(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.
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NOV 27 1996
A SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION
| Name of Device: | Piccolo K-amp VC+, Piccolo P-A1, Piccolo ATC and Piccolo P-AO |
|---|---|
| Type of Device: | BTE Aid - Substantially equivalent to other BTE aids. |
| Intended Use: | To amplify and transmit sound to the ear. |
| Features: | The Piccolo series of BTE's are a small compact hearing aid. It has incorporated init's package a very slim housing that can be worn with glasses. The use of thenew modern and small receiver enables the integrated amplifier to have betterbattery life with less distortion.The aid also has AGC-I, active low frequencytone control and a three position, rotating switch for Off-Telecoil-Microphone. |
| Assembly: | Assembled from standard components which are widely utilized by otherhearing aid manufacturers. |
| TechnicalCharacteristics: | Technical specifications comply with S3.22-1987 ANSI Specifications.Preliminary data sheets for the Piccolo K-amp VC +, Piccolo P-A1, Piccolo ATCand the Piccolo P-AO are enclosed. |
| Fit: | The frequency response of this product is dictated by the individual audiogramfrom each client. |
| Power: | Standard hearing aid battery: size 13A user's manual and other information is supplied with each hearing aid (enclosed). |
§ 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.