(88 days)
The indication for use of the air conduction hearing aids in this submission is to amplify weak sound and attenuate strong 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. Frequency: 1. High Frequency, 2. Gradually Sloping, 3. Reverse Slope, 4. Flat.
The following hearing aids are available in full concha, I.T.E., low profile, and half shells.
I am sorry, but the provided text does not contain the necessary information to answer your request. The document is an FDA 510(k) clearance letter for a line of hearing aids. It specifies regulatory details, indications for use, and severity categories for hearing loss that the devices address. However, it does not include any acceptance criteria, details of a study that proves the device meets acceptance criteria, sample sizes, ground truth establishment, expert qualifications, or information about AI involvement, which are all part of your request.
§ 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.