(127 days)
No
The summary describes a bone conduction hearing system that processes sound and transmits vibrations. There is no mention of AI or ML in the device description, intended use, or performance studies. The processing described is standard signal processing for hearing aids.
Yes
Explanation: The device is a bone conduction hearing system intended to improve hearing for patients with conductive or mixed hearing losses or single-sided deafness, which constitutes a therapeutic purpose as it addresses a health condition.
No
The Sentio system is described as an osseointegrating, transcutaneous active bone conduction hearing system intended for the improvement of hearing in patients with various types of hearing loss. It functions by transmitting sound directly to the cochlea to improve hearing, not to diagnose a condition.
No
The device description clearly states that the Sentio system primarily consists of a sound processor (Sentio 1 Mini) and an implant (Sentio Ti Implant), which are hardware components. The system involves the transmission of sound via RF link to an implant placed in the bone, which then converts the signal into mechanical energy (vibrations). This is a hardware-based system, not software-only.
Based on the provided text, the Sentio Ti implant and Sentio 1 Mini system is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Sentio System Function: The Sentio system is a surgically implanted hearing system that directly transmits sound vibrations through bone to the cochlea. It is a therapeutic device designed to improve hearing, not a diagnostic tool that analyzes biological samples.
- Intended Use: The intended use clearly states it's for patients with hearing loss to improve their hearing.
- Device Description: The description details how the device works by picking up sound, processing it, and transmitting vibrations through bone. There is no mention of analyzing biological specimens.
Therefore, the Sentio system falls under the category of a medical device, specifically a hearing implant, rather than an In Vitro Diagnostic device.
N/A
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) 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.
Product codes
PFO
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Surgically implanted in the temporal and mastoid bone area.
Indicated Patient Age Range
Patients 12 years of age or older.
Intended User / Care Setting
Implant:
- Home care
- Professional Healthcare Facility
- Magnetic Resonance (MR) Environment
Sound Processor: - Home care
- Professional Healthcare Facility
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)
Study O1 (1y follow-up)
Study design: Prospective, multi-center, 1-year FU
Aim: Safety & performance
Device: Implant: I1 Sound processor: SP1
Patient group: Patient group 1
Number of patients: 16
Status: Completed
Key results: The procedure for installing I1 is safe, and the transmission condition was stable over the follow-up time. Improvements were seen in hearing thresholds, speech reception thresholds, speech in noise recognition, and patient reported satisfaction when comparing the aided to the unaided condition. Similar or better hearing thresholds, speech reception thresholds, speech in noise recognition, and patient reported satisfaction are demonstrated compared to a conventional bone conduction device.
Study O1 (3- and 5-year FU)
Study design: Prospective, single-center, 3- and 5-year FU
Aim: Long term safety & performance
Device: Implant: I1 Sound processor: SP1
Patient group: Patient group 1 (subset)
Number of patients: 13
Status: Completed
Key results: No serious adverse events or serious adverse device effects occurred during the follow-up time confirming long-term safety. By using the system, the patients got significantly improved sensitivity (measured by hearing thresholds and speech reception thresholds), speech in noise recognition and self-assessment (questionnaire) results than compared both to the unaided condition (primary effect hypothesis) and to a conventional bone conduction device (secondary effect hypothesis). It has been shown that the effectiveness of the device in terms of audiological performance is persistent over time (5 years), thus confirming long-term effectiveness.
Study C58
Study design: Prospective, single-center, 7-month FU
Aim: Performance
Device: Implant: I1 Sound processor: SP2
Patient group: Subset of patient group 1
Number of patients: 10
Status: Completed
Key results: The results confirmed that SP2, together with the I1 implant, gave a significant functional gain benefit of 29.6 dB. In addition, SP2 gave benefit to the users in terms of improved speech intelligibility compared to unaided condition. The performance of SP2 was stable over time and similar to SP1. Very few skin reactions were reported, and retention and comfort were rated similar to the SP1. Few adverse events and no serious adverse events were reported in the study. No new safety risks were identified.
Study BC114
Study design: Prospective, single-center, 2-year FU
Aim: Performance
Device: Implant: I1 Sound processor: Sentio 1 Mini
Patient group: Subset of patient group 1
Number of patients: 11
Status: Completed primary endpoint analysis (1 month) + 2y follow up ongoing
Key results: Results showed a significant improvement in average functional gain of 32.5 dB (SD: 6.8). The difference between aided sound field thresholds and unaided sound field thresholds was shown to be significant for all measured frequencies. The effective gain showed an average effective gain of 11.9 dB PTA4 (SD: 7.7). The abbreviated Speech, Spatial and Qualities of hearing scale (SSQ12), was used to collect self-reported performance related to the subject's previous sound processor and at the 1-month follow up for the Sentio 1 Mini. There were no significant differences observed between the two devices at either the subgroup level (speech, spatial, quality) or in the overall total. A preference assessment showed that most subjects (7 out of 10) preferred the Sentio 1 Mini over their previous sound processor. Up until the 1-month follow-up no adverse events or device deficiencies had occurred.
Study BC101
Study design: Prospective, multi-center, 2-year FU
Aim: Safety & performance
Device: Implant: Sentio Ti implant Sound processor: Sentio 1 Mini
Patient group: Patient group 2
Number of patients: 51 enrolled, 29 (6 months FU), 16 (12 months FU)
Status: Completed primary endpoint analysis + 2y follow up ongoing (Q4 2025)
Key results: The Sentio system compensates for hearing loss, i.e. improves the hearing for patients within the indicated use manifested by improved ability to hear sounds (reduced disability) and improved speech intelligibility. The average aided threshold results, 26.3 dB HL (PPS) and 26.3 dB (FAS) show that patients can hear sounds at normal speech levels with the Sentio system. The average functional gain was 32.8 dB (PPS) and 29.3 dB (FAS); in line with what has been reported for similar devices. Speech recognition in quiet is significantly improved with the Sentio system compared to unaided for patients with conductive and mixed hearing losses as well as patients with single sided deafness. The speech intelligibility in quiet (at 65 dB SPL) across the intended population is 97.9% (PPS) and 97.6% (FAS). On average, the total GBI score across studies was 28.4 (PPS) and 29.2 (FAS). On an individual level 97.1% (PPS), and 96.1% (FAS), reported an improvement in quality of life using the Sentio system. No serious adverse device-related events or major complications were reported across the indicated population. The minor complications (such as dizziness/headache, numbness, swelling or erythema, pain at surgical site, and sound sensations) reported were transient and/or of mild intensity. Study concludes that the primary end-points (improved hearing and improved speech recognition on the implanted ear) were statistically significant in favor of the Sentio when compared to reference values. No major complications were reported. The Sentio system is safe to use as intended.
Study C70
Study design: Virtual implantation of Sentio implant in CT scans (retrospective and non-interventional)
Aim: Investigate need for pre-operative planning
Device: Implant: Sentio Ti implant Sound processor: NA
Patient group: Patient group 3 (CT scans- no actual implantation performed)
Number of patients: 197 CT scans (from 121 patients)
Status: Completed
Key results: In adults without known medical history that indicates anatomical malformations, the average minimum bone thickness in the combined recess and screw area was 5.55 ± 1.46 mm, with a 95% confidence interval of 5.30–5.80 mm, i.e., thicker than both the maximum transducer depth of 3 mm and the 2.7 mm bone engagement of the osseointegrating fixation screws.
BC101 sub study (MRI safety)
Study design: Clinical sub-study to ongoing pivotal study.
Aim: Further evaluate the patient experience of undergoing an MRI with the Sentio Ti implant.
Device: Sentio Ti implant
Number of patients: 9
Key results: The MRI was completed successfully in all nine cases without any complications or adverse events. Patients generally had a positive experience with an average rating of 2. As expected, there was some mild pressure at the implant site (average score of 3) and a few patients experienced mild pain due to the pressure (average score of 1). It is concluded that the clinical data supports that patients with a Sentio Ti implant can safely undergo a 1.5T MRI as per the outlined conditions.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Study BC101:
Average aided threshold results: 26.3 dB HL (PPS) and 26.3 dB (FAS)
Average functional gain: 32.8 dB (PPS) and 29.3 dB (FAS)
Speech intelligibility in quiet (at 65 dB SPL): 97.9% (PPS) and 97.6% (FAS)
Average total GBI score: 28.4 (PPS) and 29.2 (FAS)
Individual improvement in quality of life: 97.1% (PPS) and 96.1% (FAS)
Study BC114:
Significant improvement in average functional gain: 32.5 dB (SD: 6.8)
Average effective gain: 11.9 dB PTA4 (SD: 7.7)
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
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).
1
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
2
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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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 |
| Sentio 1 Mini | |
| 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 |
| BCI 602 Implant Kit | |
| 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
(predicate) | Substantial
equivalence
(Yes/No) | |
|------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | The Sentio system is intended for
improvement of hearing for
patients with conductive or mixed
hearing losses, whether
unilaterally or bilaterally fitted, or
for those with single sided
deafness. | The Bonebridge is intended to
improve hearing for patients with
conductive or mixed hearing
losses, bilateral fitting, and single-
sided deafness. | Yes, difference in
wording is not
significant | |
| Indications for
use | • 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 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. | | |
| | • 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. | • 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 a profound
sensorineural hearing loss in one
ear and normal hearing in the
opposite ear (i.e., 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 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). | | |
| | • 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. | • 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
has experience with appropriately
fitted air conduction or bone
conduction hearing aids. | • Prior to receiving the device, it is
recommended that an individual
have experience with appropriately
fit air conduction or bone
conduction hearing aids. | | |
| | • Patients 12 years of age or
older. | • Patients 12 years of age or older. | | |
| Contraindications | • Known chronic or non-revisable
vestibular or balance disorder. | • Chronic or non-revisable
vestibular or balance disorders. | Yes | |
| | • Known abnormally progressive
hearing loss. | • Abnormally progressive hearing
loss. | Patients already
implanted with, or
to be implanted | |
| | Sentio System | Bonebridge System
(predicate) | Substantial
equivalence
(Yes/No) | |
| | • 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
sound processor or that may
interfere with the use of the sound
processor.
• Patients already implanted with,
or to be implanted with,
programmable CSF shunts. | • 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. | with,
programmable
CSF shunts are
contraindicated
for Sentio since
verification has
not been done.
For Sentio, pre-
operative CT
scan is typically
not necessary for
patients with
normal anatomy,
as evaluated in a
clinical study. | |
| Design | Active implantable bone
conduction hearing system:
Transcutaneous implant which, in
use together with an external
sound processor that is held in
place on the patient's head by
magnetic attraction between the
implant and the sound processor,
uses the body's natural ability to
transfer sound through bone
conduction. | Active implantable bone conduction
hearing system:
Transcutaneous implant which, in
use together with an external
sound processor that is held in
place on the patient's head by
magnetic attraction between the
implant and the sound processor,
uses the body's natural ability to
transfer sound through bone
conduction. | Yes | |
| Anatomical site | Surgically implanted in the
temporal and mastoid bone area. | Surgically implanted into the
temporal bone. | Yes, the
difference in
wording does not
have clinical
significance as
the mastoid is
part of the
temporal bone. | |
| Intended
environment | Implant:
- Home care
- Professional Healthcare Facility
- Magnetic Resonance (MR)
Environment
Sound Processor: - Home care
- Professional Healthcare Facility | Implant:
- Home care
- Professional Healthcare Facility
- Magnetic Resonance (MR)
Environment
Sound Processor: - Home care
- Professional Healthcare Facility | Yes | |
| Transmission
scheme | The difference between force
output level at coupling distances
of 9 mm and 3 mm is ≤ 5 dB | The difference between force
output level at coupling distances
of 7 mm and 4 mm is ≤ 4 dB | Yes, difference is
not clinically
significant. | |
| System Force
Output | Frequency
[Hz]
MPO
[dB μ N]
| Frequency
[Hz]
MPO
[dB μ N] | Yes.
The choice of
resonance
frequency will
affect the overall
curve, but have
outsized effect on
specific
frequencies. The
resonance
frequency is
slightly lower for | |
| | 500
90
1000
112
2000
96
4000
90
Peak
112 | 500
90
1000
102
2000
96
4000
90
Peak
113 | | |
| | Sentio System | Bonebridge System
(predicate) | Substantial
equivalence
(Yes/No) | |
| | | | the predicate
device compared
to Sentio, and
therefore has an
outsized effect on
the 1000Hz value.
When taking the
peak output into
account we
conclude that the
overall difference
in MFO is not
clinically
significant. | |
| Table 1. Substantial Equivalence Comparison - System | | | | |
| | Sentio Ti Implant | Bonebridge BCI Implant
(predicate) | | Substantial
equivalence
(Yes/No) |
| Material | Titanium
Silicone | Titanium
Silicone | | Yes |
| Biocompatibility | The Sentio Ti Implant is
implanted in and above the
mastoid bone and as such, is a
device in permanent
tissue/bone contact.
Biocompatible.
Materials in contact with tissue:
- Implant: Titanium grade 2 and
5, medical grade silicone
elastomer - Screws: Titanium Ti6Al4V | The BCI is implanted in and above
the mastoid bone and as such, is a
device in permanent tissue/bone
contact.
Biocompatible.
Materials in contact with tissue:
- Implant: Titanium grade 5,
medical grade silicone elastomer - Screws: Titanium alloy Ti6Al7Nb | | Yes |
| Compatibility
with the
environment
and other
devices | Diagnostic ultrasound
X-Ray and CT
Radiation therapy and PET
MRI 1.5T Conditional | Diagnostic ultrasound
X-Ray and CT
Radiation therapy and PET
MRI 1.5T Conditional | | Yes |
| Sterility | EtO sterilization: Sentio Ti
Implant
Steam: Surgical templates | EtO sterilization | | Yes, the Sentio
surgical templates
has a material and
component
characterization that
doesn't require EtO,
hence a different
sterilization method
(steam) is used. |
| Dimensions | Length: 60 mm
Width: 30 mm
Thickness: 4 mm | BCI model 601
Length: 69 mm
Width: 28,6 mm
Thickness: 4,5 mm
BCI model 602
Length: 64.3 mm
Width: 28,2 mm
Thickness: 4,4 mm | | Yes, the footprint of
Sentio Ti is smaller,
a less deep recess
is needed. |
| MRI | Magnet rotatable: No
Magnet removable: No
Magnet polarization: Axial
Head bandaging requirement:
No
Patient position:
Supine position, centered in the
MRI scanner.
Temperature rise:
Less than 2°C
Permitted static magnetic field
strength: 1.5 T | Magnet rotatable: Yes
Magnet removable: No
Magnet polarization: Diametric
Head bandaging requirement:
No
Patient position:
No restrictions
Temperature rise:
Less than 4°C
Permitted static magnetic field
strength: 1.5 T | | Yes, both systems
meet the same
safety standards
and are MR
Conditional at 1.5 T
with their respective
scanner settings. |
| | Sentio Ti Implant | Bonebridge BCI Implant
(predicate) | Substantial
equivalence
(Yes/No) | |
| | Maximum spatial field gradient:
20 T/m [2,000 G/cm] | Maximum spatial field gradient:
Up to including 3000 Gauss/cm (30 T/m) | | |
| | Maximum permitted whole-body
averaged specific absorption
rate (SAR) [W/kg]:
2 W/kg
(normal operating mode) | Maximum permitted whole-body
averaged specific absorption rate
(SAR) [W/kg]:
16 hours
(avg. 61 hours,
dependent on the
usage of the sound
processor) | >16 hours
(dependent on the
usage of the sound
processor) | >16 hours
(dependent on the usage
of the sound processor) | Yes |
| Battery safety | Tamper-resistant battery drawer
Tool for opening required | | N/A | Yes, added safety
feature to Ponto
and Sentio sound
processors |
| Magnet
properties | 6 magnet strengths | N/A | 5 magnet strengths | Yes, difference is
not clinically
significant |
| Magnet safety | Tool for removing
required | N/A | Tool for removing
required | Yes |
| MRI | MR Unsafe | MR Unsafe | MR Unsafe | Yes |
| Variants | One variant
Left or right assigned during fitting | | Left and right variants | Yes, provides
flexibility for
clinician |
| Microphones | Dual directional microphones (various options) | | Dual directional
microphones (various
options) | Yes |
| Sound
processing
features | 64 processing channels
Speech and noise management
Directional microphones
Wind noise management
Feedback management | | 16 processing channels
Speech and noise
management
Directional microphones
Wind noise management | Yes |
| Frequency
range | 200-9500 Hz | | 250-8000 Hz | Yes, adds broader
band width |
| Wireless
features | Receiver and transmitter, 2.4 GHz, Bluetooth Low
Energy | | Receiver and transmitter,
3.28 MHz, NFMI (near
field magnetic induction),
Modulation type: FM
Note: Bluetooth available
through compatibility with
Siemens miniTek | Yes, difference is
not clinically
significant |
| Accessories | Fixation option:
Line a clip to be attached to sound processor and
e.g., clothes. | | Fixation option:
Line a clip to be attached
to sound processor and
e.g., clothes. | Yes |
| | Sentio 1 Mini | Ponto 5 SuperPower
(reference) | SAMBA 2 Sound
Processor
(predicate) | Substantial
equivalence
(Yes/No) |
| | Various cover colours and skins for
personalization | Various cover colours and skins for
personalization | Various cover colours
and skins for
personalization | |
| Compatibility
with wireless
accessories | Compatible wireless Oticon A/S/SBO Hearing A/S
accessories:
• Remote control 3.0
• ConnectClip
• TV Adapter 3.0
• EduMic
• Oticon Companion app
(Note: Companion app is a combination of the ON
app and the RemoteCare app, previously cleared
in K213733) | Compatible wireless Oticon A/S/SBO Hearing A/S
accessories: | SAMBA Remote control
Siemens miniTek | Yes |
| Fitting
software | Genie Medical BAHS | | SYMFIT 8.0 | Yes |
| Fitting
options | Cabled fitting
Wireless fitting
Remote fitting | | Cabled fitting | Yes, additional
wireless and
remote fitting are
available with
Sentio 1 Mini. |
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Image /page/12/Picture/0 description: The image shows the logo for Oticon Medical. The word "oticon" is written in bold, black letters, with the "i" having a small orange square above it. Below "oticon" is the word "MEDICAL" in smaller, black letters. To the right of the word "MEDICAL" is a thin, vertical orange line.
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Image /page/13/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, gray letters. To the right of the logo is a thin, vertical orange line, followed by the phrase "Because sound matters" in gray.
| Table 4 compares the surgery implantation procedures of the two systems | ||||
|---|---|---|---|---|
| Sentio Ti Implant | Bonebridge Implant | Substantial | ||
| equivalence (Yes/No) | ||||
| Pre-operative | ||||
| planning | Pre-operative CT scan is | |||
| typically not necessary for | ||||
| patients with normal anatomy. | ||||
| Pre-operative CT scan is | ||||
| recommended for patients where | ||||
| thin bone is expected including: | ||||
| • Patients who have had previous | ||||
| surgery in the area of the implant | ||||
| site, and/or congenital craniofacial | ||||
| or auricular anomalies where a | ||||
| hypoplasia of the mastoidal | ||||
| anatomy might be present, e.g., | ||||
| congenital aural atresia, | ||||
| hemifacial microsomia/Goldenhar | ||||
| syndrome, Treacher Collin like | ||||
| syndromes and Branchio-Oto- | ||||
| Renal (BOR) syndrome. | ||||
| • Patients under the age of 18. | A CT scan is evaluated to | |||
| determine where to place the BC- | ||||
| FMT (transducer) and the screws. | Yes, for Sentio, pre- | |||
| operative CT scan is | ||||
| typically not necessary | ||||
| for patients with | ||||
| normal anatomy, as | ||||
| evaluated in a clinical | ||||
| study. | ||||
| Implant | ||||
| positioning | A template is used to outline the | |||
| position of the implant on the skin | A template is used to outline the | |||
| position of the implant on the skin. | Yes | |||
| Incision | An incision is made. | An incision is made. | Yes | |
| Preparation of the | ||||
| bone bed for the | ||||
| transducer | The site for the transducer is | |||
| marked on the bone with the aid | ||||
| of a template. | ||||
| A standard otologic drill bit is | ||||
| used to createa bone bed, the | ||||
| transducer needs to be | ||||
| recessed by 3 mm. | The site for the transducer is | |||
| marked on the bone with the aid of | ||||
| a template. | ||||
| A standard otologic drill bit is | ||||
| used to create a bone bed, the | ||||
| transducer needs to be recessed | ||||
| by 8.7 mm. | Yes, a less deep | |||
| recess in the bone is | ||||
| needed for Sentio | ||||
| (3mm vs 8.75mm) | ||||
| Preparation of | ||||
| pocket for the | ||||
| receiver coil | A periosteal pocket is prepared | A periosteal pocket is prepared | Yes | |
| Implant | ||||
| installation | The receiver coil is inserted into | |||
| thesubperiosteal pocket and | ||||
| the transducer is placed in the | ||||
| recess. | The receiver coil is inserted into | |||
| the subperiosteal pocket and | ||||
| the transducer is placed in the | ||||
| recess. | Yes | |||
| Fixation | The fixation band is applied | |||
| across the transducer and two | ||||
| self-drilling, osseointegrating | ||||
| screws are inserted in the bone | The implant is fixated with self- | |||
| drilling screws into the bone. One | ||||
| screw is placed in each anchor | ||||
| hole of the BC-FMT and are | ||||
| secured tightly. | Yes, the Sentio Ti | |||
| Implant design offers | ||||
| flexibility and in | ||||
| placement of the | ||||
| fixation whereas in | ||||
| Bonebridge the | ||||
| position of the screws | ||||
| are fixed as the | ||||
| fixation device is | ||||
| integrated with the | ||||
| transducer part of the | ||||
| implant. | ||||
| Closure and | ||||
| dressing | The surgical wound is closed and | |||
| a suitable dressing applied. | The surgical wound is closed and | |||
| a suitable dressing applied. | Yes | |||
| Table 4. Comparison of Bonebridge and Sentio Surgery Implantation Procedure |
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l. Substantial Equivalence Conclusion
As the predicate MED-EL Bonebridge system (composed of Bonebridge BCI implants and SAMBA sound processors, DEN 170009, with further features developed with the K183373, K191457 and K200504), the Sentio system is an active implantable bone conduction hearing system, where the implant and the sound processor are kept in relation to each other by means of a magnetic retention system.
The Sentio system has the same principle of operation and the same source of energy as the predicate Bonebridge system; The Sentio 1 Mini sound processor incorporates an amplitude modulated signal on a carrier frequency of 120kHz in order to communicate with the Sentio Ti implant, in the same manner as the predicate system. The receiver coil of both the predicate implant and the Sentio Ti implant receives the carrier signal from the sound processors, and the signal is converted into mechanical energy (vibrations). For the Sentio system, vibrations are transferred from the bottom of the implant vibrator to the skull bone, whilst for the predicate Bonebridge implant, vibrations are transferred to the skull bone through the fixation screws. This minor difference does not affect the performance of the Sentio Ti Implant versus its predicate. The Sentio Ti Implant is installed in the temporal and mastoid bone area which is in the same anatomical position as the predicate Bonebridge implant. However, the implants differ in dimensions where the footprint of Sentio Ti is smaller and a less deep recess in the skull bone is needed for Sentio (maximum 3mm vs 8.75mm for the predicate implant).
Both the predicate and the Sentio Ti Implant are fixated in the bone with osseointegrating titanium alloy screws. In contrast to the predicate device, where the fixation is integrated with the transducer part of the implant, a fixation band is applied across the transducer of the Sentio Ti Implant. This offers flexibility in placement and allows for anatomical differences.
The Sentio 1 Mini sound processor also compares to predicate Oticon Medical Ponto 5 SuperPower (K213733) sound processor, which includes the same sound processing platform and wireless technology, enabling the same sound processing features and compatibility options. As the reference device, the Sentio 1 Mini incorporates wireless 2.4 GHz Bluetooth® Low Energy connectivity, side-neutral design, a LED status indicator, a tamper resistant battery drawer and user control of listening volume and program change.
Sentio 1 Mini sound processors are individually adjusted to the patient audiogram and needs by the Hearing Care professional using the Genie Medical BAHS fitting software, where Genie Medical BAHS 2023.1 uses the same functionality and features as Genie Medical BAHS 2022.1, previously cleared in K213733. The sound processors are connected either via cable to Hi-Pro2 or ExpressLink (wired fitting equipment) or wireless using Noahlink (wireless fitting equipment) or the Oticon Companion app (remote fitting equipment). The Oticon Companion app is a combination of the ON app and the RemoteCare app, previously cleared in K213733
J. Summary of Non-Clinical Performance
Electroacoustic verification of the Sentio system is conducted including tests for maximum force output, frequency range, peak output vibratory force level, and total harmonic distortion.
Performance of the Sentio Ti Implant and Sentio 1 Mini Sound Processor is evaluated for environmental impact relating to temperature, humidity and atmospheric pressure as applicable to their intended use environment. For the sound processors, additional noise floor testing and software verification has been performed and verified.
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Image /page/15/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 "MEDICAL" is an orange vertical line, followed by the words "Because sound matters" in a smaller, lighter font.
Mechanical integrity testing is performed to evaluate resistance of the Sentio Ti Implant to mechanical impact due to fatique, damage/breakage or loss of hermeticity and skull impact. The reliability testing is performed in consistency with the expected implant lifetime (10 years).
The Sentio system has been confirmed to not emit excessive amounts of electromagnetic energy (EMC emissions) and to operate as intended without performance degradation or generation of hazardous sound or heat in the presence of an electromagnetic disturbance (EMC immunity) and electromagnetic discharge (ESD).
The Sentio Ti Implant is confirmed to resist unique medical emitters; electrocautery, therapeutic ionizing radiation, diagnostic levels of ultrasonic energy and diagnostic ionizing radiation and is MR Conditional at 1.5T.
The Sentio Ti implant include significant engineering improvements for MRI safety compared to implants with a traditional implant design. It consists of a non-removable retention magnet placed in a casing, connected to the transducer casing using a titanium reinforcement and covered with a hardened silicone overlay.
The result of the design is an improved pressure distribution across the entire antenna surface, avoiding pressure hotspots exceeding the directionally adapted pressure pain thresholds (PPTs) with a safety margin. The stress on the skin is minimized to a level far below the thresholds for the tissue preventing periosteum weakening and avoiding any mal effects on the skin flap. Apart from preventing magnet displacement/flipping, device migration, and dislodgement, these engineering improvements also minimize device flexure and displacement, compared to "traditional" magnet designs using soft silicone.
Sentio Ti has undergone extensive testing to ensure MRI safety for the Sentio Ti MR conditional labeling. In summary the Sentio Ti Implant reduces the pressure by 5x than traditional magnets without bandage and has a pressure pain perception safety factor of 16x based on bench tests, computer modeling, and pressure pain thresholds. The Sentio Ti can withstand 10 MR scans without damage.
The Sentio 1 Mini sound processor is a non-sterile component and does not require sterilization, nor does it have a restricted shelf-life. The Sentio Ti Implant Kit (composed of Sentio Ti Implant and Sentio Surgical Template Kit) is a sterile device for single use and is not intended to be end user sterilized nor is it intended for re-use. Shelf-life for the Sentio Ti Implant Kit is 3 vears.
The Sentio system components and materials in direct and/or indirect tissue/skin contact are evaluated and tested for biocompatibility according to the requirements of ISO 10993 series.
K. Summary of Non-Clinical and Clinical Performance
Clinical data has been collected on the Sentio system in five clinical studies (see Table 1), whereof one pivotal study including 51 patients with the final design of the system (Sentio Ti implant and Sentio 1 Mini). In total, more than 113 years of accumulated patient user time have been studied with the first version of the Sentio implant (design iteration 11) and more than 47 years of accumulated patient user time have been studied with the final design of the system (Sentio Ti implant and Sentio 1 Mini).
The data consistently demonstrates that the system is safe and perform as intended. The small size and flexible implant position enables implantation without pre-operative CT scan in adult patients. Stable performance is seen across studies with improved ability to hear sounds and
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Image /page/16/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, gray letters. To the right of the word "oticon" is a thin, vertical orange line, followed by the phrase "Because sound matters" in gray letters.
improved speech intelligibility which also is reflected in higher quality of life scores reported after treatment. Performance results are in line with similar devices and other available treatment options for patients with conductive or mixed hearing loss, or single sided deafness. There are also good indications that performance results are stable over time (≥5 years) as reported for the first version of the Sentio implant (design iteration I1).
There are no indications that the Sentio system would impose new risks compared to similar devices that have been on the market for several years.
Long term safety and performance has been demonstrated for the first versions of Sentio implant. In addition, patients in study BC101 using the final design of the system (Sentio Ti implant and Sentio 1 Mini), have currently reported use of the device for more than 6 months (n = 29) and 12 months (n = 16), respectively. Long-term safety and performance are also supported by data on similar devices.
The available clinical data is deemed applicable also to the indicated age group 12-18 years. The mode of action, bone conduction, is independent on age as confirmed by data from other bone conduction devices. Considering available data on bone volume in the area of interest and the bone volume needed for implantation, it is estimated that children can be safely implanted. As a precaution, pre-operative imaging is recommended for the pediation to ensure that sufficient bone thickness is available. The risk of migration of the implant is deemed negligible and there is no risk of damaging the residual hearing or vital structures.In summary, the overall risk-benefit assessment concludes that the expected benefits with the Sentio system, used as intended, outweigh the potential risks and that the Sentio system compares favorably to similar devices and other available treatment options for patients with conductive or mixed hearing loss, or single sided deafness.
| Study | Study design | Aim | Device | Patient group | Number of
patients | Status |
|-------|-------------------------------------------------------|--------------------------------------|--------------------------------------------------------------------|---------------------------------|-----------------------|--------------------------------------------------------|
| O1 | Prospective,
multi-center
1-year FU | Safety &
performance | Implant: I1
Sound processor: SP1 | Patient group
1 | 16 | Completed |
| O1 | Prospective,
single-center,
3- and 5-year
FU | Long term
safety &
performance | | | 13 | Completed |
| C58 | Prospective,
single-center,
7-month FU | Performance | Implant: I1
Sound processor: SP2 | Subset of
patient group
1 | 10 | Completed |
| BC114 | Prospective,
single-center,
2-year FU | Performance | Implant: I1
Sound processor:
Sentio 1 Mini | Subset of
patient group
1 | 11 | Completed
primary endpoint
analysis
(1 month) |
| BC114 | | | | | | 2y follow up
ongoing |
| BC101 | Prospective,
multi-center
2-year FU | Safety &
performance | Implant: Sentio Ti
implant
Sound processor:
Sentio 1 Mini | Patient group
2 | | Completed
primary endpoint
analysis |
| BC101 | | | | | | 2y follow up
ongoing |
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Image /page/17/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.
Because
sound matters
| C70 | Virtual
implantation
of Sentio
implant in CT
scans | Investigate
need for pre-
operative
planning | Implant: Sentio Ti
implant
Sound processor: NA | Patient group
3
(CT scans- no
actual
implantation
performed) | 197 CT
scans
(from 121
patients) | Completed |
| ----- | ---------------------------------------------------------------- | ------------------------------------------------------- | ------------------------------------------------------ | ----------------------------------------------------------------------------- | ------------------------------------------- | ----------- |
|---|
Study BC101
A multicentre prospective study, including six clinics in three countries, using Sentio Ti implant and Sentio 1 Mini in the indicated population, has evaluated safety and performance three months after implantation. Fifty-one (51) adult patients (18 years or older) have been included in the study (Full Analysis Set (FAS)). The accumulated implant time for the 51 implanted patients is approximately 47 years and 29 and 16 subjects had performed 6-months and 12months follow-up visits, respectively. A calibration error, resulting in less gain than intended being prescribed, impacts the 16 first included subjects (divided between two sites) and these are excluded from the per protocol analysis set used for conclusions on performance. The clinical investigation report shows that main hypotheses can be proven with both per protocol and full analysis sets and that performance and safety for the Sentio system are verified. The study continues to run with full cohort 24-months data expected in Q4 2025. The Sentio system compensates for hearing loss, i.e. improves the hearing for patients within the indicated use manifested by improved ability to hear sounds (reduced disability) and improved speech intelligibility. The normal hearing threshold for pure tones is 20 dB HL and normal speech level is around 65 dB SPL, thus the average aided threshold results, 26.3 dB HL (PPS) and 26.3 dB (FAS) show that patients can hear sounds at normal speech levels with the Sentio system. The average functional gain was 32.8 dB (PPS) and 29.3 dB (FAS); in line with what has been reported for similar devices. Speech recognition in quiet is significantly improved with the Sentio system compared to unaided for patients with conductive and mixed hearing losses as well as patients with single sided deafness. The speech intelligibility in quiet (at 65 dB SPL) across the intended population is 97.9% (PPS) and 97.6% (FAS). Subjective measures, in the form of standardized questionnaires, complement and support the objective data. The BC101 study used the Glasgow benefit inventory (GBI), a generic health-related quality of life questionnaire developed specifically for otorhinolaryngological interventions, where scores above 0 indicate improved quality of life. On average, the total GBI score across studies was 28.4 (PPS) and 29.2 (FAS). On an individual level 97.1% (PPS), and 96.1% (FAS), reported an improvement in quality of life using the Sentio system. No serious adverse device-related events or major complications were reported across the indicated population. The minor complications (such as dizziness/headache, numbness, swelling or erythema, pain at surgical site, and sound sensations) reported were transient and/or of mild intensity. The safety profile is in line with similar devices and the reported adverse events do not reflect any new type of risk than what has been previously identified. The study concludes that the primary end-points (improved hearing and improved speech recognition on the implanted ear) were statistically significant in favor of the Sentio when compared to reference values. No major complications were reported. Based on the number, severity, duration, and type of reported adverse event, the Sentio system is safe to use as intended. Safety and performance will be evaluated again, six months after implantation, and long-term safety and performance will be evaluated at 24months follow-up. ClinicalTrials.gov Identifier: NCT05166265
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BC101 sub study
To further evaluate the patient experience of underqoing an MRI with the Sentio Ti implant a clinical sub-study to the ongoing pivotal study of the Sentio system (ClinicalTrials.Gov NCT05628285) was conducted. Nine patients voluntarily participated in the study. After the scans (all patients underwent head MRI scans), both the patients and the clinicians completed a questionnaire about their experience. Occurrence of adverse events was followed for two weeks. The patients rated their experience of various aspects, such as pain and pressure, on a scale (Numeric Rating Scale, NRS) of 0-10. The MRI was completed successfully in all nine cases without any complications or adverse events. Patients generally had a positive experience with an average rating of 2. As expected, there was some mild pressure at the implant site (average score of 3) and a few patients experienced mild pain due to the pressure (average score of 1). It is concluded that the clinical data supports that patients with a Sentio Ti implant can safely undergo a 1.5T MRI as per the outlined conditions.
Additional clinical data
Study O1 (1y follow-up): This clinical study included treatment with the first design iteration of the implant (I1, in the study documentation denoted the BCI implant/BBC) and sound processor SP1. The study was a consecutive prospective multi-centre study with the purpose to demonstrate that the system (11 and SP1) was safe and performing as expected. The study included 16 patients implanted between 11 November 2012 and 27 November 2016. Followup visits were conducted at 7-10 days. 4-6 weeks (sound processor fitting), and at 3, 6, and 12 months post-operatively. Main outcome measures were intraoperative and postoperative safety (complications and adverse events), as well as outcome measures related to the effectiveness of the device in terms of audiological performance. In summary it was concluded that the procedure for installing I1 is safe, and the transmission condition was stable over the follow-up time. Improvements were seen in hearing thresholds, speech reception thresholds, speech in noise recognition, and patient reported satisfaction when comparing the aided to the unaided condition. Similar or better hearing thresholds, speech reception thresholds, speech in noise recognition, and patient reported satisfaction are demonstrated compared to a conventional bone conduction device.
Study O1 (5y follow-up): In a continuation of the clinical study described above, a subset of the patients with the first design iteration of the implant (11) continued to be followed up at three and five years after enrolment/implantation. The aim was to report on audiometric results and patient-reported outcome measures from quality-of-life. No serious adverse events or serious adverse device effects occurred during the follow-up time confirming long-term safety. By using the system, the patients got significantly improved sensitivity (measured by hearing thresholds and speech reception thresholds), speech in noise recognition and self-assessment (questionnaire) results than compared both to the unaided condition (primary effect hypothesis) and to a conventional bone conduction device (secondary effect hypothesis). It has been shown that the effectiveness of the device in terms of audiological performance is persistent over time (5 years), thus confirming long-term effectiveness.
Study C58: After 1 year a sub-set of the patients (ten subjects) enrolled in study O1 were uparaded with the SP2 sound processor. The study was a single-centre prospective case study with the primary objective to validate the performance of the SP2 in terms of improvement in aided thresholds compared to the unaided condition. Secondary objectives included speech intelligibility with the SP2 comparing unaided to aided thresholds and speech intelligibility with SP2 over time (7 months) and compared to SP1. In addition, the study evaluated adverse events, potential skin problems, processor retention force, as well as subjective benefit,
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Image /page/19/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 words is a thin, vertical orange line, followed by the phrase "Because sound matters" in a smaller, gray font.
satisfaction, and usability. The results confirmed that SP2, together with the I1 implant, gave a significant functional gain benefit of 29.6 dB. In addition. SP2 gave benefit to the users in terms of improved speech intelligibility compared to unaided condition. The performance of SP2 was stable over time and similar to SP1. Very few skin reactions were reported, and retention and comfort were rated similar to the SP1. Few adverse events and no serious adverse events were reported in the study. No new safety risks were identified. ClinicalTrials.gov Identifier: NCT03374787
Study BC114: After closure of study C58, all patients from the study O1 cohort were upgraded to Sentio 1 Mini sound processor. Eleven subjects accepted to participate in the study and were upgraded with the Sentio 1 Mini. One subject was lost to follow-up. The study is a premarket, prospective, single-centre, comparative study with within-subject control design. The primary objective was to assess the improvement of hearing with Sentio 1 Mini. Secondary objectives included patient reported outcomes and collection of adverse events throughout the study. The performance end-point for the primary objective was the difference between Sentio 1 Mini aided sound field thresholds and unaided sound field thresholds (functional gain) PTA4 (500, 1000, 2000, 4000Hz). Results showed a significant improvement in average functional gain of 32.5 dB (SD: 6.8). The difference between aided sound field thresholds and unaided sound field thresholds was shown to be significant for all measured frequencies. The effective gain showed an average effective gain of 11.9 dB PTA4 (SD: 7.7). The abbreviated Speech, Spatial and Qualities of hearing scale (SSQ12), was used to collect self-reported performance related to the subject's previous sound processor and at the 1-month follow up for the Sentio 1 Mini. There were no significant differences observed between the two devices at either the subgroup level (speech, spatial, quality) or in the overall total. A preference assessment showed that most subjects (7 out of 10) preferred the Sentio 1 Mini over their previous sound processor. Two subjects had no preference, and one had a slight preference for his/her previous sound processor. In conversation situations all subjects either preferred the Sentio 1 Mini or had no preference, while for sound quality and loudness aspects one to two subjects preferred the previous device. Up until the 1-month follow-up no adverse events or device deficiencies had occurred. ClinicalTrials.gov Identifier: NCT05628285
Study C70: The objective of the study was to increase the knowledge about bone thickness in the relevant area for implantation of the Sentio Ti implant in order to develop surqical strategy and pre-operative planning. The study was a retrospective and non-interventional study performed on CT scans, on file at the investigator, using the final design of the implant (Sentio Ti implant). In conclusion, in adults without known medical history that indicates anatomical malformations, the average minimum bone thickness in the combined recess and screw area was 5.55 ± 1.46 mm, with a 95% confidence interval of 5.30–5.80 mm, i.e., thicker than both the maximum transducer depth of 3 mm and the 2.7 mm bone engagement of the osseointegrating fixation screws.
Devices changes
Both design iterations of the implant (11 and Sentio Ti implant) have the same mode of operations and main elements; a receiving inductive link, a holding magnet and a transducer. Except for the housing of the transducer the dimensions of the implant are similar. The implant is surqically placed under the skin and periosteum in the temporal bone area under general or local anesthesia. The transducer is placed in a recess and fixed to the bone; the lower profile of the Sentio Ti allows for a slightly shallower recess than the 11. The sound processor is held against the implant with a magnetic retention system. The different design iterations have slightly different size and weight. A tamper resistant battery door was introduced in the final
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Image /page/20/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 "MEDICAL" is a thin, vertical orange line, followed by the words "Because sound matters" in a smaller, gray font.
design (Sentio 1 Mini). The design iterations have different sound processing features and Sentio 1 Mini has Bluetooth functionality.
For efficacy, a comparison of maximum force output (MFO) can be used to verify that combinations of implants and sound processors give similar maximum force output (MFO). Based on the comparison of the Sentio system, it is concluded that the MFO differences between the different design iterations are not expected to be clinically significant. From an efficacy standpoint, similar performance will therefore be expected from the different design iterations, including the final design Sentio Ti implant and Sentio 1 Mini sound processor.
L. Conclusion
It is concluded that the Sentio Active Implantable Bone Conduction Hearing System is substantially equivalent to the predicate devices MED-EL Bonebridge system (DEN170009) and comparable to the reference device Oticon Medical Ponto 5 SuperPower (K213733). The minor technological differences between the Sentio system devices and their predicate devices raise no new issues of safety or effectiveness.