(30 days)
A. General Indications: 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 5. Profound Configuration: 1. High Frequency - Precipitously Sloping 2. Gradually Sloping 3. Reverse Slope 4. Flat 5. Other Other 1. Low tolerance To Loudness 2. 3. B. Specific Indications (Only if appropriate.): (Most psychoacoustic indications such as improved speech intelligibility in background noise, must be supported by clinical data.) 1. 2. 3.
Not Found
The provided text is a 510(k) clearance letter from the FDA for two hearing aid devices, the Audiofon H20 PC and H32 PP. This document does not contain the information requested in the prompt regarding acceptance criteria, study data, or ground truth establishment.
The document primarily focuses on:
- FDA's determination of substantial equivalence: It states that the devices are substantially equivalent to pre-amendment devices, allowing them to be marketed.
- Regulatory classification and general controls: It outlines the regulatory class (Class I), applicable CFR parts, and requirements like annual registration, good manufacturing practices, and labeling.
- Indications for Use: It provides a general statement that the devices "amplify sound for individuals with impaired hearing" and allows the manufacturer to check specific severity and configuration categories of hearing loss for which the devices are indicated.
Therefore, I cannot extract the requested information from the provided text. The information typically sought for acceptance criteria and study details would be found within the 510(k) submission itself, often in a separate section detailing performance testing or clinical studies. This letter is the FDA's response to that submission, not the submission itself.
§ 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.