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hearOAE is intended to be used by hearing healthcare professionals in the audiologic evaluation and documentation of ear function and ear disorders using Transient Evoked Otoacoustic Emissions (TEOAEs) and Distortion Product Otoacoustic Emissions (DPOAEs). The target population for the hearOAE includes all ages.

Per 21 CFR 874.1050, the hearOAE (otoacoustic emission device) is a portable, handheld, battery-operated device that can detect hearing loss using Otoacoustic Emission technologies. The hearOAE device may be configured to support one or any combination of TEOAE or DPOAE. Otoacoustic Emission devices are class II medical devices.

hearOAE consists of three main components listed below:

• hearOAE Application (available on supported Android devices supplied by i hearX)
• hearOAE Codec
• hearOAE Probe

The hearOAE Application:

• is operated on an Android smart device that uses Bluetooth connectivity to communicate with the hearOAE Codec.
• enables the user to choose and set up testing protocols for both TEOAE and DPOAE.
• enables the checking of the probe functionality, namely "Probe Check".
• controls the start and stop of a TEOAE and DPOAE test including pre-test functions such as Probe Check and in-ear calibration.
• provides feedback during and after the test in the form of tables, figures, and graphs.

The hearOAE Codec:

• consists of hardware and software for generating the test signals and measuring the responses.
• has the ability to generate, measure and process signals.
• contains a rechargeable lithium-ion battery to power the device.
• uses three light indicators to provide a visual display of the status of the hearOAE Codec to the user. A push button (signified by a Power symbol) is located on the case of the hearOAE Codec to allow the user to switch it on or off.
• communicates the test results via Bluetooth to the hearOAE smart device which will be displayed on the Smart device screen to the user within the application.

The hearOAE Probe:

• houses the speakers (drivers), and a microphone that produces the test stimuli and measures the sound pressure level (SPL) present in the ear canal.
• has a removable probe coupler with ear tips which fit onto the probe coupler.

Here's an analysis of the acceptance criteria and study detailed in the provided document:

Acceptance Criteria and Device Performance

• IEC 60645-6:2022 (Electroacoustics - Audiometric equipment – Part 6: Instruments for the measurement of otoacoustic emissions)
• IEC 60601-1:2005+A1:2012 (Basic Safety and Essential Performance)
• IEC 60601-1-2:2014 (Electromagnetic Compatibility)
• ISO 10993-1:2009 (Biocompatibility)
• IEC 62304:2006+A1:2015 (Software Verification and Validation)
• FDA Guidance for Cybersecurity
• IEEE / ANSI C63.27:2017 & AAMI TIR 69:2020 (Bluetooth SIG Compliance) | All tests passed. |
  | Clinical Study (Adults) - Test-retest Reliability (DPOAE & TEOAE) | 95% CI of the test-retest difference of the hearOAE signal, noise, and SNR had to be within a -3.0 to 3.0 dB SPL (lower and upper limit) margin. | For DPOAE, 95% CI for signal, noise, and SNR differences were within a 3 dB SPL margin across frequencies. For TEOAE, 95% CI for test-retest differences fell within a 3 dB SPL margin. |
  | Clinical Study (Adults) - Validity (DPOAE & TEOAE) | For DPOAE: 95% CI lower limit of the signal difference between the hearOAE and predicate device was no less than -3.0 dB SPL across frequencies.
  For TEOAE: (Implicitly, similar to DPOAE criteria for signal difference from predicate) | For DPOAE, differences between hearOAE and the predicate device were non-significant across all frequencies (excluding 3kHz). All but 3 kHz met OAE signal acceptance criteria (lower 95% CI limit ≥ -3.0 dB SPL). Although 3 kHz was slightly outside (-0.5 dB SPL), the device was deemed compliant.
  For TEOAE, all frequencies met the TEOAE signal acceptance criteria (lower 95% CI limit ≥ -3.0 dB SPL). |
  | Clinical Study (Infants) - Screening Outcomes | High device agreement (> 85%) for screening DPOAEs and TEOAEs between the investigational device and the comparator device in terms of Pass/Refer rates, mean signal, noise and SNR. | For DPOAE, within-participant diagnostic concordance between the two devices was 89.7%.
  For TEOAE, within-participant diagnostic concordance of 85% was measured between devices. |

Study Information

• Sample size used for the test set and the data provenance:

  • Adults (Sub-aim A):
    • DPOAEs: 78 adult ears (58 normal hearing; 20 with hearing loss).
    • TEOAEs: 90 adult ears (66 normal hearing; 24 with hearing loss).
  • Infants (Sub-aim B):
    • DPOAE screening: 175 infant ears.
    • TEOAE screening: 174 infant ears.
  • Data Provenance: The study was conducted in South Africa, as indicated by the location of the submitting company (hearX SA (Pty) Ltd) and the recruitment from "three public healthcare hospitals" for newborn hearing screening. The study design (cross-sectional, within-subject repeated measures) suggests prospective data collection for the clinical comparison.

• Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

  • The document implies that "qualified and Health Professions Council of South Africa (HPCSA) registered audiologists with prior knowledge of ears and hearing as well as prior OAE device experience" were used to operate both the investigational and predicate devices and conduct the assessments. It does not specify the number of distinct experts used for ground truth establishment if that ground truth was separate from the device readings themselves. For the adult portion, the comparator device (Otodynamics ILO288 Echoport Plus OAE System) served as a "gold standard" for validity, and the audiologists followed established audiometric procedures (e.g., pure tone audiometry for hearing loss classification) to determine participant groups. For infants, the "Pass/Refer" rates from both devices were compared, with the predicate serving as the benchmark for agreement.

• Adjudication method for the test set:

  • The document describes a "cross-sectional, within-subject repeated measures design" where "the diagnostic OAE test with each device was repeated in each ear in order to determine test-retest reliability." For validity, the hearOAE was compared against the predicate device. For screening infants, "diagnostic agreement of the investigator device and comparator device" was measured. This suggests a direct comparison method rather than an adjudication by a separate panel to establish a distinct "ground truth" that differed from the device readings or the predicate device's output. The comparison itself served as the adjudication.

• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

  • This was not an MRMC study in the typical sense of evaluating human reader performance with and without AI assistance for interpretation. It's a device comparison study where human healthcare professionals (audiologists) use the devices. The study compares the performance of a new device (hearOAE) to an existing predicate device, focusing on technical performance and diagnostic agreement, not on improving human reader interpretation with AI.

• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

  • No, a standalone (algorithm only) performance study was not described. The hearOAE device is operated by "hearing healthcare professionals" and involves a "human-in-the-loop" for setting up tests, performing "Probe Check," and interpreting results displayed on a smart device.

• The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

  • The ground truth varied:
    • For adult participant classification (normal hearing vs. SNHL): Behavioral pure tone air conduction audiometry thresholds were used as the basis for classifying normal hearing (PTA ≤ 25 dB HL) and SNHL (air conduction PTA > 25 dB HL, bone conduction within 10 dB HL of air conduction). This is an established clinical diagnostic method.
    • For device performance validation: The predicate device (Otodynamics ILO288 Echoport Plus OAE System) served as the comparator or "reference" for evaluating the hearOAE's DPOAE and TEOAE signals, noise, and SNR, and for determining diagnostic agreement in infants.
    • For test-retest reliability: The concept of test-retest reliability inherently uses repeated measures from the same device on the same subject as its own internal ground truth for consistency.

• The sample size for the training set:

  • The document describes a clinical validation study, not a study for training an AI model. Therefore, there is no mention of a "training set" in the context of machine learning.

• How the ground truth for the training set was established:

  • As no AI model training was described, there is no information on how a training set's ground truth would have been established.

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