(84 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 hearing. The devices are indicated for individuals with losses in the following category(ies): Slight, Mild, Moderate, Severe. Configuration: High Frequency - Precipitously Sloping, Gradually Sloping, Reverse Slope, Flat. Other: Low tolerance To Loudness, Peak Clipping.
The device is an air conduction hearing aid. It is a prosthetic device worn in the ear canal to amplify sound. The shell is made using light cure materials and process. Various electronic components are utilized depending upon the type of circuitry needed.
The provided document is a 510(k) summary for a hearing aid device (K972039). It describes the device, its intended use, and states that it has been found substantially equivalent to existing devices. However, this document does not contain any information about acceptance criteria or a study proving the device meets those criteria.
510(k) summaries in the US FDA regulatory process generally focus on demonstrating substantial equivalence to a predicate device rather than comprehensive performance studies with specific acceptance criteria that would typically be found in a clinical trial report or a more detailed design validation document.
Therefore, for the input provided, I cannot fulfill your request to describe acceptance criteria and a study proving the device meets them because this information is not present in the document.
Based on the provided text, I can state that:
- Acceptance Criteria and Reported Device Performance: Not provided in the document.
- Sample size used for the test set and data provenance: Not provided in the document.
- Number of experts used to establish the ground truth for the test set and their qualifications: Not provided in the document.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not provided in the document.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. This type of study is not mentioned as this is a hearing aid, not an imaging device typically assessed with MRMC studies for AI.
- If a standalone performance (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a hearing aid, not an AI algorithm.
- The type of ground truth used: Not applicable. This is a hearing aid, not an AI algorithm requiring a ground truth for a diagnostic task.
- The sample size for the training set: Not applicable. This is a hearing aid, not an AI algorithm.
- How the ground truth for the training set was established: Not applicable. This is a hearing aid, not an AI algorithm.
Additional Information from the document:
- The device is a "Hidden CIC Hearing Aid" for individuals with mild to moderately severe hearing loss.
- It is described as technologically similar to other brands like Beltone, Miracle Ear, Siemens, and Oticon.
- The FDA found the device substantially equivalent to pre-amendment devices, allowing it to be marketed.
- The FDA also suggested considering electromagnetic compatibility testing in the future due to potential interference from digital cellular telephones and modifying labeling to inform users.
§ 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.