(21 days)
To amplify and transmit sound to the ear.
The Piccolo series of BTE's are a small compact hearing aid. It has incorporated in it's package a very slim housing that can be worn with glasses. The use of the new modern and small receiver enables the integrated amplifier to have better battery life with less distortion.The aid also has AGC-I, active low frequency tone control and a three position, rotating switch for Off-Telecoil-Microphone.
This document describes a hearing aid device, not an AI/ML powered medical device. Therefore, the requested information regarding acceptance criteria and study details for an AI/ML device is not applicable and cannot be extracted from the provided text.
§ 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.