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

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

Device 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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Otoport Pro device, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document describes the performance of the Otoport Pro in comparison to its predicate device (Otoport OAE+ABR, K143395) rather than setting distinct acceptance criteria with specific threshold values. The primary acceptance criterion appears to be demonstrating substantial equivalence in performance to the predicate device.

Test Modality & Metric	Acceptance Criteria (Implied: Substantial Equivalence to Predicate)	Reported Device Performance (Otoport Pro vs. Predicate)
Acoustic Stimulus Differences	Differences in amplitude and waveform of acoustic stimulus (TEOAE, DPOAE, AABR) when using the same probe.	TEOAE: < 0.4 dB difference DPOAE: Average < 0.3 dB (1-8kHz), Max deviation 0.8 dB AABR: Average < 0.2 dB (2-4.5kHz)
Received Response Differences	Differences in recorded response (TEOAE, DPOAE, AABR) when presented with a simulated response.	TEOAE: Average 0.23 dBSPL difference DPOAE: Average 0.4 dB difference (largest differences < 2 dB) AABR: Average 0.1 dB difference
Screening Mode (Newborns)	TEOAE Screening: Consistent Pass/Refer results with predicate.	17 subjects: 15 passed on both, same 2 failed on both.
	DPOAE Screening: Consistent Pass/Refer results with predicate, same frequency of failure.	16 subjects: 13 passed on both, same 3 failed on both at the same frequency.
	AABR Screening: Consistent Pass/Refer results with predicate, comparable test times, similar ABR amplitudes and electrode impedances.	14 subjects: 12 passed on both, same 2 failed on both. Test times ~100 seconds. Average pass ABR amplitudes: Otoport Pro 0.49 µV, Predicate 0.51 µV (not significant difference). Both reported same electrode impedances within 240 ohms.
Clinical (Measurement) TEOAE	TEOAE level differences in half-octave bands.	Mean TEOAE level difference < 1 dB at each half octave frequency (1k-6kHz).
Clinical (Measurement) DPOAE	Mean DPOAE level differences.	Mean DPOAE level difference < 1 dB at each frequency (1k-8kHz) (not audiologically significant).
Electrical Safety	Compliance with ANSI/AAMI/IEC ES60601-1:2005/(R)2012 and A1:2012.	System complies.
EMC	Compliance with IEC 60601-1-2 Edition 4.0 2014-02.	System complies (confirmed by third-party testing).
Software V&V	Compliance with IEC 62304 Edition 1.1 2015-06, FDA guidance documents "General Principles of Software Validation" and "FDA Guidance for the Content of Premarket Submissions for Device Software Functions".	Testing conducted in compliance.
Cybersecurity	Measures to mitigate risks, compliance with "Cybersecurity in Medical Devices" guidance, no negative effect from hardware/firmware changes.	Issues addressed in development, risks mitigated, compliance with guidance. Hardware/firmware changes do not negatively affect cybersecurity, safety, reliability, longevity.

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

Test Set Sample Sizes:
- TEOAE Screening: 17 subjects
- DPOAE Screening: 16 subjects
- AABR Screening: 14 subjects
- Clinical Measurement TEOAE/DPOAE: 15 subjects (implied for DPOAE, TEOAE not explicitly stated as separate for clinical but likely from the same cohort)
Data Provenance: The study was conducted on a cohort of adult volunteers who gave informed consent. The tests were performed in a sound booth by a qualified audiologist. This indicates a prospective study design conducted under controlled conditions. The country of origin is not explicitly stated, but the manufacturer is Otodynamics Ltd, based in the United Kingdom.

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

The document states that tests were conducted "by a qualified audiologist." This suggests at least one qualified audiologist was involved in performing the tests and likely verifying the outcomes. Their specific qualifications (e.g., years of experience) are not detailed beyond "qualified audiologist." For AABR, the predicate device was audiologically calibrated on 25 healthy young adults, which speaks to a baseline calibration process rather than ground truth for the test set itself.

4. Adjudication Method for the Test Set

The document does not describe a formal adjudication method (like 2+1 or 3+1). The "ground truth" for the screening portion appears to be established by the consistent "Pass" or "Refer" results from both the predicate and subject devices, performed by a qualified audiologist. Discrepancies were not noted, suggesting high agreement between devices.

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

No, a MRMC comparative effectiveness study was not reported. The study focused on comparing the Otoport Pro's performance directly against the predicate device, not on assessing human reader performance with or without AI assistance.

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

Yes, the core of the clinical performance testing for screening modes (TEOAE, DPOAE, AABR) is essentially a standalone assessment of the device's automatic interpretation capabilities ("Pass" or "Refer" results are automatically interpreted and presented to the user). The audiologist's role was to perform the test, implying they observed the device's outcome, but the Pass/Refer decision was made by the device itself and then compared to the predicate's automated output.

7. Type of Ground Truth Used

The ground truth for the clinical performance testing (screening results) appears to be based on:

Comparison to a Legally Marketed Predicate Device (Otoport OAE+ABR): The consistency of "Pass" or "Refer" results between the Otoport Pro and the predicate device, performed on the same subjects, served as the primary method to establish substantial equivalence.
Expert Observational Consensus: The tests were conducted by a "qualified audiologist," suggesting that the audiologist's observation and the predicate device's established performance provided the reference.
Objective Physiological Measurements: The device measures objective physiological responses (OAEs and ABRs) and provides an automated interpretation. The ground truth essentially relied on the established reliable performance of the predicate device for such measurements.

8. Sample Size for the Training Set

The document does not provide information about the sample size used for any training set. The device is presented as a hardware/software revision with the same underlying principles and response analysis techniques as the predicate. This suggests that the "training" (development and refinement of internal algorithms for interpretation) largely predates this submission and was established with the predicate device, or that the algorithm is based on well-understood physiological models rather than machine learning on a large dataset.

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

As no training set is explicitly mentioned for the Otoport Pro as a new algorithmic development, the method for establishing its ground truth for training is not provided. Given the nature of the device (audiometer with established physiological measurement techniques) and its comparison to a predicate, it's highly probable that the underlying algorithms for interpreting OAE and ABR responses were developed based on physiological and audiological research, clinical guidelines, and extensive testing over the lifespan of the predicate device and related technologies, rather than a new machine learning paradigm requiring a distinct, large, and newly defined training set with expert-labeled ground truth for this specific 510(k) submission.

Summary

{0}------------------------------------------------

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)

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the

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

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

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

{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

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 DeviceOtoport Pro (K240430)	Predicate DeviceOtoport/Otocheck OAE+ABR(K143395)	Overview of similaritiesand differences
Common Name	AudiometerEvoked response auditory stimulator	AudiometerEvoked response auditory stimulator	Same
Class	II	II	Same
Product Code	EWO&GWJ	EWO&GWJ	Same
ClassificationRegulation	874.1050882.1900	874.1050882.1900	Same
Intended Use	For the detection of peripheralhearing loss and for use in thecharacterization of and diagnosis ofauditory and hearing-relateddisorders.	For the detection of peripheralhearing loss and for use in thecharacterization of and diagnosis ofauditory and hearing-relateddisorders.	Same
Indications for Use	The Otoport Pro device is indicated foruse when there is a requirement toscreen for hearing disorders byobjective and non-invasive means.ABR, TEOAE and DPOAE screening testresults are automatically interpretedand a clear 'Pass' or 'Refer' result ispresented to the user.	The Otoport/Otocheck OAE+ABRdevice is indicated for use when thereis a requirement to screen for hearingdisorders by objective and non-invasive means. Test results areautomatically interpreted and a clear'Pass' or 'Refer' result is presented tothe user.	Same
	Use of the device is indicated whenthe patient is unable to give reliablevoluntary responses to sound,especially with infants.	Use of the device is indicated whenthe patient is unable to give reliablevoluntary responses to sound,especially with infants.
	Use of the device facilitates the earlydetection of hearing loss and itscharacterization.	Use of the device facilitates the earlydetection of hearing loss and itscharacterization.
	Where the individual to be screened ishealthy with no medical conditionsrelated to the ear, as in the case ofwell-baby hearing screening, the usercan be a trained screener. In all othercases the user should be anaudiologist or medical professional.	Where the individual to be screened ishealthy with no medical conditionsrelated to the ear, as in the case ofwell-baby hearing screening, the usercan be a trained screener. In all othercases the user should be anaudiologist or medical professional.
	The TEOAE and DPOAE analyticalfunctions of the device are indicatedwhen objective non-invasive clinicalinvestigations require thecharacterization and monitoring of thefunctional status of the peripheralauditory function. For this purpose,the device is intended to be used byaudiologists or other professionalsskilled in audiology. These TEOAEand DPOAE tests are applicable topopulations of any age to obtainobjective evidence of peripheralauditory function	The TEOAE and DPOAE analyticalfunctions of the device are indicatedwhen objective non-invasive clinicalinvestigations require thecharacterization and monitoring of thefunctional status of the peripheralauditory function. For this purpose,the device is intended to be used byaudiologists or other professionalsskilled in audiology. These TEOAEand DPOAE tests are applicable topopulations of any age to obtainobjective evidence of peripheralauditory 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 physiologicalresponses to these sounds.Automatically evaluates the evidencefor a response.Reports a concise result output aboutthe presence or absence of normalresponses.Saves a detailed record of the test.Device alerts to the possibility ofhearing loss and documents the statusof 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 physiologicalresponses to these sounds.Automatically evaluates the evidencefor a response.Reports a concise result output aboutthe presence or absence of normalresponses.Saves a detailed record of the test.Device alerts to the possibility ofhearing loss and documents the statusof the ear.	Otoport Pro is smaller andlighter.The predicate OtoportOAE+ABR was heavier andlarger because it incorporatedan adaptor 'shell', fitted over thebasic Otoport OAE product, toprovide AABR functionality. Inthe Otoport Pro subject device,the AABR functionality has beenbuilt into the basic handhelddevice as the attachment of anABR adaptor shell is notrequired.
DeviceComponents/Features	Stimulates the ear with eithertransient or tonal sounds via aninserted earpiece	Stimulates the ear with eithertransient or tonal sounds via aninserted earpiece	Same
	Registers interfering acoustic noiseand advises users when this is toolarge for testing to take place.	Registers interfering acoustic noise andadvises users when this is too large fortesting to take place.	Same
	Implements otoacoustic emissiontechnology to record TEOAE andDPOAEs responses to sound appliedvia an inserted earpiece (probe)	Implements otoacoustic emissiontechnology to record TEOAE andDPOAEs responses to sound appliedvia an inserted earpiece (probe)	Same
	Provides an intensity and frequencyanalysis of the OAE response,numerically and graphically	Provides an intensity and frequencyanalysis of the OAE response,numerically and graphically	Same
	Automatically determines and displaysthe presence or absence of a normalTEOAE or DPOAE response	Automatically determines and displaysthe presence or absence of a normalTEOAE or DPOAE response	Same
	Implements auditory brainstemresponse (ABR) technology to recordelectro physiological responses viasurface electrodes	Implements auditory brainstemresponse (ABR) technology to recordelectro physiological responses viasurface electrodes	Same
	Stimulates the ear for ABR screeningat 30,35,40, or 45dBnHL (60dBHL fortraining)	Stimulates the ear for ABR screeningat 30,35,40, or 45dBnHL (60dBHL fortraining)	Same
	Registers interfering electrical noiseand advises users when this is toolarge for testing to take place.	Registers interfering electrical noiseand advises users when this is toolarge for testing to take place.	Same
	Registers the electrical impedance ofelectrode connections to the patientand advises users when this is toolarge for testing to take place	Registers the electrical impedance ofelectrode connections to the patientand advises users when this is toolarge for testing to take place	Same
	Performs statistical analysis on theABR response to decide if it is presentand normal	Performs statistical analysis on theABR response to decide if it is presentand normal	Same
	Automatically determines and displaysthe presence or absence of a normalABR response	Automatically determines and displaysthe presence or absence of a normalABR response	Same
	Serves as a hearing based on thepresence orabsence of a normal OAE or ABRresponse	Serves as a hearing based on thepresence orabsence of a normal OAE or ABRresponse	Same
Population	Infant and adult (Infant only forAABR)	Infant and adult (Infant only for AABR)	Same
Intended user	Trained operators for screening, andprofessionals for screening and clinicaluse	Trained operators for screening, andprofessionals for screening and clinicaluse	Same
Safetycharacteristics	Electrically isolated from any deviceconnected to its UCB-C charging anddata connector.Acoustic stimulation levels physicallyconstrained and monitored with activeprotection against single faults.	Electrically isolated from any deviceconnector to its Hirose charging anddata connector.Acoustic stimulation levels physicallyconstrained and monitored with activeprotection against single faults.	Same
Enclosure material	The device enclosure materials arePolylac PA-765 Flame retardant ABS.Injection moulding.	The device enclosure materials arePolylac PA-765 Flame retardant ABS.Injection moulding.	Same materials. Comply withthe current biocompatibilitystandards.
Materials ofConstruction	Probe: plastic encapsulated insertearphone containing microphone andreceiver, fitted with disposable singleuse plastic tip	Probe: plastic encapsulated insertearphone containing microphone andreceiver, fitted with disposable singleuse plastic tip	Same
	For ABR screening - Surface, self-adhesive skin electrodes.Electrode cables: PVC (Biocompatible)	For ABR screening - Surface, self-adhesive skin electrodesElectrode cables: PVC; Nylon(Biocompatible)	Same materials. Comply withthe biocompatibility standards.
	Electronic circuitry providingstimulation drive to the probe,amplification for the signals, receivedfrom the probe microphone andelectrodes, signal processing forresponse enhancement and noiserejection, microprocessor for signaland statistical analysis, allencapsulated in a plastic housing,including graphic display unit and datainput facilities plus rechargeablebattery.	Electronic circuitry providing stimulationdrive to the probe, amplification for thesignals, received from the probemicrophone and electrodes, signalprocessing for response enhancementand noise rejection, microprocessor forsignal and statistical analysis, allencapsulated in a plastic housing,including graphic display unit and datainput facilities plus rechargeablebattery.	Similar. Individual circuitcomponents have been changedto avoid obsolescence withequivalent or superiorperformance items.
Sterile	No	No	Same
Duration ofplacement	Less than 5 minutes per ear	Less than 5 minutes per ear	Same
Usage of patientcontact items	Acoustic probe tip and electrodes aresingle patient use only	Acoustic probe tip and electrodes aresingle patient use only	Same
Anatomicalplacement	Scalp, forehead, nape, shoulder	Scalp, forehead, nape, shoulder	Same
Number ofElectrodes	3	3	Same
Electrode Sockets	Yellow, Touchproof Connector, SSB,4-pin, 1mm. PVC. Biocompatible	DIN 42-802 Type ST 'Touchproof'terminated electrode cables. Electrodecable connectors Nylon: ZYTEL70G33L.Biocompatible	SimilarThe same Plastics Onemanufacturer of the connector.Both types are for EEG cables/electrodes.Otoport Pro has all 3 electrodecables in one single connector.
			Otoport ABR predicate hasindividual connectors for each ofthe 3 electrode cables.The connectors for both OtoportPro and predicate Otoport ABRare biocompatible andsubstantially equivalent infunctionality and performance.
Battery	Lithium-ion Battery	Lithium-ion Battery	same
Battery voltageoperatingrange:	3.2-4.2V	3.2-4.2V	same
Source	Source: 1000mAh lithium polymerinternalrechargeable cells	Source: 1000mAh lithium polymerinternalrechargeable cells	same
ElectrodeCable	Gray, Tinsel Wire, 3 x 0.023 conductor,Shielded,0.120 Dia. PVC jacket. Biocompatible.	Electrode Cable Insulations: PVC,Mexichem2235L-75. Biocompatible.	Similar. The Otoport Pro cablehas all 3 electrode cables insideone shield and also groundshielding on most of the length.The Otoport Pro electrodecables with single connector todevice run to 3 cable ends-electrode connections to patient(same with Otoport ABR).Otoport ABR electrode cablesare 3 individual electrode cablesrunning from device to patient.The electrode cables for bothOtoport Pro and predicateOtoport ABR are biocompatibleand substantially equivalent infunctionality and performance.
Probe Connector	Two (14 pin) 'Medi-Snap' connectorpush pull connector	'Triad' (8 pin) connector metal collar toscrew lock in place. Binaural option hastwo such probe connectors	Similar. The probe connectorfor the subject device is a 14pin "Medi-Snap" connectorwhile the predicate deviceuses an 8 pin "Triad"connector. The Otoport Proprobes are substantiallyequivalent with legacy probesof predicate Otoport ABR,which have been in service for20+years. The only differenceis the connectors.The 14 pin Medi-Snapconnector of the Otoport Proserves the same purpose asthe predicate, but it's insertionand removal are mechanicallydifferent. Instead of a screwedcollar locking method, theMedi-Snap features a Push-in/Pull-out mechanism withadequate retention when in.
			This provides an easier userexperience and reduces risk ofconnector damage bymishandling. Connectordamage would be detected byrecommended QA tests. TheMini-Snap further improvessafety by not exposing metalparts to user. The residual userrisks remain low/ areacceptable.
Probes	UPS, UPD & XPD probesTEOAE/ DPOAE Functionality probes.	All models take UGS & UGD probes.Can also take the XGD probe with afirmware update.TEOAE/ DPOAE Functionality probes.	Similar. Substantially equivalentTEOAE/ DPOAE probes. Thesubject device is compatiblewith all the probe types useablewith the predicate device whensupplied with a Medi-Snapconnector (UPS, UPD andXPD).Differences in the probeconnectors to the device:Predicate has UGS/ UGD/ XGDprobes with metallic screwconnectors to the Otoport.Otoport Pro has UPS/UPD &XPD probes with plastic clip-onconnectors to the device(easier to use).
Number ofProbesConnected	The Otoport Pro can accept 2 probes	The Otoport OAE+ABR binaural optioncan accept 2 probes, otherwise only1 probe	The subject and predicate basemodels (Otoport Pro andOtoport) are similar in that bothcan accept 2 probes forbinaural recording. With thepredicate 2 probes was onlyavailable with the binauralOAE+ABR variant. With thesubject device, 2 probescapacity is standard.
ElectrodeSocketConnector	Otoport Pro has one 4 Pin Plug &Socket Connector	Three Single Pin Plug and SocketConnectors	The Otoport Pro and thepredicate device are similar thatthey require 3 electrodeconnections to perform the ABRscreening test.The Otoport Pro uses a single 4pin plug and socket connector,while the predicate uses threesingle pin plug and socketconnectors. The electrodecabling is different and incudesan EMC shield, which reduceinterference noise.The 4-pin single electrode cablesocket of the port Pro provides a
Charging and datatransfer connector	USB-C for charging and download	Hirose proprietary connector forcharging and download	Similar.Improved useability andreliability.
DeviceComponents /Features	A handheld battery powered hearingscreening device with integral keypadand display which shows processedreal time data. OAE/ ABRFunctionality.	A handheld battery powered hearingscreening device with integralkeypad and display which showsprocessed real time data. For theABR functionality the ABR moduleattachment fitted on the Otoport isrequired. OAE/ ABR Functionality.	In the Otoport Pro ABRfunctionality is integral to thebasic unit. No adaptor isneeded to enable ABRscreening functionality. Thisenhances usability andconvenience- simplicity.Residual risks associated withABR adaptor shell fitting areremoved. The residual risksare found to be low/ areacceptable.
User Interface	The Otoport Pro preinstalled softwareprovides complete user control over thetesting hardware inside the Otoport Proand displays test progress, test results.,and tests saved in the in-built database.Optionally, Otoport Pro databasecontents can be securely transferred toOtodynamics Otolink software forreview, printing, or archiving.Otoport Pro firmware can be securelyupdated from Otolink	The Otoport preinstalled softwareprovides complete user control overthe testing hardware inside theOtoport and displays test progress,test results, and tests saved in thein-built database. Optionally, Otoportdatabase contents can be securelytransferred to Otodynamics Otolinksoftware for review, printing, orarchiving.Otoport firmware can be securelyupdated from Otolink"	Similar.Products usability engineeringcompliance to currentstandards/ regulations/acceptable.
Test data storage	Internal, encrypted searchabledatabase with capacity for 1024patients, 5000 test records, maximum256 tests/patients	Internal, proprietary encodedsearchable database with capacity1000 patients, 5000 test records	similar
Data Transfer	Data transfer is via wired USBI.1 or 2.0to third party computer runningOtodynamics Otolink software. OtoportPro has Bluetooth 5 functionalitywhich can also be used to transferdata to Otolink. The USB connection ismade by aUSB C connector.	Data transfer is via wired USBI.1 or 2.0to third party computer runningOtodynamics Otolink software. OtoportOAE+ABR has Bluetooth 2.0functionality can also be used totransfer data to Otolink.	Similar, both the subject andpredicate have both Bluetoothcapability for completed test datatransfer; however, the Bluetooth2 which is used on the predicatedevice is now obsolete andsuperseded by Bluetooth 5which is used on the subjectdevice. Data can also betransferred by wired USB cableas with the predicate. The use ofa USB C connector instead ofthe predicate proprietary HiRoseconnector increases userconvenience. Device safetybenefits from total electricalisolation (onto isolation) betweenit and the attached device (PC orcharger).
Barcodereader	Has optional 2D barcode scanner forpatient ID and demographics inputs.	Has optional 1D barcode scanner forpatent ID and demographics inputs.	Similar. The provision of theoptional 2D barcode readerallows more patient data to betransferred to the devicedatabase and is also compatiblewith 2D barcoding which are stillin widespread use.
Charging	Charging/ Data connector - connects toOtodynamics PSU (charging) or to PCUSB port (USB 1.lor 2.0) via Data Cable.	Charging/Data connector - connects toOtodynamics PSU (charging) or to PCUSB port (USB 1.lor 2.0) via Data Cable.	Similar, but now the subjectdevice has total electricalisolation from any deviceconnected to its USB-C port.
Power States	Intelligent multi-level power control forcharging/testing/idle/sleep/shutdown	Intelligent multi-level power control forcharging/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
Maxconsumption whentesting:	1W	1W (Otoport) or 1.3W (Otoport ABR)	Similar
Maxconsumptionwhencharging:	2.65W when charging from USBconnection. 3.5W when charging fromsupplied PSU.	2.5W	Similar. Consumption of the unit is2.5W when charging battery froma USB to comply with USBstandards. When charged withthe supplied charger/PSU,charging is faster, and theconsumption is 3.5W. Thisimprovement in charge speed ispossible because of the OtoportPro's improved 5V isolator circuit.
	Subject DeviceOtoport Pro	Predicate DeviceOtoport/ Otocheck OAE+ABR(K143395)	Overview of similarities anddifferences
	Transient Evoked Otoacoustic Emissions (TEOAE)
StimulusLevels	Idle- 80µs positive broadband squarewave pulse with an intensity of64dBpeSPL (peak equivalent) in a1cc cavity. Adjusted 80µs positivebroadband square wave.Testing- 300µs biphasic broadbandtriangular pulse;- Screening level: 84dBpeSPL-Clinical mode: adjustable in 2dBincrements; Range 50-90dBpeSPL	Idle- 80µs positive broadband squarewave pulse with an intensity of 64dBpeSPL (peak equivalent) in a 1cccavity. Adjusted 80µs positivebroadband square wave.Testing- 300µs biphasic broadbandtriangular pulse;- Screening level: 84dBpeSPL-Clinical mode: adjustable in 2dBincrements; Range: 50-90dBpeSPL	same
Sample rate	20kHz	20kHz	same
Stimulus pattern	Each sweep presents 8 stimuliresponses with the stimuluspresentation pattern:A A A B -A -A -A -BWhere: B = -3A	Each sweep presents 8 stimuliresponses with the stimuluspresentation pattern:A A A B -A -A -A -BWhere: B = -3A	same
Noise levelcalculation	The noise level for noise reject iscalculated from the difference betweenalternate averaged sweeps	The noise level for noise reject iscalculated from the difference betweenalternate averaged sweeps	same
Stimulusrepetition 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 stimuluspresentation. Cosine filtered with riseand fall time of 2ms	3-13ms or 3-9ms after start of stimuluspresentation. Cosine filtered with riseand fall time of 2ms	same
Responsefrequency 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:L260:50dBSPL; 65:55dBSPL;70:60dBSPLFor clinical measurementL1 and L2 adjustableRange 50-75dBSPL	Preset L1:L260:50dBSPL; 65:55dBSPL;70:60dBSPLFor clinical measurementL1 and L2 adjustableRange 50-75dBSPL	same
Sample rate	25.6kHz	25.6kHz	same
FFT frequency Bin	25Hz	25Hz	same
DP noisecalculation	DP noise is calculated from the fivespectral points above and the fivepoints below the DP frequency. Amargin of 1 or 2 standard deviations isapplied for precise clinicalmeasurements	DP noise is calculated from the fivespectral points above and the fivepoints below the DP frequency.A margin of 1 or 2 standard deviationsis applied for precise clinicalmeasurements	same
Stimulusfrequencies (F2)	1-6kHz, 1.5-8kHz, 2-6kHz(Recommended)1.5-8k tests at six F2 frequencies: 1.5k,2k, 3k, 4k, 6k and 8kHz1-6k tests at six F2 frequencies: 1k,1.5k, 2k, 3k, 4k and 6kHz2-6k tests at four F2 frequencies: 2k,3k, 4k and 6kHzScreening: 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 8kHz1-6k tests at six F2 frequencies: 1k,1.5k, 2k, 3k, 4k and 6kHz2-6k tests at four F2 frequencies: 2k,3k, 4k and 6kHzScreening: half or quarter octaves	same
	between 1k and 8kHzClinical measurement mode.Configurable start/stop frequencies upwithin device resolution. Up to 16frequency points per sweep, between1k and 8kHz	between 1k and 8kHzClinical measurement mode.Configurable start/stop frequencies upwithin device resolution. Up to 16frequency points per sweep, between1k and 8kHz
Frequency ratiof2/f1	1.22	1.22	same
	Automated Auditory Brainstem Response (AABR)
Stimulus levels	For infant screening only; 35 or40dBHL are recommended.(A higher level up to 60dBHL isprovided for the training of adultscreeners)	For infant screening only; 35 or40dBHL are recommended.(A higher level up to 60dBHL isprovided for the training of adultscreeners)	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 timeframe	17.3 to 18.8ms	17.3 to 18.8ms	same
Capturebandwidth	150-1000Hz	150-1000Hz	same
Evaluation method	Fsp with infant template matching	Fsp with infant template matching	same
ElectrodeImpedancesensing	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.

Regulation Number and Section

§ 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.