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510(k) Data Aggregation
K Number
K970340Device Name
AIR CONDUCTION ASSISTIVE LISTENING DEVICE.PERSONAL AMPLIFIER
Manufacturer
BELLAB
Date Cleared
1997-03-26
(56 days)
Product Code
LZI
Regulation Number
874.3320Why did this record match?
Applicant Name (Manufacturer) :
BELLAB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
To assist in conversation, meetings and TV-listening by amplifying sound.
The indications for use of the assistive listening device in this submission is to amplify-sound for individuals with impaired-hearing. The device is indicated for individuals with hearing loss in the following category(ies).
Severity: Mild, Moderate
Configuration: Gradually Sloping, Flat
Device Description
Air Conduction Assistive Listening Device. Personal Amplifier.
Features: Adjustable volume control, Microphone/Telephone/Off switch, Gain, Treble and AGC adjustment trimmers, Internal/External microphone switch.
Assembly: Assembled from standard components widely used in electronic products.
Technical Characteristics: Technical specifications comply with ANSI S3.22-1987.
Controls: Volume control, Microphone/Telephone/Off switch, Internal/External microphone switch and sound adjustment trimmers similar to those used on other assistive listening devices/Personal amplifiers.
Power: Standard alkaline AAA (or LR03) size battery.
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