(35 days)
- A. General Indications:
The intended use of this model hearing aid is to amplify sound pressure waves and transmit the signal to the external ear, through the medium of air, to compensate for impaired hearing. This device is indicated for individuals with losses in the following categories:
| Severity: | Configuration: | Other: |
|---|---|---|
| ___ 1. Slight | ___ 1. High Frequency |
- Precipitously Sloping | X 1. Low Tolerance
To Loudness |
| X 2. Mild | X 2. Gradually Sloping | 2. ___ |
| X 3. Moderate | ___ 3. Reverse Slope | 3. ___ |
| X 4. Severe | X 4. Flat | |
| ___ 5. Profound | ___ 5. Other | |
Not Found
The provided text is a 510(k) clearance letter from the FDA for a hearing aid device, the "Opus 2 - Full Concha Series - ITE." This document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.
Instead, it is a notification of substantial equivalence to a predicate device, allowing the manufacturer to market the product. It states the indications for use and general regulatory information.
Therefore, I cannot provide the requested information from the given text.
To be clear:
- There is no table of acceptance criteria or reported device performance in this document.
- There is no information about sample size, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, or ground truth establishment for a study in this document.
§ 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.