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The Lyric 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.

The Lyric Hearing Aid amplifies and delivers sounds via air conduction to the external ear of persons with hearing loss. The microphone transforms sound waves into electrical signals and delivers it to the hearing aid circuit, which is powered by the battery. The amplification characteristics are contained in digitally programmable memory and adjustment of device parameters is achieved through the proprietary HandFit™ Fitting System and Software.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Lyric Hearing Aid:

The provided document, a 510(k) summary for the Lyric Hearing Aid, is quite limited in the type of information typically found in a detailed performance study report. It primarily focuses on establishing substantial equivalence to predicate devices and states that the device meets internal specifications.

Here's an attempt to extract the requested information, with notes on what is not available in the given text:

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: Not specified. The document states "The devices met all applicable specifications," but does not provide details on how many devices were tested or how many users were involved in any performance evaluations.
• Data Provenance: Not specified. It's unclear if the testing was done internally at Insound Medical, by a third party, or if it involved human subjects. The type of study (retrospective or prospective) is also not mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Number of Experts: Not applicable or not specified. This type of information is typically relevant for studies using expert assessment as a ground truth, often clinical trials or image interpretation studies. For a hearing aid, performance is often measured objectively against standards.
• Qualifications of Experts: Not applicable or not specified.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Adjudication Method: Not applicable or not specified. Adjudication methods are typically used when multiple experts are determining a ground truth for qualitative assessments. The performance evaluation here appears to refer to objective measurements against a standard.

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

• MRMC Study: No. This is not an AI-assisted diagnostic device, so an MRMC study is not relevant to this submission. The device is a hearing aid.
• Effect Size: Not applicable.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Standalone Performance: Yes, implicitly. The performance evaluation against ANSI S3.22-2003 and Insound Medical's design specifications would be considered standalone performance testing of the device itself, separate from its use by an individual. However, the exact methodology is not detailed.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Type of Ground Truth: The "ground truth" for this device's performance is based on objective measurements against established engineering standards (ANSI S3.22-2003) and the manufacturer's own design input specifications. It is not based on expert consensus, pathology, or patient outcomes in the sense of a clinical trial proving efficacy for a disease. The efficacy of hearing aids in general for hearing loss is well-established, and this submission focuses on the device meeting performance requirements.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This device is a hardware product that amplifies sound; it does not involve machine learning algorithms that require a training set.

9. How the ground truth for the training set was established

• Ground Truth for Training Set: Not applicable. As there is no training set for an AI/ML algorithm.

Summary of Limitations in the Provided Document:

The provided 510(k) summary is very concise and primarily aims to establish substantial equivalence. It does not contain the detailed performance study information (e.g., number of subjects, detailed methodology, specific quantitative results) that would typically be found in a full study report or a more comprehensive technical summary for a device with complex clinical endpoints or AI components. The performance data section is brief, stating compliance with an industry standard and internal specifications, without elaborating on the specific tests, results, or conditions.

Ask a specific question about this device

This air conduction hearing instrument is intended to amplify sound pressure waves and transmit the signal to the external ear through the medium of air to compensate for hearing losses of mild to moderate degree.

Indications for use include persons with mild to moderate hearing impairment depending upon specific characteristics of the hearing loss and the patient's environmental situations.

The indication for use of the air conduction hearing aids in this file indication is to amplify sound for individuals with impaired hearing. The devices are indicated for individuals with losses in the following category(ies):
Severity: Slight, Mild, Moderate
Configuration: High Frequency - Precipitously Sloping, Gradually Sloping, Reverse Slope, Flat
Other: Low tolerance

The SONIC innovations Completely-in-the-Canal DSP Hearing Aid with Soft Shell is a programmable hearing aid with fully digital signal processing and full dynamic range multiband compression (multiplicative DSPTM) that allows independent adjustment of gain and compression characteristics within each frequency band from 250 to 8000 Hz. The SONIC innovations hearing aid provides database storage of patient information and hearing aid fitting parameters.

Assembled from standard hearing aid components mounted with custom microchips. The hearing aid soft shell is manufactured from biocompatible materials that have been used in other medical devices.

The Soft Shell is removable and/or replaceable, and can be cleared or replaced as needed. The shells are offered in a few basic sizes and selected by the hearing aid dispenser.

Except for the Soft Shell, the device is manufactured and delivered completely assembled to the hearing aid dispenser using materials and techniques widely used by other manufacturers of hearing devices.

Two versions of the Soft Shell are available, both made of biocompatible materials. The two versions of the shell are available in multiple sizes, the specific one being selected by the hearing aid dispenser as suitable for an individual patient.

The Soft Shell may be cleaned and/or replaced as needed by either the hearing aid dispenser or the individual patient.

The provided text for the Sonic Innovations CIC DSP Hearing Aid (K984518) does not contain any information about acceptance criteria or a study proving that the device meets such criteria.

The document is a 510(k) Premarket Notification summary that:

• Identifies the device.
• States its intended use and indications for use.
• Claims substantial equivalence to previously marketed devices.
• Lists technical characteristics in accordance with ANSI S3.22 1987.
• Describes the materials and features.

Crucially, it does not include any performance data, clinical trial results, or details of studies conducted to evaluate the device against specific performance benchmarks. The statement "Technical specifications are in accordance with ANSI S3.22 1987" implies compliance with a standard, but it doesn't provide the measured performance against that standard.

Therefore, I cannot fulfill your request for the tables and study details because the necessary information is not present in the provided text.

Ask a specific question about this device