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The Lyric 2 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 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. Upon device removal the hearing aid is discarded.

Lyric2 is a disposable, programmable, deep-canal, extended-wear, air conduction hearing device, It uses an analog, digitally programmable WDRC ("Wide Dynamic Range Compression") circuit with very low power consumption. Hearing assistance is achieved through amplification of sound pressure waves, which are transmitted to the external ear canal via air conduction. The amplification characteristics are contained in digitally programmable memory, and adjustment of device parameters is achieved through the proprietary Fitting System and Software.

The Lyric2 consists of:

• A programmable application specific integrated circuit ("ASIC") for analog signal processing. . An analog microphone receives sound waves that will be amplified and transmitted to the speaker.
• A custom made built-in battery to power the amplification circuit. .
• A magnetic sensor to program device parameters and to remotely control user settings (On/Off/Sleep/Volume).
• Mechanical components to protect the device from cerumen. .
• A removal loop to allow the user and/or professional to remove the device. .
• . Seals that allow the device to fit comfortably in the ear canal

Accessories available for Lyric2:

• User Remote Control
• . Device sizer to determine best device size
• Length sizer to determine insertion depth .
• . An insertion tool for insertion and removal of device and device sizers
• A dedicated software and programming interface to program the device with customer · ● specific settings

The Phonak's Lyric2 is a hearing aid, so the acceptance criteria would revolve around its acoustic performance, safety, and comfort, as well as its functional equivalence to the predicate device.

Here's an analysis of the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

• Appropriate device sizing
• Clinical assessments of gain
• Speech understanding
• Sound quality
• Length of device wear
• Patient ratings of comfort
• Proportion of eligible population meeting sizing parameters
• Post-removal health of the ear
• Usability evaluations by patients and audiologists | This is a broad claim of equivalence across multiple functional and clinical aspects. The details of "comparable" would be defined in the study protocol. |
  | Safety | Biocompatibility, electrical safety, and electromagnetic compatibility. | "Biocompatibility testing, electrical safety, and electromagnetic compatibility testing, has confirmed the equivalent performance of the modified Lyric compared to the cleared Lyric." | This indicates the device meets established safety standards and is comparable to the predicate for these aspects. |

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

• Sample Size: The document does not explicitly state the specific sample size(s) for the clinical testing. It refers to "clinical testing" and "post-market clinical testing" but doesn't quantify the number of participants.
• Data Provenance: The document does not specify the country of origin. It implicitly describes a prospective study ("Post-market clinical testing also confirmed the comparable performance..."). The phrase "Post-market clinical testing" suggests data collected after the original Lyric (predicate device) was on the market, but this specific study was for the Lyric2.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified. The evaluations involved "patients and audiologists." While audiologists are qualified professionals, the number and specific experience of those involved in establishing "ground truth" or performing assessments are not detailed.

4. Adjudication Method for the Test Set

• The document does not describe any adjudication method. Given the nature of the device (hearing aid) and the stated assessments (gain, speech understanding, comfort, etc.), it's more likely that direct measurements and patient/audiologist feedback were collected and potentially aggregated, rather than a consensus-based adjudication of a subjective "ground truth" in the typical sense (e.g., image interpretation).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No, an MRMC comparative effectiveness study, in the typical sense for diagnostic devices, was likely not done. This type of study (comparing human readers with and without AI assistance on specific cases) is relevant for AI algorithms that aid in interpretation or diagnosis. For a hearing aid, the "effectiveness" is measured by direct device performance and patient outcomes, not by how humans interpret findings with or without the device's "AI."
• The study did compare the Lyric2 to the predicate Lyric (without AI, as AI in hearing aids was not as prevalent then) across various clinical parameters, but not in an MRMC paradigm comparing human reading performance.

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

• Yes, performance characteristics of the device itself were evaluated in a standalone manner. "The performance characteristics of the Lyric Hearing Aid have been evaluated in accordance with ANSI S3.22:2009, 'Specification of Hearing Aid Characteristics.'" This standard involves direct measurement of the device's acoustic output and characteristics, independent of a human ear. This represents the "algorithm only" or device-only performance.

7. The Type of Ground Truth Used

• The "ground truth" for the performance evaluation appears to be a combination of:
  • Objective Measurement Standards: The ANSI S3.22:2009 standard provides objective benchmarks for hearing aid characteristics.
  • Clinical Assessments/Patient Outcomes: For aspects like gain, speech understanding, sound quality, comfort, and ear health, the "ground truth" would be derived from clinical measurements and patient self-reports, compared against a baseline or a predicate device.
  • Expert Observations: Audiologists performed "usability evaluations" and clinical assessments which would form part of the "ground truth" for those specific metrics.

8. The Sample Size for the Training Set

• Not applicable / Not specified. This device is a hardware hearing aid with an analog, digitally programmable circuit. While it uses digital programming, it is not an AI/ML algorithm that requires a "training set" in the modern sense of supervised learning for classification or prediction tasks. The "training" here refers to the engineering design, calibration, and parameter setting, not data-driven machine learning.

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

• Not applicable / Not specified. As explained above, there isn't a "training set" in the AI/ML context for this type of device. The "ground truth" for its design and programming would be based on established audiological science, hearing aid design principles, and engineering specifications.

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The target group for the Phonak Tinnitus Balance software feature are adults 18 years of age or older with tinnitus who also desire amplification.

The Tinnitus Balance software feature and accompanying hearing aid amplification is fit by a licensed hearing healthcare professional (audiologist, hearing aid specialist, notolaryngologist) familiar with the diagnosis and management of tinnitus. Phonak hearing aids provide amplification to address sensorineural, conductive, or mixed hearing losses. Depending on the specific model, Phonak hearing aids cover fitting ranges from mild to profound hearing losses.

Before being fit with Tinnitus Balance, individuals presenting with tinnitus should be assessed by a licensed ear physician to confirm the source of their tinnitus is not due to any of the following medical conditions:

• Visible congenital or traumatic deformity of the ear

· Any active drainage from the ear within the previous 90 days

· Sudden hearing loss within the previous 90 days

· Acute or chronic dizziness

• Unilateral hearing loss of sudden or recent onset within the previous 90 days

• Pain or discomfort in the ear

The Tinnitus Balance software feature is a broadband noise generator embedded in the firmware of selected Phonak hearing aids. It provides a means of sound enrichment that can be used as part of a tinnitus management program to provide relief from tinnitus. By combining a broadband noise generator and hearing aid, the patient is able to wear a single device throughout the day for both tinnitus relief and amplification. The Tinnitus Balance software is enabled and fit by a licensed hearing healthcare professional together with the hearing aid's amplification to meet the individual needs of the patient.

The provided 510(k) summary for the Phonak Tinnitus Balance software feature lacks detailed performance study information, acceptance criteria, and specific data regarding ground truth establishment as typically found in comprehensive regulatory submissions. This device was cleared in 2013, and regulatory requirements and documentation standards have evolved significantly since then.

Based on the available document, here's what can be inferred:

Acceptance Criteria and Device Performance

The document does not explicitly state quantitative acceptance criteria or report specific device performance metrics in a readily quantifiable format. Instead, it relies on a comparison to predicate devices and a general statement of safety and effectiveness.

• Broadband noise generation.
• Embeddable in digital hearing aid platforms.
• Max output of generated noise limited to 85 dB(A) SPL.
• Volume adjustment capability.
• Spectral characteristics adjustable by HCP. | The document extensively compares its technical features to three predicate devices, highlighting commonalities and differences. |

Study Details

The document mentions "Performance Testing" and a "review of published scientific literature" but does not describe a specific clinical trial or study with detailed methodology as per modern standards.

1. Sample size used for the test set and the data provenance: Not specified. The document states "Performance Testing" was conducted and a "review of published scientific literature" was performed. This implies reliance on existing knowledge rather than a new clinical study with a defined test set.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified. Given the nature of a tinnitus masker, ground truth would typically relate to user perception of tinnitus relief, sound characteristics, and safety. There is no mention of experts establishing a ground truth for a test set.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable based on the provided information, as no formal test set with ground truth adjudication is described.

4. 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 device is a tinnitus masker, not an AI-assisted diagnostic tool that would involve "human readers" or image interpretation.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device is a standalone algorithm (software feature) embedded in a hearing aid, providing noise generation without requiring continuous human interaction during its operation for tinnitus relief. However, "standalone performance" in the context of typical AI medical device studies often refers to the algorithm's diagnostic accuracy without human input. For this device, the "standalone performance" would relate to its ability to generate the specified noise and integrate with the hearing aid's amplification, which is covered by general performance testing and comparison to predicates.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not explicitly stated. For a tinnitus masker, "ground truth" would likely be based on objective sound output measurements, subjective patient feedback regarding tinnitus perception and comfort, and the ability of the device to deliver the intended sound therapy within safe limits. The document only mentions "review of published scientific literature to confirm the safety and effectiveness."

7. The sample size for the training set: Not applicable. This device is a software feature implementing a broadband noise generator; it is not an AI/ML algorithm that requires a "training set" in the conventional sense. Its design is based on established principles of sound therapy for tinnitus.

8. How the ground truth for the training set was established: Not applicable, as there is no "training set."

In summary:

The 510(k) for the Phonak Tinnitus Balance software feature relies heavily on predicate device comparison and a general statement of safety and effectiveness based on risk analysis, verification/validation, and scientific literature review. It does not present a detailed prospective clinical study with specific acceptance criteria, test sets, ground truth establishment, or human reader performance metrics characteristic of advanced AI/ML device clearances. This is consistent with regulatory submissions for certain types of Class II medical devices, especially those cleared around 2013, which leverage substantial equivalence to existing technologies.

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