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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.

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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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