PICCOLO K-AMP VC+, PICCOLO P-A1, PICCOLO P-AO AND PICCOLO ATC

K964451 · Rexton, Inc. · ESD · Nov 27, 1996 · Ear, Nose, Throat

Device Facts

• Record ID: K964451
• Device Name: PICCOLO K-AMP VC+, PICCOLO P-A1, PICCOLO P-AO AND PICCOLO ATC
• Applicant: Rexton, Inc.
• Product Code: ESD · Ear, Nose, Throat
• Decision Date: Nov 27, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.3300
• Device Class: Class 1
• Attributes: Therapeutic

Indications for Use

To amplify and transmit sound to the ear.

Device Story

Piccolo series (K-amp VC+, P-A1, ATC, P-AO) BTE hearing aids; compact housing compatible with glasses; utilizes standard hearing aid components; powered by size 13 battery. Features include AGC-I (Automatic Gain Control-Input), active low-frequency tone control, and 3-position switch (Off-Telecoil-Microphone). Operated by patient; frequency response adjusted by clinician based on individual audiogram. Benefits include improved battery life and reduced distortion via modern receiver technology.

Clinical Evidence

No clinical data; bench testing only per ANSI S3.22-1987 specifications.

Technological Characteristics

BTE hearing aid; standard components; size 13 battery; AGC-I; active low-frequency tone control; 3-position switch (Off-Telecoil-Microphone). Complies with ANSI S3.22-1987.

Indications for Use

Indicated for individuals with hearing impairment requiring sound amplification, with frequency response customized based on individual audiograms.

Regulatory Classification

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.

Submission Summary (Full Text)

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K964451

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 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.

**Assembly:** Assembled from standard components which are widely utilized by other hearing aid manufacturers.

**Technical Characteristics:** Technical specifications comply with S3.22-1987 ANSI Specifications. Preliminary data sheets for the Piccolo K-amp VC +, Piccolo P-A1, Piccolo ATC and the Piccolo P-AO are enclosed.

**Fit:** The frequency response of this product is dictated by the individual audiogram from each client.

**Power:** Standard hearing aid battery: size 13

A user’s manual and other information is supplied with each hearing aid (enclosed).

Rexton, inc. 510(k) submission; page 2