Sentiero, AuDX, AuDX PRO, Sentiero Desktop, AuDX PRO Flex, Sentiero Advanced, NavPRO ONE
Device Facts
| Record ID | K213345 |
|---|---|
| Device Name | Sentiero, AuDX, AuDX PRO, Sentiero Desktop, AuDX PRO Flex, Sentiero Advanced, NavPRO ONE |
| Applicant | Path Medical GmbH |
| Product Code | EWO · Ear, Nose, Throat |
| Decision Date | Jun 22, 2022 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 874.1050 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Indications for Use
Devices of the Sentiero device families offer different test methods which can be configured to fit the professional's needs for hearing screening or diagnostics and vestibular diagnostics (Sentiero Advanced only). Devices of the Sentiero device family provide standard psychoacoustical test procedures and additionally physiological test procedures including otoacoustic emissions (OAE) (e.g. transitory evoked otoacoustic emissions (TEOAE), distortion product otoacoustic emissions (DPOAE)), evoked potentials (e.g. auditory brainstem responses (ABR), auditory steady state responses (ASSR); vestibular evoked myogenic potentials (VEMP)) (Sentiero Advanced only), and auditory impedance and acoustic reflex measurements (Sentiero Desktop, Sentiero and Sentiero Advanced with tympanometry add-on). Available psycho-acoustical methods on Sentiero devices are especially indicated for use with cooperative patients starting at the age of two years or adequate development age, which enables them to do play/interactive audiometry. Physiological modules which require active participation (e.g. VEMP) are indicated for use with cooperative patients who are able to mentally and physically perform the required task. All other physiological modules are suitable to be used for all ages elder than infants from 34 weeks (gestational age) that are ready for discharge from the hospital. All physiological test methods are especially indicated for use in defining the type and configuration of hearing loss particularly for individuals whose behavioral audiometric results are deemed unreliable or to assist in the diagnosis of otologic or vestibular disorders. Estimation of cochlear hearing thresholds (DPOAE Threshold) is possible at various frequencies without the need of cooperative interaction with the patient. Acoustic reflex and tympanometry are featured to evaluate the functional condition of the middle and outer ear. VEMP is featured to assist in the evaluation of the functional condition of the vestibular system. For each method, several protocols can be configured. The results can be used to make further recommendations regarding appropriate intervention strategies. Devices of the Sentiero device family are intended for the following purposes: Diagnostics, monitoring and follow-up after newborn hearing screening; Pre-school, school, and adult hearing screening; ENT diagnostics based on measurement of a) Otoacoustic emissions, b) Tympanometry and acoustic reflex (Sentiero Desktop, Sentiero and Sentiero Advanced with tympanometry add-on), c) Evoked potentials (Sentiero Advanced only). Sentiero is intended for use by audiologists, ear-nose-throat (ENT) doctors, and other hearing/ENT health care professionals and personnel trained on the available test modules in a medical environment. Please consider local regulations regarding the qualification requirements for performing measurements with a specific test module. Sentiero is not intended for operational use by the general public. All test procedures must be supervised or conducted by qualified personnel. In the United States of America, Federal law restricts this device to sale by or on the order of a licensed physician. Sentiero is intended for indoor-use only and must be operated at defined environmental conditions. Sentiero is not intended for use in oxygen-rich environments. Sentiero must not be used in cases of external otitis (outer ear canal infection) or in any case which yields to pain when inserting the ear probe or applying any other transducer. cVEMP on Sentiero Advanced must not be used in cases of neck, muscular and cervical injury problems and in cervical spine problems if the sternocleidomastoid muscle contraction cannot be maintained without further discomfort or pain.
Device Story
Sentiero is an audiometric examination platform; consists of a touch-screen device with accessories (OAE probes, headphones, bone conductor, electrodes). Operates by collecting physiological signals (evoked potentials, OAEs, impedance) via connected transducers; firmware identifies accessories via plug-in sensors to adapt measurement procedures. Used by audiologists/ENT doctors in clinical environments. Provides waveform plots and signal statistics for clinician evaluation; does not provide automated diagnosis. VEMP module assists in vestibular system evaluation by recording myogenic potentials. Benefits include objective assessment of hearing and vestibular function for patients unable to perform behavioral tests. Data transferable to PC via USB for archiving.
Clinical Evidence
Clinical evaluation conducted on 16 normal-hearing adults to assess repeatability and reliability of cVEMP and oVEMP modules. Primary endpoints included P1/N1 latency and interpeak amplitude variation. Results showed low variation in latency (1.02%-4.05%) and medium variation in interpeak amplitude (7.08%-23.64%), consistent with academic literature. Bench testing verified electrical safety, EMC, and biocompatibility (ISO 10993-1).
Technological Characteristics
Platform: Touch-screen audiometer. Transducers: Headphones, insert phones, bone conductor, OAE probes. Connectivity: USB to PC. Software: Firmware-based, license-key configured modules. Biocompatibility: ISO 10993-1 compliant. Electrical Safety: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-40. Stimuli: Click, Chirp, Tone Burst. Recording: 1-3 EEG channels.
Indications for Use
Indicated for hearing screening, diagnostics, and vestibular diagnostics. Psycho-acoustical methods for cooperative patients aged 2+ years. Physiological modules (e.g., VEMP) for cooperative patients able to perform required tasks. Other physiological modules for all ages >34 weeks gestational age ready for hospital discharge. Contraindicated for external otitis, pain during transducer application, or neck/cervical spine injuries preventing muscle contraction for cVEMP.
Regulatory Classification
Identification
An audiometer or automated audiometer is an electroacoustic device that produces controlled levels of test tones and signals intended for use in conducting diagnostic hearing evaluations and assisting in the diagnosis of possible otologic disorders.
Predicate Devices
- SENTIERO (K133012)
Reference Devices
- Eclipse with VEMP (K162037)
Submission Summary (Full Text)
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June 22, 2022
Path Medical GmbH Johann Oswald Managing Director Landsberger Strasse 65 Germering, Bavaria 82110 Germany
Re: K213345
Trade/Device Name: Sentiero, AuDX, AuDX PRO, Sentiero Desktop, AuDX PRO Flex, Sentiero Advanced. NavPRO ONE Regulation Number: 21 CFR 874.1050 Regulation Name: Audiometer Regulatory Class: Class II Product Code: EWO, GWJ, ETY Dated: May 17, 2022 Received: May 20, 2022
## Dear Johann Oswald:
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 (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies.combination product submissions. The general controls provisions of the Act include requirements for 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.
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
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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (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,
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 Ouality Center for Devices and Radiological Health
Enclosure
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## Indications for Use
510(k) Number (if known) K213345
Device Name Sentiero
Indications for Use (Describe)
Devices of the Seniero device families offer different test methods which can be configured to fit the professional's needs for hearing screening or diagnostics and vestibular diagnostics (Sentiero Advanced only),
Available psycho-acoustical methods on Sentiero devices are especially indicated for use with cooperative patients starting at the age of two years or adequate development age, which enables them to do play/interactive audiometry. Physiological modules which require active paticipation (e.g. VEMP) are indicated for use with cooperative patients who are mentally and physically able to perform the required task. All other physiological modules are suitable to be used for all ages elder than infants from 34 weeks (gestational age) that are ready for discharge from the hospital.
| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|--|
|-------------------------------------------------|--|
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image is a logo for Path Medical. The logo consists of a red square with a white curved line running through it on the left side. To the right of the square is the word "PATH" in large, bold, black letters, with the word "MEDICAL" underneath it in smaller, black letters.
# 510(k) Summary
### l. SUBMISSION INFORMATION
| Date of preparation: | June 15th, 2022 |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Submitter: | PATH MEDICAL GmbH<br>Landsberger Str. 65<br>82110 Germering<br>Germany<br><br>Phone: ++49-89-80076502<br>Fax: ++49-89-80076503 |
| Contact Person: | Dr. Johann Oswald, Director<br>Landsberger Str. 65<br>82110 Germering<br>Germany<br><br>Phone: ++49-89-80076502<br>Fax: ++49-89-80076503<br>Email: oswald@pathme.de |
### II. DEVICE INFORMATION
| Device Name: | SENTIERO |
|------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|
| Device Trade Names: | Sentiero, Sentiero Screening, Sentiero<br>Diagnostic, Sentiero Advanced, Sentiero<br>Desktop, AuDX, AuDX PRO, AuDX PRO FLEX,<br>NavPRO ONE |
| Device Identification Codes: | SOH1000098, SOH100360, SOD100497 |
| Common Name: | Evoked Response Auditory Stimulator |
| Classification Name: | Evoked Response Auditory Stimulator,<br>Audiometer, Auditory Impedance Tester<br>FDA 21CFR882.1900 & 21CFR874.1050 &<br>21CFR874.1090 |
### III. PREDICATE DEVICE
| SENTIERO | 510(k) Number: K133012 |
|----------|------------------------|
|----------|------------------------|
This device has not been subject to a recall.
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Image /page/4/Picture/0 description: The image contains the logo for Path Medical. The logo consists of a red square with a white curved line inside, and the words "PATH MEDICAL" in black text to the right of the square. The word "PATH" is in a larger font than the word "MEDICAL".
### IV. REFERENCE DEVICE
| Eclipse with VEMP | 510(k) Number: K162037 |
|-------------------|------------------------|
|-------------------|------------------------|
### V. DEVICE DESCRIPTION
Sentiero is an audiometric examination platform which consists of the Sentiero device with a touch screen display together with different accessories such as mains adapter, OAE probes, headphones, bone conductor, electrode cable, ear coupler cable, patient response switch. These accessories can be connected to Sentiero based on a special plug, which holds the information about the connected transducer / cable. Therefore, the firmware can make use of this information and adapt the measurement procedures accordingly or provide information to the user via its display.
Furthermore, each model can be configured to allow different test methods and features (modules) by a license key in the device. Sentiero is based on configurable modules. Sentiero can have one single module or a combination of multiple.
The measurement application is controlled from a self-contained firmware. The measurement flow is menu guided on a touch screen. Evaluation of test results is based on signal statistics (if available for the test method). Besides that, wave forms and result information are displayed for the user's evaluation.
The patient/test data can be transferred from the device to a PC via a USB connection and the accompanied data management and archiving software MRA. Patient/test data on the PC software can be password- protected so that unauthorized access is prohibited.
Compared to the original 510(k) submission of the Sentiero in its predicate state, the Sentiero now offers a VEMP test module. Vestibular evoked myogenic potential (VEMP) is a short latency muscle reflex driven by otolithic organs that play a major role for detecting the orientation, static balance and linear acceleration of the head. Vestibular dysfunctions arise from various different regions along the vestibular pathway. Vestibular neuritis, vestibular schwannoma, multiple sclerosis or Meniere's disease will be indicated by the decrease or absence of VEMP responses.
## INTENDED USE
Devices of the Sentiero device families offer different test methods which can be configured to fit the professional's needs for hearing screening or diagnostics and vestibular diagnostics (Sentiero Advanced only). Devices of the Sentiero device family provide standard psychoacoustical test procedures and additionally physiological test procedures including otoacoustic emissions (OAE) (e.g. transitory evoked otoacoustic emissions (TEOAE), distortion product otoacoustic emissions (DPOAE)), evoked potentials (e.g. auditory brainstem responses (ABR), auditory steady state responses (ASSR); vestibular evoked myogenic potentials (VEMP)) (Sentiero Advanced only), and auditory impedance and acoustic reflex measurements (Sentiero Desktop, Sentiero and Sentiero Advanced with tympanometry add-on).
Available psycho-acoustical methods on Sentiero devices are especially indicated for use with cooperative patients starting at the age of two years or adequate development age, which enables them to do
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Image /page/5/Picture/1 description: The image contains the logo for PATH Medical. The logo consists of a red square on the left side with a white, stylized design inside. To the right of the square is the word "PATH" in large, bold, black letters, with the word "MEDICAL" underneath in smaller, black letters.
play/interactive audiometry. Physiological modules which require active paticipation (e.g. VEMP) are indicated for use with cooperative patients who are able to mentally and physically perform the required task. All other physiological modules are suitable to be used for all ages elder than infants from 34 weeks (gestational age) that are ready for discharge from the hospital.
All physiological test methods are especially indicated for use in defining the type and configuration of hearing loss particularly for individuals whose behavioral audiometric results are deemed unreliable or to assist in the diagnosis of otologic or vestibular disorders. Estimation of cochlear hearing thresholds (DPOAE Threshold) is possible at various frequencies without the need of cooperative interaction with the patient. Acoustic reflex and tympanometry are featured to evaluate the functional condition of the middle and outer ear. VEMP is featured to assist in the evaluation of the functional condition of the vestibular system. For each method, several protocols can be configured. The results can be used to make further recommendations regarding appropriate intervention strategies.
Devices of the Sentiero device family are intended for the following purposes:
- Diagnostics, monitoring and follow-up after newborn hearing screening
- . Pre-school, school, and adult hearing screening
- . ENT diagnostics based on measurement of
- a) Otoacoustic emissions
- Tympanometry and acoustic reflex (Sentiero Desktop, Sentiero and Sentiero Advanced with b) tympanometry add-on)
- c) Evoked potentials (Sentiero Advanced only)
Sentiero is intended for use by audiologists, ear-nose-throat (ENT) doctors, and other hearing/ENT health care professionals and personnel trained on the available test modules in a medical environment. Please consider local regulations regarding the qualification requirements for performing measurements with a specific test module.
Sentiero is not intended for operational use by the general public. All test procedures must be supervised or conducted by qualified personnel. In the United States of America, Federal law restricts this device to sale by or on the order of a licensed physician.
Sentiero is intended for indoor-use only and must be operated at defined environmental conditions. Sentiero is not intended for use in oxygen-rich environments.
Sentiero must not be used in cases of external otitis (outer ear canal infection) or in any case which yields to pain when inserting the ear probe or applying any other transducer. cVEMP on Sentiero Advanced must not be used in cases of neck, muscular and cervical injury problems and in cervical spine problems if the sternocleidomastoid muscle contraction cannot be maintained without further discomfort or pain.
#### VI. COMPARISONS
The Sentiero with VEMP will be compared to the predicate Sentiero ABR (without VEMP) due to the use of the same hardware, basic operating principle, and classification code (GWJ). For the parameters of the VEMP test module, the subject device will be compared to the reference device Eclipse with VEMP.
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Image /page/6/Picture/0 description: The image shows the logo for Path Medical. The logo consists of a red square with a white curved line inside, followed by the words "PATH" in bold black letters and "MEDICAL" in smaller black letters below it. The logo is simple and modern, with a focus on the company's name.
## COMPARISON TO PREDICATE DEVICE
For an easier comparison, the new VEMP module will be compared to predicate Sentiero's existing ABR module instead of all existing Sentiero test modules and their different operating principles. The new VEMP module and the existing ABR module use the same stimulus types, accessories and basic operating principle.
| | Sentiero ABR<br>(without VEMP) | Sentiero VEMP | Equivalency |
|------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Purpose | | | |
| Intended use | Detection of otologic<br>disorders through<br>evoked potentials (EP) by<br>Audiologists, ear-nose-<br>throat (ENT) doctors, and<br>other hearing health<br>care professionals and<br>audiologically trained<br>technicians. | Detection of vestibular<br>disorders through evoked<br>potentials (EP) by<br>Audiologists, ear-nose-<br>throat (ENT) doctors, and<br>other hearing/ENT health<br>care professionals and<br>personnel trained on the<br>available test modules. | Similar, both detect<br>inner ear disorders<br>through Evoked<br>Potentials. Intended<br>User is the same. |
| Indications for Use | Devices of the Sentiero<br>device families offer<br>different test methods<br>which can be configured<br>to fit the professional's<br>needs for hearing<br>screening or diagnostics.<br>Available psycho-<br>acoustical methods on<br>Sentiero are especially<br>indicated for use with<br>cooperative patients<br>starting at the age of two<br>years or adequate<br>development age, which<br>enables them to do<br>play/interactive<br>audiometry. All other<br>physiological modules<br>are suitable to be used<br>for all ages elder than<br>infants from 34 weeks<br>(gestational age) that<br>are ready for discharge<br>from the hospital. | Devices of the Sentiero<br>device families offer<br>different test methods which<br>can be configured to fit the<br>professional's needs for<br>hearing screening or<br>diagnostics and vestibular<br>diagnostics (Sentiero<br>Advanced only).<br>Available psycho-acoustical<br>methods on Sentiero devices<br>are especially indicated for<br>use with cooperative<br>patients starting at the age<br>of two years or adequate<br>development age, which<br>enables them to do<br>play/interactive audiometry.<br>Physiological modules which<br>require active patient<br>participation (e.g. VEMP) are<br>indicated for use with<br>cooperative patients who<br>are mentally and physically<br>able to perform the required<br>task. All other physiological<br>modules are suitable to be | Similar. New<br>indications for use<br>also lists VEMP; both<br>diagnostics<br>performed by ENT<br>specialists to detect<br>inner ear disorders<br>through EPs. |
| | Sentiero ABR<br>(without VEMP) | Sentiero VEMP | Equivalency |
| | | used for all ages elder than<br>infants from 34 weeks<br>(gestational age) that are<br>ready for discharge from the<br>hospital. | |
| Physiological features | | | |
| Biosignal | Evoked potential | Evoked potential | Same |
| Electrode position | Head and neck | Head, neck and<br>sternoclavicular junction<br>(cVEMP) or extraocular<br>muscle (oVEMP) | Not exactly the<br>same positions but<br>similar |
| Stimulation target | Cochlea | Circular ducts | Similar, both are<br>structures of the<br>inner ear |
| Biosignal Generator | Auditory pathway | Myogenic system | Similar |
| Patient cooperation | Calm and relaxed<br>posture to minimize<br>myogenic noise. | Calm and relaxed posture to<br>minimize myogenic noise.<br>Patient should turn head to<br>contract<br>sternocleidomastoid muscle<br>(cVEMP) or keep an upward<br>gaze of 35° to contract<br>extraocular muscle (oVEMP). | Same. Movement<br>should be kept at a<br>minimum to reduce<br>noise. The turning of<br>the head or the<br>upward gaze is just<br>one additional part<br>of the initial setup. |
| Hardware | | | |
| Hardware | Sentiero Advanced | Sentiero Advanced | Same |
| Transducer | Headphone / Insert<br>phone, bone conductor,<br>ear coupler cable, or ear<br>probe | Headphone / Insert phone,<br>bone conductor | Same (subset) |
| Potential recording | EEG sensors and PATH<br>MEDICAL electrode cable | EEG sensors and PATH<br>MEDICAL electrode cable | Same |
| EEG recording<br>channels, number of<br>electrode contacts | 1, 3 | 1, 3 | Same |
| Communication<br>interfaces | USB connection to a PC; | USB connection to a PC; | Same |
| | Sentiero ABR<br>(without VEMP) | Sentiero VEMP | Equivalency |
| | Proprietary connector<br>(label printer only) | Proprietary connector (label<br>printer only) | |
| Applied standards | All relevant<br>biocompatibility,<br>electrical safety,<br>usability, audiological<br>and medical device<br>manufacturing standards | All relevant biocompatibility,<br>electrical safety, usability,<br>audiological and medical<br>device manufacturing<br>standards | Same |
| Implementation Details | | | |
| Stimuli | Click, Chirp, Tone Burst | Click, Chirp, Tone Burst | Same |
| Stimulus repetition<br>rate | 10-100 Hz | 2-10 Hz | Similar (adjacent<br>range) |
| Stimulus levels | 0-100 dB nHL | 20-110 dB nHL | Similar |
| Result representation | Time domain waveform<br>plot with wave I, III, V<br>markers, plot range: 0-<br>25 ms | Time domain waveform plot<br>with P1, N1 markers, plot<br>range: 40-100 ms | Similar (markers<br>have different<br>names, different plot<br>range) |
| Result interpretation | by ENT specialist | by ENT specialist | Same |
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Image /page/7/Picture/0 description: The image is a logo for Path Medical. The logo consists of a red square with a white curved line running through it on the left side. To the right of the square is the word "PATH" in large, bold, black letters, with the word "MEDICAL" in smaller, black letters underneath.
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Image /page/8/Picture/0 description: The image is a logo for Path Medical. The logo consists of a red square with a white curved line inside of it on the left side. To the right of the square, the word "PATH" is written in black, with the word "MEDICAL" written in a smaller font size below it.
## COMPARISON TO REFERENCE DEVICE
| | Reference Device<br>Eclipse with VEMP | Subject Device<br>Sentiero VEMP | Equivalency |
|------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The Eclipse with VEMP<br>(Vestibular Evoked Myogenic<br>Potential) is intended for<br>vestibular evoked myogenic<br>potential testing to assist in<br>the assessment of vestibular<br>function. The target<br>population for Eclipse with<br>VEMP includes patients aged<br>from 8 years and up. The<br>device is to be used only by<br>qualified medical personnel | Devices of the Sentiero<br>device families offer<br>different test methods which<br>can be configured to fit the<br>professional's needs for<br>hearing screening or<br>diagnostics and vestibular<br>diagnostics (Sentiero<br>Advanced only).<br><br>Available psycho-acoustical<br>methods on Sentiero devices | Similar, both<br>devices are<br>(amongst others)<br>indicated for use<br>in vestibular<br>diagnostics. The<br>difference in<br>patient age does<br>not raise any<br>concerns<br>regarding safety<br>or effectiveness |
| | with prior knowledge of the<br>medical and scientific facts<br>underlying the procedure. | are especially indicated for<br>use with cooperative<br>patients starting at the age<br>of two years or adequate<br>development age, which<br>enables them to do<br>play/interactive audiometry.<br>Physiological modules which<br>require active patient<br>participation (e.g. VEMP) are<br>indicated for use with<br>cooperative patients who<br>are able to perform the<br>required task. All other<br>physiological modules are<br>suitable to be used for all<br>ages elder than infants from<br>34 weeks (gestational age)<br>that are ready for discharge<br>from the hospital. | as the limiting<br>factor has been<br>shown to be<br>patient<br>cooperation and<br>not age. Patient<br>cooperation is<br>ensured through<br>EMG Monitor and<br>trained,<br>professional<br>users. |
| EEG recording<br>channels, number of<br>electrode contacts | 2, 4 | 1, 3 | Similar, Sentiero<br>VEMP requires<br>sequential<br>testing if both<br>sides are tested. |
| Available transducers | Headphones, Insert<br>Earphones, bone conductor,<br>OAE probe, speakers | Headphone / Insert<br>Earphone, bone conductor | Similar, subset |
| EMG monitor | Range indicating the current<br>and optimal EMG readings. | Range indicating the current<br>and optimal EMG readings. | Same |
| Stimulus implementation | | | |
| Stimulus types | Click, Chirp, Tone Burst | Click, Chirp, Tone Burst | Same |
| Stimulus repetition rate | 0.1-100 Hz | 2-10 Hz | Different, both<br>cover the range<br>usually used for<br>VEMP. |
| Polarity | Rarefaction, Condensation,<br>Alternating | Rarefaction, Condensation,<br>Alternating, Randomized | Similar,<br>Randomized is<br>just one of the<br>other three |
| Frequency range | 125 Hz- 16000 Hz | 500 Hz - 4000 Hz | Smaller range,<br>covers the most<br>relevant |
| | | | frequency range<br>for VEMPs |
| Filter | Rectangular, Hann,<br>Blackman, Gaussian,<br>Trapezoidal, Extended<br>Cosine, Barlett, Cosine<br>Cubed, Exact Blackman…
