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The Earlens Contact Hearing Aid transmits amplified sound by vibrating the eardrum through direct contact. It is indicated for individuals 18 years and older with a mild to severe sensorineural hearing impairment who can benefit from amplification. The device can provide the full spectrum of amplification that includes 125 Hz - 10,000 Hz.

The Earlens Hearing Aid consists of several components including a Processor worn behind the pinna, an Ear Tip that is placed in the external ear canal, and a Tympanic Lens that is placed in the anterior sulcus near the tympanic membrane. Sound waves are received by the two directional microphones on the Processor and converted into electrical signals, digitally processed, amplified and sent to the Ear Tip through a cable. The Ear Tip houses a transmit coil, which converts the electrical signal containing the amplified sound into electromagnetic energy. This energy is transmitted to a receive coil on the Tympanic Lens. Both data and power are sent from the transmit coil to the receive coil by resonant inductive coupling. The receive coil converts the electromagnetic energy back into electrical signals, thereby activating the microactuator of the Tympanic Lens to transmit sound vibrations to the umbo.

The Tympanic Lens is placed deep in the ear canal and adiacent to the tympanic membrane by a trained ENT physician through a non-invasive and non-surgical procedure. The Tympanic Lens makes contact with the umbo of the tympanic membrane and is intended to remain in the ear for greater than 30 days.

An Audiologist uses the Earlens Fitting software (ELF) to prescribe the gain and overall output of the Processor based on the recipient's hearing profile.

A Charger is provided to the recipient to recharge the Lithium-Ion battery of the Processor daily.

The provided document describes the Earlens Contact Hearing Aid, a Class II device intended for individuals with mild to severe sensorineural hearing impairment. The submission is a 510(k) premarket notification, seeking to demonstrate substantial equivalence to a predicate device, the Wireless Earlens Light Driven Hearing Aid (K153634). The core change in the new device is the replacement of an infrared light link with resonant inductive coupling for transmitting power and data from the Ear Tip to the Tympanic Lens.

The document includes a section on "NON-CLINICAL PERFORMANCE TESTING" and "CLINICAL PERFORMANCE TESTING." These sections detail the testing performed and demonstrate that the device meets acceptance criteria.

Here's an analysis of the requested information:

1. A table of acceptance criteria and the reported device performance

The document states that the device passed all acceptance criteria, but it does not explicitly list the specific acceptance criteria for each test in a tabular format. Instead, it generally states compliance or desirable outcomes.

2. Sample size used for the test set and the data provenance

• Sample Size for Clinical Test Set: 30 subjects.
• Data Provenance: The document does not explicitly state the country of origin or whether the study was retrospective or prospective. However, given that it's a "human factors study to assess whether sound variability would be reduced... when they were refitted," it implies a prospective study design.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

The document describes a "human factors study" and assessments including objective measures (MEPO, aided sound field thresholds) and subjective questionnaires. It does not mention the use of experts to establish a "ground truth" in the context of diagnostic interpretation or classification. The assessments performed are direct measurements of device performance and wearer experience, not interpretations requiring expert consensus.

4. Adjudication method for the test set

Not applicable. The study is evaluating the performance of a hearing aid and the experience of its users, not a diagnostic classification that would require adjudication of expert opinions.

5. 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

Not applicable. This is not a study involving human readers or AI assistance in diagnostic interpretation. It is a clinical performance study of a hearing aid device.

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

This is not an AI-driven diagnostic algorithm. It is a physical medical device (hearing aid). Therefore, a "standalone algorithm performance" is not relevant in the typical sense for AI devices. However, the non-clinical tests (electrical safety, EMC, biocompatibility, mechanical integrity, etc.) can be considered "standalone" device performance without active human interaction during measurement, demonstrating the device's inherent characteristics.

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

The clinical study does not appear to rely on a "ground truth" in the diagnostic sense. Instead, it uses:

• Objective measurements: Maximum Equivalent Pressure Output (MEPO), aided sound field thresholds, aided word recognition.
• Subjective feedback: Subjective questionnaires regarding sound variability.

The "truth" for these measures is derived directly from the physical characteristics of the sound produced by the device and the subjective experience reported by the human subjects.

8. The sample size for the training set

Not applicable. This device is a hearing aid, not an AI/machine learning model that requires a training set.

9. How the ground truth for the training set was established

Not applicable, as no training set for an AI/machine learning model was used.

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The wireless Earlens Light Driven Hearing Aid (a.k.a. Earlens Hearing Aid) transmits amplified sound by vibrating the eardrum through direct contact. It is indicated for individuals 18 years and older with a mild to severe sensorineural hearing impairment who can benefit from amplification. The device can provide the full spectrum of amplification that includes 125 Hz - 10,000 Hz.

Not Found

The provided text is a 510(k) Premarket Notification from the FDA for a hearing aid device. It details the regulatory approval of the "Wireless Earlens Light Driven Hearing Aid" and its indications for use.

Crucially, this document does not contain information about acceptance criteria or a study proving the device meets those criteria, as typically seen in submissions for AI/ML-based diagnostic devices. This document is a regulatory approval letter for a hardware device (a hearing aid) based on substantial equivalence to predicate devices, not performance against specific, quantifiable metrics often associated with AI/ML evaluations.

Therefore, I cannot extract the requested information from the provided text. The questions posed in your request ("multi reader multi case (MRMC) comparative effectiveness study," "standalone (i.e. algorithm only without human-in-the-loop performance)," "training set," "ground truth establishment") are typically relevant to the performance evaluation of AI/ML software, not the regulatory approval of a physical medical device like a hearing aid based on predicate equivalence.

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The EarLens™ Contact Hearing Device transmits amplified sound by vibrating the eardrum through direct contact. It is indicated for individuals 18 years and older with a mild to severe sensorineural hearing impairment who can benefit from amplification. The device can provide the full spectrum of amplification that includes 125 Hz - 10,000 Hz.

The EarLens™ Contact Hearing Device (CHD) transmits amplified sound to compensate for hearing impairment by direct vibration of the tympanic membrane (eardrum). The EarLens™ CHD is composed of an external Audio Processor, which includes a Behind-the-Ear (BTE) Unit and an Ear Tip, a Tympanic Membrane Transducer (TMT), the EarLens™ Fitting Software (ELF), and a Charger with a Power Adapter. In this device, light is used to wirelessly transmit both signal and power from the Audio Processor to the TMT. The BTE sits behind the outer ear, housing the rechargeable battery, digital signal processor (DSP), microphones and drive electronics. The Ear Tip contains the light emitter and directs the light signal down the ear canal. The TMT resides at the end of the ear canal on the skin around the tympanic membrane. The TMT receives the light signal and converts it into direct vibration of the umbo of the tympanic membrane. The EarLens™ Charger charges two BTEs at the same time when connected to either the wall power adapter or from the internal battery contained in the Charger. The CHD is patientmatched for single patient use. The ELF enables the hearing professional to program the device specific to the patient's hearing needs. The EarLens™ Impression System is provided to the physician to enable the collection of a deep ear canal impression to create patient-matched TMTs for each patient.

The EarLens™ Contact Hearing Device (CHD) has undergone extensive testing to ensure its safety and effectiveness. Both non-clinical (bench) studies and clinical studies were conducted to support its performance and establish acceptance criteria.

The acceptance criteria and reported device performance are as follows:

1. Table of Acceptance Criteria and Reported Device Performance

Study Information:

2. Sample Size and Data Provenance:

• Pivotal Clinical Study: 48 subjects (96 ears). Prospective, single-arm, open-label study. Subjects served as their own controls (unaided vs. aided). Data provenance is not explicitly stated by country, but the inclusion criteria mention "Native speaker of American English," suggesting the study was conducted in the US.
• Ear Impression Study: 78 subjects (154 ears). Retrospective or prospective nature not explicitly stated, but implies observation of a procedure. Again, country of origin is not specified but use of American English would suggest a US-based study.
• "Roll-in cohort" (Laser Safety): 10 ears (5 subjects). Prospective.

3. Number of Experts and Qualifications for Ground Truth - Test Set:

• For the clinical studies (Pivotal and Ear Impression), the nature of the "ground truth" is based on objective audiometric measurements (hearing thresholds, word recognition scores), subjective questionnaires (APHAB, Study Exit Questionnaire), and clinical observations (tympanic membrane images, adverse event reporting, ear canal temperature measurements).
• The raw data for these measurements and observations would be collected by trained healthcare professionals (audiologists, ENT physicians, study coordinators).
• Tympanic membrane images (n=78 ears) review: Unspecified number of experts or their qualifications for reviewing these images were provided.
• Adverse Event reporting: Medical professionals (investigators, clinicians) determined the nature and resolution of AEs. Their specific qualifications (e.g., radiologist with X years of experience) were not detailed, but they would be medical doctors and/or audiologists involved in the clinical study oversight.
• Audiometric data: Audiologists performed the audiometric tests, but the number of experts for establishing "ground truth" (e.g., by consensus on diagnoses) is not specified, as it's typically based on established audiometric thresholds.

4. Adjudication Method for the Test Set:

• No specific formal adjudication method (e.g., 2+1, 3+1) is described for the clinical study endpoints or safety events. Results were reported based on statistical analyses of aggregated data and clinical observations by the study investigators.

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

• No direct MRMC comparative effectiveness study was mentioned where human readers' performance with and without AI assistance was evaluated. The clinical study compared the device's performance (aided condition) to the unaided condition (subjects essentially serving as their own control). It also made a brief comparison of APHAB scores between the EarLens™ CHD and "subjects' own conventional hearing aids," but this was not a structured MRMC study designed to measure the improvement effect size of human readers with AI vs. without AI assistance. The APHAB comparison showed essentially no clinically significant difference (1%) between the EarLens™ CHD and conventional hearing aids.

6. Standalone (Algorithm Only) Performance:

• The device itself is a hearing aid, not an AI-driven diagnostic algorithm. The "performance testing" described in the bench studies (e.g., electrical, mechanical, reliability) assesses the device's physical and functional characteristics in isolation (standalone) from patient interaction or expert interpretation, according to engineering and safety standards.
• The "software" component is for fitting and control, not standalone diagnostic or interpretative performance. The clinical study measures the overall system performance (device + patient interaction).

7. Type of Ground Truth Used:

• Clinical Studies:
  • Safety: Residual hearing function (PTA4 thresholds), adverse event reporting, tympanic membrane images, ear canal temperature measurements.
  • Effectiveness: Objective audiometric data (word recognition scores, functional gain/thresholds), subjective patient-reported outcomes (APHAB, Study Exit Questionnaire), speech-in-noise tests (HINT, Quick SIN).
• Bench Studies: Established by adherence to national/international standards (e.g., IEC, ISO, ASTM, EN) and internal engineering specifications, using calibrated instruments and measurement techniques.

8. Sample Size for the Training Set:

• There's no explicit mention of a "training set" in the context of an Artificial Intelligence (AI) or machine learning model for diagnostic or prognostic purposes, as the EarLens™ CHD is a medical device for hearing amplification rather than an AI diagnostic tool.
• The software mentioned (EarLens™ Fitting Software - ELF, and DSP firmware) is for controlling device parameters as programmed by a hearing professional, not for learning from data.
• The "design criteria" for the device would have been developed based on general principles of audiology, psychoacoustics, and engineering, likely informed by existing data and research in hearing impairment and hearing aid design.

9. How Ground Truth for Training Set was Established:

• Given that this is not an AI/ML-driven diagnostic device with a "training set" in the conventional sense, the concept of "ground truth" for a training set does not directly apply. The device's "training" or development was based on established scientific principles, engineering standards, and the expertise of hearing professionals. The software's "ground truth" is its programmed function to control the device based on clinician input, verified through functional testing against requirements.

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