SIEMENS VITA 160 SERIES POCKET HEARING INSTRUMENT: VITA 162E,166M,168PP
Applicant
Siemens Hearing Instruments, Inc.
Product Code
ESD · Ear, Nose, Throat
Decision Date
Jul 25, 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
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.
Indications for Use
Indicated for patients with moderate to profound hearing loss requiring sound amplification via body-worn hearing aid.
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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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
