(178 days)
No
The document describes "automatic analysis" and "automatic recognition" of physiological responses, but the description of the algorithms and the validation process points to traditional signal processing and template matching techniques, not AI/ML. The training and test sets are described in terms of validating a pre-existing "newborn ABR template" and the "complete ABR infant screening algorithm," which aligns with a deterministic approach rather than a learning-based one.
No.
The device is used to screen for hearing disorders and characterize and monitor peripheral auditory function, but it does not provide treatment or therapy.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device is "indicated for use when there is a requirement to screen for hearing disorders" and facilitates "the early detection of hearing loss and its characterization." It also mentions interpreting results as "Pass" or "Refer," which are indicative of a diagnostic screening process.
No
The device description explicitly states that OtoNova is a "compact, portable battery-powered electronic device" and has "two hardware variants." This indicates the presence of physical hardware components beyond just software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- Device Function: The Otonova Pro device records physiological responses to sound (OAEs and ABRs) directly from the patient's ear and scalp. It does not analyze samples taken from the body.
- Intended Use: The intended use is to screen for hearing disorders by objective and non-invasive means, directly measuring the body's response to stimuli.
Therefore, based on the provided information, the Otonova Pro device falls under the category of a medical device used for physiological measurement and screening, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes
EWO, GWJ
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.
- OtoNova has 3 separate connectors for 3 ABR electrode connections and accepts one probe.
- The OtoNova Pro has a combined electrode connector and accepts 2 probes (red and blue sockets).
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.
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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Ear, Scalp, forehead, nape, shoulder
Indicated Patient Age Range
Infants, children and adults for OAEs. Infants for AABR.
Intended User / Care Setting
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.
For TEOAE and DPOAE analytical functions, the device is intended to be used by audiologists or other professionals skilled in audiology.
Description of the training set, sample size, data source, and annotation protocol
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.
Description of the test set, sample size, data source, and annotation protocol
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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Summary of Non-Clinical testing
The OtoNova and OtoNova Pro use the same DSP firmware algorithms and amplifier circuitry as the predicate Otoport device and are designed to provide the same stimulations and register the same responses in the same conditions. This functional equivalence was verified by bench tests that compared the stimuli delivered and the response recorded by the 3 devices.
- For each device the electrical driving signals delivered by the stimulator 'probe' transducers during testing were measured on subject and predicate devices using calibrated equipment for each testing mode (i.e. TEOAE DPOAE and ABR) and compared. They were found to be substantially the same (to within 1dB) across the functional frequency range.
- The acoustic stimulation delivered by the probe into a standard calibrated acoustic ear simulator was recorded for subject and predicate devices for each test mode (TEOAE, DPOAE, ABR) and also for ABR test stimulation in the 'earcup' stimulus delivery device. They were found to be substantially the same (to within 1dB) across the functional frequency range.
- The sensitivity of each device to simulated DPOAE, TEOAE and ABR responses was recorded by fitting the probe and electrodes to Otodynamics' factory-reference 'response simulator'. Each device received the same simulated response signals. The responses recorded by the OtoNova Pro were substantially the same levels (within 1dB) across the functional frequency for OAEs, and the ABR recorded had substantially the same size and waveform for ABR (within 1dB).
Summary of Clinical testing
The operational equivalence of OtoNova Pro and predicate Otoport OAE+ABR devices was verified from data collected from 20 volunteer adult subjects with informed consent , under identical test conditions. The purpose of the trial to the compare physiological response measurement capacity and algorithms of the OtoNova and Otoport devices. Each subject was tested on each device with DPOAE, TEOAE or AABR, in the same session, with the same probe fitting (and electrode fitting for AABR), under the same test conditions. For each test mode data was recorded from a minimum 15 subjects from each device in the same session.
- OtoNova's Nova-Link gives same screening test result under the same screening criteria (i.e. clear response, no clear response, invalid result) as the predicate device. The physical characteristics of the recorded responses were similar on each device. In the case of marginal response levels, where variability is to be expected, the range of marginality was no wider than for the Otoport OAE+ABR.
- In the recording of OAE response for clinical purposes the OtoNova and OtoNova Pro the reported response levels were the same across frequency as with the Otoport OAE +ABR device within the tolerance expected due to subject movement.
- The reported noise levels reported by Novalink were similar to those reported by the Otoport C. within the expected intrinsic variability of noise.
Human Factors/ Usability Engineering Testing
A summative usability validation study was conducted with 16 participants external to Otodynamics. The study participants were asked to operate the device, run tests and provide user summative evaluation of the OtoNova medical device.
All the 16 users were able to sufficiently understand the OtoNova product/ IFU, to successfully record tests and use the medical device per its intended use, using only the instructions provided, the OtoNova product and items and the OtoNova User Manual. There were no substantial issues found during this OtoNova summative evaluation. The issues found were not substantial, and improvements were implemented.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 874.1050 Audiometer.
(a)
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.(b)
Classification. Class II. Except for the otoacoustic emission device, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, if it is in compliance with American National Standard Institute S3.6-1996, “Specification for Audiometers,” and subject to the limitations in § 874.9.
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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"
1
(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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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 ( Select one or both, as applicable ) |
|---|
| Prescription Use (Part 21 CFR 801 Subpart D) |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
SUBMITTER
Otodynamics Ltd 30-38 Beaconsfield Rd Hatfield, Hertfordshire AL10 8BB, United Kingdom
Phone: +44 1707 267540 Email: daniel.budd@otodynamics.com
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 |
| (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.
5
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.
6
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
7
'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.
9
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 | |||
| Numbers | Audiometer 21 CFR 874.1050, Evoked response auditory stimulator 21 CFR | ||
| 882.1900 | Audiometer 21 CFR 874.1050, Evoked response auditory stimulator 21 CFR | ||
| 882.1900 | same | ||
| Classification | |||
| 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, | ||
| B8and to provide objective input from OAEs for use as part of a diagnostic | |||
| audiological test battery with infants children and adults. | For use in the detection hearing disorders in infants with AABR or OAEs, and | ||
| to provide objective input from OAEs for use as part of a diagnostic | |||
| audiological test battery with infants children and adults. | same | ||
| Indications for | |||
| 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 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. | The Otoport/Otocheck OAE+ABR device is indicated for use when there is a | ||
| requirement to screen for hearing disorders by objective and non-invasive | |||
| means. 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. In all other cases the user should be an audiologist or medical | |||
| professional. | |||
| The device is also indicated when objective non-invasive clinical | |||
| investigations require the characterization and monitoring of the functional | |||
| status of the peripheral auditory function using otoacoustic emissions | |||
| (OAEs). It may also be used in populations of any age to obtain objective | |||
| evidence of normal peripheral auditory function. | Similar. The OtoNova and OtoNova Pro manuals | ||
| explicitly name the OAE's used. | |||
| Overall Device | |||
| Design | Portable device (120mm x 79mm x 26mm; 170g) | ||
| Stimulates the ear with quiet sounds. | |||
| Non-invasive, records physiological responses to these sounds. | |||
| Automatically evaluates the evidence for a response | |||
| Transmitsprocessed results by bluetooth wireless connection to the | |||
| controlling device (tablet). Controlling device displays a concise results | |||
| about the presence or absence of responses | |||
| Saves a detailed record of the test on the controlling device | |||
| As a screener the device alerts to the possibility of hearing loss and in | |||
| clinical use documents the status of the ear by OAEs | Handheld device (197mm x 70mm x 30mm; 250g) | ||
| Stimulates the ear with quiet sounds. | |||
| Non-invasive, records physiological responses to these sounds. | |||
| Automatically evaluates the evidence for a response | |||
| Displays a concise results about the presence or absence responses on | |||
| its integral display. | |||
| Saves a detailed record of the test | |||
| Device alerts to the possibility of hearing loss and documents the status | |||
| of the ear | Similar. The only significant differences between | ||
| device designs is that in the OtoNova there is a | |||
| separation of testing device from controlling | |||
| device via a bluetooth wireless link. The subject | |||
| device is of lighter weight and smaller body. It is | |||
| to be marketed as portable for use a controlling | |||
| device which runs the supplied Nova-Link | |||
| software. The predicate is a self contained | |||
| handheld device with its own diplay screen and | |||
| keypad, making it heavier and larger. | |||
| User Controls | Via touch screen or keyboard of the controlling device running the supplied | ||
| Nova-Link software which wirelessly commands the OtoNova test device | Via soft keypad on the handheld device | Equivalent.The OtoNova's 'Nova-Link' software | |
| provides the same control functions via touch | |||
| screen or keyboard of the controlling device, as | |||
| does the Otoport OAE+ABR device via its | |||
| keypad.D13 | |||
| Test | |||
| Specifications | ABR Stimulus for infant screening Chirp 30-45dBnHL . 35 & 40dBnHL, recom- | ||
| mended. 60dBnHL available as a training aid only , not for screening | |||
| DPOAEs.Frequency ratio F2/F1 1.22. F2 frequency range 1-8kHz , | |||
| Stimulus levels for screening L1/L2 preset 65/55, 60/55 or 65/50dBSPL | |||
| Stimulus levels ofr clinical use L1 & L2 configurable 40-75dBSPL | |||
| TEOAE Half octave analysis. Frequency range 1-6kHz | |||
| Stimulus levels for screening 84dBSPLpe | |||
| Stimulus levels for clinical use configurable 74- 84dBSPLpe, | |||
| Advanced clinical 60-90dBSPLpe | ABR Stimulus for infant screening Chirp 30-45dBnHL, 35&40dB recom- | ||
| mended. 60dBnHL available as a training aid only,not for screening | |||
| DPOAEs.Frequency ratio F2/F1 1.22. F2 frequency range 1-8kHz , | |||
| Stimulus levels for DP screening L1/L2 65/55dBSPL (confgurable) | |||
| Stimulus levels ofr clinical use L1 & L2 configurable 40-75dBSPL | |||
| TEOAE Half octave analysis. Frequency range 1-6kHz | |||
| Stimulus levels for screening 84dBSPLpe recommended, configurable 60- | |||
| 84dBSPLpe | |||
| Stimulus levels for clinical use configurable 60-84dBSPLpe | Similar. The OtoNova stimulus frequency range | ||
| are the same as the predicate device. Both | |||
| predicate and subject devices cover the most | |||
| commonly used and validate stimlus levels . The | |||
| OtoNova screening settings do not provide | |||
| stimulus levels no longer judged appropriate for | |||
| screening, but these are available on the clinical | |||
| mode. | |||
| Automatic | |||
| screening | |||
| decisions | In screening mode OtoNova automatically provides an on screen 'Pass, Refer | ||
| or invalid test result', plus indications of the reason for test invalidity. | In screening mode Otoport OAE+ABR automatically provides an on | ||
| screen 'Pass, Refer or invalid test' result, plus indications of the reason | |||
| for test invalidity. | Same | ||
| Stimulus | |||
| calibration | with inserted probe - In-the-ear self calibration | ||
| For AABR with ear-cup, stimulus is preset to dial level. | with inserted probe - In-the-ear self calibration | ||
| For AABR with ear-cup, stimulus is preset to dial level. | Same | ||
| Device | |||
| Components / | |||
| Features | Stimulates the ear with either transient or tonal sounds via an inserted | ||
| earpiece | Stimulates the ear with either transient or tonal sounds via an inserted | ||
| earpiece | Same | ||
| Registers interfering acoustic noise and advises users when this is too large | |||
| for testing to take place. | Registers interfering acoustic noise and advises users when this is too large | ||
| for testing to take place. | |||
| Implements otoacoustic emission technology to record TEOAE and DPOAEs | |||
| responses to sound applied via an inserted earpiece (probe) | Implements otoacoustic emission technology to record TEOAE and DPOAEs | ||
| responses to sound applied via an inserted earpiece (probe) | |||
| Provides an intensity and frequency analysis of the OAE response, | |||
| numerically and graphically | Provides an intensity and frequency analysis of the OAE response, | ||
| numerically and graphically | |||
| Automatically determines and displays the presence or absence of a normal | |||
| TEOAE or DPOAE response | Automatically determines and displays the presence or absence of a normal | ||
| TEOAE or DPOAE response | |||
| Implements auditory brainstem response (ABR) technology to record electro | |||
| physiological responses via surface electrodes | Implements auditory brainstem response (ABR) technology to record electro | ||
| physiological responses via surface electrodes | |||
| Stimulates the ear for ABR screening at 30,35,40,or 45dBnHL | Stimulates the ear for ABR screening at 30,35,40,or 45dBnHL | ||
| Registers interfering electrical noise and advises users when this is too large | |||
| for testing to take place. | Registers interfering electrical noise and advises users when this is too large | ||
| for testing to take place. | |||
| Registers the electrical impedance of electrode connections to the patient | |||
| and advises users when this is too large for testing to take place | Registers the electrical impedance of electrode connections to the patient | ||
| and advises users when this is too large for testing to take place | |||
| Performs statistical analysis on the ABR response to decide if it is present | |||
| and normal | Performs statistical analysis on the ABR response to decide if it is present | ||
| and normal | |||
| Automatically determines and displays the presence or absence of a normal | |||
| ABR response | Automatically determines and displays the presence or absence of a normal | ||
| ABR response | |||
| Serves as a hearing based on the presence or absence of a normal OAE or | |||
| ABR response | Serves as a hearing based on the presence or absence of a normal OAE or | ||
| ABR response | |||
| Population | OAEs Infant, child and adult, AABR, infant | OAEs Infant and adult, AABR, infant | Same |
| Intended user | Trained screener and professionals | Trained screener and professionals | Same |
| Safety | |||
| characteristics | Electrically isolated. Acoustic stimulation levels physically constrained and | ||
| monitored with active protection against single faults. | Electrically isolated. Acoustic stimulation levels physically constrained and | ||
| monitored with active protection against single faults. | Same | ||
| Probe: plastic encapsulated insert earphone containing microphone and | |||
| receiver, fitted with disposable single use plastic tip both as used with the | |||
| predicate. | Probe: plastic encapsulated insert earphone containing microphone and | ||
| receiver, fitted with disposable single use plastic tip | Same | ||
| Surface, disposable self-adhesive skin electrodes | Surface, disposable self-adhesive skin electrodes | Same | |
| Materials of | |||
| Construction | Electronic circuitry providing stimulation drive to the probe, amplification | ||
| for the signals, received from the probe microphone and electrodes, signal | |||
| processing for response enhancement and noise rejection and | |||
| microprocessor for signal and statistical analysis, rechargeable battery, | |||
| m=power managment, LEDs to indicate states, bluetooth communication | |||
| modules for reception of commands form the conrolling computer and the | |||
| transmission of processed test data to the conrolling devce all encapsulate | |||
| in a plastic housing, | Electronic circuitry providing stimulation drive to the probe, amplification | ||
| for the signals, received from the probe microphone and electrodes, signal | |||
| processing for response enhancement and noise rejection and | |||
| microprocessor for signal and statistical analysis, rechargeable battery, | |||
| power managment, graphic display unit and data input keypad, and | |||
| bluetooth module for tramission of test data to third party computer all | |||
| encapsulated in a plastic | Similar. All devices have similar circuits and | ||
| firmware providing the testing functions. The | |||
| differences are that in the subject device | |||
| bluetooth communication is two way and is | |||
| updated during testing, whereas it is one way in | |||
| the predicate device and it post test. | |||
| Also the subject device hardware does not | |||
| include a data input keypad or a graphic display | |||
| as this is provided by the controlling device.D37 | |||
| Sterile | No | No | same |
| Duration of | |||
| placement | Less than 5 minutes per ear | Less than 5 minutes per ear | same |
| Usage of | |||
| Patient contact | |||
| items | Acoustic probe tip and electrodes are single patient use only as used on the | ||
| predicate device | Acoustic probe tip and electrodes are single patient use only | same | |
| Electrode, | |||
| number and | |||
| Anatomical | |||
| placement | Scalp, forehead, nape, shoulder | Scalp, forehead, nape, shoulder | same |
| Number of | |||
| Electrodes | 3 | 3 | same |
| Electrode | |||
| Socket | |||
| Connector | OtoNova: Three Single Pin electrode Socket Connectors, compatible with DIN | ||
| 42-802 Type ST 'Touchproof' terminated electrode cables | |||
| OtoNova Pro: One 4 Pin Plug & Sock+B34et Connector and is compatiblel | |||
| with the supplied combined electrode cable. | Otoport OAE+ABR has three Single Pin electrode Socket Connectors, | ||
| compatible with DIN 42-802 Type ST 'Touchproof' terminated electrode | |||
| cables | Similar. The OtoNova and the predicate device | ||
| are similar in their use of three single electrode | |||
| pin plugs and socket connectors.The exact same | |||
| electrode cables and electrodes are used in | |||
| OtoNova and predicate Otoport ABR. | |||
| The OtoNova Pro uses a 4 pin plug and socket | |||
| connector- combining 3 electrode connections | |||
| and an electrical interference screen. | |||
| The 4 pin single electrode cable socket of the | |||
| OtoNova Pro provides a simpler method of | |||
| connection for the user and incorrect | |||
| connections are eliminated. | |||
| In the OtoNova basic version incorrect electrode | |||
| wires montage is mitigated by clear color coding | |||
| of the electrode cables and sockets. This | |||
| change in connector on OtoNova Pro affords less | |||
| parts/ with easier use while the functionality | |||
| remains the same and the residual user risks | |||
| remain low/ are acceptable.D42 | |||
| Battery | Lithium-ion Battery | Lithium-ion Battery | Same |
| Battery voltage | |||
| operating | |||
| range: | 3.2-4.2V | 3.2-4.2V | Same |
| Source | Source: 1000mAh lithium polymer internal rechargeable cells | Source: 1000mAh lithium polymer internal rechargeable cells | Same |
| Electrode Cable | OtoNova: compatible with DIN 42-802 Type ST 'Touchproof' terminated | ||
| electrode cables - with snap electrode connectors. | |||
| OtoNova Pro: Supplied 3 electrode combination cable with snap connectors | compatible with DIN 42-802 Type ST 'Touchproof' terminated electrode | ||
| cables with snap elelctroc connectors | OtoNova:Same | ||
| OtoNova Pro:similar, with the added simplicity of | |||
| a single connection for the 3 electrodes | |||
| Probe | |||
| Connector | (14 pin) 'Medi-Snap' connector push pull connector | (8 pin) 'Triad' connector metal collar to screw lock in place | Similar. The probe connector for the subject |
| device is a 14 pin "Medi-Snap" connector while | |||
| the predicate device uses an 8 pin "Triad" | |||
| connector. The addition 8 pins of the Medi-Snap | |||
| connector are note currently used. | |||
| The OtoNova / OtoNova Pro UPD and UPS | |||
| probes are equivalent with legacy probes of | |||
| predicate Otoport OAE+ABR which have been in | |||
| service for 20+years. The only difference is the | |||
| connectors. | |||
| The Medi-Snap probe connector of the OtoNova | |||
| serves the same purpose is the Triad connector | |||
| of the preducate but its insertion and removal | |||
| are mechanically different. Instead of a screwed | |||
| collar locking method, the Medi -Snap features a | |||
| Push-in- Pull-out mechanism with adequate | |||
| retention when in. This provides an easier user | |||
| experience and reduces risk of connector pin | |||
| damage by mishandling. Connector damage | |||
| Probes | OtoNova and OtoNova Pro accept UPS, UPD probes | ||
| OtoNova Pro is additionally compatible with Otodynamics XPD probes and | |||
| can accept two probes. | |||
| All compatable probes include a chip containing calibration data. | Otoport OAE+ABR accepts UGS, UGD, and XGD probes | ||
| All compatable probes include a chip containing calibration data. | Similar. The OtoNova Pro is compatible with all | ||
| Otodynamics probes which the predicate | |||
| Otoport devices are compatible if fitted with a | |||
| Medi-Snap connector or via a connector adaptor | |||
| OtoNova (not pro) does not recognise the XPD | |||
| probe because it has a differently structured | |||
| calibration chip | |||
| OtoNova and OtoNova Pro probes have a | |||
| different 'push pull' connector than predicate | |||
| Otoport probes but are acoustically and | |||
| mechanically identically. This connector | |||
| difference is indicated by the 'P' in their name eg | |||
| Number of | |||
| Probes | |||
| Connected | OtoNova - 1 probe | ||
| OtoNova Pro 2 probes | The Otoport OAE+ABR can operate with one probe or two probes with the | ||
| binaural option | The subject and predicate base models (OtoNova | ||
| and Otoport) are similar while the OtoNova Pro | |||
| and Otoport OAE+ABR can similarly accept two | |||
| probes | |||
| Device | |||
| Components / | |||
| Features | A handheld battery powered hearing screening device which is wirelessly | ||
| controlled (Bluetooth) by an Android or Windows PC device to display and | |||
| communicate processed real time data. | A handheld battery powered hearing screening device with integral keypad | ||
| and display which shows processed real time data | Similar. The OtoNova controlling processor | ||
| provides all the functionality of the Otoport | |||
| interface, but on a larger screen with the | |||
| convenience of touch screen function. | |||
| The wireless connection between the OtoNova | |||
| controller device running Nova-Link software | |||
| and the OtoNova test hardware gives greater | |||
| freedom to the operator, better positioning | |||
| themselves relative to the patient. The residual | |||
| users risks are found to be low/ are acceptable. | |||
| User Interface | The OtoNova's 'Novalink' software runs on the selected controlling device | ||
| and provides complete user control over the OtoNova testing hardware. | |||
| Nova-Link displays test progress, test results, and saves tests in the in-built | |||
| database. | |||
| Optionally, Novalink database contents can be securely transferred to | |||
| Otodynamics Otolink software for review, printing or archiving. Novalink is | |||
| installed from Google play for Android devices or from Microsoft Store for | |||
| PC devices" | The Otoport preinstalled software provide complete user control over the | ||
| testing hardware inside the Otoport and displays test progress, test results, | |||
| and tests saved in the in-built database. | |||
| Optionally, Otoport database contents can be securely transferred to | |||
| Otodynamics Otolink software for review, printing or archiving. | |||
| Otoport firmware can be securely updated from Otolink" | Similar. There are no significant functional | ||
| differences for the user between the OtoNova | |||
| control program Nova-Link and Otoport built in | |||
| control software. | |||
| Differences are cosmetic, and ergonomic - | |||
| resulting form the larger display screen, touch | |||
| screen controll and large storage capacity | |||
| because of access to the controlling device | |||
| processor and memory | |||
| Data Transfer | OtoNova and OtoNova Pro test devices transfer processed test data to the | ||
| third party controlling computer device wirelessly via bluetooth (4.2) as the | |||
| test progresses. The controlling devide also commands the test device via | |||
| bluetooth. | Otoport OAE+ABR can transfer completed and saved test records to a third | ||
| party computer either wirelessly via bluetooth (2.0), or via a wired USB1.1 | |||
| or 2.0 connection | Similar. The subject and predicate both use | ||
| Bluetooth to tranfer processed test data | |||
| between test and computer devices. Whereas the | |||
| predication only transfered completed and files | |||
| test records, the subject device uses bluetooth to | |||
| command the testing device as well as to recieve | |||
| processed test results from the test device as | |||
| testing progresses. Bluetooth 4.2 is more robust | |||
| than bluetooth 2. The OtoNova devices do not | |||
| have a USB port. The controling device will have | |||
| USB which can be used to securely transfer filed | |||
| test records to a PC. | |||
| Charging | compatible with wireless chargers (transmitters) meeting WPC Qi standard | ||
| v1.1 or v1.2 | Charging is via a charging/data connector on the device - which connects to | ||
| Otodynamics PSU (charging) or to PC USB port (USB 1.1or 2.0) via a Data | |||
| Cable. | Equivalent. The wireless charging of the OtoNova | ||
| is advantageous because it requires no electrical | |||
| connection of the device. This enhances its | |||
| cleanability. | |||
| Power States | Intelligent multi-level power control for | ||
| charging/testing/idle/sleep | Intelligent multi-level power control for | ||
| charging/testing/idle/sleep/shutdown | Similar. The power states of OtoNova are | ||
| identical to the Otoport except for the renaming | |||
| of 'shutdown' (predicate) as Flight Mode | |||
| (subject). | |||
| When the subject sleeps detects physical | |||
| movement and then actively searches for its host | |||
| controller by bluetooth advertising information. | |||
| For air transported this function must be | |||
| disabled. The shutsdown state is named | |||
| 'FlightMode' to make this clear. It is not | |||
| necessary for the OtoNova to be toally powered | |||
| down at any other time as the sleep mode can | |||
| sustain operational battery charge for more than | |||
| one month. | |||
| Charge Time | 3.5 Hrs to 100% | 4 Hrs to 100% | Similar. The subject device has a slightly shorter |
| battery charging time at 3.5 hours versus the | |||
| predicate device's 4 hours. This is advantageous | |||
| for the user. The battery usage time of OtoNova | |||
| is many times that of the predicate device | |||
| because it does nothave to power a display | |||
| screen. | |||
| Max | |||
| consumption | |||
| when testing: | 0.5W | 1W | Similar. The subject device uses less power than |
| the predicate Otoport (0.5W vs 1W) because it is | |||
| not powering an LCD display, which the | |||
| predicate Otoport has. | |||
| Max | |||
| consumption | |||
| when charging: | 2.5W | 2.5W | Same |
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Summary of Non-Clinical testing
The OtoNova and OtoNova Pro use the same DSP firmware algorithms and amplifier circuitry as the predicate Otoport device and are designed to provide the same stimulations and register the same responses in the same conditions. This functional equivalence was verified by bench tests that compared the stimuli delivered and the response recorded by the 3 devices. OtoNova and OtoNova Pro are operated from a tablet controlling device running Nova-Link software. The Otoport is a self -contained test device with its own firmware.
For each device the electrical driving signals delivered by the stimulator 'probe' transducers during testing were measured on subject and predicate devices using calibrated equipment for each testing mode (i.e. TEOAE DPOAE and ABR) and compared. They were found to be substantially the same (to within 1dB) across the functional frequency range.
The acoustic stimulation delivered by the probe into a standard calibrated acoustic ear simulator was recorded for subject and predicate devices for each test mode (TEOAE, DPOAE, ABR) and also for ABR test stimulation in the 'earcup' stimulus delivery device. They were found to be substantially the same (to within 1dB) across the functional frequency range.
The sensitivity of each device to simulated DPOAE, TEOAE and ABR responses was recorded by fitting the probe and electrodes to Otodynamics' factory-reference 'response simulator'. Each device received the same simulated response signals. The responses recorded by the OtoNova Pro were substantially the same levels (within 1dB) across the functional frequency for OAEs, and the ABR recorded had substantially the same size and waveform for ABR (within 1dB).
Summary of Clinical testing
The operational equivalence of OtoNova Pro and predicate Otoport OAE+ABR devices was verified from data collected from 20 volunteer adult subjects with informed consent , under identical test conditions. The purpose of the trial to the compare physiological response measurement capacity and algorithms of the OtoNova and Otoport devices. Each subject was tested on each device with DPOAE, TEOAE or AABR, in the same session, with the same probe fitting (and electrode fitting for AABR), under the same test conditions. For each test mode data was recorded from a minimum 15 subjects from each device in the same session.
- a. OtoNova's Nova-Link gives same screening test result under the same screening criteria (i.e. clear response, no clear response, invalid result) as the predicate device. The physical characteristics of the recorded responses were similar on each device. In the case of marginal response levels, where variability is to be expected, the range of marginality was no wider than for the Otoport OAE+ABR.
- b. In the recording of OAE response for clinical purposes the OtoNova and OtoNova Pro the reported response levels were the same across frequency as with the Otoport OAE +ABR device within the tolerance expected due to subject movement.
- The reported noise levels reported by Novalink were similar to those reported by the Otoport C. within the expected intrinsic variability of noise.
Based on the close agreement of the clinical test results obtained, and the equivalence of all the physical measurement characteristics of the devices as demonstrated in bench tests, on which the intended infant screening use solely depends, it is concluded that OtoNova Pro devices have the same efficacy
16
as the predicate device across all applications, including for infant screening.
Human Factors/ Usability Engineering Testing
The Human Factor (HF) engineering process applied to the OtoNova devices has been in accordance with ANSI/AAMI HE75:2009 Human factors Engineering – Design of medical devices and FDA Guidance Applying Human Factors and Usability Engineering to Medical Devices, Guidance for Industry and Food and Drug Administration Staff, issued February 3, 2016 and IEC 62366-1 Edition 1.0 2015-02.
A summative usability validation study was conducted with 16 participants external to Otodynamics. The study participants were asked to operate the device, run tests and provide user summative evaluation of the OtoNova medical device. The OtoNova simulated users, used only the OtoNova Quick Start guide- an essential OtoNova testing abbreviated IFU, the OtoNova IFU in case they needed further information, and the OtoNova device/ system items.
All the 16 users were able to sufficiently understand the OtoNova product/ IFU, to successfully record tests and use the medical device per its intended use, using only the instructions provided, the OtoNova product and items and the OtoNova User Manual. There were no substantial issues found during this OtoNova summative evaluation. The issues found were not substantial, and improvements were implemented.
User Manual
Improvements and changes to the OtoNova/Otonova Pro IFUs were made throughout the device's development and IFU change histories based on human factors testing data. Subsequently no substantial issues were found during further OtoNova Pro IFU summative evaluations or clinical applications.
Summative use evaluation for the user, patient and the environment concluded that the remaining residual risks are acceptable and that OtoNova as safe and effective as the predicate Otoport OAE+ABR device.
Biocompatibility Testing
The biocompatibility evaluation for the OtoNova Device was conducted in accordance with the FDA Guidance Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" issued September 4, 2023, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process," FDA recognition number 258.
When used as intended, the OtoNova device will be placed in transient contact with the user's skin during handling and Normal Use; the patient's total cumulative exposure of the device is expected to be