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The hearing aid is a disposable, extended-wear air conduction hearing aid, designed to be used and worn by hearing-impaired persons. Hearing assistance is achieved through amplification of sound pressure waves, which are transmitted to the external ear canal via air conduction. The hearing aid is initially placed in the ear canal by an appropriately trained ENT physician, Audiologist or Hearing Aid Dispenser and can remain in the ear canal for up to 4 months or until the battery is depleted. It is then replaced by a new device by the previously mentioned parties, or by an adult patient 22 years and older who have been wearing Lyric for a minimum period of 3 months under the direction and training of the ENT physician, Audiologist or Hearing Aid Dispenser. Upon device removal the hearing aid is discarded.

Device Description

Lyric4 is a non-sterile, extended wear hearing aid that is worn 24 hours a day, 7 days a week for months-at-a-time. Due to the deep placement inside the ear canal, it is 100% invisible. For patients, Lyric4 is very easy to operate with no batteries to change, no ongoing maintenance required and no daily insertion or removal. Lyric4 takes advantage of the deep placement in the ear canal for natural sound quality and the natural directivity of the pinna. Lyric4 is designed for single insertion and is not reused once removed from the ear (single-use only).

Compared to the currently marketed Lyric4, there are no modifications to the technology (hardware and software), materials, or accessories when Lyric4 is used for self-replacement. Only the indications for use statement and labeling have been modified.

AI/ML Overview

Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Device: Lyric4 Hearing Aid (for self-replacement)

Clinical Study Objective: To demonstrate the effectiveness and safety of the HCP-guided Lyric4 self-replacement procedure compared to the commercially available HCP-replacement procedure.

1. Table of Acceptance Criteria and Reported Device Performance

Endpoint	Acceptance Criterion	Reported Device Performance	Result
Primary Effectiveness: Achieved Insertion Depth	Non-inferiority margin of 2mm for the Mean Absolute Difference of self-replacement vs. HCP-replacement. (Lower Mean Absolute Difference indicates better agreement)	Left Ears (N=50): Mean Absolute Difference = 0.6 mm, 95% CI (0.30, 0.82 mm), p-value

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