OtoNova/OtoNova Pro

K234095 · Otodynamics · EWO · Jun 21, 2024 · Ear, Nose, Throat

Device Facts

• Record ID: K234095
• Device Name: OtoNova/OtoNova Pro
• Applicant: Otodynamics
• Product Code: EWO · Ear, Nose, Throat
• Decision Date: Jun 21, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.1050
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

This Otonova Pro device is indicated for use when there is a requirement to screen for hearing disorders by objective and non-invasive means. ABR, TEOAE and DPOAE screening test results are automatically interpreted and a clear 'Pass' or 'Refer' result is presented to the user. Use of the device is indicated when the patient is unable to give reliable voluntary responses to sound, especially with infants. Use of the device facilitates the early detection of hearing loss and its characterization. Where the individual to be screened is healthy with no medical conditions related to the ear, as in the case of well-baby hearing screening, the user can be a trained screener. In all other cases the user should be an audiologist or medical professional. The TEOAE and DPOAE analytical functions of the device are indicated when objective non-invasive clinical investigations require the characterization and monitoring of the peripheral auditory function. For this purpose, the device is intended to be used by audiologists or other professionals skilled in audiology. These TEOAE and DPOAE tests are applicable to populations of any age to obtain objective evidence of peripheral auditory function.

Device Story

OtoNova/OtoNova Pro is a portable, battery-powered device for hearing screening and clinical audiological assessment. It records Otoacoustic Emissions (OAEs) via probe microphone and Auditory Brainstem Responses (ABR) via scalp electrodes. The device is controlled wirelessly via Bluetooth from a PC or tablet running 'Nova-Link' software. It processes physiological signals to identify and quantify responses, automatically determining 'Pass' or 'Refer' results for screening or providing detailed frequency/intensity analysis for clinical use. The system separates the testing hardware from the controlling interface, allowing greater operator flexibility. Healthcare providers use the output to detect hearing loss or monitor cochlear status. Benefits include objective, non-invasive testing for patients unable to provide voluntary responses, particularly infants.

Clinical Evidence

Clinical study with 20 adult volunteers compared OtoNova Pro and predicate Otoport OAE+ABR. Subjects underwent DPOAE, TEOAE, and AABR testing on both devices in the same session. Results demonstrated identical screening outcomes (Pass/Refer) and similar physiological response measurements across frequencies. Noise levels were comparable. Bench testing confirmed acoustic and electrical output equivalence within 1dB.

Technological Characteristics

Battery-powered, Bluetooth-connected (v4.2) test hardware. Materials: plastic housing, disposable silicone probe tips, self-adhesive skin electrodes. Sensing: probe microphone (OAE), surface electrodes (ABR). Connectivity: wireless to PC/tablet. Sterilization: N/A (non-sterile). Standards: IEC 60601-1, IEC 60601-1-2, ISO 10993-1. Software: DSP firmware for signal enhancement/noise rejection; Nova-Link application for control/analysis.

Indications for Use

Indicated for hearing disorder screening in infants (AABR, OAE) and clinical characterization/monitoring of peripheral auditory function in all ages (OAE). Contraindicated for patients capable of reliable voluntary response. Use by trained screeners for healthy infants; audiologists/medical professionals for all other cases.

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

• Otoport/ Otocheck OAE+ABR (K143395)

Reference Devices

• Otodynamics ILO88 instrument (K962995)

Submission Summary (Full Text)

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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.

June 21, 2024

Otodynamics % Chandler Thames Quality/Regulatory Consultant Rook Quality Systems 1155 Mount Vernon Hwy Suite 800 Dunwoody, Georgia 30338

Re: K234095

Trade/Device Name: OtoNova/OtoNova Pro Regulation Number: 21 CFR 874.1050 Regulation Name: Audiometer Regulatory Class: Class II Product Code: EWO, GWJ Dated: Mav 21, 2024 Received: May 21, 2024

Dear Chandler Thames:

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"

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(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).

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 mediation-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Shuchen Peng -S

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

510(k) Number (if known) K234095

Device Name OtoNova/OtoNova Pro

#### Indications for Use (Describe)

This Otonova Pro device is indicated for use when there is a requirement to screen for hearing disorders by objective and non-invasive means. ABR, TEOAE and DPOAE screening test results are automatically interpreted and a clear "Pass' or 'Refer' result is presented to the user. Use of the device is indicated when the patient is unable to give reliable voluntary responses to sound, especially with infants.

Use of the device facilitates the early detection of hearing loss and its characterization. Where the individual to be screened is healthy with no medical conditions related to the ear, as in the case of well-baby hearing screening, the user can be a trained screener. In all other cases the user should be an audiologist or medical professional.

The TEOAE and DPOAE analytical functions of the device are indicated when objective non-invasive clinical investigations require the characterization and monitoring of the peripheral auditory function. For this purpose, the device is intended to be used by audiologists or other professionals skilled in audiology.

These TEOAE and DPOAE tests are applicable to populations of any age to obtain objective evidence of peripheral auditory function.

| Type of Use ( <i>Select one or both, as applicable</i> ) |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <span> <span style="margin-left: 20px;"> <b> </b> </span> <svg height="10" width="10"> <path d="M0,0 L10,10 M0,10 L10,0" stroke="black"></path> </svg> Prescription Use (Part 21 CFR 801 Subpart D) </span> |
| <span> <span style="margin-left: 20px;"> <b> </b> </span> <svg height="10" width="10"> <rect height="10" style="fill:white;stroke:black;stroke-width:1" width="10"></rect> </svg> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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### SUBMITTER

Otodynamics Ltd 30-38 Beaconsfield Rd Hatfield, Hertfordshire AL10 8BB, United Kingdom

Phone: [phone] Email: [e-mail]

Contact Person: Daniel Budd, QA Manager Date Prepared: 9 April.2024

# DEVICE

| Trade Name: | OtoNova/OtoNova Pro |
|----------------------|---------------------------------------------------------------------------|
| Common Name: | OtoNova/OtoNova Pro |
| Classification Name: | Audiometer / Evoked response auditory stimulator<br>(874.1050 & 882.1900) |
| Regulatory Class: | II |
| Product Codes: | EWO & GWJ |

# PREDICATE DEVICE

The legally marketed device to which equivalence is being claimed [807.92(a)(3)] is the Otoport/ Otocheck OAE+ABR ™, K143395.

This predicate has not been the subject of any design-related recalls.

# DEVICE DESCRIPTION

OtoNova is a compact, portable battery-powered electronic device which records physiological responses to sound for the purpose of hearing testing. It Is controlled wirelessly from a local controlling device.

OtoNova has two hardware variants: OtoNova and OtoNova Pro, illustrated below in Figure 1.

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### FIGURE 1

Image /page/4/Picture/1 description: The image shows two different versions of the OtoNova device. The OtoNova on the left has 3 single AABR electrode connectors and a single probe connector. The OtoNova Pro on the right has 1 combined AABR electrode connector and 2 probe connectors. Both devices have indicators for L/R ear, sensors, test and device status.

- . OtoNova (left) has 3 separate connectors for 3 ABR electrode connections and accepts one probe. The OtoNova Pro (right) has a combined electrode connector and accepts 2 probes (red and blue sockets).
- . The OtoNova and OtoNova Pro perform the same audiological tests. The devices are controlled wirelessly from a separate controlling device. This can be a PC, a laptop or Android tablet running the supplied 'Nova-Link' software.

Figure 2 illustrates the configuration of OtoNova Pro in use. The test operator commands the OtoNova Pro from the supplied Nova-Link application running on the controlling device. OtoNova operates in the same way.

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# Figure 2. Operation of the OtoNova with Nova-Link

Image /page/5/Figure/1 description: The image shows the OtoNova Pro testing device and its various applications. The device can be used with an OAE probe or electrodes for infants. It can wirelessly transfer processed test data between the device and a controller via Bluetooth. The controlling device can print or export reports to a PC, and an operator can conduct tests via the controlling device running Nova-Link software.

Both the OtoNova and OtoNova Pro devices have been directly engineered from Otodynamics' currently marketed Otoport OAE+ABR device, retaining all the testing algorithms of the Otoport OAE+ABR device. The primary aim of the development was to physically separate the control console from the testing device while maintaining the same performance and effectiveness.

Separation of testing and controlling devices provides several advantages to the user. It gives greater freedom for the relative positioning of patient and tester within the test environment. This may be advantageous when testing infants, children, or when testing a patient from outside of a test booth. It also provides choice of controlling processor and display. For example, a tablet allows the operator to observe tests and records on a full size display screen, rather than on a diminutive handheld device screen. It also allows access other services on the controlling device.

# Principles of operation

Like the predicate Otoport OAE+ABR device, both OtoNova devices can record two different physiological indicators of a functioning auditory system's peripheral response to sound namely a) Otoacoustic emission (OAEs), which are small sounds made by the inner ear in response to acoustic stimulation, and b) Auditory brainstem responses (ABRs) are tiny electrical signals emanating from the auditory brainstem in response to sound. Automatic recognition of an ABR response is referred to as AABR.

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During ABR or OAE testing, low-level sounds are delivered to the ear. The responses to multiple presentations of these sounds (either acoustic or electrical responses) are recorded digitally and added together to enhance repeated responses with respect to the random/ noise signals that are always present. The averaged signal is automatically analysed by the device to identify and quantify true physiological response component and to assess the degree of noise contamination. This allows the quality/ accuracy of the recording to be determined for evidence of response validity. The processed data is reported to and displayed on the controlling device.

Impaired/ defective ears do not produce a response which meets the pass criteria of the pass criteria of the OtoNova are the same as those of the predicate Otoport device. In SCREENING applications all failures to record a clear response which are not attributable to technical issues (e.g., an excess of noise or insufficient test duration) are recommended to be referred for further audiological investigations to determine if there is a hearing problem. Both serious and trivial ear problems (e.g., a blocked ear canal) can prevent the criteria being met and so cause a test failure. Technically inadequate recordings are recommended to be repeated after addressing the technical issues.

In CLINICAL OAE applications the strength of the OAE response is measured at differing stimulus frequencies and stimulus levels. The analysis is intended to be used as one input to a diagnostic process in conjunction with other audiometric tests, or as a means of monitoring cochlea status over time.

Both OAE and ABR responses are acoustically stimulated. The stimulus is delivered to the ear by an inserted earphone device called a 'probe'. The probe contains a microphone which also records the OAE response, and the acoustic stimulus given.

Figure 3 shows compatible Otodynamics probes intended for stimulation and recording of DPOAE, TEOAEs, and for both TEOAEs and DPOAE. These are the UPD, UPS and XPD probes respectively.

Image /page/6/Figure/5 description: The image shows three different types of otodynamics probes labeled UPD, UPS, and XPD. Each probe has a different design and color scheme. The UPD probe is white with a gray tip, the UPS probe is brown and white, and the XPD probe is white with a blue tip. The probes are labeled as Figure 3 and are likely part of a study or presentation on otodynamics.

The ABR response can be acoustically stimulated by any one of these probes but it is recorded electrically via 3 disposable self-adhesive conducting pads called 'electrodes', which are placed on the scalp (Fig 4).

Image /page/6/Picture/7 description: The image shows a small, white, oval-shaped object with a circular base. The object appears to be made of a translucent material, possibly plastic, with a white border. At the center of the circular base, there is a small, silver-colored button or contact point. The object is casting a shadow on a white background.

# Figure 4 Otodynamics Electrodes (AABR testing)

For ABR stimulation the probe may be inserted into the ear canal (as for OAEs) or into a plastic cushioned

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'ear cup' which is placed over the ear. ABRs recording with OtoNova are intended for infant screening only.

Both OtoNova and OtoNovaPro variants offer the same two modes of hearing function assessment, that is OAE and AABR, separately or in combination, with optional levels of utilities.

The hearing test functions available on a device are identified by 6 OtoNova model names as follows:

- OtoNova OAE,
- OtoNova AABR,
- OtoNova OAE+AABR
- OtoNova Pro OAE,
- OtoNova Pro AABR,
- OtoNova Pro OAE+ABR

The level of utilities available is further determined by the Nova-Link program and the installed application package. There are three variants of Nova-Link application levels:

SCREENER, CLINICAL and ADVANCED CLINICAL.

These are available on both standard OtoNova and OtoNova Pro.

SCREENER LEVEL functionality provides Basic OAE and or AABR screening with preset automated pass/refer test protocols.

CLINICAL LEVEL provides all of the SCREENING LEVEL functionality plus detailed OAE analysis over a selectable frequency range at configurable stimulus levels. If AABR is enabled, examination of the ABR screening waveform and test conditions are available. No ABR diagnostic information is provided.

ADVANCED CLINICAL LEVEL functionality provides the same screening and clinical tests with enhanced user protocol definitions.

# INDICATIONS FOR USE

The OtoNova device is indicated for use when there is a requirement to screen for hearing disorders by objective and non-invasive means. ABR, TEOAE and DPOAE screening test results are automatically interpreted and a clear 'Pass' or 'Refer' result is presented to the user. Use of the device is indicated when the patient is unable to give reliable voluntary responses to sound, especially with infants. Use of the device for screening facilitates the early detection of hearing loss and its characterization.

Where the individual to be screened is healthy with no medical conditions related to the case of well-baby hearing screening, the user can be a trained screener. In all other cases the user should be an audiologist or medical professional.

The TEOAE and DPOAE analytical functions of the device are indicated when objective non-invasive clinical investigations require the characterization and monitoring of the functional status of the peripheral auditory function. For this purpose, the device is intended to be used by audiologists or other professionals skilled in audiology. These TEOAE and DPOAE tests are applicable to populations of any age to obtain objective evidence of peripheral auditory function.

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# COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The same Otoacoustic Emissions (OAEs) & Auditory Brainstem Response (ABR) techniques, algorithms and principles of response analysis are utilized in both the subject and predicate devices.

The OtoNova reproduces the Otoport/Otocheck OAE+ABR predicate device with regard to its acoustic stimulation, response gathering, analysis, display, and report generation database capabilities. The OtoNova has the same intended uses and fulfills the same roles as the predicate device.

# Basis of the screening functions of the OtoNova and OtoONova Pro

The OAE and ABR screening functions of the OtoNova and OtoNova Pro are identical to the Otoport OAE+ABR predicate device (K143395).

The OAE infant screening function of OtoNova (subject) and Otoport (predicate), via its stimulus levels and pass criteria is as developed and verified in the Rhode Island Hearing Screening Assessment Project and reported in "The Rhode Island Hearing Assessment Project:Implications for universal newborn hearing screening. Seminars in Hearing 1993, Volume 14 Number 1. ". That algorithm now in use on the OtoNova requires a response to a nonlinear transient stimulus at 84dBSPL peak equivalent level, of 6dB or more greater than the measured noise level ( ie signal to noise level) in at least two half octave frequency bands between 1 and 4kHz.

The ABR infant screening function of the OtoNova presents a short chirp stimuli at 35dBHL or 40dBHL, and an requires a response waveform with a standard Fsp statistic of at least 3.1 (elevated according to noise levels) in addition to a waveform match to a newborn ABR template.

The stimulus level of the short chirp provided by the Otonova is automatically adjusted to the recommended dBHL sound level according to our measurements of hearing threshold of this stimulus in 25 healthy young adults with no hearing problems, using the Otoport and Otodynamics probe.

The newborn ABR template used as in integral part of the OtoNova and Otoport devices was derived from a database 1000 infant's ABR screening response waveforms independently collected using the Otodynamics ILO88 instrument (K962995) as part of the a multicenter investigation into the Identification of Neonatal Hearing Impairment as reported in " Identification of Neonatal Hearing lmpairment: Summary and Recommendations Norton, Susan J.; Gorga, Michael P.; Widen, Judith E.; Folsom, Richard C.; Sininger, Yvonne; Cone-Wesson, Barbara; Vohr, Betty R.; Fletcher, Kristin A. Ear and Hearing 21(5):p 529-535, October 2000.

The complete ABR infant screening algorithm of the Otoport OAE+ABR device - now duplicated in the OtoNova- was validated on 70 infants performed at Otodynamics Ltd and was then independently trialled in collaborating hospitals in USA, Brazil, Israel and UK . The algorithm was validated from 1078 tests files and results provided by these trials. Separately and independently the performance of the Otoport OAE+ABR screening function was evaluated on 56 neonates at a UK hospital by direct comparison with a Natus ABR screening product.

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# Table 1 Equivalence Table.

| | Subject Device | Predicate Device | Discussion |
|-----------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | OtoNova/OtoNova Pro | Otoport/Otocheck OAE+ABR (K143395) | |
| Common Name | Audiometer Evoked response auditory stimulator. | Audiometer Evoked response auditory stimulator | same |
| Regulaton<br>Numbers | Audiometer 21 CFR 874.1050, Evoked response auditory stimulator 21 CFR<br>882.1900 | Audiometer 21 CFR 874.1050, Evoked response auditory stimulator 21 CFR<br>882.1900 | same |
| Classification<br>Product Codes | II | II | same |
| Product Codes | EWO & GWJ | EWO & GWJ | same |
| Intended Use | For use in the detection hearing disorders in infants with AABR or OAEs,<br>B8and to provide objective input from OAEs for use as part of a diagnostic<br>audiological test battery with infants children and adults. | For use in the detection hearing disorders in infants with AABR or OAEs, and<br>to provide objective input from OAEs for use as part of a diagnostic<br>audiological test battery with infants children and adults. | same |
| Indications for<br>Use | This Otonova Pro device is indicated for use when there is a requirement<br>to screen for hearing disorders by objective and non-invasive means. ABR,<br>TEOAE and DPOAE screening test results are automatically interpreted<br>and a clear 'Pass' or 'Refer' result is presented to the user.<br>Use of the device is indicated when the patient is unable to give reliable<br>voluntary responses to sound, especially with infants.<br>Use of the device facilitates the early detection of hearing loss and its<br>characterization.<br>Where the individual to be screened is healthy with no medical conditions<br>related to the ear, as in the case of well-baby hearing screening, the<br>user can be a trained screener. In all other cases the user should be an<br>audiologist or medical professional.<br>The TEOAE and DPOAE analytical functions of the device are<br>indicated when objective non-invasive clinical investigations require the<br>characterization and monitoring of the functional status of the peripheral<br>auditory function. For this purpose, the device is intended to be used by<br>audiologists or other professionals skilled in audiology. These TEOAE and<br>DPOAE tests are applicable to populations of any age to obtain objective<br>evidence of peripheral auditory function. | The Otoport/Otocheck OAE+ABR device is indicated for use when there is a<br>requirement to screen for hearing disorders by objective and non-invasive<br>means. Test results are automatically interpreted and a clear 'Pass' or<br>'Refer' result is presented to the user.<br>Use of the device is indicated when the patient is unable to give reliable<br>voluntary responses to sound, especially with infants.<br>Use of the device facilitates the early detection of hearing loss and its<br>characterization.<br>Where the individual to be screened is healthy with no medical conditions<br>related to the ear, as in the case of well-baby hearing screening, the user can<br>be a trained. In all other cases the user should be an audiologist or medical<br>professional.<br>The device is also indicated when objective non-invasive clinical<br>investigations require the characterization and monitoring of the functional<br>status of the peripheral auditory function using otoacoustic emissions<br>(OAEs). It may also be used in populations of any age to obtain objective<br>evidence of normal peripheral auditory function. | Similar. The OtoNova and OtoNova Pro manuals<br>explicitly name the OAE's used. |
| Overall Device<br>Design | Portable device (120mm x 79mm x 26mm; 170g)<br>Stimulates the ear with quiet sounds.<br>Non-invasive, records physiological responses to these sounds.<br>Automatically evaluates the evidence for a response<br>Transmitsprocessed results by bluetooth wireless connection to the<br>controlling device (tablet). Controlling device displays a concise results<br>about the presence or absence of responses<br>Saves a detailed record of the test on the controlling device<br>As a screener the device alerts to the possibility of hearing loss and in<br>clinical use documents the status of the ear by OAEs | Handheld device (197mm x 70mm x 30mm; 250g)<br>Stimulates the ear with quiet sounds.<br>Non-invasive, records physiological responses to these sounds.<br>Automatically evaluates the evidence for a response<br>Displays a concise results about the presence or absence responses on<br>its integral display.<br>Saves a detailed record of the test<br>Device alerts to the possibility of hearing loss and documents the status<br>of the ear | Similar. The only significant differences between<br>device designs is that in the OtoNova there is a<br>separation of testing device from controlling<br>device via a bluetooth wireless link. The subject<br>device is of lighter weight and smaller body. It is<br>to be marketed as portable for use a controlling<br>device which runs the supplied Nova-Link<br>software. The predicate is a self contained<br>handheld device with its own diplay screen and<br>keypad, making it heavier and larger. |
| User Controls | Via touch screen or keyboard of the controlling device running the supplied<br>Nova-Link software which wirelessly commands the OtoNova test device | Via soft keypad on the handheld device | Equivalent.The OtoNova's 'Nova-Link' software<br>provides the same control functions via touch<br>screen or keyboard of the controlling device, as<br>does the Otoport OAE+ABR device via its<br>keypad.D13 |
| Test<br>Specifications | ABR Stimulus for infant screening Chirp 30-45dBnHL . 35 & 40dBnHL, recom-<br>mended. 60dBnHL available as a training aid only , not for screening<br>DPOAEs.Frequency ratio F2/F1 1.22. F2 frequency range 1-8kHz ,<br>Stimulus levels for screening L1/L2 preset 65/55, 60/55 or 65/50dBSPL<br>Stimulus levels ofr clinical use L1 & L2 configurable 40-75dBSPL<br>TEOAE Half octave analysis. Frequency range 1-6kHz<br>Stimulus levels for screening 84dBSPLpe<br>Stimulus levels for clinical use configurable 74- 84dBSPLpe,<br>Advanced clinical 60-90dBSPLpe | ABR Stimulus for infant screening Chirp 30-45dBnHL, 35&40dB recom-<br>mended. 60dBnHL available as a training aid only,not for screening<br>DPOAEs.Frequency ratio F2/F1 1.22. F2 frequency range 1-8kHz ,<br>Stimulus levels for DP screening L1/L2 65/55dBSPL (confgurable)<br>Stimulus levels ofr clinical use L1 & L2 configurable 40-75dBSPL<br>TEOAE Half octave analysis. Frequency range 1-6kHz<br>Stimulus levels for screening 84dBSPLpe recommended, configurable 60-<br>84dBSPLpe<br>Stimulus levels for clinical use configurable 60-84dBSPLpe | Similar. The OtoNova stimulus frequency range<br>are the same as the predicate device. Both<br>predicate and subject devices cover the most<br>commonly used and validate stimlus levels . The<br>OtoNova screening settings do not provide<br>stimulus levels no longer judged appropriate for<br>screening, but these are available on the clinical<br>mode. |
| Automatic<br>screening<br>decisions | In screening mode OtoNova automatically provides an on screen 'Pass, Refer<br>or invalid test result', plus indications of the reason for test invalidity. | In screening mode Otoport OAE+ABR automatically provides an on<br>screen 'Pass, Refer or invalid test' result, plus indications of the reason<br>for test invalidity. | Same |
| Stimulus<br>calibration | with inserted probe - In-the-ear self calibration<br>For AABR with ear-cup, stimulus is preset to dial level. | with inserted probe - In-the-ear self calibration<br>For AABR with ear-cup, stimulus is preset to dial level. | Same |
| Device<br>Components /<br>Features | Stimulates the ear with either transient or tonal sounds via an inserted<br>earpiece | Stimulates the ear with either transient or tonal sounds via an inserted<br>earpiece | Same |
| | Registers interfering acoustic noise and advises users when this is too large<br>for testing to take place. | Registers interfering acoustic noise and advises users when this is too large<br>for testing to take place. | |
| | Implements otoacoustic emission technology to record TEOAE and DPOAEs<br>responses to sound applied via an inserted earpiece (probe) | Implements otoacoustic emission technology to record TEOAE and DPOAEs<br>responses to sound applied via an inserted earpiece (probe) | |
| | Provides an intensity and frequency analysis of the OAE response,<br>numerically and graphically…