(17 days)
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
| Acceptance Criteria | Reported Device Performance |
|---|---|
| General Category: Performance Characteristics | |
| Adherence to ANSI S3.22-2003 "Specification of Hearing Aid Characteristics" | "The performance characteristics of the Lyric Hearing Aid have been evaluated in accordance with ANSI S3.22-2003, 'Specification of Hearing Aid Characteristics.'" |
| Meeting applicable specifications developed by Insound Medical (design input specifications) | "The devices met all applicable specifications developed by Insound Medical in accordance with design input specifications." |
| Specific Criteria (Not explicitly stated in the document) | (No specific numerical or analytical criteria are provided, only a general statement of compliance.) |
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.
§ 874.3300 Air-conduction hearing aid.
(a)
Identification. An air-conduction hearing aid is a wearable sound-amplifying device intended to compensate for impaired hearing that conducts sound to the ear through the air. An air-conduction hearing aid is subject to the requirements in § 800.30 or § 801.422 of this chapter, as applicable. The air-conduction hearing aid generic type excludes the group hearing aid or group auditory trainer, master hearing aid, and the tinnitus masker, regulated under §§ 874.3320, 874.3330, and 874.3400, respectively.(b)
Classification. Class I (general controls). This device is exempt from premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 874.9.