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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 <.0001 (for non-inferiority).Right Ears (N=49): Mean Absolute Difference = 0.6 mm, 95% CI (0.35, 0.89 mm), p-value <.0001 (for non-inferiority).	Met
Co-Secondary Effectiveness: Aided Audiometric Thresholds	Non-inferiority margin of 10 dB HL for the Estimated Difference of self-replacement vs. HCP-replacement at 500, 1000, 2000, and 4000 Hz.	Left Ears (N=50): Estimated Differences at all frequencies were well below 10 dB HL. (e.g., 500 Hz: -0.5 dB HL, 1000 Hz: 1.5 dB HL, etc.)Right Ears (N=49): Estimated Differences at all frequencies were well below 10 dB HL. (e.g., 500 Hz: -0.69 dB HL, 1000 Hz: 0.31 dB HL, etc.)p-value <.0001 for all frequencies in both ears.	Met
Co-Secondary Effectiveness: Aided Speech-in-Noise Testing SNR Loss	Non-inferiority margin of 5 dB for the Estimated Difference of self-replacement vs. HCP-replacement SNR Loss scores.	Left Ears: Estimated Difference = 0.10 dB, 95% CI (-0.81 dB, 1.01 dB), adjusted p-value <.0001.Right Ears: Estimated Difference = 0.46 dB, 95% CI (-0.54 dB, 1.46 dB), adjusted p-value <.0001.	Met
Primary Safety: Incidence of Ear Health Issues Requiring Medical Referral and Related to Device Placement	Not explicitly stated with a numerical acceptance criterion, but implies a low and manageable incidence.	One instance of cerumen impaction requiring medical referral and cerumen management.	Met (Implicitly)
Secondary Safety: Incidence of Treatment-Emergent Adverse Events	Not explicitly stated with a numerical acceptance criterion, but implies comparability between self-replacement and HCP-replacement conditions.	Overall incidence of AEs: Self-Replacement: 13 (23.21%) subjects; HCP-Replacement: 17 (29.82%) subjects. Overall incidence of Adverse Device Effects: Self-Replacement: 12 (21.43%) subjects; HCP-Replacement: 16 (28.07%) subjects. One subject withdrew from study due to AE under self-replacement. No SAEs or deaths. All TEAEs commonly observed ear health symptoms.	Met (Comparability)
Exploratory: Incidence of Gross Placement Errors During Self-Replacement	Not explicitly stated with a numerical acceptance criterion, but implies zero or very low incidence.	No instances of gross placement errors observed during self-replacement.	Met (Zero)
Human Factors/Usability (Non-clinical): Effectiveness of Training	Assessed through objective (performance-based) and subjective (user-feedback) evaluation of success for critical tasks. No use error leading to unknown hazardous situations with unacceptable risk.	Only a few use difficulties and errors observed. One participant omitted hand washing (considered redundant in test). Understanding of atmospheric pressure symbol was hardest but 10/15 participants used IFU successfully. No use errors leading to unacceptable risk.	Met

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

Clinical Study Test Set (Effectiveness & Safety): 57 experienced Lyric users initially enrolled across 8 sites.
- Effectiveness (Achieved Insertion Depth): N=50 Left Ears, N=49 Right Ears (Intent-to-Test Population reported for primary effectiveness).
- Effectiveness (Aided Audiometric Thresholds): N=50 Left Ears, N=49 Right Ears (Intent-to-Test).
- Effectiveness (Aided Speech-in-Noise Testing SNR Loss): Left and Right Ear groups (exact N for ITT not specified here but implied to be similar to other effectiveness endpoints).
- Safety (TEAEs): N=56 for Self-Replacement condition, N=57 for HCP-Replacement condition.
Human Factors/Usability Test Set: 15 hearing-impaired adults who were current Lyric4 users (at least 3 months).
Data Provenance: The study was a "prospective, non-randomized multi-center, longitudinal clinical investigation." The country of origin is not explicitly stated in the provided text.

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

For Clinical Effectiveness Endpoints (Achieved Insertion Depth, Audiometric Thresholds, SNR Loss): The "ground truth" seems to be derived from objective measurements taken during the study, comparing the self-replacement procedure to the HCP-replacement procedure. The measurements were likely taken by the healthcare professionals (HCPs) at the 8 study sites. Specific qualifications of the individuals taking these measurements (e.g., audiologists, ENT physicians) are not detailed beyond "appropriately trained ENT physician, Audiologist or Hearing Aid Dispenser" for initial placement and training.
For Safety Endpoints (Ear Health Issues, AE's): Adverse events and ear health issues were "judged by the HCP." This implies that the HCPs at the study sites (likely ENT physicians, audiologists, or hearing aid dispensers) were responsible for evaluating and reporting these events.
For Human Factors/Usability: Study staff captured use-error counts and responses elicited during follow-up questioning to determine the root cause, implying observation and assessment by trained personnel in the usability study.

4. Adjudication Method for the Test Set

The document does not explicitly describe a formal adjudication method (like 2+1 or 3+1 consensus) for the clinical study data or the human factors study. Measurements and observations were collected and analyzed, with statistical comparisons for effectiveness endpoints. Adverse events were "judged by the HCP."

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

This is not an AI-driven device. The study is a comparative effectiveness study comparing a self-replacement procedure (patient performing) versus an HCP-replacement procedure (healthcare professional performing) for a hearing aid. Therefore, this section is not applicable.

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

This is not an AI-driven device. There is no algorithm or AI component in the Lyric4 Hearing Aid for self-replacement being assessed for standalone performance. The study evaluated human performance (patients vs. HCPs) in replacing the device.

7. The Type of Ground Truth Used

The "ground truth" for this study is based on objective clinical measurements and observations taken by healthcare professionals (HCPs) during the study, comparing the outcomes of the self-replacement procedure to the HCP-replacement procedure. These include:

Achieved Insertion Depth (quantitative measurement)
Aided Audiometric Thresholds (quantitative measurement)
Aided Speech-in-Noise Testing SNR Loss (quantitative measurement)
Incidence of Ear Health Issues and Adverse Events (clinical observation and judgment by HCPs)
Observations of use errors in the human factors study.

8. The Sample Size for the Training Set

This product is a medical device (hearing aid) and the current submission is for a change in the indications for use (allowing self-replacement). The device's technology (hardware and software) is unchanged. Therefore, there is no "training set" in the context of an AI/algorithm-driven device.
The human factors study focused on the effectiveness of training provided to HCPs to train end-users. The participants in the clinical study (57 experienced Lyric users) received this training as part of the study design.

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

As this is not an AI/algorithm-driven device with a traditional "training set" for model development, this question is not applicable in that context. The "training" referred to in the human factors study is the instructions and guidance provided to HCPs (who then train patients) for the self-replacement procedure. The effectiveness of this training was assessed by observing the patients' performance (as described in point 7).

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