Sentio Ti Implant Kit; Sentio 1 Mini; Genie Medical BAHS
Device Facts
| Record ID | K240614 |
|---|---|
| Device Name | Sentio Ti Implant Kit; Sentio 1 Mini; Genie Medical BAHS |
| Applicant | Oticon Medical AB |
| Product Code | PFO · Ear, Nose, Throat |
| Decision Date | Jul 10, 2024 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 874.3340 |
| Device Class | Class 2 |
| Attributes | Therapeutic, Pediatric |
Intended Use
The Sentio Ti implant, in combination with Sentio 1 Mini, is indicated for the following patients: Patients with conductive or mixed hearing losses, who can still benefit from amplification of the sound. The pure tone average (PTA) bone conduction (BC) threshold (measured at 0.5, 1, 2 and 3 kHz) of the indicated ear should be better than or equal to 45 dB HL. Patients having a symmetrically conductive or mixed hearing loss are candidates for a bilateral fitting. 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 a 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 (PTA) air conduction (AC) threshold of the hearing ear should then be better than or equal to 20 dB HL (measured at 0.5, 1, 2 and 3 kHz). Patients who are 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 has experience with appropriately fitted air conduction or bone conduction hearing aids. Patients 12 years of age or older.
Device Story
Active transcutaneous bone conduction hearing system; consists of external sound processor (Sentio 1 Mini) and internal implant (Sentio Ti). Microphones in processor capture sound; signal processed and transmitted via 120kHz RF link through skin to implant receiver coil. Implant converts signal to mechanical vibrations; transducer transfers vibrations to skull bone for cochlear stimulation. Used in home/clinical settings; operated by patient/clinician. Processor held by magnetic retention. Clinician uses Genie Medical BAHS software for fitting/adjustment. System improves hearing for conductive/mixed loss or SSD; provides functional gain and speech intelligibility improvement. Benefits include reduced disability and improved quality of life.
Clinical Evidence
Clinical evidence includes five studies (O1, C58, BC114, BC101, C70). Pivotal study BC101 (n=51) showed significant improvement in hearing and speech intelligibility (97.6% in quiet). Mean functional gain 29.3 dB (FAS). Quality of life improved (GBI score 29.2). No serious adverse events reported; minor complications (dizziness, pain) were transient. Long-term safety supported by 113+ years of accumulated user time across iterations. MRI sub-study (n=9) confirmed safety at 1.5T.
Technological Characteristics
Active implantable bone conduction system. Implant: Titanium (Grade 2/5), medical grade silicone elastomer. Fixation: Titanium alloy (Ti6Al4V) screws. Dimensions: 60x30x4mm. Sterilization: EtO (implant), Steam (templates). Connectivity: 2.4 GHz Bluetooth Low Energy, RF link (120kHz). MRI: 1.5T Conditional. Sound processor: 64 processing channels, dual directional microphones, tamper-resistant battery drawer.
Indications for Use
Indicated for patients 12+ years with conductive/mixed hearing loss (PTA BC threshold ≤45 dB HL) or single-sided deafness (profound sensorineural loss in one ear, normal hearing in opposite ear with PTA AC threshold ≤20 dB HL). Candidates include those needing bilateral fitting or those indicated for AC CROS hearing aids who cannot/will not use them. Prior experience with air/bone conduction aids recommended.
Regulatory Classification
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.
Special Controls
In combination with the general controls of the FD&C Act, the active implantable bone conduction hearing system is subject to the following special controls:
*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.
Predicate Devices
- Bonebridge System (DEN170009)
Reference Devices
- Ponto 5 SuperPower (K213733)
- BCI 601 Implant kit (DEN170009)
- BCI 602 Implant Kit (DEN170009)
- Samba Audio Processor (DEN170009)
Related Devices
- K240155 — Cochlear Osia System · Cochlear Americas · Apr 18, 2024
- K220922 — Cochlear Osia 2 System, Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Cochlear Osia Fitting Software 2, Cochlear MRI Kit · Cochlear Americas · Jul 27, 2022
- K190589 — Cochlear Osia OSI100 Implant, Cochlear Osia Sound Processor, Osia Intraoperative Test Software, Osia Fitting Software, Cochlear Osia Surgical Instruments · Cochlear Americas · Jul 3, 2019
- K191921 — Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Osia Fitting Software 2.0, Osia SmartApp, Cochlear Osia Surgical Instruments · Cochlear Americas · Nov 15, 2019
Submission Summary (Full Text)
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July 10, 2024
Oticon Medical AB Pernilla Gustafsson Head of Homologation Datavagen 37 B Askim. 436 32 Sweden
Re: K240614
Trade/Device Name: Sentio Ti Implant Kit; Sentio 1 Mini; Genie Medical BAHS Regulation Number: 21 CFR 874.3340 Regulation Name: Active Implantable Bone Conduction Hearing System Regulatory Class: Class II Product Code: PFO Dated: June 10, 2024 Received: June 10, 2024
Dear Pernilla Gustafsson:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-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,
Joyce C. Lin -S
for Shu-Chen Peng, Ph.D. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
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# Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
### K240614
Device Name
Sentio Ti Implant Kit; Sentio 1 Mini; Genie Medical BAHS
Indications for Use (Describe)
The Sentio Ti implant, in combination with Sentio 1 Mini, is indicated for the following patients:
· Patients with conductive or mixed hearing losses, who can still benefit from amplification of the sound. The pure tone average (PTA) bone conduction (BC) threshold (measured at 0.5, 1, 2 and 3 kHz) of the indicated ear should be better than or equal to 45 dB HL.
• Patients having a symmetrically conductive or mixed hearing loss are candidates for a bilateral fitting. 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 a 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 (PTA) air conduction (AC) threshold of the hearing ear should then be better than or equal to 20 dB HL (measured at 0.5, 1, 2 and 3 kHz).
· Patients who are 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 has experience with
appropriately fitted air conduction or bone conduction hearing aids.
· Patients 12 years of age or older.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
ver-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the logo for Oticon Medical. The logo consists of the word "oticon" in bold, black letters, with a small orange square above the "i". Below "oticon" is the word "MEDICAL" in smaller, black letters. To the right of the logo is a thin orange vertical line, followed by the phrase "Because sound matters" in a smaller, gray font.
# 510(k) summary
## A. Submitter Information
- Submitted by: Oticon Medical AB Datavägen 37B SE 436 32 Askim Sweden
| Submission Contact Person: | Pernilla Gustafsson |
|----------------------------|------------------------|
| Phone: | +46 (0)701436994 |
| Email: | pegt@oticonmedical.com |
- B. Date prepared 2024-03-04
### C. Device Information
| Common Name: | Sentio Active Implantable Bone Conduction Hearing System |
|--------------------------------|--------------------------------------------------------------|
| Device trade/proprietary name: | Sentio Ti Implant Kit<br>Sentio 1 Mini<br>Genie Medical BAHS |
| Classification Name: | Active implantable bone conduction hearing system |
| Classification Regulation: | 21 CFR 874.3340 |
| Device Classification: | Class II |
| Device Panel: | Ear, nose and throat |
| Device Product Code: | PFO |
| 510(k) Number: | K240614 |
### D.1 Predicate device
| Common Name: | Bonebridge System |
|--------------------------------|---------------------------------------------------------------------|
| Device trade/proprietary name: | BCI 601 Implant kit<br>BCI 602 Implant Kit<br>Samba Audio Processor |
| Classification Name: | Active implantable bone conduction hearing system |
| Classification Regulation: | 21 CFR 874.3340 |
| Device Classification: | Class II |
| Device Panel: | Ear, nose and throat |
| Device Product Code: | PFO |
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Image /page/4/Picture/0 description: The image shows the logo for Oticon Medical. The logo consists of the word "oticon" in bold, black letters, with a small orange square above the "i". Below "oticon" is the word "MEDICAL" in smaller, black letters. To the right of the logo is a thin, vertical orange line, followed by the phrase "Because sound matters" in a smaller, sans-serif font.
| De Novo Number: | DEN170009 |
|--------------------------------|-----------------------------|
| D.2 Reference device | |
| Common Name: | Ponto |
| Device trade/proprietary name: | Ponto 5 SuperPower |
| Classification Name: | Bone conduction hearing aid |
| Classification Regulation: | 21 CFR, 874.3302 |
| Device Classification: | Class II |
| Device Panel: | Ear, nose and throat |
| Device Product Code: | LXB |
| 510(k) Number: | K213733 |
### E. Reason for the 510(k) Submission:
This is a new device submission for a pre-market notification 510(k).
#### F. Device Description
The Sentio system is an osseointegrating, transcutaneous active bone conduction hearing system that uses the body's natural ability to transfer sound through bone conduction, thus offering improvement of hearing for patients with conductive or mixed hearing loss whether unilaterally or bilaterally fitted, or for those with single sided deafness. A bone conduction system transmits sound directly to the cochlea independently of the function of the ear canal and middle ear.
The Sentio system primarily consists of a sound processor (Sentio 1 Mini) and an implant (Sentio Ti Implant). The two components are kept in relation to each other by means of a magnetic retention system. The sound is picked up by the microphones in the external sound processor, processed and transmitted by a transmission coil using a radio frequency (RF) link through the intact skin to an implant placed in the temporal and mastoid bone area. The receiver coil of the implant receives the signal that is converted into mechanical energy (vibrations) by the transducer. The vibrations are conveyed from the bottom of the transducer to the skull and thereafter by means of bone conduction to the cochlea. In the cochlea the vibrations are converted to signals that are transmitted to the brain through the auditory nerve.
The Sentio system is intended for improvement of hearing for patients with conductive or mixed hearing losses up to 45 dB BC. The implant has been tested and verified to allow for larger mixed hearing losses, up to an anticipated 65 dB BC.
#### G. Intended Use / Indications for Use
The Sentio Ti implant, in combination with Sentio 1 Mini, is indicated for the following patients:
- . Patients with conductive or mixed hearing losses, who can still benefit from amplification of the sound. The pure tone average (PTA) bone conduction (BC)
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Image /page/5/Picture/0 description: The image shows the logo for Oticon Medical. The logo consists of the word "oticon" in black, with a small orange square above the "i". Below "oticon" is the word "MEDICAL" in smaller, black letters. To the right of the word "oticon" is a vertical orange line, followed by the words "Because sound matters" in a smaller, gray font.
threshold (measured at 0.5. 1. 2 and 3 kHz) of the indicated ear should be better than or equal to 45 dB HL.
- . Patients having a symmetrically conductive or mixed hearing loss are candidates for a bilateral fitting. 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 a 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 (PTA) air conduction (AC) threshold of the hearing ear should then be better than or equal to 20 dB HL (measured at 0.5, 1, 2 and 3 kHz).
- Patients who are 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 has experience with appropriately fitted air conduction or bone conduction hearing aids.
- Patients 12 years of age or older.
### H. Substantial Equivalence Comparison
Assessment of substantial equivalence to the predicate devices MED-EL Bonebridge system (DEN 170009, with further features developed with the K183373, K191457 and K200504). And comparison to reference device Oticon Medical Ponto 5 SuperPower (K213733) sound processor.
The tables below summarize the substantial equivalence and reference device comparison on system (table 1, page 4-5) and component level; implant, (table 2, page 6-7) and sound processor (table 3, page 8-9). A comparison on the surgery implantation procedures of the two systems is summarized in table 4, page 10.
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Image /page/6/Picture/0 description: The image shows the logo for Oticon Medical. The logo consists of the word "oticon" in black, with the "i" in "oticon" having an orange square above it. Below "oticon" is the word "MEDICAL" in smaller black letters. To the right of the word "MEDICAL" is a thin orange vertical line.
| | Table 1 summarizes the substantial equivalence comparison on system. | | |
|--|----------------------------------------------------------------------|--|--|
| | | | |
| | Sentio System | Bonebridge System<br>(predicate) | Substantial<br>equivalence<br>(Yes/No) | |
|------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | The Sentio system is intended for<br>improvement of hearing for<br>patients with conductive or mixed<br>hearing losses, whether<br>unilaterally or bilaterally fitted, or<br>for those with single sided<br>deafness. | The Bonebridge is intended to<br>improve hearing for patients with<br>conductive or mixed hearing<br>losses, bilateral fitting, and single-<br>sided deafness. | Yes, difference in<br>wording is not<br>significant | |
| Indications for<br>use | • Patients with conductive or<br>mixed hearing losses, who can<br>still benefit from amplification of<br>the sound. The pure tone average<br>(PTA) bone conduction (BC)<br>threshold (measured at 0.5, 1, 2<br>and 3 kHz) of the indicated ear<br>should be better than or equal to<br>45 dB HL. | • Patients who have a conductive<br>or mixed hearing loss and still can<br>benefit from sound amplification.<br>The pure tone average (PTA) bone<br>conduction (BC) threshold<br>(measured at 0.5, 1, 2, and 3 kHz)<br>should be better than or equal to<br>45 dB HL. | | |
| | • Patients having a symmetrically<br>conductive or mixed hearing loss<br>are candidates for a bilateral<br>fitting. The difference between the<br>left and right sides' BC thresholds<br>should be less than 10 dB on<br>average measured at 0.5, 1, 2<br>and 3 kHz, or less than 15 dB at<br>individual frequencies. | • Bilateral fitting of the Bonebridge<br>is intended for patients having a<br>symmetrically conductive or mixed<br>hearing loss. The difference<br>between the left and right sides' BC<br>thresholds should be less than 10<br>dB on average measured at 0.5, 1,<br>2, and 3 kHz, or less than 15 dB at<br>individual frequencies. | | |
| | • Patients who have a profound<br>sensorineural hearing loss in one<br>ear and normal hearing in the<br>opposite ear (i.e., SSD). The pure<br>tone average (PTA) air<br>conduction (AC) threshold of the<br>hearing ear should then be better<br>than or equal to 20 dB HL<br>(measured at 0.5, 1, 2 and 3<br>kHz). | • Patients who have profound<br>sensorineural hearing loss in one<br>ear and normal hearing in the<br>opposite ear (i.e., single-sided<br>deafness or "SSD"). The pure tone<br>average air conduction hearing<br>thresholds of the hearing ear<br>should be better than or equal to<br>20 dB HL (measured at 0.5, 1, 2,<br>and 3 kHz). | | |
| | • Patients who are indicated for<br>an air-conduction contralateral<br>routing of signals (AC CROS)<br>hearing aid, but who for some<br>reason cannot or will not use an<br>AC CROS. | • The Bonebridge for SSD is also<br>indicated for any patient who is<br>indicated for an air-conduction<br>contralateral routing of signals (AC<br>CROS) hearing aid, but who for<br>some reason cannot or will not use<br>an AC CROS. | | |
| | • Prior to receiving the device, it is<br>recommended that an individual<br>has experience with appropriately<br>fitted air conduction or bone<br>conduction hearing aids. | • Prior to receiving the device, it is<br>recommended that an individual<br>have experience with appropriately<br>fit air conduction or bone<br>conduction hearing aids. | | |
| | • Patients 12 years of age or<br>older. | • Patients 12 years of age or older. | | |
| Contraindications | • Known chronic or non-revisable<br>vestibular or balance disorder. | • Chronic or non-revisable<br>vestibular or balance disorders. | Yes | |
| | • Known abnormally progressive<br>hearing loss. | • Abnormally progressive hearing<br>loss. | Patients already<br>implanted with, or<br>to be implanted | |
| | Sentio System | Bonebridge System<br>(predicate) | Substantial<br>equivalence<br>(Yes/No) | |
| | • Evidence of conditions that<br>would prevent good speech<br>recognition potential as<br>determined by good clinical<br>judgment.<br>• Skin or scalp conditions that<br>may preclude attachment of the<br>sound processor or that may<br>interfere with the use of the sound<br>processor.<br>• Patients already implanted with,<br>or to be implanted with,<br>programmable CSF shunts. | • Evidence of conditions that would<br>prevent good speech recognition<br>potential as determined by good<br>clinical judgment.<br>• Skin or scalp conditions that may<br>preclude attachment of the audio<br>processor or that may interfere with<br>the use of the audio processor.<br>• Skull size or abnormality that<br>would preclude appropriate<br>placement of the BONEBRIDGE<br>implant as determined by CT scan. | with,<br>programmable<br>CSF shunts are<br>contraindicated<br>for Sentio since<br>verification has<br>not been done.<br>For Sentio, pre-<br>operative CT<br>scan is typically<br>not necessary for<br>patients with<br>normal anatomy,<br>as evaluated in a<br>clinical study. | |
| Design | Active implantable bone<br>conduction hearing system:<br>Transcutaneous implant which, in<br>use together with an external<br>sound processor that is held in<br>place on the patient's head by<br>magnetic attraction between the<br>implant and the sound processor,<br>uses the body's natural ability to<br>transfer sound through bone<br>conduction. | Active implantable bone conduction<br>hearing system:<br>Transcutaneous implant which, in<br>use together with an external<br>sound processor that is held in<br>place on the patient's head by<br>magnetic attraction between the<br>implant and the sound processor,<br>uses the body's natural ability to<br>transfer sound through bone<br>conduction. | Yes | |
| Anatomical site | Surgically implanted in the<br>temporal and mastoid bone area. | Surgically implanted into the<br>temporal bone. | Yes, the<br>difference in<br>wording does not<br>have clinical<br>significance as<br>the mastoid is<br>part of the<br>temporal bone. | |
| Intended<br>environment | Implant:<br>- Home care<br>- Professional Healthcare Facility<br>- Magnetic Resonance (MR)<br>Environment<br>Sound Processor:<br>- Home care<br>- Professional Healthcare Facility | Implant:<br>- Home care<br>- Professional Healthcare Facility<br>- Magnetic Resonance (MR)<br>Environment<br>Sound Processor:<br>- Home care<br>- Professional Healthcare Facility | Yes | |
| Transmission<br>scheme | The difference between force<br>output level at coupling distances<br>of 9 mm and 3 mm is ≤ 5 dB | The difference between force<br>output level at coupling distances<br>of 7 mm and 4 mm is ≤ 4 dB | Yes, difference is<br>not clinically<br>significant. | |
| System Force<br>Output | Frequency<br>[Hz]<br>MPO<br>[dB μ N]<br> | Frequency<br>[Hz]<br>MPO<br>[dB μ N] | Yes.<br>The choice of<br>resonance<br>frequency will<br>affect the overall<br>curve, but have<br>outsized effect on<br>specific<br>frequencies. The<br>resonance<br>frequency is<br>slightly lower for | |
| | 500<br>90<br>1000<br>112<br>2000<br>96<br>4000<br>90<br>Peak<br>112 | 500<br>90<br>1000<br>102<br>2000<br>96<br>4000<br>90<br>Peak<br>113 | | |
| | Sentio System | Bonebridge System<br>(predicate) | Substantial<br>equivalence<br>(Yes/No) | |
| | | | the predicate<br>device compared<br>to Sentio, and<br>therefore has an<br>outsized effect on<br>the 1000Hz value.<br>When taking the<br>peak output into<br>account we<br>conclude that the<br>overall difference<br>in MFO is not<br>clinically<br>significant. | |
| Table 1. Substantial Equivalence Comparison - System | | | | |
| | Sentio Ti Implant | Bonebridge BCI Implant<br>(predicate) | | Substantial<br>equivalence<br>(Yes/No) |
| Material | Titanium<br>Silicone | Titanium<br>Silicone | | Yes |
| Biocompatibility | The Sentio Ti Implant is<br>implanted in and above the<br>mastoid bone and as such, is a<br>device in permanent<br>tissue/bone contact.<br><br>Biocompatible.<br><br>Materials in contact with tissue:<br>- Implant: Titanium grade 2 and<br>5, medical grade silicone<br>elastomer<br>- Screws: Titanium Ti6Al4V | The BCI is implanted in and above<br>the mastoid bone and as such, is a<br>device in permanent tissue/bone<br>contact.<br><br>Biocompatible.<br><br>Materials in contact with tissue:<br>- Implant: Titanium grade 5,<br>medical grade silicone elastomer<br>- Screws: Titanium alloy Ti6Al7Nb | | Yes |
| Compatibility<br>with the<br>environment<br>and other<br>devices | Diagnostic ultrasound<br>X-Ray and CT<br>Radiation therapy and PET<br>MRI 1.5T Conditional | Diagnostic ultrasound<br>X-Ray and CT<br>Radiation therapy and PET<br>MRI 1.5T Conditional | | Yes |
| Sterility | EtO sterilization: Sentio Ti<br>Implant<br>Steam: Surgical templates | EtO sterilization | | Yes, the Sentio<br>surgical templates<br>has a material and<br>component<br>characterization that<br>doesn't require EtO,<br>hence a different<br>sterilization method<br>(steam) is used. |
| Dimensions | Length: 60 mm<br>Width: 30 mm<br>Thickness: 4 mm | BCI model 601<br>Length: 69 mm<br>Width: 28,6 mm<br>Thickness: 4,5 mm<br><br>BCI model 602<br>Length: 64.3 mm<br>Width: 28,2 mm<br>Thickness: 4,4 mm | | Yes, the footprint of<br>Sentio Ti is smaller,<br>a less deep recess<br>is needed. |
| MRI | Magnet rotatable: No<br>Magnet removable: No<br>Magnet polarization: Axial<br>Head bandaging requirement:<br>No<br>Patient position:<br>Supine position, centered in the<br>MRI scanner.<br>Temperature rise:<br>Less than 2°C<br>Permitted static magnetic field<br>strength: 1.5 T | Magnet rotatable: Yes<br>Magnet removable: No<br>Magnet polarization: Diametric<br>Head bandaging requirement:<br>No<br>Patient position:<br>No restrictions<br>Temperature rise:<br>Less than 4°C<br>Permitted static magnetic field<br>strength: 1.5 T | | Yes, both systems<br>meet the same<br>safety standards<br>and are MR<br>Conditional at 1.5 T<br>with their respective<br>scanner settings. |
| | Sentio Ti Implant | Bonebridge BCI Implant<br>(predicate) | Substantial<br>equivalence<br>(Yes/No) | |
| | Maximum spatial field gradient:<br>20 T/m [2,000 G/cm] | Maximum spatial field gradient:<br>Up to including 3000 Gauss/cm (30 T/m) | | |
| | Maximum permitted whole-body<br>averaged specific absorption<br>rate (SAR) [W/kg]:<br>2 W/kg<br>(normal operating mode) | Maximum permitted whole-body<br>averaged specific absorption rate<br>(SAR) [W/kg]:<br><4 W/kg<br>(first level operating mode) | | |
| | Maximum permitted head<br>averaged SAR [W/kg]:<br>3.2 W/kg<br>(Normal operating mode) | Maximum permitted head averaged<br>SAR [W/kg]:<br><3.2 W/kg<br>(Normal and first-level Operating<br>Mode) | | |
| | Scan duration:<br>15 min continuous scanning | Scan duration:<br>15 min continuous scanning | | |
| | RF transmit coil type:<br>Whole body transmit coil | RF transmit coil type:<br>No restrictions | | |
| | Scanner type:<br>Cylindrical-bore | Scanner type:<br>No restrictions | | |
| | Magnetic field (B0) orientation:<br>Horizontal | Magnetic field (B0) orientation:<br>No restrictions | | |
| | Maximum gradient slew rate per<br>axis [T/m/s]:<br>200 T/m/s | Maximum gradient slew rate per<br>axis [T/m/s]:<br>No restrictions | | |
| Fixation | A fixation band is applied<br>across the transducer and two<br>self-drilling, osseointegrating<br>screws are inserted in the bone. | The implant is fixated with self-<br>drilling screws into the bone. One<br>screw is placed in each anchor hole<br>of the BC-FMT. | Yes, the Sentio Ti<br>Implant design<br>offers flexibility in<br>placement of the<br>fixation whereas in<br>Bonebridge the<br>position of the<br>screws are fixed as<br>the fixation device is<br>integrated with the<br>transducer part of<br>the implant. | |
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Image /page/7/Picture/0 description: The image shows the logo for Oticon Medical. The word "oticon" is in bold, black letters, with a small orange square above the "i". Below "oticon" is the word "MEDICAL" in smaller, black letters. To the right of the words is a thin, vertical orange line.
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Image /page/8/Picture/0 description: The image shows the logo for Oticon Medical. The word "oticon" is written in black, with a small orange square above the "i". Below "oticon" is the word "MEDICAL" in smaller, black letters. To the right of the words is a thin, vertical orange line.
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Image /page/9/Picture/0 description: The image shows the logo for Oticon Medical. The logo consists of the word "oticon" in bold, black letters, with a small orange square above the "i". Below "oticon" is the word "MEDICAL" in smaller, black letters. To the right of the logo is a vertical orange line, followed by the text "Because sound matters" in a smaller font.
# Table 2 summarizes the substantial equivalence comparison for the Sentio Ti Implant.
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Image /page/10/Picture/0 description: The image shows the logo for Oticon Medical. The word "oticon" is written in a bold, sans-serif font, with the "o" and "t" connected. The "i" in "oticon" has a small orange square above it. Below "oticon" is the word "MEDICAL" in a smaller, sans-serif font. To the right of the word "MEDICAL" is a thin, vertical orange line.
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Image /page/11/Picture/0 description: The image shows the logo for Oticon Medical. The logo consists of the word "oticon" in bold, black letters, with a small orange square above the "i". Below "oticon" is the word "MEDICAL" in smaller, black letters. To the right of the word "oticon" is a thin, vertical orange line, followed by the phrase "Because sound matters" in a smaller, gray font.
## Table 3 Comparison for the Sentio 1 Mini sound processor and SAMBA 2 Sound Processor (predicate).
| | Sentio 1 Mini | Ponto 5 SuperPower<br>(reference) | SAMBA 2 Sound<br>Processor<br>(predicate) | Substantial<br>equivalence<br>(Yes/No) |
|-----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|
| Dimensions | Length: 39 mm<br>Width: 30 mm<br>Thickness: 9 mm | Length: 31 mm<br>Width: 21 mm<br>Thickness: 15 mm | Length: 35 mm<br>Width: 30 mm<br>Thickness: 10 mm | Yes |
| Weight | 8.6 g (incl. battery and<br>magnet) | 20.3 g (w/o battery) | < 9 g (incl. battery and<br>magnet) | Yes |
| Battery | 675 Zink-Air | 675P Zink-Air | 675 Zink-Air | Yes |
| Battery<br>lifetime | >16 hours<br>(avg. 61 hours,<br>dependent on the<br>usage of the sound<br>processor) | >16 hours<br>(dependent on the<br>usage of the sound<br>processor) | >16 hours<br>(dependent on the usage<br>of the sound processor) | Yes |
| Battery safety | Tamper-resistant battery drawer<br>Tool for opening required | | N/A | Yes, added safety<br>feature to Ponto<br>and Sentio sound<br>processors |
| Magnet<br>properties | 6 magnet strengths | N/A | 5 magnet strengths | Yes, difference is<br>not clinically<br>significant |
| Magnet safety | Tool for removing<br>required | N/A | Tool for removing<br>required | Yes |
| MRI | MR Unsafe | MR Unsafe | MR Unsafe | Yes |
| Variants | One variant<br>Left or right assigned during fitting | | Left and right variants | Yes, provides<br>flexibility for<br>clinician |
| Microphones | Dual directional microphones (various options) | | Dual directional<br>microphones (various<br>options) | Yes |
| Sound<br>processing<br>features | 64 processing channels<br>Speech and noise management<br>Directional microphones<br>Wind noise management<br>Feedback management | | 16 processing channels<br>Speech and noise<br>management<br>Directional microphones<br>Wind noise management | Yes |
| Frequency<br>range | 200-9500 Hz…
