(29 days)
General Indications: A. 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: ✓ 1. Slight ✓ 2. Mild ✓ 3. Moderate ✓ 4. Severe Configuration: ✓ 1. High Frequency Precipitously Sloping ✓ 2. Gradually Sloping ✓ 3. Reverse Slope ✓ 4. Flat ✓ 5. Other Other: ✓ 1. Low tolerance to Loudness B. Specific Indications (Only if appropriate): (Most psychoacoustic indications such as improved speech intelligibility in background noise, must be supported by clinical data).
To amplify and transmit sound to the ear.
The provided text is a 510(k) summary for the Miracle-Ear Model DSF Hearing Aid. It declares the device substantially equivalent to a previously cleared device (Oticon Digifocus, K964683) and outlines its intended use and technical characteristics. However, it does not contain information about acceptance criteria, detailed device performance studies, sample sizes for testing or training, expert qualifications for ground truth, or adjudication methods.
The document from which the following information is extracted is a 510(k) summary, which often focuses on establishing substantial equivalence rather than detailing comprehensive clinical study results or performance against specific acceptance criteria. While it mentions the use of ANSI S3.22-1987 methodology for performance data, it doesn't present the data itself or define acceptance criteria for that data in this document.
Therefore, the following table and subsequent sections will indicate where the requested information is not provided in the given text.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Not explicitly stated in document) | Reported Device Performance (from document) |
|---|---|
| N/A (No specific acceptance criteria detailed) | Device Type: In-the-Ear (ITE) Hearing Aid |
| N/A | Classification: Air Conduction Hearing Aid (77ESD), Class I. |
| N/A | Intended Use: To amplify and transmit sound to the ear. |
| N/A | Substantially Equivalent to: Oticon Digifocus (cleared under 510(k) # K964683). |
| N/A | Technical Characteristics: Utilizes ANSI S3.22-1987 methodology to test and obtain performance data for hearing aids. (Specific data not provided here). |
| N/A | Fit: Mild to severe as dictated by the individual users audiogram. |
| N/A | Power: Zinc-Air size 13 hearing aid battery standard. Zinc-Air size 312 hearing aid battery is optional. |
| N/A | Indications for Use: Amplifies sound for individuals with impaired hearing across various severities (Slight, Mild, Moderate, Severe) and configurations (High Frequency, Gradually Sloping, Reverse Slope, Flat, Other) with low tolerance to loudness. |
Additional Information Not Provided in the Document:
Due to the nature of this 510(k) summary, specific details regarding performance studies, ground truth establishment, and sample sizes are not included.
2. Sample size used for the test set and the data provenance:
- Sample Size: Not provided.
- Data Provenance: Not provided. The document mentions using ANSI S3.22-1987 methodology for testing, which implies standardized acoustic measurements, but does not specify if human subjects and a test set were used, or where such data would originate.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as no specific test set or ground truth establishment by experts is detailed in this 510(k) summary. Performance data, according to the document, relies on the ANSI standard, which primarily involves objective acoustic measurements.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. No adjudication method is mentioned.
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:
- Not applicable. This is a hearing aid, not an AI-assisted diagnostic device, and no MRMC study information is provided.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a hearing aid, not an algorithm. Its performance is measured through its acoustic output and suitability for individuals.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not explicitly stated. For hearing aids tested per ANSI S3.22-1987, ground truth would typically relate to objective electroacoustic performance metrics (e.g., gain, output, frequency response, distortion) rather than clinical "ground truth" derived from expert consensus or pathology in the diagnostic sense. The "fit" based on "individual users audiogram" implies audiometric data is relevant.
8. The sample size for the training set:
- Not applicable. This device is a hardware product, not a machine learning algorithm requiring a training set.
9. How the ground truth for the training set was established:
- Not applicable. As above, this device does not involve a "training set" in the context of machine learning.
§ 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.