← Product Code [ESD](/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ESD) · K962170

# SIEMENS VITA 160 SERIES POCKET HEARING INSTRUMENT: VITA 162E,166M,168PP (K962170)

_Siemens Hearing Instruments, Inc. · ESD · Jul 25, 1996 · Ear, Nose, Throat · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ESD/K962170

## Device Facts

- **Applicant:** Siemens Hearing Instruments, Inc.
- **Product Code:** [ESD](/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ESD.md)
- **Decision Date:** Jul 25, 1996
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 874.3300
- **Device Class:** Class 1
- **Review Panel:** Ear, Nose, Throat
- **Attributes:** Therapeutic

## Indications for Use

To amplify and transmit sound to the ear.

## Device Story

Body-worn pocket hearing aid; amplifies sound for moderate to profound hearing loss. Input: acoustic signals via microphone or audio input socket. Processing: analog amplification; user-adjustable volume; dispenser-adjustable tone (NH), gain, and output compression (AGC-O) controls. Output: amplified sound transmitted via electrical cable to non-custom earpiece. Used by patients; adjusted by hearing aid dispensers. Features telecoil with O-T-M switch. Power: AA battery. Benefits: improved auditory perception for hearing-impaired users.

## Clinical Evidence

Bench testing only; compliance with ANSI S3.22-1987 specifications.

## Technological Characteristics

Body-worn pocket form factor; standard electrical earphone cable; non-custom earpiece. Power: AA battery. Controls: volume wheel, M-T-O toggle, dispenser-adjustable tone (NH), gain, and output compression (AGC-O). Technical specifications comply with ANSI S3.22-1987.

## Regulatory 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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SIEMENS
K962170
JUL 25 1996

# A SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION

**Name of Device:** VITA 160 Series Pocket Hearing Instruments

**Type of Device:** Body (Pocket) Hearing Aid – Substantially equivalent to other Body worn (Pocket) hearing aids.

**Intended Use:** To amplify and transmit sound to the ear.

**Features:**
The VITA 160 Series Pocket Hearing Instruments (Models 162E, 166M and 168PP) are designed to provide amplification for a wide range of hearing losses, from moderate to profound. Sound is transmitted from the body-worn amplifier to a non-custom earpiece through a standard electrical earphone cable.

The VITA 162E and 166M medium power models both provide 132dB peak output and 65dB peak gain. They include a telecoil with O-T-M switch (Off-Telecoil-Microphone) and an Audio Input socket. The VITA 166M medium power model additionally provides two controls for the dispenser to adjust: Low Frequency Tone (NH) and Maximum Power Output (PC).

The VITA 168PP high power model provides 142dB peak output and 79dB peak gain. It includes a telecoil with O-T-M switch (Off-Telecoil-Microphone) and an Audio Input socket. Three controls are provided for the dispenser to adjust: Low Frequency Tone (NH), Gain and Output Compression (AGC-O).

**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.

**Fit:** The frequency response of the product is included. Some adjustments may be made by the dispenser to adjust the amplification to the audiogram of the patient.

**Controls:** User controls include an adjustable volume control wheel and an M-T-O 3 position toggle switch.

**Power:** Uses one standard AA Size battery.

A user’s manual and other information is supplied with each pocket aid.

Siemens Hearing Instruments 510(k) submission; page 8 of 17

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**Source:** [https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ESD/K962170](https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ESD/K962170)

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