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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

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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The Lexie Lumen Self-Fitting OTC Hearing Aid(s) with Lexie Application is a self-fitting air-conduction hearing aid, intended to amplify sound for individuals 18 years of age or older with perceived mild to moderate hearing impairment. The device is adjusted by the user to meet the user's hearing needs. The device is intended for use without the assistance of a hearing care professional.

The Lexie Lumen Self-Fitting OTC Hearing Aid(s) with Lexie Application is a self-fitting, air conduction hearing aid consisting of the IntriCon hardware, Lexie Software, Lexie Application and accessories supplied in the carton. The Lexie App is available on Android and iOS. The Lumen self-fitting OTC hearing aid is the only model applicable to this 510(k). The Lexie Lumen Self-Fitting OTC Hearing Aid(s) with Lexie Application is a behind the ear device that includes self-adjustable coupling by means of a slim tube and ear tip/dome. The hearing aids can be fine-tuned remotely by trained hearing experts, at the request of the user, in the Lexie contact center. The Lexie app receives custom remote settings as performed through the Lexie adjustment wizard and fitting portal (internet service).

Here's a breakdown of the acceptance criteria and the study details for the Lexie Lumen Self-Fitting OTC Hearing Aid(s) with Lexie Application, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Clinical Study:
  • Sample Size: 64 participants (32 in the Audiologist Fit (AF) group, 32 in the Self-Fit (SF) group).
  • Data Provenance: Prospective, Randomized Controlled Trial conducted at the University of Pretoria, Gauteng, South Africa.
• In-situ Hearing Test Accuracy Validation (separate study):
  • Sample Size: 45 participants (90 ears).
• Human Factors Testing:
  • Sample Size: 29 adult participants.
  • Data Provenance: Simulated-use session, likely within a controlled environment (e.g., laboratory).

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

• Clinical Study:
  • The "ground truth" for the Audiologist Fit (AF) group was established by audiologists who performed standard audiometric evaluations and fitted the hearing aids to match NAL-NL2 prescriptive targets. The text doesn't specify the exact number of audiologists, but refers to "the audiologist" (singular) in descriptions of procedures, implying at least one qualified audiologist was involved in the fitting and orientation for the AF group. The context of a university setting (University of Pretoria) suggests these would be qualified professionals.
  • For the in-situ hearing test validation, "the audiologist-performed audiometry" was used as a reference, again implying qualified audiologist(s).
• Human Factors Testing:
  • No specific experts are mentioned as establishing "ground truth" in the same way as the clinical study. Instead, the "effectiveness and accuracy of the tasks" were assessed by observing participants' performance during simulated use, implying assessment by human factors specialists or researchers.

4. Adjudication Method for the Test Set

• The clinical study was a randomized controlled trial (RCT) comparing two groups (SF vs. AF).
• No explicit "adjudication method" (like 2+1 or 3+1 for expert review) is mentioned for the outcomes of the clinical study, as the primary and secondary endpoints (APHAB, IOI-HA, QuickSIN, DIN) are quantitative measures.
• For the in-situ hearing test accuracy, performance (Mean Absolute Difference) was compared against "audiologist-performed audiometry," where the audiologist's results served as the reference.
• For Human Factors Testing, an "observer" evaluated task success, and a "semi-structured interview" was used for user perceptions.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

• Yes, a comparative effectiveness study was done, comparing the Lexie Lumen in a self-fit (SF) condition against an audiologist-fit (AF) condition. This is a direct comparison of the device's performance with and without expert assistance in fitting.
• Effect Size of Human Readers Improve with AI vs. without AI assistance:
  • The study compares self-fitting (device with its AI/software-driven fitting strategy) to audiologist-fitting (human expert). It doesn't present an effect size of "human readers improve with AI vs. without AI assistance" in the context of interpretation of medical images.
  • Instead, it evaluates if the self-fitting strategy (which is AI/software-driven) is non-inferior to an audiologist's fitting. The results show that the SF group was equivalent or even slightly better in some aspects (background noise difficulty at 2 weeks, duration of use at 2 weeks) compared to the AF group, and overall achieved equivalence within the defined acceptance criteria for the primary and secondary endpoints. This implies that the device's self-fitting capability largely negates the need for a human professional's direct fitting intervention for achieving comparable outcomes for mild to moderate hearing loss.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Yes, the "Self-Fit (SF) group" in the clinical study represents the standalone performance of the device's self-fitting algorithm without human-in-the-loop fitting assistance. Participants in this group were explicitly stated to "set up and manage the devices using the Lexie app, entirely without professional support." Any assistance sought in Phase II was through the Lexie online hearing experts, but the initial fitting and core performance were self-directed via the app's algorithm.

7. The Type of Ground Truth Used

• Clinical Study (Effectiveness):
  • The ground truth was established by comparison with best-practice audiological fitting (NAL-NL2 targets) performed by audiologists. The aim was to demonstrate non-inferiority or equivalence against this established clinical standard.
  • For the in-situ hearing test, the "Reference" was audiologist-performed audiometry.
• Safety:
  • "Ground truth" for safety was the occurrence and nature of Adverse Events (AE) and Serious Adverse Events (SAE), which are reportable objective events.
• Human Factors Testing:
  • "Ground truth" was the observational assessment of task completion and accuracy by study personnel, corroborated by user self-reports and satisfaction.
• Non-clinical Performance Testing:
  • "Ground truth" was defined by the acceptance criteria within the cited national and international consensus standards (e.g., IEC, ISO, ANSI, CTA), against which the device's physical and electrical properties were measured.

8. The Sample Size for the Training Set

• The document does not provide information on the sample size for the training set used to develop the Lexie self-fitting algorithm or its core software. This information is typically proprietary and not usually disclosed in a 510(k) summary, which focuses on validation rather than development.

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

• The document does not provide information on how the ground truth for the training set was established. The text only states that the fitting algorithm (Lexie Comfort) is "based on National Acoustics Laboratories' Non-Linear Version 2 (NAL-NL2), with additional adjustments aimed for a greater listening comfort." This implies that the NAL-NL2 prescriptive targets likely form a significant part of the foundational "ground truth" or reference for the algorithm's development, but details of specific training data and its ground truth are absent.

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