been performed to demonstrate that the BCI Sizer Kit and its packaging can withstand the stresses associated with transport.
Usability
Usability tests were performed to demonstrate that the designs of the BCI Lifts are appropriate for their intended use.
- Surgeons implanted a BCI 601 using the BCI Lifts (one of each Lift variant) and BCI ● Sizer Kit
SUMMARY OF CLINICAL INFORMATION
Overall study design
A prospective, single arm, open-label, pre-market study (BB001) was conducted among 12 adult and 12 pediatric patients with mild-to-moderate degree of mixed (MHL) or conductive hearing loss (CHL) up to 3 months post implantation. 10 adults and 8 children in the BB001 study along with additional 35 adults were recruited into a post-market follow-up study (BB002) to investigate the long-term safety and effectiveness of BONEBRIDGE. A
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prospective, single arm, open-label, post-market study (BB 003) was conducted among 13 adult patients with Single Sided Deafness (SSD) (unilateral severe to profound sensorineural hearing loss) up to 12 months post implantation. Subjects were unilaterally implanted with the BONEBRIDGE implant system and served as their own controls (i.e., preoperative unaided = no treatment, comparted to postoperative aided with the BONEBRIDGE implant system).
Demographics
The table below provides information on subject demographics for BB001, including gender, age at implantation, average of previous ear surgeries, implant site, and etiology.
| Parameter/category or statistic | Total (N = 24) | Adult (N = 12) | Pediatric (N = 12) |
|---|---|---|---|
| Gender | |||
| Male % | 29.17 % (N = 7) | 25 % (N = 3) | 33.3 % (N = 4) |
| Female % | 70.83 % (N = 17) | 75 % (N = 9) | 66.7 % (N = 8) |
| Age (years) mean (min-max) | 28 (5 - 69) | 44 (19 - 69) | 11 (5 - 17) |
| Implant side | |||
| Left % | 29.2 % (N = 7) | 25 % (N = 3) | 33.3 % (N = 4) |
| Right % | 70.8 % (N = 17) | 75 % (N = 9) | 66.7 % (N = 8) |
| Previous ear surgeries | |||
| Average surgeries per subject | 1.3 | 2.1 | One pediatric subject was |
| Previously operated subjects | 50 % (N = 12) | 91.7 % (N = 11) | previously operated with five previous ear surgeries. |
| Parameter/category or statistic | Total (N=24) | Adult (N = 12) | Pediatric (N=12) | |||
|---|---|---|---|---|---|---|
| Disease etiology | % | N | % | N | % | N |
| Cholesteatoma | 16.67 | 4 | 33.33 | 4 | 0.00 | 0 |
| Atresia auris | 41.67 | 10 | 25.00 | 3 | 58.33 | 7 |
| COM | 12.50 | 3 | 16.67 | 2 | 8.33 | 1 |
| Chron. mastoiditis | 4.17 | 1 | 8.33 | 1 | 0.00 | 0 |
| Otosclerosis | 4.17 | 1 | 8.33 | 1 | 0.00 | 0 |
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| Microtia | 8.33 | 2 | 0.00 | 0 | 16.67 | 2 |
|---|---|---|---|---|---|---|
| Ear canal stenosis | 4.17 | 1 | 0.00 | 0 | 8.33 | 1 |
| Anotia | 4.17 | 1 | 0.00 | 0 | 8.33 | 1 |
| Glomus tumor | 4.17 | 1 | 8.33 | 1 | 0.00 | 0 |
The table below provides information on subject demographics for BB002, including gender, age at implantation, and implant side.
| Parameter/category or statistic | Total (N = 53) | Adult (N = 45) | Pediatric (N = 8) |
|---|---|---|---|
| Gender | |||
| Male % | 58.5 % (N = 22) | 37.7 % (N = 17) | 62.5 % (N = 5) |
| Female % | 41.5 % (N = 31) | 62.3 % (N = 28) | 37.5 % (N = 3) |
| Age (years) mean (min-max) | 41 (5 - 76) (N = 53) | 47 (18 - 76) (N = 45) | 11 (5 - 17) (N = 8) |
| Implant side | |||
| Left % | 41.5 % (N = 22) | 42.2 % (N = 19) | 37.5 % (N = 3) |
| Right % | 58.5 % (N = 31) | 57.8 % (N = 26) | 62.5 % (N = 5) |
| Previous ear surgeries | |||
| Average surgeries per subject | 3.66 | 3.61 | Only one |
| pediatric subject | |||
| was previously | |||
| operated with | |||
| five previous ear | |||
| surgeries. | |||
| Previously operated subjects | 60.38 % (N=32) | 68.89 % (N=31) |
| Parameter/category or statistic | Total (N = 53) | Adult (N = 45) | Pediatric (N =8 ) | |||
|---|---|---|---|---|---|---|
| Disease etiology | % | N | % | N | % | N |
| Chronic otitis media | 30.19 | 16 | 28.30 | 15 | 1.89 | 1 |
| Atresia | 22.64 | 12 | 16.98 | 9 | 5.66 | 3 |
| Cholesteatoma | 20.75 | 11 | 20.75 | 11 | 0 | 0 |
| Ear dysplasia | 7.55 | 4 | 5.66 | 3 | 1.89 | 1 |
| Malformation | 1.89 | 1 | 0 | 0 | 1.89 | 1 |
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| Ear dysplasia /
| Franceschetti syndrome | 1.89 | 1 | 1.89 | 1 | 0 | 0 |
|---|---|---|---|---|---|---|
| Chronic mastoiditis | 1.89 | 1 | 1.89 | 1 | 0 | 0 |
| Stenosis | 1.89 | 1 | 1.89 | 1 | 0 | 0 |
| Anomalius bar | 1.89 | 1 | 1.89 | 1 | 0 | 0 |
| Congenital syndromic malformation | 1.89 | 1 | 0 | 0 | 1.89 | 1 |
| Otosclerosis | 1.89 | 1 | 1.89 | 1 | 0 | 0 |
| Glomus tumor | 1.89 | 1 | 1.89 | 1 | 0 | 0 |
| Osteogenesis imperfecta otosclerosis | 1.89 | 1 | 1.89 | 1 | 0 | 0 |
| Microtia | 1.89 | 1 | 0 | 0 | 1.89 | 1 |
The table below provides information on subject demographics for BB003, including gender, age at implantation, and implant side.
| Parameter/Category or Statistic | Total (N=13) |
|---|---|
| gender | |
| Male % | 53.85 % (N=7) |
| Female % | 46.15 % (N=6) |
| Age (years) mean (min-max) | 39 (18-59) (N=13) |
| Implant Side | |
| Left % | 46.15 % (N=6) |
| Right % | 53.85 % (N=7) |
Study endpoints
Safety endpoints:
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- The primary safety endpoint is evaluated by tabulations of Adverse Events (AEs) and Serious Adverse Events (SAEs) through 12-month follow-up period.
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- The secondary safety endpoint was the change in bone conduction thresholds at audiometric frequencies (500-4000 Hz) from pre-operative baseline to post-operative unaided condition after completion of the 12-month study. Success criterion was no more than mean 10 dB change in individual subject PTA across 500-4000Hz and on individual frequency.
Effectiveness endpoints:
- The primary effectiveness endpoint was the improvement in word/sentence recognition 1. from the preoperative unaided condition to the 12-month postoperative aided condition. An improvement of 15% was the success criteria for the primary endpoint.
-
- The secondary effectiveness endpoints were 1) the improvement in functional gain (difference between unaided and aided hearing thresholds) defined as Pure Tone
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Average across 500-4000 Hz; and 2) the improvement in the Speech Reception Threshold (SRT; Oldenburger Satztest (OLSA)) from pre-operative baseline to postoperative aided condition after completion of the 12-month study.
Effectiveness results
The results from BB 001 and BB 002 studies demonstrate the following benefits for subjects with the MHL and CHL:
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- There was statistically and clinically significant benefit (average 63.3% improvement (p