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Found 7 results
510(k) Data Aggregation
K Number
K071462Device Name
UNITY 2 HIA & PROBE ( FOR USE WITH UNITY 2)
Manufacturer
SIEMENS HEARING INSTRUMENTS, INC.
Date Cleared
2007-06-05
(11 days)
Product Code
ETW
Regulation Number
874.3310Why did this record match?
Applicant Name (Manufacturer) :
SIEMENS HEARING INSTRUMENTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Unity 2 HIA and Probe are intended to be used as a system to: (1) perform Real Ear Measurement; (2) get an objective indication of the characteristics of a hearing aid; and (3) assist in the adjustment of hearing aids while in use by the patient. It is used by ENTprofessionals and in clinics for hearing aid fitting.
Device Description
Siemens Unity 2 HIA and Probe (for use with Siemens Unity 2 System)
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K Number
K011364Device Name
CUSTOM TCI (TINNITUS CONTROL INSTRUMENT)
Manufacturer
SIEMENS HEARING INSTRUMENTS, INC.
Date Cleared
2001-06-07
(34 days)
Product Code
KLW
Regulation Number
874.3400Why did this record match?
Applicant Name (Manufacturer) :
SIEMENS HEARING INSTRUMENTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K011366Device Name
CUSTOM TCI-COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION)
Manufacturer
SIEMENS HEARING INSTRUMENTS, INC.
Date Cleared
2001-06-01
(28 days)
Product Code
KLW
Regulation Number
874.3400Why did this record match?
Applicant Name (Manufacturer) :
SIEMENS HEARING INSTRUMENTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K003559Device Name
TCI (TINNITUS CONTROL INSTRUMENT)
Manufacturer
SIEMENS HEARING INSTRUMENTS, INC.
Date Cleared
2001-04-26
(160 days)
Product Code
KLW
Regulation Number
874.3400Why did this record match?
Applicant Name (Manufacturer) :
SIEMENS HEARING INSTRUMENTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K003558Device Name
TCI COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION)
Manufacturer
SIEMENS HEARING INSTRUMENTS, INC.
Date Cleared
2001-04-24
(158 days)
Product Code
ESD
Regulation Number
874.3300Why did this record match?
Applicant Name (Manufacturer) :
SIEMENS HEARING INSTRUMENTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K972998Device Name
PRISMA
Manufacturer
SIEMENS HEARING INSTRUMENTS, INC.
Date Cleared
1997-09-05
(24 days)
Product Code
ESD
Regulation Number
874.3300Why did this record match?
Applicant Name (Manufacturer) :
SIEMENS HEARING INSTRUMENTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A wearable sound-amplifying device that is intended to help compensate for impaired hearing. Sounds are electronically amplified and transmitted to the ear.
Device Description
PRISMA Behind the Ear and Custom Hearing Instruments are digitally programmable instruments. The dispenser programs the instrument using Siemens PC CONNEXX software with HiPro ™ hardware (K942749), Siemens Personal Programmer 2000, or UNITY with HiPro hardware This device is intended to compensate for a wide range of moderate to severe hearing losses including flat, ski-slope and reverse slope losses. It features digital control of a highly flexible digital signal processor. Up to 32 digitally adjustable parameters and two listening situations (memories) are accessible to shape and modify the instrument's response, depending on the model configuration. These include: Channel Delineation, Curvilinear Compression, Linear Compression, Syllabic Compression, Dual Compression, Voice Activity Detection System, Channel Gain, Cross Channel Shaping, Interchannel coupling, Twin Microphone System/Direction Mic, Low level Squelch, Second Program. Assembled from standard components that are widely utilized by other hearing aid manufacturers. Technical specifications comply with s3.22-1987 ANSI Specifications. The frequency response of the product is dictated by the individual Audiogram from each client and the settings of the programmable controls. User adjustable controls may be found on the Behind-the-Ear model which include a Microphone-Telecoil-Off (M-T-O) switch, and a momentary push-button switch to change between the two stored memories. Depending on the specific configuration of the instrument as ordered by the hearing instrument professional, some of these user controls may not be present. With the custom products, PRISMA comes standard with no user adjustable controls unless specifically requested by the hearing instrument professional, in which case a push button switch and/or directional microphone is available.
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K Number
K962170Device Name
SIEMENS VITA 160 SERIES POCKET HEARING INSTRUMENT: VITA 162E,166M,168PP
Manufacturer
SIEMENS HEARING INSTRUMENTS, INC.
Date Cleared
1996-07-25
(50 days)
Product Code
ESD
Regulation Number
874.3300Why did this record match?
Applicant Name (Manufacturer) :
SIEMENS HEARING INSTRUMENTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
To amplify and transmit sound to the ear. 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.
Device Description
Body (Pocket) Hearing Aid - Substantially equivalent to other Body worn (Pocket) hearing aids. 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). Assembled from standard components which are widely utilized by other hearing aid manufacturers. Technical specifications comply with S3.22-1987 ANSI Specifications. 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. User controls include an adjustable volume control wheel and an M-T-O 3 position toggle switch. Uses one standard AA Size battery.
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