(30 days)
Otoport/Otocheck OAE+ABR™, K143395
Not Found
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on standard signal processing and automated interpretation based on pre-defined criteria ("automatically interpreted and a clear 'Pass' or 'Refer' result is presented").
No
This device is designed to screen for hearing disorders and characterize and monitor peripheral auditory function, which falls under diagnostic and screening purposes rather than direct treatment or therapy.
Yes.
The device is explicitly stated to "facilitate the early detection of hearing loss and its characterization" and to be used for "clinical investigations [to] require the characterization and monitoring of the peripheral auditory function." The results are interpreted as "Pass" or "Refer," indicating it aids in identifying a condition.
No
The device description explicitly states it is a "compact handheld device" and records responses via an "applied earphone and or adhesive surface electrode pad," indicating it includes hardware components for data acquisition.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze biological samples: In Vitro Diagnostics are designed to examine specimens taken from the human body, such as blood, urine, tissue, etc., to provide information about a person's health.
- This device measures physiological responses: The Otoport Pro device measures auditory responses (OAEs and ABRs) to sound stimuli. These are physiological responses from the patient's auditory system, not the analysis of a biological sample.
The device is a diagnostic tool used to assess hearing function, but it does so by interacting directly with the patient's body and recording their responses, not by analyzing a sample taken from them.
N/A
Intended Use / Indications for Use
The Otoport 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 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 (comma separated list FDA assigned to the subject device)
EWO, GWJ
Device Description
The Otodynamics Ltd ("Otodynamics") Otoport Pro device is a compact handheld device capable of high quality OAE measurements for clinical purposes and also automated ABR and OAE testing for fast infant screening.
Responses to sound are recorded via an applied earphone and or adhesive surface electrode pad. Specifically, the device can record Otoacoustic Emissions (type DPOAEs or TEOAEs) and auditory brainstem responses (ABRs) to sound. These responses are especially useful in the hearing of infants for deafness. The more detailed analysis of DPOAE and TEOAE responses is additionally useful as a component of the audiological diagnostic test battery.
The Otoport Pro is simple to use with customizable automation to make testing easy and the results clear. It has user access controls, graphical display panel, and extensive test database features. The Otoport Pro when configured for clinical use has advanced test features including extensive raw data capture for offline review and analysis if required.
Otoport Pro device is a hardware/ software revision of the currently marketed Otoport OAE+ABR, having the same performance and intended uses as the Otoport OAE+ABR device.
The previous version of the Otoport product (Otoport OAE+ABR) required an adaptor 'shell' to be fitted over the base unit if AABR functionality was required (Figure 1 below)
In the Otoport Pro design (Figure 2 below) all test modalities are included inside the base unit.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Scalp, forehead, nape, shoulder
Indicated Patient Age Range
population of any age, Infant and adult (Infant only 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 clinical investigations, 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
Not Found
Description of the test set, sample size, data source, and annotation protocol
Clinical measurement comparison: AABR, TEOAE and DPOAE measurements were made on a cohort of adult volunteers giving informed consent, using both the Otoport Pro and the predicate Otoport OAE+ABR, using the same probe which remained in position for each comparison. Tests were conducted in a sound booth by a qualified audiologist.
TEOAE screening: 17 subjects
DPOAE screening: 16 subjects
AABR screening: 14 subjects
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Performance Testing:
Electrical safety and electromagnetic compatibility (EMC): The system complies with ANSI/AAMI/IEC ES60601-1:2005/(R)2012 and Al:2012. Electromagnetic compatibility of the system confirmed through third-party testing to collateral standard IEC 60601-1-2 Edition 4.0 2014-02.
Software Verification and Validation Testing: Conducted in compliance with IEC 62304 Edition 1.1 2015-06, ANSI/AAMI/IEC ES60601-1:2005//R/2012, and FDA guidance documents "General Principles of Software Validation; Final Guidance for Industry and FDA Staff" (11-Jan-2002) and "FDA Guidance for the Content of Premarket Submissions for Device Software Functions" (14-June-2023).
Cybersecurity: Issues regarding cybersecurity are included for resolution at all appropriate phases of the products development process. Cybersecurity addressed in the Software Risk mitigation measures against cybersecurity risks are incorporated into the software requirements specifications. The Otodynamics products/ services considered and followed the recommendations in "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions, Guidance for Industry and Food and Drug Administration Staff (27-September- 2023)" and current medical devices cybersecurity regulations.
Clinical Performance Testing:
Measurements of the acoustic stimulus and recorded auditory response:
- Measurement by a calibrated microphone of the amplitude and waveform of the acoustic stimulus delivered into 1. a calibrated ear simulator after level setting by the Otoport OAE+ABR, in TEOAE, DPOAE and AABR testing modes, using the same probe on each device.
- Measurement by the device of the response recorded by both Otoport OAE+ABR in TEOAE, 2. DPOAE and AABR testing modes, when presented with an electronically generated from the device's acoustic stimulus (i.e., simulated) TEOAE, DPOAE or ABR response signal respectively.
Results:
Acoustic stimulus differences between devices (using the same probe):
- TEOAE differences less than 0.4dB
- DPOAE an average difference of less than 0.3dB from 1-8kHz, with a maximum deviation of 0.8dB
- AABR an average difference of 0.2dB from 2-4.5kHz
Received response differences:
- TEOAE average of 0.23 dBSPL
- DPOAE average difference 0.4dB, with largest differences less than 2dB
- AABR average difference 0.1dB
Clinical measurement comparison (on adult volunteers):
- TEOAE screening (click stimulus at 84dBSPLpe, 6dBSNR pass criteria in 2 half octave bands): 17 subjects tested, 15 passed on both instruments, the same 2 failed on both.
- DPOAE screening (stimulus levels L1 65 dBSPL for f1 and f2 tones at half octave intervals from 1.5 to 6kHz): 16 subjects tested, 13 subjects passed the default (newborn) screening criteria on both instruments, 3 failed on both instruments, and these subjects failed at the same frequency on each instrument.
- AABR screening (chirp of 40dBHL audiologically calibrated on 25 healthy young adults): 14 subjects tested, 12 subjects passed on both instruments, the same 2 subjects failed on both instruments (with no clear response and high EEG). Test times were similar on both instruments at about 100 seconds. Average pass ABR amplitudes were 0.49 microV for Otoport Pro and 0.51 microV for the predicate. Both devices reported the same electrode impedances within 240 ohms.
Clinical (measurement) mode:
- TEOAE: Difference between mean TEOAE levels reported by the two devices was less than 1dB at each half octave frequency (1k to 6kHz).
- DPOAE: 13-point DPqrams recorded. Averaged across 15 subjects, the mean DPOAE level difference was less than 1dB at each frequency (1k-8kHz).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Otoport/Otocheck OAE+ABR™, K143395
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 shows the logo of the U.S. Food & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a sans-serif font.
March 15, 2024
Otodynamics Ltd % Chandler Thames Director of Quality Rook Quality Systems 1155 Mount Vernon Hwy #800 Dunwoody, Georgia 30338
Re: K240430
Trade/Device Name: Otoport Pro Regulation Number: 21 CFR 874.1050 Regulation Name: Audiometer Regulatory Class: Class II Product Code: EWO, GWJ Dated: February 12, 2024 Received: February 14, 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" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about 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
2
Indications for Use
510(k) Number (if known) K240430
Device Name Otoport Pro
Indications for Use (Describe)
The Otoport 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 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 ALI0 8BB, United Kingdom
Phone: +44 1707 267540 Email: daniel.budd@otodynamics.com
Contact Person: Daniel Budd, QA Manager Date Prepared: 15.03.2024
DEVICE
| Trade Name: | Otoport Pro |
|---|---|
| Common Name: | Otoport Pro |
| Classification Name: | Audiometer/ Evoked response auditory stimulator (874.1050 & 882.1900) |
| Regulatory Class: | 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
The Otodynamics Ltd ("Otodynamics") Otoport Pro device is a compact handheld device capable of high quality OAE measurements for clinical purposes and also automated ABR and OAE testing for fast infant screening.
Responses to sound are recorded via an applied earphone and or adhesive surface electrode pad. Specifically, the device can record Otoacoustic Emissions (type DPOAEs or TEOAEs) and auditory brainstem responses (ABRs) to sound. These responses are especially useful in the hearing of infants for deafness. The more detailed analysis of DPOAE and TEOAE responses is additionally useful as a component of the audiological diagnostic test battery.
The Otoport Pro is simple to use with customizable automation to make testing easy and the results clear. It has user access controls, graphical display panel, and extensive test database features. The Otoport Pro when configured for clinical use has advanced test features including extensive raw data capture for offline review and analysis if required.
Otoport Pro device is a hardware/ software revision of the currently marketed Otoport OAE+ABR, having the same performance and intended uses as the Otoport OAE+ABR device.
The previous version of the Otoport product (Otoport OAE+ABR) required an adaptor 'shell' to be fitted over the base unit if AABR functionality was required (Figure 1 below)
In the Otoport Pro design (Figure 2 below) all test modalities are included inside the base unit.
4
Image /page/4/Picture/0 description: The image shows a handheld Otodynamics device being held by two hands. The device has a screen at the top, followed by a series of buttons and a keypad. The keypad has numbers 1-9 and 0, along with other symbols. The device is white and has the brand name "Otodynamics" printed on it.
Image /page/4/Figure/1 description: The image shows a handheld device with a screen displaying a graph labeled "DPZ TEST". The graph shows a red line fluctuating between -10 and 20 dBSPL across a frequency range of 2 to 8 kHz. Below the screen, there are several buttons, including a numeric keypad from 1 to 9, a 0 button, and other function buttons labeled "CANCEL", "MANUAL", and "END".
Figure 2
INDICATIONS FOR USE
Figure 1
The Otoport 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 trained. 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.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The same Otoacoustic Emissions (OAEs) & Auditory Brainstem Response (ABR) techniques and principles of response analysis are utilized in both the subject and predicate devices.
5
TABLE 1. COMPARISON BETWEEN THE SUBJECT DEVICE AND THE PREDICATE OTOPORT/OTOCHECK 0AE+ABR (K143395)
| TABLE 1. COMPARISON BETWEEN THE SUBJECT DEVICE AND THE PREDICATE OTOPORT/OTOCHECK 0AE+ABR (K143395) | |||
|---|---|---|---|
| Subject Device | |||
| Otoport Pro (K240430) | Predicate Device | ||
| Otoport/Otocheck OAE+ABR | |||
| (K143395) | Overview of similarities | ||
| and differences | |||
| Common Name | Audiometer | ||
| Evoked response auditory stimulator | Audiometer | ||
| Evoked response auditory stimulator | Same | ||
| Class | II | II | Same |
| Product Code | EWO&GWJ | EWO&GWJ | Same |
| Classification | |||
| Regulation | 874.1050 | ||
| 882.1900 | 874.1050 | ||
| 882.1900 | Same | ||
| Intended Use | For the detection of peripheral | ||
| hearing loss and for use in the | |||
| characterization of and diagnosis of | |||
| auditory and hearing-related | |||
| disorders. | For the detection of peripheral | ||
| hearing loss and for use in the | |||
| characterization of and diagnosis of | |||
| auditory and hearing-related | |||
| disorders. | Same | ||
| Indications for Use | The Otoport 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. | 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. | Same | ||
| 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 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. | 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. | 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 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 | |||
| Overall Device Design | Handheld device (L195mm x W70mm x D2.8mm; 214g) | ||
| (7 3/4" x 2 3/4"x 11/8" 0.47pounds) | |||
| Stimulates the ear with quiet sounds. | |||
| Non-invasive, records physiological | |||
| responses to these sounds. | |||
| Automatically evaluates the evidence | |||
| for a response. | |||
| Reports a concise result output about | |||
| the presence or absence of normal | |||
| responses. | |||
| Saves a detailed record of the test. | |||
| Device alerts to the possibility of | |||
| hearing loss and documents the status | |||
| of the ear. | Handheld device (L280mm x W83mm x D45mm; 446g) | ||
| (11" x 3 1/4" x 13/4" 1 pound) | |||
| Stimulates the ear with quiet sounds. | |||
| Non-invasive, records physiological | |||
| responses to these sounds. | |||
| Automatically evaluates the evidence | |||
| for a response. | |||
| Reports a concise result output about | |||
| the presence or absence of normal | |||
| responses. | |||
| Saves a detailed record of the test. | |||
| Device alerts to the possibility of | |||
| hearing loss and documents the status | |||
| of the ear. | Otoport Pro is smaller and | ||
| lighter. | |||
| The predicate Otoport | |||
| OAE+ABR was heavier and | |||
| larger because it incorporated | |||
| an adaptor 'shell', fitted over the | |||
| basic Otoport OAE product, to | |||
| provide AABR functionality. In | |||
| the Otoport Pro subject device, | |||
| the AABR functionality has been | |||
| built into the basic handheld | |||
| device as the attachment of an | |||
| ABR adaptor shell is not | |||
| required. | |||
| 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. | Same | ||
| 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) | Same | ||
| 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 | Same | ||
| 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 | Same | ||
| 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 | Same | ||
| Stimulates the ear for ABR screening | |||
| at 30,35,40, or 45dBnHL (60dBHL for | |||
| training) | Stimulates the ear for ABR screening | ||
| at 30,35,40, or 45dBnHL (60dBHL for | |||
| training) | Same | ||
| 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. | Same | ||
| 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 | Same | ||
| 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 | Same | ||
| 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 | Same | ||
| 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 | Same | ||
| Population | Infant and adult (Infant only for | ||
| AABR) | Infant and adult (Infant only for AABR) | Same | |
| Intended user | Trained operators for screening, and | ||
| professionals for screening and clinical | |||
| use | Trained operators for screening, and | ||
| professionals for screening and clinical | |||
| use | Same | ||
| Safety | |||
| characteristics | Electrically isolated from any device | ||
| connected to its UCB-C charging and | |||
| data connector. | |||
| Acoustic stimulation levels physically | |||
| constrained and monitored with active | |||
| protection against single faults. | Electrically isolated from any device | ||
| connector to its Hirose charging and | |||
| data connector. | |||
| Acoustic stimulation levels physically | |||
| constrained and monitored with active | |||
| protection against single faults. | Same | ||
| Enclosure material | The device enclosure materials are | ||
| Polylac PA-765 Flame retardant ABS. | |||
| Injection moulding. | The device enclosure materials are | ||
| Polylac PA-765 Flame retardant ABS. | |||
| Injection moulding. | Same materials. Comply with | ||
| the current biocompatibility | |||
| standards. | |||
| Materials of | |||
| Construction | Probe: plastic encapsulated insert | ||
| earphone containing microphone and | |||
| receiver, fitted with disposable single | |||
| use plastic tip | Probe: plastic encapsulated insert | ||
| earphone containing microphone and | |||
| receiver, fitted with disposable single | |||
| use plastic tip | Same | ||
| For ABR screening - Surface, self- | |||
| adhesive skin electrodes. | |||
| Electrode cables: PVC (Biocompatible) | For ABR screening - Surface, self- | ||
| adhesive skin electrodes | |||
| Electrode cables: PVC; Nylon | |||
| (Biocompatible) | Same materials. Comply with | ||
| the biocompatibility standards. | |||
| 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, microprocessor for signal | |||
| and statistical analysis, all | |||
| encapsulated in a plastic housing, | |||
| including graphic display unit and data | |||
| input facilities plus rechargeable | |||
| battery. | 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, microprocessor for | |||
| signal and statistical analysis, all | |||
| encapsulated in a plastic housing, | |||
| including graphic display unit and data | |||
| input facilities plus rechargeable | |||
| battery. | Similar. Individual circuit | ||
| components have been changed | |||
| to avoid obsolescence with | |||
| equivalent or superior | |||
| performance items. | |||
| 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 | Acoustic probe tip and electrodes are | ||
| single patient use only | Same | ||
| Anatomical | |||
| placement | Scalp, forehead, nape, shoulder | Scalp, forehead, nape, shoulder | Same |
| Number of | |||
| Electrodes | 3 | 3 | Same |
| Electrode Sockets | Yellow, Touchproof Connector, SSB, | ||
| 4-pin, 1mm. PVC. Biocompatible | DIN 42-802 Type ST 'Touchproof' | ||
| terminated electrode cables. Electrode | |||
| cable connectors Nylon: ZYTEL | |||
| 70G33L. | |||
| Biocompatible | Similar | ||
| The same Plastics One | |||
| manufacturer of the connector. | |||
| Both types are for EEG cables/ | |||
| electrodes. | |||
| Otoport Pro has all 3 electrode | |||
| cables in one single connector. | |||
| Otoport ABR predicate has | |||
| individual connectors for each of | |||
| the 3 electrode cables. | |||
| The connectors for both Otoport | |||
| Pro and predicate Otoport ABR | |||
| are biocompatible and | |||
| substantially equivalent in | |||
| functionality and performance. | |||
| 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 | Gray, Tinsel Wire, 3 x 0.023 conductor, | ||
| Shielded, | |||
| 0.120 Dia. PVC jacket. Biocompatible. | Electrode Cable Insulations: PVC, | ||
| Mexichem | |||
| 2235L-75. Biocompatible. | Similar. The Otoport Pro cable | ||
| has all 3 electrode cables inside | |||
| one shield and also ground | |||
| shielding on most of the length. | |||
| The Otoport Pro electrode | |||
| cables with single connector to | |||
| device run to 3 cable ends- | |||
| electrode connections to patient | |||
| (same with Otoport ABR). | |||
| Otoport ABR electrode cables | |||
| are 3 individual electrode cables | |||
| running from device to patient. | |||
| The electrode cables for both | |||
| Otoport Pro and predicate | |||
| Otoport ABR are biocompatible | |||
| and substantially equivalent in | |||
| functionality and performance. | |||
| Probe Connector | Two (14 pin) 'Medi-Snap' connector | ||
| push pull connector | 'Triad' (8 pin) connector metal collar to | ||
| screw lock in place. Binaural option has | |||
| two such probe connectors | 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 Otoport Pro | |||
| probes are substantially | |||
| equivalent with legacy probes | |||
| of predicate Otoport ABR, | |||
| which have been in service for | |||
| 20+years. The only difference | |||
| is the connectors. | |||
| The 14 pin Medi-Snap | |||
| connector of the Otoport Pro | |||
| serves the same purpose as | |||
| the predicate, but it's 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 damage by | |||
| mishandling. Connector | |||
| damage would be detected by | |||
| recommended QA tests. The | |||
| Mini-Snap further improves | |||
| safety by not exposing metal | |||
| parts to user. The residual user | |||
| risks remain low/ are | |||
| acceptable. | |||
| Probes | UPS, UPD & XPD probes | ||
| TEOAE/ DPOAE Functionality probes. | All models take UGS & UGD probes. | ||
| Can also take the XGD probe with a | |||
| firmware update. | |||
| TEOAE/ DPOAE Functionality probes. | Similar. Substantially equivalent | ||
| TEOAE/ DPOAE probes. The | |||
| subject device is compatible | |||
| with all the probe types useable | |||
| with the predicate device when | |||
| supplied with a Medi-Snap | |||
| connector (UPS, UPD and | |||
| XPD). | |||
| Differences in the probe | |||
| connectors to the device: | |||
| Predicate has UGS/ UGD/ XGD | |||
| probes with metallic screw | |||
| connectors to the Otoport. | |||
| Otoport Pro has UPS/UPD & | |||
| XPD probes with plastic clip-on | |||
| connectors to the device | |||
| (easier to use). | |||
| Number of | |||
| Probes | |||
| Connected | The Otoport Pro can accept 2 probes | The Otoport OAE+ABR binaural option | |
| can accept 2 probes, otherwise only | |||
| 1 probe | The subject and predicate base | ||
| models (Otoport Pro and | |||
| Otoport) are similar in that both | |||
| can accept 2 probes for | |||
| binaural recording. With the | |||
| predicate 2 probes was only | |||
| available with the binaural | |||
| OAE+ABR variant. With the | |||
| subject device, 2 probes | |||
| capacity is standard. | |||
| Electrode | |||
| Socket | |||
| Connector | Otoport Pro has one 4 Pin Plug & | ||
| Socket Connector | Three Single Pin Plug and Socket | ||
| Connectors | The Otoport Pro and the | ||
| predicate device are similar that | |||
| they require 3 electrode | |||
| connections to perform the ABR | |||
| screening test. | |||
| The Otoport Pro uses a single 4 | |||
| pin plug and socket connector, | |||
| while the predicate uses three | |||
| single pin plug and socket | |||
| connectors. The electrode | |||
| cabling is different and incudes | |||
| an EMC shield, which reduce | |||
| interference noise. | |||
| The 4-pin single electrode cable | |||
| socket of the port Pro provides a | |||
| Charging and data | |||
| transfer connector | USB-C for charging and download | Hirose proprietary connector for | |
| charging and download | Similar. | ||
| Improved useability and | |||
| reliability. | |||
| Device | |||
| Components / | |||
| Features | A handheld battery powered hearing | ||
| screening device with integral keypad | |||
| and display which shows processed | |||
| real time data. OAE/ ABR | |||
| Functionality. | A handheld battery powered hearing | ||
| screening device with integral | |||
| keypad and display which shows | |||
| processed real time data. For the | |||
| ABR functionality the ABR module | |||
| attachment fitted on the Otoport is | |||
| required. OAE/ ABR Functionality. | In the Otoport Pro ABR | ||
| functionality is integral to the | |||
| basic unit. No adaptor is | |||
| needed to enable ABR | |||
| screening functionality. This | |||
| enhances usability and | |||
| convenience- simplicity. | |||
| Residual risks associated with | |||
| ABR adaptor shell fitting are | |||
| removed. The residual risks | |||
| are found to be low/ are | |||
| acceptable. | |||
| User Interface | The Otoport Pro preinstalled software | ||
| provides complete user control over the | |||
| testing hardware inside the Otoport Pro | |||
| and displays test progress, test results., | |||
| and tests saved in the in-built database. | |||
| Optionally, Otoport Pro database | |||
| contents can be securely transferred to | |||
| Otodynamics Otolink software for | |||
| review, printing, or archiving. | |||
| Otoport Pro firmware can be securely | |||
| updated from Otolink | The Otoport preinstalled software | ||
| provides 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. | ||
| Products usability engineering | |||
| compliance to current | |||
| standards/ regulations/ | |||
| acceptable. | |||
| Test data storage | Internal, encrypted searchable | ||
| database with capacity for 1024 | |||
| patients, 5000 test records, maximum | |||
| 256 tests/patients | Internal, proprietary encoded | ||
| searchable database with capacity | |||
| 1000 patients, 5000 test records | similar | ||
| Data Transfer | Data transfer is via wired USBI.1 or 2.0 | ||
| to third party computer running | |||
| Otodynamics Otolink software. Otoport | |||
| Pro has Bluetooth 5 functionality | |||
| which can also be used to transfer | |||
| data to Otolink. The USB connection is | |||
| made by a | |||
| USB C connector. | Data transfer is via wired USBI.1 or 2.0 | ||
| to third party computer running | |||
| Otodynamics Otolink software. Otoport | |||
| OAE+ABR has Bluetooth 2.0 | |||
| functionality can also be used to | |||
| transfer data to Otolink. | Similar, both the subject and | ||
| predicate have both Bluetooth | |||
| capability for completed test data | |||
| transfer; however, the Bluetooth | |||
| 2 which is used on the predicate | |||
| device is now obsolete and | |||
| superseded by Bluetooth 5 | |||
| which is used on the subject | |||
| device. Data can also be | |||
| transferred by wired USB cable | |||
| as with the predicate. The use of | |||
| a USB C connector instead of | |||
| the predicate proprietary HiRose | |||
| connector increases user | |||
| convenience. Device safety | |||
| benefits from total electrical | |||
| isolation (onto isolation) between | |||
| it and the attached device (PC or | |||
| charger). | |||
| Barcode | |||
| reader | Has optional 2D barcode scanner for | ||
| patient ID and demographics inputs. | Has optional 1D barcode scanner for | ||
| patent ID and demographics inputs. | Similar. The provision of the | ||
| optional 2D barcode reader | |||
| allows more patient data to be | |||
| transferred to the device | |||
| database and is also compatible | |||
| with 2D barcoding which are still | |||
| in widespread use. | |||
| Charging | Charging/ Data connector - connects to | ||
| Otodynamics PSU (charging) or to PC | |||
| USB port (USB 1.lor 2.0) via Data Cable. | Charging/Data connector - connects to | ||
| Otodynamics PSU (charging) or to PC | |||
| USB port (USB 1.lor 2.0) via Data Cable. | Similar, but now the subject | ||
| device has total electrical | |||
| isolation from any device | |||
| connected to its USB-C port. | |||
| Power States | Intelligent multi-level power control for | ||
| charging/testing/idle/sleep/shutdown | Intelligent multi-level power control for | ||
| charging/testing/idle/sleep/shutdown | The same way of charging, | ||
| testing, Idle mode, sleep, | |||
| shutdown. | |||
| Charge Time | 3.5 Hrs. to 100% for supplied PSU charge, | ||
| 5 hours for PC charge | 4 Hrs. to 100% | Similar | |
| Max | |||
| consumption when | |||
| testing: | 1W | 1W (Otoport) or 1.3W (Otoport ABR) | Similar |
| Max | |||
| consumption | |||
| when | |||
| charging: | 2.65W when charging from USB | ||
| connection. 3.5W when charging from | |||
| supplied PSU. | 2.5W | Similar. Consumption of the unit is | |
| 2.5W when charging battery from | |||
| a USB to comply with USB | |||
| standards. When charged with | |||
| the supplied charger/PSU, | |||
| charging is faster, and the | |||
| consumption is 3.5W. This | |||
| improvement in charge speed is | |||
| possible because of the Otoport | |||
| Pro's improved 5V isolator circuit. | |||
| Subject Device | |||
| Otoport Pro | Predicate Device | ||
| Otoport/ Otocheck OAE+ABR | |||
| (K143395) | Overview of similarities and | ||
| differences | |||
| Transient Evoked Otoacoustic Emissions (TEOAE) | |||
| Stimulus | |||
| Levels | Idle |
- 80µs positive broadband square
wave pulse with an intensity of
64dBpeSPL (peak equivalent) in a
1cc cavity. Adjusted 80µs positive
broadband square wave.
Testing
- 300µs biphasic broadband
triangular pulse; - Screening level: 84dBpeSPL-
Clinical mode: adjustable in 2dB
increments; Range 50-90dBpeSPL | Idle - 80µs positive broadband square
wave pulse with an intensity of 64
dBpeSPL (peak equivalent) in a 1cc
cavity. Adjusted 80µs positive
broadband square wave.
Testing
- 300µs biphasic broadband
triangular pulse; - Screening level: 84dBpeSPL-
Clinical mode: adjustable in 2dB
increments; Range: 50-90dBpeSPL | same |
| Sample rate | 20kHz | 20kHz | same |
| Stimulus pattern | Each sweep presents 8 stimuli
responses with the stimulus
presentation pattern:
A A A B -A -A -A -B
Where: B = -3A | Each sweep presents 8 stimuli
responses with the stimulus
presentation pattern:
A A A B -A -A -A -B
Where: B = -3A | same |
| Noise level
calculation | The noise level for noise reject is
calculated from the difference between
alternate averaged sweeps | The noise level for noise reject is
calculated from the difference between
alternate averaged sweeps | same |
| Stimulus
repetition rate | One stimulus every 13ms,
approximately 80 stims per second | One stimulus every 13ms,
approximately 80 stims per second | same |
| Response window | 3-13ms or 3-9ms after start of stimulus
presentation. Cosine filtered with rise
and fall time of 2ms | 3-13ms or 3-9ms after start of stimulus
presentation. Cosine filtered with rise
and fall time of 2ms | same |
| Response
frequency bands | Half octave, centered at 1k, 1.4k, 2k,
2.8k, 4k and 5.6kHz | Half octave, centered at 1k, 1.4k, 2k,
2.8k, 4k and 5.6kHz | same |
| | Distortion Product Otoacoustic Emissions (DPOAE) | | |
| Stimulus level | Preset L1:L2
60:50dBSPL; 65:55dBSPL;
70:60dBSPL
For clinical measurement
L1 and L2 adjustable
Range 50-75dBSPL | Preset L1:L2
60:50dBSPL; 65:55dBSPL;
70:60dBSPL
For clinical measurement
L1 and L2 adjustable
Range 50-75dBSPL | same |
| Sample rate | 25.6kHz | 25.6kHz | same |
| FFT frequency Bin | 25Hz | 25Hz | same |
| DP noise
calculation | DP noise is calculated from the five
spectral points above and the five
points below the DP frequency. A
margin of 1 or 2 standard deviations is
applied for precise clinical
measurements | DP noise is calculated from the five
spectral points above and the five
points below the DP frequency.
A margin of 1 or 2 standard deviations
is applied for precise clinical
measurements | same |
| Stimulus
frequencies (F2) | 1-6kHz, 1.5-8kHz, 2-6kHz
(Recommended)
1.5-8k tests at six F2 frequencies: 1.5k,
2k, 3k, 4k, 6k and 8kHz
1-6k tests at six F2 frequencies: 1k,
1.5k, 2k, 3k, 4k and 6kHz
2-6k tests at four F2 frequencies: 2k,
3k, 4k and 6kHz
Screening: half or quarter octaves | 1-6kHz, 1.5-8kHz, 2-6kHz
(Recommended)
1.5-8k tests at six F2 frequencies: 1.5k,
2k, 3k, 4k, 6k and 8kHz
1-6k tests at six F2 frequencies: 1k,
1.5k, 2k, 3k, 4k and 6kHz
2-6k tests at four F2 frequencies: 2k,
3k, 4k and 6kHz
Screening: half or quarter octaves | same |
| | between 1k and 8kHz
Clinical measurement mode.
Configurable start/stop frequencies up
within device resolution. Up to 16
frequency points per sweep, between
1k and 8kHz | between 1k and 8kHz
Clinical measurement mode.
Configurable start/stop frequencies up
within device resolution. Up to 16
frequency points per sweep, between
1k and 8kHz | |
| Frequency ratio
f2/f1 | 1.22 | 1.22 | same |
| | Automated Auditory Brainstem Response (AABR) | | |
| Stimulus levels | For infant screening only; 35 or
40dBHL are recommended.
(A higher level up to 60dBHL is
provided for the training of adult
screeners) | For infant screening only; 35 or
40dBHL are recommended.
(A higher level up to 60dBHL is
provided for the training of adult
screeners) | same |
| Stimulus rate | 51.8-57.9/second, alternating polarity. | 51.8-57.9/second, alternating polarity. | same |
| Stimulus type | Chirp (default recommended) or click | Chirp (default recommended) or click | same |
| Sampling rate | 25.6kHz | 25.6kHz | same |
| Capture time
frame | 17.3 to 18.8ms | 17.3 to 18.8ms | same |
| Capture
bandwidth | 150-1000Hz | 150-1000Hz | same |
| Evaluation method | Fsp with infant template matching | Fsp with infant template matching | same |
| Electrode
Impedance
sensing | 400Hz. Less than 5microamps - to over 16kohms | 400Hz. Less than 5microamps
- to over 16kohms | same |
| Amplifier | Differential, 75dB CMR>60dB@100Hz,
1Mohm. Dynamic powerline rejection. | Differential, 75dB CMR>60dB@100Hz,
1Mohm. Dynamic powerline rejection. | same |
6
7
8
9
10
11
12
TABLE 2. COMPARISON BETWEEN THE SUBJECT DEVICE AND THE PREDICATE – Stimulus Parameters
13
Non-Clinical Performance Testing
Electrical safety and electromagnetic compatibility (EMC)
Both electrical safety and EMC testing have been conducted on the Otoport Pro Device. The system complies with ANSI/AAMI/IEC ES60601-1:2005/(R)2012 and Al:2012 for basic safety and essential performance of medical electrical equipment.
14
The electromagnetic compatibility of the system has been confirmed through third-party testing to collateral standard IEC 60601-1-2 Edition 4.0 2014-02.
Software Verification and Validation Testing
Software verification and validation testing has been conducted in compliance with IEC 62304 Edition 1.1 2015-06 (which is the principal normative standard applied), ANSI/AAMI/IEC ES60601-1:2005//R/2012 and the FDA guidance documents "General Principles of Software Validation; Final Guidance for Industry and FDA Staff" (11-Jan-2002) and "FDA Guidance for the Content of Premarket Submissions for Device Software Functions" (14-June-2023).
Cybersecurity
lssues regarding cybersecurity are included for resolution at all appropriate phases of the products development process. Cybersecurity is addressed in the Software Risk mitigation measures against cybersecurity risks are incorporated into the software requirements specifications. The Otodynamics products/ services considered and followed the recommendations in "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions, Guidance for Industry and Food and Drug Administration Staff (27-September- 2023)" and current medical devices cybersecurity regulations.
The hardware and firmware changes do not negatively affect the cybersecurity, safety, reliability, and longevity of service of the device relative to the predicate.
Clinical Performance Testing
The indications of use of the Otoport Pro are the same as for the predicate device Otoport OAE+ABR.
The performance of each test modality of the Otoport Pro has been demonstrated to be similar to that of the predicate Otoport OAE+ABR in bench tests and in a clinical measurement trial.
Measurements of the acoustic stimulus and recorded auditory response
- Measurement by a calibrated microphone of the amplitude and waveform of the acoustic stimulus delivered into 1. a calibrated ear simulator after level setting by the Otoport OAE+ABR, in TEOAE, DPOAE and AABR testing modes, using the same probe on each device.
- Measurement by the device of the response recorded by both Otoport OAE+ABR in TEOAE, 2. DPOAE and AABR testing modes, when presented with an electronically generated from the device's acoustic stimulus (i.e., simulated) TEOAE, DPOAE or ABR response signal respectively.
The acoustic stimulus differences between the devices (using the same probe) were
TEOAE differences were less than 0.4dB,
DPOAE an average difference of less than 0.3dB form 1-8kHz, with a maximum deviation of 0.8dB, and AABR an average difference of 0.2dB from 2-4.5kHz
The received response differences TEOAE average of 0.23 dBSPL, DPOAE average difference 0.4dB, with largest differences less than 2dB, and AABR average difference 0.1dB
Clinical measurement comparison
15
AABR, TEOAE and DPOAE measurements were made on a cohort of adult volunteers giving informed consent, using both the Otoport Pro and the predicate Otoport OAE+ABR, using the same probe which remained in position for each comparison. Tests were conducted in a sound booth by a qualified audiologist.
Screening mode (default for newborns)
TEOAE screening was performed with a click stimulus at level 84dBSPLpe, with 6dBSNR pass criteria in 2 half octave bands;
TEOAE screening of 17 subjects tested for TEOAE, 15 passed on both instruments, the same 2 failed on both instruments.
DPOAE screening was performed at stimulus levels of L1 65 dBSPL for f1 and f2 tones at half octave intervals from 1.5 to 6kHz;
DPOAE screening of 16 subjects tested for DPOAE, 13 subjects passed the default (newborn) screening criteria on both instruments, 3 failed on both instruments, and these subjects failed at the same frequency on each instrument.
AABR screening was performance with a chirp of 40dBHL - audiologically calibrated on 25 healthy young adults; AABR of 14 subjects tested for ABR, 12 subjects passed on both instruments, the same 2 subjects failed on both instruments (with no clear response and high EEG).
Test times were similar on both instruments at about 100 seconds. Average pass ABR amplitudes were 0.49 µV for the Otoport Pro and 0.51 µV for the predicate. This difference is not significant. Both devices reported the same electrode impedances within 240 ohms.
Clinical (measurement) mode
TEOAE: the TEOAE level in half octave bands were measured from 1k to 6kHz. The difference between the mean TEOAE levels reported by the two devices was less than 1dB at each half octave frequency. DPOAE: 13-point DPqrams were recorded on both devices, using the same probe. Levels of L1=L2 of 70 dBSPL were chosen for this older subject cohort, as this might be used clinically to measure DPOAE strength. Averaged across 15 subjects, the mean DPOAE level difference was less than 1dB at each frequency (1k-8kHz). This difference in DPOAE levels between instrument is not audiologically significant.
AABR - no clinical /diagnostic ABR facilities are available on the Otoport Pro.
CONCLUSIONS
The Otoport Pro Device has the same intended use as the predicate device.
The Otoport Pro is substantially equivalent to the Otoport/Otocheck OAE+ABR predicate device with respect to overall device design elements and features. Functional bench testing supported the electronic and acoustic equivalence of the subject and predicate devices. The non-clinical testing has supported the safety and functionality of the device and the indications for use whilst the performance testing data demonstrates that the device is substantially equivalent to the predicate.