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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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