· 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 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.

AI/ML Overview

Here's an analysis of the acceptance criteria and study detailed in the provided text:

The document describes the Sentio Active Implantable Bone Conduction Hearing System, including the Sentio Ti Implant Kit, Sentio 1 Mini, and Genie Medical BAHS. The primary study referenced for demonstrating safety and performance is Study BC101.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a formal "acceptance criteria" table with pre-defined thresholds for performance that the device must meet in a comparative format. Instead, it discusses performance results in context of showing meaningful improvement and equivalence to predicate devices. However, we can infer performance targets based on the documented results and comparisons to normal hearing/speech levels.

Performance Metric	Acceptance Criteria (Inferred/Contextual)	Reported Device Performance (Study BC101)
Safety	No serious adverse device-related events or major complications; safety profile in line with similar devices.	No serious adverse device-related events or major complications reported across the indicated population. Minor complications (dizziness/headache, numbness, swelling/erythema, pain at surgical site, sound sensations) were transient and/or mild intensity, in line with expectations for similar devices.
Hearing Improvement (Aided Threshold)	Enable patients to hear sounds at normal speech levels (e.g., around 65 dB SPL); demonstrate significant improvement in hearing thresholds.	Average aided threshold results: 26.3 dB HL (PPS) and 26.3 dB HL (FAS). This shows patients can hear sounds at normal speech levels.
Functional Gain	Demonstrate functional gain in line with or comparable to similar devices.	Average functional gain: 32.8 dB (PPS) and 29.3 dB (FAS). Reported as "in line with what has been reported for similar devices."
Speech Recognition in Quiet	Significant improvement compared to unaided condition; high percentage of speech intelligibility at normal speech levels.	Speech intelligibility in quiet (at 65 dB SPL) across the intended population: 97.9% (PPS) and 97.6% (FAS). Significantly improved compared to unaided for conductive/mixed hearing loss and SSD.
Quality of Life (GBI Score)	Scores above 0 (indicating improvement); high percentage of patients reporting improvement.	Average total GBI score: 28.4 (PPS) and 29.2 (FAS). 97.1% (PPS) and 96.1% (FAS) reported an improvement in quality of life using the Sentio system.
MRI Safety (1.5T Conditional)	Ability to undergo 1.5T MRI safely with outlined conditions; minimal pain/pressure experienced by patients.	Clinical sub-study supports safe 1.5T MRI. MRI completed successfully in all 9 cases without complications/adverse events. Patients rated positive experience (average NRS 2), mild pressure (average NRS 3), and mild pain (average NRS 1).

Note: PPS = Per Protocol Set, FAS = Full Analysis Set. The document clarifies that a calibration error impacted some early subjects, leading to the use of both sets for analysis.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size (Study BC101): 51 adult patients (18 years or older) were included in the Full Analysis Set (FAS).
Data Provenance (Study BC101):
- Country of Origin: Multi-center study, including six clinics in three countries (specific countries are not named in the provided text).
- Retrospective or Prospective: Prospective study.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The document does not specify the number or qualifications of experts used to establish ground truth for the test set. Clinical studies of this nature typically involve audiologists and ENT surgeons who administer tests and evaluate outcomes, but no explicit details are provided regarding their role in establishing a "ground truth" independent of the device's own performance measurements. The "normal hearing threshold for pure tones (20 dB HL)" and "normal speech level (65 dB SPL)" serve as general external benchmarks.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1). For an audiology study focused on objective measurements (e.g., dB HL, speech recognition percentages) and patient-reported outcomes, a formal adjudication process akin to image interpretation may not be necessary in the same way. The results are primarily based on quantifiable audiometric tests and standardized questionnaires.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

An MRMC study was not conducted in the traditional sense involving multiple human readers interpreting cases with and without AI assistance. This device is a hearing aid system, not an imaging AI diagnostic tool. The "assistance" it provides is direct auditory amplification and sound processing for the patient, not a clinical interpretation aid for a human expert.

The study does compare aided performance (with the device) against unaided performance (without the device), demonstrating the effectiveness directly. For example:

"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 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."

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Performance

The device's core function is as a "standalone" system in its operation for the patient. While it requires clinical fitting and programming (Genie Medical BAHS software, performed by a Hearing Care professional), the performance metrics presented (e.g., aided thresholds, speech recognition, functional gain) are reflective of the device's performance as used by the patient, meaning the algorithm's output directly impacts the patient's hearing perception. There's no separate human-in-the-loop task where the algorithm assists a human to perform a diagnostic task; rather, the device is the therapeutic intervention.

7. Type of Ground Truth Used

The ground truth for evaluating the device's performance is established through a combination of:

Objective Audiometric Measurements: This includes bone conduction thresholds, air conduction thresholds, pure tone average (PTA), functional gain, and speech intelligibility percentages. These are standard, quantifiable audiological assessments.
Patient-Reported Outcomes (PROs): Standardized questionnaires, specifically the Glasgow Benefit Inventory (GBI), were used to assess health-related quality of life and patient satisfaction.
Safety Data: Adverse event reporting and MRI experience questionnaires.
Comparison to Reference Values: Performance is compared to established "normal" hearing thresholds (20 dB HL) and speech levels (65 dB SPL), and also to unaided listening conditions.

8. Sample Size for the Training Set

The document does not explicitly describe a separate "training set" for the Sentio system in the context of an AI/machine learning model. The device is a medical device (active implantable bone conduction hearing system) with specific mechanical and electrical properties, and its "programming" or "fitting" (e.g., using Genie Medical BAHS software) is based on established audiological science and algorithms, not typically on a large-scale, iterative machine learning training process with a distinct training dataset.

The clinical studies (O1, C58, BC114, BC101) described are clinical trials to evaluate the device's safety and performance in humans, not "training sets" for an AI algorithm in the conventional sense. Previous design iterations or prototypes might have undergone internal development and testing, but the text doesn't detail this as a formal "training set."

9. How the Ground Truth for the Training Set Was Established

As noted above, the concept of a "training set" and associated ground truth is not directly applicable in the typical AI/ML sense for this device based on the provided text. The device's design, functionality, and fitting parameters are developed and refined through engineering principles, audiological research, and validation against clinical needs and outcomes (as demonstrated in the clinical studies listed).

Summary

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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).

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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 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.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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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 KitSentio 1 MiniGenie 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 kitBCI 602 Implant KitSamba 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

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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	Table 1 summarizes the substantial equivalence comparison on system.

	Sentio System	Bonebridge System(predicate)	Substantialequivalence(Yes/No)
Intended use	The Sentio system is intended forimprovement of hearing forpatients with conductive or mixedhearing losses, whetherunilaterally or bilaterally fitted, orfor those with single sideddeafness.	The Bonebridge is intended toimprove hearing for patients withconductive or mixed hearinglosses, bilateral fitting, and single-sided deafness.	Yes, difference inwording is notsignificant
Indications foruse	• Patients with conductive ormixed hearing losses, who canstill benefit from amplification ofthe sound. The pure tone average(PTA) bone conduction (BC)threshold (measured at 0.5, 1, 2and 3 kHz) of the indicated earshould be better than or equal to45 dB HL.	• Patients who have a conductiveor mixed hearing loss and still canbenefit from sound amplification.The pure tone average (PTA) boneconduction (BC) threshold(measured at 0.5, 1, 2, and 3 kHz)should be better than or equal to45 dB HL.
	• Patients having a symmetricallyconductive or mixed hearing lossare candidates for a bilateralfitting. The difference between theleft and right sides' BC thresholdsshould be less than 10 dB onaverage measured at 0.5, 1, 2and 3 kHz, or less than 15 dB atindividual frequencies.	• Bilateral fitting of the Bonebridgeis intended for patients having asymmetrically conductive or mixedhearing loss. The differencebetween the left and right sides' BCthresholds should be less than 10dB on average measured at 0.5, 1,2, and 3 kHz, or less than 15 dB atindividual frequencies.
	• Patients who have a profoundsensorineural hearing loss in oneear and normal hearing in theopposite ear (i.e., SSD). The puretone average (PTA) airconduction (AC) threshold of thehearing ear should then be betterthan or equal to 20 dB HL(measured at 0.5, 1, 2 and 3kHz).	• Patients who have profoundsensorineural hearing loss in oneear and normal hearing in theopposite ear (i.e., single-sideddeafness or "SSD"). The pure toneaverage air conduction hearingthresholds of the hearing earshould be better than or equal to20 dB HL (measured at 0.5, 1, 2,and 3 kHz).
	• Patients who are indicated foran air-conduction contralateralrouting of signals (AC CROS)hearing aid, but who for somereason cannot or will not use anAC CROS.	• The Bonebridge for SSD is alsoindicated for any patient who isindicated for an air-conductioncontralateral routing of signals (ACCROS) hearing aid, but who forsome reason cannot or will not usean AC CROS.
	• Prior to receiving the device, it isrecommended that an individualhas experience with appropriatelyfitted air conduction or boneconduction hearing aids.	• Prior to receiving the device, it isrecommended that an individualhave experience with appropriatelyfit air conduction or boneconduction hearing aids.
	• Patients 12 years of age orolder.	• Patients 12 years of age or older.
Contraindications	• Known chronic or non-revisablevestibular or balance disorder.	• Chronic or non-revisablevestibular or balance disorders.	Yes
	• Known abnormally progressivehearing loss.	• Abnormally progressive hearingloss.	Patients alreadyimplanted with, orto be implanted
	Sentio System	Bonebridge System(predicate)	Substantialequivalence(Yes/No)
	• Evidence of conditions thatwould prevent good speechrecognition potential asdetermined by good clinicaljudgment.• Skin or scalp conditions thatmay preclude attachment of thesound processor or that mayinterfere with the use of the soundprocessor.• Patients already implanted with,or to be implanted with,programmable CSF shunts.	• Evidence of conditions that wouldprevent good speech recognitionpotential as determined by goodclinical judgment.• Skin or scalp conditions that maypreclude attachment of the audioprocessor or that may interfere withthe use of the audio processor.• Skull size or abnormality thatwould preclude appropriateplacement of the BONEBRIDGEimplant as determined by CT scan.	with,programmableCSF shunts arecontraindicatedfor Sentio sinceverification hasnot been done.For Sentio, pre-operative CTscan is typicallynot necessary forpatients withnormal anatomy,as evaluated in aclinical study.
Design	Active implantable boneconduction hearing system:Transcutaneous implant which, inuse together with an externalsound processor that is held inplace on the patient's head bymagnetic attraction between theimplant and the sound processor,uses the body's natural ability totransfer sound through boneconduction.	Active implantable bone conductionhearing system:Transcutaneous implant which, inuse together with an externalsound processor that is held inplace on the patient's head bymagnetic attraction between theimplant and the sound processor,uses the body's natural ability totransfer sound through boneconduction.	Yes
Anatomical site	Surgically implanted in thetemporal and mastoid bone area.	Surgically implanted into thetemporal bone.	Yes, thedifference inwording does nothave clinicalsignificance asthe mastoid ispart of thetemporal bone.
Intendedenvironment	Implant:- Home care- Professional Healthcare Facility- Magnetic Resonance (MR)EnvironmentSound Processor:- Home care- Professional Healthcare Facility	Implant:- Home care- Professional Healthcare Facility- Magnetic Resonance (MR)EnvironmentSound Processor:- Home care- Professional Healthcare Facility	Yes
Transmissionscheme	The difference between forceoutput level at coupling distancesof 9 mm and 3 mm is ≤ 5 dB	The difference between forceoutput level at coupling distancesof 7 mm and 4 mm is ≤ 4 dB	Yes, difference isnot clinicallysignificant.
System ForceOutput	Frequency[Hz]MPO[dB μ N]	Frequency[Hz]MPO[dB μ N]	Yes.The choice ofresonancefrequency willaffect the overallcurve, but haveoutsized effect onspecificfrequencies. Theresonancefrequency isslightly lower for
	500901000112200096400090Peak112	500901000102200096400090Peak113
	Sentio System	Bonebridge System(predicate)	Substantialequivalence(Yes/No)
			the predicatedevice comparedto Sentio, andtherefore has anoutsized effect onthe 1000Hz value.When taking thepeak output intoaccount weconclude that theoverall differencein MFO is notclinicallysignificant.
Table 1. Substantial Equivalence Comparison - System
	Sentio Ti Implant	Bonebridge BCI Implant(predicate)		Substantialequivalence(Yes/No)
Material	TitaniumSilicone	TitaniumSilicone		Yes
Biocompatibility	The Sentio Ti Implant isimplanted in and above themastoid bone and as such, is adevice in permanenttissue/bone contact.Biocompatible.Materials in contact with tissue:- Implant: Titanium grade 2 and5, medical grade siliconeelastomer- Screws: Titanium Ti6Al4V	The BCI is implanted in and abovethe mastoid bone and as such, is adevice in permanent tissue/bonecontact.Biocompatible.Materials in contact with tissue:- Implant: Titanium grade 5,medical grade silicone elastomer- Screws: Titanium alloy Ti6Al7Nb		Yes
Compatibilitywith theenvironmentand otherdevices	Diagnostic ultrasoundX-Ray and CTRadiation therapy and PETMRI 1.5T Conditional	Diagnostic ultrasoundX-Ray and CTRadiation therapy and PETMRI 1.5T Conditional		Yes
Sterility	EtO sterilization: Sentio TiImplantSteam: Surgical templates	EtO sterilization		Yes, the Sentiosurgical templateshas a material andcomponentcharacterization thatdoesn't require EtO,hence a differentsterilization method(steam) is used.
Dimensions	Length: 60 mmWidth: 30 mmThickness: 4 mm	BCI model 601Length: 69 mmWidth: 28,6 mmThickness: 4,5 mmBCI model 602Length: 64.3 mmWidth: 28,2 mmThickness: 4,4 mm		Yes, the footprint ofSentio Ti is smaller,a less deep recessis needed.
MRI	Magnet rotatable: NoMagnet removable: NoMagnet polarization: AxialHead bandaging requirement:NoPatient position:Supine position, centered in theMRI scanner.Temperature rise:Less than 2°CPermitted static magnetic fieldstrength: 1.5 T	Magnet rotatable: YesMagnet removable: NoMagnet polarization: DiametricHead bandaging requirement:NoPatient position:No restrictionsTemperature rise:Less than 4°CPermitted static magnetic fieldstrength: 1.5 T		Yes, both systemsmeet the samesafety standardsand are MRConditional at 1.5 Twith their respectivescanner settings.
	Sentio Ti Implant	Bonebridge BCI Implant(predicate)	Substantialequivalence(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-bodyaveraged specific absorptionrate (SAR) [W/kg]:2 W/kg(normal operating mode)	Maximum permitted whole-bodyaveraged specific absorption rate(SAR) [W/kg]:<4 W/kg(first level operating mode)
	Maximum permitted headaveraged SAR [W/kg]:3.2 W/kg(Normal operating mode)	Maximum permitted head averagedSAR [W/kg]:<3.2 W/kg(Normal and first-level OperatingMode)
	Scan duration:15 min continuous scanning	Scan duration:15 min continuous scanning
	RF transmit coil type:Whole body transmit coil	RF transmit coil type:No restrictions
	Scanner type:Cylindrical-bore	Scanner type:No restrictions
	Magnetic field (B0) orientation:Horizontal	Magnetic field (B0) orientation:No restrictions
	Maximum gradient slew rate peraxis [T/m/s]:200 T/m/s	Maximum gradient slew rate peraxis [T/m/s]:No restrictions
Fixation	A fixation band is appliedacross the transducer and twoself-drilling, osseointegratingscrews are inserted in the bone.	The implant is fixated with self-drilling screws into the bone. Onescrew is placed in each anchor holeof the BC-FMT.	Yes, the Sentio TiImplant designoffers flexibility inplacement of thefixation whereas inBonebridge theposition of thescrews are fixed asthe fixation device isintegrated with thetransducer part ofthe implant.

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Table 2 summarizes the substantial equivalence comparison for the Sentio Ti Implant.

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Table 3 Comparison for the Sentio 1 Mini sound processor and SAMBA 2 Sound Processor (predicate).

	Sentio 1 Mini	Ponto 5 SuperPower(reference)	SAMBA 2 SoundProcessor(predicate)	Substantialequivalence(Yes/No)
Dimensions	Length: 39 mmWidth: 30 mmThickness: 9 mm	Length: 31 mmWidth: 21 mmThickness: 15 mm	Length: 35 mmWidth: 30 mmThickness: 10 mm	Yes
Weight	8.6 g (incl. battery andmagnet)	20.3 g (w/o battery)	< 9 g (incl. battery andmagnet)	Yes
Battery	675 Zink-Air	675P Zink-Air	675 Zink-Air	Yes
Batterylifetime	>16 hours(avg. 61 hours,dependent on theusage of the soundprocessor)	>16 hours(dependent on theusage of the soundprocessor)	>16 hours(dependent on the usageof the sound processor)	Yes
Battery safety	Tamper-resistant battery drawerTool for opening required		N/A	Yes, added safetyfeature to Pontoand Sentio soundprocessors
Magnetproperties	6 magnet strengths	N/A	5 magnet strengths	Yes, difference isnot clinicallysignificant
Magnet safety	Tool for removingrequired	N/A	Tool for removingrequired	Yes
MRI	MR Unsafe	MR Unsafe	MR Unsafe	Yes
Variants	One variantLeft or right assigned during fitting		Left and right variants	Yes, providesflexibility forclinician
Microphones	Dual directional microphones (various options)		Dual directionalmicrophones (variousoptions)	Yes
Soundprocessingfeatures	64 processing channelsSpeech and noise managementDirectional microphonesWind noise managementFeedback management		16 processing channelsSpeech and noisemanagementDirectional microphonesWind noise management	Yes
Frequencyrange	200-9500 Hz		250-8000 Hz	Yes, adds broaderband width
Wirelessfeatures	Receiver and transmitter, 2.4 GHz, Bluetooth LowEnergy		Receiver and transmitter,3.28 MHz, NFMI (nearfield magnetic induction),Modulation type: FMNote: Bluetooth availablethrough compatibility withSiemens miniTek	Yes, difference isnot clinicallysignificant
Accessories	Fixation option:Line a clip to be attached to sound processor ande.g., clothes.		Fixation option:Line a clip to be attachedto sound processor ande.g., clothes.	Yes
	Sentio 1 Mini	Ponto 5 SuperPower(reference)	SAMBA 2 SoundProcessor(predicate)	Substantialequivalence(Yes/No)
	Various cover colours and skins forpersonalization	Various cover colours and skins forpersonalization	Various cover coloursand skins forpersonalization
Compatibilitywith wirelessaccessories	Compatible wireless Oticon A/S/SBO Hearing A/Saccessories:• Remote control 3.0• ConnectClip• TV Adapter 3.0• EduMic• Oticon Companion app(Note: Companion app is a combination of the ONapp and the RemoteCare app, previously clearedin K213733)	Compatible wireless Oticon A/S/SBO Hearing A/Saccessories:	SAMBA Remote controlSiemens miniTek	Yes
Fittingsoftware	Genie Medical BAHS		SYMFIT 8.0	Yes
Fittingoptions	Cabled fittingWireless fittingRemote fitting		Cabled fitting	Yes, additionalwireless andremote fitting areavailable withSentio 1 Mini.

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Table 4 compares the surgery implantation procedures of the two systems
	Sentio Ti Implant	Bonebridge Implant	Substantialequivalence (Yes/No)
Pre-operativeplanning	Pre-operative CT scan istypically not necessary forpatients with normal anatomy.Pre-operative CT scan isrecommended for patients wherethin bone is expected including:• Patients who have had previoussurgery in the area of the implantsite, and/or congenital craniofacialor auricular anomalies where ahypoplasia of the mastoidalanatomy might be present, e.g.,congenital aural atresia,hemifacial microsomia/Goldenharsyndrome, Treacher Collin likesyndromes and Branchio-Oto-Renal (BOR) syndrome.• Patients under the age of 18.	A CT scan is evaluated todetermine where to place the BC-FMT (transducer) and the screws.	Yes, for Sentio, pre-operative CT scan istypically not necessaryfor patients withnormal anatomy, asevaluated in a clinicalstudy.
Implantpositioning	A template is used to outline theposition of the implant on the skin	A template is used to outline theposition of the implant on the skin.	Yes
Incision	An incision is made.	An incision is made.	Yes
Preparation of thebone bed for thetransducer	The site for the transducer ismarked on the bone with the aidof a template.A standard otologic drill bit isused to createa bone bed, thetransducer needs to berecessed by 3 mm.	The site for the transducer ismarked on the bone with the aid ofa template.A standard otologic drill bit isused to create a bone bed, thetransducer needs to be recessedby 8.7 mm.	Yes, a less deeprecess in the bone isneeded for Sentio(3mm vs 8.75mm)
Preparation ofpocket for thereceiver coil	A periosteal pocket is prepared	A periosteal pocket is prepared	Yes
Implantinstallation	The receiver coil is inserted intothesubperiosteal pocket andthe transducer is placed in therecess.	The receiver coil is inserted intothe subperiosteal pocket andthe transducer is placed in therecess.	Yes
Fixation	The fixation band is appliedacross the transducer and twoself-drilling, osseointegratingscrews are inserted in the bone	The implant is fixated with self-drilling screws into the bone. Onescrew is placed in each anchorhole of the BC-FMT and aresecured tightly.	Yes, the Sentio TiImplant design offersflexibility and inplacement of thefixation whereas inBonebridge theposition of the screwsare fixed as thefixation device isintegrated with thetransducer part of theimplant.
Closure anddressing	The surgical wound is closed anda suitable dressing applied.	The surgical wound is closed anda 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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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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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 ofpatients	Status
O1	Prospective,multi-center1-year FU	Safety &performance	Implant: I1Sound processor: SP1	Patient group1	16	Completed
O1	Prospective,single-center,3- and 5-yearFU	Long termsafety &performance			13	Completed
C58	Prospective,single-center,7-month FU	Performance	Implant: I1Sound processor: SP2	Subset ofpatient group1	10	Completed
BC114	Prospective,single-center,2-year FU	Performance	Implant: I1Sound processor:Sentio 1 Mini	Subset ofpatient group1	11	Completedprimary endpointanalysis(1 month)
BC114						2y follow upongoing
BC101	Prospective,multi-center2-year FU	Safety &performance	Implant: Sentio TiimplantSound processor:Sentio 1 Mini	Patient group2		Completedprimary endpointanalysis
BC101						2y follow upongoing

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Because
sound matters

C70	Virtualimplantationof Sentioimplant in CTscans	Investigateneed for pre-operativeplanning	Implant: Sentio TiimplantSound processor: NA	Patient group3(CT scans- noactualimplantationperformed)	197 CTscans(from 121patients)	Completed
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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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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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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.

Regulation Number and Section

§ 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.