(29 days)
The indication for use of the air conduction hearing aids in this submission is to amplify sound for individuals with impaired hearing. The devices are indicated for individuals with losses in the following category(ies). (Check appropriate space(s)):
Severity: Slight, Mild, Moderate, Severe
Configuration: High Frequency Precipitously Sloping, Gradually Sloping, Reverse Slope, Flat, Other ski-sloping
Other: Low tolerance to Loudness, Compression Limiting, Loudness Growth Compensation
CIC, ITE and BTE Hearing Aids
The provided document describes a 510(k) submission for the "Miracle-Ear Programmable Sharp Dynamic Hearing Aids". However, it is a notification of intent to market a device and focuses on establishing substantial equivalence to a predicate device, rather than providing a detailed study that proves the device meets specific acceptance criteria through performance data.
Therefore, many of the requested items cannot be fully extracted from this document because it does not contain a study report with performance metrics, ground truth establishment, or sample sizes related to clinical validation.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document explicitly states that "Dahlberg utilizes the ANSI S3.22-1987 methodology to test and obtain performance data for hearing aids." This implies that the acceptance criteria are likely derived from or comply with the standards set forth in ANSI S3.22-1987. However, the specific acceptance criteria (e.g., maximum output, frequency response characteristics, total harmonic distortion limits) and the reported device performance against those criteria are not provided in this document. The table in Appendix B only lists technical characteristics and fit details, not specific performance metrics.
2. Sample size used for the test set and the data provenance:
- Sample Size (Test Set): Not specified in the provided document. The 510(k) summary focuses on substantial equivalence rather than a detailed clinical trial's test set.
- Data Provenance: Not specified in the provided document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
4. Adjudication method for the test set:
- Adjudication Method: Not specified.
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: Not applicable. This device is a hearing aid, not an AI-assisted diagnostic tool that would involve human "readers" or AI-driven improvements in diagnostic accuracy.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: Not applicable in the context of AI algorithms. This refers to the standalone performance of the hearing aid itself, which would be assessed against ANSI standards. The document states that the ANSI S3.22-1987 methodology is used to test performance, implying a standalone assessment of the device's electroacoustic characteristics. However, the results of this standalone testing are not provided.
7. The type of ground truth used:
- Type of Ground Truth: For hearing aids, "ground truth" typically refers to objective electroacoustic measurements against established performance standards (such as ANSI S3.22-1987). It also involves fitting parameters based on an individual's audiogram. Clinical efficacy might be assessed through user perception and audiological benefits, but comprehensive "ground truth" like pathology or outcomes data in the AI diagnostic sense is not relevant here. The clinical indications for use are based on the amplification of sound for individuals with impaired hearing, linked to audiogram severity and configuration (e.g., slight to severe hearing loss, high frequency sloping, gradually sloping, etc.).
8. The sample size for the training set:
- Sample Size (Training Set): Not applicable in the context of machine learning. This device does not appear to be an AI/ML driven device that requires a "training set."
9. How the ground truth for the training set was established:
- Ground Truth Establishment (Training Set): Not applicable, as there is no indication of an AI/ML training set.
Summary based on the document:
The document is a 510(k) premarket notification for a hearing aid, seeking substantial equivalence to a predicate device. It explicitly states that the device utilizes the ANSI S3.22-1987 methodology for performance testing. This standard would define the acceptance criteria and the methods for obtaining performance data. However, the actual performance data against these criteria is not included in this summary. The "Indications For Use" (Page 3) specify the types and severities of hearing loss the device is intended to address, but these are indications, not performance metrics or acceptance criteria per se.
In essence, the document serves as a regulatory clearance document based on substantial equivalence, rather than a detailed scientific study report demonstrating the device's performance against specific acceptance criteria.
§ 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.