(23 days)
A. General Indications: The indication for use of the air conduction hearing aids in this The indication for use of the individuals with impaired The devices are indicated for individuals with losses in hearing. nearing. The devices are indicated appropriate space(s)): Severity: 2. Mild, Configuration: 1. High Frequency - Precipitously Sloping, 3. Reverse Slope, 5. Other, Other: 1. Low tolerance To Loudness, 2., 3.
B. Specific Indications (Only if appropriate.): (Most psychoacoustic indications such as improved speech (Most psychoacouscic Indications back as supported by clinical data.) 1., 2., 3.
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This document is a 510(k) premarket notification from the FDA for a hearing aid, which approves the device based on its substantial equivalence to previously marketed devices. It does not contain a study describing acceptance criteria or device performance in the way requested.
Therefore, I cannot extract the information to complete the table and answer the specific questions about "acceptance criteria and the study that proves the device meets the acceptance criteria."
The document primarily focuses on:
- Regulatory approval: Stating that the Philips S1694, S1695 Body Worn Hearing Aids are substantially equivalent to devices marketed prior to May 28, 1976.
- General controls: Listing requirements like annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
- Electromagnetic interference (EMI): Warning about potential EMI from digital cellular telephones and encouraging labeling modifications, noting that claims of compatibility would require a new 510(k) submission with supporting data.
- Indications for Use: Specifying the general indications for use as "air conduction hearing aids" for individuals with "impaired hearing" and outlining the severity and configuration of hearing loss these devices are indicated for (slight, moderate, severe, profound range; gradually sloping, flat configurations).
To reiterate, there is no information about specific performance metrics, acceptance criteria, or a study demonstrating the device meets those criteria within this FDA letter.
§ 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.